Medicare Plus Blue Group PPO / Prescription Blue Group PDP — Prior Authorization and Step Therapy Criteria (Pharmacy & Specialty Drugs)
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Lists prior authorization and step therapy requirements for multiple prescription drugs covered under the BCBSM Medicare Plus Blue Group PPO and Prescription Blue Group PDP Healthy Value Comprehensive Formulary for the 2026 plan year; intended for providers and pharmacists submitting PA/ST requests for affected members.
No material clinical or coverage changes in this revision.
Product-level Coverage Criteria
Adbry coverage
Covered when ALL of the following are met:
Coverage duration: 1 year; prerequisite Part D drug required; 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
Bronchitol coverage
Covered when ALL of the following are met:
Coverage duration: 1 year
Tadalafil coverage/exclusion
Tadalafil (BPH indication):
Coverage not provided when patient is receiving nitrate therapy; coverage duration: 1 year
Anticonvulsant prerequisite therapy
Certain anticonvulsant agents:
Coverage duration: 1 year; document trials
Document inability to swallow; coverage duration: 1 year
Biologics / targeted DMARDs - general rules
Covered when ALL of the following are met (general biologic/targeted DMARD rules):
Coverage duration commonly 1 year; many products require prerequisite Part D drug trials and reauthorization requires documentation of positive clinical response
Dupixent - indication-specific criteria
Dupixent — indication-specific rules (examples):
Reauthorization requires documentation of positive clinical response; cannot be used in combination with another biologic/targeted DMARD for same condition
Reauthorization requires documentation of response; cannot be used in combination with another biologic/targeted DMARD for same condition
Dalfampridine - initiation and reauthorization
Dalfampridine — initiation and reauthorization:
Reauthorization requires documentation of stability or improvement on T25FW; coverage duration: 1 year
Prerequisite therapy required examples
Products requiring prerequisite DMARD or prior therapies (examples):
Document trials and durations as applicable; some products have lifetime coverage durations
Reauthorization generally requires documentation of positive clinical response
Preventative migraine coverage
Coverage for preventive treatment of migraine is provided when one of the following is met:
Coverage duration: 1 year; document trials or inability to swallow
Seizure disorder/epilepsy coverage
Coverage for treatment of seizure disorder/epilepsy requires:
Document trials and baseline assessments as required; coverage duration commonly 1 year
Schizophrenia coverage
Coverage for treatment of schizophrenia requires ALL of the following:
Document trials; coverage duration for listed products may be lifetime
Fasenra - Eosinophilic asthma (EA) coverage
Fasenra — Eosinophilic asthma (EA) coverage (initiation):
Reauthorization requires documentation of positive clinical response; cannot be used in combination with another biologic/targeted DMARD for same condition
Fasenra - EGPA coverage
Fasenra — EGPA coverage:
Reauthorization requires documentation of positive clinical response; cannot be used in combination with another biologic/targeted DMARD for same condition
Tumor necrosis factor / Adalimumab-class coverage (examples)
Coverage for specified indications requires diagnosis plus prior therapy trials:
Reauthorization requires documentation of positive clinical response; cannot be used in combination with another biologic/targeted DMARD for same condition
Document trial
Teriparatide (Forteo) coverage
Teriparatide (Forteo) — covered when ALL of the following are met:
Coverage duration: 2 years; document trials
GLP-1 agonists / incretin agents (examples: Mounjaro, Ozempic, Rybelsus, Trulicity)
GLP-1 agonists / incretin agents — coverage requires diabetes documentation and excludes weight-loss-only use:
Excluded if used for weight loss only; coverage duration: 1 year
Ibrance (palbociclib) coverage
Ibrance (palbociclib) — coverage for HR+/HER2- advanced/metastatic breast cancer:
Coverage duration: 1 year; document combination endocrine therapy
Product-specific coverage criteria
Product-specific coverage criteria (selected examples):
Many require prerequisite Part D drug trials; reauthorization generally requires documentation of positive clinical response
Product-specific coverage criteria
Representative product-specific coverage criteria (examples):
Coverage duration: 1 year; document prior platinum-based chemotherapy
Mutation must be detected by FDA-approved test; document prior regimens
Coverage duration: 1 year
Nucala: Indication-specific coverage
Nucala — indication-specific coverage:
Reauthorization requires documentation of positive clinical response; cannot be used in combination with another biologic/targeted DMARD for same condition
Mektovi: Combination therapy requirements
Mektovi — combination therapy requirements (examples):
Coverage duration: 1 year; document prior combination trial where applicable
Nexletol/Nexlizet: Statin prerequisite
Nexletol / Nexlizet — statin prerequisite:
Document statin trial or intolerance; coverage duration: 1 year
Opfolda: Diagnostic confirmation and clinical criteria
Opfolda — diagnostic confirmation and clinical criteria:
Coverage duration: 1 year; prerequisite Part D drug required; document assay and genetic testing
Opfolda — AML post-remission coverage
Opfolda — AML post-remission coverage (example):
Coverage duration: 1 year; document CR/CRi status and inability to complete curative therapy
Opfolda/related agent — Pompe disease
Opfolda / related agent — Pompe disease:
Coverage duration: 1 year; prerequisite Part D drug required; document assay, genetic testing, and symptoms
Orenitram and Jubbonti/Stoboclo — PAH and osteoporosis
Orenitram and Jubbonti/Stoboclo — PAH and osteoporosis agents:
Coverage duration: 1 year; document prior PDE5 inhibitor trial
Coverage excludes hypocalcemia; coverage duration: 3 years; document trials or intolerance
Posaconazole DR — IFI prophylaxis and treatment criteria
Posaconazole DR — prophylaxis and treatment criteria:
Coverage duration: 6 months for prophylaxis; document prior azole trials
Document prior therapy trials
Praluent — initial and reauthorization criteria
Praluent — initial and reauthorization criteria:
Document LDL while on high-intensity statin and statin trial/intolerance; coverage duration: 3 years for reauthorization
Coverage duration: 3 years; document LDL response
Piqray — PIK3CA-mutated breast cancer
Piqray (alpelisib) — PIK3CA‑mutated breast cancer:
Coverage duration: 1 year; document PIK3CA mutation and prior endocrine therapy
Pomalidomide — disease-specific criteria
Pomalidomide — disease‑specific criteria (examples):
Coverage duration: 1 year; document prior therapies
Document HAART trial
Eltrombopag — platelet count–based criteria
Eltrombopag — platelet count–based criteria:
Coverage duration: 1 year; document baseline platelet count and prior therapies
Document baseline platelet count
Document baseline platelet count
Jubbonti / Stoboclo bisphosphonate prerequisite
Jubbonti / Stoboclo — bisphosphonate prerequisite:
Coverage duration: 3 years for listed products; coverage excludes hypocalcemia
Eltrombopag Olamine clinical criteria
Eltrombopag Olamine — clinical criteria (summary):
Coverage duration: 1 year; document baseline labs and prior therapies
Retevmo indication criteria
Retevmo — indication criteria:
Coverage duration: 1 year; document RET gene fusion/mutation testing results
NASH/MASH coverage and renewal criteria
NASH / MASH — coverage and renewal criteria:
Coverage duration: 1 year; document semaglutide trial and fibrosis verification
Rinvoq indication-specific criteria
Rinvoq (upadacitinib) — indication‑specific criteria (summary):
Coverage duration: 1 year; document prior trials and response
Rivfloza coverage criteria
Rivfloza — coverage criteria (PH1):
Coverage duration: 1 year; exclusions include history of kidney or liver transplant and combination use with OXLUMO; document AGXT genetic testing
Secuado formulation-based coverage
Secuado — formulation‑based coverage (schizophrenia):
Coverage duration: lifetime; document trial or documented difficulty swallowing; prerequisite Part D drug required
Selected product criteria
Selected product criteria (examples):
Coverage duration: 1 year; prerequisite Part D drug required; document prior therapies
Coverage duration: 1 year; document prior combination therapies and inability to swallow if requesting liquid formulation
Secuado
Secuado / Sirturo / Spritam / Sunosi — single-node examples:
Coverage duration: lifetime; prerequisite Part D drug required
Coverage duration: 1 year
Coverage duration: 1 year; document trials
Coverage duration: 1 year; document trial
Sirturo
Sirturo — coverage condition:
Coverage duration: 1 year; document combination regimen
Spritam
Spritam / Tafinlar (examples):
Coverage duration: 1 year; document trials
Coverage duration: 1 year; document prior therapies and inability to swallow for liquid
Sunosi
Sunosi — example criterion:
Coverage duration: 1 year; document trial
Tafinlar
Tafinlar — formulation and indication notes:
Coverage duration: 1 year; document prior combination therapy
Coverage duration: 1 year; document inability to swallow
Tagrisso
Tagrisso — indication snapshot:
Mutation detection by FDA‑approved test; coverage duration: 1 year
Nilotinib
Nilotinib — coverage condition (example):
Coverage duration: 1 year; document prior TKI therapy
General coverage statement
General coverage statement (applies across many listed products):
See individual product entries for specific prerequisites or restrictions; reauthorization generally requires documentation of positive clinical response
TOCILIZUMAB: Indication-specific criteria
Tocilizumab — indication‑specific criteria (summary):
Cannot be used in combination with another biologic or targeted DMARD for the same condition; document prior trials
Tetrabenazine: Exclusions and testing
Tetrabenazine — exclusions and testing:
Do not combine with contraindicated agents; document genotype when applicable
Tymlos: Eligibility and prerequisites
Tymlos — eligibility and prerequisites:
Coverage duration: 2 years; document BMD and bisphosphonate trials/intolerance
VERZENIO: Indication-specific criteria
Verzenio — indication‑specific criteria (examples):
Document combination endocrine therapy or prior regimens per indication; coverage duration: 1 year
Voquezna: H. pylori treatment criteria
Voquezna — H. pylori treatment criteria:
Coverage duration: 1 year; document prior first-line regimen trial; prerequisite Part D drug required
Voquezna — H. pylori treatment
Voquezna (Dual/Triple Pak) — covered when ALL of the following are met:
Coverage duration: 1 year; prerequisite Part D drug required; document diagnosis and prior regimen
Vosevi — Hepatitis C
Vosevi — Hepatitis C:
Document clinical indications per guidance; coverage duration per guidance
Welireg — oncology indications & prerequisites
Welireg — oncology indications & prerequisites (summary):
Prerequisite Part D drug required; document prior therapies
Winrevair — PAH
Winrevair — PAH criteria (example):
Coverage duration: 1 year; document prior PDE5 inhibitor and ERA trials
Xdemvy — Demodex blepharitis
Xdemvy — Demodex blepharitis:
Coverage duration: 1 year; document slit lamp findings
Xifaxan — indication-specific prerequisite therapy
Xifaxan 550 mg — indication‑specific prerequisite therapy:
Coverage duration: typically 1 year; document prior trials
Xolair — allergy and ENT indications
Xolair — allergy and ENT indications (summary):
Reauthorization requires positive clinical response; cannot be used with another biologic/targeted DMARD for same condition; document IgE and allergen testing
Reauthorization requires positive clinical response
Reauthorization requires positive clinical response; document IgE and prior intranasal steroid therapy
Voydeya — PNH EVH
Voydeya — PNH extravascular hemolysis (EVH):
Coverage duration: 1 year; document labs and combination therapy with Soliris/Ultomiris
Abiraterone products
Abiraterone products — prerequisite trial:
Document trial of abiraterone 250 mg tablets
Zilbrysq (myasthenia gravis)
Zilbrysq — myasthenia gravis coverage:
Exclusions: no thymectomy within 12 months, no current thymoma or other thymus neoplasms; cannot be combined with other biologic therapies for MG or immunoglobulin therapy; document antibody testing and prior therapies
Sodium oxybate
Sodium oxybate — coverage conditions and exclusions:
Coverage duration: 1 year; exclusions include patients taking sedative hypnotics or with succinic semialdehyde dehydrogenase deficiency
Zurzuvae (postpartum depression)
Zurzuvae — postpartum depression:
Coverage duration: 60 days; document timing of onset and postpartum status
Zejula
Zejula — maintenance therapy criteria:
Coverage duration: 1 year; document chemo response
Zepzelca
Zepzelca — small cell lung cancer criteria:
Coverage duration: 1 year; document prior platinum‑based chemotherapy and induction regimen response
Zarxio (AML)
Zarxio — AML coverage condition:
Coverage duration: 1 year; document prior chemotherapy
Caplyta / Rexulti / Vraylar CAPS / Zyprexa Relprevv criteria
Antidepressant and antipsychotic step/coverage requirements (examples):
Coverage duration is lifetime; document trials
Coverage duration is lifetime; document trial or intolerance
Products requiring conventional antipsychotic trial
Products requiring conventional antipsychotic or specific aripiprazole trials (selected entries):
Coverage duration often lifetime; document trial or intolerance
Coverage duration: lifetime; document trial durations where specified
Product-specific coverage criteria
Supply and injectable product prerequisites (examples):
Coverage duration: 1 year; document insulin claim
Coverage duration: lifetime; document trial duration
Coverage duration: lifetime; document trial or intolerance
Product-specific step therapy and trial requirements
Product-specific step therapy and trial requirements (selected examples):
Coverage duration: lifetime; document methotrexate trial
Coverage duration: lifetime; document trial
Coverage duration: 1 year; document trial
Coverage duration: 1 year; document trial
Document trial or exception
Coverage duration: lifetime; document trial or contraindication
Coverage for Adbry excludes concurrent use with any other biologic or targeted DMARD indicated for the same condition. This is an explicit exclusion and will be a basis for denial if documentation shows overlap with another biologic/targeted DMARD for the same diagnosis. (Coverage details: age ≥12 years; PA required; duration 1 year.)
Requests for tadalafil will be denied when the member is receiving concomitant nitrate therapy. The policy explicitly states coverage is not provided for tadalafil in situations where patients are on nitrate medications; clinical documentation should confirm absence of nitrates prior to approval.
Budesonide ER is not covered for the maintenance of remission in ulcerative colitis. The policy lists this as an explicit non‑coverage statement for that specific use.
The policy repeats that tadalafil is not covered for patients receiving concurrent nitrate therapy. Prior authorization reviewers should confirm medication lists to ensure no concomitant nitrates before approving tadalafil for BPH.
Dalfampridine ER is excluded from coverage if the patient is wheelchair bound or becomes wheelchair bound. A baseline T25FW must be submitted for initiation and reauthorization requires documentation of stability or improvement on the timed 25‑foot walk; coverage will be denied where wheelchair dependence is documented.
Many biologic and targeted DMARDs in this policy carry a common restriction: they cannot be used in combination with another biologic or targeted DMARD indicated for the same condition. This combination exclusion is listed across multiple product entries and may trigger denial if concurrent therapy is documented. Providers must show the requested biologic is not being given with another biologic/targeted DMARD for the same diagnosis.
The policy consistently disallows combination biologic therapy: a product cannot be used in combination with another biologic or targeted DMARD indicated for the same condition. This prohibition appears in multiple product entries (for example, Fasenra and other tumor‑necrosis factor/adalimumab‑class entries) and is an explicit exclusion that may lead to denial if concurrent biologic use is present.
Certain agents in the formulary are expressly excluded when used solely for treatment of weight loss. The policy states that coverage will be denied if the indication documented is weight loss only; providers must document an approved medical diagnosis (e.g., T2DM with laboratory confirmation) to support coverage.
Codes, Clinical Thresholds and Key Values
| Braftovi CAPS 75MG | Drug/product listing as shown |
| Lynparza TABS | Product name as listed |
| Mekinist TABS | Mekinist tablet formulation |
| Mekinist SOLR | Mekinist liquid/solution formulation |
Prior Authorization, Step Therapy and Documentation Requirements
PA/ST required for listed drugs
Prior authorization (PA) or step therapy (ST) is required for many drugs listed in this formulary; clinical and/or administrative criteria must be met before coverage is provided.
Adbry PA criteria (summary)
Adbry requires prior authorization for atopic dermatitis in patients ≥12 years with moderate to severe disease and a trial and failure of one listed topical or systemic therapy; reauthorization requires documentation of positive clinical response and dosing for patients <100 kg is limited after 16 weeks unless justified.
- Age ≥ 12 years; diagnosis of moderate to severe atopic dermatitis
- Trial and treatment failure of one: high‑potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil
- Reauthorization: documentation of positive clinical response; dosing limit for <100 kg after 16 weeks (300 mg q4w) unless rationale provided
Prior authorization and duration
Prior authorization is required for the listed Part D specialty drugs and, unless specified otherwise, coverage durations are commonly set to one year.
- Coverage duration default: 1 year for many products
Combination biologic/DMARD restriction
Biologic and targeted DMARD agents cannot be used in combination with another biologic or targeted DMARD indicated for the same condition; such combination use is an exclusion and may trigger denial.
- Applies across multiple biologic/targeted DMARD product entries
Prior authorization and coverage duration
Prior authorization is required for many Part D drugs listed and, unless otherwise specified, approval is generally granted for one year.
- Some products have different durations where noted (e.g., Praluent: 3 years; select products: lifetime)
Prior authorization and coverage duration
Many Part D specialty products require prior authorization with coverage typically granted for one year and may require documented trials of prerequisite Part D drugs where specified.
- Providers must document required prior trials when indicated to avoid denial
Lynparza PA requirements
Lynparza (tablets) requires prior authorization with a one‑year coverage duration and indication-specific prerequisite therapies (for example, prior platinum‑based chemotherapy for BRCA‑mutated ovarian cancer).
- Document prior platinum‑based chemotherapy where applicable
Mekinist PA requirements
Mekinist (tablet and liquid formulations) requires prior authorization with one‑year duration; BRAF V600E/V600K mutated indications are provided as monotherapy only for BRAF‑inhibitor–treatment–naive patients otherwise combination use or prior trials of specified BRAF/MEK regimens are required.
- Liquid/solution covered only if patient unable to swallow tablets
- For many BRAF‑mutant indications, combination with dabrafenib or other BRAF/MEK regimens is required
Mektovi combination and prerequisite therapy
Mektovi prior authorization requires combination use with encorafenib for specified melanoma indications and prior trial of vemurafenib + cobimetinib for unresectable or metastatic melanoma with BRAF V600E or V600K.
- Document prior trial of vemurafenib + cobimetinib where required
Nucala indication-specific PA
Nucala prior authorization requires indication‑specific diagnostic criteria (e.g., eosinophil thresholds for EA, EGPA features, HES thresholds) and reauthorization requires documentation of positive clinical response.
- EA: eosinophil criteria and failure to maintain control after appropriate steroid/controller trials
- HES: eosinophil ≥1000 cells/µL and stability on HES therapy
- Reauthorization: documentation of clinical response
Nexletol/Nexlizet prerequisite statin trial
Nexletol and Nexlizet prior authorization require trial of one high‑intensity statin unless statin intolerance or contraindication is documented.
- Provide documentation of statin trial or intolerance/contraindication
Opfolda — authorization requirement
Opfolda coverage for certain indications requires documentation that the patient achieved first complete remission (CR) or CRi after intensive induction chemotherapy and cannot complete intensive curative therapy; authorization duration is one year.
- For Pompe disease: require serum assay and genetic testing confirming GAA mutation and symptomatic disease
Posaconazole DR — step requirements
Posaconazole DR prior authorization for IFI prophylaxis or treatment requires trial with two alternative azoles (e.g., fluconazole, itraconazole, voriconazole) before coverage.
- Prophylaxis: patient at high risk (HSCT with GVHD or prolonged neutropenia) or prior fungal infection
- Document trials of two alternative azoles
Praluent — lipid management requirements
Praluent prior authorization requires documentation of ASCVD/HeFH/primary HLD criteria, LDL measured while on a high‑intensity statin within the last 120 days meeting specified thresholds, and at least 12 weeks of high‑intensity statin unless intolerant; reauthorization requires continued statin and LDL reduction on Praluent.
- ASCVD: LDL ≥ 55 mg/dL (while on high‑intensity statin)
- Without ASCVD: LDL > 70 mg/dL (while on high‑intensity statin)
- Document 12 weeks of high‑intensity statin or intolerance
Bisphosphonate trial required (Jubbonti and Stoboclo mention)
Coverage for Jubbonti and Stoboclo requires trial of an oral bisphosphonate or, if intolerant, an IV bisphosphonate; coverage is also provided if the patient is unable to be treated with both oral and IV bisphosphonates.
- Document trial or intolerance to oral bisphosphonate (or IV if oral intolerant)
- Coverage duration noted where specified
Diagnostic and prior therapy requirements for Retevmo
Retevmo prior authorization requires documentation of RET gene fusion or RET mutation detected by an FDA‑approved test; for some thyroid indications, prior radioactive iodine trial is required when appropriate.
- Provide FDA‑approved test result for RET fusion/mutation
- Document prior radioactive iodine trial for thyroid indications when applicable
Step/prior therapy requirements for Rinvoq
Rinvoq coverage requires prior trials specific to the indication (e.g., trial of a DMARD such as methotrexate for RA; trial of an NSAID for AS/axSpA) and reauthorization requires documentation of positive clinical response and avoidance of combination with potent immunosuppressants or another biologic/targeted DMARD.
- RA: trial of one DMARD (methotrexate, leflunomide, or sulfasalazine)
- AS/axSpA: trial of one NSAID
- Reauthorization: documentation of response and no disallowed combinations
Prior authorization required
Prior authorization is required for the listed Part D specialty drugs; coverage durations and prerequisite therapy requirements differ by product and must be documented per product‑specific criteria.
Tafinlar (liquid) prior auth
Tafinlar liquid formulation requires prior authorization; coverage for the liquid is limited to patients unable to swallow the capsule and is subject to the same indication‑specific prior therapy requirements as the capsule.
- Document inability to swallow capsule formulation
TOCILIZUMAB prior authorization
Tocilizumab (tocilizumab) requires prior authorization; many indications require trials of specified alternative biologic or targeted DMARD therapies and reauthorization requires documentation of positive clinical response.
- Cannot be used in combination with another biologic/targeted DMARD for the same condition
VERZENIO prior authorization
Verzenio requires prior authorization; coverage for adjuvant or advanced/metastatic breast cancer mandates combination with specific endocrine agents or prior endocrine/chemotherapy per the indication.
- Document combination partner (tamoxifen or aromatase inhibitor) or prior therapies as specified
Vanflyta prior authorization
Vanflyta coverage for newly diagnosed FLT3‑ITD positive AML requires prior authorization and must be used in combination with standard cytarabine and anthracycline induction and cytarabine consolidation.
- Document combination with standard induction/consolidation regimens
Prior authorization and coverage duration
Many listed products require prior authorization with coverage commonly set to one year; providers must follow the product‑specific prerequisite therapy and documentation requirements to obtain approval.
Voquezna — prerequisite therapy
Voquezna coverage for H. pylori requires documented diagnosis of H. pylori infection and a trial of a guideline‑recommended, generic first‑line regimen (clarithromycin triple therapy or bismuth quadruple therapy) prior to coverage.
- Document prior trial of clarithromycin triple or bismuth quadruple therapy
Abiraterone 250 mg trial required
Coverage for several abiraterone products requires prior trial of abiraterone 250 mg tablet strength before coverage of other formulations.
- Document trial of abiraterone 250 mg tablet
Antidepressant step therapy
Exxua/Exxua Titration Pack and Trintellix require trial of at least two listed generic antidepressants prior to coverage.
- Document trials of two listed generics (e.g., bupropion, citalopram, escitalopram, sertraline, etc.)
Aripiprazole trial required
Abilify Asimtufii and Abilify Maintena require prior trial of oral aripiprazole before approval; coverage duration is lifetime.
- Document trial of oral aripiprazole
Products requiring PA
Products such as Caplyta, Rexulti, Vraylar CAPS, and Zyprexa Relprevv require prior authorization per their product‑specific criteria as listed.
Aristada PA
Aristada requires prior authorization with documentation of trial of listed oral or injectable antipsychotics per criteria.
- Document trials or intolerances as specified in the Aristada entry
Aristada Initio PA
Aristada Initio requires prior authorization with trial or documented intolerance to Abilify Maintena or oral aripiprazole.
- Document trial or intolerance to Abilify Maintena or oral aripiprazole
Supply products PA
Coverage for specified supply products (gauze, alcohol prep pads) is subject to the criteria in this section; for certain supply products, an insulin claim within the prior 180 days is required.
- For insulin‑related supplies: document insulin claim within prior 180 days
Pancreatic enzyme PA
Pancreaze CPEP formulations require prior authorization with documented trial or intolerance to Zenpep before coverage is approved.
- Document trial of Zenpep or documented intolerance
Rasuvo prior authorization
Rasuvo requires prior authorization and a documented trial of generic injectable methotrexate for coverage; coverage duration is lifetime.
- Document trial of generic injectable methotrexate
Rhopressa prior authorization
Rhopressa requires trial of any generic formulary ophthalmic glaucoma medication or Lumigan prior to approval; coverage duration is one year.
- Document trial of generic ophthalmic glaucoma med or Lumigan
Risperidone ER prior authorization
Risperidone ER requires prior trial of oral risperidone before coverage; coverage duration is lifetime.
- Document trial of oral risperidone
Rocklatan prior authorization
Rocklatan requires prior trial of any generic formulary ophthalmic glaucoma medication or Lumigan; coverage duration is one year.
- Document trial of generic ophthalmic glaucoma med or Lumigan
Rykindo prior authorization
Rykindo requires prior trial of oral risperidone for coverage; coverage duration is lifetime.
- Document trial of oral risperidone
Rytary prior authorization
Rytary requires prior trial of generic oral extended‑release carbidopa & levodopa before approval; coverage duration is one year.
- Document trial of generic ER carbidopa/levodopa
Farxiga/Jardiance prior authorization
Farxiga and Jardiance require trial of generic dapagliflozin before approval; exception: step therapy does not apply for Jardiance when used to reduce risk of cardiovascular death in adults with T2DM and established cardiovascular disease.
- Document trial of generic dapagliflozin unless exception applies
Febuxostat prior authorization
Febuxostat requires prior trial of allopurinol or documentation of contraindication to allopurinol; coverage duration is lifetime.
- Document allopurinol trial or contraindication
Prerequisite therapy requirements (general)
Certain agents require prior trial of specified alternatives or Part D drugs before approval; providers must document trials and failures or contraindications per the product entry.
Anticonvulsant step therapy
Some anticonvulsant products require documented trial of divalproex or valproic acid and lamotrigine prior to coverage.
- Document specific anticonvulsant trials as listed
Prior therapy trials required for many products
Multiple products require documented trials of specified prior therapies (examples: two second‑generation antipsychotics for schizophrenia; trials of generic anticonvulsants for seizure disorders); lack of documentation may trigger denial.
- Document drug names, durations, and reasons for failure/intolerance
Required trials of prior therapies
Providers must document prior trials of specified generic alternatives or classes (e.g., two generics for migraine prevention, two generic anticonvulsants for seizures) before coverage is approved.
Step/ prerequisite therapy requirements
Several products require step or prerequisite therapy trials (e.g., Kevzara and Kineret require trials of two specified agents for RA); document those trials to support the PA request.
Libervant step requirements
Libervant coverage requires trial of levetiracetam oral solution and documentation that the patient is unable to swallow tablets or capsules.
- Document trial of levetiracetam oral solution and swallowing inability
Lumakras step/combination requirements
Lumakras coverage for KRAS G12C‑mutated locally advanced or metastatic NSCLC requires trial of at least one prior systemic therapy; for certain colorectal indications additional combination requirements apply.
- Document prior systemic therapy trial(s)
Motpoly XR step therapy
Motpoly XR coverage for seizures requires trial of two generic anticonvulsant alternatives prior to approval.
- Document trials of two generic anticonvulsants
Ninlaro combination/step requirement
Ninlaro for multiple myeloma requires at least one prior therapy and use in combination with lenalidomide and dexamethasone.
- Document prior therapy and combination use
Orenitram — prerequisite agent
Orenitram coverage requires trial and failure or contraindication to sildenafil prior to approval.
- Document trial/failure or contraindication to sildenafil
Jubbonti / Stoboclo — bisphosphonate trial
Jubbonti and Stoboclo require trial of an oral bisphosphonate or, if intolerant, an IV bisphosphonate; coverage is also provided if patient unable to be treated with both.
- Document bisphosphonate trial or intolerance
Step therapy for NASH/MASH
For NASH/MASH, coverage requires a trial of semaglutide prior to approval and documentation of advanced fibrosis (stage F2–F3) by FibroScan or other imaging‑based non‑invasive assessment.
- Document semaglutide trial and fibrosis staging
Formulation trial for Secuado
Secuado coverage for schizophrenia requires trial of asenapine sublingual tablet or documentation of inability to use oral/ODT formulations.
- Document trial of sublingual asenapine or difficulty with oral/ODT
Step therapy examples
The formulary includes multiple examples of step therapy requirements—providers must document trials and failures of specified alternatives (e.g., Sunosi requires prior armodafinil trial).
- Provide records of prior trials and reasons for failure/intolerance
Tymlos step therapy
Tymlos requires prior trials of JUBBONTI or STOBOCLO and either an oral bisphosphonate (or IV bisphosphonate if intolerant) before approval; document BMD T‑score ≤ −2.5.
- Document BMD T‑score ≤ −2.5 and bisphosphonate trial or intolerance
Ubrelvy step therapy
Ubrelvy for acute migraine requires trial of at least two generic triptans (e.g., sumatriptan and rizatriptan) unless contraindicated or not tolerated.
- Document trials of two triptans or contraindication/intolerance
Xifaxan — step requirements
Xifaxan 550 mg coverage depends on indication‑specific prior trials: hepatic encephalopathy requires prior trial of lactulose; IBS‑D requires trial of loperamide, dicyclomine, or diphenoxylate/atropine; recurrent C. diff requires trial of vancomycin.
- Document the specific prior trial relevant to the indication
Winrevair — step requirements
Winrevair for pulmonary arterial hypertension requires trials of both a generic PDE5 inhibitor (sildenafil or tadalafil) and an ERA (bosentan or ambrisentan) prior to approval.
- Document trials of both required drug classes
Depression step therapy
Depression step therapy entries require trial of at least two specified generic antidepressants before coverage of agents like Trintellix/Exxua; failure to document these trials may trigger denial.
- Provide documentation of two generic antidepressant trials and outcomes
Antidepressant step therapy
Antidepressant step therapy: coverage of certain antidepressant products requires documented trial of at least two listed generic antidepressants before approval.
Antipsychotic step therapy
Antipsychotic step therapy: several antipsychotic products require trial of at least one listed conventional antipsychotic agent prior to approval.
- Document trial of at least one conventional antipsychotic listed
Paliperidone step therapy
Prior to approval of Invega Hafyera, document trial of paliperidone palmitate once‑monthly for ≥4 months or the three‑month formulation for at least one three‑month cycle.
- Provide dates and duration of prior paliperidone palmitate formulation trials
SGLT2 inhibitor step therapy
SGLT2 inhibitor step therapy requires trial of generic dapagliflozin before Farxiga or Jardiance except Jardiance requests for reducing risk of cardiovascular death in adults with T2DM and established CVD are exempt.
- Document trial of generic dapagliflozin or document qualifying exception
Adbry reauthorization and dosing documentation
Adbry reauthorization requires documentation of positive clinical response to therapy; dosing restriction applies for patients <100 kg after 16 weeks unless clinical rationale is provided.
- Submit clinical response documentation at reauthorization
- Note dosing limitation (300 mg every 4 weeks) for <100 kg responders after 16 weeks unless justified
Bronchitol test documentation
Bronchitol requires documentation that the member has passed the Bronchitol tolerance test prior to coverage.
- Submit Bronchitol tolerance test results
Dalfampridine T25FW requirement
Dalfampridine initiation requires submission of a baseline timed 25‑foot walk (T25FW) test; reauthorization requires documentation of stability or improvement on the T25FW.
- Provide baseline T25FW and follow‑up results at reauthorization
Weight requirement for Ebglyss
Ebglyss requires documentation that the patient weighs at least 40 kilograms prior to coverage.
- Provide weight documentation (≥40 kg)
Dupixent eosinophil requirement
Dupixent for eosinophilic asthma requires an eosinophil count ≥150 cells/µL at initiation as part of the prior authorization criteria.
- Document eosinophil count at initiation (≥150 cells/µL)
Required supporting documentation
Submission of supporting medical records is required for certain products (examples: T2DM labs for GLP‑1 agents, BMD T‑score for teriparatide, prior chemotherapy documentation for Lynparza).
- Include lab values, imaging, or prior therapy records as specified per product
Reauthorization response documentation
Reauthorization for many biologic and specialty products generally requires documentation of a positive clinical response to therapy.
- Provide objective or clinical notes demonstrating improvement
Reauthorization and required documentation
Reauthorization requests commonly require documentation of continued positive clinical response; some products also require specific diagnostic mutation or prior therapy documentation at renewal.
- Follow product‑specific reauthorization requirements (e.g., genetic tests, prior therapy evidence)
T2DM documentation
For liraglutide used to treat type 2 diabetes, submit medical records or labs confirming T2DM diagnosis (A1c ≥6.5% or FPG ≥126 mg/dL or 2‑hr OGTT ≥200 mg/dL).
- Provide A1c or glucose lab values or chart notes confirming T2DM
Prior chemotherapy documentation
For Lynparza in certain oncology indications, prior platinum‑based chemotherapy or other specified prior therapies must be documented to support coverage.
- Include chemotherapy regimen and dates demonstrating prior platinum‑based chemotherapy
Reauthorization documentation (Nucala)
Nucala reauthorization requires documentation of a positive clinical response to therapy for all indications.
- Provide clinical outcome evidence at renewal
Diagnostic and clinical documentation (Opfolda)
Opfolda coverage requires diagnostic confirmation by serum assay showing decreased acid alpha‑glucosidase activity and genetic testing demonstrating a GAA mutation; symptomatic manifestations and lack of improvement on ERT must be documented.
- Submit serum assay, genetic test results, and clinical symptom documentation
Diagnostic confirmation for Opfolda
Opfolda diagnostic confirmation requires serum assay showing decreased acid alpha‑glucosidase activity followed by genetic testing showing a GAA mutation.
Laboratory and medication history for Praluent
Praluent initial approvals require LDL values measured while on a high‑intensity statin within the last 120 days and documentation of statin trials or statin intolerance.
- Provide LDL value while on high‑intensity statin and evidence of 12 weeks trial or intolerance
Baseline laboratory requirements (Eltrombopag Olamine)
Eltrombopag Olamine coverage requires baseline platelet counts: ITP <30,000/mcL; thrombocytopenia with chronic hepatitis C <75,000/mcL; severe aplastic anemia <30,000/mcL.
- Document baseline platelet count meeting the specified threshold
Genetic test requirement (Rivfloza)
Rivfloza (lumasiran) requires genetic testing confirming AGXT mutation for diagnosis of primary hyperoxaluria type 1; coverage exclusions include history of kidney or liver transplant and combination use with OXLUMO.
- Submit AGXT genetic test results
- Do not request coverage for patients with prior kidney or liver transplant
Fibrosis verification (unnamed product)
For NASH/MASH coverage, verify advanced liver fibrosis (stage F2–F3) by FibroScan or other imaging‑based noninvasive assessment and document a trial of semaglutide prior to approval.
- Provide fibrosis staging and semaglutide trial documentation
Reauthorization response documentation
Reauthorization for many biologic indications requires documentation of positive clinical response to therapy; submit objective or clinical notes demonstrating benefit.
CYP2D6 testing for tetrabenazine
Tetrabenazine documentation: CYP2D6 genotype testing is required for doses above 50 mg/day; coverage is excluded for hepatic impairment, active suicidal ideation, untreated/ inadequately treated depression, or concurrent MAO inhibitor or reserpine use.
- Provide CYP2D6 genotype when dose >50 mg/day
- Do not request coverage if exclusion conditions present
BMD requirement for Tymlos
Tymlos coverage requires documentation of bone mineral density with a T‑score ≤ −2.5 prior to approval.
- Submit BMD T‑score documentation (≤ −2.5)
Clinical documentation for Verquvo
Verquvo coverage requires documentation of chronic heart failure NYHA class II–IV with LVEF <45% and evidence of recent hospitalization for heart failure or outpatient IV diuretic use as specified.
- Provide LVEF and hospitalization or IV diuretic documentation
Diagnosis required (H. pylori)
Voquezna regimens for H. pylori require a documented diagnosis of H. pylori infection before coverage.
- Provide test results confirming H. pylori infection
Diagnostic confirmation (Demodex blepharitis)
Xdemvy for Demodex blepharitis requires confirmation of diagnosis via presence of collarettes on slit‑lamp exam.
- Submit slit‑lamp exam findings documenting collarettes
Laboratory/diagnostic requirements (Xolair)
Xolair for allergic asthma requires IgE within specified age‑based ranges and positive skin test or in vitro reactivity to a perennial aeroallergen; reauthorization requires positive clinical response and combination biologic use is excluded.
- IgE ranges: adults ≥12 yrs: >30 and <700 IU/mL; 6–12 yrs: >30 and <1300 IU/mL; CRSwNP: 30–1500 IU/mL
- Provide allergen reactivity testing and clinical response documentation
Zilbrysq required documentation
Zilbrysq coverage for myasthenia gravis requires documentation of anti‑AChR antibody positive MG plus one confirmatory test (edrophonium, clinical response to cholinesterase inhibitors, or electrophysiological evidence) and prior 12‑week courses of listed immunosuppressants unless contraindicated.
- Submit anti‑AChR antibody result and confirmatory test
- Document prior immunosuppressant therapy courses or contraindications
Zurzuvae required documentation
Zurzuvae for postpartum depression coverage requires documentation of onset in the third trimester or within 4 weeks postpartum and that the member is ≤12 months postpartum.
- Provide timing of symptom onset and postpartum status (≤12 months)
Insulin claim
A claim for an insulin product within the prior 180 days must be documented for coverage of specified supply/insulin‑related products.
Paliperidone trial documentation
Documentation of trial duration for paliperidone palmitate is required: once‑monthly formulation ≥4 months or three‑month formulation ≥1 three‑month cycle.
- Provide dates and duration of prior paliperidone palmitate use
Prior trial or intolerance documentation
Providers must document prior trials or intolerance to the specified alternative generic agents named for each product to support PA/ST requests.
- Include drug names, trial duration, and reason for discontinuation (failure or intolerance)
Required documentation of prior trial or contraindication
Documentation must show trial of the specified alternative medication (e.g., oral risperidone; generic injectable methotrexate; generic ophthalmic glaucoma medication or Lumigan; generic ER carbidopa/levodopa; generic dapagliflozin) or a documented contraindication as stated for each product.
- Provide records demonstrating trial, failure, or contraindication per product entry
Requirements to Start Therapy
Reauthorization and Ongoing Use
Step Therapy Tables and Prior Trials
| Step therapy requirement | Details |
|---|---|
| Prior trial of specified formulary or Part D drugs required where indicated | Criteria specifies that many products require a documented trial of listed alternative Part D agents before coverage is approved (examples: Adbry, multiple oncology and specialty agents). |
| Source examples | See product entries requiring prerequisite Part D drugs; e.g., Adbry requires prerequisite Part D drug use for atopic dermatitis (chunk 2). |
| Step therapy requirement | Details |
|---|---|
| Specified trials of alternative therapies required before approval | Several products mandate trials of named alternative therapies (e.g., two second‑generation antipsychotics for schizophrenia; trial of high‑intensity statin for Nexletol/Nexlizet). |
| Source examples | See schizophrenia (chunk 20), Nexletol/Nexlizet statin requirement (chunk 97). |
| Step therapy requirement | Details |
|---|---|
| Trials of specified generic alternatives or named therapies required | For seizure and migraine products many entries require trials of at least two generic anticonvulsants or two generic migraine preventives prior to coverage. |
| Source examples | Motpoly XR and other seizure entries require two generic anticonvulsant trials (chunk 93); migraine preventive requirements listed (chunk 36). |
| Step therapy requirement | Details |
|---|---|
| Prior trials or prior lines of systemic therapy required for select products | Many oncology and specialty agents require prior lines of therapy or specific prior regimens before approval (examples cited per product). |
| Source examples | Iclusig requires prior kinase inhibitor trials (chunk 56); Lenvima/Lorbrena/Lumakras combination or prior therapy rules (chunks 71,77). |
| Step therapy requirement | Details |
|---|---|
| Cancer products: specified systemic chemotherapy or combination therapy prerequisites | Multiple cancer products list required prior systemic chemotherapies or combination partners as prerequisites to coverage. |
| Source examples | Lenvima metastatic colorectal cancer requirements (chunk 77); Mekinist/Mektovi BRAF combination rules (chunks 86,91). |
| Step therapy requirement | Details |
|---|---|
| Prior trial of specified medications required before coverage | Product entries commonly state that a trial and failure or intolerance to specified alternatives must be documented prior to approval. |
| Source examples | Examples include Ninlaro (prior therapy and combination requirement, chunk 99) and other product entries (multiple chunks). |
| Step therapy requirement | Details |
|---|---|
| Prior trial of alternative azoles required for Posaconazole DR | Prophylaxis and treatment coverage requires trial with two of: fluconazole, itraconazole, or voriconazole. |
| Source examples | Posaconazole DR prophylaxis/treatment criteria specify trial with two alternative azoles (chunk 120). |
| Step therapy requirement | Details |
|---|---|
| Prior bisphosphonate therapy required (Jubbonti / Stoboclo) | Coverage requires trial of an oral bisphosphonate or, if intolerant, an IV bisphosphonate; coverage also provided if unable to be treated with both. |
| Source examples | Jubbonti and Stoboclo bisphosphonate prerequisite explicitly stated (chunk 126). |
| Step therapy requirement | Details |
|---|---|
| Prior PAH therapy required for Orenitram | Orenitram coverage requires trial and failure or contraindication to sildenafil prior to approval. |
| Source examples | Orenitram prerequisite agent requirement noted (chunk 112). |
| Step therapy requirement | Details |
|---|---|
| Trial of one DMARD required for RA prior to Rinvoq | Rinvoq coverage for RA requires prior trial of a DMARD such as methotrexate, leflunomide, or sulfasalazine. |
| Source examples | Rinvoq DMARD trial requirement described in product criteria (chunk 136). |
| Step therapy requirement | Details |
|---|---|
| Trial of one NSAID required for AS / nonradiographic axSpA prior to Rinvoq | Coverage requires an inadequate response or intolerance to an NSAID before Rinvoq for ankylosing spondylitis and related indications. |
| Source examples | Rinvoq NSAID prerequisite for AS/axSpA described (chunk 137). |
| Step therapy requirement | Details |
|---|---|
| Trial of sublingual asenapine or documentation of inability to use oral/ODT required prior to Secuado | Secuado coverage for schizophrenia requires prior trial of asenapine sublingual tablet or documented difficulty with oral/ODT formulations. |
| Source examples | Secuado formulation trial requirement shown (chunk 145). |
| Step therapy requirement | Details |
|---|---|
| Step therapy required prior to coverage (general entries) | Multiple product entries denote step therapy is required; product-specific lines list the required alternative(s). |
| Source examples | Several entries mark 'Criteria DOES require use of a prerequisite Part D drug' across product list (multiple chunks such as 77, 151). |
| Step therapy requirement | Details |
|---|---|
| Step therapy required prior to coverage (additional entries) | Other listed products similarly require documented trials of prior agents before approval; see product-level entries for specifics. |
| Source examples | Examples include Spritam (chunk 149), Sunosi (chunk 152) and others indicating prerequisite therapy. |
| Step therapy requirement | Details |
|---|---|
| Tymlos: prior trials required (Jubbonti/Stoboclo + bisphosphonate) | Tymlos coverage requires prior trial of Jubbonti or Stoboclo and either an oral bisphosphonate (or IV bisphosphonate if intolerant) before approval. |
| Source examples | Tymlos BMD and prerequisite therapy requirements detailed (chunk 174). |
| Step therapy requirement | Details |
|---|---|
| Ubrelvy acute migraine: two generic triptans required prior to coverage | Coverage for acute migraine with Ubrelvy requires trial of at least two generic triptans unless contraindicated or not tolerated. |
| Source examples | Ubrelvy step therapy described (chunk 175). |
| Step therapy requirement | Details |
|---|---|
| Step therapy required for select products per product-specific entries | Some products require step therapy with specified generics or regimens depending on indication (e.g., H. pylori, Xifaxan indications, PAH therapies). |
| Source examples | Voquezna H. pylori (chunk 181), Xifaxan indication-specific requirements (chunk 193), Voranigo/Winrevair PAH prerequisites (chunks 187, 181). |
| Step therapy requirement | Details |
|---|---|
| Trial of at least two specified generic antidepressants required before Exxua/Trintellix | Antidepressant-class step therapy mandates documented trials of two listed generic antidepressants prior to coverage; coverage duration is lifetime. |
| Source examples | Antidepressant trial list and lifetime coverage noted (chunk 216). |
| Step therapy requirement | Details |
|---|---|
| Trial of oral aripiprazole required before Abilify Asimtufii and Abilify Maintena | Coverage for these aripiprazole formulations requires prior trial of oral aripiprazole; coverage duration is lifetime. |
| Source examples | Aripiprazole trial requirement specified (chunks 212,214). |
| Step therapy requirement | Details |
|---|---|
| Trial of at least two listed generic antidepressants required before coverage (general) | Multiple antidepressant product entries repeat the requirement for two prior generic antidepressant trials before approval. |
| Source examples | Antidepressant step therapy policy repeated (chunk 216). |
| Step therapy requirement | Details |
|---|---|
| Trial of at least one listed conventional antipsychotic required before coverage | Product groups requiring conventional antipsychotic trial list the acceptable agents; failure/intolerance must be documented. |
| Source examples | Conventional antipsychotic list and requirement provided (chunk 218). |
| Step therapy requirement | Details |
|---|---|
| Trial or intolerance to Zenpep required before Pancreaze coverage | Pancreaze CPEP formulations require documentation of prior trial or intolerance to Zenpep; coverage duration is lifetime. |
| Source examples | Pancreaze prerequisite documented (chunk 232). |
| Step therapy requirement | Details |
|---|---|
| Trial of generic dapagliflozin before Farxiga or Jardiance (exception noted) | Farxiga and Jardiance generally require prior trial of generic dapagliflozin; exception for Jardiance when used to reduce cardiovascular death risk in T2DM with established CVD. |
| Source examples | Farxiga/Jardiance step therapy and exception described (chunk 248). |
| Site of care | Details |
|---|---|
| hospital outpatient | infusion center | home (dependent on circumstances) | Coverage determination may depend on the use and setting of the drug; submit information describing use and setting to determine Part B vs Part D coverage. |
Place of Service Considerations
hospital outpatient | infusion center | home (dependent on circumstances)
Coverage determination may depend on the drug use setting (Part B vs Part D); submit information describing use and setting (hospital outpatient, infusion center, or home) to determine appropriate benefit.
- Provide site‑of‑care details to clarify Part B vs Part D coverage
Policy Background and Scope
This PA/ST program is intended to ensure members receive appropriate, evidence‑based, and cost‑effective drug therapy in line with the payer's Pharmacy & Therapeutics recommendations. It outlines prior authorization and step‑therapy requirements, indication‑specific diagnostic and laboratory thresholds, documentation expectations for initiation and reauthorization, and explicit exclusions that may trigger denials. Providers submitting requests should follow the product‑specific criteria, supply required supporting records (for example, labs, baseline functional tests, prior trial documentation), and confirm no disallowed combinations or contraindicated co‑therapies are present to avoid administrative or clinical denials.
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.