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Prior authorization and step therapy criteria for specialty and pharmacy drugs

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Lists prior authorization and step therapy requirements for multiple prescription drugs under the BCBSM Medicare Plus Blue Group PPO and Prescription Blue Group PDP Healthy Value Enhanced Comprehensive Formulary for the 2026 plan year; affects prescribers and pharmacists seeking drug coverage for plan members.

Policy Summary

Payerblue cross blue shield - michigan

PolicyPrior authorization and step therapy criteria for specialty and pharmacy drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionContact the pharmacy help desk to request prior authorization or step therapy and submit required clinical documentation per product-specific criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

391document pages

multipleproducts with PA/ST criteria

1 YEARtypical coverage duration

Product-Specific Coverage Criteria

Adbry — Initial and reauthorization criteria

Covered when ALL of the following are met:

Adbry initial coverage: Patient is at least 12 years of age AND diagnosis of moderate to severe atopic dermatitis AND trial and treatment failure of one of: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil.

Reauthorization requires documentation of positive clinical response; dosing limit for patients <100 kg after 16 weeks to 300 mg every 4 weeks unless clinical rationale provided.

Braftovi — Indication-based requirements

Covered when ANY of the following indication-specific conditions are met:

Braftovi indication-specific requirements: Coverage for BRAF V600E or V600K mutated unresectable or metastatic melanoma requires prior trial of vemurafenib + cobimetinib or use in combination with binimetinib; metastatic CRC with BRAF V600E requires combination with cetuximab and fluorouracil-based chemotherapy (or cetuximab after prior therapy); metastatic NSCLC with BRAF V600E requires combination with binimetinib.

Coverage requires the combination or prior therapy per indication.

Prerequisite therapy and testing requirements

Covered when ALL of the following prerequisite therapy or testing requirements are met (product-specific):

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

From product-specific prerequisite therapy listing.

Brukinsa/Bosulif (selected hematologic agents): Coverage requires documentation of trials of specified prior agents as listed for each hematologic indication (e.g., trial of Calquence for MCL; anti-CD20 regimen for MZL; prior systemic lines for FL).

Refer to product-specific entry for required prior agents.

Bronchitol tolerance: Documentation that the member has passed the Bronchitol tolerance test is required prior to coverage.

From Bronchitol entry.

Octreotide (acromegaly): Trial of bromocriptine mesylate at maximally tolerated doses is required prior to coverage of octreotide for acromegaly.

From octreotide prerequisite therapy requirement.

General coverage conditions

Covered when ALL of the following general conditions are satisfied:

Combination biologic/DMARD restriction: Requested product is not being used in combination with another biologic or targeted DMARD indicated for the same condition.

Applies across multiple biologic entries (combination exclusion).

Reauthorization requirement: Reauthorization requires documentation of positive clinical response to therapy for biologic and other specialty agents.

Stated across multiple products.

Indication-specific prior therapy: Coverage for many products requires trials of specified prior therapies (e.g., trials of generic anticonvulsants for seizure-indications; DMARD or NSAID trials for rheumatologic indications; prior systemic chemotherapy for many oncology agents).

See product-level entries for details.

Cosentyx — indication criteria

Covered when ALL of the following indication-specific criteria are met:

Psoriatic arthritis: Diagnosis of active psoriatic arthritis documented.

From Cosentyx product entry.

Plaque psoriasis: Diagnosis of moderate to severe chronic plaque psoriasis documented.

From Cosentyx product entry.

Ankylosing spondylitis: Diagnosis of ankylosing spondylitis AND trial of one NSAID (e.g., diclofenac, ibuprofen, meloxicam, naproxen).

From Cosentyx product entry.

Non-radiographic axial spondyloarthritis: Diagnosis with objective signs of inflammation AND trial of one NSAID.

From Cosentyx product entry.

Hidradenitis suppurativa: Diagnosis of moderate to severe hidradenitis suppurativa documented.

From Cosentyx product entry.

Tadalafil — BPH

Covered when ALL of the following are met:

BPH diagnosis: Diagnosis of benign prostatic hyperplasia documented.

Tadalafil not covered when patient is receiving nitrate therapy (contraindication/exclusion).

Dalfampridine — MS mobility

Covered when ALL of the following are met:

Ambulatory status and testing: Patient is not wheelchair bound AND baseline timed 25-foot walk (T25FW) test submitted prior to initiation.

Dalfampridine is excluded if patient is wheelchair bound or becomes wheelchair bound; reauthorization requires stability or improvement on T25FW.

Epidiolex — seizure disorder criteria

Covered when ANY of the following, per syndrome, are met:

Lennox-Gastaut syndrome: Diagnosis of Lennox-Gastaut syndrome AND trial of two generic alternatives for seizure treatment.

From Epidiolex seizure indications.

Dravet syndrome: Diagnosis of Dravet syndrome AND trial of two of: valproic acid, clobazam, or topiramate.

From Epidiolex seizure indications.

Tuberous sclerosis complex seizures: Diagnosis of seizures associated with tuberous sclerosis complex AND trial of two generic alternatives for seizure treatment.

From Epidiolex seizure indications.

Seizure-related step therapy

Examples of seizure-related step therapy (covered when the listed trials are documented):

Lennox-Gastaut step: Trial of two generic anticonvulsant alternatives documented prior to approval for Lennox-Gastaut syndrome.

From seizure-related step therapy examples.

Dravet step: Trial of two of valproic acid, clobazam, or topiramate documented prior to approval for Dravet syndrome.

From seizure-related step therapy examples.

Tuberous sclerosis complex step: Trial of two generic anticonvulsant alternatives documented prior to approval for tuberous sclerosis complex seizures.

From seizure-related step therapy examples.

Topiramate clinical criteria

Covered when ANY of the following apply:

Migraine prevention: Trial of at least two generic alternatives for migraine prevention documented OR patient unable to swallow tablets/capsules.

From topiramate clinical criteria.

Seizure disorder/epilepsy: Trial of at least two generic anticonvulsants documented OR patient unable to swallow tablets/capsules.

From topiramate clinical criteria.

Schizophrenia prerequisite therapy

Covered when ALL of the following are met:

Schizophrenia prior therapy: Diagnosis of schizophrenia AND trial of two generic formulary atypical antipsychotics (examples: aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone).

From schizophrenia prerequisite therapy entry.

Fasenra coverage criteria

Covered when ALL of the following per-indication criteria are met:

Eosinophilic asthma (EA): Diagnosis of eosinophilic asthma with eosinophil count ≥150 cells/µL at initiation AND failure to maintain control after trial of systemic corticosteroids OR high-dose inhaled corticosteroids plus trial of one additional controller (e.g., leukotriene modifier, LABA, or LAMA).>=150 cells/µL

Applies to adults and children per product labeling.

EGPA: Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) AND at least two typical clinical features consistent with EGPA (e.g., histopathologic eosinophilic vasculitis, neuropathy, pulmonary infiltrates, nasal polyps, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, ANCA positivity).

From Fasenra indication entry.

Reauthorization: For all indications, reauthorization requires documentation of positive clinical response to therapy.

Reauthorization requirement stated for biologics.

Osteoporosis product criteria

Covered when ALL of the following are met:

Bone mineral density: Documentation of bone mineral density T-score ≤ -2.5.T-score <= -2.5

Required baseline BMD for osteoporosis product coverage.

Prior therapy requirement: Trial of both Jubbonti or Stoboclo AND either an oral bisphosphonate (or IV bisphosphonate if intolerant) documented prior to approval OR documentation that patient is unable to be treated with listed options.

From osteoporosis product criteria.

Antiseizure product requirements

Covered when ALL of the following are met (product-specific antiseizure prerequisites):

Fintepla: Trial of two of the following: valproic acid, clobazam, topiramate documented prior to coverage for indicated seizures.

From antiseizure product examples.

Other antiseizure agents: Coverage for select antiseizure agents requires trial of two generic anticonvulsants prior to approval.

General antiseizure requirement entry.

Adalimumab class criteria

Covered when ALL of the following are met:

Adalimumab-class indications: Diagnosis appropriate to indication (e.g., moderately to severely active RA) AND trial of at least one DMARD where specified (e.g., methotrexate, leflunomide, sulfasalazine).

Reauthorization requires documentation of positive clinical response; cannot be used in combination with another biologic/targeted DMARD for same condition.

Combination exclusion: Product is not being used in combination with another biologic or targeted DMARD indicated for the same condition.

Applies across adalimumab biosimilars.

Selected oncology coverage conditions

Covered when ALL of the following product- and indication-specific criteria are met:

Breast cancer combination requirement: For HR-positive, HER2-negative advanced/metastatic breast cancer coverage requires combination with an aromatase inhibitor as initial endocrine-based therapy or with fulvestrant after progression; endocrine-resistant PIK3CA-mutated disease requires combination with inavolisib and fulvestrant as specified.

From Ibrance product entry.

Iclusig/Ph+ leukemias: For newly diagnosed Ph+ ALL coverage requires combination with chemotherapy; monotherapy allowed for T315I-positive Ph+ ALL when no other kinase inhibitors indicated; T315I-positive CML coverage provided; other chronic-phase CML indications require trial of at least two prior therapies.

From Iclusig product entry.

Breast cancer — combination therapy requirements

Covered when ALL of the following are met:

HR+/HER2- breast cancer: Diagnosis of HR-positive, HER2-negative advanced or metastatic breast cancer AND combination use with an aromatase inhibitor as initial endocrine therapy or with fulvestrant after progression on endocrine therapy; for endocrine-resistant, PIK3CA-mutated disease requires combination with inavolisib and fulvestrant following recurrence on/after adjuvant endocrine therapy.

From Ibrance product entry.

Philadelphia chromosome–positive leukemias

Covered when ANY of the following scenarios apply (per disease phase/mutation):

Ph+ ALL: Newly diagnosed Ph+ ALL requires combination with chemotherapy; T315I-positive Ph+ ALL may be covered as monotherapy when no other kinase inhibitors are indicated.

From Iclusig entry.

CML indications: T315I-positive CML (any phase) covered; accelerated or blast-phase CML covered when no other kinase inhibitors indicated; other chronic-phase CML indications require trial of at least two prior kinase inhibitors.

From Iclusig entry.

Rheumatology agents — trial requirements and combination restrictions

Covered when ALL of the following are met:

Rheumatologic agents prerequisites: Diagnosis appropriate to indication (e.g., moderately to severely active RA) AND trials of required prior agents (examples: trial of two specified agents such as Enbrel, adalimumab biosimilars, Rinvoq, Xeljanz/XR, Orencia) as listed per product entry.

Cannot be used in combination with another biologic/targeted DMARD for same condition.

Activated PI3K delta syndrome (APDS)

Covered when ALL of the following are met:

Joenja for APDS: Diagnosis of activated PI3K delta syndrome (APDS) with documented PI3Kδ mutation AND documented variant in PIK3CD or PIK3R1 AND documented symptoms associated with APDS (e.g., nodal/extranodal lymphoproliferation, recurrent oto‑sino‑pulmonary infections, organ dysfunction).

Molecular and clinical documentation required.

Lenvima indication-specific criteria

Covered when ANY of the following per‑indication criteria are met:

Lenvima (RCC and others): First-line renal cell carcinoma (RCC) coverage requires combination with pembrolizumab; other RCC uses may require combination with everolimus following one prior anti-angiogenic therapy; advanced endometrial carcinoma requires combination with pembrolizumab after progression on prior systemic therapy.

From Lenvima product entry.

Levetiracetam — formulation-specific coverage

Covered when ALL of the following are met:

Levetiracetam oral solution prerequisite: Both: 1) documented trial of levetiracetam oral solution, AND 2) documentation that the patient is unable to swallow tablets or capsules.

Coverage dependent on formulation trials.

Basal cell carcinoma — prior therapy requirement

Covered when ANY of the following are met:

Basal cell carcinoma prior therapy: Coverage for basal cell carcinoma requires either prior treatment with a hedgehog pathway inhibitor OR documentation of ineligibility for hedgehog pathway inhibitor therapy.

From Libtayo/BCC entry.

Oral solution prerequisite

Covered when ALL of the following are met:

Oral solution and swallowing inability: Documentation of trial of oral solution formulation AND documentation patient cannot swallow tablets or capsules.

Example: levetiracetam oral solution prerequisite.

Basal cell carcinoma prerequisite

Basal cell carcinoma hedgehog requirement: Either prior hedgehog pathway inhibitor therapy documented OR documented ineligibility for hedgehog pathway inhibitor treatment.

Coverage duration typically 1 year.

Liraglutide diabetes criteria

Liraglutide diabetes documentation: For ongoing T2DM treatment, submit medical records confirming diagnosis OR lab evidence: A1c ≥6.5% OR fasting plasma glucose ≥126 mg/dL OR 2‑hour plasma glucose ≥200 mg/dL during OGTT.A1c >= 6.5%; FPG >= 126 mg/dL; 2-hour PG >= 200 mg/dL

Excluded if used for weight‑loss only.

Lonsurf combination and prior chemo requirements

Lonsurf for mCRC: Diagnosis of metastatic colorectal cancer AND combination use with bevacizumab AND prior fluoropyrimidine-, oxaliplatin-, irinotecan‑based chemotherapy documented; for RAS wild‑type also requires prior anti‑EGFR therapy.

Coverage duration 1 year.

Lynparza prior therapy requirements

Lynparza prerequisites: Coverage for BRCA/HRR-related ovarian, breast, pancreatic, and prostate cancer indications requires prior platinum‑based chemotherapy or other specified prior therapies depending on indication (e.g., prior enzalutamide/abiraterone for HRR‑mutated mCRPC).

See Lynparza product entries for indication‑specific prior therapy details.

Mavyret per guideline

Mavyret (HCV): Treatment criteria applied consistent with current AASLD/IDSA guidance for hepatitis C virus infection.

Follow guideline-based regimen and eligibility.

Mekinist mutation-based criteria

Mekinist mutation and combination requirements: For BRAF V600E or V600K mutated unresectable/metastatic melanoma coverage as monotherapy only for BRAF‑inhibitor–naive patients; otherwise requires combination with dabrafenib (or other specified BRAF combinations). Liquid formulation requires inability to swallow tablets.mutation documented by FDA‑approved test

Coverage duration 1 year.

Lybalvi prerequisite generics

Lybalvi prerequisite generics: Trial of at least one of the following generic antipsychotics documented: aripiprazole, asenapine, fluphenazine, haloperidol, loxapine, lurasidone, molindone, paliperidone, pimozide, quetiapine, risperidone, thioridazine, thiothixene, trifluoperazine, ziprasidone.

Coverage duration 1 year.

Nucala (mepolizumab) initial and reauthorization criteria

Nucala is covered when ONE of the indication‑specific pathways below is met:

Nucala general: Not used in combination with another biologic/targeted DMARD for the same condition AND documentation meets the indication‑specific diagnostic or treatment criteria; reauthorization requires documentation of clinical benefit.

Cannot be combined with another biologic for same condition.

Eosinophilic asthma (EA): Diagnosis of EA with eosinophils >=150 cells/µL at initiation AND failure to maintain control after trial of systemic corticosteroids OR high‑dose inhaled corticosteroids plus trial of one additional controller (leukotriene modifier OR LABA OR LAMA).eosinophils >=150 cells/µL

Applies to adults and children >=12 years.

EGPA: Diagnosis of EGPA with required clinical features (at least two typical EGPA criteria).

EGPA entry requirements.

HES: Diagnosis of hypereosinophilic syndrome (HES) AND eosinophils >=1000 cells/µL at initiation AND stability on HES therapy (e.g., oral corticosteroids, immunosuppressive or cytotoxic therapy).eosinophils >=1000 cells/µL

HES-specific requirement.

COPD add-on maintenance: Uncontrolled, moderate‑to‑severe COPD AND (current eosinophils >=150 cells/µL OR historical >=300 cells/µL within past 12 months) AND current/planned use of LABA + LAMA + inhaled corticosteroid unless contraindicated.eosinophils >=150 cells/µL or historical >=300 cells/µL

From Nucala COPD criteria.

Nexletol/Nexlizet criteria

Covered when ALL of the following are met:

Nexletol/Nexlizet initiation: Diagnosis of hypercholesterolemia (including HeFH) or elevated ASCVD risk AND documented trial of one high‑intensity statin unless statin intolerance/contraindication documented.

Statin intolerance examples include skeletal muscle symptoms or rhabdomyolysis.

Octreotide (acromegaly) criteria

Covered when ALL of the following are met:

Octreotide for acromegaly: Diagnosis of acromegaly AND trial of bromocriptine mesylate at maximally tolerated doses documented prior to octreotide approval.

From octreotide product criteria.

Opfolda diagnostic and treatment criteria

Covered when ALL of the following diagnostic and treatment criteria are met:

Opfolda (Pompe disease): Confirmation of diagnosis by serum assay showing decreased acid alpha‑glucosidase activity AND genetic testing showing a GAA mutation AND presence of symptomatic manifestations (e.g., progressive muscle weakness, respiratory failure, frequent upper airway infections, orthopnea, sleep apnea, morning headaches) AND lack of improvement on current enzyme replacement therapy.

Cardiac hypertrophy alone is not sufficient; coverage duration 1 year.

Onureg criteria

Covered when ALL of the following are met:

Onureg (maintenance AML): Adult patient with AML who achieved first complete remission (CR) or CR with incomplete count recovery (CRi) after intensive induction chemotherapy and is not able to complete intensive curative therapy.

From Onureg product entry.

Nuedexta criteria

Covered when ALL of the following are met:

Nuedexta for pseudobulbar affect (PBA): Presence of an underlying neurologic condition causing PBA symptoms (e.g., MS, ALS, Parkinson's disease, stroke, TBI) documented.

From Nuedexta product entry.

Pompe disease therapy - initial coverage

Covered when ALL of the following are met:

Pompe disease coverage conditions: (1) Confirmation of diagnosis by serum assay showing decreased acid alpha‑glucosidase activity AND genetic testing showing a GAA mutation; (2) Presence of symptomatic manifestations (e.g., progressive muscle weakness, respiratory failure, frequent upper airway infections, orthopnea, sleep apnea, morning headaches) — must not be limited to cardiac hypertrophy only; (3) No improvement on current enzyme replacement therapy; (4) Prerequisite Part D drug has been used.

Coverage duration = 1 year.

Orencia coverage

Covered when ALL of the following are met:

Orencia coverage: (1) Diagnosis appropriate to indication (e.g., moderately to severely active RA, active polyarticular JIA, active psoriatic arthritis); (2) Trial of one DMARD for RA (e.g., methotrexate, leflunomide, sulfasalazine) or specific DMARDs for JIA; (3) Not used in combination with other immunosuppressives (e.g., JAK inhibitors, biologic DMARDs); (4) Documentation of positive clinical response for reauthorization; (5) Prerequisite Part D drug required.

Coverage duration = 1 year.

Posaconazole DR – prophylaxis and treatment

Covered when ANY of the following indication‑specific criteria are met:

Posaconazole prophylaxis or treatment: Prophylaxis: patient at high risk for invasive fungal infection (e.g., HSCT with GVHD or hematologic malignancy with prolonged neutropenia) OR prior fungal infection requiring secondary prophylaxis AND trial with two of: fluconazole, itraconazole, or voriconazole documented. Treatment: invasive Aspergillus or Candida infection AND trial with two of listed azoles documented.

Coverage duration = 6 months.

Praluent coverage

Praluent initiation covered when ALL of the following are met; reauthorization requires the conditions below:

Praluent initiation: (1) Indication documented (ASCVD, primary hyperlipidemia, HeFH, HoFH as appropriate); (2) LDL measurement while on a high‑intensity statin within last 120 days meeting thresholds (≥55 mg/dL with ASCVD or >70 mg/dL without ASCVD); (3) Patient has received at least 12 weeks of high‑intensity statin and will continue statin at max tolerated dose OR has documented inability to tolerate statins after trials of atorvastatin and rosuvastatin; (4) Prerequisite Part D drug required.

Coverage duration = 3 years.

Praluent reauthorization: Continued use of statin at max tolerated dose and documentation of LDL reduction while on Praluent therapy.

Reauthorization criteria.

Polivy coverage

Covered when ALL of the following are met:

Polivy for r/r DLBCL: Diagnosis of relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) NOS AND trial of at least two prior therapies documented.

Coverage duration = 1 year; prerequisite Part D drug required.

Eltrombopag coverage

Covered when ANY of the following per‑indication criteria are met:

Eltrombopag indications: ITP: baseline platelet count <30,000/mcL AND trial of corticosteroids, IVIG, or splenectomy documented. Thrombocytopenia with chronic hepatitis C: baseline platelet count <75,000/mcL. Severe aplastic anemia: baseline platelet count <30,000/mcL.

Coverage duration = 1 year; prerequisite Part D drug required for ITP.

Pretomanid coverage

Covered when ALL of the following are met:

Pretomanid for pulmonary TB: Indication of adult pulmonary tuberculosis AND use in combination with bedaquiline and linezolid.

Coverage duration = 1 year.

Piqray coverage

Covered when ALL of the following are met:

Piqray (alpelisib): Adult patient with HR‑positive, HER2‑negative, PIK3CA‑mutated advanced or metastatic breast cancer AND disease progression on or after an endocrine‑based regimen AND planned combination therapy with fulvestrant.

Coverage duration = 1 year; prerequisite Part D drug required.

Qinlock coverage

Covered when ALL of the following are met:

Qinlock for advanced GIST: Adult patient with advanced gastrointestinal stromal tumor (GIST) AND prior therapy with ≥3 kinase inhibitors, including imatinib documented.prior >=3 kinase inhibitors

Coverage duration = 1 year.

Pomalidomide coverage

Covered when ALL of the following are met:

Pomalidomide for multiple myeloma: At least two prior therapies including lenalidomide and a proteasome inhibitor AND disease progression on or within 60 days of last therapy AND combination use with dexamethasone documented.

Coverage duration = 1 year; prerequisite Part D drug required.

Pomalidomide for AIDS-related Kaposi sarcoma: Trial and failure of highly active antiretroviral therapy (HAART) documented.

Indication-specific requirement.

Advanced GIST prerequisite therapy

Advanced GIST prerequisite: Adult patient with advanced GIST AND prior therapy with ≥3 kinase inhibitors including imatinib documented.

Product‑level prerequisite requirement.

Retevmo coverage criteria

Retevmo indications: Adult patients with locally advanced/metastatic NSCLC with RET fusion (FDA‑approved test) OR patients ≥2 years with advanced/metastatic MTC with RET mutation requiring systemic therapy OR advanced thyroid cancer with RET‑fusion after RAI trial when appropriate OR locally advanced/metastatic solid tumors with RET fusion who have progressed on prior systemic treatment.age >=2 for specified pediatric indications

Requires FDA‑approved test for RET alterations.

Rinvoq coverage criteria

Rinvoq general: Diagnosis matching an approved inflammatory indication AND trial/failure of prerequisite therapies per indication (e.g., DMARD trial for RA; NSAID for AS/axSpA) AND inadequate response or intolerance to TNF inhibitors where specified; reauthorization requires positive clinical response and no combination with potent immunosuppressant or another biologic/targeted DMARD.

Coverage duration 1 year.

Rubraca coverage criteria

Rubraca maintenance ovarian cancer: Maintenance treatment for adult patients with deleterious BRCA mutation‑associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to platinum‑based chemotherapy documented.

BRCA mutation and response to platinum chemotherapy required.

Tolvaptan coverage criteria

Tolvaptan initial criteria: Documentation that patient does not have underlying liver disease AND trial of at least two of: furosemide, demeclocycline, or fluid restriction prior to tolvaptan approval.trial >=2 alternatives

Coverage duration noted per entry.

Sarclisa coverage criteria

Sarclisa (multiple myeloma): Treatment requires at least two prior therapies including lenalidomide and a proteasome inhibitor (other indications specify 1–3 prior lines); newly diagnosed non‑ASCT candidates require combination with bortezomib, lenalidomide and dexamethasone.prior therapies >=2 or 1-3 per indication

Product‑level prerequisites specified.

Skyrizi (risankizumab) — coverage conditions

Covered when ALL of the following are met:

Skyrizi coverage: Diagnosis matches indication‑specific requirement (e.g., active PsA; moderate to severe plaque psoriasis; moderately to severely active Crohn's disease or ulcerative colitis) AND reauthorization requires documentation of positive clinical response.

Cannot be used in combination with another biologic/targeted DMARD for same condition.

Ustekinumab (Stelara) — coverage conditions

Covered when ALL of the following are met:

Stelara (ustekinumab) coverage: Diagnosis matches indication (active PsA, moderate to severe chronic plaque psoriasis, moderately to severely active Crohn's disease, or moderately to severely active ulcerative colitis) AND reauthorization requires documentation of positive clinical response; cannot be used in combination with another biologic/targeted DMARD for same condition.

Coverage duration 1 year.

Stivarga (regorafenib) — colorectal cancer/GIST/HCC criteria

Covered when ALL of the following are met (disease‑ and prior‑therapy specific):

Stivarga for CRC/GIST/HCC: For colorectal cancer: prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapy AND an anti‑VEGF therapy AND if RAS wild‑type, an anti‑EGFR therapy documented. For GIST: prior treatment with imatinib and sunitinib documented. For HCC: prior treatment with sorafenib documented.

Product‑level prior therapy requirements.

Tafinlar (dabrafenib) — melanoma and other solid tumor criteria

Covered when ALL of the following are met:

Tafinlar (dabrafenib) BRAF‑mutant melanoma: Treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutation requires prior trial of vemurafenib + cobimetinib or combination with dabrafenib per indication; certain indications require combination with trametinib; liquid formulation coverage requires inability to swallow capsules.

From Tafinlar product entry.

Tagrisso (osimertinib) — EGFR-mutant NSCLC criteria

Covered when ANY of the following scenarios apply:

Tagrisso EGFR‑mutant NSCLC scenarios: Coverage for EGFR exon 19 deletion or exon 21 L858R mutation‑positive NSCLC is provided for: adjuvant therapy after tumor resection; first‑line treatment in metastatic disease; or first‑line treatment in locally advanced/metastatic disease in combination with pemetrexed and platinum‑based chemotherapy. Coverage for EGFR T790M mutation‑positive NSCLC requires progression on or after prior EGFR TKI therapy.

From Tagrisso product entry.

Tetrabenazine — coverage and exclusions

Covered when ALL of the following are met:

Tetrabenazine coverage: Indication appropriate and no exclusions present (notably: hepatic function impairment, active suicidal ideation or untreated/inadequately treated depression, or concomitant use of MAO inhibitors or reserpine). Documentation of CYP2D6 genotype required for doses >50 mg/day.

Coverage duration 1 year; safety exclusions apply.

General coverage

Covered when ALL product‑specific criteria are met:

General product coverage: Requested product is one of the listed drugs AND all product‑specific prior therapy, diagnostic, and combination‑use criteria stated in the product entry are satisfied.

Many products have 1‑year coverage durations unless otherwise specified.

Tocilizumab (Tyenne) coverage

Covered when ALL of the following are met:

Tocilizumab coverage: Diagnosis appropriate to indication AND trials of specified prior agents per indication documented AND not used in combination with another biologic/targeted DMARD for same condition; reauthorization requires documentation of positive clinical response.

Applies to RA, polyarticular JIA, SJIA, GCA as specified.

Selected oncology and specialty drug criteria

Covered when ANY of the following oncology or specialty drug criteria are met (product‑specific):

Selected oncology examples: Many oncology agents require prior systemic therapy or documented progression (e.g., Trodelvy requires prior systemic therapies; Tivdak requires progression on/after chemotherapy). Document the prior therapies per product entry.

See product‑level entries for exact prior therapy requirements.

Tymlos

Covered when ALL of the following are met:

Tymlos coverage: Documentation of bone mineral density T‑score ≤ -2.5 AND trial of both Jubbonti or Stoboclo AND either an oral bisphosphonate or, if intolerant, an IV bisphosphonate documented; coverage allowed if patient unable to be treated with all listed agents.T-score ≤ -2.5

Coverage duration 2 years.

Verquvo

Covered when ALL of the following are met:

Verquvo coverage: Diagnosis of chronic heart failure NYHA class II‑IV AND LVEF <45% AND either prior hospitalization for heart failure within prior 6 months OR outpatient IV diuretic treatment within prior 3 months AND combination with at least two specified classes of heart failure therapies unless contraindicated or not tolerated.LVEF <45%

Coverage duration 1 year.

Voquezna

Covered when ALL of the following are met:

Voquezna coverage: Diagnosis of Helicobacter pylori infection AND trial of a guideline‑recommended first‑line regimen (e.g., clarithromycin triple therapy or bismuth quadruple therapy) documented.

Coverage duration 1 year.

Verzenio

Covered when ANY of the following per‑indication criteria are met:

Verzenio indications: Adjuvant HR+/HER2‑ early breast cancer at high risk requires combination with tamoxifen or an aromatase inhibitor; advanced/metastatic settings require combination with aromatase inhibitor as initial endocrine therapy or with fulvestrant after progression; monotherapy for advanced disease requires prior endocrine and chemotherapy in the metastatic setting.

Prior Part D therapy required for certain indications.

Per-product coverage criteria

Covered when ALL of the following product‑specific criteria are met:

Per‑product coverage summaries: Product coverage is provided only when the product‑specific prior therapy, diagnostic, combination‑use and other stated criteria are met as listed in the product entries (examples include voriconazole, pazopanib, Voydeya, Winrevair, Xeljanz, Xolair, Xifaxan, Xpovio, Zejula, Zepzelca).

See per‑product entries for details and durations.

Maintenance therapy for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer

Maintenance therapy is covered when ALL of the following are satisfied:

Maintenance ovarian cancer: Patient has complete or partial response to first‑line platinum‑based chemotherapy AND meets product‑specific maintenance criteria.

Coverage duration = 1 year.

Coverage duration for maintenance therapy is 1 year per product listing unless otherwise specified.1 Year

From maintenance oncology continuation entry.

Metastatic and extensive-stage small cell lung cancer (SCLC)

Covered when ALL of the following are met:

Metastatic SCLC prior chemo/progression: Disease progression on or after platinum‑based chemotherapy documented for metastatic SCLC coverage.

Maintenance extensive‑stage SCLC: Maintenance treatment requires combination use with atezolizumab (± hyaluronidase‑TQIS) AND confirmation patient has not progressed following first‑line induction therapy with the specified regimen.

Zilbrysq (for myasthenia gravis)

Covered when ALL of the following are met:

Zilbrysq diagnosis confirmation: Anti‑AChR antibody positive myasthenia gravis documented by lab record or chart notes AND at least one confirmatory test (positive edrophonium test OR history of clinical response to oral cholinesterase inhibitors OR electrophysiological evidence by RNS or SFEMG).

Additionally, prior immunosuppressant courses of ≥12 weeks required unless contraindicated; patient must be on and continue stable regimen.

Prior immunosuppressant 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.12 weeks

From Zilbrysq product entry.

Zolinza (cutaneous T-cell lymphoma)

Covered when ALL of the following are met:

Zolinza for CTCL: Cutaneous T‑cell lymphoma with progressive, persistent, or recurrent disease AND trial of two systemic therapies documented prior to coverage.

Coverage duration = 1 year.

Zonisade (seizure disorder)

Covered when ANY of the following are met:

Zonisade anticonvulsant trial: Trial of at least two generic anticonvulsants, one of which must be generic zonisamide, documented; alternatively coverage if patient is unable to swallow tablets/capsules.

From Zonisade seizure disorder entry.

Unable to swallow: Patient is unable to swallow tablets or capsules (documentation required).

Alternative pathway for coverage.

Exxua / Trintellix (depression agents)

Covered when ALL of the following are met:

Exxua/Trintellix prior trials: Trial of at least two of the listed generic antidepressants (e.g., bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, etc.) documented prior to coverage.2 agents

Coverage duration is lifetime for these products.

Aripiprazole formulations and certain antipsychotics

Covered when ALL of the following are met:

Oral aripiprazole prerequisite: Trial of oral aripiprazole documented prior to coverage of certain aripiprazole formulations (e.g., Abilify products).

Coverage duration often lifetime for these products.

Generic antipsychotic alternative trial: Trial of at least one listed generic antipsychotic documented prior to coverage of listed antipsychotic products (e.g., Caplyta, Rexulti, Vraylar, Zyprexa Relprevv).1 agent

Coverage duration often lifetime.

Aristada initial therapy requirements

Covered when ALL of the following are met:

Aristada prior trial: Trial of at least one of the listed generic antipsychotics (aripiprazole, asenapine, fluphenazine, haloperidol, loxapine, lurasidone, molindone, olanzapine injection, paliperidone, pimozide, quetiapine, risperidone, thioridazine, thiothixene, trifluoperazine, ziprasidone) documented prior to Aristada coverage.trial documented

Coverage duration is lifetime.

Aristada Initio requirements

Covered when ANY of the following are met:

Aristada Initio prior trial/intolerance: Trial OR intolerance to Abilify Maintena or oral aripiprazole documented.trial or intolerance documented

Coverage duration is lifetime for Aristada Initio.

Aristada (alternate) requirements

Covered when ALL of the following are met:

Aristada alternate prior trial: Trial of oral aripiprazole documented prior to coverage of alternate Aristada listing.trial documented

Coverage duration is lifetime.

Gauze/pads coverage requirements

Covered when ALL of the following are met:

Gauze/pads insulin claim: A claim for an insulin product in the last 180 days is required to establish coverage for listed alcohol prep pads or Curity gauze pads.claim within 180 days

Coverage duration 1 year.

Invega Hafyera requirements

Covered when ANY of the following are met:

Invega Hafyera paliperidone palmitate trial: Trial of once‑a‑month paliperidone palmitate extended‑release injectable for ≥4 months OR every‑three‑month paliperidone palmitate extended‑release injectable for at least one three‑month cycle documented.monthly x >=4 months OR one 3-month cycle

Coverage duration is lifetime.

Invega Sustenna requirements

Covered when ALL of the following are met:

Invega Sustenna prior trial: Trial of oral paliperidone or oral risperidone documented prior to coverage.trial documented

Coverage duration is lifetime.

Invega Trinza requirements

Covered when ALL of the following are met:

Invega Trinza prior trial: Trial of oral paliperidone or oral risperidone documented prior to coverage.trial documented

Coverage duration is lifetime.

Pancreaze requirements

Covered when ALL of the following are met:

Pancreaze prerequisites: Trial of Zenpep or documentation of intolerance to Zenpep prior to Pancreaze coverage.trial or intolerance documented

Coverage duration is lifetime.

Perseris requirements

Covered when ALL of the following are met:

Perseris prior trial: Trial of oral risperidone documented prior to Perseris coverage.trial documented

Coverage duration is lifetime.

Rasuvo requirements

Covered when ALL of the following are met:

Rasuvo methotrexate trial: Trial of generic injectable methotrexate documented prior to Rasuvo coverage.trial documented

Coverage duration is lifetime.

Generic injectable methotrexate requirement

Generic injectable methotrexate requirement: Trial of generic injectable methotrexate must be documented prior to approval of the affected product(s).

Coverage duration is lifetime for affected products upon meeting criteria.

Ophthalmic glaucoma medication trial

Rhopressa/Rocklatan ophthalmic trial: Trial of any generic formulary ophthalmic glaucoma medication OR Lumigan documented prior to coverage.

Coverage duration 1 year.

Risperidone ER/Rykindo trial

Risperidone ER/Rykindo trial: Trial of oral risperidone documented prior to coverage of risperidone ER or Rykindo formulations.

Coverage duration is lifetime.

Rytary trial

Rytary trial: Trial of generic oral extended‑release carbidopa & levodopa documented prior to Rytary coverage.

Coverage duration is 1 year.

SGLT2 inhibitor trial and exception

SGLT2 inhibitor trial and exception: Trial of generic dapagliflozin documented prior to Farxiga or Jardiance coverage; exception: step therapy does not apply for Jardiance when requested to reduce risk of cardiovascular death in adults with T2DM and established cardiovascular disease.

From SGLT2 prior auth rules.

Febuxostat trial or contraindication

Febuxostat trial or contraindication: Trial of allopurinol documented OR documentation of contraindication to allopurinol prior to febuxostat coverage.

Coverage duration is lifetime.

Clinical Thresholds and Key Values

Listed product names (no billing codes provided)mixed

Abelcet	Abelcet
Acetylcysteine INHALATION SOLN	Acetylcysteine INHALATION SOLN
Acyclovir Sodium INJ 50MG/ML	Acyclovir Sodium INJ 50MG/ML
Albuterol Sulfate NEBU 0.083%, 0.63MG/3ML, 1.25MG/3ML, 2.5MG/0.5ML	Albuterol Sulfate NEBU 0.083%, 0.63MG/3ML, 1.25MG/3ML, 2.5MG/0.5ML
Amphotericin B INJ	Amphotericin B INJ
Amphotericin B Liposome	Amphotericin B Liposome
Aprepitant	Aprepitant
Arformoterol Tartrate	Arformoterol Tartrate
Astagraf XL	Astagraf XL
Azathioprine TABS 50MG	Azathioprine TABS 50MG

1–10 of 53

1/6

Other listed products from Prior Authorization list (no billing codes)mixed

Abelcet	Abelcet
Plenamine INJ 147.4MEQ/L etc.	Plenamine INJ (multiple concentrations listed)
Premasol INJ 52MEQ/L etc.	Premasol INJ (multiple concentrations listed)
Prograf PACK	Prograf PACK
Prosol	Prosol
Pulmozyme SOLN 2.5MG/2.5ML	Pulmozyme SOLN 2.5MG/2.5ML
Rabavert	Rabavert
Recombivax Hb	Recombivax Hb
Sirolimus SOLN	Sirolimus SOLN
Sirolimus TABS	Sirolimus TABS

1–10 of 15

1/2

Products (short list duplicates removed)mixed

Everolimus TABS 0.25MG, 0.5MG, 0.75MG, 1MG	Everolimus TABS 0.25MG, 0.5MG, 0.75MG, 1MG
Tacrolimus CAPS	Tacrolimus CAPS
Sirolimus TABS	Sirolimus TABS

inv-115: Eosinophil count

DefinitionAbsolute eosinophil count used to determine eligibility for eosinophil-targeted biologics and COPD add-on maintenance.

EA initiation threshold>= 150 cells/µL at initiation for eosinophilic asthma.

COPD add-on threshold>=150 cells/µL now OR >=300 cells/µL within past 12 months for COPD add-on maintenance.

HES threshold (related context)>=1000 cells/µL at initiation for hypereosinophilic syndrome (HES).

inv-116: T25FW

TestTimed 25-foot walk (T25FW) test

When requiredSubmission of baseline T25FW prior to initiation of dalfampridine; reauthorization requires documentation of stability or improvement on T25FW.

Use caseDemonstrates ambulatory status and response for multiple sclerosis mobility indication.

inv-117: Eosinophil threshold

Primary threshold>= 150 cells per microliter for eosinophilic asthma at initiation.

COPD contextFor COPD add-on maintenance: current >=150 cells/µL or historical >=300 cells/µL within past 12 months.

HES initiation>= 1000 cells/µL required for hypereosinophilic syndrome initiation (in Nucala context).

inv-118: BMD T-score

MeasurementBone mineral density (BMD) reported as T-score (standard deviations from young-adult mean).

Osteoporosis thresholdT-score <= -2.5 (T-score at or below -2.5 required for coverage).

Documentation requirementSubmit BMD report showing T-score <= -2.5 for product coverage (e.g., Tymlos/Fotivda context).

inv-119: Diabetes diagnostic thresholds

A1c (HbA1c)>= 6.5% indicates diabetes for coverage documentation.

Fasting plasma glucose (FPG)>= 126 mg/dL indicates diabetes for coverage documentation.

2-hour plasma glucose (OGTT)>= 200 mg/dL during OGTT indicates diabetes for coverage documentation.

inv-120: Eosinophil count thresholds

EA initiation>=150 cells/µL at initiation for eosinophilic asthma (Nucala/Nucala-related criteria).

COPD add-onEither current >=150 cells/µL OR >=300 cells/µL within past 12 months for uncontrolled moderate-to-severe COPD add-on maintenance.

HES initiation>=1000 cells/µL at initiation for hypereosinophilic syndrome with stability on HES therapy required for coverage.

inv-121: LDL thresholds on statin

With ASCVD>=55 mg/dL LDL while on a high-intensity statin within the last 120 days for Praluent initiation.

Without ASCVD>70 mg/dL LDL while on a high-intensity statin within the last 120 days for Praluent initiation.

Statin requirementPatient must have had at least 12 weeks of high-intensity statin unless statin intolerance/contraindication documented.

inv-122: Baseline platelet count

ITP baselineBaseline platelet count <30,000/mcL required for coverage of persistent/chronic immune thrombocytopenia (ITP).

Hepatitis C thrombocytopeniaBaseline platelet count <75,000/mcL required for thrombocytopenia with chronic hepatitis C.

Severe aplastic anemiaBaseline platelet count <30,000/mcL for severe aplastic anemia indication.

inv-123: Bone Mineral Density (T-score)

MetricBone mineral density expressed as T-score (SD below young-adult mean).

Osteoporosis thresholdT-score <= -2.5 required for coverage (document BMD demonstrating <= -2.5).

Coverage noteDocumentation of BMD T-score required for product-specific approval (e.g., Tymlos).

inv-124: Left ventricular ejection fraction (LVEF)

DefinitionLeft ventricular ejection fraction (LVEF) — percent of blood ejected per cardiac cycle measured by echocardiography or equivalent.

Coverage thresholdLVEF < 45% required for Verquvo coverage in chronic heart failure NYHA class II-IV.

Associated requirementsAlso requires NYHA class II-IV and recent heart-failure–related hospitalization or outpatient IV diuretic within specified lookback periods.

inv-125: Insulin claim lookback

Lookback periodClaim for an insulin product in the last 180 days required to establish coverage for listed gauze/pad products.

PurposeUsed to confirm active insulin use for coverage of alcohol prep pads and Curity gauze pads.

Coverage durationCoverage for these supplies is limited to 1 year when criteria met.

Authorization, Documentation, and Denial Risks

Prior Authorization

Adbry-specific PA requirements

Prior authorization is required for Adbry. Coverage limited to patients ≥12 years. For atopic dermatitis, require diagnosis of moderate-to-severe AD and prior trial and failure of one of: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil. Cannot be used in combination with another biologic or targeted DMARD for same condition. Reauthorization requires documentation of positive clinical response; dose for patients <100 kg who respond after 16 weeks limited to 300 mg every 4 weeks unless clinical rationale provided.

Products: Adbry
Age: ≥12 years
Coverage duration: 1 year
Prerequisite therapy: Part D drug required
Combination rule: No concomitant biologic/targeted DMARD for same condition

Prior Authorization

Calquence — prior authorization

Calquence (acalabrutinib) requires prior authorization. Coverage duration one year. For mantle cell lymphoma (MCL) the patient must have received at least one prior therapy; previously untreated MCL patients ineligible for autologous HSCT require combination with bendamustine + rituximab. Coverage may require documented prior therapies per indication.

Product: Calquence TABS
Coverage duration: 1 year
MCL: ≥1 prior therapy required
Untreated MCL (HSCT-ineligible): must combine with bendamustine + rituximab

Prior Authorization

Dupixent — prior authorization

Dupixent requires prior authorization. Age and indication-specific weight/age requirements apply (eg AD ≥6 months; eosinophilic esophagitis, chronic spontaneous urticaria, CRSwNP etc.). Dupixent cannot be used in combination with another biologic or targeted DMARD for the same condition. Reauthorization requires documentation of positive clinical response. For eosinophilic esophagitis require trial of either a PPI or topical (esophageal) corticosteroid prior to approval.

Products: Dupixent INJ 200 mg/1.14 mL, 300 mg/2 mL
Exclusion: No concomitant biologic/targeted DMARD for same condition
AD age: ≥6 months; EOE age: ≥1 year; PN age and others per indication
Prerequisite: Trial of PPI or topical esophageal steroid for symptomatic EOE
Coverage duration: 1 year

Prior Authorization

Doptelet — prior authorization

Doptelet (and Doptelet Sprinkle) requires prior authorization for chronic immune thrombocytopenia. Coverage duration one year. Coverage requires documentation of prior treatment/trial for ITP (eg corticosteroids, immunoglobulins, or splenectomy) per indication.

Products: Doptelet; Doptelet Sprinkle
Indication: chronic immune thrombocytopenia
Coverage duration: 1 year
Other criteria: requires trial of previous treatment for ITP

Prior Authorization

Epidiolex — prior authorization

Epidiolex requires prior authorization. Coverage duration one year. For Lennox‑Gastaut syndrome and tuberous sclerosis complex seizure indications, require trials of two generic alternatives; for Dravet syndrome require trial of two of valproic acid, clobazam, or topiramate. Reauthorization requires documentation of positive clinical response.

Product: Epidiolex
Coverage duration: 1 year
Lennox‑Gastaut: trial of 2 generic alternatives for seizures
Dravet: trial of 2 of valproic acid, clobazam, topiramate
TSC-associated seizures: trial of 2 generic alternatives

Prior Authorization

Lenvima (lenvatinib) PA requirements

Lenvima (lenvatinib) requires prior authorization. Coverage duration typically one year. Indication-specific combination requirements apply (eg combination with pembrolizumab for certain settings); document prior systemic therapy as indicated by tumor type per policy.

Product: Lenvima (lenvatinib)
Coverage duration: 1 year
Requirement: follow indication-specific combination and prior therapy rules (document prior systemic therapy when required)

Prior Authorization

Oral solution trial and swallowing inability required

Oral solution formulations may require trial of the oral solution and documentation that the patient is unable to swallow tablets/capsules (eg levetiracetam oral solution required trial prior to approval when tablet not swallowable).

Example: Levetiracetam oral solution trial required + inability to swallow tablets/capsules
Mekinist liquid: patient must be unable to swallow tablets for liquid formulation

Prior Authorization

Prior systemic therapy required for Lumakras

Lumakras (sotorasib) prior authorization: coverage for KRAS G12C‑mutated locally advanced or metastatic NSCLC requires documentation of KRAS G12C mutation and a trial of at least one prior systemic therapy. For mCRC, prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy is required and combination with panitumumab when indicated.

Product: Lumakras
Coverage duration: 1 year
Requirement: KRAS G12C mutation and ≥1 prior systemic therapy for NSCLC
mCRC: prior fluoropyrimidine-, oxaliplatin-, irinotecan-based chemo; combine with panitumumab if indicated

Prior Authorization

Prior chemotherapy or specific prior agents required for Lynparza

Lynparza requires prior authorization. For gBRCA‑mutated advanced ovarian/fallopian/primary peritoneal cancer, a trial of platinum‑based chemotherapy is required; other indications may require prior chemotherapy or specific prior agents (eg prior platinum‑based, prior enzalutamide/abiraterone for mCRPC). Coverage duration one year.

Product: Lynparza
Coverage duration: 1 year
Ovarian/related cancers: prior platinum‑based chemotherapy required
Breast: prior chemotherapy or specific prior agents required; HR‑positive breast requires prior endocrine therapy or deemed inappropriate

Prior Authorization

Treatment per current AASLD/IDSA guidance

For hepatitis C and other liver-related antivirals (eg Vosevi, others), criteria will be applied consistent with current AASLD/IDSA guidance; prior authorization decisions follow those guidelines.

AASLD/IDSA guidance governs criteria application
Products: Vosevi and other HCV agents

Prior Authorization

Mekinist coverage requires mutation testing and specified combination therapy

Mekinist coverage requires documentation of a BRAF V600E or V600K mutation detected by an FDA‑approved test for relevant indications. Coverage rules depend on line of therapy and require specific combination partners (eg dabrafenib for many indications). Monotherapy may be acceptable for BRAF‑inhibitor treatment‑naive unresectable/metastatic melanoma per the policy; other indications require combination therapy as specified.

Products: Mekinist tabs and liquid/solution
Requirement: BRAF V600E or V600K mutation by FDA‑approved test
Combination rules: often requires dabrafenib; some settings require trial of vemurafenib + cobimetinib first

Prior Authorization

Age-based prior authorization

Prior authorization may be age‑based for certain drugs (example: PA applies only to patients <30 years of age for select products). Always verify age restrictions in the product entry.

Example: PA applies only to patients <30 years for specified products

Prior Authorization

Prior authorization and coverage duration

Prior authorization generally grants coverage for one year unless otherwise noted; reauthorization typically requires documentation of positive clinical response. Some products have different durations (eg posaconazole DR prophylaxis 6 months, Praluent 3 years, others lifetime).

Typical coverage duration: 1 year
Exceptions: Posaconazole DR prophylaxis = 6 months; Praluent = 3 years; some products list lifetime duration
Reauthorization: documentation of positive clinical response usually required

Prior Authorization

Retevmo prior authorization summary

Retevmo prior authorization: coverage provided for RET fusion‑positive NSCLC (adults) detected by an FDA‑approved test; for RET‑mutant medullary thyroid cancer and RET fusion thyroid cancer coverage for patients ≥2 years old who require systemic therapy; prior radioactive iodine required when appropriate. Coverage for RET fusion solid tumors provided for patients who progressed on or after prior systemic therapy.

Product: Retevmo
Coverage: RET fusion/mutation confirmed by FDA‑approved test
Thyroid cancer: trial and failure with radioactive iodine if appropriate
Solid tumors: progressed on/after prior systemic treatment

Prior Authorization

Stelara prior authorization

Stelara (ustekinumab) requires prior authorization. Cannot be used in combination with another biologic or targeted DMARD indicated for the same condition. Coverage duration one year; reauthorization requires documentation of positive clinical response. Indication‑specific diagnoses are required (eg active PsA, moderate‑to‑severe plaque psoriasis, Crohn's disease, ulcerative colitis).

Product: Stelara
Coverage duration: 1 year
Exclusion: No concomitant biologic/targeted DMARD for same condition
Reauthorization: documentation of positive clinical response

Prior Authorization

Verzenio PA requirement

Verzenio requires prior authorization. Coverage duration one year. For adjuvant HR‑positive, HER2‑negative high‑risk early breast cancer requires combination with tamoxifen or an aromatase inhibitor; for advanced/metastatic disease requires combination with endocrine therapy per setting; monotherapy requires prior endocrine and chemotherapy in the metastatic setting.

Product: Verzenio
Coverage duration: 1 year
Adjuvant high‑risk: must combine with tamoxifen or an aromatase inhibitor
Advanced/metastatic: combination with endocrine therapy or prior therapies as specified

Prior Authorization

General prior authorization and maintenance therapy requirement

General prior authorization and maintenance therapy rules: many oncology and specialty drugs require prior systemic or maintenance therapies (document prior lines of therapy, combination partners, and progression status). Reauthorization often requires evidence of clinical benefit.

Document prior systemic/maintenance therapy when required
Provide evidence of progression or response per product criteria
Reauthorization: documentation of positive clinical response

Prior Authorization

Product list prior authorization

Product lists across the document identify many drugs subject to PA or step therapy. Verify the formulary/PA designation and follow the specific product entry for required documentation and prerequisite trials.

Refer to formulary for PA/ST flags
Follow per‑product criteria in this section

Prior Authorization

Aristada Initio / Aristada prior authorization

Aristada Initio / Aristada prior authorization: requires trial of a once‑a‑month paliperidone palmitate extended‑release injectable for at least 4 months or the every‑three‑month paliperidone palmitate ER injectable for at least one three‑month cycle. Coverage duration is lifetime where specified.

Products: Aristada Initio / Aristada
Prerequisite: trial of paliperidone palmitate LAI per durations above
Coverage duration: lifetime (per product details)

Step Therapy

SGLT2 inhibitor prior authorization rules

SGLT2 inhibitor prior authorization and step rules: Farxiga and Jardiance require trial of generic dapagliflozin before coverage; exceptions apply (eg Jardiance when used to reduce CV death in T2DM with established CVD is exempt).

Products: Farxiga (dapagliflozin), Jardiance (empagliflozin)
Step: trial of generic dapagliflozin required for Farxiga/Jardiance; Jardiance CV indication exempt from step therapy

Prior Authorization

Methotrexate-related prior authorization

Methotrexate-related prior authorization: some products require trial of generic injectable methotrexate (example: Zilbrysq coverage requires prior trials of agents such as methotrexate among others for myasthenia gravis — see product criteria).

Example: Zilbrysq requires prior immunosuppressant trials and restricts combinations; methotrexate trials may be required where specified
Generic injectable methotrexate trial required per product details

Denial Risk

Combination therapy exclusion / Prohibited combinations

Combination therapy exclusions and prohibited combinations: many biologic/targeted DMARDs cannot be used in combination with another biologic or targeted DMARD for the same condition (explicitly stated for multiple products). Some product entries list specific prohibited combinations (eg Zilbrysq — no concurrent immunoglobulin therapy; certain PH1 or other disease drugs may exclude transplant history or specific combinations).

General biologic combination exclusion: no concomitant biologic/targeted DMARD for same condition
Specific prohibitions: Zilbrysq — cannot be used with other biologic therapies for MG or IVIG; PH1 product excludes history of kidney/liver transplant and combination with Oxlumo

Denial Risk

Explicit denial situations / Contraindicated combinations

Contraindicated combinations and explicit denial situations: coverage will not be provided where product‑specific contraindications exist (examples include transplant history, concurrent prohibited agents, use for weight loss only for certain GLP‑1s). Explicit denial situations should be checked per product entry.

Weight‑loss exclusion: certain agents excluded if used solely for weight loss (eg liraglutide, others)
Transplant exclusions: some drugs deny coverage with history of kidney/liver transplant
Prohibited combinations: see per‑product entries for explicit denial situations

Denial Risk

Weight-loss exclusion

Weight‑loss exclusion: Several agents (eg liraglutide, other GLP‑1 products) are excluded if used solely for weight loss. For ongoing T2DM treatment, submit medical records confirming T2DM diagnosis or supporting labs (A1c ≥6.5%, FPG ≥126 mg/dL, or 2‑hour OGTT ≥200 mg/dL).

Do not approve when primary use is weight loss only
Documentation: medical records or lab evidence of T2DM required for diabetes indication

Denial Risk

Combination biologic exclusion

Combination biologic exclusion / Biologic combination exclusion: repeated — biologics and targeted DMARDs listed throughout cannot be combined for the same condition; requests documenting combination therapy will be denied.

Products explicitly stating exclusion: Adbry, Skyrizi, Stelara, Nucala, Xolair, Dupixent, others
Operational impact: deny requests for concurrent use of two biologics/targeted DMARDs for same indication

Prior Authorization

Nucala exclusion and diagnostic requirements

Nucala exclusion and diagnostic requirements: Nucala cannot be used in combination with another biologic/targeted DMARD for the same condition. Indication‑specific diagnostic and laboratory criteria apply (eg eosinophil counts thresholds for various indications, EGPA diagnostic criteria). Reauthorization requires documentation of positive clinical response.

Product: Nucala
Exclusion: no concomitant biologic/targeted DMARD
EGPA: requires two typical EGPA criteria
Eosinophilic asthma: eosinophil ≥150 cells/µL at initiation; other thresholds apply per indication

Step Therapy

Octreotide prerequisite therapy

Octreotide prerequisite therapy: coverage for acromegaly requires trial of bromocriptine mesylate at maximally tolerated doses prior to octreotide approval.

Product: Octreotide acetate inj
Prerequisite: trial of bromocriptine for acromegaly

Step Therapy

Posaconazole DR prophylaxis prerequisite trials

Posaconazole DR prophylaxis prerequisite trials: for IFI prophylaxis posaconazole DR requires trial with two of fluconazole, itraconazole, or voriconazole; coverage duration 6 months for prophylaxis indication.

Product: Posaconazole DR
Prophylaxis: trial of two of fluconazole/itraconazole/voriconazole required
Coverage duration for prophylaxis: 6 months

Prior Authorization

Polivy prior therapy requirement

Polivy prior therapy requirement: many oncology agents require prior lines of therapy; confirm specific prior therapy requirements in the product entry before approving Polivy or other cancer agents.

Check product‑specific prior therapy/line requirements (eg Polivy, Fotivda, Lonsurf)

Denial Risk

Tetrabenazine exclusions

Tetrabenazine exclusions: certain contraindications apply; review product entry for excluded situations (eg hepatic impairment, active suicidality where specified).

Product examples list hepatic impairment and psychiatric risk exclusions; documentation of CYP2D6 genotype may be required for higher doses

Denial Risk

Missing prerequisite therapy / Required prior trial evidence

Missing prerequisite therapy or required trials (common denial reasons): absent required prior trials such as oral aripiprazole for LAI antipsychotics, paliperidone palmitate trials for Aristada, oral risperidone/paliperidone trials, Zenpep trial for pancreatic enzyme replacements, generic methotrexate for certain agents, allopurinol trial for febuxostat, dapagliflozin trial for SGLT2 step rules, recent insulin claim where required, and others — ensure documentation and claims evidence are submitted.

Examples of missing prerequisites that cause denials: oral aripiprazole (LAI)
Paliperidone palmitate LAI trial for Aristada
Oral risperidone/paliperidone trials
Trial or intolerance to Zenpep for pancreatic enzyme drugs
Generic injectable methotrexate trial required where specified
Allopurinol trial or contraindication required for febuxostat
Claim for an insulin product within prior 180 days for certain products

Documentation Required

Documentation requirements and Zilbrysq required medical information

Documentation requirements (examples): Zilbrysq requires anti‑AChR antibody positivity and one confirmatory test (edrophonium, clinical response to cholinesterase inhibitors, or electrophysiologic testing). Opfolda/Pompe disease drugs require serum assay and genetic testing confirmation. Eltrombopag requires baseline platelet counts for ITP/HCV/aplastic anemia. Nucala, Xolair, Xeljanz, Voquezna and others list detailed diagnostic/lab documentation—submit relevant labs, genotyping, and prior therapy records with PA request.

Zilbrysq: anti‑AChR antibody positive + confirmatory test required
Opfolda/Pompe: serum assay showing decreased enzyme activity + GAA gene mutation testing
Eltrombopag: baseline platelet count thresholds required
Nucala/Xolair: eosinophil counts, IgE levels, or other labs per indication
Voquezna: documentation of H. pylori infection and trial of guideline‑recommended first‑line regimen

Prior Authorization

Progression requirement for SCLC and other oncology drugs

Progression requirement for certain SCLC and other oncology drugs: coverage may require documented disease progression on or after prior therapies or lines of chemotherapy; provide clinical notes/pathology/imaging showing progression.

Document prior progression for line‑specific oncology approvals
Provide imaging/clinical documentation of progression and prior regimen details

Step Therapy

Step therapy / prerequisite trials

Step therapy overview and examples: many products require step therapy — e.g., trial of generics for migraine preventive anticonvulsants, trials of specific statins for lipid agents, trials of generic anticonvulsants for certain seizure products, and trial of generic dapagliflozin for SGLT2 agents. Step therapy exceptions and combination‑as‑step rules are noted per product.

Step therapy commonly required before brand coverage
Examples: migraine prevention generics; statin + PCSK9 prerequisites; generic anticonvulsant trials

Step Therapy

Combination requirement as step

Combination requirement as a step: some drugs require combination with another agent as a condition of coverage (eg Jylamvo or other oncology agents requiring combination with pembrolizumab or everolimus; Verzenio requires combination with endocrine therapies in many settings). Document combination partner and rationale.

Examples: Jylamvo combinations (pembrolizumab, everolimus)
Verzenio: combine with tamoxifen or aromatase inhibitor in adjuvant high‑risk setting

Step Therapy

Step therapy: trial of generic antipsychotic / Missing oral trials

Step therapy for psychiatric long‑acting injectables: Many LAI antipsychotics require a prior trial of oral formulations (eg oral aripiprazole before Abilify Maintena; oral paliperidone or risperidone before paliperidone LAI products). Coverage durations are often lifetime when step satisfied.

Oral aripiprazole required prior to LAI antipsychotics where specified
Oral paliperidone or risperidone required prior to paliperidone LAIs

Step Therapy

Step therapy for Livtencity (post-transplant CMV)

Step therapy for Livtencity (post‑transplant CMV): coverage requires trial of one of ganciclovir, valganciclovir, cidofovir, or foscarnet prior to Livtencity approval.

Product: Livtencity
Prerequisite: trial of ganciclovir, valganciclovir, cidofovir, or foscarnet

Prior Authorization

Age-based restriction / step

Age‑based restriction/step: some products include age thresholds as part of authorization (see product-specific entries). Verify age and apply PA only when patient meets age criteria.

Examples: Adbry age ≥12; other products have pediatric/adult age cutoffs

Step Therapy

Motpoly Xr step therapy

Motpoly XR and similar seizure products: require trial of two generic anticonvulsants for migraine/seizure prevention indications prior to authorization.

Product: Motpoly XR
Prerequisite: trial of two generic anticonvulsants for seizure/migraine prevention

Step Therapy

Nexletol/Nexlizet step therapy

Nexletol/Nexlizet step therapy: require trial of one high‑intensity statin (or documentation of intolerance) and specific LDL thresholds or risk criteria prior to PCSK9 or other adjunctive lipid therapies.

Prerequisite: high‑intensity statin trial unless intolerant
Document LDL values and ASCVD/HeFH status as specified

Step Therapy

Product-specific step therapy and required alternative trials

Product‑specific step therapy and prerequisite rules, Xtandi prerequisites, required trials of alternative therapies, and step therapy for Invega Hafyera are all enforced as listed — ensure the PA request includes the documented trials and reasons for exceptions.

Xtandi: requires complete/partial response to first‑line platinum chemo for maintenance ovarian cancer indications
Invega Hafyera: follow paliperidone LAI trial requirements

Initial Approval Requirements

Reauthorization / Continuation Requirements

Required Prior Trials (Step Therapy) Summary

Product / Topic	Step therapy requirement
{"text":"Auvelity","status":""},{"text":"Trial of bupropion and one other generic formulary antidepressant required prior to coverage for major depressive disorder.","status":""}

Product / Topic	Step therapy requirement
{"text":"Braftovi (encorafenib) 75 mg","status":""},{"text":"Coverage for specified indications requires combination use or prior therapy per indication (e.g., combination with vemurafenib + cobimetinib for melanoma; combination with cetuximab + fluorouracil-based chemotherapy for BRAF V600E metastatic CRC).", "status":""}

Product / Topic	Step therapy requirement
{"text":"Various biologics (example group) — psoriatic arthritis / plaque psoriasis / ankylosing spondylitis","status":""},{"text":"Indication-specific prerequisite trials required (e.g., trial of an NSAID for AS; DMARD trial for RA) and cannot be used in combination with another biologic/targeted DMARD for the same condition.","status":""}

Product / Topic	Step therapy requirement
{"text":"Antiseizure / migraine products (examples: Topiramate solution, Epidiolex, Fintepla)","status":""},{"text":"Trials of specified generic anticonvulsants/generic alternatives required prior to coverage (e.g., 2 generics for Lennox-Gastaut; 2 of valproic acid, clobazam, or topiramate for Dravet; for migraine prevention, trial of at least 2 generic alternatives or inability to swallow tablets/capsules).","status":""}

Product / Topic

Step therapy requirement

{"text":"Antiseizure / migraine products (examples: Topiramate solution, Epidiolex, Fintepla)","status":""},{"text":"Trials of specified generic anticonvulsants/generic alternatives required prior to coverage (e.g., 2 generics for Lennox-Gastaut; 2 of valproic acid, clobazam, or topiramate for Dravet; for migraine prevention, trial of at least 2 generic alternatives or inability to swallow tablets/capsules).","status":""}

Product / Topic	Step therapy requirement
{"text":"Selected oncology agents (examples: Idhifa, Lenvima)","status":""},{"text":"Prior trials or combination therapy required per indication (e.g., combination with pembrolizumab for first-line RCC; prior systemic or kinase inhibitor therapy as specified for hematologic/solid tumor indications).","status":""}

Product / Topic	Step therapy requirement
{"text":"Lybalvi","status":""},{"text":"Requires trial of at least one listed generic antipsychotic (e.g., aripiprazole, risperidone, quetiapine, etc.) prior to coverage.","status":""}

Product / Topic	Step therapy requirement
{"text":"Levetiracetam (formulation-specific)","status":""},{"text":"Coverage requires BOTH: trial of levetiracetam oral solution and documentation that the patient is unable to swallow tablets or capsules prior to approval for the oral solution formulation.","status":""}

Product / Topic	Step therapy requirement
{"text":"Motpoly Xr","status":""},{"text":"Coverage for seizure indication requires trial of two generic anticonvulsant alternatives prior to approval.","status":""}

Product / Topic	Step therapy requirement
{"text":"Nexletol / Nexlizet","status":""},{"text":"Requires trial of one high-intensity statin prior to coverage unless statin intolerance or contraindication is documented.","status":""}

Product / Topic	Step therapy requirement
{"text":"Posaconazole DR","status":""},{"text":"For prophylaxis or treatment, requires trial with two of the following azoles (fluconazole, itraconazole, or voriconazole) prior to coverage; coverage duration noted as 6 months.","status":""}

Product / Topic	Step therapy requirement
{"text":"Praluent (alirocumab)","status":""},{"text":"Initiation requires at least 12 weeks of high-intensity statin therapy (unless statin intolerance documented); statin values on high-intensity statin within last 120 days required for assessment prior to approval.","status":""}

Product / Topic	Step therapy requirement
{"text":"Tolvaptan","status":""},{"text":"Coverage requires trial of at least two of the following measures before approval: furosemide, demeclocycline, or fluid restriction; documentation that patient does not have underlying liver disease is required.","status":""}

Product / Topic	Step therapy requirement
{"text":"Agents with TNF inhibitor prerequisite (example group)","status":""},{"text":"Certain indications require trial and failure or intolerance to one or more TNF inhibitors prior to coverage (trial requirements vary by product/indication).", "status":""}

Product / Topic	Step therapy requirement
{"text":"Oncology agents (general)","status":""},{"text":"Many oncology products require prior specific chemotherapy or targeted therapy trials or documented disease progression before coverage per product-specific criteria.","status":""}

Product / Topic	Step therapy requirement
{"text":"Ubrelvy / Voquezna (examples)","status":""},{"text":"Ubrelvy (acute migraine): trial of two generic triptans required unless contraindicated; Voquezna (H. pylori): trial of a guideline-recommended first-line regimen required prior to coverage.","status":""}

Product / Topic	Step therapy requirement
{"text":"Various oncology agents (examples: multiple myeloma, DLBCL)","status":""},{"text":"Coverage requires failure of prior therapies as specified (e.g., failure of one prior therapy for multiple myeloma; trial of at least two lines for relapsed/refractory DLBCL).","status":""}

Product / Topic	Step therapy requirement
{"text":"Xermelo / Xifaxan (examples)","status":""},{"text":"Xermelo (carcinoid syndrome diarrhea): trial of somatostatin analog required; Xifaxan 550 mg (hepatic encephalopathy/IBS-D/recurrent C. diff) requires specified prior therapy trials (e.g., lactulose for HE, loperamide for IBS-D, vancomycin for recurrent C. diff) prior to coverage.","status":""}

Product / Topic	Step therapy requirement
{"text":"Certain antidepressants and antipsychotics (examples: Exxua/Trintellix, various aripiprazole formulations)","status":""},{"text":"Requires trials of specified generic alternatives prior to coverage (e.g., at least 2 listed generic antidepressants for Exxua/Trintellix; trial of at least one listed generic antipsychotic before coverage of listed antipsychotic products).","status":""}

Product / Topic	Step therapy requirement
{"text":"Aristada (long-acting aripiprazole formulations)","status":""},{"text":"Requires trial of at least one listed generic antipsychotic (e.g., aripiprazole, paliperidone, quetiapine, risperidone, etc.) prior to coverage; lifetime coverage duration when criteria met.","status":""}

Product / Topic	Step therapy requirement
{"text":"Invega Hafyera","status":""},{"text":"Requires prior trial of once-a-month paliperidone palmitate for at least 4 months OR an every-three-month paliperidone palmitate cycle for at least one three-month cycle prior to coverage.","status":""}

Product / Topic	Step therapy requirement
{"text":"Farxiga / Jardiance (SGLT2 inhibitors)","status":""},{"text":"Step therapy requires trial of generic dapagliflozin prior to coverage for Farxiga and Jardiance, with an exception that the Jardiance step does not apply when used to reduce risk of cardiovascular death in adults with T2DM and established CVD.","status":""}

Product / Topic	Step therapy requirement
{"text":"Ophthalmic glaucoma agents and Rytary","status":""},{"text":"Coverage requires trial of a generic formulary ophthalmic glaucoma medication or Lumigan for Rhopressa/Rocklatan; Rytary requires trial of generic oral extended‑release carbidopa & levodopa prior to coverage.","status":""}

Product / Topic	Step therapy requirement
{"text":"Products requiring generic methotrexate / oral risperidone / allopurinol trials (examples: Rasuvo, Perseris, Febuxostat)","status":""},{"text":"Require documented trial of the specified generic agent prior to coverage (e.g., trial of generic injectable methotrexate for Rasuvo; trial of oral risperidone for Perseris and ER risperidone products; trial of or contraindication to allopurinol for febuxostat).","status":""}

Product / Topic

Step therapy requirement

{"text":"Products requiring generic methotrexate / oral risperidone / allopurinol trials (examples: Rasuvo, Perseris, Febuxostat)","status":""},{"text":"Require documented trial of the specified generic agent prior to coverage (e.g., trial of generic injectable methotrexate for Rasuvo; trial of oral risperidone for Perseris and ER risperidone products; trial of or contraindication to allopurinol for febuxostat).","status":""}

Benefit Determination by Setting

Billing Rule

Provide setting/use info for Part B vs Part D determination

Provide information describing the drug’s use and the care setting (hospital outpatient, infusion center, or pharmacy) when requested to determine Medicare Part B vs Part D coverage.

Submit setting/use information to determine Part B vs Part D coverage

Policy Background

This document defines the prior authorization (PA) and step therapy (ST) requirements that apply to the listed specialty and pharmacy drugs for Blue Cross Blue Shield of Michigan Medicare Plus Blue Group PPO and Prescription Blue Group PDP Healthy Value Enhanced Comprehensive Formulary for the 2026 plan year. Coverage decisions in this program require that clinical and/or administrative criteria be met before benefits are provided; drugs subject to ST may require documented trials of one or more formulary alternatives before a non‑formulary or higher‑cost agent will be approved.

The clinical criteria are based on current medical evidence and the recommendations of the Blues' Pharmacy and Therapeutics Committee. Providers may request PA or ST by contacting the pharmacy help desk; members with questions should call customer service on the back of their ID card. For many products, PA is required and coverage durations are commonly 1 year unless otherwise specified in the product entry.

Key Definitions and Terms

inv-262: PA

DefinitionPrior authorization (PA): Clinical and/or administrative criteria must be met before coverage is provided for listed drugs.

How to requestPhysician may contact the pharmacy help desk to request prior authorization; members may call customer service on their ID card.

Typical durationCoverage duration for many PA-approved products is commonly 1 year unless otherwise specified.

inv-263: ST

DefinitionStep therapy (ST): Requires prior treatment with one or more formulary drugs before coverage of the requested agent.

PurposeEnsures trials of less-costly or formulary alternatives before approving higher-cost or specialty agents.

ExamplesMany products in the document require ST (see product-specific entries for required prior agents).

inv-264: Eosinophilic asthma (EA)

DefinitionEosinophilic asthma (EA): asthma phenotype requiring elevated blood eosinophils and inadequate control despite standard controller therapy.

Diagnostic threshold>=150 cells/µL at initiation required for EA indications (e.g., Nucala/Fasenra).

Therapy contextCoverage also requires failure to maintain adequate control after systemic corticosteroids or high‑dose inhaled corticosteroids plus trial of an additional controller (LEUK, LABA, or LAMA).

inv-265: Reauthorization requirement

Reauthorization general ruleReauthorization for many biologic and specialty products requires documentation of positive clinical response to therapy.

Biologic examplesReauthorization requirement explicitly stated for agents such as Skyrizi, Stelara, Nucala, Dupixent, and others.

DocumentationProvider must submit clinical notes or objective measures demonstrating benefit at reauthorization time.

inv-266: APDS

ConditionActivated phosphoinositide 3-kinase delta syndrome (APDS).

Molecular requirementCoverage requires documented PI3Kδ mutation: variant in PIK3CD or PIK3R1.

Clinical requirementAlso requires documented APDS-associated symptoms (e.g., nodal/extranodal lymphoproliferation, recurrent oto‑sino‑pulmonary infections, organ dysfunction).

inv-267: Confirmation of Pompe disease

Test sequenceConfirmation of Pompe disease requires serum assay showing decreased acid alpha‑glucosidase activity followed by genetic testing demonstrating a GAA mutation.

Clinical requirementCoverage also requires symptomatic manifestations (progressive muscle weakness, respiratory failure, frequent infections, orthopnea, sleep apnea) and lack of improvement on current ERT.

Coverage durationCoverage duration noted as 1 year when criteria met.

inv-268: High-intensity statin

ExamplesHigh-intensity statins referenced include atorvastatin 40-80 mg or rosuvastatin 20-40 mg.

Role in criteriaDocumented trial of a high-intensity statin (12 weeks) is required prior to PCSK9 inhibitor initiation unless statin intolerance is documented.

Statin intoleranceIntolerance examples include skeletal muscle symptoms or rhabdomyolysis; documentation may substitute for trial requirement.

inv-269: RET gene alterations as detected by an FDA-approved test

DefinitionRET gene alterations: RET fusion or RET mutation identified by an FDA‑approved test.

Indication examplesUsed to establish eligibility for RET-targeted therapies (e.g., Retevmo) in NSCLC, MTC, and other RET‑fusion tumors.

Age noteSome pediatric indications specify age >=2 years for coverage when RET alteration is present.

inv-270: PH1 confirmed by genetic testing of the AGXT mutation

RequirementPrimary hyperoxaluria type 1 (PH1) coverage (Ryfloza/Rivfloza context) requires genetic testing confirming AGXT mutation.

Associated documentationGenetic confirmation is required in the product entry; absence may preclude coverage.

Related noteSome products tied to PH1 criteria also have transplant/history exclusions (see product-level entries).

inv-271: FOP (Fibrodysplasia ossificans progressiva)

DefinitionFibrodysplasia ossificans progressiva (FOP) — genetically confirmed disorder requiring ACVR1 mutation testing for coverage.

DocumentationGenetic testing confirmation showing ACVR1 mutation is required prior to approval.

Coverage durationCoverage typically noted as 1 year when criteria met.

inv-272: EGFR mutation-positive NSCLC

DefinitionEGFR mutation–positive NSCLC: tumors with EGFR exon 19 deletion or exon 21 L858R mutation.

Coverage scenariosTagrisso coverage applies in adjuvant, first-line metastatic, or concurrent chemoradiation settings per mutation‑positive status.

Progression criterionT790M-positive disease coverage requires progression on or after prior EGFR TKI therapy.

inv-273: NYHA class II-IV

DefinitionNew York Heart Association (NYHA) functional classification II-IV indicating symptomatic chronic heart failure.

Use in criteriaRequired for Verquvo coverage when combined with LVEF <45% and recent hospitalization or IV diuretic treatment.

DocumentationProvider must document NYHA class II-IV in medical record for authorization.

inv-274: Bone mineral density threshold for osteoporosis

ThresholdBone mineral density T-score <= -2.5 defines osteoporosis for coverage purposes.

Required evidenceSubmit BMD report demonstrating T-score at or below -2.5 to support therapy (e.g., Tymlos, osteoporosis agents).

Associated prior therapySome agents require trials of specified prior bone therapies in addition to T-score documentation.

inv-275: Anti-AChR antibody positive myasthenia gravis

Diagnostic requirementAnti‑AChR antibody–positive myasthenia gravis requires lab documentation of positive anti‑AChR antibodies.

Confirmatory testingPlus one confirmatory test such as positive edrophonium test, documented clinical response to cholinesterase inhibitors, or electrophysiological evidence (RNS or SFEMG).

Prior therapyPrevious treatment courses of at least 12 weeks with specified immunosuppressants are required unless contraindicated.

Policy Summary

Payerblue cross blue shield - michigan

PolicyPrior authorization and step therapy criteria for specialty and pharmacy drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionContact the pharmacy help desk to request prior authorization or step therapy and submit required clinical documentation per product-specific criteria.

SourceLink

On This Page

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Policy Summary

Payerblue cross blue shield - michigan

PolicyPrior authorization and step therapy criteria for specialty and pharmacy drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewJun 1, 2026

Next Review DateN/A

Key ActionContact the pharmacy help desk to request prior authorization or step therapy and submit required clinical documentation per product-specific criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

391document pages

multipleproducts with PA/ST criteria

1 YEARtypical coverage duration

Product-Specific Coverage Criteria

Adbry — Initial and reauthorization criteria

Covered when ALL of the following are met:

Reauthorization requires documentation of positive clinical response; dosing limit for patients <100 kg after 16 weeks to 300 mg every 4 weeks unless clinical rationale provided.

Braftovi — Indication-based requirements

Covered when ANY of the following indication-specific conditions are met:

Coverage requires the combination or prior therapy per indication.

Prerequisite therapy and testing requirements

Covered when ALL of the following prerequisite therapy or testing requirements are met (product-specific):

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

From product-specific prerequisite therapy listing.

Refer to product-specific entry for required prior agents.

Bronchitol tolerance: Documentation that the member has passed the Bronchitol tolerance test is required prior to coverage.

From Bronchitol entry.

Octreotide (acromegaly): Trial of bromocriptine mesylate at maximally tolerated doses is required prior to coverage of octreotide for acromegaly.

From octreotide prerequisite therapy requirement.

General coverage conditions

Covered when ALL of the following general conditions are satisfied:

Combination biologic/DMARD restriction: Requested product is not being used in combination with another biologic or targeted DMARD indicated for the same condition.

Applies across multiple biologic entries (combination exclusion).

Reauthorization requirement: Reauthorization requires documentation of positive clinical response to therapy for biologic and other specialty agents.

Stated across multiple products.

See product-level entries for details.

Cosentyx — indication criteria

Covered when ALL of the following indication-specific criteria are met:

Psoriatic arthritis: Diagnosis of active psoriatic arthritis documented.

From Cosentyx product entry.

Plaque psoriasis: Diagnosis of moderate to severe chronic plaque psoriasis documented.

From Cosentyx product entry.

Ankylosing spondylitis: Diagnosis of ankylosing spondylitis AND trial of one NSAID (e.g., diclofenac, ibuprofen, meloxicam, naproxen).

From Cosentyx product entry.

Non-radiographic axial spondyloarthritis: Diagnosis with objective signs of inflammation AND trial of one NSAID.

From Cosentyx product entry.

Hidradenitis suppurativa: Diagnosis of moderate to severe hidradenitis suppurativa documented.

From Cosentyx product entry.

Tadalafil — BPH

Covered when ALL of the following are met:

BPH diagnosis: Diagnosis of benign prostatic hyperplasia documented.

Tadalafil not covered when patient is receiving nitrate therapy (contraindication/exclusion).

Dalfampridine — MS mobility

Covered when ALL of the following are met:

Ambulatory status and testing: Patient is not wheelchair bound AND baseline timed 25-foot walk (T25FW) test submitted prior to initiation.

Dalfampridine is excluded if patient is wheelchair bound or becomes wheelchair bound; reauthorization requires stability or improvement on T25FW.

Epidiolex — seizure disorder criteria

Covered when ANY of the following, per syndrome, are met:

Lennox-Gastaut syndrome: Diagnosis of Lennox-Gastaut syndrome AND trial of two generic alternatives for seizure treatment.

From Epidiolex seizure indications.

Dravet syndrome: Diagnosis of Dravet syndrome AND trial of two of: valproic acid, clobazam, or topiramate.

From Epidiolex seizure indications.

Tuberous sclerosis complex seizures: Diagnosis of seizures associated with tuberous sclerosis complex AND trial of two generic alternatives for seizure treatment.

From Epidiolex seizure indications.

Seizure-related step therapy

Examples of seizure-related step therapy (covered when the listed trials are documented):

Lennox-Gastaut step: Trial of two generic anticonvulsant alternatives documented prior to approval for Lennox-Gastaut syndrome.

From seizure-related step therapy examples.

Dravet step: Trial of two of valproic acid, clobazam, or topiramate documented prior to approval for Dravet syndrome.

From seizure-related step therapy examples.

Tuberous sclerosis complex step: Trial of two generic anticonvulsant alternatives documented prior to approval for tuberous sclerosis complex seizures.

From seizure-related step therapy examples.

Topiramate clinical criteria

Covered when ANY of the following apply:

Migraine prevention: Trial of at least two generic alternatives for migraine prevention documented OR patient unable to swallow tablets/capsules.

From topiramate clinical criteria.

Seizure disorder/epilepsy: Trial of at least two generic anticonvulsants documented OR patient unable to swallow tablets/capsules.

From topiramate clinical criteria.

Schizophrenia prerequisite therapy

Covered when ALL of the following are met:

Schizophrenia prior therapy: Diagnosis of schizophrenia AND trial of two generic formulary atypical antipsychotics (examples: aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone).

From schizophrenia prerequisite therapy entry.

Fasenra coverage criteria

Covered when ALL of the following per-indication criteria are met:

Applies to adults and children per product labeling.

From Fasenra indication entry.

Reauthorization: For all indications, reauthorization requires documentation of positive clinical response to therapy.

Reauthorization requirement stated for biologics.

Osteoporosis product criteria

Covered when ALL of the following are met:

Bone mineral density: Documentation of bone mineral density T-score ≤ -2.5.T-score <= -2.5

Required baseline BMD for osteoporosis product coverage.

From osteoporosis product criteria.

Antiseizure product requirements

Covered when ALL of the following are met (product-specific antiseizure prerequisites):

Fintepla: Trial of two of the following: valproic acid, clobazam, topiramate documented prior to coverage for indicated seizures.

From antiseizure product examples.

Other antiseizure agents: Coverage for select antiseizure agents requires trial of two generic anticonvulsants prior to approval.

General antiseizure requirement entry.

Adalimumab class criteria

Covered when ALL of the following are met:

Reauthorization requires documentation of positive clinical response; cannot be used in combination with another biologic/targeted DMARD for same condition.

Combination exclusion: Product is not being used in combination with another biologic or targeted DMARD indicated for the same condition.

Applies across adalimumab biosimilars.

Selected oncology coverage conditions

Covered when ALL of the following product- and indication-specific criteria are met:

From Ibrance product entry.

From Iclusig product entry.

Breast cancer — combination therapy requirements

Covered when ALL of the following are met:

From Ibrance product entry.

Philadelphia chromosome–positive leukemias

Covered when ANY of the following scenarios apply (per disease phase/mutation):

Ph+ ALL: Newly diagnosed Ph+ ALL requires combination with chemotherapy; T315I-positive Ph+ ALL may be covered as monotherapy when no other kinase inhibitors are indicated.

From Iclusig entry.

Rheumatology agents — trial requirements and combination restrictions

Covered when ALL of the following are met:

Cannot be used in combination with another biologic/targeted DMARD for same condition.

Activated PI3K delta syndrome (APDS)

Covered when ALL of the following are met:

Molecular and clinical documentation required.

Lenvima indication-specific criteria

Covered when ANY of the following per‑indication criteria are met:

From Lenvima product entry.

Levetiracetam — formulation-specific coverage

Covered when ALL of the following are met:

Levetiracetam oral solution prerequisite: Both: 1) documented trial of levetiracetam oral solution, AND 2) documentation that the patient is unable to swallow tablets or capsules.

Coverage dependent on formulation trials.

Basal cell carcinoma — prior therapy requirement

Covered when ANY of the following are met:

From Libtayo/BCC entry.

Oral solution prerequisite

Covered when ALL of the following are met:

Oral solution and swallowing inability: Documentation of trial of oral solution formulation AND documentation patient cannot swallow tablets or capsules.

Example: levetiracetam oral solution prerequisite.

Basal cell carcinoma prerequisite

Basal cell carcinoma hedgehog requirement: Either prior hedgehog pathway inhibitor therapy documented OR documented ineligibility for hedgehog pathway inhibitor treatment.

Coverage duration typically 1 year.

Liraglutide diabetes criteria

Excluded if used for weight‑loss only.

Lonsurf combination and prior chemo requirements

Coverage duration 1 year.

Lynparza prior therapy requirements

See Lynparza product entries for indication‑specific prior therapy details.

Mavyret per guideline

Mavyret (HCV): Treatment criteria applied consistent with current AASLD/IDSA guidance for hepatitis C virus infection.

Follow guideline-based regimen and eligibility.

Mekinist mutation-based criteria

Coverage duration 1 year.

Lybalvi prerequisite generics

Coverage duration 1 year.

Nucala (mepolizumab) initial and reauthorization criteria

Nucala is covered when ONE of the indication‑specific pathways below is met:

Cannot be combined with another biologic for same condition.

Applies to adults and children >=12 years.

EGPA: Diagnosis of EGPA with required clinical features (at least two typical EGPA criteria).

EGPA entry requirements.

HES-specific requirement.

From Nucala COPD criteria.

Nexletol/Nexlizet criteria

Covered when ALL of the following are met:

Statin intolerance examples include skeletal muscle symptoms or rhabdomyolysis.

Octreotide (acromegaly) criteria

Covered when ALL of the following are met:

Octreotide for acromegaly: Diagnosis of acromegaly AND trial of bromocriptine mesylate at maximally tolerated doses documented prior to octreotide approval.

From octreotide product criteria.

Opfolda diagnostic and treatment criteria

Covered when ALL of the following diagnostic and treatment criteria are met:

Cardiac hypertrophy alone is not sufficient; coverage duration 1 year.

Onureg criteria

Covered when ALL of the following are met:

From Onureg product entry.

Nuedexta criteria

Covered when ALL of the following are met:

Nuedexta for pseudobulbar affect (PBA): Presence of an underlying neurologic condition causing PBA symptoms (e.g., MS, ALS, Parkinson's disease, stroke, TBI) documented.

From Nuedexta product entry.

Pompe disease therapy - initial coverage

Covered when ALL of the following are met:

Coverage duration = 1 year.

Orencia coverage

Covered when ALL of the following are met:

Coverage duration = 1 year.

Posaconazole DR – prophylaxis and treatment

Covered when ANY of the following indication‑specific criteria are met:

Coverage duration = 6 months.

Praluent coverage

Praluent initiation covered when ALL of the following are met; reauthorization requires the conditions below:

Coverage duration = 3 years.

Praluent reauthorization: Continued use of statin at max tolerated dose and documentation of LDL reduction while on Praluent therapy.

Reauthorization criteria.

Polivy coverage

Covered when ALL of the following are met:

Polivy for r/r DLBCL: Diagnosis of relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) NOS AND trial of at least two prior therapies documented.

Coverage duration = 1 year; prerequisite Part D drug required.

Eltrombopag coverage

Covered when ANY of the following per‑indication criteria are met:

Coverage duration = 1 year; prerequisite Part D drug required for ITP.

Pretomanid coverage

Covered when ALL of the following are met:

Pretomanid for pulmonary TB: Indication of adult pulmonary tuberculosis AND use in combination with bedaquiline and linezolid.

Coverage duration = 1 year.

Piqray coverage

Covered when ALL of the following are met:

Coverage duration = 1 year; prerequisite Part D drug required.

Qinlock coverage

Covered when ALL of the following are met:

Qinlock for advanced GIST: Adult patient with advanced gastrointestinal stromal tumor (GIST) AND prior therapy with ≥3 kinase inhibitors, including imatinib documented.prior >=3 kinase inhibitors

Coverage duration = 1 year.

Pomalidomide coverage

Covered when ALL of the following are met:

Coverage duration = 1 year; prerequisite Part D drug required.

Pomalidomide for AIDS-related Kaposi sarcoma: Trial and failure of highly active antiretroviral therapy (HAART) documented.

Indication-specific requirement.

Advanced GIST prerequisite therapy

Advanced GIST prerequisite: Adult patient with advanced GIST AND prior therapy with ≥3 kinase inhibitors including imatinib documented.

Product‑level prerequisite requirement.

Retevmo coverage criteria

Requires FDA‑approved test for RET alterations.

Rinvoq coverage criteria

Coverage duration 1 year.

Rubraca coverage criteria

BRCA mutation and response to platinum chemotherapy required.

Tolvaptan coverage criteria

Coverage duration noted per entry.

Sarclisa coverage criteria

Product‑level prerequisites specified.

Skyrizi (risankizumab) — coverage conditions

Covered when ALL of the following are met:

Cannot be used in combination with another biologic/targeted DMARD for same condition.

Ustekinumab (Stelara) — coverage conditions

Covered when ALL of the following are met:

Coverage duration 1 year.

Stivarga (regorafenib) — colorectal cancer/GIST/HCC criteria

Covered when ALL of the following are met (disease‑ and prior‑therapy specific):

Product‑level prior therapy requirements.

Tafinlar (dabrafenib) — melanoma and other solid tumor criteria

Covered when ALL of the following are met:

From Tafinlar product entry.

Tagrisso (osimertinib) — EGFR-mutant NSCLC criteria

Covered when ANY of the following scenarios apply:

From Tagrisso product entry.

Tetrabenazine — coverage and exclusions

Covered when ALL of the following are met:

Coverage duration 1 year; safety exclusions apply.

General coverage

Covered when ALL product‑specific criteria are met:

General product coverage: Requested product is one of the listed drugs AND all product‑specific prior therapy, diagnostic, and combination‑use criteria stated in the product entry are satisfied.

Many products have 1‑year coverage durations unless otherwise specified.

Tocilizumab (Tyenne) coverage

Covered when ALL of the following are met:

Applies to RA, polyarticular JIA, SJIA, GCA as specified.

Selected oncology and specialty drug criteria

Covered when ANY of the following oncology or specialty drug criteria are met (product‑specific):

See product‑level entries for exact prior therapy requirements.

Tymlos

Covered when ALL of the following are met:

Coverage duration 2 years.

Verquvo

Covered when ALL of the following are met:

Coverage duration 1 year.

Voquezna

Covered when ALL of the following are met:

Coverage duration 1 year.

Verzenio

Covered when ANY of the following per‑indication criteria are met:

Prior Part D therapy required for certain indications.

Per-product coverage criteria

Covered when ALL of the following product‑specific criteria are met:

See per‑product entries for details and durations.

Maintenance therapy for advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer

Maintenance therapy is covered when ALL of the following are satisfied:

Maintenance ovarian cancer: Patient has complete or partial response to first‑line platinum‑based chemotherapy AND meets product‑specific maintenance criteria.

Coverage duration = 1 year.

Coverage duration for maintenance therapy is 1 year per product listing unless otherwise specified.1 Year

From maintenance oncology continuation entry.

Metastatic and extensive-stage small cell lung cancer (SCLC)

Covered when ALL of the following are met:

Metastatic SCLC prior chemo/progression: Disease progression on or after platinum‑based chemotherapy documented for metastatic SCLC coverage.

Zilbrysq (for myasthenia gravis)

Covered when ALL of the following are met:

Additionally, prior immunosuppressant courses of ≥12 weeks required unless contraindicated; patient must be on and continue stable regimen.

From Zilbrysq product entry.

Zolinza (cutaneous T-cell lymphoma)

Covered when ALL of the following are met:

Zolinza for CTCL: Cutaneous T‑cell lymphoma with progressive, persistent, or recurrent disease AND trial of two systemic therapies documented prior to coverage.

Coverage duration = 1 year.

Zonisade (seizure disorder)

Covered when ANY of the following are met:

From Zonisade seizure disorder entry.

Unable to swallow: Patient is unable to swallow tablets or capsules (documentation required).

Alternative pathway for coverage.

Exxua / Trintellix (depression agents)

Covered when ALL of the following are met:

Coverage duration is lifetime for these products.

Aripiprazole formulations and certain antipsychotics

Covered when ALL of the following are met:

Oral aripiprazole prerequisite: Trial of oral aripiprazole documented prior to coverage of certain aripiprazole formulations (e.g., Abilify products).

Coverage duration often lifetime for these products.

Coverage duration often lifetime.

Aristada initial therapy requirements

Covered when ALL of the following are met:

Coverage duration is lifetime.

Aristada Initio requirements

Covered when ANY of the following are met:

Aristada Initio prior trial/intolerance: Trial OR intolerance to Abilify Maintena or oral aripiprazole documented.trial or intolerance documented

Coverage duration is lifetime for Aristada Initio.

Aristada (alternate) requirements

Covered when ALL of the following are met:

Aristada alternate prior trial: Trial of oral aripiprazole documented prior to coverage of alternate Aristada listing.trial documented

Coverage duration is lifetime.

Gauze/pads coverage requirements

Covered when ALL of the following are met:

Gauze/pads insulin claim: A claim for an insulin product in the last 180 days is required to establish coverage for listed alcohol prep pads or Curity gauze pads.claim within 180 days

Coverage duration 1 year.

Invega Hafyera requirements

Covered when ANY of the following are met:

Coverage duration is lifetime.

Invega Sustenna requirements

Covered when ALL of the following are met:

Invega Sustenna prior trial: Trial of oral paliperidone or oral risperidone documented prior to coverage.trial documented

Coverage duration is lifetime.

Invega Trinza requirements

Covered when ALL of the following are met:

Invega Trinza prior trial: Trial of oral paliperidone or oral risperidone documented prior to coverage.trial documented

Coverage duration is lifetime.

Pancreaze requirements

Covered when ALL of the following are met:

Pancreaze prerequisites: Trial of Zenpep or documentation of intolerance to Zenpep prior to Pancreaze coverage.trial or intolerance documented

Coverage duration is lifetime.

Perseris requirements

Covered when ALL of the following are met:

Perseris prior trial: Trial of oral risperidone documented prior to Perseris coverage.trial documented

Coverage duration is lifetime.

Rasuvo requirements

Covered when ALL of the following are met:

Rasuvo methotrexate trial: Trial of generic injectable methotrexate documented prior to Rasuvo coverage.trial documented

Coverage duration is lifetime.

Generic injectable methotrexate requirement

Generic injectable methotrexate requirement: Trial of generic injectable methotrexate must be documented prior to approval of the affected product(s).

Coverage duration is lifetime for affected products upon meeting criteria.

Ophthalmic glaucoma medication trial

Rhopressa/Rocklatan ophthalmic trial: Trial of any generic formulary ophthalmic glaucoma medication OR Lumigan documented prior to coverage.

Coverage duration 1 year.

Risperidone ER/Rykindo trial

Risperidone ER/Rykindo trial: Trial of oral risperidone documented prior to coverage of risperidone ER or Rykindo formulations.

Coverage duration is lifetime.

Rytary trial

Rytary trial: Trial of generic oral extended‑release carbidopa & levodopa documented prior to Rytary coverage.

Coverage duration is 1 year.

SGLT2 inhibitor trial and exception

From SGLT2 prior auth rules.

Febuxostat trial or contraindication

Febuxostat trial or contraindication: Trial of allopurinol documented OR documentation of contraindication to allopurinol prior to febuxostat coverage.

Coverage duration is lifetime.

Clinical Thresholds and Key Values

Listed product names (no billing codes provided)mixed

Abelcet	Abelcet
Acetylcysteine INHALATION SOLN	Acetylcysteine INHALATION SOLN
Acyclovir Sodium INJ 50MG/ML	Acyclovir Sodium INJ 50MG/ML
Albuterol Sulfate NEBU 0.083%, 0.63MG/3ML, 1.25MG/3ML, 2.5MG/0.5ML	Albuterol Sulfate NEBU 0.083%, 0.63MG/3ML, 1.25MG/3ML, 2.5MG/0.5ML
Amphotericin B INJ	Amphotericin B INJ
Amphotericin B Liposome	Amphotericin B Liposome
Aprepitant	Aprepitant
Arformoterol Tartrate	Arformoterol Tartrate
Astagraf XL	Astagraf XL
Azathioprine TABS 50MG	Azathioprine TABS 50MG

1–10 of 53

1/6

Other listed products from Prior Authorization list (no billing codes)mixed

Abelcet	Abelcet
Plenamine INJ 147.4MEQ/L etc.	Plenamine INJ (multiple concentrations listed)
Premasol INJ 52MEQ/L etc.	Premasol INJ (multiple concentrations listed)
Prograf PACK	Prograf PACK
Prosol	Prosol
Pulmozyme SOLN 2.5MG/2.5ML	Pulmozyme SOLN 2.5MG/2.5ML
Rabavert	Rabavert
Recombivax Hb	Recombivax Hb
Sirolimus SOLN	Sirolimus SOLN
Sirolimus TABS	Sirolimus TABS

1–10 of 15

1/2

Products (short list duplicates removed)mixed

Everolimus TABS 0.25MG, 0.5MG, 0.75MG, 1MG	Everolimus TABS 0.25MG, 0.5MG, 0.75MG, 1MG
Tacrolimus CAPS	Tacrolimus CAPS
Sirolimus TABS	Sirolimus TABS

inv-115: Eosinophil count

DefinitionAbsolute eosinophil count used to determine eligibility for eosinophil-targeted biologics and COPD add-on maintenance.

EA initiation threshold>= 150 cells/µL at initiation for eosinophilic asthma.

COPD add-on threshold>=150 cells/µL now OR >=300 cells/µL within past 12 months for COPD add-on maintenance.

HES threshold (related context)>=1000 cells/µL at initiation for hypereosinophilic syndrome (HES).

inv-116: T25FW

TestTimed 25-foot walk (T25FW) test

When requiredSubmission of baseline T25FW prior to initiation of dalfampridine; reauthorization requires documentation of stability or improvement on T25FW.

Use caseDemonstrates ambulatory status and response for multiple sclerosis mobility indication.

inv-117: Eosinophil threshold

Primary threshold>= 150 cells per microliter for eosinophilic asthma at initiation.

COPD contextFor COPD add-on maintenance: current >=150 cells/µL or historical >=300 cells/µL within past 12 months.

HES initiation>= 1000 cells/µL required for hypereosinophilic syndrome initiation (in Nucala context).

inv-118: BMD T-score

MeasurementBone mineral density (BMD) reported as T-score (standard deviations from young-adult mean).

Osteoporosis thresholdT-score <= -2.5 (T-score at or below -2.5 required for coverage).

Documentation requirementSubmit BMD report showing T-score <= -2.5 for product coverage (e.g., Tymlos/Fotivda context).

inv-119: Diabetes diagnostic thresholds

A1c (HbA1c)>= 6.5% indicates diabetes for coverage documentation.

Fasting plasma glucose (FPG)>= 126 mg/dL indicates diabetes for coverage documentation.

2-hour plasma glucose (OGTT)>= 200 mg/dL during OGTT indicates diabetes for coverage documentation.

inv-120: Eosinophil count thresholds

EA initiation>=150 cells/µL at initiation for eosinophilic asthma (Nucala/Nucala-related criteria).

COPD add-onEither current >=150 cells/µL OR >=300 cells/µL within past 12 months for uncontrolled moderate-to-severe COPD add-on maintenance.

HES initiation>=1000 cells/µL at initiation for hypereosinophilic syndrome with stability on HES therapy required for coverage.

inv-121: LDL thresholds on statin

With ASCVD>=55 mg/dL LDL while on a high-intensity statin within the last 120 days for Praluent initiation.

Without ASCVD>70 mg/dL LDL while on a high-intensity statin within the last 120 days for Praluent initiation.

Statin requirementPatient must have had at least 12 weeks of high-intensity statin unless statin intolerance/contraindication documented.

inv-122: Baseline platelet count

ITP baselineBaseline platelet count <30,000/mcL required for coverage of persistent/chronic immune thrombocytopenia (ITP).

Hepatitis C thrombocytopeniaBaseline platelet count <75,000/mcL required for thrombocytopenia with chronic hepatitis C.

Severe aplastic anemiaBaseline platelet count <30,000/mcL for severe aplastic anemia indication.

inv-123: Bone Mineral Density (T-score)

MetricBone mineral density expressed as T-score (SD below young-adult mean).

Osteoporosis thresholdT-score <= -2.5 required for coverage (document BMD demonstrating <= -2.5).

Coverage noteDocumentation of BMD T-score required for product-specific approval (e.g., Tymlos).

inv-124: Left ventricular ejection fraction (LVEF)

DefinitionLeft ventricular ejection fraction (LVEF) — percent of blood ejected per cardiac cycle measured by echocardiography or equivalent.

Coverage thresholdLVEF < 45% required for Verquvo coverage in chronic heart failure NYHA class II-IV.

Associated requirementsAlso requires NYHA class II-IV and recent heart-failure–related hospitalization or outpatient IV diuretic within specified lookback periods.

inv-125: Insulin claim lookback

Lookback periodClaim for an insulin product in the last 180 days required to establish coverage for listed gauze/pad products.

PurposeUsed to confirm active insulin use for coverage of alcohol prep pads and Curity gauze pads.

Coverage durationCoverage for these supplies is limited to 1 year when criteria met.

Authorization, Documentation, and Denial Risks

Prior Authorization

Adbry-specific PA requirements

Products: Adbry
Age: ≥12 years
Coverage duration: 1 year
Prerequisite therapy: Part D drug required
Combination rule: No concomitant biologic/targeted DMARD for same condition

Prior Authorization

Calquence — prior authorization

Product: Calquence TABS
Coverage duration: 1 year
MCL: ≥1 prior therapy required
Untreated MCL (HSCT-ineligible): must combine with bendamustine + rituximab

Prior Authorization

Dupixent — prior authorization

Products: Dupixent INJ 200 mg/1.14 mL, 300 mg/2 mL
Exclusion: No concomitant biologic/targeted DMARD for same condition
AD age: ≥6 months; EOE age: ≥1 year; PN age and others per indication
Prerequisite: Trial of PPI or topical esophageal steroid for symptomatic EOE
Coverage duration: 1 year

Prior Authorization

Doptelet — prior authorization

Products: Doptelet; Doptelet Sprinkle
Indication: chronic immune thrombocytopenia
Coverage duration: 1 year
Other criteria: requires trial of previous treatment for ITP

Prior Authorization

Epidiolex — prior authorization

Product: Epidiolex
Coverage duration: 1 year
Lennox‑Gastaut: trial of 2 generic alternatives for seizures
Dravet: trial of 2 of valproic acid, clobazam, topiramate
TSC-associated seizures: trial of 2 generic alternatives

Prior Authorization

Lenvima (lenvatinib) PA requirements

Product: Lenvima (lenvatinib)
Coverage duration: 1 year
Requirement: follow indication-specific combination and prior therapy rules (document prior systemic therapy when required)

Prior Authorization

Oral solution trial and swallowing inability required

Example: Levetiracetam oral solution trial required + inability to swallow tablets/capsules
Mekinist liquid: patient must be unable to swallow tablets for liquid formulation

Prior Authorization

Prior systemic therapy required for Lumakras

Product: Lumakras
Coverage duration: 1 year
Requirement: KRAS G12C mutation and ≥1 prior systemic therapy for NSCLC
mCRC: prior fluoropyrimidine-, oxaliplatin-, irinotecan-based chemo; combine with panitumumab if indicated

Prior Authorization

Prior chemotherapy or specific prior agents required for Lynparza

Product: Lynparza
Coverage duration: 1 year
Ovarian/related cancers: prior platinum‑based chemotherapy required
Breast: prior chemotherapy or specific prior agents required; HR‑positive breast requires prior endocrine therapy or deemed inappropriate

Prior Authorization

Treatment per current AASLD/IDSA guidance

For hepatitis C and other liver-related antivirals (eg Vosevi, others), criteria will be applied consistent with current AASLD/IDSA guidance; prior authorization decisions follow those guidelines.

AASLD/IDSA guidance governs criteria application
Products: Vosevi and other HCV agents

Prior Authorization

Mekinist coverage requires mutation testing and specified combination therapy

Products: Mekinist tabs and liquid/solution
Requirement: BRAF V600E or V600K mutation by FDA‑approved test
Combination rules: often requires dabrafenib; some settings require trial of vemurafenib + cobimetinib first

Prior Authorization

Age-based prior authorization

Prior authorization may be age‑based for certain drugs (example: PA applies only to patients <30 years of age for select products). Always verify age restrictions in the product entry.

Example: PA applies only to patients <30 years for specified products

Prior Authorization

Prior authorization and coverage duration

Typical coverage duration: 1 year
Exceptions: Posaconazole DR prophylaxis = 6 months; Praluent = 3 years; some products list lifetime duration
Reauthorization: documentation of positive clinical response usually required

Prior Authorization

Retevmo prior authorization summary

Product: Retevmo
Coverage: RET fusion/mutation confirmed by FDA‑approved test
Thyroid cancer: trial and failure with radioactive iodine if appropriate
Solid tumors: progressed on/after prior systemic treatment

Prior Authorization

Stelara prior authorization

Product: Stelara
Coverage duration: 1 year
Exclusion: No concomitant biologic/targeted DMARD for same condition
Reauthorization: documentation of positive clinical response

Prior Authorization

Verzenio PA requirement

Product: Verzenio
Coverage duration: 1 year
Adjuvant high‑risk: must combine with tamoxifen or an aromatase inhibitor
Advanced/metastatic: combination with endocrine therapy or prior therapies as specified

Prior Authorization

General prior authorization and maintenance therapy requirement

Document prior systemic/maintenance therapy when required
Provide evidence of progression or response per product criteria
Reauthorization: documentation of positive clinical response

Prior Authorization

Product list prior authorization

Refer to formulary for PA/ST flags
Follow per‑product criteria in this section

Prior Authorization

Aristada Initio / Aristada prior authorization

Products: Aristada Initio / Aristada
Prerequisite: trial of paliperidone palmitate LAI per durations above
Coverage duration: lifetime (per product details)

Step Therapy

SGLT2 inhibitor prior authorization rules

Products: Farxiga (dapagliflozin), Jardiance (empagliflozin)
Step: trial of generic dapagliflozin required for Farxiga/Jardiance; Jardiance CV indication exempt from step therapy

Prior Authorization

Methotrexate-related prior authorization

Example: Zilbrysq requires prior immunosuppressant trials and restricts combinations; methotrexate trials may be required where specified
Generic injectable methotrexate trial required per product details

Denial Risk

Combination therapy exclusion / Prohibited combinations

General biologic combination exclusion: no concomitant biologic/targeted DMARD for same condition
Specific prohibitions: Zilbrysq — cannot be used with other biologic therapies for MG or IVIG; PH1 product excludes history of kidney/liver transplant and combination with Oxlumo

Denial Risk

Explicit denial situations / Contraindicated combinations

Weight‑loss exclusion: certain agents excluded if used solely for weight loss (eg liraglutide, others)
Transplant exclusions: some drugs deny coverage with history of kidney/liver transplant
Prohibited combinations: see per‑product entries for explicit denial situations

Denial Risk

Weight-loss exclusion

Do not approve when primary use is weight loss only
Documentation: medical records or lab evidence of T2DM required for diabetes indication

Denial Risk

Combination biologic exclusion

Products explicitly stating exclusion: Adbry, Skyrizi, Stelara, Nucala, Xolair, Dupixent, others
Operational impact: deny requests for concurrent use of two biologics/targeted DMARDs for same indication

Prior Authorization

Nucala exclusion and diagnostic requirements

Product: Nucala
Exclusion: no concomitant biologic/targeted DMARD
EGPA: requires two typical EGPA criteria
Eosinophilic asthma: eosinophil ≥150 cells/µL at initiation; other thresholds apply per indication

Step Therapy

Octreotide prerequisite therapy

Octreotide prerequisite therapy: coverage for acromegaly requires trial of bromocriptine mesylate at maximally tolerated doses prior to octreotide approval.

Product: Octreotide acetate inj
Prerequisite: trial of bromocriptine for acromegaly

Step Therapy

Posaconazole DR prophylaxis prerequisite trials

Product: Posaconazole DR
Prophylaxis: trial of two of fluconazole/itraconazole/voriconazole required
Coverage duration for prophylaxis: 6 months

Prior Authorization

Polivy prior therapy requirement

Polivy prior therapy requirement: many oncology agents require prior lines of therapy; confirm specific prior therapy requirements in the product entry before approving Polivy or other cancer agents.

Check product‑specific prior therapy/line requirements (eg Polivy, Fotivda, Lonsurf)

Denial Risk

Tetrabenazine exclusions

Tetrabenazine exclusions: certain contraindications apply; review product entry for excluded situations (eg hepatic impairment, active suicidality where specified).

Product examples list hepatic impairment and psychiatric risk exclusions; documentation of CYP2D6 genotype may be required for higher doses

Denial Risk

Missing prerequisite therapy / Required prior trial evidence

Examples of missing prerequisites that cause denials: oral aripiprazole (LAI)
Paliperidone palmitate LAI trial for Aristada
Oral risperidone/paliperidone trials
Trial or intolerance to Zenpep for pancreatic enzyme drugs
Generic injectable methotrexate trial required where specified
Allopurinol trial or contraindication required for febuxostat
Claim for an insulin product within prior 180 days for certain products

Documentation Required

Documentation requirements and Zilbrysq required medical information

Zilbrysq: anti‑AChR antibody positive + confirmatory test required
Opfolda/Pompe: serum assay showing decreased enzyme activity + GAA gene mutation testing
Eltrombopag: baseline platelet count thresholds required
Nucala/Xolair: eosinophil counts, IgE levels, or other labs per indication
Voquezna: documentation of H. pylori infection and trial of guideline‑recommended first‑line regimen

Prior Authorization

Progression requirement for SCLC and other oncology drugs

Document prior progression for line‑specific oncology approvals
Provide imaging/clinical documentation of progression and prior regimen details

Step Therapy

Step therapy / prerequisite trials

Step therapy commonly required before brand coverage
Examples: migraine prevention generics; statin + PCSK9 prerequisites; generic anticonvulsant trials

Step Therapy

Combination requirement as step

Examples: Jylamvo combinations (pembrolizumab, everolimus)
Verzenio: combine with tamoxifen or aromatase inhibitor in adjuvant high‑risk setting

Step Therapy

Step therapy: trial of generic antipsychotic / Missing oral trials

Oral aripiprazole required prior to LAI antipsychotics where specified
Oral paliperidone or risperidone required prior to paliperidone LAIs

Step Therapy

Step therapy for Livtencity (post-transplant CMV)

Step therapy for Livtencity (post‑transplant CMV): coverage requires trial of one of ganciclovir, valganciclovir, cidofovir, or foscarnet prior to Livtencity approval.

Product: Livtencity
Prerequisite: trial of ganciclovir, valganciclovir, cidofovir, or foscarnet

Prior Authorization

Age-based restriction / step

Age‑based restriction/step: some products include age thresholds as part of authorization (see product-specific entries). Verify age and apply PA only when patient meets age criteria.

Examples: Adbry age ≥12; other products have pediatric/adult age cutoffs

Step Therapy

Motpoly Xr step therapy

Motpoly XR and similar seizure products: require trial of two generic anticonvulsants for migraine/seizure prevention indications prior to authorization.

Product: Motpoly XR
Prerequisite: trial of two generic anticonvulsants for seizure/migraine prevention

Step Therapy

Nexletol/Nexlizet step therapy

Prerequisite: high‑intensity statin trial unless intolerant
Document LDL values and ASCVD/HeFH status as specified

Step Therapy

Product-specific step therapy and required alternative trials

Xtandi: requires complete/partial response to first‑line platinum chemo for maintenance ovarian cancer indications
Invega Hafyera: follow paliperidone LAI trial requirements

Initial Approval Requirements

Reauthorization / Continuation Requirements

Required Prior Trials (Step Therapy) Summary

Product / Topic	Step therapy requirement
{"text":"Auvelity","status":""},{"text":"Trial of bupropion and one other generic formulary antidepressant required prior to coverage for major depressive disorder.","status":""}

Product / Topic	Step therapy requirement
{"text":"Braftovi (encorafenib) 75 mg","status":""},{"text":"Coverage for specified indications requires combination use or prior therapy per indication (e.g., combination with vemurafenib + cobimetinib for melanoma; combination with cetuximab + fluorouracil-based chemotherapy for BRAF V600E metastatic CRC).", "status":""}

Product / Topic	Step therapy requirement
{"text":"Various biologics (example group) — psoriatic arthritis / plaque psoriasis / ankylosing spondylitis","status":""},{"text":"Indication-specific prerequisite trials required (e.g., trial of an NSAID for AS; DMARD trial for RA) and cannot be used in combination with another biologic/targeted DMARD for the same condition.","status":""}

Product / Topic	Step therapy requirement
{"text":"Antiseizure / migraine products (examples: Topiramate solution, Epidiolex, Fintepla)","status":""},{"text":"Trials of specified generic anticonvulsants/generic alternatives required prior to coverage (e.g., 2 generics for Lennox-Gastaut; 2 of valproic acid, clobazam, or topiramate for Dravet; for migraine prevention, trial of at least 2 generic alternatives or inability to swallow tablets/capsules).","status":""}

Product / Topic

Step therapy requirement

Product / Topic	Step therapy requirement
{"text":"Selected oncology agents (examples: Idhifa, Lenvima)","status":""},{"text":"Prior trials or combination therapy required per indication (e.g., combination with pembrolizumab for first-line RCC; prior systemic or kinase inhibitor therapy as specified for hematologic/solid tumor indications).","status":""}

Product / Topic	Step therapy requirement
{"text":"Lybalvi","status":""},{"text":"Requires trial of at least one listed generic antipsychotic (e.g., aripiprazole, risperidone, quetiapine, etc.) prior to coverage.","status":""}

Product / Topic	Step therapy requirement
{"text":"Levetiracetam (formulation-specific)","status":""},{"text":"Coverage requires BOTH: trial of levetiracetam oral solution and documentation that the patient is unable to swallow tablets or capsules prior to approval for the oral solution formulation.","status":""}

Product / Topic	Step therapy requirement
{"text":"Motpoly Xr","status":""},{"text":"Coverage for seizure indication requires trial of two generic anticonvulsant alternatives prior to approval.","status":""}

Product / Topic	Step therapy requirement
{"text":"Nexletol / Nexlizet","status":""},{"text":"Requires trial of one high-intensity statin prior to coverage unless statin intolerance or contraindication is documented.","status":""}

Product / Topic	Step therapy requirement
{"text":"Posaconazole DR","status":""},{"text":"For prophylaxis or treatment, requires trial with two of the following azoles (fluconazole, itraconazole, or voriconazole) prior to coverage; coverage duration noted as 6 months.","status":""}

Product / Topic	Step therapy requirement
{"text":"Praluent (alirocumab)","status":""},{"text":"Initiation requires at least 12 weeks of high-intensity statin therapy (unless statin intolerance documented); statin values on high-intensity statin within last 120 days required for assessment prior to approval.","status":""}

Product / Topic	Step therapy requirement
{"text":"Tolvaptan","status":""},{"text":"Coverage requires trial of at least two of the following measures before approval: furosemide, demeclocycline, or fluid restriction; documentation that patient does not have underlying liver disease is required.","status":""}

Product / Topic	Step therapy requirement
{"text":"Agents with TNF inhibitor prerequisite (example group)","status":""},{"text":"Certain indications require trial and failure or intolerance to one or more TNF inhibitors prior to coverage (trial requirements vary by product/indication).", "status":""}

Product / Topic	Step therapy requirement
{"text":"Oncology agents (general)","status":""},{"text":"Many oncology products require prior specific chemotherapy or targeted therapy trials or documented disease progression before coverage per product-specific criteria.","status":""}

Product / Topic	Step therapy requirement
{"text":"Ubrelvy / Voquezna (examples)","status":""},{"text":"Ubrelvy (acute migraine): trial of two generic triptans required unless contraindicated; Voquezna (H. pylori): trial of a guideline-recommended first-line regimen required prior to coverage.","status":""}

Product / Topic	Step therapy requirement
{"text":"Various oncology agents (examples: multiple myeloma, DLBCL)","status":""},{"text":"Coverage requires failure of prior therapies as specified (e.g., failure of one prior therapy for multiple myeloma; trial of at least two lines for relapsed/refractory DLBCL).","status":""}

Product / Topic	Step therapy requirement
{"text":"Xermelo / Xifaxan (examples)","status":""},{"text":"Xermelo (carcinoid syndrome diarrhea): trial of somatostatin analog required; Xifaxan 550 mg (hepatic encephalopathy/IBS-D/recurrent C. diff) requires specified prior therapy trials (e.g., lactulose for HE, loperamide for IBS-D, vancomycin for recurrent C. diff) prior to coverage.","status":""}

Product / Topic	Step therapy requirement
{"text":"Certain antidepressants and antipsychotics (examples: Exxua/Trintellix, various aripiprazole formulations)","status":""},{"text":"Requires trials of specified generic alternatives prior to coverage (e.g., at least 2 listed generic antidepressants for Exxua/Trintellix; trial of at least one listed generic antipsychotic before coverage of listed antipsychotic products).","status":""}

Product / Topic	Step therapy requirement
{"text":"Aristada (long-acting aripiprazole formulations)","status":""},{"text":"Requires trial of at least one listed generic antipsychotic (e.g., aripiprazole, paliperidone, quetiapine, risperidone, etc.) prior to coverage; lifetime coverage duration when criteria met.","status":""}

Product / Topic	Step therapy requirement
{"text":"Invega Hafyera","status":""},{"text":"Requires prior trial of once-a-month paliperidone palmitate for at least 4 months OR an every-three-month paliperidone palmitate cycle for at least one three-month cycle prior to coverage.","status":""}

Product / Topic	Step therapy requirement
{"text":"Farxiga / Jardiance (SGLT2 inhibitors)","status":""},{"text":"Step therapy requires trial of generic dapagliflozin prior to coverage for Farxiga and Jardiance, with an exception that the Jardiance step does not apply when used to reduce risk of cardiovascular death in adults with T2DM and established CVD.","status":""}

Product / Topic	Step therapy requirement
{"text":"Ophthalmic glaucoma agents and Rytary","status":""},{"text":"Coverage requires trial of a generic formulary ophthalmic glaucoma medication or Lumigan for Rhopressa/Rocklatan; Rytary requires trial of generic oral extended‑release carbidopa & levodopa prior to coverage.","status":""}

Product / Topic

Step therapy requirement

Benefit Determination by Setting

Billing Rule

Provide setting/use info for Part B vs Part D determination

Provide information describing the drug’s use and the care setting (hospital outpatient, infusion center, or pharmacy) when requested to determine Medicare Part B vs Part D coverage.

Submit setting/use information to determine Part B vs Part D coverage