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Prior authorization and step therapy criteria — pharmacy & specialty drugs

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Lists drugs subject to prior authorization and step therapy for BCBSM Medicare Plus Blue Group PPO and Prescription Blue Group PDP (2026 plan year), including coverage requirements, prerequisite therapies, age/prescriber restrictions, and durations.

Policy Summary

Payerblue cross blue shield - michigan

PolicyPrior authorization and step therapy criteria — pharmacy & specialty drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2026

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required clinical documentation (e.g., diagnostic labs, prior therapy trials) because PA is required for listed drugs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2026plan year covered

387pages (partial)

multipleproducts in segment

1 YEARcommon duration

Coverage Criteria — Product-Level Rules

Adbry - Initial Therapy

Covered when ALL of the following are met:

Adbry initial coverage criteria: Patient is at least 12 years of age; diagnosis of moderate to severe atopic dermatitis; trial and treatment failure of one of: high‑potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil; product is not used in combination with another biologic or targeted DMARD indicated for the same condition; for patients <100 kg who achieve positive clinical response after 16 weeks, dosage limited to 300 mg every 4 weeks unless clinical rationale provided.

Coverage duration: 1 year; reauthorization requires documentation of positive clinical response.

Prerequisite therapy requirements

Selected product-specific prerequisite therapy/coverage rules:

Auvelity for MDD: Requires trial of bupropion and one other generic formulary antidepressant prior to coverage.

Coverage duration: LIFETIME.

Brivaracetam: Requires trial of levetiracetam and one other formulary generic anticonvulsant prior to coverage.

Coverage duration: 1 year.

Bosulif for accelerated/blast phase Ph+ CML: Requires prior therapy as specified in product entry prior to coverage.

Coverage duration: 1 year.

Cimzia — Initial therapy and indication-specific prerequisites

Cimzia covered when ALL of the following are met:

Cimzia general: Indication is a medically‑accepted indication; product not used in combination with another biologic or targeted DMARD for the same condition; coverage duration 1 year; reauthorization requires documentation of positive clinical response.

Rheumatoid arthritis prior therapy: For rheumatoid arthritis: diagnosis of moderately to severely active RA AND trial of two of: Enbrel, adalimumab biosimilars (adalimumab‑AATY or adalimumab‑ADBM), Rinvoq, Xeljanz/XR, Orencia.2 of list

Psoriatic arthritis prior therapy: For psoriatic arthritis: diagnosis of active PsA AND trial of two of: Cosentyx, Enbrel, adalimumab biosimilars, Rinvoq, Skyrizi, Wezlana/Yesintek, Xeljanz/XR, Orencia, Otezla.2 of list

Dupixent — Indication-specific coverage criteria

Dupixent covered when ALL of the following are met (indication-dependent):

Dupixent general: Indication is medically‑accepted; product is not used in combination with another biologic or targeted DMARD for the same condition; coverage duration 1 year; reauthorization requires documentation of positive clinical response; age and weight minimums apply for some indications.

Atopic dermatitis prerequisites: For atopic dermatitis (patients ≥2 years): diagnosis of moderate to severe AD AND trial and treatment failure of one of: high‑potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil.1 of list

Applies to patients ≥2 years.

Eosinophilic asthma prerequisites: For eosinophilic asthma: diagnosis with eosinophil count ≥150 cells/µL at initiation AND failure to maintain control after systemic corticosteroids or high‑dose inhaled corticosteroids plus trial of an additional controller (e.g., leukotriene modifier, LABA, or LAMA) for patients ≥12 years.eosinophils ≥150 cells/µL

COPD add‑on prerequisites: For add‑on maintenance in COPD: diagnosis of uncontrolled moderate to severe COPD AND eosinophil count ≥300 cells/µL AND current use of and plan to continue LABA, LAMA, and inhaled corticosteroid unless contraindicated.eosinophils ≥300 cells/µL

Cosentyx — Indication-specific coverage criteria

Cosentyx covered when ALL of the following are met:

Cosentyx general: Indication is medically‑accepted; product not used in combination with another biologic or targeted DMARD for the same condition; coverage duration 1 year; reauthorization requires documentation of positive clinical response.

AS/axSpA prerequisites: For ankylosing spondylitis and non‑radiographic axial spondyloarthritis: diagnosis required AND trial of one NSAID (e.g., diclofenac, ibuprofen, meloxicam, naproxen); non‑radiographic axSpA also requires objective signs of inflammation.1 NSAID trial

ERA prerequisites: For enthesitis‑related arthritis (ERA): diagnosis of active ERA AND trial of one NSAID.1 NSAID trial

Dalfampridine — MS walking impairment

Dalfampridine covered when ALL of the following are met:

Dalfampridine prerequisites: Indication is multiple sclerosis walking impairment; submission of baseline timed 25‑foot walk (T25FW) prior to initiation; patient is not wheelchair‑bound and does not become wheelchair‑bound; reauthorization requires documentation of stability or improvement on T25FW.

Coverage duration 1 year.

Diacomit — Anticonvulsant prerequisite

Diacomit covered when ALL of the following are met:

Diacomit prerequisites: Coverage requires trial of two generic anticonvulsants; for seizures associated with Dravet syndrome, requires combination use with clobazam.trial of 2 anticonvulsants

Coverage duration 1 year.

Copiktra — Prior therapy requirement

Copiktra covered when ALL of the following are met for relapsed/refractory CLL or SLL:

Copiktra prerequisites: Coverage requires trial of at least two prior therapies for relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).>=2 prior therapies

Coverage duration 1 year.

L-glutamine — Sickle cell

L‑glutamine covered when ALL of the following are met:

L‑glutamine prerequisites: Patient has experienced ≥2 sickle cell‑related crises in the past 12 months AND trial of or intolerance to hydroxyurea is documented.≥2 crises in 12 months

Coverage duration 1 year.

Eosinophilic asthma (Fasenra)

Covered when ALL of the following are met for eosinophilic asthma:

Eosinophilic asthma (general): Diagnosis of eosinophilic asthma; eosinophil count ≥150 cells/µL at initiation; failure to maintain control after systemic corticosteroids or high‑dose inhaled corticosteroids plus trial of one additional controller (leukotriene modifier, LABA, or LAMA).eosinophils ≥150 cells/µL

Reauthorization requires documentation of positive clinical response.

Eosinophilic granulomatosis with polyangiitis (EGPA)

Covered when ALL of the following are met for EGPA:

EGPA coverage: Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) with history or presence of asthma AND at least two characteristic features (examples: histopathologic eosinophilic vasculitis or perivascular eosinophilic infiltration/granulomatous inflammation; neuropathy; pulmonary infiltrates; allergic rhinitis/nasal polyps; cardiomyopathy; glomerulonephritis; alveolar hemorrhage; palpable purpura; ANCA positivity).2 features required

Reauthorization requires documentation of positive clinical response.

Rheumatoid arthritis

Covered when ALL of the following are met for rheumatoid arthritis:

Rheumatoid arthritis coverage: Diagnosis of moderately to severely active rheumatoid arthritis AND trial of one DMARD (e.g., methotrexate, leflunomide, sulfasalazine).trial of one DMARD

Cannot be used in combination with another biologic or targeted DMARD for the same condition; coverage duration 1 year.

Sickle cell disease (L-glutamine)

Covered when ALL of the following are met for L‑glutamine:

L‑glutamine coverage: Patient has experienced ≥2 sickle cell‑related crises in the past 12 months AND trial of or intolerance to hydroxyurea is documented.≥2 crises in 12 months

Coverage duration 1 year.

Seizure disorders (Epidiolex)

Covered when ALL of the following are met for Epidiolex:

Epidiolex seizure indications: For Lennox‑Gastaut syndrome and tuberous sclerosis complex: trial of two generic alternatives for seizure treatment required; for Dravet syndrome: trial of two of valproic acid, clobazam, or topiramate.2 alternatives or specified agents

Coverage duration 1 year.

Schizophrenia (selected products)

Covered when ALL of the following are met for schizophrenia:

Schizophrenia coverage: Diagnosis of schizophrenia AND trial of two generic formulary atypical antipsychotics (e.g., aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone).trial of two agents

Coverage duration: LIFETIME.

Severe osteoporosis

Covered when ALL of the following are met for specified osteoporosis agent:

Severe osteoporosis criteria: Documentation of bone mineral density with T‑score ≤ ‑2.5 AND trial of listed agents (Jubbonti or Stoboclo) AND trial of an oral bisphosphonate or, if intolerant, an IV bisphosphonate (coverage also allowed if patient unable to be treated with these agents).T‑score ≤ -2.5

Coverage duration: 2 years.

Short bowel syndrome (Gattex)

Covered when ALL of the following are met for Gattex:

Gattex coverage: Documentation of dependence on parenteral support for ≥ 12 months.≥12 months

Coverage duration: 1 year.

Type 2 diabetes mellitus (GLP-1 agents)

Covered when ALL of the following are met for GLP‑1 agonists/related agents for T2DM:

T2DM coverage: Submission of medical records confirming diagnosis of type 2 diabetes mellitus OR laboratory evidence (A1C ≥ 6.5% OR fasting plasma glucose ≥ 126 mg/dL OR 2‑hour plasma glucose ≥ 200 mg/dL during OGTT); excluded if used solely for weight loss.diagnostic labs or records

Coverage duration: 1 year.

T2DM product coverage rules

Covered when documentation and indications meet product‑specific criteria:

T2DM product documentation: Submission of medical records confirming diagnosis of T2DM OR lab evidence (A1c ≥6.5% OR FPG ≥126 mg/dL OR 2‑hour PG ≥200 mg/dL) is required; exclude use for weight‑loss only.as stated

Coverage duration: 1 year.

Biologic and targeted DMARDs

Covered when ALL of the following are met for indication‑specific biologic therapies:

General biologic/targeted DMARD criteria: Diagnosis specific to the indication (e.g., moderately to severely active RA, active polyarticular JIA, active PsA, moderate‑to‑severe plaque psoriasis, active AS, Crohn's disease, UC, HS, non‑infectious uveitis). Trial of indicated prior therapy required (e.g., one DMARD for RA; NSAID for AS). Reauthorization requires documentation of positive clinical response. Product not used in combination with another biologic/targeted DMARD for same condition.as stated

Coverage duration: typically 1 year.

Activated PI3K delta syndrome (APDS)

Coverage for activated PI3K delta syndrome (APDS) requires ALL of the following:

APDS criteria: 1) Diagnosis of APDS with an associated PI3Kd mutation; 2) documented variant in PIK3CD or PIK3R1; 3) documented APDS‑related clinical manifestations such as nodal/extranodal lymphoproliferation, recurrent oto‑sino‑pulmonary infections, or organ dysfunction (e.g., lung, liver).genetic testing and clinical features required

Cannot be used in combination with an immunosuppressive medication for the APDS indication.

Prerequisite therapy requirements (selected)

Coverage requires prior trial of specified therapies for certain products:

Topical metronidazole/ oral tetracycline sequence: For indicated dermatologic conditions (e.g., ivermectin cream for rosacea): trial of topical metronidazole AND one of oral tetracycline, doxycycline, or minocycline is required.trial documented

Kerendia (CKD/T2DM) prerequisite: For CKD associated with T2DM (or HF with LVEF ≥40% where applicable), trial of an SGLT2 inhibitor (e.g., empagliflozin or dapagliflozin) is required unless contraindicated or intolerant.trial documented or contraindication noted

General product-level coverage

Products in this excerpt are covered with specified prior authorization criteria and coverage durations when the listed prerequisite therapy and additional product‑specific requirements are met.

General product‑level coverage: Coverage durations typically 1 year; prerequisite Part D drug trials required for many products as specified per product; see product‑level entries for specifics.

Liraglutide coverage criteria

Liraglutide-specific criteria:

Liraglutide for T2DM: Excluded if used solely for weight loss. For ongoing treatment of type 2 diabetes mellitus, submit medical records confirming diagnosis OR laboratory evidence (A1c ≥6.5% OR FPG ≥126 mg/dL OR 2‑hour PG ≥200 mg/dL during OGTT).A1c ≥6.5% / FPG ≥126 mg/dL / 2‑hour PG ≥200 mg/dL

Coverage duration 1 year.

Breast cancer combination therapy

Products requiring combination endocrine therapy for HR‑positive breast cancer:

Breast cancer combination requirement: Coverage requires combination use with an aromatase inhibitor or fulvestrant as initial endocrine‑based therapy or following progression on endocrine therapy; see product entry for exact context.

Coverage duration: 1 year.

Mekinist (tablet) — coverage conditions

Covered when ALL of the following are met

Mekinist (tablet) general: Medically‑accepted indication; coverage duration 1 year; for specified indications BRAF V600E or V600K mutation detected by an FDA‑approved test is required.

Melanoma prerequisite therapy: For unresectable or metastatic melanoma with BRAF V600E or V600K mutation requires prior trial of vemurafenib (Zelboraf) and cobimetinib (Cotellic) used in combination; many indications require combination use with dabrafenib.

Combination requirement: For specified indications (melanoma, NSCLC BRAF V600E, ATC, certain solid tumors, low‑grade glioma) coverage requires combination use with dabrafenib.

Mekinist (liquid SOLR) — coverage conditions

Covered when ALL of the following are met

Mekinist SOLR — swallowing impairment: Patient is unable to swallow the tablet formulation.

Mekinist SOLR — mutation and prior therapy: Same BRAF mutation requirement and prior trial of vemurafenib + cobimetinib and combination with dabrafenib requirements as for the tablet formulation.

Coverage duration 1 year.

Mektovi — coverage conditions

Covered when ALL of the following are met

Mektovi general: Medically‑accepted indication; coverage duration 1 year.

Mektovi — melanoma prior therapy: For unresectable or metastatic melanoma with BRAF V600E or V600K mutation requires prior trial of vemurafenib + cobimetinib used in combination.

Mektovi — combination requirement: Coverage for melanoma and for NSCLC with BRAF V600E requires combination use with encorafenib.

Nucala — indication-specific coverage

Covered when ALL of the following per indication are met

Nucala — indications: Indications include eosinophilic asthma (EA), EGPA, HES, chronic rhinosinusitis with nasal polyposis (CRSwNP), and add‑on maintenance treatment of COPD as specified.

Coverage duration 1 year; cannot be combined with another biologic/targeted DMARD for same condition.

Nucala — EA criteria: Diagnosis of eosinophilic asthma with eosinophil count ≥150 cells/µL at initiation AND failure to maintain adequate control after systemic corticosteroids or high‑dose ICS plus trial of one additional controller (leukotriene modifier, LABA, or LAMA) for patients ≥12 years.>=150 cells/µL

Nucala — EGPA criteria: Diagnosis of EGPA AND at least two typical EGPA features (e.g., histopathologic eosinophilic vasculitis, neuropathy, pulmonary infiltrates, nasal polyps, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, ANCA positivity).2 features required

Nucala — HES criteria: Diagnosis of HES AND eosinophil count ≥1000 cells/µL at initiation AND stability on HES therapy (oral corticosteroids, immunosuppressives, or cytotoxic therapy).>=1000 cells/µL

Nucala — CRSwNP criteria: Diagnosis of CRSwNP AND recurring polyps despite prior intranasal corticosteroid therapy (e.g., fluticasone, mometasone).

Nucala — COPD criteria: Diagnosis of uncontrolled moderate to severe COPD AND either current eosinophil ≥150 cells/µL OR eosinophil ≥300 cells/µL within past 12 months AND current use (and plan to continue) of LABA, LAMA, and inhaled corticosteroid unless contraindicated.>=150 cells/µL or historical >=300 cells/µL

Age-restricted prior authorization (example)

Age‑restricted prior authorization: Prior authorization applies only to patients less than 30 years of age for the specified product entry.<30 years

Coverage duration 1 year.

Migraine — triptan prerequisite

Acute migraine treatment:

Migraine acute treatment: Coverage for acute migraine headaches requires trial of at least two generic triptans (e.g., sumatriptan and rizatriptan) unless triptan therapy is contraindicated, not tolerated, or clinically inappropriate.trial of two triptans

Coverage duration 1 year.

Opfolda — diagnostic and prior ERT requirements

Opfolda (Pompe disease) coverage:

Opfolda diagnostic and prior ERT: Confirmation of diagnosis by decreased acid alpha‑glucosidase activity on serum assay and genetic testing showing a GAA mutation; presence of symptomatic manifestations (eg progressive muscle weakness, respiratory failure, frequent upper airway infections, orthopnea, sleep apnea, morning headaches); no improvement on current enzyme replacement therapy (ERT).diagnostic testing

Coverage duration 1 year.

Posaconazole DR — criteria

Posaconazole DR — prophylaxis and treatment of invasive fungal infections:

Prophylaxis eligibility: Used as prophylaxis for invasive fungal infections (Aspergillus or Candida) in high‑risk conditions (HSCT with GVHD, hematologic malignancies with prolonged neutropenia) or for secondary prophylaxis after prior fungal infection; prophylaxis also requires trial with two of: fluconazole, itraconazole, or voriconazole.trial with two azoles

Coverage duration 6 months for prophylaxis.

Treatment eligibility: Used as treatment for invasive fungal infections caused by Aspergillus and Candida; treatment also requires trial with two of listed azoles.trial with two azoles

Praluent — initiation and reauth

Praluent (alirocumab) initiation and reauthorization criteria:

Praluent initiation: Initiation requires confirmation of HeFH/HoFH or ASCVD/primary hyperlipidemia as appropriate; LDL while on a high‑intensity statin within last 120 days must meet thresholds (≥55 mg/dL with ASCVD; >70 mg/dL without ASCVD) and at least 12 weeks of high‑intensity statin therapy unless statin intolerance documented.LDL thresholds on high‑intensity statin

Coverage duration: 3 years for reauthorization context.

Praluent reauthorization: Patient continues background lipid‑lowering therapy and has demonstrated LDL reduction while on Praluent.documented LDL reduction

Pomalidomide — prior therapy requirement

Pomalidomide coverage for multiple myeloma:

Pomalidomide prior therapy: Requires at least two prior therapies including lenalidomide and a proteasome inhibitor, with disease progression on or within 60 days of last therapy; must be used in combination with dexamethasone.>=2 prior therapies

Reauthorization requires continued benefit.

Prevymis — CMV prophylaxis

Prevymis coverage when ALL of the following are met:

Prevymis CMV prophylaxis: Recipient is a CMV‑seropositive allogeneic HSCT recipient OR a kidney transplant recipient at high risk (donor CMV‑seropositive/recipient CMV‑seronegative D+/R-).

Coverage duration 1 year; applies to Prevymis PACK and TABS.

Retevmo — RET-altered cancers

Retevmo coverage when ALL of the following are met:

Retevmo RET alteration: Patient has locally advanced or metastatic NSCLC with RET fusion, or medullary thyroid cancer (MTC) with RET mutation, or advanced/metastatic thyroid cancer with RET fusion, or locally advanced/metastatic solid tumors with RET fusion; RET alteration detected by an FDA‑approved test. Some indications require prior therapy such as radioactive iodine for thyroid when appropriate or prior systemic therapy for RET‑fusion solid tumors.RET fusion or mutation by FDA‑approved test

Coverage duration 1 year.

Eltrombopag — platelet disorders

Eltrombopag covered when ALL of the following are met:

Eltrombopag indications: For persistent or chronic ITP: baseline platelet count <30,000/µL AND trial of corticosteroids, IVIG, or splenectomy; for thrombocytopenia with chronic hepatitis C: baseline platelet count <75,000/µL; for severe aplastic anemia: baseline platelet count <30,000/µL.baseline platelet thresholds per indication

Coverage duration 1 year; prerequisite Part D drug required.

NASH/MASH — fibrosis and semaglutide trial

NASH/MASH drug coverage when ALL of the following are met:

NASH/MASH fibrosis requirement: Diagnosis of noncirrhotic NASH or MASH with advanced liver fibrosis (stage F2–F3) verified by FibroScan or other imaging‑based noninvasive assessment AND trial of semaglutide prior to authorization.fibrosis stage F2–F3

Renewal requires no progression to cirrhosis and demonstration of response or clinical benefit as specified; coverage duration 1 year.

Rinvoq — multiple immune-mediated indications

Rinvoq covered when ALL of the following are met:

Rinvoq general: Indication‑specific diagnosis (eg moderately to severely active RA, active PsA, AS, moderately to severely active UC, CD, nonradiographic axSpA, atopic dermatitis, GCA) AND required prior trials per indication (DMARDs for RA, NSAID for AS/axSpA; for several indications trial/failure or intolerance to TNF inhibitors is required); cannot be used in combination with a potent immunosuppressant (eg azathioprine, cyclosporine) or with another biologic/targeted DMARD for the same condition.as stated

Coverage duration 1 year; reauthorization requires documentation of positive clinical response and confirmation patient is not on a potent immunosuppressant.

Tolvaptan — liver safety and conservative therapy trial

Tolvaptan covered when ALL of the following are met:

Tolvaptan criteria: Documentation that the patient does not have underlying liver disease AND trial of at least two of: furosemide, demeclocycline, or fluid restriction prior to authorization.trial of ≥2 conservative measures

Coverage duration 1 month; prerequisite Part D drug required.

Rezurock — chronic GVHD

Rezurock coverage when ALL of the following are met:

Rezurock chronic GVHD: Patient is ≥12 years with chronic graft‑versus‑host disease AND trial and failure of at least two prior lines of systemic therapy.≥2 prior systemic therapy lines

Coverage duration 1 year.

Initial product — medically-accepted indications with specified prerequisites

Covered when ALL of the following are met for the unnamed initial product entry:

Initial product criteria: Documentation that the patient does not have underlying liver disease; trial of at least two of furosemide, demeclocycline, or fluid restriction; prerequisite Part D drug use as specified.trial of ≥2 measures

Coverage duration 1 month.

Simponi — indication-specific criteria

Covered when ALL of the following are met for Simponi:

Simponi — RA: Diagnosis of moderately to severely active rheumatoid arthritis AND trial of two of: Enbrel, adalimumab‑AATY or adalimumab‑ADBM, Rinvoq, Xeljanz/XR, Orencia AND combination use with methotrexate.trial of two agents

Reauthorization requires documentation of positive clinical response; coverage duration 1 year.

Simponi — PsA: Diagnosis of active psoriatic arthritis AND trial of two of: Cosentyx, Enbrel, adalimumab variants, Rinvoq, Skyrizi, Wezlana/Yesintek, Xeljanz/XR, Orencia, Otezla.trial of two agents

Reauthorization requires documentation of positive clinical response.

Stelara — indication-specific criteria

Covered when ALL of the following are met for Stelara (ustekinumab / Wezlana / Yesintek):

Stelara general: Diagnosis consistent with the indicated disease (active PsA, moderate to severe plaque psoriasis, moderately to severely active Crohn's disease, or moderately to severely active UC); product not used in combination with another biologic or targeted DMARD for the same condition; reauthorization requires documentation of positive clinical response.

Coverage duration 1 year.

Tafinlar — mutation and combination requirements

Covered when ALL of the following are met for Tafinlar (and liquid formulation):

Tafinlar criteria: For unresectable or metastatic melanoma with BRAF V600E or V600K mutation requires prior trial of vemurafenib and cobimetinib used in combination; for multiple indications Tafinlar must be used in combination with trametinib; liquid form coverage requires inability to swallow capsule formulation.

Coverage duration 1 year.

Tagrisso — indication-specific criteria

Covered when ALL of the following are met for Tagrisso:

Tagrisso NSCLC EGFR criteria: Coverage for EGFR exon 19 deletion or exon 21 L858R mutation‑positive NSCLC for adjuvant therapy after resection, first‑line in metastatic disease, or first‑line in locally advanced/metastatic disease in combination with pemetrexed and platinum‑based chemotherapy; EGFR T790M‑positive NSCLC requires progression on or after EGFR TKI therapy; other specified indications per product entry.

Coverage duration 1 year.

Product-specific initial coverage criteria

Covered when product‑specific conditions and any required prior/concomitant therapies or documentation are met (see each product entry).

Talzenna: Coverage for metastatic castration‑resistant prostate cancer requires use in combination with enzalutamide.

Coverage duration 1 year.

Erlotinib: For NSCLC, requires concurrent treatment with first‑line/maintenance/second+ line therapy after progression following at least one prior chemotherapy regimen; pancreatic cancer requires combination with gemcitabine; prescriber must be an oncologist.

Coverage duration 1 year.

Bexarotene: Capsule for cutaneous T‑cell lymphoma requires refractory disease to at least one prior systemic therapy; gel requires refractory/persistent after or intolerant of other therapies; prescriber: dermatologist or oncologist.

Coverage duration 1 year.

Nilotinib: Adults with CML‑CP not newly diagnosed and AP Ph+ CML require prior therapy that included imatinib; pediatric Ph+ CML‑CP and CML‑AP require prior TKI therapy.

Coverage duration 1 year.

Tazverik: EZH2 mutation‑positive follicular lymphoma requires prior treatment with at least two systemic therapies.

Coverage duration 1 year.

Tetrabenazine: Not covered in hepatic impairment, active suicidality or untreated/inadequately treated depression, or with MAO inhibitors or reserpine; CYP2D6 genotype documentation required for doses >50 mg/day.

Coverage duration 1 year.

Thalomid: Multiple myeloma coverage requires use in combination with dexamethasone; ENL with moderate‑to‑severe neuritis requires combination therapy.

Coverage duration 1 year.

Tibsovo: Coverage for cholangiocarcinoma requires previous treatment.

Coverage duration 1 year.

Tivdak: Recurrent or metastatic cervical cancer requires disease progression on or after chemotherapy.

Coverage duration 1 year.

Actemra: RA coverage requires diagnosis of moderately to severely active RA and trial of two listed agents; polyarticular JIA requires trial of two listed agents; systemic JIA requires trial of NSAID, systemic glucocorticoid, or methotrexate.

Reauthorization requires documentation of positive clinical response; coverage 1 year.

Trodelvy: For unresectable locally advanced/metastatic TNBC requires prior use of ≥2 systemic therapies with at least one for metastatic disease; for HR+/HER2‑ requires prior endocrine therapy and ≥2 additional systemic therapies in metastatic setting.

Coverage duration 1 year.

Truqap: HR+/HER2‑ advanced/metastatic breast cancer with PIK3CA/AKT1/PTEN alterations requires progression on ≥1 endocrine‑based regimen or recurrence within 12 months of adjuvant therapy and combination use with fulvestrant.

Coverage duration 1 year.

Tukysa: Advanced unresectable/metastatic HER2+ breast cancer requires trial of ≥1 prior anti‑HER2 regimen and combination with trastuzumab and capecitabine; RAS WT HER2+ metastatic CRC requires prior fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy and combination with trastuzumab.

Coverage duration 1 year.

Tymlos: Requires documentation of BMD T‑score ≤ ‑2.5 AND trial of Jubbonti or Stoboclo and an oral bisphosphonate (or IV if intolerant).T‑score ≤ -2.5

Coverage duration 2 years.

Ubrelvy: Acute migraine treatment requires trial of ≥2 generic triptans unless contraindicated or not tolerated.trial of two triptans

Coverage duration 1 year.

Vanflyta: For newly diagnosed AML FLT3‑ITD positive requires use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation.

Coverage duration 1 year.

Venclexta: Newly diagnosed AML in adults ≥75 years or with comorbidities precluding intensive therapy requires combination with azacitidine, decitabine, or low‑dose cytarabine.

Coverage duration 1 year.

Veozah: Moderate‑to‑severe vasomotor symptoms due to menopause requires trial, failure, contraindication or intolerance to one preferred or generic medication for VMS.

Coverage duration 1 year.

Verquvo: Requires NYHA class II–IV AND LVEF <45% AND either prior HF hospitalization in prior 6 months OR outpatient IV diuretic in prior 3 months; must be taken with at least two background HF therapies (beta‑blocker, ACE/ARB/ARNI, SGLT2 approved for HF, mineralocorticoid) unless contraindicated.LVEF <45%

Coverage duration 1 year.

Heart failure coverage criteria (product-specific)

Covered when ALL of the following are met for the heart‑failure‑related product(s):

Heart failure initial criteria: Diagnosis of chronic heart failure NYHA class II–IV AND left ventricular ejection fraction (LVEF) <45%.LVEF <45%

Additional qualifying event: Either previous hospitalization for heart failure within prior 6 months OR outpatient intravenous diuretic treatment for heart failure within prior 3 months.

Background heart failure therapy: Must be taken in combination with at least two of: (1) metoprolol succinate, carvedilol, or bisoprolol; (2) an ACE‑inhibitor or ARB or ARNI; (3) an SGLT2 inhibitor approved for heart failure; (4) a mineralocorticoid receptor antagonist, unless contraindicated or not tolerated.

H. pylori treatment coverage

Covered when ALL of the following are met for H. pylori therapy products:

H. pylori diagnosis: Documentation of Helicobacter pylori infection.

Prior therapy requirement: Trial of a guideline‑recommended generic first‑line regimen such as clarithromycin triple therapy (PPI + clarithromycin + amoxicillin or metronidazole) OR bismuth quadruple therapy (PPI + bismuth + tetracycline + metronidazole).

PNH EVH coverage criteria

Covered when ALL of the following are met for treatment of EVH in PNH:

PNH EVH diagnosis: Clinically significant extravascular hemolysis (EVH) due to paroxysmal nocturnal hemoglobinuria (PNH).

Laboratory thresholds: Hemoglobin ≤ 9.5 g/dL AND absolute reticulocyte count ≥ 120 × 10^9/L.Hgb ≤ 9.5 g/dL; retic ≥ 120 ×10^9/L

Combination therapy: Must be used in combination with Soliris or Ultomiris only.

Coverage duration 1 year.

Demodex blepharitis coverage

Covered when ALL of the following are met for demodex blepharitis product:

Demodex blepharitis diagnosis: Confirmation of demodex blepharitis via presence of collarettes on slit‑lamp examination.

Coverage duration 1 year.

Xolair coverage criteria

Covered when ALL of the following are met for Xolair by indication:

Xolair — allergic asthma: IgE level >30 and <700 IU/mL for ages ≥12 (age‑adjusted ranges apply for younger ages) AND positive skin test or in‑vitro reactivity to a perennial aeroallergen AND failure to maintain control after systemic corticosteroids or high‑dose inhaled corticosteroids plus trial of one additional controller (leukotriene modifier, LABA, or LAMA).IgE thresholds per age

Coverage duration 1 year.

Xolair — CSU: Diagnosis of chronic spontaneous urticaria with symptoms despite H1 antihistamine treatment AND trial of at least one second‑generation antihistamine.

Reauthorization requires documentation of positive clinical response.

Xolair — CRSwNP: Diagnosis of chronic rhinosinusitis with nasal polyposis with recurring polyps despite intranasal corticosteroid therapy.

Reauthorization requires documentation of positive clinical response.

Verzenio coverage criteria

Covered when ALL of the following are met for Verzenio:

Verzenio — adjuvant high‑risk EBC: Adjuvant treatment of HR‑positive, HER2‑negative, node‑positive early breast cancer at high risk of recurrence requires combination use with tamoxifen or an aromatase inhibitor.

Verzenio — advanced/metastatic initial therapy: HR‑positive, HER2‑negative advanced or metastatic breast cancer requires combination with an aromatase inhibitor as initial endocrine‑based therapy.

Verzenio — progression after endocrine therapy: Advanced/metastatic disease with progression following endocrine therapy requires combination use with fulvestrant.

Verzenio — monotherapy advanced disease: Monotherapy for advanced/metastatic HR‑positive, HER2‑negative cancer with progression requires prior endocrine and chemotherapy in the metastatic setting.

PAH prior therapy criteria

Covered when ALL of the following are met for pulmonary arterial hypertension (Winrevair):

PAH prior therapy: Requires a trial of both a generic PDE5 inhibitor (sildenafil or tadalafil) AND a generic endothelin receptor antagonist (bosentan or ambrisentan).

Coverage duration 1 year.

Xolair initial and reauthorization criteria

Covered when ALL of the following are met (example: Xolair for CSU and CRSwNP):

Xolair — CSU initial: Symptoms despite H1 antihistamine treatment AND trial of at least one second‑generation antihistamine.

Reauthorization requires documentation of positive clinical response.

Xolair — CRSwNP initial: Diagnosis of CRSwNP AND recurring disease despite intranasal corticosteroids (e.g., fluticasone, mometasone).

Reauthorization requires documentation of positive clinical response.

Zilbrysq (myasthenia gravis) criteria

Covered when ALL of the following are met for Zilbrysq in myasthenia gravis:

Zilbrysq — diagnostic confirmation: Patient is anti‑AChR antibody positive (lab record or chart notes) AND one confirmatory test: positive edrophonium test OR history of clinical response to oral cholinesterase inhibitors OR electrophysiologic evidence (RNS or SFEMG).

Zilbrysq — prior therapy: Previous treatment courses of at least 12 weeks with one of: methotrexate, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, or tacrolimus, unless all are contraindicated or not tolerated; patient must be currently receiving and will continue a stable regimen.

Coverage duration 1 year.

Xpovio coverage criteria

Coverage for select oncology agents (example: Xpovio) when ALL are met:

Xpovio — multiple myeloma: Adult patients with multiple myeloma: failure of one prior therapy; for relapsed/refractory multiple myeloma requires trial of at least four prior therapies including failures of specified drug classes (proteasome inhibitors, immunomodulatory agents, anti‑CD38 antibody).

Coverage duration 1 year.

Xpovio — DLBCL: Relapsed or refractory diffuse large B‑cell lymphoma requires trial of at least two lines of systemic therapy.

Oxcarbazepine ER criteria

Oxcarbazepine ER TB24 coverage:

Oxcarbazepine ER initial: Requires trial or documented intolerance to at least two generic anticonvulsants prior to approval.trial of ≥2 anticonvulsants

Coverage duration: LIFETIME.

Abilify products criteria

Abilify formulations coverage:

Abilify Asimtufii: Requires trial of oral aripiprazole prior to coverage.trial of oral aripiprazole

Coverage duration: LIFETIME.

Abilify Maintena: Requires trial of oral aripiprazole prior to coverage.trial of oral aripiprazole

Coverage duration: LIFETIME.

Oxcarbazepine ER - Initial

Covered when ALL of the following are met:

Oxcarbazepine ER - Initial: Requires trial or intolerance to at least two generic anticonvulsants prior to initiation.2 trials

Coverage duration: LIFETIME.

Desvenlafaxine / Trintellix / Exxua - Initial

Covered when ALL of the following are met:

Desvenlafaxine / Trintellix / Exxua initiation: Requires trial of at least two listed generic antidepressants (examples enumerated in product entry) prior to coverage.2 trials from list

Coverage duration: LIFETIME.

Caplyta / Rexulti / Vraylar / Zyprexa Relprevv - Initial

Covered when ALL of the following are met:

Atypical antipsychotics initial: Requires trial of at least one listed generic antipsychotic (examples enumerated in product entry) prior to coverage.1 trial from list

Coverage duration: LIFETIME.

Apidra - Initial

Covered when ALL of the following are met:

Apidra initiation: Requires trial or documented intolerance to NovoLog 70/30 or NovoLog prior to coverage.trial or intolerance documented

Coverage duration: LIFETIME.

Aristada / Aristada Initio - Initial

Covered when ALL of the following are met:

Aristada: Requires trial or intolerance to Abilify Maintena or oral aripiprazole prior to coverage.trial or intolerance documented

Coverage duration: LIFETIME.

Aristada Initio: Requires trial of oral aripiprazole prior to coverage.trial documented

Coverage duration: LIFETIME.

Alcohol Prep Pads / Gauze - Initial

Covered when ALL of the following are met:

Supplies for insulin: Coverage for alcohol prep pads or gauze requires a claim for an insulin product within the last 180 days.insulin claim within 180 days

Coverage duration: 1 year.

Coding, Thresholds, and Key Numeric Criteria

Products AffectedNDC | product

Oxcarbazepine Er TB24 300MG, 600MG

Product listed

Products AffectedNDC | product

Desvenlafaxine Er TB24 100MG, 50MG	Product listed
Exxua	Product listed
Exxua Titration Pack	Product listed
Trintellix	Product listed

Products AffectedNDC | product

Caplyta	Product listed
Rexulti	Product listed
Vraylar CAPS	Product listed
Zyprexa Relprevv	Product listed

Products AffectedNDC | product

Apidra	Insulin product
Apidra Solostar	Insulin product

Products AffectedNDC | product

Aristada	Long-acting injectable aripiprazole
Aristada Initio	Initiation product for Aristada

Products Affected - suppliesproduct

Alcohol Prep Pads PADS 70%	Supply product
Curity Gauze Pads 2"x2" 12 Ply	Supply product

Products Affected - Invega familyNDC | product

Invega Hafyera	Paliperidone palmitate long-acting injectable
Invega Sustenna	Paliperidone palmitate long-acting injectable
Invega Trinza	Paliperidone palmitate long-acting injectable

inv-104: Eosinophil count thresholds for asthma/COPD indications

Eosinophilic asthma (initiation)>= 150 cells/µL at initiation of treatment

COPD add-on maintenance (current)>= 150 cells/µL current

COPD add-on maintenance (historical)>= 300 cells/µL within past 12 months

HES (for contrast)>= 1000 cells/µL at initiation (HES specific)

inv-105: Weight requirement for Ebglyss (≥ 40 kg)

Minimum weight>= 40 kilograms

Age requirement referenceAge >= 12 years (applies with weight criterion)

DocumentationWeight must be documented in medical record at baseline

inv-106: Eosinophil count at initiation (≥150 cells/µL)

Initiation eosinophil threshold>= 150 cells/µL

Indication contextRequired for eosinophilic asthma at treatment initiation

Related requirementsFailure to maintain control after systemic corticosteroids or high‑dose ICS plus trial of an additional controller required

inv-107: BMD T-score threshold (≤ -2.5)

BMD T-score threshold<= -2.5 (T-score at or below -2.5)

Documentation requiredBone mineral density documentation required (T-score <= -2.5)

Prerequisite therapyTrial of Jubbonti or Stoboclo and oral bisphosphonate (or IV if intolerant) typically required

inv-108: Parenteral support duration (≥ 12 months) for Gattex

Parenteral support duration>= 12 months of dependence on parenteral support

DocumentationMedical record must document dependence on parenteral support for >= 12 months

Coverage duration noteCoverage duration typically 1 year when criteria met

inv-109: Diabetes lab thresholds (A1C, FPG, 2-hour PG)

A1C threshold>= 6.5%

Fasting plasma glucose (FPG)>= 126 mg/dL

2-hour plasma glucose (OGTT)>= 200 mg/dL during OGTT

inv-110: A1c / FPG / 2-hour PG thresholds (duplicate threshold block)

A1C>= 6.5%

Fasting plasma glucose (FPG)>= 126 mg/dL

2-hour plasma glucose (OGTT)>= 200 mg/dL

inv-111: Eosinophil count for eosinophilic asthma (>=150 cells/µL)

Eosinophil count at initiation (EA)>= 150 cells/µL

Required contextApplies to eosinophilic asthma at treatment start; also requires prior controller trials as specified

Age noteCriteria described for adults and children >=12 years where applicable

inv-112: Eosinophil count for HES (>=1000 cells/µL)

HES eosinophil threshold>= 1000 cells/µL at initiation of treatment

Stability requirementCoverage for HES also requires stability on HES therapy (eg oral corticosteroids, immunosuppressive, or cytotoxic therapy)

Indication specificityThreshold specific to hypereosinophilic syndrome indication for Nucala

inv-113: Eosinophil count for COPD indication (>=150 current or >=300 past 12 months)

COPD current eosinophil threshold>= 150 cells/µL (current)

COPD historical eosinophil threshold>= 300 cells/µL within past 12 months

Concomitant therapy requirementPatient must be currently receiving and will continue LABA, LAMA, and inhaled corticosteroid unless contraindicated

inv-114: LDL thresholds while on high-intensity statin for Praluent

LDL threshold with ASCVD>= 55 mg/dL while on high-intensity statin within last 120 days

LDL threshold without ASCVD> 70 mg/dL while on high-intensity statin within last 120 days

Statin therapy requirementAt least 12 weeks of high-intensity statin unless statin intolerance documented

inv-115: Baseline platelet count for ITP (< 30,000 / mcl)

ITP baseline platelet count< 30,000 / mcl

Prerequisite therapiesTrial of corticosteroids, IVIG, or splenectomy required prior to authorization

Coverage durationTypically 1 year when criteria met

inv-116: Baseline platelet count for thrombocytopenia with chronic hepatitis C (< 75,000 / mcl)

Thrombocytopenia with chronic hepatitis C baseline< 75,000 / mcl

Indication-specific noteThreshold applies for this specific thrombocytopenia indication

Coverage durationTypically 1 year when criteria met

inv-117: Baseline platelet count for severe aplastic anemia (< 30,000 / mcl)

Severe aplastic anemia baseline platelet count< 30,000 / mcl

ContextThreshold specified for severe aplastic anemia indication

Coverage durationTypically 1 year when criteria met

inv-118: Liver fibrosis stage for NASH/MASH (F2 to F3)

Liver fibrosis stage requirementF2 to F3 (advanced liver fibrosis) verified by FibroScan or imaging-based noninvasive assessment

Prerequisite therapyTrial of semaglutide required prior to authorization

Renewal criteriaRenewal requires no progression to cirrhosis and evidence of response or clinical benefit

inv-119: Bone mineral density (T-score) requirement

Bone mineral density (T-score) requirement<= -2.5 (T-score at or below -2.5)

DocumentationBMD must be documented in the medical record

Prior therapiesTrial of listed agents (Jubbonti or Stoboclo) and an oral bisphosphonate (or IV if intolerant) required

inv-120: Hemoglobin threshold (≤ 9.5 g/dL) for PNH EVH

Hemoglobin threshold (PNH EVH)<= 9.5 g/dL

ContextRequired laboratory threshold for extravascular hemolysis in PNH

Combination therapyMust be used in combination with Soliris or Ultomiris only

inv-121: Absolute reticulocyte count (≥ 120 × 10^9/L) for PNH EVH

Absolute reticulocyte count threshold>= 120 × 10^9/L

ContextRequired laboratory threshold for EVH in PNH (with Hgb <= 9.5 g/dL)

Combination therapyTreatment must be combined with Soliris or Ultomiris

inv-122: Left ventricular ejection fraction (LVEF) threshold (< 45%) for heart failure agents

LVEF threshold< 45%

Additional HF criteriaNYHA class II-IV and recent HF hospitalization within 6 months OR outpatient IV diuretic within 3 months required

Concomitant therapyMust be taken with at least two specified HF therapies unless contraindicated

inv-123: Insulin claim history requirement (claim in last 180 days) for supplies

Insulin claim history requirementClaim for an insulin product in the last 180 days

Applies toCoverage for alcohol prep pads and gauze supplies

DocumentationClaim history must be present in pharmacy/claims records

inv-124: Paliperidone LAI duration requirement (once-monthly x4 months OR every-3-months x1 cycle)

Paliperidone LAI duration requirementOnce-monthly paliperidone palmitate for at least 4 months OR every-three-month paliperidone palmitate for at least one 3-month cycle

Applies toInvega Hafyera prior authorization (maintenance LAI requirement)

Coverage durationCoverage duration noted as lifetime when requirement met

Provider Actions, Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for drugs listed with (PA); clinical and/or administrative criteria must be met before coverage is provided.

Prior Authorization

Adbry prior authorization requirements

Adbry requests must document patient age ≥ 12 years, trial and failure of one listed topical or systemic agent, and dosing limits for responders <100 kg; coverage duration: 1 year.

Age at least 12 years
Trial and treatment failure of one of: high‑potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil
Cannot be used in combination with another biologic/targeted DMARD for same condition
For patients <100 kg who respond at 16 weeks, dosage limited to 300 mg every 4 weeks unless rationale provided
Coverage duration: 1 year

Prior Authorization

Cimzia prior authorization and duration

Cimzia requires prior authorization for all labeled indications, must not be combined with another biologic/targeted DMARD for the same condition, and requires indication‑specific prior trials; coverage duration: 1 year.

Coverage duration: 1 year
Cannot be used in combination with another biologic/targeted DMARD for the same condition
Indication‑specific prerequisite trials required (e.g., RA and PsA require trials of specified biologics/DMARDs)
Reauthorization requires documentation of positive clinical response

Prior Authorization

Dupixent PA prerequisites and 1‑year duration

Dupixent prior authorization is required for all medically‑accepted indications; follow the indication‑specific prerequisites (diagnosis, prior therapy failures, eosinophil thresholds where applicable) and expect 1‑year coverage.

Cannot be used in combination with another biologic/targeted DMARD for the same condition
Coverage duration: 1 year
Atopic dermatitis: trial and failure of one of listed topical/systemic agents
Eosinophilic asthma: eosinophil ≥150 cells/µL at initiation and failure of controller therapy per criteria
COPD add‑on: eosinophil ≥300 cells/µL and concomitant LABA/LAMA/ICS

Prior Authorization

General PA expectations and typical 1‑year duration

Most product prior authorizations in this list are granted for one year; PA requests must meet the product‑specific indications and any required prerequisite therapy trials.

Typical coverage duration: 1 year
PA requires documentation meeting the product‑specific criteria and prerequisite therapy trials where specified

Documentation Required

Reauthorization requires documented positive clinical response

Reauthorization for many biologic and specialty agents requires documentation of a positive clinical response to the therapy to support continued coverage.

Submit clinical documentation demonstrating improvement or maintained benefit at reauthorization
Applies to multiple biologics (example: Adbry, Cimzia, Dupixent)

Prior Authorization

T2DM PA — confirm diagnosis or lab evidence

Prior authorization for agents used to treat type 2 diabetes mellitus requires submission of medical records confirming the diagnosis or laboratory evidence (A1C ≥ 6.5%, FPG ≥ 126 mg/dL, or 2‑hr PG ≥ 200 mg/dL).

Acceptable documentation: chart notes or lab results showing A1C ≥ 6.5%, fasting plasma glucose ≥ 126 mg/dL, or 2‑hour OGTT ≥ 200 mg/dL
Requests for GLP‑1 agents are excluded if used for weight loss only

Prior Authorization

Biologic PA — diagnosis and mandated prior trials

Biologic therapy PA requests must include the diagnosis specific to the indication and documentation of mandated prior trials (for example, DMARD trial for RA or NSAID trial for AS); reauthorization requires documented clinical response.

Provide indication‑specific prior therapy trials as listed (e.g., one DMARD for RA; NSAID for AS)
Document positive clinical response for reauthorization

Step Therapy

Methotrexate trial required before biologic PA

Several rheumatoid‑arthritis and related indications require a trial of methotrexate (oral tablet) or documented difficulty with oral methotrexate before PA approval; coverage duration commonly one year.

Document trial of methotrexate tablet or inability to use oral methotrexate
PA typically issued for 1 year when criteria met

Prior Authorization

Combination endocrine therapy required for specified breast cancer indications

For certain HR‑positive breast cancer indications, PA requires combination endocrine therapy (aromatase inhibitor or fulvestrant) as the initial endocrine‑based regimen or after progression, with coverage typically for one year.

Combination use with an aromatase inhibitor or fulvestrant as specified in the product entry
Coverage duration: 1 year

Prior Authorization

NSCLC — amivantamab combination requirement

Coverage for specified NSCLC indications requires combination use with amivantamab; confirm combination regimen in the PA request.

Confirm intended concurrent use with amivantamab for locally advanced or metastatic NSCLC per product criteria
Coverage duration: 1 year

Prior Authorization

RCC — pembrolizumab (and other) combination requirements

First‑line RCC coverage requires combination with pembrolizumab; other RCC settings require specified combinations (e.g., everolimus after prior anti‑angiogenic therapy).

Document combination with pembrolizumab for first‑line RCC where required
Document prior anti‑angiogenic therapy and planned combination with everolimus where applicable

Prior Authorization

KRAS G12C NSCLC — prior systemic therapy required

Lumakras (KRAS G12C) and similar agents require at least one prior systemic therapy for locally advanced or metastatic NSCLC; expect PA for 1 year.

Document at least one prior systemic therapy for KRAS G12C–mutated NSCLC
Coverage duration: 1 year

Prior Authorization

mCRC — prior chemo and panitumumab combination required

For KRAS G12C–mutated metastatic colorectal cancer, PA requires prior fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy and combination use with panitumumab as specified.

Document prior receipt of fluoropyrimidine, oxaliplatin, and irinotecan regimens
Document plan for combination with panitumumab

Prior Authorization

Lynparza — platinum‑based prior chemotherapy required

Lynparza maintenance or treatment PAs require prior platinum‑based chemotherapy for BRCA/HRR indications or other specified prior therapies (e.g., AR‑directed therapy for mCRPC); coverage duration: 1 year.

Document prior platinum‑based chemotherapy response for ovarian maintenance
For mCRPC, document prior androgen receptor‑directed therapy
Coverage duration: 1 year

Prior Authorization

Mekinist — BRAF/MEK therapy rules and combination constraints

Mekinist (trametinib) coverage follows BRAF/MEK therapy rules: monotherapy permitted only for BRAF‑inhibitor‑naïve melanoma; many indications require prior vemurafenib+cobimetinib and/or combination with dabrafenib.

Monotherapy only for BRAF‑inhibitor‑naïve unresectable/metastatic melanoma with BRAF V600E/V600K detected by FDA‑approved test
Requires trial of vemurafenib + cobimetinib used in combination
Many indications require combination with dabrafenib

Prior Authorization

Mekinist (tablet) PA — trials and 1‑year coverage

Mekinist tablet PA: prior authorization required; coverage duration 1 year; prior trial of vemurafenib + cobimetinib and combination/dabrafenib requirements apply per indication.

Prior authorization required
Coverage duration: 1 year
Prior trial of vemurafenib + cobimetinib required where specified

Prior Authorization

Mekinist (liquid SOLR) PA when tablets not tolerated

Mekinist SOLR (liquid) requires PA when patient cannot swallow tablets; coverage duration 1 year and same BRAF mutation and combination/prior therapy requirements as the tablet formulation.

Patient must be unable to swallow tablets
Same BRAF V600E/V600K and prior therapy/combination requirements as tablet
Coverage duration: 1 year

Prior Authorization

Mektovi PA — oncology prior trials and 1‑year duration

Mektovi prior authorization is required; for melanoma and NSCLC with BRAF V600E/V600K mutations, prior trials of vemurafenib + cobimetinib and combination with encorafenib are required; coverage duration: 1 year.

Prior authorization required
Prior trial of vemurafenib + cobimetinib required for melanoma
Combination with encorafenib required for melanoma and NSCLC per product criteria
Coverage duration: 1 year

Prior Authorization

Nucala PA — eosinophil thresholds and documentation

Nucala PAs require indication‑specific documentation including eosinophil thresholds (e.g., ≥150 cells/µL for eosinophilic asthma; ≥1000 cells/µL for HES), relevant diagnostic features, and cannot be combined with another biologic/targeted DMARD for the same condition; coverage duration: 1 year.

Eosinophilic asthma: eosinophils ≥150 cells/µL at initiation and failure of controller therapy per criteria
HES: eosinophils ≥1000 cells/µL and stability on HES therapy
CRSwNP, EGPA, COPD add‑on each have specified diagnostic/lab requirements
Cannot be used in combination with another biologic/targeted DMARD for same condition
Coverage duration: 1 year

Step Therapy

Migraine — trial of two generic triptans required

For acute migraine therapies, prior authorization requires documentation of trial and failure of at least two generic triptans (e.g., sumatriptan and rizatriptan) unless contraindicated or not tolerated.

Trial of ≥2 generic triptans required prior to approval unless contraindicated or not tolerated
Document trials in the PA submission

Step Therapy

Posaconazole — step therapy: trial of two alternative azoles

Posaconazole DR prophylaxis/treatment PAs require trials of two alternative azoles (choose two of fluconazole, itraconazole, voriconazole) before approval.

Prophylaxis: trial with two of fluconazole, itraconazole, or voriconazole required
Treatment: trial with two of the listed azoles required

Prior Authorization

Praluent — LDL and statin criteria for initiation

Praluent initiation requires LDL thresholds while on a high‑intensity statin within the prior 120 days (≥55 mg/dL with ASCVD; >70 mg/dL without ASCVD) and prior statin therapy or documented statin intolerance; reauthorization requires ongoing background lipid therapy and LDL reduction.

Document LDL while on high‑intensity statin within last 120 days
Require at least 12 weeks of high‑intensity statin unless intolerant
Reauthorization: continued background therapy and documented LDL reduction
Coverage duration noted (e.g., 3 years in entry)

Prior Authorization

Prevymis — CMV prophylaxis eligibility and 1‑year coverage

Prevymis PA for CMV prophylaxis covers CMV‑seropositive HSCT recipients and high‑risk kidney transplant recipients (donor + / recipient −); coverage duration: 1 year.

Eligible: CMV‑seropositive HSCT recipients (R+) or high‑risk kidney transplant recipients (D+/R-)
Coverage duration: 1 year

Prior Authorization

Retevmo — RET testing and indication‑specific prerequisites

Retevmo prior authorization requires documentation of a RET fusion or RET mutation detected by an FDA‑approved test and any indication‑specific prerequisites such as prior radioactive iodine or prior systemic therapy when applicable.

RET alteration must be detected by an FDA‑approved test
Document prior RAI for thyroid cancer when appropriate or prior systemic therapy for RET‑fusion solid tumors
Coverage duration: 1 year

Prior Authorization

Rubraca — BRCA mutation and prior chemo requirements

Rubraca maintenance coverage requires a deleterious BRCA mutation and response to platinum‑based chemotherapy; MCRPC indication requires prior androgen‑receptor‑directed therapy.

Document deleterious BRCA mutation for ovarian maintenance
Document prior platinum‑based chemotherapy response
For MCRPC, document prior AR‑directed therapy

Step Therapy

Initial conservative therapy trial required (example)

Prior authorization for unspecified initial product (example) requires trial of at least two conservative measures (furosemide, demeclocycline, or fluid restriction) before approval; coverage duration noted as 1 month.

Trial of at least two of: furosemide, demeclocycline, or fluid restriction required
Document absence of underlying liver disease if requested
Coverage duration: 1 month

Prior Authorization

Simponi PA — trials, combination exclusion, reauthorization

Simponi prior authorization requires trials of two specified alternative therapies depending on indication, cannot be combined with another biologic/targeted DMARD for the same condition, and reauthorization requires documented positive clinical response; coverage: 1 year.

Trial of two alternatives (list varies by indication)
Cannot be used in combination with another biologic/targeted DMARD for same condition
Reauthorization requires documentation of positive clinical response
Coverage duration: 1 year

Prior Authorization

Stelara PA — trials, exclusions, reauth

Stelara prior authorization requires indication‑appropriate diagnosis, cannot be used with another biologic/targeted DMARD for the same condition, and reauthorization requires documentation of positive clinical response; coverage duration: 1 year.

Cannot be used in combination with another biologic/targeted DMARD for same condition
Reauthorization requires documented positive clinical response
Coverage duration: 1 year

Prior Authorization

Talzenna — enzalutamide combination required

Talzenna for mCRPC requires use in combination with enzalutamide per the PA criteria; coverage duration: 1 year.

Document combination use with enzalutamide
Coverage duration: 1 year

Prior Authorization

Erlotinib — concurrent/combination therapy and prescriber restriction

Erlotinib PAs require concurrent appropriate‑line systemic therapy for NSCLC and combination with gemcitabine for pancreatic cancer; prescriber must be an oncologist; coverage duration: 1 year.

NSCLC: concurrent first‑line/maintenance/second+ line therapy after progression following ≥1 prior chemotherapy regimen
Pancreatic cancer: must be used in combination with gemcitabine
Prescriber restriction: oncologist
Coverage duration: 1 year

Prior Authorization

Bexarotene — refractory disease requirement

Bexarotene capsule coverage for cutaneous T‑cell lymphoma requires refractory disease to at least one prior systemic therapy; the gel form requires refractory/persistent/intolerant status to other therapies; prescriber: dermatologist or oncologist.

Capsule: refractory to ≥1 prior systemic therapy
Gel: refractory/persistent after or intolerant of other therapies
Prescriber restriction: dermatologist or oncologist
Coverage duration: 1 year

Prior Authorization

Nilotinib — prior TKI/imatinib therapy required

Nilotinib coverage for CML (adult CP not newly diagnosed; accelerated phase Ph+ CML) requires prior therapy that included imatinib; pediatric Ph+ CML-CP and CML‑AP require prior TKI therapy; coverage duration: 1 year.

Document prior therapy including imatinib for adult CML settings
Pediatric patients require prior TKI trial
Coverage duration: 1 year

Prior Authorization

Tazverik — prior systemic therapies required

Tazverik prior authorization for EZH2‑mutant follicular lymphoma requires prior treatment with at least two systemic therapies; coverage duration: 1 year.

Document ≥2 prior systemic therapies
Coverage duration: 1 year

Prior Authorization

Thalomid — combination therapy requirement

Thalomid coverage for multiple myeloma requires combination use with dexamethasone; coverage for ENL with moderate‑to‑severe neuritis requires combination therapy; coverage duration: 1 year.

Document combination use with dexamethasone for MM
ENL with neuritis: part of combination therapy
Coverage duration: 1 year

Prior Authorization

Tibsovo — prior treatment required

Tibsovo coverage for cholangiocarcinoma requires prior treatment; coverage duration: 1 year.

Document prior therapy for cholangiocarcinoma
Coverage duration: 1 year

Prior Authorization

Tivdak — progression after chemotherapy required

Tivdak coverage for recurrent or metastatic cervical cancer requires disease progression on or after chemotherapy; coverage duration: 1 year.

Document disease progression on/after chemotherapy
Coverage duration: 1 year

Prior Authorization

Trodelvy — prior systemic therapies required for TNBC

Trodelvy for unresectable locally advanced or metastatic triple‑negative breast cancer requires prior use of two or more systemic therapies (one for metastatic disease); coverage duration: 1 year.

Document prior use of ≥2 systemic therapies with ≥1 for metastatic disease
Coverage duration: 1 year

Prior Authorization

Truqap — endocrine therapy progression and fulvestrant combo

Truqap coverage for HR+/HER2‑ advanced/metastatic breast cancer with PIK3CA/AKT1/PTEN alterations requires progression on at least one endocrine‑based regimen or recurrence within 12 months of adjuvant therapy and combination use with fulvestrant; coverage duration: 1 year.

Document progression on ≥1 endocrine regimen or recurrence within 12 months
Document planned combination with fulvestrant
Coverage duration: 1 year

Prior Authorization

Tukysa — prior regimens and combination requirements

Tukysa coverage for advanced unresectable or metastatic HER2+ breast cancer requires prior trial of one or more anti‑HER2 regimens and combination with trastuzumab and capecitabine; RAS wild‑type HER2+ mCRC requires prior fluoropyrimidine/oxaliplatin/irinotecan chemotherapy and combination with trastuzumab; coverage duration: 1 year.

Document prior anti‑HER2 regimen(s)
Document planned combination with trastuzumab + capecitabine
For mCRC, document prior fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapy

Step Therapy and Required Prior Trials

Requirement	Details
Step therapy required where specified
See individual product entries for specific step therapy requirements (number and class of prior agents vary by drug and indication).

Requirement	Details
Number and list of required prior agent trials vary by drug and indication
Examples: RA/PsA/psoriasis agents commonly require trials of two listed alternatives; some oncology and specialty agents list indication‑specific prior therapies—see product nodes for exact lists.

Requirement	Examples / Notes
Two generic alternatives or multiple prior systemic therapies may be required
Epidiolex: trial of 2 generic alternatives for Lennox‑Gastaut and TSC seizures; many oncology agents (e.g., Fotivda) require two or more prior systemic therapies.

Requirement	Supported by (product examples)
Trial of specified prior therapy is required and must be documented
Methotrexate trial required for some biologics; products require documentation of prior DMARD or other named prior agents per product entry.

Requirement	Products / Details
Trial of two specified biologic/targeted DMARDs required
Example: Kevzara and Kineret for RA indications require trials of two of listed alternatives (e.g., Enbrel, adalimumab biosimilars, Rinvoq, Xeljanz/XR, Orencia).

Requirement	Details
Antipsychotic prior trial required
Lybalvi and similar atypical antipsychotic approvals require trial of at least one listed generic antipsychotic (e.g., aripiprazole, quetiapine, risperidone).

Requirement	Product examples
Multiple products require prior trials of specific agents or classes
Examples include two generic triptans prior to acute migraine agents; vemurafenib + cobimetinib prior to Mekinist/Mektovi in BRAF‑mutant melanoma; other oncology combos noted per product.

Requirement	Details / Examples
Trials of specified prior therapies required before approval
Acute migraine: trial of at least two generic triptans required; Posaconazole DR prophylaxis/treatment requires trial with two of fluconazole, itraconazole, or voriconazole.

Requirement	Products / Details
Bisphosphonate trial required prior to specified osteoporosis agents
Jubbonti and Stoboclo require trial of an oral bisphosphonate or, if intolerant, an IV bisphosphonate; Tymlos also requires prior osteoporosis therapies and BMD documentation (T‑score ≤ -2.5).

Requirement	Products / Details
Semaglutide trial required prior to NASH/MASH agents
Coverage for NASH/MASH requires diagnosis with advanced fibrosis (F2–F3) and a prior trial of semaglutide before authorization.

Requirement	Details / Examples
Conservative therapy trial required before tolvaptan
Requires trial of at least two of furosemide, demeclocycline, or fluid restriction documented prior to tolvaptan authorization.

Requirement	Details
Many biologic agents require documented trials of specified alternatives (commonly two prior therapies)
Simponi, Stelara, Taltz and other biologics specify trials of two listed alternative biologic/targeted agents or DMARDs prior to coverage; reauthorization generally requires documented clinical response.

Requirement	Details / Examples
Product-specific trials required before coverage
Actemra, Trodelvy, many oncology and specialty products list required prior systemic therapies or combinations—see each product entry for the enumerated agents.

Requirement	Details
PAH step therapy — trial of PDE5 inhibitor and endothelin receptor antagonist required
Pulmonary arterial hypertension coverage requires trial of both a generic PDE5 inhibitor (sildenafil or tadalafil) and a generic endothelin receptor antagonist (bosentan or ambrisentan) prior to approval.

Requirement	Details
Somatostatin analog trial required for carcinoid diarrhea
Coverage for carcinoid syndrome diarrhea requires prior trial of somatostatin analog therapy (e.g., octreotide, lanreotide).

Requirement	Details
Trials of prior agents enumerated per product
Many products (notably oncology and specialty agents) list specific prior therapies or lines of therapy required — e.g., Xpovio requires failure of one prior therapy for MM and multiple class failures for relapsed/refractory disease.

Requirement	Details / Examples
Antidepressant step — trial of at least 2 listed generic antidepressants required
Desvenlafaxine/Trintellix/Exxua initiation requires documented trial of at least two generic antidepressants from the listed options prior to coverage.

Requirement	Details / Examples
Antipsychotic step — trial of at least one listed generic antipsychotic required
Prior trial of one listed generic antipsychotic (e.g., aripiprazole, risperidone, quetiapine) is required before coverage of certain atypical antipsychotics (Caplyta, Rexulti, Vraylar, Zyprexa Relprevv).

Requirement	Details / Duration
Paliperidone LAI prior use requirement for Invega Hafyera
Requires prior use of once‑monthly paliperidone palmitate for at least 4 months OR an every‑three‑month paliperidone palmitate cycle for at least one 3‑month cycle; coverage duration is lifetime.

Requirement	Details / Exceptions
SGLT2 step therapy — trial of generic dapagliflozin required
Farxiga and Jardiance requests require prior trial of generic dapagliflozin; exception: step therapy does not apply to Jardiance when used to reduce risk of cardiovascular death in adults with T2DM and established CVD.

Information to provide	Notes
Provide setting and intended use to determine Medicare Part B vs Part D coverage
Submit information describing the use and setting of the drug (e.g., outpatient infusion in physician office vs pharmacy dispensed outpatient) to determine benefit processing under Medicare Part B or Part D.

Continuation / Reauthorization Requirements

Actionable Highlights and Denial Risks

Denial Risk

Denial risk if PA/ST criteria not met

Failure to meet the listed PA or ST clinical and administrative criteria may result in denial of the request.

Ensure all prerequisite trials, diagnostic tests, and documentation are included with the PA submission

Denial Risk

Tadalafil‑nitrate drug‑drug exclusion

Tadalafil is not covered when the patient is receiving nitrate therapy; do not submit PA for concurrent nitrate use.

Coverage is not provided for tadalafil in situations where patients are receiving nitrate therapy

Denial Risk

Dalfampridine — functional status exclusion and documentation

Dalfampridine is excluded for use in patients who are wheelchair‑bound or who become wheelchair‑bound; baseline T25FW must be submitted prior to initiation.

Excluded if patient is wheelchair‑bound or becomes wheelchair‑bound
Submit baseline timed 25‑foot walk (T25FW) prior to initiation

Denial Risk

Combination biologic/targeted DMARD exclusion

Use of a biologic or targeted DMARD in combination with another biologic/targeted DMARD indicated for the same condition is prohibited and may lead to denial.

Do not combine biologic/targeted DMARDs for the same indication when requesting PA
Absence of documentation confirming monotherapy where required may trigger denial

Denial Risk

Indication exclusion — weight‑loss use

Requests for products used solely for weight‑loss purposes are excluded from coverage; clearly document the indication to avoid denial.

Excluded if medication is used solely for weight loss
Examples: liraglutide excluded if used for weight loss only

Note

Denial Risk

Heart failure coverage triggers — documentation required

Coverage for chronic heart failure therapies (e.g., Verquvo) is triggered only for NYHA class II–IV with LVEF <45% plus recent HF hospitalization or recent outpatient IV diuresis; missing these elements may preclude coverage.

Document NYHA II–IV and LVEF <45%
Provide evidence of HF hospitalization within 6 months OR outpatient IV diuretic within 3 months

Denial Risk

H. pylori — diagnosis and guideline regimen trial required

H. pylori treatment coverage requires a documented diagnosis of H. pylori infection and trial of a guideline‑recommended generic first‑line regimen (clarithromycin triple or bismuth quadruple therapy); lack of documentation may cause denial.

Document H. pylori infection diagnosis
Document trial of a guideline‑recommended first‑line generic regimen (clarithromycin triple or bismuth quadruple)

Denial Risk

PNH EVH — lab thresholds and combination requirement

PNH EVH treatment requires hemoglobin ≤ 9.5 g/dL and absolute reticulocyte count ≥ 120 × 10^9/L and must be used in combination with Soliris or Ultomiris; missing lab thresholds or combination use will not meet criteria.

Hgb ≤ 9.5 g/dL and absolute reticulocyte count ≥ 120 × 10^9/L required
Must be used in combination with Soliris or Ultomiris

Denial Risk

Demodex — slit‑lamp confirmation required

Demodex blepharitis coverage requires confirmation via presence of collarettes on slit‑lamp exam; absence of this finding may lead to denial.

Provide slit‑lamp exam documentation showing collarettes
Lack of exam confirmation may result in coverage denial

Denial Risk

Reauthorization and prerequisite‑therapy documentation gaps — denial risk

Failure to document required reauthorization information or prerequisite therapy trials (e.g., for CSU or CRSwNP) may result in denial of continued coverage.

Reauthorization requires documentation of positive clinical response for many biologics
Ensure prior therapy trials (e.g., second‑generation antihistamine for CSU; intranasal corticosteroids for CRSwNP) are documented

Denial Risk

MG documentation required — denial risk if missing

For myasthenia gravis PAs, absence of required confirmatory testing (anti‑AChR antibody plus one confirmatory test) or documentation of prior immunosuppressant courses may result in noncoverage.

Anti‑AChR antibody positive result plus one confirmatory test required
Document prior courses (≥12 weeks) of listed immunosuppressants or provide contraindication/intolerance

Denial Risk

Oxcarbazepine ER — trial documentation required or denial

Oxcarbazepine ER requests will be denied unless trials or intolerance to at least two generic anticonvulsants are documented.

Document trial or intolerance to ≥2 generic anticonvulsants
Coverage duration for qualifying patients: lifetime

Denial Risk

Antidepressant step — documentation required to avoid denial

Desvenlafaxine/Trintellix/Exxua PAs will be denied if trials of at least two listed generic antidepressants are not documented.

Document trials of ≥2 listed generic antidepressants
Coverage duration: lifetime when criteria met

Denial Risk

Antipsychotic step — trial documentation required

Antipsychotic PAs (Caplyta, Rexulti, Vraylar, Zyprexa Relprevv) require documentation of trial of at least one listed generic antipsychotic; lacking this may lead to denial.

Document trial of ≥1 listed generic antipsychotic
Coverage duration: lifetime when documented

Billing Rule

Insulin claim required for supplies coverage

Coverage for alcohol prep pads/gauze requires an insulin claim within the prior 180 days; absence of an insulin claim will preclude coverage.

Provide claim history showing insulin fill in last 180 days

Step Therapy

Febuxostat — allopurinol trial/contraindication required

Febuxostat prior authorization will be denied if trial of or documented contraindication/intolerance to allopurinol is not provided.

Document trial of allopurinol or provide documented contraindication/intolerance

Site of Care and Medicare Part B vs Part D Considerations

Note

Medicare Part B vs Part D — provide use and setting information

When a drug may be covered under Medicare Part B or Part D, submit information describing the intended use and site/setting to allow correct benefit determination (Part B vs Part D).

Provide use and setting details (e.g., physician‑administered in infusion center vs outpatient pharmacy) with the PA request

Background and Policy Scope

This prior authorization (PA) list reflects the recommendations of the Blues' Pharmacy and Therapeutics Committee and is intended to ensure appropriate, safe, and cost‑effective use of specialty and pharmacy drugs for Blue Cross Blue Shield of Michigan members in the 2026 plan year. As described in the policy, medications identified with (PA) or (ST) on the formulary require that clinical and/or administrative criteria be met before coverage is provided, and some products are subject to step therapy requiring documented trials of specified formulary agents prior to approval. (See the Formulary to confirm PA/ST status and the product‑specific entries for exact prerequisites and coverage durations.)

Prior authorization decisions are based on the clinically specific criteria in this document—age and diagnosis limits, required laboratory or diagnostic confirmation, prerequisite therapies, prescriber or site‑of‑care restrictions, dosing or quantity limits, and reauthorization requirements. Coverage durations are typically 1 year for many products; other durations (e.g., lifetime, 3 months, or 1 month) are indicated on individual product pages. Reauthorization often requires documentation of a positive clinical response to continued therapy.

Providers seeking authorization must submit the medical information specified in the product entry (for example: diagnostic test results, prior trial documentation, baseline measures such as timed walk tests or eosinophil counts, and evidence of ongoing background therapy). Failure to meet the listed PA/ST criteria (including missing prerequisite trials or required documentation) may result in denial of coverage. If a drug’s benefit determination may be Medicare Part B vs Part D–dependent, submit information describing the drug use and setting so the plan can determine appropriate processing.

Definitions and Key Terms

inv-286: Prior authorization (PA) definition

Prior authorization (PA)A process where clinical and/or administrative criteria must be met before coverage is provided for specified medications.

PurposeEnsures appropriate and cost-effective drug therapy per P&T Committee recommendations

IdentifiersDrugs subject to PA/ST are identified in formulary with (PA) or (ST)

inv-287: Step therapy (ST) definition

Step therapy (ST)Requirement that members try and fail specified formulary drugs before a non-formulary or higher-cost drug is covered.

ApplicationSome drugs require prior treatment with one or more formulary drugs (examples provided in policy)

IdentificationDrugs subject to step therapy are identified in the formulary with (ST)

inv-288: Reauthorization definition

ReauthorizationRenewal of prior authorization which, for many biologics, requires documentation of positive clinical response to therapy.

DocumentationMedical records or clinical notes showing improvement or benefit required at reauth

Common durationCoverage durations for reauth commonly set to 1 year

inv-289: EGPA definition

EGPAEosinophilic granulomatosis with polyangiitis; coverage requires diagnosis of EGPA and history or presence of asthma plus at least two characteristic clinical features (e.g., eosinophilic vasculitis, neuropathy, pulmonary infiltrates, nasal polyps, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, ANCA positivity)

Feature requirementTwo typical EGPA features required for coverage

Related testingEosinophil counts and diagnostic workup per product (eg Nucala) required

inv-290: T2DM diagnostic criteria

T2DM diagnostic criteriaDiagnosis documented by A1C >= 6.5% OR fasting plasma glucose >= 126 mg/dL OR 2-hour plasma glucose >= 200 mg/dL on OGTT

Documentation optionsMedical records (chart notes) or lab values acceptable for PA submission

ExclusionAgents excluded if used solely for weight loss

inv-292: BRAF V600E/V600K mutation definition

BRAF V600E or V600K mutationTumor genomic alteration (BRAF V600E or V600K) detectable by an FDA‑approved test required for Mekinist coverage in specified indications

ApplicationRequired for melanoma, NSCLC, ATC, certain solid tumors, and low-grade glioma indications

Prerequisite therapyMekinist often requires prior or concurrent BRAF inhibitor combination therapy as specified

inv-295: RET alteration definition

RET alterationPresence of RET gene fusion or RET mutation as detected by an FDA‑approved test required for Retevmo coverage

Indication examplesRET fusion in NSCLC, RET mutation in MTC, RET fusion in other solid tumors per product criteria

Prior therapy notesSome indications require prior therapies (eg RAI for thyroid when appropriate)

inv-296: Deleterious BRCA mutation-associated definition

Deleterious BRCA mutation-associatedBRCA mutation associated with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer required for Rubraca maintenance coverage

Therapy contextMaintenance coverage requires response to platinum-based chemotherapy

TestingGenetic testing documentation required

inv-297: FOP genetic confirmation requirement

FOP genetic confirmationCoverage for fibrodysplasia ossificans progressiva requires genetic testing confirmation showing an ACVR1 mutation

DocumentationGenetic test report required in medical record for PA

Coverage noteIf genetic confirmation absent, not eligible per policy

inv-298: Chronic heart failure criteria (NYHA II-IV, LVEF <45%)

Chronic heart failure criteriaNYHA class II-IV with LVEF <45%

Additional qualifying eventsRecent HF hospitalization within 6 months OR outpatient IV diuretic within prior 3 months typically required

Concomitant therapyMust be taken with at least two specified HF therapies unless contraindicated

inv-299: PNH EVH thresholds definition

PNH EVH thresholdsHemoglobin <= 9.5 g/dL AND absolute reticulocyte count >= 120 × 10^9/L

Combination therapy requirementTreatment must be used in combination with Soliris or Ultomiris only

DocumentationLab values must be documented in medical record for PA

inv-300: CRSwNP definition

CRSwNPChronic rhinosinusitis with nasal polyposis; coverage requires diagnosis and recurrent disease despite intranasal corticosteroid therapy

Prior therapyFailure of intranasal corticosteroids (eg fluticasone, mometasone) required

ReauthorizationDocumentation of positive clinical response required for continued coverage

inv-301: Anti-AChR antibody positive MG definition

Anti-AChR antibody positive MGMyasthenia gravis confirmed by positive anti-acetylcholine receptor antibody testing plus one confirmatory test (edrophonium, clinical response to cholinesterase inhibitors, or electrophysiologic evidence)

Prior therapy requirementPrevious treatment courses of at least 12 weeks with listed immunosuppressants required unless contraindicated

DocumentationLab record and confirmatory test required in PA submission

inv-302: Paliperidone LAI description and duration thresholds

Paliperidone LAI descriptionOnce-a-month paliperidone palmitate extended-release injectable suspension (maintenance LAI)

Duration thresholds for Invega HafyeraOnce-monthly for >=4 months OR every-three-month formulation for >= one 3-month cycle required prior to Invega Hafyera

DocumentationPrior use must be documented in medical record for PA

Policy Summary

Payerblue cross blue shield - michigan

PolicyPrior authorization and step therapy criteria — pharmacy & specialty drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2026

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required clinical documentation (e.g., diagnostic labs, prior therapy trials) because PA is required for listed drugs.

SourceLink

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Policy Summary

Payerblue cross blue shield - michigan

PolicyPrior authorization and step therapy criteria — pharmacy & specialty drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2026

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required clinical documentation (e.g., diagnostic labs, prior therapy trials) because PA is required for listed drugs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2026plan year covered

387pages (partial)

multipleproducts in segment

1 YEARcommon duration

Coverage Criteria — Product-Level Rules

Adbry - Initial Therapy

Covered when ALL of the following are met:

Coverage duration: 1 year; reauthorization requires documentation of positive clinical response.

Prerequisite therapy requirements

Selected product-specific prerequisite therapy/coverage rules:

Auvelity for MDD: Requires trial of bupropion and one other generic formulary antidepressant prior to coverage.

Coverage duration: LIFETIME.

Brivaracetam: Requires trial of levetiracetam and one other formulary generic anticonvulsant prior to coverage.

Coverage duration: 1 year.

Bosulif for accelerated/blast phase Ph+ CML: Requires prior therapy as specified in product entry prior to coverage.

Coverage duration: 1 year.

Cimzia — Initial therapy and indication-specific prerequisites

Cimzia covered when ALL of the following are met:

Dupixent — Indication-specific coverage criteria

Dupixent covered when ALL of the following are met (indication-dependent):

Applies to patients ≥2 years.

Cosentyx — Indication-specific coverage criteria

Cosentyx covered when ALL of the following are met:

ERA prerequisites: For enthesitis‑related arthritis (ERA): diagnosis of active ERA AND trial of one NSAID.1 NSAID trial

Dalfampridine — MS walking impairment

Dalfampridine covered when ALL of the following are met:

Coverage duration 1 year.

Diacomit — Anticonvulsant prerequisite

Diacomit covered when ALL of the following are met:

Diacomit prerequisites: Coverage requires trial of two generic anticonvulsants; for seizures associated with Dravet syndrome, requires combination use with clobazam.trial of 2 anticonvulsants

Coverage duration 1 year.

Copiktra — Prior therapy requirement

Copiktra covered when ALL of the following are met for relapsed/refractory CLL or SLL:

Copiktra prerequisites: Coverage requires trial of at least two prior therapies for relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).>=2 prior therapies

Coverage duration 1 year.

L-glutamine — Sickle cell

L‑glutamine covered when ALL of the following are met:

L‑glutamine prerequisites: Patient has experienced ≥2 sickle cell‑related crises in the past 12 months AND trial of or intolerance to hydroxyurea is documented.≥2 crises in 12 months

Coverage duration 1 year.

Eosinophilic asthma (Fasenra)

Covered when ALL of the following are met for eosinophilic asthma:

Reauthorization requires documentation of positive clinical response.

Eosinophilic granulomatosis with polyangiitis (EGPA)

Covered when ALL of the following are met for EGPA:

Reauthorization requires documentation of positive clinical response.

Rheumatoid arthritis

Covered when ALL of the following are met for rheumatoid arthritis:

Rheumatoid arthritis coverage: Diagnosis of moderately to severely active rheumatoid arthritis AND trial of one DMARD (e.g., methotrexate, leflunomide, sulfasalazine).trial of one DMARD

Cannot be used in combination with another biologic or targeted DMARD for the same condition; coverage duration 1 year.

Sickle cell disease (L-glutamine)

Covered when ALL of the following are met for L‑glutamine:

L‑glutamine coverage: Patient has experienced ≥2 sickle cell‑related crises in the past 12 months AND trial of or intolerance to hydroxyurea is documented.≥2 crises in 12 months

Coverage duration 1 year.

Seizure disorders (Epidiolex)

Covered when ALL of the following are met for Epidiolex:

Coverage duration 1 year.

Schizophrenia (selected products)

Covered when ALL of the following are met for schizophrenia:

Coverage duration: LIFETIME.

Severe osteoporosis

Covered when ALL of the following are met for specified osteoporosis agent:

Coverage duration: 2 years.

Short bowel syndrome (Gattex)

Covered when ALL of the following are met for Gattex:

Gattex coverage: Documentation of dependence on parenteral support for ≥ 12 months.≥12 months

Coverage duration: 1 year.

Type 2 diabetes mellitus (GLP-1 agents)

Covered when ALL of the following are met for GLP‑1 agonists/related agents for T2DM:

Coverage duration: 1 year.

T2DM product coverage rules

Covered when documentation and indications meet product‑specific criteria:

Coverage duration: 1 year.

Biologic and targeted DMARDs

Covered when ALL of the following are met for indication‑specific biologic therapies:

Coverage duration: typically 1 year.

Activated PI3K delta syndrome (APDS)

Coverage for activated PI3K delta syndrome (APDS) requires ALL of the following:

Cannot be used in combination with an immunosuppressive medication for the APDS indication.

Prerequisite therapy requirements (selected)

Coverage requires prior trial of specified therapies for certain products:

General product-level coverage

Products in this excerpt are covered with specified prior authorization criteria and coverage durations when the listed prerequisite therapy and additional product‑specific requirements are met.

General product‑level coverage: Coverage durations typically 1 year; prerequisite Part D drug trials required for many products as specified per product; see product‑level entries for specifics.

Liraglutide coverage criteria

Liraglutide-specific criteria:

Coverage duration 1 year.

Breast cancer combination therapy

Products requiring combination endocrine therapy for HR‑positive breast cancer:

Coverage duration: 1 year.

Mekinist (tablet) — coverage conditions

Covered when ALL of the following are met

Mekinist (tablet) general: Medically‑accepted indication; coverage duration 1 year; for specified indications BRAF V600E or V600K mutation detected by an FDA‑approved test is required.

Combination requirement: For specified indications (melanoma, NSCLC BRAF V600E, ATC, certain solid tumors, low‑grade glioma) coverage requires combination use with dabrafenib.

Mekinist (liquid SOLR) — coverage conditions

Covered when ALL of the following are met

Mekinist SOLR — swallowing impairment: Patient is unable to swallow the tablet formulation.

Mekinist SOLR — mutation and prior therapy: Same BRAF mutation requirement and prior trial of vemurafenib + cobimetinib and combination with dabrafenib requirements as for the tablet formulation.

Coverage duration 1 year.

Mektovi — coverage conditions

Covered when ALL of the following are met

Mektovi general: Medically‑accepted indication; coverage duration 1 year.

Mektovi — melanoma prior therapy: For unresectable or metastatic melanoma with BRAF V600E or V600K mutation requires prior trial of vemurafenib + cobimetinib used in combination.

Mektovi — combination requirement: Coverage for melanoma and for NSCLC with BRAF V600E requires combination use with encorafenib.

Nucala — indication-specific coverage

Covered when ALL of the following per indication are met

Nucala — indications: Indications include eosinophilic asthma (EA), EGPA, HES, chronic rhinosinusitis with nasal polyposis (CRSwNP), and add‑on maintenance treatment of COPD as specified.

Coverage duration 1 year; cannot be combined with another biologic/targeted DMARD for same condition.

Nucala — CRSwNP criteria: Diagnosis of CRSwNP AND recurring polyps despite prior intranasal corticosteroid therapy (e.g., fluticasone, mometasone).

Age-restricted prior authorization (example)

Age‑restricted prior authorization: Prior authorization applies only to patients less than 30 years of age for the specified product entry.<30 years

Coverage duration 1 year.

Migraine — triptan prerequisite

Acute migraine treatment:

Coverage duration 1 year.

Opfolda — diagnostic and prior ERT requirements

Opfolda (Pompe disease) coverage:

Coverage duration 1 year.

Posaconazole DR — criteria

Posaconazole DR — prophylaxis and treatment of invasive fungal infections:

Coverage duration 6 months for prophylaxis.

Treatment eligibility: Used as treatment for invasive fungal infections caused by Aspergillus and Candida; treatment also requires trial with two of listed azoles.trial with two azoles

Praluent — initiation and reauth

Praluent (alirocumab) initiation and reauthorization criteria:

Coverage duration: 3 years for reauthorization context.

Praluent reauthorization: Patient continues background lipid‑lowering therapy and has demonstrated LDL reduction while on Praluent.documented LDL reduction

Pomalidomide — prior therapy requirement

Pomalidomide coverage for multiple myeloma:

Reauthorization requires continued benefit.

Prevymis — CMV prophylaxis

Prevymis coverage when ALL of the following are met:

Prevymis CMV prophylaxis: Recipient is a CMV‑seropositive allogeneic HSCT recipient OR a kidney transplant recipient at high risk (donor CMV‑seropositive/recipient CMV‑seronegative D+/R-).

Coverage duration 1 year; applies to Prevymis PACK and TABS.

Retevmo — RET-altered cancers

Retevmo coverage when ALL of the following are met:

Coverage duration 1 year.

Eltrombopag — platelet disorders

Eltrombopag covered when ALL of the following are met:

Coverage duration 1 year; prerequisite Part D drug required.

NASH/MASH — fibrosis and semaglutide trial

NASH/MASH drug coverage when ALL of the following are met:

Renewal requires no progression to cirrhosis and demonstration of response or clinical benefit as specified; coverage duration 1 year.

Rinvoq — multiple immune-mediated indications

Rinvoq covered when ALL of the following are met:

Coverage duration 1 year; reauthorization requires documentation of positive clinical response and confirmation patient is not on a potent immunosuppressant.

Tolvaptan — liver safety and conservative therapy trial

Tolvaptan covered when ALL of the following are met:

Coverage duration 1 month; prerequisite Part D drug required.

Rezurock — chronic GVHD

Rezurock coverage when ALL of the following are met:

Rezurock chronic GVHD: Patient is ≥12 years with chronic graft‑versus‑host disease AND trial and failure of at least two prior lines of systemic therapy.≥2 prior systemic therapy lines

Coverage duration 1 year.

Initial product — medically-accepted indications with specified prerequisites

Covered when ALL of the following are met for the unnamed initial product entry:

Coverage duration 1 month.

Simponi — indication-specific criteria

Covered when ALL of the following are met for Simponi:

Reauthorization requires documentation of positive clinical response; coverage duration 1 year.

Simponi — PsA: Diagnosis of active psoriatic arthritis AND trial of two of: Cosentyx, Enbrel, adalimumab variants, Rinvoq, Skyrizi, Wezlana/Yesintek, Xeljanz/XR, Orencia, Otezla.trial of two agents

Reauthorization requires documentation of positive clinical response.

Stelara — indication-specific criteria

Covered when ALL of the following are met for Stelara (ustekinumab / Wezlana / Yesintek):

Coverage duration 1 year.

Tafinlar — mutation and combination requirements

Covered when ALL of the following are met for Tafinlar (and liquid formulation):

Coverage duration 1 year.

Tagrisso — indication-specific criteria

Covered when ALL of the following are met for Tagrisso:

Coverage duration 1 year.

Product-specific initial coverage criteria

Covered when product‑specific conditions and any required prior/concomitant therapies or documentation are met (see each product entry).

Talzenna: Coverage for metastatic castration‑resistant prostate cancer requires use in combination with enzalutamide.

Coverage duration 1 year.

Nilotinib: Adults with CML‑CP not newly diagnosed and AP Ph+ CML require prior therapy that included imatinib; pediatric Ph+ CML‑CP and CML‑AP require prior TKI therapy.

Coverage duration 1 year.

Tazverik: EZH2 mutation‑positive follicular lymphoma requires prior treatment with at least two systemic therapies.

Coverage duration 1 year.

Thalomid: Multiple myeloma coverage requires use in combination with dexamethasone; ENL with moderate‑to‑severe neuritis requires combination therapy.

Coverage duration 1 year.

Tibsovo: Coverage for cholangiocarcinoma requires previous treatment.

Coverage duration 1 year.

Tivdak: Recurrent or metastatic cervical cancer requires disease progression on or after chemotherapy.

Coverage duration 1 year.

Reauthorization requires documentation of positive clinical response; coverage 1 year.

Coverage duration 1 year.

Tymlos: Requires documentation of BMD T‑score ≤ ‑2.5 AND trial of Jubbonti or Stoboclo and an oral bisphosphonate (or IV if intolerant).T‑score ≤ -2.5

Coverage duration 2 years.

Ubrelvy: Acute migraine treatment requires trial of ≥2 generic triptans unless contraindicated or not tolerated.trial of two triptans

Coverage duration 1 year.

Vanflyta: For newly diagnosed AML FLT3‑ITD positive requires use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation.

Coverage duration 1 year.

Venclexta: Newly diagnosed AML in adults ≥75 years or with comorbidities precluding intensive therapy requires combination with azacitidine, decitabine, or low‑dose cytarabine.

Coverage duration 1 year.

Veozah: Moderate‑to‑severe vasomotor symptoms due to menopause requires trial, failure, contraindication or intolerance to one preferred or generic medication for VMS.

Coverage duration 1 year.

Heart failure coverage criteria (product-specific)

Covered when ALL of the following are met for the heart‑failure‑related product(s):

Heart failure initial criteria: Diagnosis of chronic heart failure NYHA class II–IV AND left ventricular ejection fraction (LVEF) <45%.LVEF <45%

Additional qualifying event: Either previous hospitalization for heart failure within prior 6 months OR outpatient intravenous diuretic treatment for heart failure within prior 3 months.

H. pylori treatment coverage

Covered when ALL of the following are met for H. pylori therapy products:

H. pylori diagnosis: Documentation of Helicobacter pylori infection.

PNH EVH coverage criteria

Covered when ALL of the following are met for treatment of EVH in PNH:

PNH EVH diagnosis: Clinically significant extravascular hemolysis (EVH) due to paroxysmal nocturnal hemoglobinuria (PNH).

Laboratory thresholds: Hemoglobin ≤ 9.5 g/dL AND absolute reticulocyte count ≥ 120 × 10^9/L.Hgb ≤ 9.5 g/dL; retic ≥ 120 ×10^9/L

Combination therapy: Must be used in combination with Soliris or Ultomiris only.

Coverage duration 1 year.

Demodex blepharitis coverage

Covered when ALL of the following are met for demodex blepharitis product:

Demodex blepharitis diagnosis: Confirmation of demodex blepharitis via presence of collarettes on slit‑lamp examination.

Coverage duration 1 year.

Xolair coverage criteria

Covered when ALL of the following are met for Xolair by indication:

Coverage duration 1 year.

Xolair — CSU: Diagnosis of chronic spontaneous urticaria with symptoms despite H1 antihistamine treatment AND trial of at least one second‑generation antihistamine.

Reauthorization requires documentation of positive clinical response.

Xolair — CRSwNP: Diagnosis of chronic rhinosinusitis with nasal polyposis with recurring polyps despite intranasal corticosteroid therapy.

Reauthorization requires documentation of positive clinical response.

Verzenio coverage criteria

Covered when ALL of the following are met for Verzenio:

Verzenio — progression after endocrine therapy: Advanced/metastatic disease with progression following endocrine therapy requires combination use with fulvestrant.

PAH prior therapy criteria

Covered when ALL of the following are met for pulmonary arterial hypertension (Winrevair):

PAH prior therapy: Requires a trial of both a generic PDE5 inhibitor (sildenafil or tadalafil) AND a generic endothelin receptor antagonist (bosentan or ambrisentan).

Coverage duration 1 year.

Xolair initial and reauthorization criteria

Covered when ALL of the following are met (example: Xolair for CSU and CRSwNP):

Xolair — CSU initial: Symptoms despite H1 antihistamine treatment AND trial of at least one second‑generation antihistamine.

Reauthorization requires documentation of positive clinical response.

Xolair — CRSwNP initial: Diagnosis of CRSwNP AND recurring disease despite intranasal corticosteroids (e.g., fluticasone, mometasone).

Reauthorization requires documentation of positive clinical response.

Zilbrysq (myasthenia gravis) criteria

Covered when ALL of the following are met for Zilbrysq in myasthenia gravis:

Coverage duration 1 year.

Xpovio coverage criteria

Coverage for select oncology agents (example: Xpovio) when ALL are met:

Coverage duration 1 year.

Xpovio — DLBCL: Relapsed or refractory diffuse large B‑cell lymphoma requires trial of at least two lines of systemic therapy.

Oxcarbazepine ER criteria

Oxcarbazepine ER TB24 coverage:

Oxcarbazepine ER initial: Requires trial or documented intolerance to at least two generic anticonvulsants prior to approval.trial of ≥2 anticonvulsants

Coverage duration: LIFETIME.

Abilify products criteria

Abilify formulations coverage:

Abilify Asimtufii: Requires trial of oral aripiprazole prior to coverage.trial of oral aripiprazole

Coverage duration: LIFETIME.

Abilify Maintena: Requires trial of oral aripiprazole prior to coverage.trial of oral aripiprazole

Coverage duration: LIFETIME.

Oxcarbazepine ER - Initial

Covered when ALL of the following are met:

Oxcarbazepine ER - Initial: Requires trial or intolerance to at least two generic anticonvulsants prior to initiation.2 trials

Coverage duration: LIFETIME.

Desvenlafaxine / Trintellix / Exxua - Initial

Covered when ALL of the following are met:

Desvenlafaxine / Trintellix / Exxua initiation: Requires trial of at least two listed generic antidepressants (examples enumerated in product entry) prior to coverage.2 trials from list

Coverage duration: LIFETIME.

Caplyta / Rexulti / Vraylar / Zyprexa Relprevv - Initial

Covered when ALL of the following are met:

Atypical antipsychotics initial: Requires trial of at least one listed generic antipsychotic (examples enumerated in product entry) prior to coverage.1 trial from list

Coverage duration: LIFETIME.

Apidra - Initial

Covered when ALL of the following are met:

Apidra initiation: Requires trial or documented intolerance to NovoLog 70/30 or NovoLog prior to coverage.trial or intolerance documented

Coverage duration: LIFETIME.

Aristada / Aristada Initio - Initial

Covered when ALL of the following are met:

Aristada: Requires trial or intolerance to Abilify Maintena or oral aripiprazole prior to coverage.trial or intolerance documented

Coverage duration: LIFETIME.

Aristada Initio: Requires trial of oral aripiprazole prior to coverage.trial documented

Coverage duration: LIFETIME.

Alcohol Prep Pads / Gauze - Initial

Covered when ALL of the following are met:

Supplies for insulin: Coverage for alcohol prep pads or gauze requires a claim for an insulin product within the last 180 days.insulin claim within 180 days

Coverage duration: 1 year.

Coding, Thresholds, and Key Numeric Criteria

Products AffectedNDC | product

Oxcarbazepine Er TB24 300MG, 600MG

Product listed

Products AffectedNDC | product

Desvenlafaxine Er TB24 100MG, 50MG	Product listed
Exxua	Product listed
Exxua Titration Pack	Product listed
Trintellix	Product listed

Products AffectedNDC | product

Caplyta	Product listed
Rexulti	Product listed
Vraylar CAPS	Product listed
Zyprexa Relprevv	Product listed

Products AffectedNDC | product

Apidra	Insulin product
Apidra Solostar	Insulin product

Products AffectedNDC | product

Aristada	Long-acting injectable aripiprazole
Aristada Initio	Initiation product for Aristada

Products Affected - suppliesproduct

Alcohol Prep Pads PADS 70%	Supply product
Curity Gauze Pads 2"x2" 12 Ply	Supply product

Products Affected - Invega familyNDC | product

Invega Hafyera	Paliperidone palmitate long-acting injectable
Invega Sustenna	Paliperidone palmitate long-acting injectable
Invega Trinza	Paliperidone palmitate long-acting injectable

inv-104: Eosinophil count thresholds for asthma/COPD indications

Eosinophilic asthma (initiation)>= 150 cells/µL at initiation of treatment

COPD add-on maintenance (current)>= 150 cells/µL current

COPD add-on maintenance (historical)>= 300 cells/µL within past 12 months

HES (for contrast)>= 1000 cells/µL at initiation (HES specific)

inv-105: Weight requirement for Ebglyss (≥ 40 kg)

Minimum weight>= 40 kilograms

Age requirement referenceAge >= 12 years (applies with weight criterion)

DocumentationWeight must be documented in medical record at baseline

inv-106: Eosinophil count at initiation (≥150 cells/µL)

Initiation eosinophil threshold>= 150 cells/µL

Indication contextRequired for eosinophilic asthma at treatment initiation

Related requirementsFailure to maintain control after systemic corticosteroids or high‑dose ICS plus trial of an additional controller required

inv-107: BMD T-score threshold (≤ -2.5)

BMD T-score threshold<= -2.5 (T-score at or below -2.5)

Documentation requiredBone mineral density documentation required (T-score <= -2.5)

Prerequisite therapyTrial of Jubbonti or Stoboclo and oral bisphosphonate (or IV if intolerant) typically required

inv-108: Parenteral support duration (≥ 12 months) for Gattex

Parenteral support duration>= 12 months of dependence on parenteral support

DocumentationMedical record must document dependence on parenteral support for >= 12 months

Coverage duration noteCoverage duration typically 1 year when criteria met

inv-109: Diabetes lab thresholds (A1C, FPG, 2-hour PG)

A1C threshold>= 6.5%

Fasting plasma glucose (FPG)>= 126 mg/dL

2-hour plasma glucose (OGTT)>= 200 mg/dL during OGTT

inv-110: A1c / FPG / 2-hour PG thresholds (duplicate threshold block)

A1C>= 6.5%

Fasting plasma glucose (FPG)>= 126 mg/dL

2-hour plasma glucose (OGTT)>= 200 mg/dL

inv-111: Eosinophil count for eosinophilic asthma (>=150 cells/µL)

Eosinophil count at initiation (EA)>= 150 cells/µL

Required contextApplies to eosinophilic asthma at treatment start; also requires prior controller trials as specified

Age noteCriteria described for adults and children >=12 years where applicable

inv-112: Eosinophil count for HES (>=1000 cells/µL)

HES eosinophil threshold>= 1000 cells/µL at initiation of treatment

Stability requirementCoverage for HES also requires stability on HES therapy (eg oral corticosteroids, immunosuppressive, or cytotoxic therapy)

Indication specificityThreshold specific to hypereosinophilic syndrome indication for Nucala

inv-113: Eosinophil count for COPD indication (>=150 current or >=300 past 12 months)

COPD current eosinophil threshold>= 150 cells/µL (current)

COPD historical eosinophil threshold>= 300 cells/µL within past 12 months

Concomitant therapy requirementPatient must be currently receiving and will continue LABA, LAMA, and inhaled corticosteroid unless contraindicated

inv-114: LDL thresholds while on high-intensity statin for Praluent

LDL threshold with ASCVD>= 55 mg/dL while on high-intensity statin within last 120 days

LDL threshold without ASCVD> 70 mg/dL while on high-intensity statin within last 120 days

Statin therapy requirementAt least 12 weeks of high-intensity statin unless statin intolerance documented

inv-115: Baseline platelet count for ITP (< 30,000 / mcl)

ITP baseline platelet count< 30,000 / mcl

Prerequisite therapiesTrial of corticosteroids, IVIG, or splenectomy required prior to authorization

Coverage durationTypically 1 year when criteria met

inv-116: Baseline platelet count for thrombocytopenia with chronic hepatitis C (< 75,000 / mcl)

Thrombocytopenia with chronic hepatitis C baseline< 75,000 / mcl

Indication-specific noteThreshold applies for this specific thrombocytopenia indication

Coverage durationTypically 1 year when criteria met

inv-117: Baseline platelet count for severe aplastic anemia (< 30,000 / mcl)

Severe aplastic anemia baseline platelet count< 30,000 / mcl

ContextThreshold specified for severe aplastic anemia indication

Coverage durationTypically 1 year when criteria met

inv-118: Liver fibrosis stage for NASH/MASH (F2 to F3)

Liver fibrosis stage requirementF2 to F3 (advanced liver fibrosis) verified by FibroScan or imaging-based noninvasive assessment

Prerequisite therapyTrial of semaglutide required prior to authorization

Renewal criteriaRenewal requires no progression to cirrhosis and evidence of response or clinical benefit

inv-119: Bone mineral density (T-score) requirement

Bone mineral density (T-score) requirement<= -2.5 (T-score at or below -2.5)

DocumentationBMD must be documented in the medical record

Prior therapiesTrial of listed agents (Jubbonti or Stoboclo) and an oral bisphosphonate (or IV if intolerant) required

inv-120: Hemoglobin threshold (≤ 9.5 g/dL) for PNH EVH

Hemoglobin threshold (PNH EVH)<= 9.5 g/dL

ContextRequired laboratory threshold for extravascular hemolysis in PNH

Combination therapyMust be used in combination with Soliris or Ultomiris only

inv-121: Absolute reticulocyte count (≥ 120 × 10^9/L) for PNH EVH

Absolute reticulocyte count threshold>= 120 × 10^9/L

ContextRequired laboratory threshold for EVH in PNH (with Hgb <= 9.5 g/dL)

Combination therapyTreatment must be combined with Soliris or Ultomiris

inv-122: Left ventricular ejection fraction (LVEF) threshold (< 45%) for heart failure agents

LVEF threshold< 45%

Additional HF criteriaNYHA class II-IV and recent HF hospitalization within 6 months OR outpatient IV diuretic within 3 months required

Concomitant therapyMust be taken with at least two specified HF therapies unless contraindicated

inv-123: Insulin claim history requirement (claim in last 180 days) for supplies

Insulin claim history requirementClaim for an insulin product in the last 180 days

Applies toCoverage for alcohol prep pads and gauze supplies

DocumentationClaim history must be present in pharmacy/claims records

inv-124: Paliperidone LAI duration requirement (once-monthly x4 months OR every-3-months x1 cycle)

Paliperidone LAI duration requirementOnce-monthly paliperidone palmitate for at least 4 months OR every-three-month paliperidone palmitate for at least one 3-month cycle

Applies toInvega Hafyera prior authorization (maintenance LAI requirement)

Coverage durationCoverage duration noted as lifetime when requirement met

Provider Actions, Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for drugs listed with (PA); clinical and/or administrative criteria must be met before coverage is provided.

Prior Authorization

Adbry prior authorization requirements

Adbry requests must document patient age ≥ 12 years, trial and failure of one listed topical or systemic agent, and dosing limits for responders <100 kg; coverage duration: 1 year.

Age at least 12 years
Trial and treatment failure of one of: high‑potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil
Cannot be used in combination with another biologic/targeted DMARD for same condition
For patients <100 kg who respond at 16 weeks, dosage limited to 300 mg every 4 weeks unless rationale provided
Coverage duration: 1 year

Prior Authorization

Cimzia prior authorization and duration

Coverage duration: 1 year
Cannot be used in combination with another biologic/targeted DMARD for the same condition
Indication‑specific prerequisite trials required (e.g., RA and PsA require trials of specified biologics/DMARDs)
Reauthorization requires documentation of positive clinical response

Prior Authorization

Dupixent PA prerequisites and 1‑year duration

Cannot be used in combination with another biologic/targeted DMARD for the same condition
Coverage duration: 1 year
Atopic dermatitis: trial and failure of one of listed topical/systemic agents
Eosinophilic asthma: eosinophil ≥150 cells/µL at initiation and failure of controller therapy per criteria
COPD add‑on: eosinophil ≥300 cells/µL and concomitant LABA/LAMA/ICS

Prior Authorization

General PA expectations and typical 1‑year duration

Most product prior authorizations in this list are granted for one year; PA requests must meet the product‑specific indications and any required prerequisite therapy trials.

Typical coverage duration: 1 year
PA requires documentation meeting the product‑specific criteria and prerequisite therapy trials where specified

Documentation Required

Reauthorization requires documented positive clinical response

Reauthorization for many biologic and specialty agents requires documentation of a positive clinical response to the therapy to support continued coverage.

Submit clinical documentation demonstrating improvement or maintained benefit at reauthorization
Applies to multiple biologics (example: Adbry, Cimzia, Dupixent)

Prior Authorization

T2DM PA — confirm diagnosis or lab evidence

Acceptable documentation: chart notes or lab results showing A1C ≥ 6.5%, fasting plasma glucose ≥ 126 mg/dL, or 2‑hour OGTT ≥ 200 mg/dL
Requests for GLP‑1 agents are excluded if used for weight loss only

Prior Authorization

Biologic PA — diagnosis and mandated prior trials

Provide indication‑specific prior therapy trials as listed (e.g., one DMARD for RA; NSAID for AS)
Document positive clinical response for reauthorization

Step Therapy

Methotrexate trial required before biologic PA

Document trial of methotrexate tablet or inability to use oral methotrexate
PA typically issued for 1 year when criteria met

Prior Authorization

Combination endocrine therapy required for specified breast cancer indications

Combination use with an aromatase inhibitor or fulvestrant as specified in the product entry
Coverage duration: 1 year

Prior Authorization

NSCLC — amivantamab combination requirement

Coverage for specified NSCLC indications requires combination use with amivantamab; confirm combination regimen in the PA request.

Confirm intended concurrent use with amivantamab for locally advanced or metastatic NSCLC per product criteria
Coverage duration: 1 year

Prior Authorization

RCC — pembrolizumab (and other) combination requirements

First‑line RCC coverage requires combination with pembrolizumab; other RCC settings require specified combinations (e.g., everolimus after prior anti‑angiogenic therapy).

Document combination with pembrolizumab for first‑line RCC where required
Document prior anti‑angiogenic therapy and planned combination with everolimus where applicable

Prior Authorization

KRAS G12C NSCLC — prior systemic therapy required

Lumakras (KRAS G12C) and similar agents require at least one prior systemic therapy for locally advanced or metastatic NSCLC; expect PA for 1 year.

Document at least one prior systemic therapy for KRAS G12C–mutated NSCLC
Coverage duration: 1 year

Prior Authorization

mCRC — prior chemo and panitumumab combination required

For KRAS G12C–mutated metastatic colorectal cancer, PA requires prior fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy and combination use with panitumumab as specified.

Document prior receipt of fluoropyrimidine, oxaliplatin, and irinotecan regimens
Document plan for combination with panitumumab

Prior Authorization

Lynparza — platinum‑based prior chemotherapy required

Document prior platinum‑based chemotherapy response for ovarian maintenance
For mCRPC, document prior androgen receptor‑directed therapy
Coverage duration: 1 year

Prior Authorization

Mekinist — BRAF/MEK therapy rules and combination constraints

Monotherapy only for BRAF‑inhibitor‑naïve unresectable/metastatic melanoma with BRAF V600E/V600K detected by FDA‑approved test
Requires trial of vemurafenib + cobimetinib used in combination
Many indications require combination with dabrafenib

Prior Authorization

Mekinist (tablet) PA — trials and 1‑year coverage

Mekinist tablet PA: prior authorization required; coverage duration 1 year; prior trial of vemurafenib + cobimetinib and combination/dabrafenib requirements apply per indication.

Prior authorization required
Coverage duration: 1 year
Prior trial of vemurafenib + cobimetinib required where specified

Prior Authorization

Mekinist (liquid SOLR) PA when tablets not tolerated

Mekinist SOLR (liquid) requires PA when patient cannot swallow tablets; coverage duration 1 year and same BRAF mutation and combination/prior therapy requirements as the tablet formulation.

Patient must be unable to swallow tablets
Same BRAF V600E/V600K and prior therapy/combination requirements as tablet
Coverage duration: 1 year

Prior Authorization

Mektovi PA — oncology prior trials and 1‑year duration

Prior authorization required
Prior trial of vemurafenib + cobimetinib required for melanoma
Combination with encorafenib required for melanoma and NSCLC per product criteria
Coverage duration: 1 year

Prior Authorization

Nucala PA — eosinophil thresholds and documentation

Eosinophilic asthma: eosinophils ≥150 cells/µL at initiation and failure of controller therapy per criteria
HES: eosinophils ≥1000 cells/µL and stability on HES therapy
CRSwNP, EGPA, COPD add‑on each have specified diagnostic/lab requirements
Cannot be used in combination with another biologic/targeted DMARD for same condition
Coverage duration: 1 year

Step Therapy

Migraine — trial of two generic triptans required

Trial of ≥2 generic triptans required prior to approval unless contraindicated or not tolerated
Document trials in the PA submission

Step Therapy

Posaconazole — step therapy: trial of two alternative azoles

Posaconazole DR prophylaxis/treatment PAs require trials of two alternative azoles (choose two of fluconazole, itraconazole, voriconazole) before approval.

Prophylaxis: trial with two of fluconazole, itraconazole, or voriconazole required
Treatment: trial with two of the listed azoles required

Prior Authorization

Praluent — LDL and statin criteria for initiation

Document LDL while on high‑intensity statin within last 120 days
Require at least 12 weeks of high‑intensity statin unless intolerant
Reauthorization: continued background therapy and documented LDL reduction
Coverage duration noted (e.g., 3 years in entry)

Prior Authorization

Prevymis — CMV prophylaxis eligibility and 1‑year coverage

Prevymis PA for CMV prophylaxis covers CMV‑seropositive HSCT recipients and high‑risk kidney transplant recipients (donor + / recipient −); coverage duration: 1 year.

Eligible: CMV‑seropositive HSCT recipients (R+) or high‑risk kidney transplant recipients (D+/R-)
Coverage duration: 1 year

Prior Authorization

Retevmo — RET testing and indication‑specific prerequisites

RET alteration must be detected by an FDA‑approved test
Document prior RAI for thyroid cancer when appropriate or prior systemic therapy for RET‑fusion solid tumors
Coverage duration: 1 year

Prior Authorization

Rubraca — BRCA mutation and prior chemo requirements

Rubraca maintenance coverage requires a deleterious BRCA mutation and response to platinum‑based chemotherapy; MCRPC indication requires prior androgen‑receptor‑directed therapy.

Document deleterious BRCA mutation for ovarian maintenance
Document prior platinum‑based chemotherapy response
For MCRPC, document prior AR‑directed therapy

Step Therapy

Initial conservative therapy trial required (example)

Trial of at least two of: furosemide, demeclocycline, or fluid restriction required
Document absence of underlying liver disease if requested
Coverage duration: 1 month

Prior Authorization

Simponi PA — trials, combination exclusion, reauthorization

Trial of two alternatives (list varies by indication)
Cannot be used in combination with another biologic/targeted DMARD for same condition
Reauthorization requires documentation of positive clinical response
Coverage duration: 1 year

Prior Authorization

Stelara PA — trials, exclusions, reauth

Cannot be used in combination with another biologic/targeted DMARD for same condition
Reauthorization requires documented positive clinical response
Coverage duration: 1 year

Prior Authorization

Talzenna — enzalutamide combination required

Talzenna for mCRPC requires use in combination with enzalutamide per the PA criteria; coverage duration: 1 year.

Document combination use with enzalutamide
Coverage duration: 1 year

Prior Authorization

Erlotinib — concurrent/combination therapy and prescriber restriction

Erlotinib PAs require concurrent appropriate‑line systemic therapy for NSCLC and combination with gemcitabine for pancreatic cancer; prescriber must be an oncologist; coverage duration: 1 year.

NSCLC: concurrent first‑line/maintenance/second+ line therapy after progression following ≥1 prior chemotherapy regimen
Pancreatic cancer: must be used in combination with gemcitabine
Prescriber restriction: oncologist
Coverage duration: 1 year

Prior Authorization

Bexarotene — refractory disease requirement

Capsule: refractory to ≥1 prior systemic therapy
Gel: refractory/persistent after or intolerant of other therapies
Prescriber restriction: dermatologist or oncologist
Coverage duration: 1 year

Prior Authorization

Nilotinib — prior TKI/imatinib therapy required

Document prior therapy including imatinib for adult CML settings
Pediatric patients require prior TKI trial
Coverage duration: 1 year

Prior Authorization

Tazverik — prior systemic therapies required

Tazverik prior authorization for EZH2‑mutant follicular lymphoma requires prior treatment with at least two systemic therapies; coverage duration: 1 year.

Document ≥2 prior systemic therapies
Coverage duration: 1 year

Prior Authorization

Thalomid — combination therapy requirement

Thalomid coverage for multiple myeloma requires combination use with dexamethasone; coverage for ENL with moderate‑to‑severe neuritis requires combination therapy; coverage duration: 1 year.

Document combination use with dexamethasone for MM
ENL with neuritis: part of combination therapy
Coverage duration: 1 year

Prior Authorization

Tibsovo — prior treatment required

Tibsovo coverage for cholangiocarcinoma requires prior treatment; coverage duration: 1 year.

Document prior therapy for cholangiocarcinoma
Coverage duration: 1 year

Prior Authorization

Tivdak — progression after chemotherapy required

Tivdak coverage for recurrent or metastatic cervical cancer requires disease progression on or after chemotherapy; coverage duration: 1 year.

Document disease progression on/after chemotherapy
Coverage duration: 1 year

Prior Authorization

Trodelvy — prior systemic therapies required for TNBC

Trodelvy for unresectable locally advanced or metastatic triple‑negative breast cancer requires prior use of two or more systemic therapies (one for metastatic disease); coverage duration: 1 year.

Document prior use of ≥2 systemic therapies with ≥1 for metastatic disease
Coverage duration: 1 year

Prior Authorization

Truqap — endocrine therapy progression and fulvestrant combo

Document progression on ≥1 endocrine regimen or recurrence within 12 months
Document planned combination with fulvestrant
Coverage duration: 1 year

Prior Authorization

Tukysa — prior regimens and combination requirements

Document prior anti‑HER2 regimen(s)
Document planned combination with trastuzumab + capecitabine
For mCRC, document prior fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapy

Step Therapy and Required Prior Trials

Requirement	Details
Step therapy required where specified
See individual product entries for specific step therapy requirements (number and class of prior agents vary by drug and indication).

Requirement	Details
Number and list of required prior agent trials vary by drug and indication
Examples: RA/PsA/psoriasis agents commonly require trials of two listed alternatives; some oncology and specialty agents list indication‑specific prior therapies—see product nodes for exact lists.

Requirement	Examples / Notes
Two generic alternatives or multiple prior systemic therapies may be required
Epidiolex: trial of 2 generic alternatives for Lennox‑Gastaut and TSC seizures; many oncology agents (e.g., Fotivda) require two or more prior systemic therapies.

Requirement	Supported by (product examples)
Trial of specified prior therapy is required and must be documented
Methotrexate trial required for some biologics; products require documentation of prior DMARD or other named prior agents per product entry.

Requirement	Products / Details
Trial of two specified biologic/targeted DMARDs required
Example: Kevzara and Kineret for RA indications require trials of two of listed alternatives (e.g., Enbrel, adalimumab biosimilars, Rinvoq, Xeljanz/XR, Orencia).

Requirement	Details
Antipsychotic prior trial required
Lybalvi and similar atypical antipsychotic approvals require trial of at least one listed generic antipsychotic (e.g., aripiprazole, quetiapine, risperidone).

Requirement	Product examples
Multiple products require prior trials of specific agents or classes
Examples include two generic triptans prior to acute migraine agents; vemurafenib + cobimetinib prior to Mekinist/Mektovi in BRAF‑mutant melanoma; other oncology combos noted per product.

Requirement	Details / Examples
Trials of specified prior therapies required before approval
Acute migraine: trial of at least two generic triptans required; Posaconazole DR prophylaxis/treatment requires trial with two of fluconazole, itraconazole, or voriconazole.

Requirement	Products / Details
Bisphosphonate trial required prior to specified osteoporosis agents
Jubbonti and Stoboclo require trial of an oral bisphosphonate or, if intolerant, an IV bisphosphonate; Tymlos also requires prior osteoporosis therapies and BMD documentation (T‑score ≤ -2.5).

Requirement	Products / Details
Semaglutide trial required prior to NASH/MASH agents
Coverage for NASH/MASH requires diagnosis with advanced fibrosis (F2–F3) and a prior trial of semaglutide before authorization.

Requirement	Details / Examples
Conservative therapy trial required before tolvaptan
Requires trial of at least two of furosemide, demeclocycline, or fluid restriction documented prior to tolvaptan authorization.

Requirement	Details
Many biologic agents require documented trials of specified alternatives (commonly two prior therapies)
Simponi, Stelara, Taltz and other biologics specify trials of two listed alternative biologic/targeted agents or DMARDs prior to coverage; reauthorization generally requires documented clinical response.

Requirement	Details / Examples
Product-specific trials required before coverage
Actemra, Trodelvy, many oncology and specialty products list required prior systemic therapies or combinations—see each product entry for the enumerated agents.

Requirement	Details
PAH step therapy — trial of PDE5 inhibitor and endothelin receptor antagonist required
Pulmonary arterial hypertension coverage requires trial of both a generic PDE5 inhibitor (sildenafil or tadalafil) and a generic endothelin receptor antagonist (bosentan or ambrisentan) prior to approval.

Requirement	Details
Somatostatin analog trial required for carcinoid diarrhea
Coverage for carcinoid syndrome diarrhea requires prior trial of somatostatin analog therapy (e.g., octreotide, lanreotide).

Requirement	Details
Trials of prior agents enumerated per product
Many products (notably oncology and specialty agents) list specific prior therapies or lines of therapy required — e.g., Xpovio requires failure of one prior therapy for MM and multiple class failures for relapsed/refractory disease.

Requirement	Details / Examples
Antidepressant step — trial of at least 2 listed generic antidepressants required
Desvenlafaxine/Trintellix/Exxua initiation requires documented trial of at least two generic antidepressants from the listed options prior to coverage.

Requirement	Details / Examples
Antipsychotic step — trial of at least one listed generic antipsychotic required
Prior trial of one listed generic antipsychotic (e.g., aripiprazole, risperidone, quetiapine) is required before coverage of certain atypical antipsychotics (Caplyta, Rexulti, Vraylar, Zyprexa Relprevv).

Requirement	Details / Duration
Paliperidone LAI prior use requirement for Invega Hafyera
Requires prior use of once‑monthly paliperidone palmitate for at least 4 months OR an every‑three‑month paliperidone palmitate cycle for at least one 3‑month cycle; coverage duration is lifetime.

Requirement	Details / Exceptions
SGLT2 step therapy — trial of generic dapagliflozin required
Farxiga and Jardiance requests require prior trial of generic dapagliflozin; exception: step therapy does not apply to Jardiance when used to reduce risk of cardiovascular death in adults with T2DM and established CVD.

Information to provide	Notes
Provide setting and intended use to determine Medicare Part B vs Part D coverage
Submit information describing the use and setting of the drug (e.g., outpatient infusion in physician office vs pharmacy dispensed outpatient) to determine benefit processing under Medicare Part B or Part D.

Continuation / Reauthorization Requirements

Actionable Highlights and Denial Risks

Denial Risk

Denial risk if PA/ST criteria not met

Failure to meet the listed PA or ST clinical and administrative criteria may result in denial of the request.

Ensure all prerequisite trials, diagnostic tests, and documentation are included with the PA submission

Denial Risk

Tadalafil‑nitrate drug‑drug exclusion

Tadalafil is not covered when the patient is receiving nitrate therapy; do not submit PA for concurrent nitrate use.

Coverage is not provided for tadalafil in situations where patients are receiving nitrate therapy

Denial Risk

Dalfampridine — functional status exclusion and documentation

Dalfampridine is excluded for use in patients who are wheelchair‑bound or who become wheelchair‑bound; baseline T25FW must be submitted prior to initiation.

Excluded if patient is wheelchair‑bound or becomes wheelchair‑bound
Submit baseline timed 25‑foot walk (T25FW) prior to initiation

Denial Risk

Combination biologic/targeted DMARD exclusion

Use of a biologic or targeted DMARD in combination with another biologic/targeted DMARD indicated for the same condition is prohibited and may lead to denial.

Do not combine biologic/targeted DMARDs for the same indication when requesting PA
Absence of documentation confirming monotherapy where required may trigger denial

Denial Risk

Indication exclusion — weight‑loss use

Requests for products used solely for weight‑loss purposes are excluded from coverage; clearly document the indication to avoid denial.

Excluded if medication is used solely for weight loss
Examples: liraglutide excluded if used for weight loss only

Note

Denial Risk

Heart failure coverage triggers — documentation required

Document NYHA II–IV and LVEF <45%
Provide evidence of HF hospitalization within 6 months OR outpatient IV diuretic within 3 months

Denial Risk

H. pylori — diagnosis and guideline regimen trial required

Document H. pylori infection diagnosis
Document trial of a guideline‑recommended first‑line generic regimen (clarithromycin triple or bismuth quadruple)

Denial Risk

PNH EVH — lab thresholds and combination requirement

Hgb ≤ 9.5 g/dL and absolute reticulocyte count ≥ 120 × 10^9/L required
Must be used in combination with Soliris or Ultomiris

Denial Risk

Demodex — slit‑lamp confirmation required

Demodex blepharitis coverage requires confirmation via presence of collarettes on slit‑lamp exam; absence of this finding may lead to denial.

Provide slit‑lamp exam documentation showing collarettes
Lack of exam confirmation may result in coverage denial

Denial Risk

Reauthorization and prerequisite‑therapy documentation gaps — denial risk

Failure to document required reauthorization information or prerequisite therapy trials (e.g., for CSU or CRSwNP) may result in denial of continued coverage.

Reauthorization requires documentation of positive clinical response for many biologics
Ensure prior therapy trials (e.g., second‑generation antihistamine for CSU; intranasal corticosteroids for CRSwNP) are documented

Denial Risk

MG documentation required — denial risk if missing

For myasthenia gravis PAs, absence of required confirmatory testing (anti‑AChR antibody plus one confirmatory test) or documentation of prior immunosuppressant courses may result in noncoverage.

Anti‑AChR antibody positive result plus one confirmatory test required
Document prior courses (≥12 weeks) of listed immunosuppressants or provide contraindication/intolerance

Denial Risk

Oxcarbazepine ER — trial documentation required or denial

Oxcarbazepine ER requests will be denied unless trials or intolerance to at least two generic anticonvulsants are documented.

Document trial or intolerance to ≥2 generic anticonvulsants
Coverage duration for qualifying patients: lifetime

Denial Risk

Antidepressant step — documentation required to avoid denial

Desvenlafaxine/Trintellix/Exxua PAs will be denied if trials of at least two listed generic antidepressants are not documented.

Document trials of ≥2 listed generic antidepressants
Coverage duration: lifetime when criteria met

Denial Risk

Antipsychotic step — trial documentation required

Antipsychotic PAs (Caplyta, Rexulti, Vraylar, Zyprexa Relprevv) require documentation of trial of at least one listed generic antipsychotic; lacking this may lead to denial.

Document trial of ≥1 listed generic antipsychotic
Coverage duration: lifetime when documented

Billing Rule

Insulin claim required for supplies coverage

Coverage for alcohol prep pads/gauze requires an insulin claim within the prior 180 days; absence of an insulin claim will preclude coverage.

Provide claim history showing insulin fill in last 180 days

Step Therapy

Febuxostat — allopurinol trial/contraindication required

Febuxostat prior authorization will be denied if trial of or documented contraindication/intolerance to allopurinol is not provided.

Document trial of allopurinol or provide documented contraindication/intolerance

Site of Care and Medicare Part B vs Part D Considerations

Note

Medicare Part B vs Part D — provide use and setting information

When a drug may be covered under Medicare Part B or Part D, submit information describing the intended use and site/setting to allow correct benefit determination (Part B vs Part D).

Provide use and setting details (e.g., physician‑administered in infusion center vs outpatient pharmacy) with the PA request

Background and Policy Scope

Definitions and Key Terms

inv-286: Prior authorization (PA) definition

Prior authorization (PA)A process where clinical and/or administrative criteria must be met before coverage is provided for specified medications.

PurposeEnsures appropriate and cost-effective drug therapy per P&T Committee recommendations

IdentifiersDrugs subject to PA/ST are identified in formulary with (PA) or (ST)

inv-287: Step therapy (ST) definition

Step therapy (ST)Requirement that members try and fail specified formulary drugs before a non-formulary or higher-cost drug is covered.

ApplicationSome drugs require prior treatment with one or more formulary drugs (examples provided in policy)

IdentificationDrugs subject to step therapy are identified in the formulary with (ST)

inv-288: Reauthorization definition

ReauthorizationRenewal of prior authorization which, for many biologics, requires documentation of positive clinical response to therapy.

DocumentationMedical records or clinical notes showing improvement or benefit required at reauth

Common durationCoverage durations for reauth commonly set to 1 year

inv-289: EGPA definition

Feature requirementTwo typical EGPA features required for coverage

Related testingEosinophil counts and diagnostic workup per product (eg Nucala) required

inv-290: T2DM diagnostic criteria

T2DM diagnostic criteriaDiagnosis documented by A1C >= 6.5% OR fasting plasma glucose >= 126 mg/dL OR 2-hour plasma glucose >= 200 mg/dL on OGTT

Documentation optionsMedical records (chart notes) or lab values acceptable for PA submission

ExclusionAgents excluded if used solely for weight loss

inv-292: BRAF V600E/V600K mutation definition

BRAF V600E or V600K mutationTumor genomic alteration (BRAF V600E or V600K) detectable by an FDA‑approved test required for Mekinist coverage in specified indications

ApplicationRequired for melanoma, NSCLC, ATC, certain solid tumors, and low-grade glioma indications

Prerequisite therapyMekinist often requires prior or concurrent BRAF inhibitor combination therapy as specified

inv-295: RET alteration definition

RET alterationPresence of RET gene fusion or RET mutation as detected by an FDA‑approved test required for Retevmo coverage

Indication examplesRET fusion in NSCLC, RET mutation in MTC, RET fusion in other solid tumors per product criteria

Prior therapy notesSome indications require prior therapies (eg RAI for thyroid when appropriate)

inv-296: Deleterious BRCA mutation-associated definition

Deleterious BRCA mutation-associatedBRCA mutation associated with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer required for Rubraca maintenance coverage

Therapy contextMaintenance coverage requires response to platinum-based chemotherapy

TestingGenetic testing documentation required

inv-297: FOP genetic confirmation requirement

FOP genetic confirmationCoverage for fibrodysplasia ossificans progressiva requires genetic testing confirmation showing an ACVR1 mutation

DocumentationGenetic test report required in medical record for PA

Coverage noteIf genetic confirmation absent, not eligible per policy

inv-298: Chronic heart failure criteria (NYHA II-IV, LVEF <45%)

Chronic heart failure criteriaNYHA class II-IV with LVEF <45%

Additional qualifying eventsRecent HF hospitalization within 6 months OR outpatient IV diuretic within prior 3 months typically required

Concomitant therapyMust be taken with at least two specified HF therapies unless contraindicated

inv-299: PNH EVH thresholds definition

PNH EVH thresholdsHemoglobin <= 9.5 g/dL AND absolute reticulocyte count >= 120 × 10^9/L

Combination therapy requirementTreatment must be used in combination with Soliris or Ultomiris only

DocumentationLab values must be documented in medical record for PA

inv-300: CRSwNP definition

CRSwNPChronic rhinosinusitis with nasal polyposis; coverage requires diagnosis and recurrent disease despite intranasal corticosteroid therapy

Prior therapyFailure of intranasal corticosteroids (eg fluticasone, mometasone) required

ReauthorizationDocumentation of positive clinical response required for continued coverage

inv-301: Anti-AChR antibody positive MG definition

Prior therapy requirementPrevious treatment courses of at least 12 weeks with listed immunosuppressants required unless contraindicated

DocumentationLab record and confirmatory test required in PA submission

inv-302: Paliperidone LAI description and duration thresholds

Paliperidone LAI descriptionOnce-a-month paliperidone palmitate extended-release injectable suspension (maintenance LAI)

Duration thresholds for Invega HafyeraOnce-monthly for >=4 months OR every-three-month formulation for >= one 3-month cycle required prior to Invega Hafyera

DocumentationPrior use must be documented in medical record for PA

Policy Summary

Payerblue cross blue shield - michigan

PolicyPrior authorization and step therapy criteria — pharmacy & specialty drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2026

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required clinical documentation (e.g., diagnostic labs, prior therapy trials) because PA is required for listed drugs.

SourceLink

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