Currentblue cross blue shield - michiganPolicy N/A

BCN Advantage HMO-POS Comprehensive Formulary Prior Authorization / Step Therapy Program (partial extract, Part 1)

Partial extract of the BCN Advantage HMO-POS Group 2026 formulary prior authorization and step therapy criteria listing multiple specific prescription products and per-product coverage conditions, age/prescriber restrictions, coverage durations, prerequisite therapy requirements, and indication-specific additional criteria.

Policy Summary

Payerblue cross blue shield - michigan

PolicyBCN Advantage HMO-POS Comprehensive Formulary Prior Authorization / Step Therapy Program (partial extract, Part 1)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2026

Next Review Date

Key ActionProviders must request prior authorization or step therapy for listed drugs and supply required documentation of prior trials, diagnostic tests, and positive clinical response for reauthorization.

POLICY UPDATE CHANGES

No material clinical or coverage changes — has_material_change=false.

40+Products listed in Part 1 (approximate)

50+Drugs listed in excerpt

ManyRequire prior therapy trial

>=150/>=300Eosinophil thresholds present

Several

Require diagnostic/genetic testing

Coverage summary

This is part of the BCN Advantage HMO-POS Comprehensive Formulary Prior Authorization / Step Therapy Program for the 2026 plan year. The program lists drugs that require prior authorization (PA) or step therapy (ST) and provides per-product clinical and administrative criteria based on the Blues' Pharmacy & Therapeutics Committee recommendations. Effective: 05/01/2026. Last review: 05/01/2026. Coverage stance for products in this extract is mixed — some products are subject to PA, some to ST, and criteria vary by product.

Key numeric thresholds & rules

Common eosinophil thresholds>= 150 cells/µL; >= 300 cells/µL; >= 1000 cells/µL

Age/weight numeric limits>= 12 years (Ebglyss); weight >= 40 kg (Ebglyss); Dupixent EOE: patient must weigh >=15 kg

Adbry dosing limit for responders <100 kgLimit to 300 mg every 4 weeks after 16 weeks unless clinical rationale provided

Coverage duration (typical)Most product entries: 1 YEAR (many exceptions noted)

Prerequisite Part D drug flagMany criteria require a prerequisite Part D drug (document indicates 'Criteria DOES require use of a prerequisite Part D drug' for numerous products); some entries explicitly DO NOT require it

EOE / EA initiation thresholdEosinophilic asthma / CDA / EA: eosinophil >=150 cells/µL at initiation

COPD add-on eosinophil thresholdCOPD add-on maintenance requires eosinophil >=300 cells/µL

HES threshold (Nucala)HES requires eosinophil >=1000 cells/µL at initiation

General formulary PA / Step Therapy program

The BCN Advantage prior authorization (PA) and step therapy (ST) program identifies certain drugs that require prior authorization or step therapy prior to coverage. The program-level statements below summarize drugs subject to PA or ST and define PA and ST.

ALL of the following

Program-level requirements: Drugs listed in the formulary with (PA) require prior authorization; drugs listed with (ST) are subject to step therapy requirements.
Prior Authorization (PA) definition: Coverage will be provided only when required clinical and/or administrative criteria are met and documented on the PA request.
Step Therapy (ST) definition: Coverage for the requested drug requires prior trial and failure or intolerance to one or more specified formulary alternatives before the requested drug is authorized.
Specific criteria groups included in this program-level summary

Initial therapy / product-specific criteria (selected products)

Product-specific criteria (selected products from Part 1)

Each product below lists per-product conditions (indications, exclusions, required medical information, age restrictions, prescriber restrictions, coverage duration, other criteria, prerequisite therapy).

Adapalene GEL: Indications: Indications; Off-Label Uses: Off-Label Uses; Age Restrictions: N/A; Prescriber Restrictions: N/A; Coverage Duration: 1 YEAR; Prerequisite Therapy Required: Criteria DOES NOT require use of a prerequisite Part D drug.

Adbry: Indications: All Medically-accepted Indications; Age: at least 12 years; Coverage Duration: 1 YEAR; Exclusion: Cannot be used in combination with another biologic or targeted DMARD for same condition; Other Criteria: For AD (>=12 yrs) requires diagnosis of moderate-to-severe AD and trial and failure of one of: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine or mycophenolate mofetil; dosing limit for patients <100 kg after 16 weeks: 300 mg every 4 weeks unless rationale provided; Reauthorization requires documentation of positive clinical response; Prerequisite Therapy Required: Criteria DOES require use of a prerequisite Part D drug.

Adempas:

Fasenra — indication-specific criteria

Fasenra - Indication-specific criteria

Coverage when ALL of the following are met:

Fasenra - overall: Indications: All medically-accepted indications; Exclusion: Cannot be used in combination with another biologic or targeted DMARD for the same condition; Coverage Duration: 1 YEAR; Reauthorization requires documentation of positive clinical response to therapy; Prerequisite Therapy Required: Criteria DOES require use of a prerequisite Part D drug.

Eosinophilic Asthma (EA): Diagnosis of eosinophilic asthma; Eosinophil count of at least 150 cells per microliter at initiation of treatment; Failure to maintain adequate control after a trial of systemic corticosteroids or high-dose inhaled corticosteroids plus trial of ONE of: leukotriene modifier, LABA, or LAMA; Applies to adults and children 6 years or older.>= 150 cells/µL

Corticosteroid Dependent Asthma (CDA): Diagnosis of moderate to severe asthma currently dependent on oral corticosteroids; Failure to maintain adequate control after trial of systemic corticosteroids or high-dose inhaled corticosteroids plus trial of ONE of: leukotriene modifier, LABA, or LAMA; Requires eosinophil count >=150 cells/µL at initiation.

Selected product summaries (Ebglyss, Eucrisa, Emsam, Epidiolex, Enbrel, etc.)

Per-product summaries (selected products)

Ebglyss (product-level summary): Indications: All medically-accepted indications; Exclusion: Cannot be used in combination with another biologic or targeted DMARD indicated for the same condition; Required medical information: patient must weigh at least 40 kilograms; Age restriction: at least 12 years; Coverage duration: 1 year; Other: AD for patients 12 years and older requires diagnosis of moderate to severe AD and trial and failure of listed topical/systemic agents; Prerequisite therapy: DOES require use of a prerequisite Part D drug.>= 12 years

weight >= 40 kg

Eucrisa - Atopic dermatitis requirement: Indications: All medically-accepted indications; Coverage duration: 1 year; Other criteria: coverage for atopic dermatitis requires a trial of one of: a topical steroid, generic Protopic, or generic Elidel; Prerequisite therapy: DOES require use of a prerequisite Part D drug.

Emsam - MAOI trial requirement:

Individual drug coverage criteria (excerpt)

Each product node shows indication-specific combination/ trial requirements and reauthorization notes.

Lynparza (olaparib): Coverage duration: One Year; Other criteria: multiple indication-specific requirements including trial of platinum-based chemotherapy for ovarian indications and combination requirements for other indications; Prerequisite: Criteria DOES require use of a prerequisite Part D drug.

Reauthorization requires documentation per product

Epidiolex: Coverage Duration: One Year; Other Criteria: Lennox-Gastaut requires trial of 2 generic alternatives; Dravet requires trial of 2 of valproic acid, clobazam, or topiramate; Prerequisite Therapy Required: DOES require use of a prerequisite Part D drug.

Pirfenidone (caps/tabs): Coverage duration: 1 year; Prerequisite Therapy Required: Criteria DOES NOT require use of a prerequisite Part D drug.

Per-product coverage criteria (multiple products)

Each product entry includes Indications, Off-Label Uses, Exclusions, Required Medical Information, Age/Prescriber restrictions, Coverage Duration, Other Criteria, and whether a prerequisite Part D drug is required.

Uptravi: Products: Uptravi TABS; Uptravi Titration Pack; Indications: Indications; Coverage Duration: 1 YEAR; Prerequisite Part D drug: Criteria DOES require use of a prerequisite Part D drug.

Valchlor: Products: Valchlor; Indications: All medically-accepted indications; Coverage Duration: One Year; Other Criteria: topical treatment of Stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma requires prior skin-directed therapy; Prerequisite Part D drug: Criteria DOES NOT require use of a prerequisite Part D drug.

Vanflyta: Products: Vanflyta; Indications: All medically-accepted indications; Coverage Duration: 1 YEAR; Other Criteria: treatment of adult patients with newly diagnosed FLT3-ITD positive AML requires use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation; Prerequisite Part D drug: Criteria DOES NOT require use of a prerequisite Part D drug.

Prior authorization and provider requirements

Prior Authorization

Prior authorization required for listed drugs

Prior authorization (PA) or step therapy (ST) is required for many listed drugs and products. Providers must request PA/ST prior to dispensing and supply supporting clinical documentation (diagnoses, prior therapies, treatment dates, and response). Include copies of relevant chart notes, specialty pharmacy documentation, and any prior authorization forms. Failure to submit required documentation may delay or result in denial of coverage.

PA required for drugs and products listed in the formulary and policy (identified with PA/ST flags).
When requested, submit full clinical notes showing diagnosis, medical necessity, prior treatments and response.
Coverage duration requests (e.g., 1 year) and reauthorization requests require supporting evidence of benefit.

Prior Authorization

Applicable products / codes (excerpt)

No codes listed in this partmixed

No codes listed

Products listed in this excerptmixed

Fasenra	Benralizumab product entries (Fasenra, Fasenra Pen)
Ebglyss	Product listed (no additional codes in excerpt)
Emsam	Selegiline transdermal (MAOI)
Epidiolex	Cannabidiol oral solution
Enbrel	Etanercept and device formulations
L-glutamine	Sickle cell product
Topiramate SOLN	Topiramate solution
Pirfenidone	Idiopathic pulmonary fibrosis product
Eucrisa	Crisaborole topical
Forteo/Teriparatide	Teriparatide products

Products listed in this part (no codes provided)mixed

No codes listed

Products requiring prior authorization (selected injectable/complex products)

Examples of injectable/complex products requiring prior authorization in this selected extract include: Abelcet; Acetylcysteine inhalation solution; Acyclovir sodium injection; multiple albuterol nebulizer formulations; Amphotericin B injection; Amphotericin B liposome; Aprepitant; Arformoterol tartrate; Astagraf XL; Azathioprine tablets; Budesonide suspension; Clinimix E formulations (including 4.25%/5%, 5%/15%, 5%/20%); Cromolyn sodium nebule; Cyclophosphamide capsules; Cyclosporine (various formulations); Dronabinol; Engerix-B; Envarsus XR; Everolimus tablets; Formoterol nebule; Gengraf; Granisetron; Heplisav-B; Imovax Rabies; Intralipid injection; Ipratropium formulations; Levalbuterol nebules; Mycophenolate mofetil formulations; Ondansetron formulations; Pentamidine inhalation; Plenamine; Premasol; Prograf; Prosol; Pulmozyme; Rabavert; Recombivax HB; Sirolimus (solution/tabs); Tacrolimus capsules; Tobramycin nebulizer; Travasol; Tyvaso (and starter/refill kits); Ventavis; and many others as listed in the program.

Specific product trial/step requirements (examples)

Specific product trial requirements (selected examples)

Products that require trial of specific generics or formulations prior to coverage (selected examples).

Abilify Asimtufii: Requires trial of oral aripiprazole; coverage duration is lifetime.

Abilify Maintena: Requires trial of oral aripiprazole; coverage duration is lifetime.

Oxcarbazepine ER TB24 (300,600 mg): Requires trial or intolerance to at least 2 generic anticonvulsants; coverage duration is lifetime.

Desvenlafaxine ER / Trintellix / Exxua: Requires trial of at least 2 of listed generics (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, phenelzine, protriptyline, sertraline, tranylcypromine, trazodone, trimipramine, venlafaxine, vilazodone); coverage duration lifetime.

Medicare Part B vs Part D determination

Medicare Part B vs Part D coverage can vary by drug and by the clinical setting. Documentation describing the drug's use and the setting of administration may be requested to determine whether coverage is under Part B or Part D. Providers should submit the requested clinical information and setting-of-use details when asked so the plan can make the Part B vs Part D determination and process the prior authorization appropriately.

Definitions

PA — Prior Authorization: clinical and/or administrative criteria must be met before coverage is provided.

ST — Step Therapy: requires previous treatment with one or more formulary drugs prior to coverage.

Prerequisite Part D drug — A required prior medication (typically a generic or formulary alternative) that must be tried before coverage of the listed product is approved. This term also indicates whether coverage criteria require that a Part D drug trial be attempted prior to coverage approval.

Background

Background: This document is a partial extract (Part 1 of 6) of the BCN Advantage HMO-POS Comprehensive Formulary Prior Authorization / Step Therapy Program for the 2026 plan year. It enumerates drugs subject to PA or ST and provides per-product clinical and administrative criteria that reflect the recommendations of the Blues' Pharmacy & Therapeutics Committee. This extract includes selected product entries and criteria; additional parts contain the remaining formulary PA/ST details.

Document dates and payer metadata

Effective date05/01/2026

Last review05/01/2026

Next review(not specified)

Document type / planBCN Advantage HMO-POS Comprehensive Formulary Prior Authorization / Step Therapy Program, 2026 plan year

Scope / payer metadataFormulary PA/ST list; clinical criteria based on Blues' Pharmacy & Therapeutics Committee; many products require PA or ST

Revision history

2026-05-01policy_effectiveLatest

Effective/Last review: 2026-05-01 - policy part extract published/last reviewed

Policy Summary

Payerblue cross blue shield - michigan

PolicyBCN Advantage HMO-POS Comprehensive Formulary Prior Authorization / Step Therapy Program (partial extract, Part 1)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2026

Next Review Date

On This Page

L‑glutamine (pack) for sickle cell disease: requires PA. Authorization requires documentation of a diagnosis of sickle cell disease with symptomatic vaso-occlusive crises and prior optimization of hydroxyurea therapy unless hydroxyurea is contraindicated or not tolerated. Coverage duration and reauthorization require documentation of clinical benefit in reduction of vaso-occlusive episodes.

Forteo (teriparatide) for osteoporosis: requires PA. Authorization requires a diagnosis of severe osteoporosis (e.g., T-score ≤ -3.0, or T-score ≤ -2.5 with fragility fracture) or high fracture risk, and documentation of trial and failure or intolerance to first-line osteoporosis therapies (e.g., bisphosphonates) unless contraindicated. Limitations: cumulative lifetime duration restrictions for teriparatide should be honored per product labeling; reauthorization requires evidence of continued therapeutic benefit and adherence to duration limits.

Selected injectable/complex products: numerous high-cost injectable and complex specialty products are subject to PA. These products require submission of relevant documentation including diagnosis, prior medication trials, dosing, weight where applicable, prior authorization forms for specialty drugs, and justification for off-label uses when requested. Examples include but are not limited to biologics, enzyme therapies, and other specialty injectables listed in the formulary (see product‑specific PA criteria pages).

Medicare Part B vs Part D determination: Coverage responsibility (Part B versus Part D) follows CMS and payer guidance. Providers should determine benefit coverage based on the member’s entitlement and the specific drug delivery setting and administration services. If a drug is covered under Medicare Part B (typically physician‑administered drugs and certain infusions), a Part D PA is not appropriate; similarly, if the drug is a Part D pharmacy benefit, Part B billing is not applicable. When benefit responsibility is unclear, contact BCN Advantage Medicare customer service for a Part B/Part D determination prior to submitting a PA or claim.

Indications: Indications; Coverage Duration: 1 YEAR; Prerequisite Therapy Required: Criteria DOES NOT require use of a prerequisite Part D drug.

Everolimus (TABS / Torpenz): Indications: All medically-accepted indications; Coverage Duration: One Year; Other Criteria: Breast cancer indication requires combination with exemestane and a trial of letrozole or anastrozole; RCC requires a trial of sunitinib or sorafenib; Prerequisite Therapy Required: Criteria DOES require use of a prerequisite Part D drug.

Aimovig: Indications: Indications; Coverage Duration: 1 YEAR; Prerequisite Therapy Required: Criteria DOES NOT require use of a prerequisite Part D drug.

Ebglyss: Indications: All medically-accepted indications; Exclusion: Cannot be used in combination with another biologic or targeted DMARD for same condition; Required medical information: patient must weigh at least 40 kg; Age restriction: at least 12 years; Coverage duration: 1 year; Other: AD for patients >=12 requires diagnosis of moderate-to-severe AD and trial/failure of one of: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine or mycophenolate mofetil; Prerequisite Therapy Required: Criteria DOES require use of a prerequisite Part D drug.>= 12 years

weight >= 40 kg

Eucrisa: Indications: All medically-accepted indications; Coverage duration: 1 year; Other criteria: Coverage for atopic dermatitis requires trial of one of: a topical steroid, generic Protopic, or generic Elidel; Prerequisite Therapy Required: Criteria DOES require use of a prerequisite Part D drug.

Emsam: Coverage duration: 1 year; Other criteria: coverage requires trial with two of: marplan, phenelzine, tranylcypromine; Prerequisite Therapy Required: Criteria DOES require use of a prerequisite Part D drug.

MAOI trial requirement

Epidiolex: Indications: All medically-accepted indications; Coverage duration: 1 year; Other criteria: Lennox-Gastaut syndrome requires trial of 2 generic alternatives for seizures; Dravet syndrome requires trial of 2 of: valproic acid, clobazam, or topiramate; Tuberous sclerosis complex seizures require trial of 2 generic alternatives; Prerequisite Therapy Required: Criteria DOES require use of a prerequisite Part D drug.

Enbrel (and device formulations): Indications: All medically-accepted indications; Exclusion: Cannot be used in combination with another biologic or targeted DMARD indicated for the same condition; Coverage duration: 1 year; Other criteria: RA requires diagnosis of moderately to severely active RA and trial of one DMARD (e.g., methotrexate, leflunomide, sulfasalazine); JIA polyarticular requires trial of leflunomide or methotrexate; AS requires trial of one NSAID; Reauthorization requires documentation of positive clinical response for all indications; Prerequisite Therapy Required: Criteria DOES require use of a prerequisite Part D drug.

L-glutamine pack: Required medical information: patient has experienced 2 or more sickle cell-related crises in past 12 months; Coverage duration: 1 year; Other criteria: requires trial of or intolerance to hydroxyurea; Prerequisite Therapy Required: Criteria DOES require use of a prerequisite Part D drug.

Topiramate solution: Coverage duration: 1 year; Migraine prevention requires trial of at least 2 generic alternatives OR patient unable to swallow tablets/capsules; Seizure disorder requires trial of at least 2 generic anticonvulsants OR patient unable to swallow tablets/capsules; Prerequisite Therapy Required: Criteria DOES require use of a prerequisite Part D drug.

Pirfenidone (caps/tabs): Coverage duration: 1 year; Prerequisite Therapy Required: Criteria DOES NOT require use of a prerequisite Part D drug.

Forteo / Teriparatide: Required medical information: documentation of bone mineral density T-score at or below -2.5; Coverage duration: 2 years; Other: coverage requires trial of both (1) JUBBONTI or STOBOCLO and (2) either an oral bisphosphonate or, if intolerant, an IV bisphosphonate; Prerequisite Therapy Required: Criteria DOES require use of a prerequisite Part D drug.T-score <= -2.5

CRSwNP: Diagnosis of chronic rhinosinusitis with nasal polyposis and recurring CRSwNP despite previous intranasal corticosteroids.

EGPA: Diagnosis of eosinophilic granulomatosis with polyangiitis and history or presence of asthma and two of the listed typical EGPA criteria (histopathologic eosinophilic vasculitis/perivascular eosinophilic infiltration/eosinophil-rich granulomatous inflammation; neuropathy; pulmonary infiltrates; allergic rhinitis and nasal polyps; cardiomyopathy; glomerulonephritis; alveolar hemorrhage; palpable purpura; ANCA positivity).

COPD add-on maintenance: Diagnosis of uncontrolled, moderate-to-severe COPD; Eosinophil count >= 300 cells per microliter; Patient currently receiving and will continue LABA, LAMA, and inhaled corticosteroid unless contraindicated.>= 300 cells/µL

Chronic spontaneous urticaria (CSU): Diagnosis of CSU with symptoms despite H1 antihistamine treatment and trial of at least one second-generation antihistamine.

Allergic fungal rhinosinusitis (AFRS): Diagnosis of AFRS with history of sino-nasal surgery.

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

Coverage duration: 1 year; Other criteria: coverage requires trial with two of: marplan, phenelzine, tranylcypromine; Prerequisite therapy: DOES require use of a prerequisite Part D drug.

Epidiolex - epilepsy syndromes: Indications: All medically-accepted indications; Coverage duration: 1 year; Other criteria: Lennox-Gastaut requires trial of 2 generic alternatives; Dravet requires trial of 2 of: valproic acid, clobazam, or topiramate; TSC seizures require trial of 2 generic alternatives; Prerequisite therapy: DOES require use of a prerequisite Part D drug.

Enbrel (and formulations) - rheumatologic/autoimmune criteria: Indications: All medically-accepted indications; Exclusion: Cannot be used in combination with another biologic or targeted DMARD indicated for the same condition; Coverage duration: 1 year; RA requires diagnosis of moderately to severely active RA and trial of one DMARD (eg methotrexate, leflunomide, sulfasalazine); For all indications reauthorization requires documentation of positive clinical response; Prerequisite therapy: DOES require use of a prerequisite Part D drug.

Nucala (mepolizumab): Coverage duration: 1 YEAR; Exclusion: cannot be used with another biologic for same condition; Indication-specific thresholds: EGPA requires two typical EGPA criteria; EA requires eosinophil >=150 cells/µL at initiation and failure of systemic or high-dose inhaled corticosteroids plus trial of one additional controller in adults and children >=12; HES requires eosinophil >=1000 cells/µL at initiation; COPD add-on requires uncontrolled moderate-to-severe COPD and either current eosinophil >=150 cells/µL or >=300 cells/µL within past 12 months and concurrent LABA/LAMA/ICS; Reauthorization requires documentation of positive clinical response; Prerequisite: DOES require use of a prerequisite Part D drug.>=150; >=1000; >=300 cells/µL

Forteo / Teriparatide: Required medical information: documentation of BMD T-score at or below -2.5; Coverage duration: 2 years; Other criteria: coverage requires trial of both JUBBONTI or STOBOCLO and either an oral bisphosphonate or if intolerant an IV bisphosphonate; Prerequisite therapy: DOES require use of a prerequisite Part D drug.T-score <= -2.5

Venclexta: Products: Venclexta; Venclexta Starting Pack; Indications: All medically-accepted indications; Coverage Duration: One Year; Other Criteria: newly diagnosed AML in adults 75+ or with comorbidities precluding intensive induction chemo requires combination use with azacitidine, decitabine, or low-dose cytarabine; Prerequisite Part D drug: Criteria DOES NOT require use of a prerequisite Part D drug.

Verquvo: Products: Verquvo; Indications: All medically-accepted indications; Required Medical Information: diagnosis of chronic heart failure NYHA class II-IV and LVEF <45% and prior HF hospitalization within 6 months OR outpatient IV diuretic within 3 months; Other Criteria: must be taken in combination with at least two specified HF therapies unless contraindicated; Coverage Duration: 1 YEAR; Prerequisite Part D drug: Criteria DOES NOT require use of a prerequisite Part D drug.LVEF <45%

NYHA II-IV

Voquezna / H. pylori regimen: Products: Voquezna Dual/Triple Pak; Coverage requires diagnosis of H. pylori infection; Other Criteria: coverage requires trial of a generic, guideline-recommended, first-line regimen (clarithromycin triple therapy or bismuth quadruple therapy); Coverage Duration: 1 YEAR; Prerequisite Part D drug: Criteria DOES require use of a prerequisite Part D drug.

Pazopanib Hydrochloride: Products: Pazopanib Hydrochloride; Indications: All medically-accepted indications; Prescriber Restrictions: prescribed by an oncologist; Coverage Duration: One Year; Other Criteria: coverage for advanced soft tissue sarcoma requires previous treatment with chemotherapy; Prerequisite Part D drug: Criteria DOES require use of a prerequisite Part D drug.

Prior authorization required per product

Some products have PA criteria that apply per specific product or formulation. Confirm the exact product (brand, strength, formulation, NDC) when submitting a request and include product-specific documentation.

Prior authorization required per product (e.g., specific brand vs biosimilar, tablet vs injection).
Indicate exact product name, strength, route, and NDC when requesting PA.
If multiple formulations exist (e.g., tablet vs TBSO), supply rationale for chosen formulation.

Documentation Required

Document prerequisite trials and responses

Requests must document prerequisite therapy trials and clinical responses where required. Provide specific trial medications, dates, duration, reason for discontinuation, and objective/subjective response to therapy.

Document prerequisite trials and responses: list drug name, start/stop dates, dose, and reason for failure or intolerance.
Document prior therapy trials (including generic or formulary alternatives) when step/ trial requirements are specified.
Examples of required generic/formulary trials: trials of letrozole or anastrozole before everolimus+exemestane for HR+ breast cancer; trial of sunitinib or sorafenib before certain RCC agents.
Reauthorization often requires documentation of positive clinical response to therapy (e.g., symptom improvement, reduced exacerbations, tumor response).

Documentation Required

Provide diagnostic or lab evidence where specified

Some therapies require specific diagnostic or laboratory evidence to support approval. Submit pertinent lab values, imaging, or functional test results with the PA request.

Provide diagnostic or lab evidence where specified (e.g., confirmatory imaging, genetic testing where required).
Lab documentation for eosinophil counts: submit absolute eosinophil count values and dates when criteria reference eosinophilia.
Timed walk test for Dalfampridine: include documented T25FW (Timed 25-Foot Walk) results showing baseline and treatment response as required.
Examples of other lab/diagnostic evidence: A1C or OGTT results for metabolic indications, specific genetic test reports, pulmonary function tests (FEV1%), or pathology reports.

Prior Authorization

Combination-use requirements

Combination-use rules and step/trial requirements are enforced for certain oncology and specialty regimens. Indicate concomitant agents and prior required agents when applicable.

Combination-use requirements: many products require use in combination with a specific agent (examples include Everolimus + exemestane; Akeega with prednisone; certain PARP or hormonal therapy combinations).
Other example combination requirements: Cabometyx combined with nivolumab where specified, or PARP inhibitors paired with corticosteroids as noted in product criteria.
Step/Trial requirements: list required prior trials of generics or formulary alternatives (e.g., trial of letrozole or anastrozole prior to coverage for certain breast cancer regimens; trial of sunitinib or sorafenib prior to some RCC therapies).
When combination-use is an exclusion (e.g., cannot be used with another biologic or targeted DMARD for the same condition), include documentation confirming absence of concurrent biologic therapy.

Documentation Required

Submit clinical documentation for Part B vs Part D determination

When a drug may be payable under Medicare Part B vs Part D, the plan may request additional information to make the determination. Submit treatment setting and administration details when requested.

Submit clinical documentation indicating whether the drug is administered in a physician office/clinic (Part B) or self-administered/retail pharmacy (Part D).
Include infusion/administration records, claim information, or provider attestation when requested to support Part B vs Part D determination.

Documentation Required

Reauthorization requirements

Reauthorization requests commonly require evidence of ongoing benefit. Many biologics and specialty agents require documentation of positive clinical response and continued medical necessity for renewal.

Reauthorization requirement: supply objective or clinician-documented evidence of improvement or stabilization since initiation (e.g., reduced symptom scores, improved labs, imaging, or functional tests).
Reauthorization requirements: many products list a 1-year coverage duration and require renewal requests with supporting outcome documentation.
Documented positive clinical response is frequently required for continuation of biologic therapies (e.g., Adbry reauthorization requires documentation of positive clinical response).

Aristada / Aristada Initio: Aristada requires trial or intolerance to Abilify Maintena or oral aripiprazole; Aristada Initio requires trial of oral aripiprazole; coverage duration is lifetime.

Invega Hafyera / Invega Sustenna / Trinza: Invega Hafyera requires trial of once-monthly paliperidone palmitate ER injectable for >=4 months OR every-3-month paliperidone palmitate ER for at least one 3-month cycle; Invega Sustenna and Trinza require trial of oral paliperidone or oral risperidone; coverage duration lifetime.

Perseris: Requires trial of oral risperidone; coverage duration is lifetime.

Rasuvo INJ: Coverage requires trial of generic methotrexate injection; coverage duration is lifetime.

Rhopressa / Rocklatan: Coverage requires trial of any generic formulary ophthalmic glaucoma medication or Lumigan; coverage duration 1 year.

Rytary: Coverage requires trial of generic oral extended-release carbidopa & levodopa; coverage duration 1 year.

Farxiga / Jardiance: Farxiga requires trial of generic dapagliflozin; Jardiance requires trial of generic dapagliflozin. Step therapy does not apply for Jardiance when used to reduce risk of cardiovascular death in adults with T2DM and established CVD.

Febuxostat: Requires trial or contraindication to allopurinol; coverage duration lifetime.