Prior Authorization and Step Therapy Coverage Criteria (Pharmacy & Specialty Drugs)
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Rules and criteria governing when Blue Cross Blue Shield of Michigan and Blue Care Network require prior authorization or step therapy for prescription medications; intended for providers and pharmacists submitting coverage requests under BCN/BCBSM drug benefits.
New or revised coverage criteria published for multiple specific drugs (examples: Xromi, Siklos, Takhzyro, Fruzaqla, Vyvgart Hytrulo, Voyaxct, Tarpeyo, Filspari, Fabhalta, Vanrafia, Gomekli) with publish and effective dates noted for some.
For oncology drugs covered under the pharmacy benefit, prior authorization is required through the Oncology Value Management program administered by OncoHealth with approvals granted 60 days up to six months.
Coverage Criteria (Drug-specific)
Selected new drug coverage criteria (summary)
Select drugs have new or revised coverage criteria; examples and top-level conditions listed below (full entries are in drug-specific sections).
Publish 7/1/2026; Effective 9/1/2026
(publish/effective dates not provided)
Publish 7/1/2026; Effective 9/1/2026
Publish 8/1/2026; Effective 10/1/2026
Program-level coverage
Coverage and program applicability
Alhemo initial therapy
Alhemo coverage when ALL of the following are met (prophylaxis in hemophilia A with inhibitors):
Also criteria exist for prophylaxis without inhibitors (factor levels and bleed documentation)
Andembry initial therapy
Andembry coverage when ALL of the following are met (HAE prophylaxis):
Renewal requires >=50% reduction in number or severity of attacks.
Adbry initial therapy
Adbry coverage when ALL of the following are met (moderate-severe atopic dermatitis):
Initial approval: 6 months; renewal requires clinical benefit.
Alyftrek initial therapy
Alyftrek coverage when ALL of the following are met (cystic fibrosis):
Initial approval: 1 year; renewal requires clinical benefit.
Adzenys ER therapy
Adzenys ER coverage when ANY of the following are met (ADHD):
Initial approval: 1 year; renewal requires clinical benefit.
Andembry — Initial and renewal criteria
Covered when ALL of the following are met
Renewal requires >=50% reduction in number or severity of attacks.
Anzupgo — Initial and renewal criteria
Covered when ALL of the following are met
Renewal requires current criteria met and evidence of clinical benefit.
Aqneursa — Initial and renewal criteria
Covered when ALL of the following are met
Renewal requires current criteria met and clinical benefit.
Aqvesme — Eligibility by transfusion status
Covered when ANY of the following labeled clinical presentations are met (non-transfusion dependent OR transfusion dependent)
Renewal requires clinical benefit.
Renewal requires clinical benefit.
Arcalyst — Multiple indications
Covered when ONE of the indication-specific sets is met
Not to be used with other biologics/targeted DMARDs.
Renewal requires clinical benefit.
Renewal requires clinical benefit.
Arikayce / Auvelity / Austedo — Criteria
Covered when specified indication and baseline criteria are met
Benlysta — Initial and renewal criteria
Covered when ALL of the following are met
Renewal requires clinical benefit.
Bonjesta — Initial criteria
Covered when ALL of the following are met
bosentan (Tracleer) — PAH coverage
Covered when ALL of the following are met
bosutinib (Bosulif) — CML coverage
Covered when ALL of the following are met
Bronchitol — CF maintenance coverage (partial)
Covered when ALL of the following are met
Initial approval: 1 year; documented tolerance testing required.
Bosentan (Tracleer) – pulmonary arterial hypertension
Coverage is provided when the following are met
Bosutinib (Bosulif) – Ph+ CML
Coverage requires ALL of the following
Bronchitol – cystic fibrosis
Coverage requires ALL of the following
Brinsupri – non-cystic fibrosis bronchiectasis
Coverage requires ALL of the following
Initial approval: 1 year; renewal requires clinical benefit.
Brivaracetam (Briviact) – multiple indications
Coverage requires one of the following sets of conditions
Initial approval: 1 year for some formulations.
Initial approval: 1 year for some indications.
Buprenorphine HCl (Belbuca) – chronic pain
Coverage requires ALL of the following
Initial approval: 1 year; renewal requires clinical benefit.
Camzyos – symptomatic obstructive HCM
Coverage requires ALL of the following
Initial approval: 1 year; renewal requires clinical benefit and LVEF >=50%.
Cardamyst – PSVT and NAGSD
Coverage requires ALL of the following
Initial approval: 1 year; renewal requires clinical benefit.
Initial approval: 1 year; renewal requires clinical benefit.
Chenodal – gallstones or cerebrotendinous xanthomatosis
Coverage requires ALL of the following depending on indication
Initial approval:1 year; renewal requires clinical benefit; prescribed by or in consultation with hepatologist/gastroenterologist.
Cholbam – bile acid and peroxisomal disorders
Coverage requires ALL of the following
Initial approval:1 year; renewal requires clinical benefit.
Initial approval:1 year; renewal requires clinical benefit.
Cayston – Pseudomonas aeruginosa in CF
Coverage is provided when the following are met
Initial approval:1 year; renewal requires clinical benefit.
Cibinqo – moderate to severe atopic dermatitis
Coverage requires ALL of the following
Initial approval:6 months; renewal requires clinical benefit.
Cablivi – acquired aTTP
Coverage requires ALL of the following
Approval:60 days
Chorionic gonadotropin (infertility and other indications)
Coverage requires ALL of the following for infertility-related use
Cimzia — multiple indications (Crohn's, RA, AS, PsA, Psoriasis, pJIA, non-radiographic axial spondyloarthritis)
Covered when specified diagnosis- and age-specific criteria plus required prior trials are met
Preferred biosimilars referenced in prior-therapy lists.
Cladribine — multiple sclerosis
Covered when ALL criteria are met
Compounds (compounded medications)
Coverage requires ALL of the following
Initial approval: 2 years; renewal requires clinical benefit.
Continuous Glucose Monitors (listed models)
Coverage requires ONE of the following patient conditions
Specific CGM models listed.
Contrave (weight management)
Covered when ALL criteria are met
Initial approval: 1 year; renewal requires clinical benefit.
Cosentyx (secukinumab) — psoriasis, psoriatic arthritis, ankylosing spondylitis, pediatric indications
Covered when diagnosis-, age-, and prior-therapy-specific criteria are met
Initial approval: 1 year; detailed prior-therapy lists per diagnosis.
Crenessity (classic congenital adrenal hyperplasia)
Covered when ALL criteria are met
Initial approval: 1 year; renewal requires clinical benefit.
Crexont (parkinsonian indication — coverage requires trial/failure)
Covered when trial/failure of generic Sinemet CR is documented
Crinone 8% (infertility)
Covered when ALL criteria are met
Ctexli (chenodeoxycholic acid) — gallstones and CTX
Covered when indication-specific criteria are met
Initial approval for CTX: 1 year; renewal requires clinical benefit.
Cystaran (corneal cystine crystal accumulation)
Covered when used in combination with oral Cystagon
Dasatinib (Ph+ CML and Ph+ ALL)
Covered when ALL criteria are met
Daybue Stix (Rett syndrome)
Covered when ALL criteria are met
Dawnzera and Dayvigo (HAE and insomnia/sedative hypnotic therapy respectively)
Covered when indication-specific prior therapy and diagnostic criteria met
Initial approval: 1 year; renewal requires >=50% reduction in attacks or severity.
Initial approval: 1 year; renewal requires clinical benefit.
Deferiprone tablets
Covered when ALL criteria are met
Initial approval: 1 year; renewal requires clinical benefit.
Deflazacort/Jaythari/Kymbee (Emflaza) for DMD
Covered when ALL criteria are met
Initial approval:1 year; renewal requires clinical benefit.
Deferiprone — Initial therapy criteria
Deferiprone tablets — Covered when ALL of the following are met
Initial approval:1 year; renewal requires clinical benefit.
Descovy (PrEP) — Initial therapy criteria
Descovy 200 mg for HIV prevention — Covered when ALL of the following are met
Initial approval: 2 years; renewal requires negative HIV test within past 3 months and demonstrated clinical benefit.
Doptelet — Indication-specific criteria
Doptelet — Covered when ANY of the following indication-specific criteria are met (OR logic between indications)
Initial approval for chronic liver disease: 60 days.
Initial approval for chronic ITP: 3 months; renewal requires recent platelet count between 50,000–200,000/mcL or dosage adjustment per FDA.
Dichlorphenamide — Initial therapy criteria
Dichlorphenamide — Covered when ALL of the following are met
Initial approval: 1 year; renewal requires clinical benefit.
Diclofenac 2% topical — Initial therapy criteria
Diclofenac 2% external solution — Covered when ALL of the following are met
Initial approval: 1 year; renewal requires clinical benefit.
Dupixent — Indication-specific criteria
Dupixent — Covered when ANY of the indication-specific sets are met (OR between distinct indications)
Initial approval and renewal require clinical benefit.
Initial therapy criteria (non‑bullous)
Covered when ALL of the following are met
Bullous pemphigoid
Covered when ALL of the following are met
Other diagnoses must be ruled out; renewal requires clinical benefit.
Indication-specific coverage criteria (AD, bullous pemphigoid, AFRS)
Covered when one of the indication-specific groups is met:
Alternatives include second-generation antihistamine, H2 antagonist, leukotriene receptor antagonist, first-generation antihistamine at bedtime, hydroxyzine or doxepin when age-appropriate.
Other diagnoses must be ruled out.
Indication-specific initial coverage criteria
Covered when ALL of the following are met for each listed indication
Renewal requires clinical benefit.
Dupilumab will not be used in combination with other biologics/targeted DMARDs for same indication.
Prior/concomitant therapies include trials of multiple antihistamines and adjunctive agents.
Indication-specific coverage criteria
Covered when ALL of the following are met for the specified indication
Indication-specific coverage criteria
Covered when the following indication-specific criteria are met:
Indication-specific coverage criteria
Covered when ALL of the following conditions are met for the specified indication
Renewal requires clinical benefit.
Initial approval for other indications commonly 1 year.
Covered when criteria met (by indication)
Covered when ALL of the following indication-specific criteria are met
Renewal requires demonstration of clinical benefit.
Indication-specific coverage criteria
Covered when ALL of the following are met for each diagnosis-specific indication:
Dupilumab/related biologics not to be used with other biologics/targeted DMARDs for same indication.
Indication-specific criteria (partial)
Covered when ALL of the following are met for the specified indication
Dupilumab will not be used in combination with other biologics/targeted DMARDs for same indication.
Some medications that are typically administered in a physician's office, infusion center, or other site-of-care may be excluded from the prescription drug benefit and instead be covered under the medical benefit. Examples include drugs ordinarily given by a clinician in a treatment setting; these items are referenced in the policy and providers should check the Blue Cross and BCN Utilization Management Medical Drug List to confirm medical‑benefit coverage and billing expectations.
Several product-specific entries include explicit prohibitions on combination use with other agents for the same indication. These exclusions are enforced at prior authorization and mean coverage will not be approved when the request proposes concurrent therapy with listed drugs (for example, do not combine certain endothelin receptor antagonists or biologic/targeted DMARDs unless the policy explicitly allows it). Providers must document that the requested agent will not be used concurrently with the excluded therapies to avoid denial.
Arcalyst is specifically noted as not to be used in combination with other biologics or targeted disease‑modifying antirheumatic drugs (DMARDs) for the same indication; prior authorization requires documentation of indication‑specific criteria and confirmation that no concurrent biologic/targeted DMARD therapy will be used.
Aqneursa (for neurologic manifestations of Niemann‑Pick type C) must not be used in combination with other NPC therapies except for generic miglustat; the prior authorization criteria require diagnostic/genetic confirmation and documentation that excluded combination agents are not being co‑prescribed.
Entries with an NC designation mean Not Covered under the listed prescription drug program; members may be responsible for the full cost. The policy uses the NC flag to indicate formulations or product/tiers that the pharmacy benefit will not cover and to signal when medical‑benefit review may be required instead.
The document notes that Skyrizi and Rinvoq are not covered on certain Custom Select Drug Lists; when a drug is listed as not covered on a program list, requests are at risk of denial under that program.
The policy provides examples of NC designations and explicit exclusions: e.g., Dayvigo is subject to noncoverage when requested in combination with other sedative‑hypnotics, and diclofenac 2% external solution will not be covered if the member is on concurrent oral NSAIDs. These examples illustrate how NC flags and combination exclusions are applied in practice.
Several coverage pathways require that alternative diagnoses be excluded before approval (for example, for non‑bullous allergic/urticarial presentations and for bullous pemphigoid). The policy explicitly states that other diagnoses must be ruled out and lack of that documentation may be a reason for denial.
Provider Actions — Prior Authorization, Documentation, Step Therapy
Obtain prior authorization for listed drugs
Prior authorization required for drugs listed on BCN/BCBSM program lists (e.g., Custom Drug List, Clinical Drug List, Custom Select, Lite PA, Preferred Therapy Program, Off‑Label/High‑Cost Specialty); most approvals are issued for a set period (commonly one year).
- Prior authorization must be obtained before coverage will be provided.
- Most approved prior authorizations last for a defined period (usually one year).
Submit oncology PA via OncoHealth/Availity
For oncology and supportive‑care drugs under the pharmacy benefit, submit prior authorization requests through the Oncology Value Management program (OncoHealth) via Availity; approvals are granted for at least 60 days and up to six months and off‑label uses must align with NCCN or other consensus guidelines.
- Use OncoHealth/Availity for electronic PA submission for oncology/supportive care drugs.
- If off‑label, include documentation showing consistency with NCCN or other consensus guidelines.
Document Adbry indication, prior trial, and no combined biologics
Adbry requests must document diagnosis of moderate‑to‑severe atopic dermatitis, age ≥12, prior trial and failure of a listed systemic or topical agent, and that Adbry will not be used with other biologics/targeted DMARDs for the same indication; initial approval is 6 months.
- Document age (≥12) and diagnosis of moderate‑to‑severe atopic dermatitis.
- Provide record of trial/failure of one listed therapy (e.g., high‑potency topical corticosteroid, tacrolimus, cyclosporine, methotrexate, azathioprine, mycophenolate).
- Confirm Adbry will not be combined with other biologics/targeted DMARDs.
- Initial authorization duration: 6 months.
Document NF1 diagnosis and Koselugo trial/failure
For NF1/plexiform neurofibroma therapies (e.g., Gomekli), prior authorization requires documentation of NF1 with symptomatic plexiform neurofibromas not amenable to complete resection, age ≥2 years, and trial/failure/intolerance/contraindication to Koselugo.
- Provide diagnosis of NF1 with symptomatic PN not amenable to complete resection.
- Document age (≥2 years) and prior trial and failure/intolerance/contraindication to Koselugo.
Provide CF diagnosis and responsive CFTR genetic test
Alyftrek PA requests must include CF diagnosis, age ≥6 years, genetic test confirming at least one CFTR variant responsive to Alyftrek, and confirmation it will not be used with other CFTR potentiators; initial approval is 1 year.
- Submit genetic test demonstrating a responsive CFTR variant.
- Confirm patient age ≥6 and that Alyftrek will not be combined with Trikafta, Orkambi, Kalydeco, or Symdeko.
- Initial approval duration: 1 year.
Document prior antiemetic trials for Akynzeo PA
Akynzeo coverage requires prior authorization documenting prevention of chemotherapy‑induced nausea/vomiting and prior trial of a generic 5‑HT3 antagonist and a preferred NK1 antagonist.
- Document prior trial of a generic 5‑HT3 antagonist (e.g., generic ondansetron).
- Document trial of a preferred NK1 antagonist when applicable.
Include HAE diagnostic labs and attack history for Andembry PA
For Andembry (HAE prophylaxis), prior authorization must include documented diagnosis with laboratory confirmation (low C4 and low C1‑INH antigenic or functional), history of ≥2 attacks/month or severe attacks, prescriber specialty (immunologist/allergist/hematologist), and statement that it will not be used with other HAE prophylaxis products; initial approval is 1 year and renewal requires ≥50% reduction in attack number or severity.
- Include lab results showing C4 below lab normal range and C1‑INH (antigenic or function) below normal.
- Document attack frequency (≥2 per month) or history of severe attacks (face, throat, GI).
- Confirm prescriber specialty and that Andembry will not be combined with other HAE prophylactics.
- Initial approval: 1 year; renewal: ≥50% reduction in attacks or severity.
Avoid combination biologic/targeted DMARD therapy (denial risk)
Do not approve combination use: many agents (examples: Arcalyst, Adbry, Cibinqo, Cimzia, Cosentyx, Dupixent) must not be used with other biologics or targeted DMARDs for the same indication — requests proposing concurrent biologic/DMARD therapy will be denied.
- If request proposes combination with another biologic/targeted DMARD for the same indication, do not approve and note denial risk.
- Ensure documentation states no concurrent biologic/targeted DMARD use.
Document prior topical therapy failures for Anzupgo PA
Anzupgo PA requires documentation of age ≥18, diagnosis of moderate‑to‑severe chronic hand eczema (≥3 months or ≥2 relapses in 12 months), trial and failure of a high‑ or super‑high‑potency topical corticosteroid and generic tacrolimus 0.1% ointment, and confirmation it will not be used with other JAK inhibitors or potent immunosuppressants; initial approval 1 year.
- Document disease duration/relapse history and prior topical therapy failures.
- Confirm no concomitant JAK inhibitors or potent immunosuppressants.
- Initial approval duration: 1 year.
Submit NPC diagnostic testing and neurologic findings for Aqneursa PA
For Aqneursa (NPC neurologic manifestations), prior authorization must include diagnostic confirmation (genetic/pathologic testing per criteria), age ≥18 or weight ≥15 kg, presence of neurologic manifestations, and confirmation it will not be used with other NPC medications except generic miglustat; initial approval is 1 year.
- Attach genetic testing showing biallelic pathogenic/likely pathogenic NPC1/NPC2 mutations or alternative diagnostic criteria (filipin or oxysterols) as specified.
- Document neurologic manifestations and patient age/weight.
- Confirm no concurrent NPC treatments except generic miglustat.
Provide genetic, transfusion history, and Reblozyl trial info for Aqvesme PA
Aqvesme PA requires genetic confirmation of α/β‑thalassemia, transfusion history and hemoglobin thresholds per transfusion‑dependent or non‑transfusion‑dependent pathways, and for β‑thalassemia document trial/failure/contraindication/intolerance to Reblozyl; initial approval 1 year.
- Provide genetic testing confirming α‑ or β‑thalassemia.
- For non‑transfusion dependent: document RBC units <5 in last 6 months and Hb <10 g/dL.
- For transfusion dependent: document ≥6 RBC units in last 6 months (or 100 mL/kg/year) and prior Reblozyl trial/failure for β‑thalassemia.
Provide indication‑specific evidence and prior trial data for Arcalyst PA
Arcalyst requests must include indication‑specific documentation (diagnosis, age/weight limits, genetic or lab evidence where required) and show prior trial/failure when indicated (e.g., Kineret or NSAID+colchicine for recurrent pericarditis); note Arcalyst must not be used with other biologics/targeted DMARDs.
- Attach diagnostic and laboratory/genetic evidence per the indication (CAPS, DIRA, recurrent pericarditis).
- Document prior trial/failure of Kineret or NSAID+colchicine when required.
- Confirm no concurrent biologics/targeted DMARDs for same indication.
Document MAC diagnosis and age for Arikayce PA
Arikayce PA must document MAC infection diagnosis and patient age ≥18; initial approval is 1 year.
- Provide microbiology/clinical evidence of MAC infection and patient age confirmation.
- Initial authorization duration: 1 year.
Document trials/failures of ≥3 antidepressants for Auvelity
Auvelity PA requires documentation of trials and failures of at least three antidepressant agents prior to coverage; initial approval is 1 year.
- List prior antidepressants tried, durations, and reason for failure/intolerance.
- Initial approval duration: 1 year.
Document tetrabenazine trial/failure for Austedo PA
Austedo PA requests must include diagnosis (chorea associated with Huntington's disease or tardive dyskinesia) and documentation of trial and failure/intolerance to tetrabenazine (Xenazine) when indicated; initial approval is 1 year.
- Provide diagnosis and prior tetrabenazine (Xenazine) trial/failure or rationale for not using tetrabenazine.
- Initial authorization duration: 1 year.
Provide serology/biopsy and prior immunosuppressive trials for Benlysta PA
Benlysta prior authorization requires age ≥5, SLE diagnosis with positive serology on two occasions, renal biopsy confirmation when lupus nephritis only, prior trials of at least two immunosuppressive agents (unless contraindicated), continuation of standard‑of‑care concomitant therapy, and not to be used with other biologics/B‑cell targeted therapies; initial approval is 1 year.
- Attach serology results (two separate positive tests) and renal biopsy if lupus nephritis is the only manifestation.
- Document prior immunosuppressive agent trials and ongoing standard‑of‑care therapies.
- Confirm no concurrent B‑cell targeted biologics.
Document prior pregnancy antiemetic trials for Bonjesta
Bonjesta PA for nausea/vomiting of pregnancy requires age ≥18 and documentation of trial/failure of doxylamine/pyridoxine combination and generic Diclegis prior to approval.
- Document prior trial and inadequate response to doxylamine/pyridoxine combination and to generic Diclegis.
- Confirm patient age ≥18.
Document PAH diagnosis and check formulary for bosentan
bosentan (Tracleer) PA for PAH requires documentation of pulmonary arterial hypertension (WHO Group 1); some formulations (suspension) may be marked NC on certain lists — check formulary flags.
- Provide diagnostic evidence supporting WHO Group 1 PAH.
- Verify program/formulary applicability and NC status for specific formulations (e.g., suspension).
Document imatinib and dasatinib trial/failure for bosutinib PA
bosutinib (Bosulif) PA requires documentation of Ph+ CML per phase and prior trial/failure or intolerance to imatinib and dasatinib.
- Provide CML phase documentation and evidence of imatinib and dasatinib trial and failure/intolerance.
Include Bronchitol tolerance test and CF use plan
Bronchitol PA requires documentation that it will be used as add‑on maintenance for CF, patient age ≥18, proof of passing the Bronchitol Tolerance Test, and instruction that a short‑acting bronchodilator be taken 5–15 minutes before each dose.
- Provide CF diagnosis and age confirmation (≥18).
- Include Bronchitol Tolerance Test result.
- Document plan to use short‑acting bronchodilator prior to dosing.
Document HCM severity, LVEF, LVOT gradient, and prior therapy for Camzyos PA
Camzyos PA must document symptomatic obstructive hypertrophic cardiomyopathy (NYHA II–III), age ≥18, LVEF >55%, LVOT peak gradient ≥50 mmHg, and trial/failure/intolerance to a non‑vasodilating beta blocker or nondihydropyridine CCB at maximally tolerated dose; renewal requires clinical benefit and LVEF ≥50%.
- Provide NYHA class, LVEF, and LVOT gradient measurements.
- Document trial/failure or intolerance to a non‑vasodilating beta blocker or nondihydropyridine CCB.
Provide biochemical/genetic confirmation for Cerdelga PA
Cerdelga PA requires biochemical assay confirmation of Gaucher disease type 1 and genotyping showing two pathogenic GBA mutations plus CYP2D6 genotyping; include clinical manifestations to support therapy.
- Attach enzymatic assay and genotyping results demonstrating two pathogenic GBA mutations.
- Include CYP2D6 genotyping and clinical symptom documentation.
Document long‑acting opioid trials and avoid concurrent long‑acting opioids for Belbuca PA
Belbuca PA requires documentation of moderate‑to‑severe chronic pain needing around‑the‑clock opioid analgesia and trial/failure/intolerance to two long‑acting opioids (one must be buprenorphine patch); concurrent multiple long‑acting opioids are not covered.
- Document prior trials/failures of two long‑acting opioids (one buprenorphine patch).
- Confirm patient is not on more than one long‑acting opioid concurrently.
Document required prior trials and obtain PA to avoid denial
Many listed drugs require prior authorization with diagnosis, age, and documented trial/failure of preferred or specified prior therapies; failure to document required prior trials or obtain PA may result in denial and member financial responsibility.
- Provide documentation of required prior trials, durations, and reasons for failure/intolerance.
- Obtain prior authorization before dispensing when listed; missing PA or unmet step therapy may lead to denial and member liability.
Document prior MS therapy failure for Cladribine PA
Cladribine prior authorization requires trial/failure or intolerance to one generic/preferred MS medication (examples provided); initial approval is 1 year and renewal requires clinical benefit.
- List prior MS medications tried and reason for failure/intolerance.
- Initial approval duration: 1 year; renewal requires evidence of benefit.
Include age, transfusional iron overload diagnosis, and prior chelation failure for deferiprone PA
Deferiprone PA requires patient age criteria (typically ≥8 years for initial criteria), diagnosis of transfusional iron overload due to thalassemia with inadequate chelation, and documentation of failure/intolerance to generic Jadenu or Exjade; initial approval is 1 year.
- Provide age and diagnosis documentation and prior chelation history.
- Document failure or intolerance to Jadenu or Exjade.
Provide HIV risk status and negative HIV test for Descovy (PrEP) PA/renewal
Descovy (PrEP) prior authorization requires that the member is high‑risk, not on concomitant antiretroviral therapy, and for renewal include a negative HIV test within the past 3 months.
- Document high‑risk indication and absence of concomitant ART.
- For renewals, attach negative HIV test within last 3 months.
Document platelet counts and prior therapy for Doptelet PA
Doptelet PA requires documentation of indication‑specific platelet thresholds and prior therapy failures where applicable; initial approval durations vary by indication (e.g., 60 days for chronic liver disease, 3 months for chronic ITP) and renewals require recent platelet counts and evidence of clinical benefit.
- Provide platelet counts and indication (chronic liver disease vs chronic ITP) with supporting labs.
- Attach documentation of prior therapies tried and responses as applicable.
- Note initial approval duration varies by indication.
Document indication, prior trials, corticosteroid taper plan, and no combined biologics for Dupixent PA
Dupixent requests must document indication‑specific criteria (age thresholds, diagnosis confirmation where required, prior trials/optimization of listed therapies, and when indicated a plan for use with a tapering course of oral corticosteroids); Dupixent must not be used in combination with other biologics/targeted DMARDs for the same indication. Initial approval for AD is 6 months; other indications commonly 1 year.
- Attach evidence of diagnosis and age eligibility (e.g., bullous pemphigoid: biopsy/serology; AFRS: history of sino‑nasal surgery and age ≥6).
- Document trials/failure of required prior agents (e.g., second‑generation antihistamine trial ≥2 months plus one additional agent) or note why age‑inappropriate.
- Provide a corticosteroid taper plan where required (e.g., bullous pemphigoid: prednisone taper until disease control).
- Confirm Dupixent will not be combined with other biologics/targeted DMARDs for the same indication.
- Initial approval: AD = 6 months; other indications often 1 year.
Document 2‑month second‑generation antihistamine trial and additional agent failure
Prior authorization requires documented trial and failure of a second‑generation antihistamine at maximal tolerated dose for ≥2 months plus trial/failure of one additional agent from a specified list (H2 antagonist, leukotriene receptor antagonist, first‑generation antihistamine at bedtime, hydroxyzine or doxepin when age‑appropriate); failure to document these trials may trigger denial.
- Provide dates, dosages, and outcomes for second‑generation antihistamine trial (≥2 months).
- Document trial and inadequate response to one additional listed agent at maximal dosing.
Provide biopsy/serology and corticosteroid taper plan for bullous pemphigoid PA
For bullous pemphigoid, PA must include diagnosis confirmation by skin biopsy or serology, patient age ≥18, and a documented plan to use Dupixent in combination with a tapering course of oral corticosteroids (e.g., prednisone) until disease control; absence of biopsy/serology or steroid plan may result in denial.
- Attach skin biopsy or serology confirming bullous pemphigoid.
- Document age (≥18) and a corticosteroid taper plan (e.g., prednisone course until disease control).
- Failure to provide biopsy/serology or taper plan is a denial trigger.
Document failure of listed alternative therapies before specialty biologics
Prior authorization routinely requires documentation of trials and failure of at least one alternative therapy (examples include another second‑generation antihistamine, H2 antagonist, leukotriene receptor antagonist, first‑generation antihistamine at bedtime, hydroxyzine or doxepin when age‑appropriate); lack of these documented trials increases denial risk.
- List prior alternatives tried with durations and failure reasons.
- Ensure maximal dosing trials are documented where required.
Request appropriate initial approval duration (AD = 6 months; others commonly 1 year)
Initial authorization durations: atopic dermatitis approvals are commonly 6 months; many other specialty agents have initial approvals of 1 year — include the requested initial approval period in the PA.
- Specify initial approval duration requested (AD = 6 months; many others = 1 year).
- Provide supporting documentation for duration selection.
Document required step therapy trials and Preferred Therapy Program conditions
When a therapy is subject to step therapy, document trials of preferred, clinically sound, cost‑effective drugs (often generics or preferred formulary agents) before requesting non‑preferred/brand alternatives; Preferred Therapy Program may require the brand not be filled in the last 180 days to qualify.
- Provide medication history showing trials of preferred/generic agents and dates.
- If relying on Preferred Therapy Program, confirm no brand fill in prior 180 days when applicable.
Document generic stimulant trials or swallow‑inability for Adzenys ER PA
Adzenys ER PA (ADHD) requires documentation of age ≥6 and treatment failure or intolerance to both a generic methylphenidate and a generic amphetamine product (one must be long‑acting), or documentation that the patient cannot swallow tablets/capsules and failed sprinkle options.
- Document trials and failures of a generic methylphenidate and a generic amphetamine (one long‑acting).
- If inability to swallow is claimed, provide evidence and prior attempt of sprinkle agent.
Document trials of two generic triptans before almotriptan approval
Almotriptan (Axert) step therapy requires trial of two generic triptans (examples: sumatriptan/Imitrex, rizatriptan/Maxalt, naratriptan/Amerge, zolmitriptan/Zomig) prior to approval; document those trials.
- Provide dates and outcomes for trials of two different generic triptans.
- Initial approval commonly 1 year.
Document sequential biologic/DMARD trials per step therapy lists
Multiple biologics require sequential trials of preferred biologics/DMARDs (lists vary by indication — e.g., Cimzia/Cosentyx require documented failure of specified biosimilars/agents); include exact prior biologic/DMARD trial dates, doses, and reasons for failure/intolerance.
- List each biologic/DMARD trial with dates, dosing, and clinical response or intolerance.
- Where biosimilar preference is listed, indicate use of preferred biosimilar when applicable.
Document NSAID trials and ensure no concurrent oral NSAIDs for topical diclofenac
For certain topical/oral products (e.g., diclofenac 2% external solution), PA requires prior trials of generic oral/topical NSAIDs and Pennsaid; coverage will not be provided if the member is on concurrent oral NSAIDs.
- Document trials/intolerance to generic oral diclofenac and at least two other oral NSAIDs and trial of Pennsaid 1.5% topical.
- Confirm there is no concurrent oral NSAID therapy at time of request.
Submit oncology PA with FDA/NCCN alignment via OncoHealth/Availity
Oncology PA submissions must be sent through OncoHealth via Availity and include documentation that use is consistent with FDA labeling or, for off‑label uses, NCCN/consensus guidelines; approvals range from 60 days up to six months.
- Use Availity to submit oncology/supportive care PA requests to OncoHealth.
- Include evidence of guideline‑consistent use (FDA or NCCN/consensus) for off‑label indications.
Include prior trials, indication, and safety/abuse info in PA
Providers must document prior trials of preferred alternatives (per step therapy rules), indication, and any safety/abuse considerations in the PA; absence of this supporting clinical documentation is a common denial trigger.
- Include medication history showing prior trials and failures, pertinent diagnoses, and safety/abuse risk notes.
- Missing prior trial documentation or missing PA are grounds for denial.
Submit factor levels, inhibitor titers, bleed history, and treatment center info for hemophilia PA
For hemophilia agents (e.g., Alhemo), include factor levels, inhibitor titers (Bethesda Units/mL), number of bleeds in the past 12 months, documentation of prior prophylactic factor therapy effectiveness, and that prescriptions are by specialists at accredited hemophilia treatment centers.
- Provide factor VIII level and inhibitor titer (>5 BU/mL when applicable) and bleed history in last 12 months.
- Confirm specialist prescriber and dispensing at an accredited hemophilia treatment center.
- Document trial/failure or intolerance to Hemlibra when required.
Provide C4/C1‑INH labs and attack history for HAE agents
HAE documentation: include laboratory confirmation (C4 below lab normal range and C1‑INH antigenic or functional below lab normal), documentation of attack frequency/severity, prescriber specialty, and confirmation the agent won’t be used with other HAE prophylaxis products; failure to include labs or attack history may cause denial.
- Attach lab reports showing C4 and C1‑INH results per lab reference ranges.
- Document attack frequency (≥2/month) or history of severe attacks and prescriber specialty.
- Confirm no concurrent HAE prophylaxis products.
Provide attack‑reduction data (≥50%) for HAE renewals
For Dawnzera (HAE) renewal, include documentation demonstrating improvement (≥50% reduction in number or severity of attacks) and recent attack counts in prior 6 months; for Andembry renewal likewise show ≥50% reduction.
- Submit attack counts for the prior 6 months and documentation showing ≥50% reduction in attacks or severity.
- Include treatment start/response timeline.
Avoid concurrent sedative hypnotics or concurrent HAE prophylaxis (denial risk)
Dawnzera and Dayvigo: Dayvigo will not be approved for combination therapy with other sedative hypnotics — propose no concurrent sedative hypnotic use; Dawnzera and other HAE agents must not be used with other HAE prophylaxis products.
- Confirm no concurrent sedative hypnotics when requesting Dayvigo.
- Confirm no concurrent HAE prophylaxis products for Dawnzera.
Include age and prior chelation failure for deferiprone PA
Deferiprone PA: include patient age (≥8 years per initial criteria or noted alternate age entries), transfusional iron overload diagnosis, and failed/intolerant chelation history (Jadenu/Exjade); initial approval 1 year and renewal requires clinical benefit.
- Provide age and documentation of inadequate response to Jadenu or Exjade.
- Initial approval duration: 1 year; renewal requires evidence of benefit.
Include recent negative HIV test for Descovy renewal
Descovy (PrEP) renewals must include a negative HIV test within the past 3 months; initial approval is 2 years for high‑risk members not on ART.
- Attach negative HIV test within 3 months for renewal requests.
- Document high‑risk status and no concomitant ART for initial PA.
Attach age, biopsy/serology, sino‑nasal surgery history, and prior trial records for Dupixent PA
Required supporting documentation for Dupixent and related indications: include patient age, diagnosis confirmation (e.g., skin biopsy or serology for bullous pemphigoid), history of sino‑nasal surgery for AFRS, and records of prior trials/failures of listed adjunctive agents (second‑generation antihistamine ≥2 months plus an additional agent).
- Attach biopsy/serology for bullous pemphigoid and operative history for AFRS.
- Provide prior medication trial records (second‑generation antihistamine ≥2 months and one additional listed agent).
Provide complete supporting clinical documentation to avoid denial
Supporting clinical documentation must confirm diagnosis (e.g., biopsy/serology for bullous pemphigoid), prior trials of required agents, and a plan for adjunctive therapy where required (e.g., corticosteroid taper for bullous pemphigoid); missing these items may trigger denial.
- Provide concrete prior trial dates/doses and objective diagnostic test results.
- Include corticosteroid taper plan when policy requires combination therapy.
Document sino‑nasal surgery history and age ≥6 for AFRS PA
For AFRS, required documentation includes patient age (≥6 years) and a history of sino‑nasal surgery; absence of surgical history or age documentation may result in denial.
- Attach operative report or clinical documentation of prior sino‑nasal surgery.
- Verify patient age (≥6 years) for AFRS pathway.
Attach all required diagnostic tests and prior trial records to avoid NC/denial
When required clinical documentation (e.g., biopsy/serology for bullous pemphigoid, sino‑nasal surgery for AFRS, lab confirmation for HAE) is missing, requests are at high risk of denial or being marked NC; providers should ensure all required tests and records are attached.
- Check that diagnostic tests and prior trial documentation are included before submission.
- Incomplete documentation commonly triggers denials or Not Covered (NC) designations.
Avoid common denial triggers: missing PA, unmet steps, missing diagnostics, or concurrent biologics
Denial triggers include missing prior authorization or unmet step therapy requirements (documented trials and failures of required agents), missing diagnostic confirmation (e.g., biopsy/serology for bullous pemphigoid), absence of required steroid taper plan, or proposing concurrent biologic/DMARD therapy for the same indication.
- Obtain required PA and document step therapy trials/failures.
- Attach required diagnostic confirmation and corticosteroid taper plans where indicated.
- Do not request concurrent biologic/targeted DMARD use for the same indication.
Initial Therapy Criteria and Approval Durations
Continuation / Renewal Criteria
Step Therapy Requirements and Tables
| Requirement | Details |
|---|---|
| Must document prior trials of specified preferred agents before approval of non-preferred/brand or higher-cost alternatives. | |
| Providers should document trials, failures, contraindications, or intolerance to the listed preferred agents as evidence for step therapy prior to approval (see drug-specific entries for required agents). |
| Drug | Step therapy requirement |
|---|---|
| Adzenys ER (amphetamine suspension) | |
| Treatment failure or intolerance to both a generic methylphenidate AND a generic amphetamine product (one must be long‑acting) OR inability to swallow with failed sprinkle option (tried/opened sprinkle agent). |
| Drug | Step therapy requirement |
|---|---|
| Almotriptan (Axert) | |
| Trial of two different generic triptans required (examples listed: Imitrex, Maxalt, Amerge, Zomig/ZMT) prior to approval. |
| Scope | Requirement |
|---|---|
| Various single-entity and specialty drugs (examples in document) | |
| Documented trial and inadequate response, contraindication, or intolerance to the specified prior therapies listed in each drug entry is required before coverage; specifics vary by drug (e.g., Auvelity: trial/failure of ≥3 antidepressants; bosutinib: trial/failure of imatinib and dasatinib). |
| Context | Step requirement |
|---|---|
| Drugs with specified prior alternatives (e.g., oncology, cardiology) | |
| Must document trial and failure/intolerance or contraindication to specified therapies noted for the indication (examples include prior beta‑blocker or nondihydropyridine CCB for Camzyos; imatinib/dasatinib for bosutinib). |
| Situation | Requirement |
|---|---|
| Biologics and targeted DMARDs for immunologic/autoimmune indications | |
| Step therapy requires sequential trials of preferred biologics/DMARDs or designated agents as listed for each indication (example: Cimzia for Crohn's requires trial/failure of specified biosimilars and other biologics). |
| General rule | Examples |
|---|---|
| Prior trials or failures are required as listed per drug before the requested agent will be approved. | |
| Examples: Desvenlafaxine ER requires trial/failure of ≥3 antidepressants; Dexilant requires failure/intolerance to four generic PPIs; Doryx/Doxycycline entries require trial/failure of generic doxycycline formulations. Specific lists are in each drug entry. |
| Requirement | Supporting detail |
|---|---|
| Must document trials/failures of required agents before approval | |
| For allergic/urticarial and related non‑bullous indications, prior documented trial and inadequate response to a second‑generation antihistamine at maximal tolerated dose for ≥2 months plus failure of one additional listed agent is required (see drug-specific step lists). |
| Alternatives to try | Notes |
|---|---|
| Examples include: another second‑generation antihistamine; H2 antagonist; leukotriene receptor antagonist; first‑generation antihistamine at bedtime; hydroxyzine when age‑appropriate; doxepin when age‑appropriate. | |
| These alternatives are referenced as required or prior/concomitant therapies before biologic therapy (e.g., dupilumab) for relevant indications; documentation of trials at maximal dosing is expected. |
| Context | Requirement |
|---|---|
| Dupixent (dupilumab) — select indications | |
| Policy references prior or concomitant therapies (multiple antihistamines, H2 antagonists, leukotriene receptor antagonists, first‑generation antihistamine at bedtime, hydroxyzine, doxepin) to be trialed or optimized prior to authorization for some indications. |
| Optimization requirement | Exception |
|---|---|
| Prior optimization with listed antihistamines and adjunct agents is expected (document trials at maximal tolerated doses for ≥2 months where specified). | |
| If agents are age‑inappropriate for the member, documentation that the agent is not suitable for the patient's age should be provided instead of trial. |
| Listed adjunct/alternative agents | Context |
|---|---|
| Documented trial (and failure/intolerance) of at least one of: another second‑generation antihistamine; H2 antagonist; leukotriene receptor antagonist; first‑generation antihistamine at bedtime; hydroxyzine when age‑appropriate; doxepin when age‑appropriate. | |
| These agents are listed as prior or adjunctive therapies in the policy and are referenced in authorization requirements for several allergic/atopic indications. |
| Adjunct agents and corticosteroid use | Policy expectation |
|---|---|
| Adjunctive/alternative agents: second‑generation antihistamines, H2 antagonists, leukotriene receptor antagonists, first‑generation antihistamine at bedtime, hydroxyzine or doxepin where age‑appropriate. | |
| For certain indications (notably some Dupixent indications and bullous pemphigoid), Dupixent is expected to be used in combination with a tapering course of oral corticosteroids until disease control; documentation of this plan is required. |
| Indication | Requirement |
|---|---|
| Bullous pemphigoid | |
| Dupixent (for bullous pemphigoid) must be used in combination with a tapering course of oral corticosteroids (e.g., prednisone) until disease control has occurred; diagnosis must be confirmed by skin biopsy or serology and age ≥18. |
| Reference | Interpretation |
|---|---|
| Policy excerpts (multiple chunks) | |
| The policy repeatedly references use of a tapering course of oral corticosteroids in bullous pemphigoid prior to/during Dupixent therapy; explicit prior step failures for biologic initiation are not always enumerated in these excerpts but documentation of the corticosteroid plan and biopsy/serology confirmation is required. |
| Indication | Combination therapy instruction |
|---|---|
| Bullous pemphigoid | |
| Dupixent is to be used in combination with a tapering course of oral corticosteroids (e.g., prednisone) until disease control has occurred; provide documentation of plan and disease control monitoring. |
Key Clinical Thresholds and Coding-related Values
Site of Care / Administration Notes
Biosimilar Preferences and Prior Agents
adalimumab — required prior agent (biosimilar)
Preferred adalimumab biosimilar is listed as a required prior agent in multiple biologic step‑therapy sequences; document trials of preferred biosimilars where required before requesting alternative biologics.
ustekinumab — preferred biosimilar prior trial
Preferred ustekinumab biosimilar appears among required prior‑therapy lists for psoriasis/psoriatic disease; include documentation of prior trial of preferred ustekinumab biosimilar when applicable.
Background and Policy Scope
Prior authorization and step therapy are utilization management tools that ensure medications are used safely, effectively, and in a cost‑effective manner. Prior authorization is a payer review required before the plan will cover certain drugs, and step therapy requires documented trials and inadequate response (or contraindication/intolerance) to preferred alternatives before approving higher‑cost or non‑preferred agents. For oncology and supportive‑care drugs covered under the pharmacy benefit, prior authorization requests are submitted through the Oncology Value Management program (OncoHealth) via Availity and approvals may be issued for periods ranging from about 60 days up to six months.
Definitions and Terms
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.