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Prior authorization and step therapy coverage criteria for formulary prescription drugs

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Formulary prior authorization and step therapy rules for BCBSM Prescription Blue PDP members; lists medications that require PA or ST and the clinical/administrative requirements for coverage. Affects prescribers and pharmacists managing member drug benefits.

Policy Summary

Payerblue cross blue shield - michigan

PolicyPrior authorization and step therapy coverage criteria for formulary prescription drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective Date02/01/2026

Last ReviewFeb 1, 2026

Next Review DateN/A

Key ActionContact the pharmacy help desk to request prior authorization or step therapy and submit required clinical documentation (e.g., prior therapy trials, lab values, or diagnostic confirmation) for approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

351total pages

02/01/2026effective date

Version 11formulary version

1 YEARtypical auth duration

Multiplelisted products (excerpt)

Product-Specific Coverage Criteria

Product-specific prior authorization criteria (partial)

Product-specific prior authorization and step therapy rules — covered when ALL of the following product-level criteria are satisfied:

Adbry (atopic dermatitis): Diagnosis of moderate to severe atopic dermatitis in patients >=12 years 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; dose limits for patients <100 kg after 16 weeks.

Coverage duration 1 year; prerequisite Part D drug required.

Calcipotriene topical products: Trial of at least one generic topical steroid prior to coverage of calcipotriene solution.

Coverage duration 1 year; prerequisite Part D drug required.

Calquence (MCL): For mantle cell lymphoma, patient must have received at least one prior therapy; previously untreated MCL patients ineligible for autologous HSCT require combination with bendamustine + rituximab.

Policy Summary

Payerblue cross blue shield - michigan

PolicyPrior authorization and step therapy coverage criteria for formulary prescription drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective Date02/01/2026

Last ReviewFeb 1, 2026

Next Review DateN/A

SourceLink

On This Page

Authorized for 1 year; prerequisite Part D drug required.

Copiktra (CLL/SLL): Relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma requires trial of at least two prior therapies.

Authorized 1 year; prerequisite Part D drug required.

Cosentyx (representative biologic): Indication-specific requirements (e.g., active PsA, moderate-to-severe plaque psoriasis, AS with prior NSAID trial, non-radiographic axSpA with objective inflammation); reauthorization requires documentation of positive clinical response.

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

Dupixent (indication-specific): Indication-specific entry criteria (examples): atopic dermatitis requires moderate-to-severe disease and trial/failure of listed topical/systemic agents; eosinophilic asthma requires eosinophils >=150 cells/µL at initiation and failure to maintain control after systemic or high‑dose inhaled corticosteroids plus an additional controller; CRSwNP, EOE and others require diagnosis and prior specified trials; reauthorization requires positive clinical response.

Authorized 1 year; age/weight limits apply per indication; prerequisite Part D drug required.

Dalfampridine ER: Submission of baseline Timed 25‑Foot Walk (T25FW) prior to initiation; reauthorization requires stability or improvement on T25FW; excluded if patient is wheelchair‑bound or becomes wheelchair‑bound.

Authorized 1 year.

Epidiolex (seizure indications): Lennox‑Gastaut: trial of two generic alternatives for seizure treatment required; Dravet: trial of two of valproic acid, clobazam, or topiramate; TSC‑associated seizures: trial of two generic alternatives.

Authorized 1 year; prerequisite Part D drug required.

Topiramate solution: Migraine prevention: trial of >=2 generic alternatives OR inability to swallow tablets/capsules; seizure disorder: trial of >=2 generic anticonvulsants OR inability to swallow tablets/capsules.

Authorized 1 year; prerequisite Part D drug required.

General prerequisite Part D drug rule: Many products require a prerequisite Part D drug trial before approval and are typically authorized for 1 year; see individual product entries for exact prior‑therapy requirements and documentation.

Coverage duration typically 1 year unless otherwise noted.

Calcipotriene SOLN - Initial Therapy

Covered when ALL of the following are met:

Calcipotriene SOLN coverage criteria: Trial of at least one generic topical steroid prior to initiation of calcipotriene solution.

Authorized for 1 year; prerequisite Part D drug required.

Calquence - MCL criteria

Mantle cell lymphoma coverage — covered when ALL of the following are met:

Calquence for mantle cell lymphoma: Patient has mantle cell lymphoma AND has received at least one prior therapy for MCL.

Authorized for 1 year; previously untreated MCL patients ineligible for autologous HSCT require combination with bendamustine + rituximab; prerequisite Part D drug required.

Copiktra - Prior therapy requirement

Covered when ALL of the following are met:

Copiktra for CLL/SLL: Diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) AND trial of at least two prior therapies.

Authorized for one year; prerequisite Part D drug required.

Cosentyx - Indication-specific criteria

Covered when indication-specific baseline and prior‑therapy criteria are met:

Cosentyx indications: Indication-specific entry: psoriatic arthritis (diagnosis of active PsA); plaque psoriasis (moderate‑to‑severe chronic plaque psoriasis); ankylosing spondylitis (AS) requires prior NSAID trial; non‑radiographic axial spondyloarthritis requires objective signs of inflammation and prior NSAID trial; enthesitis‑related arthritis and hidradenitis suppurativa require respective diagnostic criteria.

Reauthorization requires documentation of positive clinical response; cannot combine with another biologic/targeted DMARD for same condition; coverage duration 1 year.

Dupixent - Indication-specific coverage

Dupixent is covered when ALL of the following per indication are met:

Dupixent — atopic dermatitis: Diagnosis of moderate‑to‑severe atopic dermatitis AND trial and failure of one listed systemic or topical agent as specified in the policy.

Authorization duration 1 year; age/weight limits apply per indication; reauthorization requires documentation of positive clinical response.

Dupixent — eosinophilic asthma: Diagnosis of eosinophilic asthma with blood eosinophil count >=150 cells/µL at initiation AND failure to maintain adequate control after systemic corticosteroids OR high‑dose inhaled corticosteroids plus trial of one additional controller (leukotriene modifier, LABA, or LAMA).>=150 cells/µL

Prerequisite therapy documentation required; authorized for 1 year.

Dupixent — EOE/CRSwNP/others: Indication‑specific diagnostic confirmation (e.g., symptomatic EOE with trial of PPI or topical esophageal steroids; CRSwNP recurrent despite intranasal corticosteroids) as specified in policy.

Reauthorization requires documentation of positive clinical response.

Dalfampridine - Mobility test requirement

Covered when ALL of the following are met:

Dalfampridine coverage: Baseline Timed 25‑Foot Walk (T25FW) test submitted prior to initiation AND patient is ambulatory (not wheelchair bound); reauthorization requires documentation of stability or improvement on T25FW.

Excluded if patient is wheelchair bound or becomes wheelchair bound; authorized 1 year.

Epidiolex - Prior anticonvulsant trials

Covered when ALL of the following are met for the specified seizure indications:

Epidiolex — Lennox‑Gastaut: Diagnosis of Lennox‑Gastaut syndrome AND trial of two generic alternatives for seizure treatment prior to initiation.

Authorized 1 year; prerequisite Part D drug required.

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

Prerequisite Part D drug required; authorization 1 year.

Epidiolex — TSC‑associated seizures: Seizures associated with tuberous sclerosis complex AND trial of two generic alternatives for seizure treatment.

Prerequisite Part D drug required; authorization 1 year.

Topiramate SOLN - Indication-specific criteria

Covered when ALL of the following are met:

Topiramate SOLN indications: Migraine prevention: trial of at least two generic alternatives for migraine prevention OR inability to swallow tablets/capsules; Seizure disorder: trial of at least two generic anticonvulsants OR inability to swallow tablets/capsules.

Authorized 1 year; prerequisite Part D drug required.

Products with 1-year coverage and prerequisite Part D drug

General rule for products that list a 1‑year coverage duration and a prerequisite Part D drug:

General prerequisites: Product‑specific entry criteria are satisfied AND any required prerequisite Part D drug trials have been documented or deemed inappropriate/contraindicated.

Coverage duration typically 1 year; see individual product entries for exact prior‑therapy lists and documentation requirements.

Fasenra coverage criteria

Fasenra is covered when ALL of the following are met (indication-specific):

Fasenra — eosinophilic asthma: Diagnosis of eosinophilic asthma AND blood eosinophil count >=150 cells/µL at initiation AND failure to maintain adequate control after a trial of systemic corticosteroids OR high‑dose inhaled corticosteroids plus trial of one additional controller (leukotriene modifier, LABA, or LAMA).>=150 cells/µL

Applies to adults and children per policy; reauthorization requires documentation of positive clinical response; cannot be used in combination with another biologic/targeted DMARD for same condition; authorized 1 year.

Fasenra — EGPA: Diagnosis of EGPA with history or presence of asthma AND at least two EGPA‑typical criteria (e.g., histopathologic eosinophilic vasculitis, neuropathy, pulmonary infiltrates, nasal polyps, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, ANCA positivity).

Cannot be used in combination with another biologic/targeted DMARD for same condition; reauthorization requires positive clinical response.

Adalimumab products coverage criteria (representative biologic)

Adalimumab and representative biologic coverage — covered when ALL of the following are met:

RA biologic initiation: Diagnosis of moderately to severely active rheumatoid arthritis AND trial of one DMARD (e.g., methotrexate, leflunomide, sulfasalazine) prior to biologic initiation.

Reauthorization requires documentation of positive clinical response; cannot be used in combination with another biologic/targeted DMARD for same condition; coverage duration typically 1 year.

Polyarticular JIA: Diagnosis of active polyarticular juvenile idiopathic arthritis AND trial of methotrexate or leflunomide before biologic therapy.

Reauthorization requires positive clinical response.

Ankylosing spondylitis: Diagnosis of active AS AND trial of one NSAID prior to biologic therapy.

Reauthorization requires positive clinical response.

GLP-1 and related agents for T2DM

GLP‑1 and related agents for type 2 diabetes mellitus — covered when ALL of the following are met:

Diabetes documentation: Submission of medical records confirming diagnosis of type 2 diabetes mellitus OR laboratory evidence meeting diagnostic thresholds (A1C >= 6.5% OR fasting plasma glucose >= 126 mg/dL OR 2‑hour OGTT >= 200 mg/dL).A1C >=6.5% OR FPG >=126 mg/dL OR 2‑hr OGTT >=200 mg/dL

Excluded if used for weight‑loss only.

Anticonvulsant / seizure disorder product criteria

Anticonvulsant and seizure‑disorder product criteria — covered when ALL of the following apply:

Lennox‑Gastaut syndrome: Diagnosis of Lennox‑Gastaut syndrome AND trial of two generic alternatives for treatment of seizures prior to coverage of listed specialty agents.

Applies to specific products listed in policy.

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

From policy examples.

Tuberous sclerosis complex seizures: Seizures associated with tuberous sclerosis complex AND trial of two generic anticonvulsant alternatives prior to specialty therapy.

Prerequisite Part D drug required for many entries.

Diagnosis severity and reauthorization

Coverage for selected inflammatory and ophthalmologic indications — covered when ALL of the following are met:

Inflammatory/uveitis criteria: Diagnosis of moderately to severely active disease (e.g., Crohn's disease, ulcerative colitis, hidradenitis suppurativa) or classification of non‑infectious uveitis as intermediate/posterior/panuveitis AND documentation of disease severity.

Reauthorization requires documentation of positive clinical response to therapy.

Rheumatology prior therapy requirements

Rheumatology prior therapy rules — covered when ALL of the following are met:

Kevzara/Kineret RA criteria: Diagnosis of moderately to severely active rheumatoid arthritis AND trial of two specified prior agents (examples include ENBREL, adalimumab biosimilars, Rinvoq, Xeljanz/XR, Orencia).

Cannot be used in combination with another biologic/targeted DMARD for same condition; reauthorization requires positive clinical response; coverage duration 1 year.

Breast cancer combination therapy requirements

Breast‑cancer endocrine combination therapy requirements — covered when ALL of the following are met:

CDK4/6 and endocrine therapy: HR‑positive, HER2‑negative advanced/metastatic breast cancer requires combination use with an aromatase inhibitor as initial endocrine‑based therapy or fulvestrant after progression; specific molecular contexts may require additional combination agents.

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

Product-specific prerequisite therapy notes

Product-specific prerequisite therapy notes — coverage conditioned on prior or alternative therapies:

Inqovi/other oncology prerequisites: Selected oncology and specialty agents require specified prior therapies or lines of therapy (examples: Inqovi requires trial with azacitidine; others require prior platinum chemotherapy or PD‑1/PD‑L1 therapy per indication).

See per‑product entries for exact prior therapy lists and documentation.

Kerendia heart/CKD considerations: Coverage of Kerendia for CKD associated with type 2 diabetes may require trial of an SGLT2 inhibitor for heart‑failure‑related indications unless contraindicated or intolerant.

Prerequisite Part D drug rules apply where noted.

Coverage duration and formulation requirements

Coverage duration and formulation considerations — covered when ALL of the following are met:

Coverage duration: Many products have a standard coverage duration of one year unless another duration (e.g., 6 months, lifetime) is specified in the product entry.

See individual product nodes for exceptions (e.g., Praluent 3 years, some psychiatric injectables lifetime, Posaconazole 6 months).

Formulation-specific coverage: Alternative or liquid formulations are covered only when the patient is unable to swallow the standard tablet/capsule/oral disintegrating tablet formulation; documentation of inability to swallow is required.

Applies to specified products (e.g., Mekinist liquid, Tafinlar TBSO); coverage durations and priors still apply.

Komzifti criteria

Komzifti coverage — covered when ALL of the following are met:

Komzifti — HR+/HER2- advanced/metastatic breast cancer: Diagnosis of HR‑positive, HER2‑negative advanced or metastatic breast cancer AND combination use with an aromatase inhibitor or fulvestrant as specified by line of therapy.

Coverage duration 1 year; prerequisite Part D drug required.

Krazati criteria

Krazati coverage — covered when the following are met:

Krazati — KRAS G12C NSCLC: Diagnosis of KRAS G12C‑mutated locally advanced or metastatic non‑small cell lung cancer AND trial of at least one prior systemic therapy.

Coverage duration 1 year; prerequisite Part D drug required.

Lenvima criteria

Lenvima coverage — covered when ALL of the following are met according to indication:

Lenvima — RCC/EC: First‑line RCC requires combination use with pembrolizumab; other RCC and advanced endometrial carcinoma indications require specified combinations or prior anti‑angiogenic therapy per product guidance.

Coverage duration 1 year; prerequisite Part D drug required.

Liraglutide criteria

Liraglutide coverage for T2DM — covered when ALL of the following are met:

Liraglutide for T2DM: Used for ongoing treatment of type 2 diabetes mellitus with submission of medical records confirming diagnosis OR laboratory evidence (A1C >=6.5% OR FPG >=126 mg/dL OR 2‑hr OGTT >=200 mg/dL).A1C >=6.5% OR FPG >=126 mg/dL OR 2‑hr OGTT >=200 mg/dL

Excluded if used for weight‑loss only; coverage duration 1 year; documentation required.

Livtencity criteria

Livtencity coverage — covered when ALL of the following are met:

Livtencity — post‑transplant CMV: Post‑transplant CMV infection/disease and trial of one of: ganciclovir, valganciclovir, cidofovir, or foscarnet prior to initiation of Livtencity.

Coverage duration 1 year; prerequisite Part D drug required.

Lonsurf criteria

Lonsurf coverage — covered when ALL of the following are met:

Lonsurf — metastatic colorectal cancer: Use in metastatic colorectal cancer requires combination use with bevacizumab AND prior trials of fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy and an anti‑VEGF therapy; tumor‑specific requirements apply per policy.

Coverage duration 1 year; prerequisite Part D drug required.

Lumakras criteria

Lumakras coverage — covered when ALL of the following are met:

Lumakras — KRAS G12C: Diagnosis of KRAS G12C‑mutated locally advanced or metastatic NSCLC AND trial of at least one prior systemic therapy; for mCRC indication requires prior fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy and combination with panitumumab.

Coverage duration 1 year; prerequisite Part D drug required.

Lynparza criteria

Lynparza (olaparib) coverage — covered when ALL of the following are met per indication:

Lynparza — BRCA/HRR indications: Coverage for germline or somatic deleterious BRCA‑mutated ovarian, breast, pancreatic, or HRR‑mutated mCRPC requires prior platinum‑based chemotherapy or other specified prior therapies depending on indication; some indications require combination with bevacizumab or androgen‑directed therapy as specified.

Coverage duration 1 year; prerequisite Part D drug required for certain indications.

Mekinist criteria

Mekinist (trametinib) coverage — covered when ALL of the following are met:

Mekinist — BRAF‑mutant tumors: For unresectable or metastatic melanoma with BRAF V600E or V600K mutation, Mekinist may be used as monotherapy only in BRAF‑inhibitor treatment‑naïve patients; many indications require combination use with dabrafenib and prior trial of vemurafenib + cobimetinib in some contexts.

Coverage duration 1 year; prerequisite Part D drug required.

Mekinist (liquid) initial coverage

Mekinist (liquid formulation) — initial coverage criteria (ALL):

Mekinist liquid — unable to swallow: Patient is unable to swallow the tablet formulation AND other indication‑specific criteria for Mekinist are met (e.g., BRAF V600E or V600K mutation as detected by an FDA‑approved test).

Coverage requires combination with dabrafenib for many indications where indicated; coverage duration 1 year.

Mekinist liquid — combination trials: When indicated per tumor type, requires combination use with dabrafenib and may require prior trial with vemurafenib + cobimetinib for selected melanoma contexts.

Documentation of inability to swallow tablets required.

Mektovi initial coverage

Mektovi (encorafenib + binimetinib context) — covered when ALL of the following are met:

Mektovi initial coverage: Unresectable or metastatic melanoma with BRAF V600E or V600K mutation AND trial of vemurafenib + cobimetinib used in combination as specified; other combination requirements apply per indication.

Coverage duration 1 year; prerequisite Part D drug required.

Nucala indication-specific coverage

Nucala (mepolizumab) — covered when ALL of the following are met (indication‑specific):

Nucala — general exclusion: Cannot be used in combination with another biologic or targeted DMARD indicated for the same condition.

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

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

Applies to adults and children as specified.

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

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

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

Reauthorization requires positive clinical response.

Nexletol/Nexlizet coverage

Nexletol/Nexlizet coverage — covered when ALL of the following are met:

Diagnosis requirement: Diagnosis of hypercholesterolemia (including HeFH) OR increased risk of major adverse cardiovascular events.

Coverage duration 1 year.

Statin trial requirement: Trial of one high‑intensity statin unless documented statin intolerance or contraindication; examples include skeletal muscle symptoms or rhabdomyolysis.

Documentation of statin use or intolerance required.

Nucala — Indication criteria

Nucala — additional indication criteria (summary):

HES specific: Eosinophil count >=1000 cells/µL at initiation AND stability on HES therapy.>=1000 cells/µL

Per product-specific rules.

CRSwNP specific: Diagnosis of chronic rhinosinusitis with nasal polyposis with recurring CRSwNP despite prior intranasal corticosteroids.

Per product-specific rules.

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

Per product-specific rules.

Nurtec — Acute migraine

Nurtec (rimegepant) — acute migraine coverage — covered when ALL of the following are met:

Nurtec acute migraine: Used for acute treatment of migraine headaches AND trial of at least two generic triptans (e.g., sumatriptan and rizatriptan) unless triptan therapy is contraindicated, not tolerated, or clinically inappropriate.trial of >=2 generic triptans

Authorized 1 year; prerequisite Part D drug required.

Octreotide (INJ) — Acromegaly

Octreotide injection — acromegaly coverage — covered when ALL of the following are met:

Octreotide for acromegaly: Used for acromegaly AND trial of bromocriptine mesylate at maximally tolerated doses prior to initiation of octreotide injection.trial of bromocriptine

Authorized 1 year; prerequisite Part D drug required.

Opfolda — Coverage criteria

Opfolda (miglustat/pompe context) — covered when ALL of the following are met:

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

Authorized 1 year; prerequisite Part D drug required.

Posaconazole DR — Prophylaxis and treatment

Posaconazole DR — prophylaxis and treatment coverage — covered when ALL of the following are met:

Posaconazole prophylaxis: Patient at high risk for invasive fungal infection due to severe immunosuppression (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.trial of >=2 alternative azoles

Coverage duration 6 months; prerequisite Part D drug required.

Posaconazole treatment: Used as treatment of invasive fungal infections caused by Aspergillus or Candida AND trial with two of fluconazole, itraconazole, or voriconazole.trial of >=2 alternatives

Coverage duration 6 months; prerequisite Part D drug required.

Prerequisite therapy for select oncology/specialty agents

Selected oncology/specialty agents — covered when specified prior therapies or lines of therapy are tried (or contraindicated):

Padcev (urothelial cancer): Locally advanced or metastatic urothelial cancer requires prior PD‑1/PD‑L1 inhibitor and platinum‑containing chemotherapy OR ineligible for cisplatin plus previously received one or more prior lines of therapy.prior PD‑1/PD‑L1 + platinum chemo

Coverage duration 1 year; prerequisite Part D drug required.

Polivy (DLBCL): Relapsed or refractory diffuse large B‑cell lymphoma requires trial of at least two prior therapies.>=2 prior therapies

Coverage duration 1 year; prerequisite Part D drug required.

Pomalyst (multiple myeloma): Requires at least two prior therapies including lenalidomide and a proteasome inhibitor with progression on or within 60 days of last therapy AND combination use with dexamethasone.>=2 prior therapies including specified agents

Coverage duration 1 year; prerequisite Part D drug required.

Orgovyx: Coverage requires trial of or intolerance to Firmagon per product guidance.trial/intolerance to Firmagon

Prerequisite Part D drug rules apply.

Posaconazole: Prophylaxis and Treatment

Posaconazole — prophylaxis and treatment (duplicate emphasis):

Posaconazole prerequisites: Trial with two of fluconazole, itraconazole, or voriconazole is required prior to coverage for prophylaxis or treatment of invasive fungal infections in high‑risk patients.trial of >=2 alternatives

Coverage duration 6 months; prerequisite Part D drug required.

Praluent: ASCVD/Primary HLD/HeFH/HoFH

Praluent (alirocumab) — covered when criteria specific to indication are met:

Praluent — indications: Indications include ASCVD, primary hyperlipidemia, HeFH, HoFH as defined by the policy; diagnostic confirmation for HeFH/HoFH required per product rules.

Coverage duration 3 years for approved cases.

Praluent — ASCVD/Primary HLD initiation: LDL measured while on a high‑intensity statin within last 120 days: (1) LDL >=55 mg/dL with ASCVD OR (2) LDL >70 mg/dL without ASCVD AND patient has been receiving >=12 weeks of high‑intensity statin and will continue statin at max tolerated dose OR documented statin intolerance after trial of atorvastatin and rosuvastatin.LDL thresholds as specified

Documentation of LDL and statin use/intolerance required.

Praluent — HoFH initiation: HoFH confirmed by genetics (two mutations) OR LDL thresholds (untreated >500 mg/dL or treated >300 mg/dL) or clinical criteria (xanthoma before age 10 or affected parents); patient must be receiving other lipid‑lowering therapy.

Reauthorization: continued statin use (or documented inability) and LDL reduction on therapy.

Prevymis: CMV prophylaxis

Prevymis (letermovir) — CMV prophylaxis coverage — covered when ALL of the following are met:

Prevymis indications: CMV prophylaxis for CMV‑seropositive allogeneic HSCT recipients OR high‑risk kidney transplant recipients (donor+/recipient‑).

Coverage duration 1 year; documentation of CMV serostatus and transplant type required.

Retevmo: RET-altered cancers

Retevmo (selpercatinib) — RET‑altered tumor coverage — covered when ALL of the following are met:

Retevmo — NSCLC/MTC/other solid tumors: Adult patients with locally advanced/metastatic NSCLC with RET fusion detected by FDA‑approved test; adult and pediatric patients >=2 years with advanced/metastatic medullary thyroid cancer with RET mutation detected by FDA‑approved test and requiring systemic therapy; advanced solid tumors with RET fusion progressed on prior systemic therapy per product guidance.

Coverage duration 1 year; molecular confirmation by FDA‑approved test required; prerequisite Part D drug required in some indications.

Rezdiffra: NASH/MASH with advanced fibrosis

Rezdiffra (for NASH/MASH with advanced fibrosis) — covered when ALL of the following are met:

Rezdiffra initial: Diagnosis of noncirrhotic NASH or MASH AND documented advanced liver fibrosis stage F2–F3 verified by FibroScan or other imaging‑based non‑invasive assessment AND trial of semaglutide prior to initiation.F2–F3

Coverage duration 1 year; renewal requires documented improvement or stabilization as specified.

Rezdiffra reauthorization: Patient has not progressed to cirrhosis AND one of: NASH/MASH resolution without worsening fibrosis, improvement in fibrosis >=1 stage without worsening NASH/MASH or demonstrated clinical benefit, or imaging/blood‑based improvement or stabilization.

Documentation required for renewal; prerequisite Part D drug required.

Rezlidhia — Initial therapy

Rezlidhia — initial therapy — covered when ALL of the following are met:

Rezlidhia initial: Diagnosis of noncirrhotic NASH or MASH with advanced liver fibrosis (stage F2–F3) verified by FibroScan or other imaging‑based non‑invasive assessment AND trial of semaglutide prior to initiation.

Coverage duration 1 year; prerequisite Part D drug required.

Rinvoq — Indication-specific coverage

Rinvoq (upadacitinib) — indication‑specific coverage — covered when ALL per‑indication criteria are met:

Rinvoq — rheumatoid arthritis: Diagnosis of moderately to severely active RA AND trial of one DMARD (e.g., methotrexate, leflunomide, sulfasalazine); reauthorization requires documentation of positive clinical response and that upadacitinib is not used with potent immunosuppressants or another biologic/targeted DMARD for the same condition.

Coverage duration 1 year; prerequisite Part D drug required.

Rinvoq — psoriatic arthritis/other indications: Diagnosis of active PsA, AS, axial spondyloarthritis, UC, CD or other indicated condition with prior therapy requirements (e.g., inadequate response/intolerance to TNF inhibitors for certain indications) documented as specified.

See product entry for specific prior‑therapy requirements.

Skyrizi — Indication-specific coverage

Skyrizi (risankizumab) — covered when ALL of the following are met for the specific indication:

Skyrizi — psoriatic arthritis: Diagnosis of active psoriatic arthritis.

Coverage duration 1 year; cannot be used in combination with another biologic/targeted DMARD for the same condition.

Skyrizi — plaque psoriasis: Diagnosis of moderate‑to‑severe chronic plaque psoriasis. 90 mg/mL strength requires patient weight >100 kg for the indicated dosing strength.>100 kg for 90 mg/mL strength

Reauthorization requires documentation of positive clinical response.

Skyrizi — inflammatory bowel disease: Diagnosis of moderately to severely active Crohn's disease or ulcerative colitis with product‑specific prior therapy requirements as listed.

Reauthorization requires positive clinical response.

Rubraca — Maintenance therapy

Rubraca (rucaparib) — maintenance therapy — covered when ALL of the following are met:

Rubraca maintenance: Adult patient with deleterious BRCA mutation‑associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who is in complete or partial response to platinum‑based chemotherapy.

Coverage duration 1 year; other indications (e.g., mCRPC) have separate prior‑therapy requirements.

Sirturo — Combination regimen requirement

Sirturo (bedaquiline) — covered when ALL of the following are met:

Sirturo combination regimen: Bedaquiline used as part of an appropriate combination regimen for tuberculosis treatment per clinical guidance.

Coverage duration 1 year.

Sapropterin — Initial response requirement

Sapropterin dihydrochloride — initial response and renewal rules:

Sapropterin initial/renewal: Initial authorization for 2 months; extension to 1 year requires documented clinical response after initial therapy; renewal requires continued improvement compared with baseline.

Documentation of response required for extension/renewal.

Sarclisa — Multiple myeloma coverage

Sarclisa (isatuximab) — multiple myeloma coverage — covered when one of the following is met:

Sarclisa — relapsed/refractory MM: Treatment of relapsed/refractory multiple myeloma after 1 to 3 prior lines of therapy (some settings require at least 2 prior therapies including lenalidomide and a proteasome inhibitor).

Coverage duration 1 year; see product entry for exact line‑of‑therapy requirements.

Sarclisa — newly diagnosed not eligible for ASCT: Use in combination with bortezomib, lenalidomide and dexamethasone for patients not eligible for autologous stem cell transplant.

Rydapt — Combination chemotherapy requirement

Rydapt (midostaurin) — AML FLT3‑positive combination requirement — covered when ALL of the following are met:

Rydapt AML: Newly diagnosed acute myeloid leukemia that is FLT3 mutation‑positive AND use in combination with standard cytarabine + daunorubicin induction and cytarabine consolidation per protocol.

Coverage duration 1 year.

Spritam — Step therapy

Spritam (levetiracetam ODT) — step therapy rule:

Spritam step therapy: Coverage requires trial of two generic anticonvulsants prior to authorization.

Coverage duration 1 year.

Sunosi — Step therapy

Sunosi (solriamfetol) — step therapy rule:

Sunosi step: Trial of armodafinil is required prior to approval of Sunosi.

Prerequisite Part D drug required; coverage duration per product entry.

Product-level criteria (see details)

Product‑level criteria (see individual entries) — general extracted coverage stance and examples:

General coverage stance: Prior authorization is required for listed formulary products; most products specify a coverage duration (commonly 1 year) and many require documented trials of specified prior therapies or demonstration of inability to use alternative formulations.

Failure to meet PA/ST criteria may result in denial.

Prohibited combinations: Several biologics and targeted agents are prohibited from being used in combination with another biologic or targeted DMARD indicated for the same condition, or with a potent immunosuppressant (e.g., azathioprine, cyclosporine); such combinations may trigger non‑coverage.

Examples: Tocilizumab, Xolair, Rinvoq, others per product entries.

Formulation exceptions: Liquid or alternative formulations require documentation that the patient is unable to swallow the standard tablet/capsule formulation to be covered (e.g., Mekinist liquid, Tafinlar TBSO).

Documentation required at initial request; coverage duration per product.

Tocilizumab (Actemra/Tyenne) criteria

Tocilizumab (Actemra/Tyenne) — covered when ALL indication‑specific criteria are met:

Tocilizumab — RA: Diagnosis of moderately to severely active rheumatoid arthritis AND trial of two of the listed agents (e.g., etanercept, adalimumab biosimilars, Rinvoq, Xeljanz/XR, Orencia);

Reauthorization requires documented positive clinical response; cannot be used in combination with another biologic/targeted DMARD for same condition; coverage duration 1 year.

Tocilizumab — polyarticular JIA: Diagnosis of active polyarticular juvenile idiopathic arthritis AND trial of two of the listed agents (e.g., etanercept, adalimumab biosimilars, Xeljanz/XR, Orencia).

Reauthorization requires documented positive clinical response.

Tocilizumab — systemic JIA: Diagnosis of systemic juvenile idiopathic arthritis AND trial of one of: NSAID, systemic glucocorticoid, or methotrexate; reauthorization requires documented positive clinical response.

Coverage duration 1 year.

Tocilizumab — GCA: Diagnosis of giant cell arteritis; reauthorization requires documented positive clinical response.

Coverage duration 1 year.

Tetrabenazine criteria

Tetrabenazine — coverage contingent on safety and genotype documentation:

Tetrabenazine exclusions: No coverage for patients with 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.

Tymlos coverage rules

Tymlos — coverage rules (example):

Tymlos coverage: Documentation of bone mineral density T‑score <= ‑2.5 AND trial of both Prolia and either an oral bisphosphonate (or IV bisphosphonate if intolerant) OR documented inability to be treated with Prolia, oral bisphosphonate and IV bisphosphonate.T‑score <= -2.5

Coverage duration 2 years per product entry.

Verquvo coverage rules

Verquvo (vericiguat) — covered when ALL of the following are met:

Verquvo coverage: Diagnosis of chronic heart failure NYHA class II–IV AND left ventricular ejection fraction (LVEF) <45% AND either prior hospitalization for heart failure within 6 months OR outpatient IV diuretic treatment within 3 months, AND concomitant use of at least two guideline‑directed therapies unless contraindicated or not tolerated.LVEF <45%

Coverage duration 1 year; documentation of NYHA class, LVEF, and recent HF events required.

Verzenio coverage rules

Verzenio (abemaciclib) — breast cancer setting coverage rules:

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

Coverage duration 1 year; prerequisite therapy required as specified.

Voquezna (H. pylori) coverage rules

Voquezna (H. pylori) — covered when ALL of the following are met:

Voquezna coverage: Documented diagnosis of Helicobacter pylori infection AND trial and failure of or contraindication to a guideline‑recommended first‑line regimen (e.g., clarithromycin triple therapy or bismuth quadruple therapy).

Coverage duration 1 year; prerequisite Part D drug required.

Trodelvy coverage rules (breast cancer)

Trodelvy (sacituzumab govitecan) — breast cancer coverage rules:

Trodelvy TNBC/HR+ criteria: For unresectable locally advanced or metastatic triple‑negative breast cancer: prior use of two or more systemic therapies with at least one for metastatic disease. For unresectable locally advanced or metastatic HR+/HER2‑ breast cancer: prior endocrine‑based therapy and at least two additional systemic therapies in the metastatic setting.

Coverage duration 1 year; prerequisite Part D drug required.

Valchlor coverage rules

Valchlor topical treatment — covered when ALL of the following are met:

Valchlor for MF: Topical treatment of stage 1A or 1B mycosis fungoides‑type cutaneous T‑cell lymphoma AND prior skin‑directed therapy documented.

Coverage duration 1 year.

Voydeya coverage rules (EVH with PNH)

Voydeya — EVH with PNH coverage — covered when ALL of the following are met:

Voydeya coverage: Clinically significant extravascular hemolysis due to PNH with hemoglobin <= 9.5 g/dL AND absolute reticulocyte count >= 120 × 10^9/L AND concomitant use with Soliris or Ultomiris only.HGB <= 9.5 g/dL; retic >= 120 x 10^9/L

Coverage duration 1 year.

Winrevair coverage rules (PAH)

Winrevair (PAH) — covered when ALL of the following are met:

Winrevair PAH coverage: Diagnosis of pulmonary arterial hypertension AND trial of both a generic PDE‑5 inhibitor (sildenafil or tadalafil) AND a generic endothelin receptor antagonist (bosentan or ambrisentan) prior to approval.

Coverage duration 1 year; prerequisite Part D drug required.

Extracted coverage stance and general criteria

Extracted coverage stance and general criteria (summary nodes):

General: Prior authorization required for listed formulary products; coverage durations commonly 1 year unless otherwise specified; many products require documented trials of specified prior therapies, diagnostic confirmations, or inability to use standard formulations.

Failure to meet PA/ST criteria may result in denial.

Documentation requirements: Requests must include required clinical documentation such as lab thresholds (e.g., eosinophil counts, LDL values), evidence of prior therapy trials or contraindications, and setting/use information to determine Part B vs Part D where applicable.

See per‑product documentation nodes for specifics (e.g., Praluent LDL within 120 days, Mekinist inability to swallow tablets).

Prohibited combinations: Use of some biologics/targeted agents in combination with another biologic/targeted DMARD for the same condition or with potent immunosuppressants is prohibited and may trigger denial (examples: Tocilizumab, Xolair, Xeljanz, Rinvoq).

Document that prohibited combinations are not being used for reauthorization where required.

General Prior Authorization

General prior authorization framework — covered when ALL of the following are met:

General PA: Prior authorization is requested and product‑specific clinical criteria (indication, prior therapy trials, laboratory thresholds, formulation requirements) are documented as required.

Formulary ID 26449; coverage durations specified per product (commonly 1 year/lifetime where noted).

Formulary Identifiers and Key Clinical Thresholds

Formulary identifiermixed

Formulary ID: 26449

Identifier repeated for multiple products in this segment

Eosinophil count for EA/COPD

Eosinophil threshold (EA)>= 150 cells/μl at initiation for eosinophilic asthma

COPD eosinophil requirement>= 300 cells/μl for COPD add-on maintenance (or current >=150 cells/μl)

Documentation window (COPD)Either current eosinophil >=150 cells/μl OR >=300 cells/μl within past 12 months

Dupixent weight/age limits

Age minimums (Dupixent)Atopic dermatitis: >= 6 months; Eosinophilic asthma, chronic rhinosinusitis with NP, other indications vary by age

Weight minimum (EOE)Eosinophilic esophagitis: patient must weigh at least 15 kg

Other indication age limitsPrurigo nodularis: >=18 years; CRSwNP and CSU: >=12 years; some indications >=6 years

Eosinophil count

General eosinophil threshold>= 150 cells per microliter for eosinophilic asthma initiation

HES initiation threshold>= 1000 cells per microliter for hypereosinophilic syndrome (HES) initiation

COPD add-on thresholdsCurrent >=150 cells/μl OR >=300 cells/μl within prior 12 months

A1c (for T2DM documentation)

A1c diagnostic threshold (T2DM)>= 6.5%

Documentation requirementSubmit medical records confirming T2DM or lab evidence (A1c >=6.5%)

Use exclusionAgents excluded if used for weight loss only

Fasting plasma glucose (for T2DM documentation)

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

Documentation guidanceSubmit medical records confirming T2DM or laboratory evidence (FPG >=126 mg/dL)

Alternate lab criteriaA1c >=6.5% or 2-hour OGTT >=200 mg/dL are acceptable alternatives

2-hour plasma glucose during OGTT (for T2DM documentation)

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

Alternative diagnostic criteriaA1c >=6.5% or FPG >=126 mg/dL acceptable

Documentation guidanceSubmit OGTT result in medical records to support T2DM diagnosis

Laboratory thresholds for T2DM

Accepted lab criteria for T2DMA1C >= 6.5% OR FPG >= 126 mg/dL OR 2-hour PG >= 200 mg/dL during OGTT

Clinical documentationMedical records (chart notes) confirming diagnosis or lab values must be submitted

Exclusion noteSome GLP-1 agents are excluded if used for weight loss only

Eosinophil count for eosinophilic asthma

Eosinophilic asthma initiation>= 150 cells/μl at initiation

Required prior controller trialsFailure to maintain control after systemic corticosteroids OR high-dose ICS plus trial of an additional controller (leukotriene modifier, LABA, or LAMA)

Documentation for reauthorizationDocumentation of positive clinical response required for reauthorization

Eosinophil count for HES

HES initiation threshold>= 1000 cells/μl at initiation

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

DocumentationSubmit medical records confirming eosinophil count and stability on therapy

COPD eosinophil thresholds

COPD eosinophil criteriaCurrent >=150 cells/μl OR >=300 cells/μl within past 12 months

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

Diagnosis requirementUncontrolled, moderate to severe COPD

Eosinophil count thresholds

Eosinophil count summary>=1000 cells/μl for HES at initiation; >=150 cells/μl current for eosinophilic asthma; COPD: current >=150 or >=300 within prior 12 months

Indication-specific notesThresholds apply at initiation and reauthorization requires clinical response documentation per product

Combination/prohibition noteMany biologics cannot be used in combination with another biologic/targeted DMARD for the same condition

LDL while on high-intensity statin

LDL threshold (ASCVD)>= 55 mg/dL while on a high-intensity statin (measured within last 120 days)

LDL threshold (no ASCVD)>70 mg/dL while on a high-intensity statin (measured within last 120 days)

Statin documentationPatient must have received at least 12 weeks of high-intensity statin or documented statin intolerance after trials of atorvastatin and rosuvastatin

Liver fibrosis stage for Rezdiffra

Required fibrosis stageStage F2 to F3 (advanced fibrosis) verified by FibroScan or other imaging-based non-invasive assessment

Prerequisite therapyTrial of semaglutide required prior to authorization

Renewal criteriaRenewal requires no progression to cirrhosis and improvement or stabilization by imaging or non-invasive assessment

Baseline platelet counts for eltrombopag indications

Baseline platelet counts<30,000/mcL for persistent/chronic ITP; <75,000/mcL for thrombocytopenia with chronic hepatitis C; <30,000/mcL for severe aplastic anemia

Prior therapy requirementCoverage for ITP requires trial of corticosteroids, immunoglobulins, or splenectomy as applicable

Coverage durationTypically 1 year where specified

Weight threshold for 90mg/mL Skyrizi strength

Weight requirement for 90 mg/mL Skyrizi> 100 kg (220 lbs) required for coverage of 90 mg/mL strength

Indication examplesApplies to psoriasis and psoriatic arthritis dosing per product criteria

Coverage durationCoverage duration commonly 1 year; reauthorization requires clinical response

Voydeya hemoglobin and reticulocyte thresholds

Voydeya HGB thresholdHemoglobin <= 9.5 g/dL

Voydeya reticulocyte thresholdAbsolute reticulocyte count >= 120 x 10^9/L

Combination therapy requirementMust be used in combination with Soliris or Ultomiris for EVH with PNH

Verquvo LVEF threshold

Verquvo LVEF thresholdLeft ventricular ejection fraction (LVEF) < 45%

Additional event requirementAND prior HF hospitalization within 6 months OR outpatient IV diuretic within 3 months

Documentation requiredNYHA class, LVEF, and recent hospitalization/IV diuretic use must be documented

Tymlos BMD threshold (for related products)

Tymlos BMD thresholdBone mineral density T-score <= -2.5 (documented BMD required)

Prior therapy requirementTrial of Prolia and an oral bisphosphonate (or IV bisphosphonate if intolerant) required prior to Tymlos

Coverage durationCoverage duration listed as 2 years in product entry

Authorization, Documentation, and Step Therapy Actions

Prior Authorization

Prior authorization required for listed products

Prior authorization is required for many listed specialty and Part D drugs; coverage durations and product-specific criteria (commonly 1 year) apply and must be met before coverage is provided.

PA required for listed products; see individual product entries for criteria and duration (commonly 1 year).

Prior Authorization

Calcipotriene SOLN requires trial of topical steroid

Calcipotriene solution requires prior authorization and is authorized for 1 year; the request must document a trial of at least one generic topical steroid prior to approval.

Coverage duration: 1 year
Must have trial of ≥1 generic topical steroid

Prior Authorization

Calquence PA for MCL requires prior therapy

Calquence (acalabrutinib) tablets require prior authorization for one year; for mantle cell lymphoma (MCL) the patient must have received at least one prior therapy, and previously untreated MCL patients ineligible for autologous HSCT require combination use with bendamustine and rituximab.

Coverage duration: 1 year
MCL: ≥1 prior therapy; untreated MCL ineligible for HSCT: combo with bendamustine + rituximab

Prior Authorization

Copiktra requires ≥2 prior therapies

Copiktra (duvelisib) requires prior authorization for one year and coverage for relapsed/refractory CLL or SLL requires a trial of at least two prior therapies.

Coverage duration: 1 year
Must document trial of ≥2 prior therapies for relapsed/refractory CLL/SLL

Prior Authorization

Dupixent PA: indication- and trial-based

Dupixent (dupilumab) requires prior authorization for one year; approvals must meet indication‑specific requirements (age/weight minima) and document required prior therapy trials (e.g., topical corticosteroids or systemic agents for atopic dermatitis) with reauthorization requiring evidence of positive clinical response.

Coverage duration: 1 year
Must meet indication-specific age/weight limits and prerequisite therapy trials
Reauthorization: documentation of positive clinical response

Prior Authorization

General PA framework and prerequisite Part D drug

Many products have PA with typical coverage duration of one year and often require a prerequisite Part D drug or specified prior therapy trials before approval.

Coverage commonly limited to 1 year unless noted otherwise
Prerequisite Part D drug required for many products; see product entry

Prior Authorization

Fasenra PA: eosinophil threshold and prior controller trial

Fasenra requires prior authorization for one year; eosinophilic asthma initiation requires blood eosinophils ≥150 cells/µL and failure to maintain control after systemic corticosteroids or high‑dose inhaled corticosteroids plus trial of an additional controller.

Eosinophil threshold at initiation: ≥150 cells/µL
Must have failure after systemic or high‑dose ICS plus another controller (e.g., leukotriene modifier, LABA, or LAMA)

Prior Authorization

Prior authorization required (summary)

Prior authorization is required for the listed Part D drugs; coverage is governed by the indication‑specific criteria and prerequisite therapy requirements shown per product entry.

Providers must submit documentation meeting the product-level criteria noted in the formulary entry
Failure to meet PA criteria may result in denial

Prior Authorization

Komzifti requires combination endocrine therapy

Komzifti coverage is limited to 1 year and requires combination use with an aromatase inhibitor or fulvestrant depending on the line of endocrine therapy for HR‑positive, HER2‑negative advanced/metastatic breast cancer.

Coverage duration: 1 year
Requires combination with an aromatase inhibitor or fulvestrant per indication

Prior Authorization

Krazati requires prior systemic therapy

Krazati for KRAS G12C‑mutated locally advanced or metastatic NSCLC requires prior authorization; coverage requires a trial of at least one prior systemic therapy and is authorized for one year.

Coverage duration: 1 year
Must have trial of ≥1 prior systemic therapy

Prior Authorization

Lazcluze PA: combine with amivantamab

Lazcluze coverage for locally advanced or metastatic NSCLC requires combination use with amivantamab; prior authorization is required and typical coverage duration is one year.

Coverage duration: 1 year
Must be used in combination with amivantamab for the NSCLC indication

Prior Authorization

Lenvima: combination and prior therapy requirements

Lenvima prior authorization requires specified combination regimens for certain indications (e.g., first‑line RCC requires combination with pembrolizumab) and may require prior anti‑angiogenic therapy for other settings.

First‑line RCC: combine with pembrolizumab
Other RCC/advanced endometrial carcinoma: combination or sequence requirements per entry

Prior Authorization

Livtencity requires prior antiviral trial

Livtencity for post‑transplant CMV infection/disease requires prior authorization and documented trial of one of: ganciclovir, valganciclovir, cidofovir, or foscarnet before approval.

Coverage duration: 1 year
Must document trial of ganciclovir, valganciclovir, cidofovir, or foscarnet

Prior Authorization

Lonsurf requires prior lines and combination therapy

Lonsurf for metastatic colorectal cancer requires prior authorization and documentation of prior chemotherapy classes (fluoropyrimidine, oxaliplatin, irinotecan), an anti‑VEGF, and combination use with bevacizumab where specified.

Coverage duration: 1 year
Must document prior lines including fluoropyrimidine, oxaliplatin, irinotecan and anti‑VEGF; requires combination with bevacizumab for mCRC

Prior Authorization

Lumakras: prior therapy and panitumumab for mCRC

Lumakras requires prior authorization for KRAS G12C‑mutated NSCLC and mandates a trial of at least one prior systemic therapy; for mCRC it requires prior chemotherapy and combination use with panitumumab.

Coverage duration: 1 year
NSCLC: trial of ≥1 prior systemic therapy required
mCRC: prior fluoropyrimidine/oxaliplatin/irinotecan chemotherapy and combo with panitumumab

Prior Authorization

Lynparza requires prior chemotherapy

Lynparza requires prior authorization for BRCA/HRR‑related indications and generally requires prior platinum‑based chemotherapy or other specified prior therapies depending on indication; coverage duration is typically one year.

Coverage duration: 1 year
Initiation requires prior platinum‑based chemotherapy or other specified prior therapies per indication

Prior Authorization

Mekinist: BRAF mutation and combination rules

Mekinist PA requires confirmation of BRAF V600E or V600K mutation for specified indications; many indications mandate combination use with dabrafenib and prior trials of vemurafenib + cobimetinib where noted.

Coverage duration: 1 year
Mekinist monotherapy limited to BRAF‑inhibitor treatment‑naive melanoma with BRAF V600E/K; many indications require combination with dabrafenib and prior vemurafenib+cobimetinib trials

Documentation Required

Mekinist (liquid) requires inability to swallow tablets

Mekinist liquid formulation requires prior authorization for one year and coverage is provided only when the patient is unable to swallow the tablet formulation; combination and prior‑trial requirements apply per indication.

Coverage duration: 1 year
Must document inability to swallow tablets to authorize liquid formulation
Combination use with dabrafenib and prior trials may be required per indication

Prior Authorization

Nucala PA: eosinophil thresholds and prior therapy

Nucala requires prior authorization (coverage duration 1 year) and approval depends on indication‑specific eosinophil thresholds and prior therapy trials (e.g., eosinophils ≥150 cells/µL for eosinophilic asthma or ≥1000 cells/µL for HES; COPD add‑on requires current LABA, LAMA, and inhaled corticosteroid).

Coverage duration: 1 year
EA threshold: ≥150 cells/µL at initiation; HES: ≥1000 cells/µL at initiation
COPD add‑on: current eosinophil ≥150 or ≥300 within 12 months and current LABA+LAMA+ICS

Prior Authorization

Nexletol/Nexlizet PA: statin trial required

Nexletol/Nexlizet require prior authorization for one year and initiation requires diagnosis of hypercholesterolemia or ASCVD risk plus a trial of one high‑intensity statin unless documented statin intolerance or contraindication.

Coverage duration: 1 year
Must trial one high‑intensity statin unless intolerance/contraindication documented

Note

Prior authorization requirement summary

Summary: prior authorization is required for the listed specialty products; many require documented trials of specified prior therapies, prerequisite Part D drugs, diagnostic confirmation, or lab thresholds and may be denied if criteria are not met.

Providers must supply required prior‑therapy and diagnostic documentation per product entry
Failure to meet PA or step therapy criteria may result in denial

Prior Authorization

Posaconazole PA: must fail two azoles

Posaconazole DR requires prior authorization for prophylaxis or treatment (coverage duration 6 months) and mandates prior trial with two of: fluconazole, itraconazole, or voriconazole before approval.

Coverage duration: 6 months
Must trial ≥2 of fluconazole, itraconazole, voriconazole

Prior Authorization

Praluent PA: LDL and statin documentation required

Praluent (alirocumab) requires prior authorization—initiation criteria include LDL values while on a high‑intensity statin (≥55 mg/dL with ASCVD or >70 mg/dL without ASCVD measured within last 120 days) and documentation of statin trial or statin intolerance; coverage duration: 3 years.

Coverage duration: 3 years
LDL thresholds while on high‑intensity statin as specified
Document trial of high‑intensity statin or documented statin intolerance

Prior Authorization

Retevmo PA: FDA‑approved molecular confirmation required

Retevmo requires prior authorization for RET‑altered cancers with molecular confirmation by an FDA‑approved test; coverage duration is one year and some indications require prior systemic therapy.

Coverage duration: 1 year
Molecular confirmation by FDA‑approved test required for RET fusion/mutation indications
Some indications require prior systemic therapy

Prior Authorization

Rezdiffra PA: semaglutide trial and fibrosis staging

Rezdiffra requires prior authorization for NASH/MASH with advanced fibrosis (stage F2–F3) after a trial of semaglutide; renewal requires specified improvement or stabilization and initial duration is one year.

Coverage duration: 1 year
Requires diagnosis of NASH/MASH with F2–F3 fibrosis verified by FibroScan or imaging
Trial of semaglutide required prior to authorization
Renewal: improvement/stabilization criteria as listed

Prior Authorization

Rezlidhia PA: prerequisite semaglutide and fibrosis verification

Rezlidhia prior authorization requires diagnosis of noncirrhotic NASH or MASH with advanced fibrosis (F2–F3) verified by FibroScan or other imaging and a trial of semaglutide prior to approval; initial coverage is 1 year.

Coverage duration: 1 year
Must document FibroScan or imaging confirming F2–F3 fibrosis
Semaglutide trial required before approval

Prior Authorization

Rinvoq PA: indication‑ and trial‑based requirements

Rinvoq (including liquid) requires prior authorization per indication with trials of specified DMARDs or NSAIDs; for some indications a TNF inhibitor trial or documentation that a trial is inappropriate is required; reauthorization requires documentation of positive clinical response and avoidance of prohibited combinations.

Coverage duration: 1 year
Requires prior trials (DMARDs/NSAIDs) per indication; TNF inhibitor trial may be required for some indications
Reauthorization: positive clinical response and no combination with potent immunosuppressants

Prior Authorization

Skyrizi PA and dosing restriction

Skyrizi products require prior authorization with indication‑specific criteria and dosing restrictions (e.g., 90 mg/mL strength requires patient weight >100 kg for certain indications); reauthorization requires documentation of positive clinical response.

Coverage duration: 1 year
90 mg/mL strength coverage requires patient weight >100 kg
Reauthorization: documentation of positive clinical response

Documentation Required

Unable to swallow requirement for liquid formulations

Liquid or nonstandard formulations are covered only when the member is unable to swallow tablets, orally disintegrating tablets, or chewable tablets; documentation of inability to swallow must be provided.

Applies to specific products (e.g., Mekinist liquid)
Must document inability to swallow standard tablet/capsule formulations

Prior Authorization

Coverage duration and formulation requirement

Coverage duration for most listed products is generally limited to one year unless otherwise noted; requests for alternative formulations (e.g., liquid) require documentation (e.g., inability to swallow) as specified per product.

Typical coverage duration: 1 year
Alternative formulations require specified documentation

Prior Authorization

TAFINLAR prerequisite therapy and combination use

Tafinlar (and its liquid) require prior trials of specified therapies for certain indications (e.g., prior vemurafenib + cobimetinib combinations); tafinlar is frequently required to be used in combination with trametinib for listed indications.

Prior vemurafenib + cobimetinib trial required in some melanoma indications
Tafinlar often must be combined with trametinib per indication

Step Therapy

Sunosi requires prior armodafinil trial

Sunosi coverage requires prior authorization and documentation of a trial of armodafinil prior to approval.

Must document trial of armodafinil before Sunosi approval

Prior Authorization

Sunitinib requires prior imatinib progression/intolerance

Sunitinib for GIST requires disease progression on or intolerance to imatinib mesylate prior to coverage; prior therapy documentation must be provided.

Document disease progression on or intolerance to imatinib

Prior Authorization

Tagrisso: indication‑specific prior therapy requirements

Tagrisso requires prior authorization and is indicated per setting (adjuvant after resection, first‑line metastatic, or in combination with pemetrexed/platinum for locally advanced/metastatic disease); T790M‑positive disease coverage requires progression on/after an EGFR TKI.

Coverage duration: 1 year
T790M: requires progression on/after EGFR TKI therapy

Prior Authorization

Bexarotene requires prior systemic therapy for capsules

Bexarotene capsules for cutaneous T‑cell lymphoma require prior authorization and documentation that disease is refractory to at least one prior systemic therapy; gel formulation requires refractory/persistent disease or intolerance to other therapies.

Capsules: refractory to ≥1 prior systemic therapy
Gel: refractory/persistent after or intolerant of other therapies

Prior Authorization

Nilotinib requires prior imatinib trial

Nilotinib coverage for adult chronic phase CML (not newly diagnosed) and accelerated phase CML requires documentation of prior therapy that included imatinib; pediatric coverage requires prior TKI trial.

Document prior therapy that included imatinib for adult CML CP/AP

Prior Authorization

Tazverik requires ≥2 prior systemic therapies

Tazverik (tazemetostat) coverage for EZH2 mutation–positive follicular lymphoma requires prior treatment with at least two systemic therapies before approval.

Must document ≥2 prior systemic therapies for EZH2‑positive follicular lymphoma

Prior Authorization

Tibsovo requires prior treatment

Tibsovo coverage for cholangiocarcinoma requires prior systemic treatment; documentation of previous treatment must be submitted with the PA request.

Document prior treatment for cholangiocarcinoma indication

Prior Authorization

Tivdak requires progression on/after chemotherapy

Tivdak coverage for recurrent or metastatic cervical cancer requires disease progression on or after chemotherapy; prior chemotherapy documentation is required for authorization.

Document disease progression on/after chemotherapy

Prior Authorization

Tocilizumab: prior trials and combination exclusion

Tocilizumab prior authorization requires trials of listed agents for RA (e.g., etanercept, adalimumab biosimilars, Rinvoq, Xeljanz/XR, Orencia) and reauthorization requires documentation of positive clinical response; tocilizumab cannot be used in combination with another biologic/targeted DMARD for the same condition.

Coverage duration: 1 year
Requires trial of two listed agents for RA per entry
Cannot be combined with another biologic/targeted DMARD for same condition

Prior Authorization

General PA and coverage duration note

Many listed products require prior authorization with coverage commonly set to one year; providers must follow each product's clinical requirements and submit supporting documentation to avoid denial.

PA commonly required; typical coverage duration 1 year
Submit required clinical documentation per product to support approval

Step Therapy

PAH prerequisite: trials of PDE‑5 inhibitor and ERA

Pulmonary arterial hypertension (PAH) agents require prior authorization and step therapy: trials of both a generic PDE‑5 inhibitor (sildenafil or tadalafil) and a generic endothelin receptor antagonist (bosentan or ambrisentan) are required prior to coverage.

Must document trials of generic sildenafil or tadalafil AND generic bosentan or ambrisentan prior to PAH therapy approval

Documentation Required

Demodex blepharitis diagnosis required (collarettes)

Demodex blepharitis (Xdemvy) requires prior authorization and confirmation of diagnosis via slit‑lamp exam demonstrating collarettes; include that documentation with the PA request.

Document presence of collarettes on slit‑lamp exam to confirm Demodex blepharitis

Step Therapy

Xcopri requires trial of two generic anticonvulsants

Xcopri prior authorization requires documentation of trials of two generic anticonvulsants before approval.

Document trial of ≥2 generic anticonvulsants

Step Therapy

Xermelo requires somatostatin analog trial

Xermelo for carcinoid syndrome diarrhea requires prior authorization and a trial of a somatostatin analog (e.g., octreotide, Somatuline) before approval.

Document trial of a somatostatin analog prior to Xermelo approval

Prior Authorization

Xifaxan: indication‑specific prior therapy trials

Xifaxan prior authorization depends on indication: hepatic encephalopathy requires trial of lactulose; IBS‑D requires trial of loperamide, dicyclomine, or diphenoxylate/atropine; recurrent C. difficile requires trial of vancomycin—document the appropriate prior therapy.

HE: trial of lactulose required
IBS‑D: trial of loperamide, dicyclomine, or diphenoxylate/atropine required
Recurrent C. diff: trial of vancomycin required

Prior Authorization

Xpovio requires documented prior lines of therapy

Xpovio for multiple myeloma requires prior lines of therapy per indication: e.g., adult MM requires one prior therapy; relapsed/refractory MM requires four prior therapies including specified refractory classes—document prior therapy history.

Document prior lines per indication (e.g., adult MM: ≥1 prior therapy; relapsed/refractory MM: ≥4 prior therapies with specified refractory classes)

Prior Authorization

Xtandi requires abiraterone trial

Xtandi prior authorization requires a trial of abiraterone 250 mg tablet for indicated prostate cancer diagnoses prior to coverage.

Document trial of abiraterone 250 mg tablet prior to Xtandi approval

Denial Risk

Sodium oxybate exclusions and prerequisite trials

Sodium oxybate requires prior authorization and is not covered for patients taking sedative hypnotics or those with succinic semialdehyde dehydrogenase deficiency; for patients ≥18 years, document prior trials of armodafinil and Sunosi where applicable.

Not covered if patient is taking sedative hypnotics or has succinic semialdehyde dehydrogenase deficiency
For adults, document prior trials of armodafinil and Sunosi where required

Prior Authorization

Zejula requires response to platinum‑based chemo

Zejula maintenance therapy requires prior authorization and documentation of complete or partial response to first‑line platinum‑based chemotherapy.

Document complete or partial response to first‑line platinum chemotherapy for maintenance Zejula

Prior Authorization

Zolinza requires two prior systemic therapies

Zolinza for cutaneous T‑cell lymphoma requires prior authorization and a trial of two systemic therapies prior to coverage; include prior therapy documentation in the PA request.

Document trial of ≥2 systemic therapies before approval

Step Therapy

Zonisade requires two anticonvulsant trials or inability to swallow

Zonisade prior authorization for seizure disorder requires trial of at least two generic anticonvulsants (one must be generic zonisamide) or documentation of inability to swallow tablets/capsules.

Trial of ≥2 generic anticonvulsants, one being generic zonisamide, OR inability to swallow tablets/capsules

Prior Authorization

Zurzuvae: indication timing and 60‑day duration

Zurzuvae for postpartum depression requires prior authorization: diagnosis onset in third trimester or within 4 weeks postpartum, current postpartum status ≤12 months, and coverage duration is 60 days.

Onset within third trimester or ≤4 weeks postpartum
Member currently ≤12 months postpartum
Coverage duration: 60 days

Documentation Required

PA required — submit product‑specific documentation

Prior authorization is required for listed formulary products (Formulary ID 26449); providers must submit product‑specific documentation (lab values, prior therapy trials, genetic testing, imaging) noted in each entry to support approval.

Submit required documentation (lab values, prior therapy, genotype, imaging) as specified per product entry
If setting/use not clear (Part B vs Part D), provide setting information to avoid denial/delay

Step Therapy

Step/prior trials required for certain products

Certain products require step therapy or prerequisite trials before authorization—examples include trials of specified oral or injectable alternatives (e.g., oral aripiprazole for Abilify Asimtufii/Abilify Maintena; paliperidone long‑acting injectables require specific prior paliperidone regimens).

Document trials of the listed alternatives per product (e.g., oral aripiprazole for Abilify products; paliperidone formulations per Invega Hafyera criteria)

Prior Authorization

Invega Hafyera: trial of paliperidone palmitate injectables required

Invega Hafyera PA requires documented trial of once‑monthly paliperidone palmitate ER injectable for ≥4 months OR every‑three‑month paliperidone palmitate ER for at least one three‑month cycle; coverage duration is lifetime when met.

Trial options: once‑monthly paliperidone palmitate ≥4 months OR every‑3‑month paliperidone palmitate for ≥1 three‑month cycle
Coverage duration: lifetime

Prior Authorization

Invega Sustenna requires oral paliperidone/risperidone trial

Invega Sustenna prior authorization requires trial of oral paliperidone or oral risperidone prior to approval; coverage duration is lifetime when criteria met.

Document trial of oral paliperidone OR oral risperidone
Coverage duration: lifetime

Prior Authorization

Invega Trinza requires oral paliperidone/risperidone trial

Invega Trinza prior authorization requires trial of oral paliperidone or oral risperidone prior to approval; coverage duration is lifetime when criteria met.

Document trial of oral paliperidone OR oral risperidone
Coverage duration: lifetime

Step Therapy

Rhopressa/Rocklatan require ophthalmic trial

Rhopressa and Rocklatan prior authorization requires trial of a generic formulary ophthalmic glaucoma medication or Lumigan; include documentation of that trial for PA; coverage duration is 1 year.

Trial of a generic formulary ophthalmic glaucoma medication OR Lumigan required
Coverage duration: 1 year

Prior Authorization

Risperidone ER/Rykindo require oral risperidone trial

Risperidone ER and Rykindo prior authorization require trial of oral risperidone before approval; coverage duration is lifetime when criteria met.

Document trial of oral risperidone
Coverage duration: lifetime

Step Therapy

Rytary requires ER carbidopa/levodopa trial

Rytary PA requires trial of generic oral extended‑release carbidopa/levodopa prior to authorization; coverage duration is 1 year.

Document trial of generic ER carbidopa/levodopa
Coverage duration: 1 year

Step Therapy

Farxiga/Jardiance SGLT2 step therapy

Farxiga and Jardiance prior authorization requires trial of generic dapagliflozin; Jardiance is exempt from step therapy when used to reduce cardiovascular death in adults with T2DM and established CVD—document prior trial unless exempt.

Trial of generic dapagliflozin required for Farxiga; Jardiance requires trial unless used for CV death reduction in established CVD

Prior Authorization

Febuxostat requires allopurinol trial or contraindication

Febuxostat prior authorization requires trial of or contraindication to allopurinol; coverage duration when approved is lifetime—submit documentation of allopurinol trial or contraindication.

Document trial of allopurinol or contraindication to allopurinol
Coverage duration: lifetime

Step Therapy

Step therapy examples require documented alternative trials

Examples: some drugs (e.g., Auvelity, Trintellix) are subject to step therapy requiring trials of specified generics prior to coverage—providers must document those prior trials in the PA/ST request.

Document trials of specified alternative agents per product (e.g., bupropion + another generic for Auvelity; ≥2 generics for Trintellix)

Step Therapy

Calcipotriene SOLN step therapy: topical steroid trial

Calcipotriene solution requires a prior trial of at least one generic topical steroid before authorization; include documentation of that trial with the PA request.

Document trial of ≥1 generic topical steroid prior to Calcipotriene SOLN approval

Step Therapy

Dupixent step requirements for asthma

Dupixent step requirements: for asthma indications document failure to maintain control after systemic or high‑dose inhaled corticosteroids plus trial of an additional controller medication (leukotriene modifier, LABA, or LAMA).

Document failure after systemic or high‑dose ICS plus trial of additional controller (leukotriene modifier, LABA, or LAMA) for eosinophilic asthma

Step Therapy

Diacomit step therapy: two anticonvulsant trials

Diacomit requires prior authorization and a trial of two generic anticonvulsants; for Dravet syndrome, it also requires combination use with clobazam—document trials and combination therapy where applicable.

Trial of 2 generic anticonvulsants required
Dravet: combination with clobazam required

Step Therapy

Step/prerequisite trials across multiple products

Multiple products require documented trials of specified generic alternatives or class agents (often two agents) before coverage; providers must submit evidence of those trials (e.g., seizure products, migraine prevention, atopic dermatitis).

Document trials of specified generics or class agents as listed per product

Documentation Required

Prerequisite therapy trials must be documented

Many products require prerequisite therapy trials (e.g., Kevzara/Kineret require trials of two listed agents for RA); absence of documented prior trials may lead to denial—submit prior therapy records.

Document trials of required prior agents (example: two specified agents for RA)

Step Therapy

Krazati: prior systemic therapy (step) required

Krazati step requirement: Krazati requires a prior systemic therapy trial before approval; include documentation of the prior systemic therapy.

Document prior systemic therapy trial for Krazati

Step Therapy

Multiple drugs: sequence and step requirements

Some products (e.g., Livtencity, Lonsurf, Lumakras) have step/sequence requirements—document prior antiviral or chemotherapy lines and combinations as specified in the product entries.

Provide records of prior antivirals (Livtencity) or prior chemotherapy lines and anti‑VEGF/EGFR agents (Lonsurf, Lumakras)

Note

How to request prior authorization

Providers must contact the pharmacy help desk to request prior authorization or step therapy for listed drugs; clinical criteria are based on the Pharmacy & Therapeutics Committee recommendations—follow the PA submission process and include required documentation.

Contact pharmacy help desk to request PA/ST
Include required clinical and prior therapy documentation per product

Documentation Required

T25FW test required for dalfampridine

Timed 25‑Foot Walk (T25FW) test is required documentation prior to initiation of dalfampridine; reauthorization requires documentation of stability or improvement on the T25FW.

Submit baseline T25FW prior to initiation
Reauthorization: document stability or improvement on T25FW

Documentation Required

Submit prior therapy documentation with PA

Prior therapy documentation: PA requests must include evidence of the specified prior therapies or trials as required by each product (e.g., topical steroid trial for calcipotriene solution; prior antiviral for Livtencity).

Attach chart notes, prescriptions, or other records documenting required prior trials

Documentation Required

Diabetes documentation and weight‑loss exclusion

For diabetes‑related agents (GLP‑1 and liraglutide), submit medical records or lab evidence confirming T2DM (A1c ≥6.5% OR FPG ≥126 mg/dL OR 2‑hour OGTT ≥200 mg/dL) when requested; agents are excluded if used for weight‑loss only.

Provide medical records or lab values confirming T2DM
Exclude requests for weight‑loss–only use (liraglutide and similar)

Documentation Required

Biologic reauthorization requires documented response

Biologic reauthorization requires documentation of positive clinical response to therapy; providers must submit outcome documentation for continued coverage.

Reauthorization: submit clinical response documentation

Documentation Required

Reauthorization: response documentation and combination exclusions

Reauthorization for multiple biologic and immunomodulatory products generally requires documentation of positive clinical response and avoidance of prohibited combinations (e.g., with another biologic or potent immunosuppressant).

Document ongoing positive clinical response
Confirm the patient is not receiving prohibited combinations

Documentation Required

Liraglutide: diabetes documentation required; not for weight loss

Liraglutide when used for T2DM requires medical records or lab evidence confirming diagnosis (A1c ≥6.5% or FPG ≥126 mg/dL or 2‑hour OGTT ≥200 mg/dL); liraglutide is excluded if used for weight‑loss only.

Provide lab evidence or chart notes confirming T2DM
Excluded for weight‑loss–only use

Documentation Required

Required eosinophil counts and prior medication trials

For eosinophilic conditions (e.g., Nucala/Fasenra), submit eosinophil counts (current or within prior 12 months where specified) and documentation of prior medication trials (systemic corticosteroids or inhaled corticosteroids plus another controller) to support PA.

Provide eosinophil counts per indication thresholds (e.g., ≥150 cells/µL for EA; ≥1000 cells/µL for HES)
Document prior controller/systemic corticosteroid trials

Documentation Required

Mekinist (liquid) documentation: inability to swallow and prior trials

Mekinist liquid requires documentation that the patient is unable to swallow tablet formulation; include this inability and prior trial combination documentation (e.g., prior vemurafenib+cobimetinib) where applicable.

Document inability to swallow tablets to justify liquid formulation
Provide prior trial/combo therapy records as indicated

Documentation Required

Examples of required clinical documentation to include with PA

Required documentation examples include lab values, prior therapy trials, imaging or FibroScan for liver fibrosis, genetic test results (BRCA), and genotype (CYP2D6) where indicated—submit these with the PA request to avoid denial.

FibroScan/imaging for F2–F3 fibrosis (Rezdiffra/Rezlidhia)
BRCA mutation documentation for Rubraca maintenance
CYP2D6 genotype for tetrabenazine doses >50 mg/day

Documentation Required

Praluent: include LDL and HeFH/HoFH documentation

Praluent medical information must include LDL values while on a high‑intensity statin within the last 120 days and confirmation of HeFH/HoFH diagnostic criteria where applicable.

Include LDL while on high‑intensity statin (within 120 days) per thresholds and HeFH/HoFH confirmation when applicable

Documentation Required

Rezdiffra: FibroScan or imaging required

Rezdiffra requires documentation of NASH/MASH diagnosis with advanced fibrosis (stage F2–F3) verified by FibroScan or other imaging‑based non‑invasive assessment; include the imaging report with the PA.

Attach FibroScan or imaging evidence confirming F2–F3 fibrosis

Documentation Required

Prevymis: document CMV serostatus and transplant type

Prevymis PA requires documentation of CMV serostatus and transplant type (e.g., CMV‑seropositive allogeneic HSCT recipient or D+/R‑ kidney transplant) for CMV prophylaxis approvals.

Provide CMV serostatus and transplant type details (e.g., D+/R‑ kidney transplant or CMV‑seropositive HSCT recipient)

Documentation Required

Reauthorization: document positive clinical response (e.g., tocilizumab)

Reauthorization of tocilizumab and other biologics requires documentation of positive clinical response to therapy; include objective or clinician‑documented improvement in submitted records.

Submit objective or documented clinical improvement for reauthorization

Documentation Required

Voydeya: lab thresholds and combination therapy required

Voydeya coverage requires hemoglobin ≤9.5 g/dL and absolute reticulocyte count ≥120 ×10^9/L and must be used in combination with Soliris or Ultomiris; include these lab values and combination therapy documentation with the PA.

HGB ≤9.5 g/dL and absolute reticulocyte count ≥120 ×10^9/L required
Must document combination use with Soliris or Ultomiris

Step Therapy

Voquezna requires trial of first‑line H. pylori regimen

Voquezna for H. pylori requires prior authorization and documentation of a guideline‑recommended first‑line regimen trial (e.g., clarithromycin triple therapy or bismuth quadruple therapy) before coverage.

Document trial and failure or contraindication to a guideline‑recommended first‑line H. pylori regimen

Documentation Required

Xolair: IgE and prior controller documentation required

Xolair prior authorization requires documentation of IgE level within specified ranges for allergic asthma or CRSwNP at initiation and evidence of prior controller therapy failure; reauthorization requires documented positive clinical response.

IgE level ranges per indication and prior controller failure documentation required
Reauthorization: positive clinical response documentation

Documentation Required

Xeljanz: TNF inhibitor trial and reauthorization documentation

Xeljanz prior authorization requires documentation of inadequate response or intolerance to one or more TNF inhibitors (or documentation that a trial is inappropriate); reauthorization requires documentation of positive clinical response and avoidance of prohibited combinations.

Document TNF inhibitor failure/intolerance or rationale why trial is inappropriate
Reauthorization: clinical response and no prohibited combinations

Documentation Required

Provide site‑of‑care information for Part B vs Part D determination

When the setting of administration is unclear, submit information describing the drug use and site of care (hospital outpatient vs other) to determine Part B vs Part D coverage; lack of setting information may delay or deny coverage.

Provide site‑of‑care/use details to clarify Part B vs Part D coverage

Documentation Required

Invega Hafyera: document prior paliperidone palmitate trial duration

Invega Hafyera documentation must include prior trial duration of paliperidone palmitate injectables (monthly ≥4 months OR every‑three‑month formulation for ≥1 three‑month cycle) to meet PA criteria.

Document duration of prior paliperidone palmitate injectable trial (≥4 months monthly OR ≥1 three‑month cycle for 3‑month formulation)

Documentation Required

Document oral paliperidone/risperidone trial for injectable antipsychotics

Oral antipsychotic documentation: for products requiring oral trial (e.g., Invega Sustenna/Trinza, Risperidone ER, Rykindo), submit records of trial of oral paliperidone or oral risperidone as specified.

Provide records of oral paliperidone OR oral risperidone trial where required

Documentation Required

Ophthalmic agents require prior trial documentation

Ophthalmic documentation: Rhopressa and Rocklatan PA requests must include documentation of trial of a generic formulary ophthalmic glaucoma medication or Lumigan prior to approval.

Document trial of any generic formulary ophthalmic glaucoma med OR Lumigan

Documentation Required

Rytary: document ER carbidopa/levodopa trial

Rytary documentation: prior trial of generic ER carbidopa/levodopa must be documented for PA approval.

Provide documentation of trial of generic ER carbidopa/levodopa

Documentation Required

SGLT2 step therapy and documentation (Farxiga/Jardiance)

SGLT2 documentation: for Farxiga/Jardiance requests provide documentation of trial of generic dapagliflozin unless the request is for Jardiance to reduce CV death in T2DM with established CVD (exception from step therapy).

Document trial of generic dapagliflozin unless Jardiance is for CV death reduction in established CVD

Documentation Required

Febuxostat requires allopurinol trial or contraindication documentation

Febuxostat documentation: PA requires documentation of trial of or contraindication to allopurinol; include prior allopurinol trial records or contraindication evidence.

Document trial of allopurinol or provide contraindication evidence

Denial Risk

PA/ST denial risk if criteria or documentation missing

PA/ST denial risk: coverage is subject to prior authorization and step therapy; if PA or ST criteria are not met or required documentation is missing, coverage will be denied.

Failure to meet PA/ST criteria or provide required documentation may result in denial

Denial Risk

Nitrate therapy exclusion for tadalafil/sildenafil

Nitrate therapy exclusion: tadalafil and sildenafil are not covered when the patient is receiving nitrate therapy—do not submit PA requests in that setting.

Tadalafil/sildenafil: coverage not provided for patients receiving nitrate therapy

Denial Risk

Dalfampridine excluded for wheelchair‑bound patients

Wheelchair‑bound exclusion: dalfampridine is excluded for patients who are wheelchair bound or become wheelchair bound; do not request PA for such patients.

Dalfampridine excluded if patient is wheelchair bound or becomes wheelchair bound

Denial Risk

Combination biologic/targeted DMARD exclusion (deny if combined)

Combination biologic/targeted DMARD exclusion: several biologics (e.g., Kevzara, Kineret, Nucala, Tocilizumab, Xolair, Xeljanz) cannot be used in combination with another biologic or targeted DMARD for the same condition; combination use may trigger denial.

Do not combine with another biologic/targeted DMARD for the same condition; prohibited combinations may result in non‑coverage

Denial Risk

Exclusion for weight‑loss‑only use (GLP‑1s)

Weight‑loss exclusion: certain GLP‑1 agonists (e.g., liraglutide) are excluded if used solely for weight loss; ensure indication and diabetes documentation are provided when requesting PA.

Exclude requests for weight‑loss–only use; provide T2DM documentation if intended for diabetes treatment

Denial Risk

Eosinophilic asthma: eosinophil thresholds and prior controller trial required

Eosinophilic asthma prerequisites (denial triggers): requests lacking required eosinophil counts (≥150 cells/µL at initiation) or missing documentation of prior systemic or high‑dose inhaled corticosteroid plus additional controller trial may be denied.

Eosinophil ≥150 cells/µL at initiation required for EA
Document failure of systemic or high‑dose ICS plus additional controller

Denial Risk

Mekinist combination/liquid documentation to avoid denial

Mekinist combination requirements (denial risk): failure to document required combination use with dabrafenib or prior trial of vemurafenib+cobimetinib where specified may result in denial, and Mekinist liquid requires documented inability to swallow tablets.

Document combination use with dabrafenib when required and prior vemurafenib+cobimetinib trials as indicated
For liquid, document inability to swallow tablets

Denial Risk

Statin trial documentation required for Nexletol/Nexlizet

Statin trial requirement (denial risk): Nexletol/Nexlizet requests missing documentation of a trial of a high‑intensity statin (or documented statin intolerance) may be denied—include statin trial records or intolerance evidence.

Provide evidence of trial of high‑intensity statin within required timeframe or documented statin intolerance

Denial Risk

Praluent: LDL and statin documentation required to avoid denial

Praluent initial coverage denial trigger: lack of LDL values while on a high‑intensity statin measured within the last 120 days or missing documentation of statin use/intolerance may lead to denial—submit LDL and statin history.

Include LDL value on high‑intensity statin (within 120 days) and statin trial/intolerance documentation

Denial Risk

Retevmo denial risk without FDA‑approved molecular test

Retevmo diagnostic confirmation risk: absence of molecular confirmation by an FDA‑approved test for RET fusions/mutations may cause denial—attach the FDA‑approved test report with the PA.

Attach FDA‑approved molecular test confirming RET fusion/mutation

Denial Risk

Prohibition on combining with potent immunosuppressants or another biologic/DMARD

Combination therapy exclusions involving potent immunosuppressants: products such as Rinvoq, Skyrizi, Xeljanz, and similar agents cannot be used with a potent immunosuppressant (e.g., azathioprine, cyclosporine) or another biologic/targeted DMARD for the same condition; such combinations are prohibited and may trigger denial.

Do not use in combination with potent immunosuppressants (azathioprine, cyclosporine) or another biologic/targeted DMARD for same condition

Denial Risk

Rybrevant: prior progression on platinum chemo/EGFR TKI required

Rybrevant prior therapy requirement: for certain EGFR‑mutant NSCLC indications, coverage requires prior progression on platinum‑based chemotherapy or prior EGFR TKI and specified combination chemotherapy—document prior therapies to avoid denial.

Document prior progression on platinum‑based chemotherapy or prior EGFR TKI and required combination chemotherapy

Denial Risk

Tetrabenazine: absolute exclusions and genotype requirement

Tetrabenazine absolute exclusions: coverage will not be provided for patients with hepatic impairment, active suicidal ideation or untreated/inadequately treated depression, or concomitant MAO inhibitors or reserpine; CYP2D6 genotype documentation required for doses >50 mg/day.

Exclude patients with hepatic impairment, active suicidality, untreated depression, or on MAO inhibitors/reserpine
Genotype (CYP2D6) documentation required for doses >50 mg/day

Prior Authorization

Valchlor requires prior skin‑directed therapy

Valchlor prior therapy requirement: topical Valchlor for stage 1A–1B mycosis fungoides requires prior skin‑directed therapy; lack of prior therapy documentation may lead to denial.

Document prior skin‑directed therapy before Valchlor approval for stage 1A–1B MF

Prior Authorization

Trodelvy requires ≥2 prior systemic therapies for TNBC

Trodelvy prior systemic therapy requirement: for unresectable locally advanced or metastatic triple‑negative breast cancer, coverage requires prior use of two or more systemic therapies with at least one for metastatic disease; document prior therapy history.

Document prior use of ≥2 systemic therapies with ≥1 for metastatic disease

Documentation Required

Verquvo: NYHA/LVEF and recent HF event required

Verquvo coverage requires prior authorization and documentation of NYHA class II–IV, LVEF <45%, and either prior HF hospitalization within 6 months or outpatient IV diuretic within 3 months; include these clinical details with the PA.

Document NYHA class, LVEF (<45%), and recent HF hospitalization or outpatient IV diuretic use

Denial Risk

Xolair: prohibited combination with another biologic/DMARD

Xolair combination prohibition: use of Xolair in combination with another biologic or targeted DMARD for the same condition is prohibited and may trigger denial—ensure no prohibited combinations are used.

Confirm Xolair is not being used with another biologic/targeted DMARD for the same condition

Denial Risk

Xeljanz: prohibited combinations may trigger denial

Xeljanz combination prohibition: use of Xeljanz with a potent immunosuppressant (e.g., azathioprine, cyclosporine) or another biologic/targeted DMARD for the same condition is prohibited and may trigger denial—document concomitant therapies.

Do not combine Xeljanz with potent immunosuppressants or another biologic/targeted DMARD; document concomitant therapy status

Denial Risk

Sodium oxybate exclusion (sedative hypnotics/SSADH deficiency)

Sodium oxybate exclusion: coverage is not provided for patients taking sedative hypnotics or with succinic semialdehyde dehydrogenase deficiency; do not submit PA if exclusion applies.

Not covered for patients on sedative hypnotics or with succinic semialdehyde dehydrogenase deficiency

Documentation Required

Provide site/use details to determine Part B vs Part D coverage

Part B vs Part D coverage determination: if the submitted information does not clarify whether the drug is covered under Medicare Part B or Part D (including use and setting), coverage determination may be delayed or denied—provide setting and use details.

Provide setting/use information to clarify Part B vs Part D coverage to avoid delays/denials

Denial Risk

Invega Hafyera denial risk without injectable trial documentation

Invega Hafyera trial omission risk: absence of documented trial of once‑monthly paliperidone palmitate for ≥4 months or the every‑three‑month formulation for ≥1 three‑month cycle may lead to denial—include injectable trial records.

Document the prior paliperidone palmitate injectable trial duration as required

Denial Risk

Denial risk if oral antipsychotic trial not documented

Oral antipsychotic trial omission risk: PA requests missing documentation of prior oral paliperidone or oral risperidone where required may be denied—attach oral trial records.

Include documentation of prior oral paliperidone or oral risperidone trial where applicable

Denial Risk

Ophthalmic step therapy denial risk without trial

Ophthalmic step omission risk: Rhopressa/Rocklatan requests lacking trial of a generic formulary ophthalmic glaucoma medication or Lumigan may be denied—submit trial documentation.

Provide evidence of trial of a generic ophthalmic glaucoma medication or Lumigan

Denial Risk

Rytary denial risk without prior ER carbidopa/levodopa trial

Rytary omission risk: absence of a documented trial of generic ER carbidopa/levodopa for Rytary may result in denial—include trial evidence.

Attach documentation of trial of generic ER carbidopa/levodopa

Denial Risk

SGLT2 denial risk if dapagliflozin trial not documented

SGLT2 step therapy omission risk: requests for Farxiga or Jardiance without documentation of trial of generic dapagliflozin (except Jardiance when used to reduce CV death in established CVD) may be denied—provide prior dapagliflozin trial records as applicable.

Document trial of generic dapagliflozin unless Jardiance is for CV death reduction in established CVD (exempt)

Denial Risk

Febuxostat denial risk without allopurinol trial/contraindication

Allopurinol trial omission risk for Febuxostat: PA for Febuxostat may be denied if no trial of allopurinol or contraindication documentation is provided—include allopurinol trial or contraindication evidence.

Provide allopurinol trial records or documented contraindication

Note

Policy Background

BCBSM Prescription Blue PDP requires prior authorization (PA) for many formulary drugs to ensure appropriate, evidence‑based, and cost‑effective therapy; PA means clinical and/or administrative criteria must be met before coverage is provided. The plan’s PA framework typically sets an initial authorization period of 1 year for most drugs (exceptions noted per product) and, where applicable, requires documentation of prior treatment trials, diagnostic confirmation, or laboratory thresholds as specified in each product entry. [[chunk 0]]

Some products in the formulary also require step therapy (ST) — i.e., documented trials of specified formulary alternatives (generics or lower‑cost agents) and evidence of failure, intolerance, contraindication, or inability to use alternatives before a PA will be approved. Examples in this extract include topical steroid trial prior to calcipotriene solution, trials of generic anticonvulsants before Epidiolex or topiramate solution, and trials of high‑intensity statins before Praluent/Nexletol‑type agents. [[chunk 18]] [[chunk 36]]

Per the drug listings, many specialty and oncology agents require specific prior therapies or combination regimens (for example, Calquence for mantle cell lymphoma requires ≥1 prior therapy; Copiktra for relapsed/refractory CLL/SLL requires ≥2 prior therapies). Where a prerequisite Part D drug is required, the policy entries state that documentation of those prior trials must be provided with the PA request. Providers should consult the individual product entry for the exact trial, diagnostic, age, weight, or lab thresholds that must be met. [[chunk 18]] [[chunk 22]]

To request PA or ST, the prescriber should contact the pharmacy help desk and submit the required clinical documentation (e.g., chart notes, lab results, prior‑therapy records, T25FW for dalfampridine). Failure to submit required documentation or to meet the product‑specific criteria (including prohibited combinations such as concurrent use of two biologics/targeted DMARDs for the same condition) may result in denial of coverage. [[chunk 0]] [[chunk 26]] [[chunk 128]]

Key Definitions and Abbreviations

PA definitionPrior authorization — clinical and/or administrative criteria that must be met before coverage is provided

ST definitionStep therapy — requires previous treatment with one or more formulary drugs prior to coverage

T25FWTimed 25-Foot Walk (T25FW) test required as baseline for dalfampridine initiation; reauthorization requires stability or improvement

ST definitionStep therapy — requires previous treatment with one or more formulary drugs prior to coverage

ExamplesSeveral drugs in the formulary require step trials (examples: Calcipotriene, Epidiolex, Dupixent components require prior trials)

Provider actionPhysician may contact pharmacy help desk to request step therapy exceptions or PA

T25FW

T25FW requirementSubmission of a baseline Timed 25-Foot Walk (T25FW) test is required for dalfampridine initiation; reauthorization requires stability or improvement on T25FW

ExclusionDalfampridine excluded for patients who are wheelchair bound or become wheelchair bound

Coverage durationCoverage duration typically 1 year for dalfampridine

EOE

EOE diagnostic requirementEosinophilic esophagitis (EOE) requires diagnosis of symptomatic EOE and trial of PPI or topical esophageal corticosteroids prior to coverage

Dupixent relationEOE is an indication listed for Dupixent with age/weight minima noted elsewhere

DocumentationSubmit evidence of prior PPI or topical steroid trial as part of PA documentation

EGPA

EGPA diagnostic criteriaEosinophilic granulomatosis with polyangiitis (EGPA) coverage requires diagnosis plus two typical EGPA features (e.g., histopathologic eosinophilic vasculitis, neuropathy, pulmonary infiltrates, nasal polyps)

Asthma requirementEGPA entry often requires history or presence of asthma

Combination exclusionCannot be used in combination with another biologic or targeted DMARD indicated for the same condition

DMARD

DMARD definitionDisease-modifying antirheumatic drug (examples: methotrexate, leflunomide, sulfasalazine) — required as prior therapy for certain rheumatologic biologic indications

Use in prior therapy trialsA trial of a DMARD is commonly required before initiating biologic therapies for RA and related conditions

ReauthorizationReauthorization for biologics typically requires documentation of positive clinical response

Moderately to severely active

Clinical implicationCoverage requires documentation of disease severity as part of PA requests

Reauthorization noteReauthorization requires documentation of positive clinical response

Eosinophilic asthma

Eosinophilic asthma definitionAsthma with elevated blood eosinophil counts used as a criterion for biologic therapy eligibility

Required labEosinophil count (e.g., >=150 cells/µL) must be documented

Prior therapy requirementFailure to maintain control after systemic corticosteroids or high-dose ICS plus another controller is required for coverage

BRAF V600E/V600K mutation

BRAF V600E/V600K mutation definitionBRAF V600E or V600K mutation: tumor genetic alterations that guide use of BRAF/MEK inhibitor combinations (e.g., Mekinist + dabrafenib)

Testing implicationFDA-approved test results are required for mutation-directed therapies per product criteria

Formulation noteLiquid formulations (e.g., Mekinist SOLR) require inability to swallow tablets for coverage

Eosinophil threshold

Eosinophil threshold conceptPolicy defines eosinophil thresholds for specific indications (e.g., >=1000 cells/µL for HES; >=150 current or >=300 within 12 months for COPD)

Implication for PARequests failing to meet specified eosinophil thresholds may be denied

DocumentationSubmit eosinophil counts (current or within prior 12 months) with PA requests where specified

Diagnostic confirmation for Opfolda

Opfolda diagnostic confirmationCoverage requires serum assay showing decreased acid alpha-glucosidase activity followed by genetic testing showing a GAA gene mutation and symptomatic disease manifestations

Symptom examplesProgressive muscle weakness, respiratory failure, frequent infections, orthopnea, sleep apnea, morning headaches

Prerequisite Part D drugPolicy notes prerequisite Part D drug use may be required for some products (check product entry)

HeFH / HoFH

HeFH / HoFH definition (summary)HeFH and HoFH defined by genetic confirmation or specific untreated/treated LDL thresholds and clinical features (e.g., xanthoma before 10 years)

DocumentationGenetic confirmation or LDL criteria must be provided per Praluent initiation rules

Statin contextPatients must be on high-intensity statin (or have documented intolerance) when LDL thresholds are assessed

RET alteration

RET alteration definitionRET gene fusions or RET mutations detected by an FDA-approved test used to determine eligibility for Retevmo

Testing requirementMolecular confirmation by an FDA-approved test is required for coverage

Indication examplesRET fusion-positive NSCLC and RET-mutant medullary thyroid cancer (MTC)

Part B vs Part D

Part B vs Part D determinationCoverage under Medicare Part B or Part D depends on the drug, its use, and the setting of administration; documentation of use/setting may be required

Provider actionSubmit information describing drug use and site of administration to determine Part B vs Part D coverage

Potential impactIf unclear, determination may be delayed or denied

Initial Authorization Requirements

Reauthorization / Continuation Rules

Step Therapy Tables and Prior Trial Requirements

Product / Scenario	Step therapy requirement
General (multiple products)
Prior trial of specified formulary drugs (product-specific; e.g., Auvelity requires trial of bupropion + another generic antidepressant).

Product	Required prior trial
Calcipotriene SOLN
Trial of at least one generic topical steroid required prior to coverage; coverage duration 1 year.

Product	Required prior trials
Epidiolex
Requires trials of two generic alternatives for Lennox–Gastaut; for Dravet requires trial of two of valproic acid, clobazam, or topiramate; prerequisite Part D drug required; coverage typically 1 year.

Product	Dupixent asthma-related prior therapy
Dupixent (eosinophilic asthma)
Requires eosinophil count ≥150 cells/µL at initiation AND failure to maintain control after systemic corticosteroids OR high‑dose inhaled corticosteroids plus trial of one additional controller (e.g., leukotriene modifier, LABA, or LAMA).

Examples of generic/alternative agents	Context / requirement
Generic topical steroids; generic tacrolimus or pimecrolimus (examples for topical AD alternatives)
Required prior trials for topical agents before coverage of products like calcipotriene solution or Eucrisa (trial of topical steroid or generic tacrolimus/pimecrolimus).

Products (examples)	Prior trial requirement
Topiramate SOLN
Requires trial of at least two generic migraine-preventive alternatives or inability to swallow tablets/capsules; seizure uses require two generic anticonvulsant trials.

Oncology / antiviral product	Prerequisite therapy examples
Padcev (urothelial cancer)
Requires prior PD‑1/PD‑L1 inhibitor and platinum-containing chemotherapy or prior lines as specified before coverage.

Requirement type	Documentation / evidence needed
Documented trial and failure/intolerance/contraindication
Policy requires evidence of trials and either failure, intolerance, contraindication, or inability to use alternative formulations as specified per product entry (e.g., Nurtec needs ≥2 triptans trial; Mekinist liquid requires inability to swallow tablets).

Prior agents / lines	Example product context
Two generic triptans (e.g., sumatriptan, rizatriptan)
Required prior to Nurtec for acute migraine (trial of at least two generic triptans unless contraindicated).

Product	Azole trial requirement
Posaconazole (DR)
Must have failed or been intolerant to two of fluconazole, itraconazole, or voriconazole prior to coverage for prophylaxis or treatment.

Product	Multi‑kinase inhibitor prior therapy
Qinlock (ripretinib)
Coverage for advanced GIST requires prior therapy with three or more kinase inhibitors including imatinib.

Product	Required prior GLP‑1 trial
Rezdiffra / Rezlidhia
Requires trial of semaglutide prior to authorization for noncirrhotic NASH/MASH with advanced fibrosis (stage F2‑F3); coverage duration and renewal criteria specified.

Products	Specified prior therapies required (selected examples)
Rinvoq / Rezlidhia / Rezdiffra
Multiple products require specified prior therapies: e.g., Rinvoq requires prior DMARD/NSAID trials (and TNF inhibitor failure for some indications); Rezlidhia/Rezdiffra require semaglutide trial for NASH/MASH as noted.

Product	Required prior stimulant
Sunosi
Coverage requires a prior trial of armodafinil before Sunosi is authorized.

Product	Tafinlar prior therapy
Tafinlar (dabrafenib combinations context)
For some melanoma indications tafinlar requires prior use of vemurafenib + cobimetinib and is often required to be used in combination with trametinib for listed indications.

Product	Required bone therapy trials
Tymlos
Requires documentation of BMD T‑score ≤ -2.5 and trial of both Prolia and an oral bisphosphonate (or IV bisphosphonate if intolerant) prior to coverage, or documented inability to be treated with these agents.

Product / Condition	PAH prior therapy requirement
Winrevair (PAH)
Requires trials of both a generic PDE‑5 inhibitor (sildenafil or tadalafil) AND a generic endothelin receptor antagonist (bosentan or ambrisentan) prior to coverage.

Product	H. pylori prior regimen requirement
Voquezna
Coverage requires documented H. pylori infection AND trial and failure of or contraindication to a guideline‑recommended first‑line regimen (e.g., clarithromycin triple therapy or bismuth quadruple therapy).

General prior therapy trial examples	Policy citation / note
Statin trial for Praluent; corticosteroid/controller trials for biologics; prior BRAF/MEK combinations for certain BRAF inhibitors
Examples: Nexletol/Nexlizet require trial of high‑intensity statin (chunk 100); Nucala/Eosinophilic biologics require corticosteroid and additional controller trials (chunks 106); Mekinist/Mektovi require prior BRAF combinations in some contexts (chunk 95).

Products (step examples)	Required alternative agent trial
Abilify Asimtufii / Abilify Maintena
Require trial of oral aripiprazole prior to LAI formulations (coverage duration lifetime).

Class	SGLT2 step therapy rule
Farxiga / Jardiance
Trial of generic dapagliflozin required before Farxiga or Jardiance; exception: Jardiance used to reduce CV death in T2DM with established CVD is exempt from step therapy.

Ophthalmic products	Prior trial required
Rhopressa / Rocklatan
Require trial of a generic formulary ophthalmic glaucoma medication OR Lumigan prior to coverage; coverage duration 1 year.

Site‑of‑care consideration	Implication
Hospital outpatient (site‑of‑care relevance)
Coverage determination between Medicare Part B and Part D may depend on the setting of administration; documentation of use and setting may be required.

Administration Setting and Benefit Determination

Documentation Required

Provide site‑of‑care (hospital outpatient) information for coverage determination

Hospital outpatient/site‑of‑care: provide setting information when needed because coverage determinations between Part B and Part D may depend on the site of administration; include site details in the PA submission.

If drug administration occurs in hospital outpatient setting, indicate this to clarify Part B vs Part D coverage