Medicare Plus Blue Prior Authorization and Step Therapy Criteria — Pharmacy & Specialty Drugs (2026 Plan Year)
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Lists prior authorization and step therapy criteria for Medicare Plus Blue Group PPO and Prescription Blue Group PDP (2026), including product-specific coverage rules, prerequisite therapies, exclusions, age/diagnostic thresholds, documentation and reauthorization requirements.
No material clinical or coverage changes in this revision.
Product Coverage Criteria
Adbry — Initial and reauthorization criteria
Covered when ALL of the following are met:
Reauthorization requires documentation of positive clinical response; for patients <100 kg who achieve response after 16 weeks, dosage limited to 300 mg every 4 weeks unless clinical rationale provided.
Coverage duration: 1 year per product entry
Braftovi — Indication-specific requirements
Coverage for BRAF-mutated and other listed indications when the following condition-specific requirements are met:
Prerequisite therapy may be required for some indications; coverage duration 1 year.
See product entry for indication‑specific prior therapy requirements.
Prior trials and combination partners vary by tumor type.
Auvelity — Step therapy requirement
Covered when ALL of the following are met:
Coverage duration listed as lifetime for Auvelity.
Tadalafil — Coverage and exclusion
Covered when ALL of the following are met:
Coverage excluded if patient is receiving nitrate therapy; coverage duration 1 year.
Fasenra: Initial and EGPA criteria
Covered when ALL of the following are met:
Applies to adults and children ≥6 years; reauthorization requires documentation of positive clinical response.
Reauthorization requires documentation of positive clinical response.
Schizophrenia - antipsychotic trial requirement
Covered when ALL of the following are met:
Coverage duration commonly lifetime for these formulations.
Adalimumab family: Indication-specific prerequisites
Covered when ALL of the following are met:
Reauthorization requires documentation of positive clinical response; cannot be used in combination with another biologic/targeted DMARD for the same condition.
Apply pediatric criteria as specified.
Reauthorization requires clinical response.
Teriparatide: BMD and prior therapy requirements
Covered when ALL of the following are met:
Coverage duration 2 years; prerequisite Part D drug required per entry.
Fruzaqla: mCRC prior therapy requirements
Covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Ulcerative colitis (UC) — coverage criteria
Covered when ALL of the following are met:
Reauthorization requires documentation of positive clinical response to therapy
Hidradenitis suppurativa (HS) — coverage criteria
Reauthorization requires documentation of positive clinical response to therapy
Non-infectious uveitis — coverage criteria
Reauthorization requires documentation of positive clinical response to therapy
Joenja (APDS) — coverage criteria
Coverage for activated PI3K‑delta syndrome (APDS) requires ALL of the following:
Cannot be used in combination with an immunosuppressive medication; coverage duration 1 year.
Kevzara — RA coverage criteria
Kevzara coverage for rheumatoid arthritis requires ALL of the following:
Cannot be used in combination with another biologic or targeted DMARD for same condition; reauthorization requires documentation of positive clinical response.
Kineret — RA coverage criteria
Kineret coverage for rheumatoid arthritis requires ALL of the following:
Cannot be used in combination with another biologic or targeted DMARD for same condition; reauthorization requires documentation of positive clinical response.
Libervant — coverage criteria
Coverage duration typically 1 year
Lidocaine PTCH 5% / Lidocaine/prilocaine cream (BCC)
Covered when ANY of the following are met:
Coverage duration 1 year; prerequisite Part D drug may be required per entry.
Liraglutide
Covered when ANY of the following are met:
Excluded if used for weight loss only; coverage duration 1 year.
Livtencity (post-transplant CMV)
Covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Lonsurf (metastatic colorectal cancer / gastric)
Covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Lumakras
Covered when ALL of the following are met:
For mCRC requires prior chemotherapy and combination with panitumumab as specified; coverage duration 1 year.
Lybalvi (psychiatric therapy)
Covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Mekinist / Mekinist liquid / Mektovi
BRAF V600E/V600K mutation‑positive tumors: covered when ALL of the following are met:
Liquid formulations require inability to swallow tablets; coverage duration 1 year; prerequisite Part D drug required.
Mektovi — combination or prerequisite therapy
Covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Nucala — indication-specific coverage
Nucala is covered when the indication‑specific criteria below are met:
Coverage duration 1 year; reauthorization requires documentation of positive clinical response.
Reauthorization requires documentation of positive clinical response.
Opfolda — diagnostic and failure criteria
Opfolda is covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Acute Myeloid Leukemia — adult consolidation
Covered when ALL of the following are met:
Coverage duration: 1 year; prior authorization required.
GAA deficiency disease — diagnostic confirmation
Covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Abatacept (Orencia) — indications and prerequisites
Covered when ALL of the following are met:
Reauthorization requires documentation of positive clinical response and Abatacept not used in combination with other immunosuppressives (e.g., JAK inhibitors, biologic DMARDs).
Posaconazole DR — prophylaxis and treatment
Covered when ANY of the following are met:
Coverage duration: 6 months; prerequisite Part D drug required.
Coverage per product entry; prior authorization required.
Praluent — lipid disorders
Praluent initiation and reauthorization covered when the following diagnostic and treatment history criteria are met:
Coverage duration 3 years; prerequisite Part D drug required.
Reauthorization requires continued LDL reduction while on therapy.
Eltrombopag — thrombocytopenia indications
Covered when ANY of the following indication‑specific criteria are met:
Coverage duration 1 year; prerequisite Part D drug required.
Jubbonti / Stoboclo
Covered when ALL prerequisite and exclusion conditions are satisfied:
Coverage duration 3 years; coverage not provided for hypocalcemia per product entry.
Eltrombopag olamine
Covered when ANY of the following are met:
Coverage duration 1 year; requires prior trials of corticosteroids, immunoglobulins, or splenectomy for ITP.
Retevmo
Covered when ANY of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Rezdiffra (NASH/MASH)
Rezdiffra is covered when ALL of the following initial criteria are met:
Coverage duration 1 year; renewal requires no progression to cirrhosis and demonstration of histologic/imaging improvement or clinical benefit.
Rinvoq (upadacitinib)
Rinvoq (oral and liquid) coverage requires ALL of the following depending on indication:
Reauthorization requires documentation of positive clinical response and avoidance of prohibited combinations.
Reauthorization requires documentation of positive clinical response; prerequisite Part D drug required for many indications.
Rivfloza
Covered when ALL of the following are met:
Exclusions: history of kidney or liver transplant and combination use with Oxlumo; coverage duration 1 year.
Rybrevant
Covered when ANY of the following are met:
Other EGFR mutation settings have specific combination requirements per product entry; coverage duration 1 year.
Rydapt
Covered when ALL of the following are met:
Coverage duration 1 year.
Secuado
Covered when ANY of the following are met:
Coverage duration: lifetime.
Multiple myeloma — initial coverage criteria
Covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Tafinlar — indication-specific criteria
Tafinlar (capsule and liquid) covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Tagrisso — EGFR mutation indications
Tagrisso is covered for the following EGFR mutation‑defined settings when the listed prerequisites are met:
Coverage duration 1 year; prerequisite Part D drug required.
General product coverage statements
Per‑product coverage statements summarize whether coverage is indication‑specific or applies to all medically‑accepted indications. Many products listed below have additional indication‑dependent requirements (see individual entries).
Refer to each product's detailed criteria for prerequisites, exclusions, and reauthorization rules.
Tocilizumab
Tocilizumab coverage for listed rheumatologic indications requires ALL of the following:
Cannot be used in combination with another biologic/targeted DMARD for same condition; reauthorization requires documentation of positive clinical response; coverage duration 1 year.
Reauthorization requires documentation of positive clinical response.
Tetrabenazine
Notable limitations and documentation requirements:
Coverage duration 1 year where indicated.
Tymlos
Tymlos is covered when ALL of the following are met:
Coverage duration 2 years; prerequisite Part D drug required.
Ubrelvy
Covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Verquvo
Verquvo is covered when ALL of the following clinical criteria are met:
Coverage duration 1 year; prerequisite Part D drug not required per entry.
Voquezna
Voquezna (Dual/Triple Pak) is covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Oncology product prerequisite therapy examples
Selected oncology and specialty product prerequisite therapy examples (coverage requires meeting ALL listed product‑specific prerequisites):
Refer to each product entry for the exact prior therapy and sequencing requirements.
Vigabatrin
Covered when ALL product‑specific criteria are satisfied:
Coverage duration 1 year where indicated.
Voquezna
Covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Vosevi
Covered when ALL of the following are met:
Criteria follow guideline‑recommended sequencing of antiviral therapy.
Voydeya (extravascular hemolysis in PNH)
Voydeya is covered when ALL of the following are met:
Coverage duration 1 year; combination use only with Soliris or Ultomiris as specified.
Welireg
Covered when ANY of the following indication‑specific criteria are met:
Prerequisite Part D drug required where noted; coverage duration 1 year.
Winrevair (PAH)
Winrevair is covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Xatmep
Covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug required.
Xeljanz (tofacitinib)
Xeljanz (tofacitinib) coverage requires ALL of the following per indication:
Reauthorization requires documentation of positive clinical response; coverage duration 1 year; prerequisite Part D drug required for many indications.
Xifaxan TABS 550MG
Xifaxan 550 mg coverage is indication‑specific and requires prior trials:
Coverage duration 1 year; prerequisite Part D drug required.
Xdemvy (demodex blepharitis)
Covered when ALL of the following are met:
Coverage duration 1 year; prerequisite Part D drug not required.
Sodium oxybate
Covered when ALL product‑specific criteria are satisfied; notable exclusions apply:
Coverage duration 1 year; prerequisite Part D drug required.
Yonsa / Zarxio
Covered when ALL of the following are met:
Prerequisite Part D drug required; coverage duration 1 year.
Coverage duration 1 year; prerequisite Part D drug not required.
This section summarizes product-specific coverage criteria and general rules that apply across listed drugs. Many products require prior authorization and coverage is provided only when the product-specific clinical criteria are met (see individual product entries). Reauthorization typically requires documentation of a positive clinical response to therapy. Examples: Adbry (dupilumab-bxxx) is covered for patients ≥12 years with moderate–severe atopic dermatitis after a trial and failure of one listed topical or systemic therapy; dosing for patients weighing <100 kg who achieve response at 16 weeks is limited to 300 mg every 4 weeks unless clinical rationale is provided (chunk 2).
Biologic and targeted immunomodulators often carry a combination-use prohibition: coverage is not provided when used concurrently with another biologic or targeted DMARD indicated for the same condition (examples: Adbry, Fasenra, Nucala, many abatacept/tofa/Rinvoq entries) — such combination use may trigger denial (chunks 2, 41, 101, 111).
Many products include indication-specific prerequisites and measurable thresholds. Examples include eosinophil-count requirements for anti‑eosinophil agents (e.g., EA initiation commonly requires ≥ 150 cells/μL), baseline diagnostic confirmation for genetic or enzyme-deficiency disorders (e.g., Rivfloza: AGXT genetic testing), and laboratory or imaging thresholds for metabolic/hepatic or bone conditions (see Nucala, Rivfloza, Praluent and Tymlos entries) (chunks 41, 139, 101, 126).
Initial coverage commonly requires documented trials of specified alternatives (step therapy) or failure/intolerance to lower-tier agents prior to approval; for some psychiatric and neurologic agents lifetime coverage is contingent on documented comparator trials (e.g., antidepressant and antipsychotic comparator lists; oral risperidone before long‑acting risperidone formulations) (chunks 216, 218, 234).
Documentation expectations: providers must submit the clinical data specified in each product entry (examples: baseline T25FW for dalfampridine, IgE and allergy testing for Xolair, genetic or enzyme testing for Opfolda and Rivfloza, BMD T‑score for teriparatide/Tymlos). Absence of required documentation or failure to meet prerequisite trial requirements may result in denial (chunks 24, 194, 109, 44, 247).
Coverage durations are product-specific but commonly set to 1 YEAR; select products have different durations (e.g., Praluent 3 years, certain osteoporosis agents 2–3 years, lifetime for some long‑acting injectables) — confirm the duration in the product entry before authorizing (chunks 2, 124, 44, 216).
Tadalafil (oral tablets) is not covered when the patient is receiving concomitant nitrate therapy; requests for BPH treatment must document the diagnosis and the absence of nitrate therapy. Coverage duration is typically 1 year per the product entry (chunk 19).
Budesonide ER is specifically excluded for the indication of maintenance of remission in ulcerative colitis; the product entry states that coverage will not be provided for maintenance of remission in UC (chunk 14).
Two distinct exclusions are highlighted: tadalafil coverage is not provided when patients are receiving nitrates; dalfampridine ER is excluded for patients who are wheelchair‑bound or who become wheelchair‑bound. For dalfampridine, a baseline timed 25‑foot walk (T25FW) must be submitted prior to initiation and reauthorization requires documentation of stability or improvement (chunks 19, 24).
Fasenra (benralizumab) must not be used in combination with another biologic or targeted DMARD indicated for the same condition. Indication‑specific criteria apply (e.g., for eosinophilic asthma an eosinophil count ≥ 150 cells/μL at initiation and prior controller/systemic steroid trial), and reauthorization requires documentation of clinical response (chunk 41).
Products indicated or used solely for weight loss are excluded. For agents that have diabetes indications (e.g., liraglutide), coverage is allowed when used for type 2 diabetes mellitus with supporting documentation (medical records or labs such as A1c ≥ 6.5%, FPG ≥ 126 mg/dL, or 2‑hour OGTT ≥ 200 mg/dL); however, requests solely for weight loss will be denied as not medically necessary (chunks 49, 75).
Kevzara (sarilumab) may not be used in combination with another biologic or targeted DMARD indicated for the same condition. For rheumatoid arthritis coverage requires diagnosis of moderately to severely active RA and a trial of two specified alternatives (examples include ENBREL, adalimumab biosimilars, RINVOQ, XELJANZ/XR, or ORENCIA); reauthorization requires documentation of positive clinical response (chunk 67).
Some immunomodulators and immunosuppressive biologics carry combination‑use prohibitions: abatacept/Orencia and other agents cannot be used concurrently with other immunosuppressives (e.g., JAK inhibitors or biologic DMARDs) — such use is an exclusion and may trigger denial. Kevzara and Kineret entries likewise prohibit concurrent use with another biologic or targeted DMARD for the same condition (chunks 111, 67, 68).
Joenja coverage for activated PI3K‑delta syndrome (APDS) requires genetic confirmation (documented variant in PIK3CD or PIK3R1) plus clinical manifestations consistent with APDS (e.g., nodal/extranodal lymphoproliferation, recurrent oto‑sino‑pulmonary infections, organ dysfunction). Joenja cannot be used in combination with an immunosuppressive medication for APDS (chunk 64).
Liraglutide is covered for treatment of type 2 diabetes when diagnostic documentation is provided (A1c ≥ 6.5% or FPG ≥ 126 mg/dL or 2‑hr OGTT ≥ 200 mg/dL), but it is explicitly excluded if prescribed solely for weight loss (chunk 75). More generally, the policy excludes use for weight loss only for several specified products (chunk 49).
Nucala (mepolizumab) is not to be used in combination with another biologic or targeted DMARD indicated for the same condition. Coverage is indication‑specific with eosinophil thresholds (e.g., eosinophilic asthma initiation usually ≥ 150 cells/μL, HES ≥ 1000 cells/μL) and reauthorization requires documentation of positive clinical response (chunks 101, 103).
Requests that propose combination use of biologics, JAK inhibitors, or other potent immunosuppressants with another biologic/targeted DMARD for the same indication are excluded across multiple product entries; several agents explicitly prohibit such concurrent use (examples include abatacept/Orencia, Xeljanz/tofacitinib, and Xolair) and these prohibitions may lead to denial if documented (chunks 111, 191, 194).
Certain products include explicit non‑coverage for hypocalcemia. The product entries state that coverage is not provided for hypocalcemia for the specified products; refer to the product line for the full list and context (chunk 126).
Rivfloza (lumasiran) coverage requires genetic confirmation of primary hyperoxaluria type 1 (AGXT mutation). Coverage will not be provided for patients with a history of kidney or liver transplant, and combination use with Oxlumo is prohibited (chunk 139).
Initial Authorization Requirements
Reauthorization / Continuation Requirements
Adbry — Reauthorization
Adbry reauthorization
Refer to initial dosing limitations for patients <100 kg (300 mg q4w after 16 weeks if responsive) and do not combine with other biologic/targeted DMARDs for same condition.
Reauthorization/documented response
Reauthorization requirements
Applies to Fasenra, adalimumab family, Tocilizumab, Nucala, and others as specified; coverage durations commonly 1 year.
Reauthorization requirements
Reauthorization rules
Applies across product classes where noted in product entries.
Nucala reauthorization
For all Nucala indications:
Coverage duration typically 1 year.
Zilbrysq continuation
Continuation requirements for Zilbrysq
Coverage duration 1 year; prerequisite Part D drug required.
Step Therapy Requirements and Tables
| Product | Step requirement |
|---|---|
| Auvelity | |
| Trial of bupropion and one other generic formulary antidepressant required prior to coverage |
| Product / group | Step requirement |
|---|---|
| Topical agents (examples) | |
| Trial of at least one generic topical steroid (or generic Protopic or generic Elidel) required prior to coverage |
| Product | Step requirement |
|---|---|
| Arcalyst (recurrent pericarditis) | |
| Trial of a nonsteroidal anti-inflammatory drug (NSAID) in combination with colchicine required prior to coverage |
| Scope / examples | Typical requirement |
|---|---|
| Antipsychotics (schizophrenia examples) | |
| Trial of two generic formulary atypical antipsychotics required (examples: aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone) |
| Requirement category | Policy |
|---|---|
| Trial of specified alternative(s) | |
| Many products require trial and documented failure or intolerance to specified generic or formulary alternatives prior to approval (product-specific list) |
| Product | Required prior agents |
|---|---|
| Kevzara (RA) | |
| Trial of two of: Enbrel, adalimumab biosimilars, Rinvoq, Xeljanz/XR, Orencia required prior to coverage |
| Context / example | Step requirement |
|---|---|
| Oncology examples (selected) | |
| Many oncology indications require trial of at least one prior systemic therapy or specified prior chemotherapies (examples: Lumakras requires ≥1 prior systemic therapy; Lonsurf requires prior fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy and anti‑VEGF therapy) |
| General rule | Requirement |
|---|---|
| Must have trial and documented failure/ineligibility | |
| Products frequently require documented trial and failure of specified prior agents or documented ineligibility/intolerance before approval; details are product-specific |
| Requirement type | Documentation expected |
|---|---|
| Prior trial or contraindication/intolerance | |
| Approval requires documentation of prior trial or clinical contraindication/intolerance to listed comparator agents (examples vary by product) |
| Area / drug class | Step therapy example |
|---|---|
| Antifungals / DMARDs / Statins (examples) | |
| Posaconazole prophylaxis requires trial with two of fluconazole, itraconazole, or voriconazole; DMARDs required prior to Orencia; Praluent requires trial of high-intensity statin (or documented intolerance) |
| Multiple products | Prior trial requirement (examples) |
|---|---|
| Various specialty products (examples) | |
| Jubbonti/Stoboclo require trial of an oral bisphosphonate (or IV if intolerant); Retevmo may require prior radioactive iodine when appropriate; Rezdiffra requires trial of semaglutide; Tolvaptan requires trials of furosemide, demeclocycline, or fluid restriction |
| Scenario | Step requirement |
|---|---|
| Lower-tier or specified agent required first | |
| Some branded products require trial of lower-tier generics or specific comparators (e.g., Spritam requires trial of 2 generic anticonvulsants; Sunosi requires trial of armodafinil) |
| Product / indication | Step requirement |
|---|---|
| Ubrelvy (acute migraine) | |
| Trial of at least two generic triptans required unless triptan therapy is contraindicated, not tolerated, or clinically inappropriate |
| Product | Required prior regimen |
|---|---|
| Voquezna (H. pylori dual/triple Pak) | |
| Trial of a guideline-recommended generic first-line H. pylori regimen (clarithromycin triple therapy or bismuth quadruple therapy) required prior to Voquezna |
| Product | Step therapy examples by indication |
|---|---|
| Xifaxan (various indications) | |
| Hepatic encephalopathy: trial of lactulose required; Recurrent C. diff: trial of vancomycin required; IBS-D: trial of loperamide, dicyclomine, or diphenoxylate/atropine required |
| Product | Step requirement |
|---|---|
| Winrevair (PAH) | |
| Trial of both: (1) generic sildenafil or tadalafil AND (2) generic bosentan or ambrisentan required prior to coverage |
| Product | Step requirement |
|---|---|
| Trintellix (and Exxua products) | |
| Trial of at least two specified generic antidepressants required prior to coverage |
| Product | Prerequisite |
|---|---|
| Abilify Asimtufii / Abilify Maintena | |
| Trial of oral aripiprazole required prior to coverage |
| Comparator requirement | Policy |
|---|---|
| Generic comparator failure (general) | |
| Many products require documented failure or intolerance to specified generic comparator drugs before approval (provider must document trials or contraindications) |
| Product | Step requirement |
|---|---|
| Paliperidone palmitate (long-acting injectables) | |
| Trial of once-monthly paliperidone palmitate for ≥4 months OR every-three-month paliperidone palmitate for at least one 3‑month cycle required prior to coverage |
| Situation / product examples | Required prior trial or documentation |
|---|---|
| Risperidone long‑acting / Perseris / Rasuvo / Rytary / Farxiga/Jardiance / Febuxostat (examples) | |
| Prior trial of the specified generic/comparator agent or documented contraindication/intolerance is required before approval (e.g., oral risperidone before long‑acting risperidone; generic injectable methotrexate before Rasuvo; generic ER carbidopa/levodopa before Rytary; dapagliflozin trial before Farxiga/Jardiance; allopurinol trial before febuxostat) |
Code Tables and Key Values
| Braftovi CAPS 75MG | Product listing as provided |
| DABRAFENIB | Mekinist SOLR DABRAFENIB (reference to combination use with dabrafenib) |
| 149900UNIT | Pancreaze CPEP 149900UNIT |
| 37000UNIT | Pancreaze CPEP 37000UNIT |
| 97300UNIT | Pancreaze CPEP 97300UNIT |
| 15200UNIT | Pancreaze CPEP 15200UNIT |
| 2600UNIT | Pancreaze CPEP 2600UNIT |
| 8800UNIT | Pancreaze CPEP 8800UNIT |
| 24600UNIT | Pancreaze CPEP 24600UNIT |
| 4200UNIT | Pancreaze CPEP 4200UNIT |
| 14200UNIT | Pancreaze CPEP 14200UNIT |
| 61500UNIT | Pancreaze CPEP 61500UNIT |
What Providers Must Submit / Watch For
Submit prior authorization per product
Prior authorization is required for each listed product; verify the drug on the formulary and submit PA that meets the product-specific clinical and administrative criteria before coverage is provided.
- Each product entry includes indications, exclusions, age/prescriber limits, coverage duration, and prerequisite therapy requirements.
- Providers can contact the pharmacy help desk or the customer service number on the member ID card to request PA/ST.
Confirm PA identification and meet criteria
Drugs identified with (PA) or (ST) in the formulary must meet the documented clinical and/or administrative criteria prior to coverage; many PAs specify a standard coverage duration (commonly one year) and reauthorization requires documentation of positive clinical response.
- Coverage duration is commonly 1 year unless otherwise noted (some products list lifetime or multi-year durations).
- Reauthorization generally requires documentation of positive clinical response.
Provide reauthorization and response documentation
Prior authorization approvals and reauthorizations commonly require documentation of positive clinical response; coverage durations are typically one year unless otherwise specified in the product entry.
- Reauthorization for Adbry and many biologics requires documentation of positive clinical response.
- Coverage durations are specified per product (e.g., 1 year typical; some products list lifetime or multi‑year durations).
Document two triptan trials before dihydroergotamine
For dihydroergotamine mesylate prior authorization, document a trial of two formulary triptans — one oral and one non‑oral (e.g., nasal or injectable) — before approval.
- PA requires trial of two triptans on the formulary: one oral and one non‑oral.
Document indication‑specific prerequisite trials (Dupixent/Nucala examples)
For dupilumab and related biologics (e.g., Dupixent/Adbry), document indication‑specific prerequisite trials and thresholds: e.g., for atopic dermatitis a trial and failure of one: high‑potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine or mycophenolate mofetil; for eosinophilic asthma include eosinophil count thresholds (≥150 cells/µL) and prior controller/systemic steroid trials per the product entry.
- Adbry AD: trial and failure of one specified topical/systemic therapy required; reauthorization requires positive clinical response and dosing limits for patients <100 kg.
- Dupixent: EOE requires trial of PPI or topical esophageal corticosteroid; EA requires eosinophils ≥150 cells/µL and controller failure.
- Nucala/related entries also specify eosinophil thresholds and prior therapy trials where applicable.
Submit PA for Part D specialty products per entry
Part D specialty products listed require prior authorization; coverage durations, prerequisite therapy, and documentation requirements vary by product and indication — follow the specific product entry.
- Many specialty agents require PA with one‑year duration and indication‑specific prerequisites.
- Some oncology and specialty agents require prior systemic therapies or combination regimens as specified.
Meet diagnosis‑specific PA criteria (UC/HS/uveitis)
Coverage for specified indications (e.g., UC, hidradenitis suppurativa, non‑infectious uveitis) requires meeting diagnosis‑specific criteria and documentation of disease severity; reauthorization requires demonstrated clinical benefit.
- UC: diagnosis of moderately to severely active disease required.
- HS: diagnosis of moderate to severe HS required.
- Non‑infectious uveitis: diagnosis classified as intermediate, posterior, or panuveitis required.
Provide Lenvima indication and combination documentation
Lenvima requests must meet the dose‑ and indication‑specific PA criteria; certain RCC indications require combination use (e.g., with pembrolizumab) or prior anti‑angiogenic therapy as specified.
- Follow the Prior Authorization Criteria section for the specified Lenvima daily dose.
- RCC first‑line: combination with pembrolizumab required; other RCC settings may require prior anti‑angiogenic therapy or everolimus.
Document Lenvima combination/prior therapy
For some Lenvima indications, verify required combination or prior therapies in the request (e.g., pembrolizumab for RCC first‑line or everolimus following prior anti‑angiogenic therapy).
- Document the specific combination partner or prior anti‑angiogenic therapy per the labeled indication before approval.
Include general PA elements and prior therapy evidence
Ensure submitted PA requests include the general prior authorization elements: specific indication, required prior therapy trials or contraindications, prescriber/age restrictions, and intended duration (commonly 1 year).
- Some products also require a prerequisite Part D drug — confirm and document prior treatments.
- Reauthorization ordinarily requires documentation of positive clinical response.
Document Lynparza prior platinum chemotherapy
Lynparza coverage requires documentation of prior platinum‑based chemotherapy for BRCA‑mutated advanced ovarian/fallopian tube/primary peritoneal cancer and other indication‑specific prior therapies per the product entry.
- Document prior platinum chemotherapy and any other required prior regimens as noted in the Lynparza criteria before PA approval.
Show Mekinist combination and swallowing rationale
Mekinist (tablet and liquid) approvals require combination use with dabrafenib for most BRAF V600E/V600K indications; liquid formulation requires documentation of inability to swallow tablets.
- For BRAF‑mutant melanoma/NSCLC/ATC and other specified tumors, document combination therapy with dabrafenib.
- If requesting liquid Mekinist, include documentation the patient cannot swallow tablets.
Provide Mektovi combination/prior therapy details
Mektovi prior authorization requires documentation of indicated combination or prior trial(s) for melanoma or NSCLC BRAF V600E/V600K indications; coverage duration is typically one year.
- Document prior trial of vemurafenib + cobimetinib or combination with encorafenib per the Mektovi product criteria.
Document Nucala indication‑specific criteria and labs
Nucala PA approvals must document indication‑specific criteria (e.g., eosinophil thresholds and required prior controller/systemic steroid trials for eosinophilic asthma; EGPA diagnostic features; HES eosinophil ≥1000 cells/µL and stability on therapy); reauthorization requires documentation of clinical response.
- EA: eosinophils ≥150 cells/µL at initiation and failure to maintain control after systemic or high‑dose inhaled steroids plus another controller.
- EGPA: diagnosis plus two typical clinical features per the Nucala criteria.
- HES: eosinophil ≥1000 cells/µL at initiation and stability on HES therapy.
Attach product‑specific prerequisite documentation
Refer to product PA summaries for Movantik, Octreotide, and Opfolda — include indication‑specific prerequisites (e.g., opioid stability for Movantik; trial of bromocriptine for acromegaly with octreotide; enzyme assay and confirmatory genetic testing for Opfolda) when submitting PA.
- Opfolda: include decreased acid alpha‑glucosidase assay result and GAA gene mutation plus symptomatic manifestations and lack of improvement on ERT.
- Movantik/Octreotide: include required prior therapy evidence as noted in each product entry.
Document AML consolidation remission and inability to complete curative therapy
For adult AML consolidation prior authorization, document that the patient achieved CR/CRi after intensive induction chemotherapy and is unable to complete intensive curative therapy; coverage duration is one year.
- Include clinical documentation of CR/CRi status and the inability to complete intensive curative therapy in the PA submission.
Document prior azole trials for posaconazole DR
Posaconazole DR prior authorization for prophylaxis requires trial of two of fluconazole, itraconazole, or voriconazole; for specified prophylaxis/treatment uses include the required prior antifungal trials and note the 6‑month coverage duration.
- Prophylaxis: document trials of two specified azoles when indicated.
- Coverage duration for prophylaxis is 6 months.
Provide LDL and statin trial documentation for Praluent
Praluent PA requires diagnostic and treatment history documentation: LDL thresholds while on high‑intensity statin (e.g., ≥55 mg/dL with ASCVD or >70 mg/dL without ASCVD) and evidence of prior high‑intensity statin use or statin intolerance plus trials of atorvastatin and rosuvastatin.
- Provide LDL while on high‑intensity statin and record of at least 12 weeks of high‑intensity statin therapy or documented statin intolerance.
- Include trials of atorvastatin and rosuvastatin per the Praluent criteria.
Document bisphosphonate trial/intolerance for Jubbonti/Stoboclo
Jubbonti/Stoboclo PA requires documentation of trial of an oral bisphosphonate or, if intolerant, an IV bisphosphonate (or inability to be treated with both); coverage duration is 3 years.
- Attach records showing trial of an oral bisphosphonate or documentation of intolerance to oral bisphosphonates and reasons for IV therapy.
Submit baseline platelet counts and prior therapy for eltrombopag
For eltrombopag PA, include baseline platelet counts and prior therapy trials: ITP baseline platelets <30,000/mcL and prior corticosteroids/IVIG or splenectomy as applicable; thrombocytopenia with chronic hepatitis C requires baseline platelets <75,000/mcL.
- Provide baseline platelet count and prior therapy history (corticosteroids, IVIG, splenectomy) as specified in the eltrombopag criteria.
Attach RET molecular testing for Retevmo
Retevmo PA requires documentation of RET gene fusion or RET mutation detected by an FDA‑approved test for the indicated NSCLC/thyroid/solid tumor uses; include prior radioactive iodine trial when appropriate.
- Attach molecular testing results confirming RET fusion/mutation via an FDA‑approved test.
- For thyroid indications, document trial/failure of radioactive iodine if appropriate.
Provide fibrosis staging and semaglutide trial for Rezdiffra
Rezdiffra coverage requires verification of noncirrhotic NASH/MASH with advanced fibrosis (F2‑F3) by FibroScan or other imaging‑based noninvasive assessment and documentation of a trial of semaglutide prior to approval; reauthorization criteria require no progression to cirrhosis and objective improvement/stability.
- Submit FibroScan or equivalent imaging evidence of fibrosis stage F2–F3 and documentation of semaglutide trial.
- For renewal, include imaging/histologic or clinical evidence per the renewal criteria.
Include Rinvoq prior therapy and prohibition documentation
Rinvoq (oral and liquid) PA requires indication‑specific prerequisites (e.g., trials of DMARDs, NSAIDs, TNF inhibitors where applicable) and documentation that the drug will not be used with potent immunosuppressants or another biologic/targeted DMARD; reauthorization requires positive clinical response.
- For RA/PsA/AS/UC: document prior DMARD/NSAID/TNF inhibitor trials per the Rinvoq criteria.
- Confirm the patient is not receiving Rinvoq with a potent immunosuppressant or another biologic.
Document prior platinum chemotherapy for Rybrevant requests
Rybrevant PA for NSCLC with EGFR exon 20 insertion requires documentation of disease progression on or after platinum‑based chemotherapy; include mutation and prior therapy details.
- Attach evidence of EGFR exon 20 insertion and prior platinum‑based chemotherapy with documentation of progression.
Confirm Rydapt combination with standard induction/consolidation
Rydapt PA for newly diagnosed FLT3‑mutated AML requires that the drug be used in combination with standard cytarabine + daunorubicin induction and cytarabine consolidation; include regimen details in the PA submission.
- Document that Rydapt will be given in combination with standard induction and consolidation chemotherapy as specified.
Provide documented prior myeloma therapies
For products treating multiple myeloma, document prior therapy history showing at least two prior therapies including lenalidomide and a proteasome inhibitor (relapsed/refractory criteria and coverage duration are specified in the product entry).
- Include prior therapy lines and agents (lenalidomide and a proteasome inhibitor) per the multiple myeloma prerequisite criteria.
Document trial of sublingual asenapine or inability to use oral forms
Secuado (asenapine patch) coverage requires documentation of a trial of sublingual asenapine OR documented inability to use oral/ODT formulations; include this trial or swallowing/intolerance evidence.
- Attach records showing trial of sublingual asenapine or documented difficulty with oral/ODT formulations supporting patch use.
Document two prior alternatives for Kevzara/Kineret and exclude combination use
Kevzara and Kineret PA/step requirements for RA require trials of two specified alternatives (e.g., Enbrel, adalimumab biosimilars, Rinvoq, Xeljanz/XR, Orencia); document these prior trials and that the agent will not be combined with another biologic/targeted DMARD.
- Include records of trials of two listed alternatives.
- Confirm no concurrent use with another biologic/targeted DMARD for the same condition.
Document prior systemic therapies for Trodelvy (TNBC)
Trodelvy coverage for triple‑negative breast cancer requires prior use of two or more systemic therapies (one for metastatic disease); document the prior systemic therapy history per the Trodelvy criteria.
- Include prior systemic therapy names, lines of therapy, and which was used for metastatic disease.
Submit indication documentation for Vigabatrin PA
Vigabatrin requests require prior authorization consistent with the listed indications and usually a one‑year coverage duration; include indication‑specific documentation per the product entry.
- Attach documentation supporting the indicated use and any required prior trials as described.
Document H. pylori diagnosis and first‑line regimen trial for Voquezna
Voquezna Dual/Triple Pak for H. pylori requires documented H. pylori infection and a trial of a guideline‑recommended generic first‑line regimen (clarithromycin triple or bismuth quadruple therapy) prior to coverage; include the first‑line regimen trial evidence.
- Document positive H. pylori diagnosis and prior trial of a guideline‑recommended first‑line regimen (clarithromycin triple or bismuth quadruple).
Provide IgE/allergy testing and prior therapy evidence for Xolair PA
Xolair prior authorization requires documentation of IgE level and allergy testing (positive skin test or in‑vitro reactivity) for allergic asthma, and other indication‑specific diagnostic and prior therapy documentation; reauthorization requires documented clinical response.
- For allergic asthma: include IgE level in the specified range and evidence of positive skin or in‑vitro reactivity to a perennial aeroallergen.
- For CRSwNP/CSU: include the diagnostic criteria and prior therapy trials as specified.
Document oral aripiprazole trial before Abilify injectable approvals
Require trial of oral aripiprazole before approving Abilify Asimtufii or Abilify Maintena; include documentation of the oral trial (or intolerance) with the PA request.
- Coverage duration for these products is lifetime pending the required trial documentation.
Document two generic antidepressant trials for Trintellix
Trintellix (and Exxua/Exxua Titration Pack) requires documentation of trials of at least two listed generic antidepressants prior to coverage; include medication names and trial durations in the PA request.
- List the two (or more) generic antidepressants tried (from the enumerated list) and evidence of inadequate response or intolerance.
Attach required prior oncology therapy evidence
Many oncology/specialty agents require documentation of specific prior therapies (e.g., abiraterone 250 mg tablet trial for selected prostate cancer uses); include exact prior therapy and dosing evidence as specified in the product entry.
- For prostate cancer products note the required abiraterone 250 mg tablet trial where indicated.
- For oncology agents generally, document prior systemic lines, specific agents, and combination regimens per criteria.
Provide two generic antidepressant trials or risk denial
Antidepressant comparator requirement: submit documentation of trials of at least two specified generic antidepressants (from the listed set) before PA approval for indicated products; failure to document these trials may result in denial.
- Include drug names, treatment dates, and reason for failure/intolerance for each trial.
Document antipsychotic comparator trial to support PA
Antipsychotic comparator requirement: prior authorization requires trial of at least one listed generic typical/atypical antipsychotic before coverage of certain products; document the trial to avoid denial.
- List the specific antipsychotic(s) tried and the treatment outcome or intolerance.
Document prior paliperidone palmitate injectable regimen
For paliperidone palmitate long‑acting injectables, document trial of once‑monthly paliperidone palmitate for ≥4 months or an every‑three‑month cycle for at least one three‑month cycle prior to approval.
- Provide treatment dates and formulation details of the prior paliperidone palmitate regimen.
Document trial of oral paliperidone/risperidone
Prior authorization for oral paliperidone/risperidone formulations requires documentation of a prior trial of oral paliperidone or oral risperidone where specified; include trial details to support coverage.
- Include medication name, dosing, dates, and reason for failure/intolerance.
Document Zenpep trial/intolerance for pancreatic enzyme PA
Pancreatic enzyme product PA requires documentation of trial or intolerance to Zenpep (comparator) before approval for the listed products; include prior trial details.
- Provide documentation of trial duration and outcomes or intolerance to Zenpep.
Billing / Site of Care Notes
Submit site‑of‑care information (Part B vs D)
Coverage determinations between Medicare Part B and Part D may depend on the use and setting of the drug; submit information describing the drug use and setting when requested to determine appropriate coverage.
Program Background
The prior authorization and step‑therapy program is intended to ensure clinically appropriate, evidence‑based, and cost‑effective use of specialty and other high‑cost drugs for Medicare Plus Blue members. Providers should submit required clinical documentation (diagnosis, prior therapy trials, relevant laboratory or genetic test results, baseline measures such as T25FW where required) as specified in each product entry. Many products include indication‑specific prerequisites, age or weight minimums, and reauthorization requirements that document a positive clinical response; typical coverage durations are listed in the product entries (commonly 1 year). For drugs that may be covered under Medicare Part B or Part D, the setting and use may affect coverage determination and should be included with the request.
Key Definitions
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.