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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsPriority Health Medicare Drug Prior Auth | OpenPay…
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    CurrentPriority Health MedicarePolicy N/A

    Pharmacy Drug Prior Authorization Criteria

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    This manual governs prior authorization requirements for medications covered under Priority Health pharmacy benefits, including requests exceeding Approved Drug List coverage limits. Coverage depends on the member’s prescription drug plan and the plan-specific Approved Drug List.

    Policy Summary
    PayerPriority Health Medicare
    PolicyPharmacy Drug Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit the applicable pharmacy drug request form or electronic prior authorization after confirming coverage and requirements in the plan-specific Approved Drug List.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    120 MEqD/dayOpioid dose limit
    2Generic oral iron therapies before Accrufer
    12 monthsStandard approval duration
    8 weeksHigh-intensity statin trial

    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.

    4+ days/month
    Migraine frequency threshold
    3Drug groups covered

    Medication Coverage Criteria

    Initial Therapy and Drug-Specific Coverage Criteria

    Covered when the applicable drug-specific initial-therapy criteria below are met.

    Initial therapy criteria

    • Opioid quantity and dose-limit exception

      • Requests exceeding 120 MEqD (morphine equivalent dose per day) require an opioid treatment agreement; documented chronic pain due to a medical condition; documented taper or taper attempt, or valid rationale why taper was not attempted; routine validated pain/function assessments showing sustained improvement; non-drug therapy tried within 18 months or contraindicated; concurrent non-opioid medication unless contraindicated; documentation supporting safety when opioids are used with benzodiazepines, sedative-hypnotics, barbiturates, or other harmful interacting drugs; and naloxone education.
      • Individual drug quantity limits, step therapy, and other utilization management continue to apply. Non-preferred long-acting opioids require prior authorization.
      • When approved, opioid treatment may be authorized for the necessary duration, up to 12 months.
    • Accrufer initial therapy

      • Diagnosis of iron deficiency anemia.
      • Baseline pre-treatment hemoglobin and ferritin are documented.
      • Inadequate response to two different generic oral iron therapies.
    • Acthar initial therapy

      • Diagnosis of infantile spasms.
      • Patient is younger than 2 years of age.
    • Adalimumab Crohn's disease

      • Prescriber is a specialist or has consulted a specialist.
      • Moderate-to-severe Crohn's disease.
      • Adequate conventional therapy, such as steroids for 7 days or an immunomodulator such as azathioprine for at least 2 months, was tried and failed or is contraindicated or not tolerated.
    • Adalimumab ulcerative colitis

      • Moderate-to-severe ulcerative colitis.
      • Adequate conventional therapy, such as steroids for 7 days or an immunomodulator such as azathioprine for at least 2 months, was tried and failed or is contraindicated or not tolerated.
    • Adalimumab autoimmune and inflammatory indications

      • For uveitis, the patient tried one other agent, such as periocular, intraocular, or systemic corticosteroids or an immunosuppressive agent.
      • For hidradenitis suppurativa, the patient tried at least one other agent, such as corticosteroids, systemic antibiotics, or isotretinoin.
      • For plaque psoriasis, the patient tried one traditional non-biologic systemic agent for at least 3 months.
      • For psoriatic arthritis, the patient tried one traditional non-biologic systemic agent for at least 3 months.
      • For ankylosing spondylitis, no specific induction criterion applies when the general initiation criteria are met.
      • For rheumatoid arthritis, the patient tried one traditional non-biologic systemic agent for at least 3 months.
    • Adalimumab juvenile idiopathic arthritis

      • The patient tried at least one other agent, will start adalimumab concurrently with methotrexate, sulfasalazine, or leflunomide, or has aggressive disease as determined by the prescriber.
    • Adbry initial therapy

      • Prescriber is a specialist or has consulted a specialist.
      • Moderate-to-severe atopic dermatitis.
      • Tried one medium- to high-potency topical corticosteroid for at least 3 months or one topical calcineurin inhibitor for at least 3 months.
    • PCSK9 inhibitor coverage

      • For hypercholesterolemia with or without ASCVD, HoFH, or HeFH, tried high-intensity atorvastatin at least 40 mg daily or rosuvastatin at least 20 mg daily continuously for at least 8 weeks, with LDL-C remaining above goal.
      • Not used with another PCSK9 inhibitor, Leqvio, Nexletol, or Nexlizet.
      • For a non-preferred product, prescribed by a cardiologist, endocrinologist, or board-certified lipidologist, with trial and failure or intolerance/contraindication to the preferred product and an additional statin.
    • Acute migraine treatment

      • Migraine with or without aura; patient is at least 18 years old; and has tried one triptan, such as sumatriptan, rizatriptan, naratriptan, or zolmitriptan.
      • For a non-preferred product, trial and failure or intolerance/contraindication to the preferred product and an additional triptan.
    • Migraine initial therapy

      • Migraine with or without aura and at least four migraine days per month.
      • Tried any two of the following: antidepressants, beta blockers, or antiepileptics.
      • For non-preferred therapy, trial and failure, intolerance, or contraindication to Aimovig, Emgality, and Ajovy for 3 continuous months each without adequate reduction in migraines.
    • Emgality cluster headache initial therapy

      • Patient is at least 18 years old and has episodic cluster headache.
      • Tried and failed at least two of injectable or intranasal triptans, oxygen therapy, verapamil, topiramate, or valproate.
    • Non-preferred antimigraine therapy

      • Trial and failure, intolerance, or contraindication to the preferred product and required additional triptan or preventive therapy, as applicable.
    • Miscellaneous antiretroviral initial therapy

      • Heavily treatment-experienced adult with multidrug-resistant HIV-1; confirmed HIV infection with failure of the current regimen, baseline HIV-1 RNA at least 400 copies/mL, and no viable combination regimen because of documented resistance to at least two agents in three of four major ARV classes.
      • Used with an optimized background ARV regimen and resistance testing documents full susceptibility to at least one other ARV.
      • Non-preferred products require trial and failure or intolerance/contraindication to the preferred product.
    • Arcalyst initial therapy

      • Diagnosis of CAPS, including FCAS or MWS, in adults or children at least 12 years; DIRA in adults or children weighing at least 10 kg; or recurrent pericarditis in adults or children at least 12 years.
    • Arikayce initial therapy

      • MAC lung disease documented by sputum culture submitted to Priority Health.
      • Failure to obtain a negative sputum culture after at least 6 consecutive months of a multidrug regimen, such as clarithromycin or azithromycin, rifampin, and ethambutol.
      • Used only as part of a multidrug regimen and prescribed by or in consultation with an infectious-disease specialist.
    • Benlysta initial therapy

      • For active autoantibody-positive SLE: age at least 5 years, ANA at least 1:80 or anti-dsDNA at least 30 IU/mL, and active disease with SELENA-SLEDAI score greater than 6 despite standard therapy for at least 12 weeks.
      • For biopsy-proven lupus nephritis class III-V: age at least 5 years, ANA at least 1:80 or anti-dsDNA at least 30 IU/mL, active renal disease requiring standard therapy, and eGFR at least 30 mL/min/1.73m2.
    • Besremi initial therapy

      • High-risk polycythemia vera, age at least 18 years, prescribed by or in consultation with hematology/oncology.
      • Trial and failure of hydroxyurea and pegylated interferon-alfa 2a; ECOG 0-2; and eGFR at least 30 mL/min/1.73m2.
    • Bimzelx general and diagnosis-specific coverage

      • Prescriber is a specialist or has consulted a specialist.
      • Plaque psoriasis: traditional non-biologic systemic agent for at least 3 months and at least two of adalimumab, Cosentyx, Enbrel, Otezla/XR, or ustekinumab for at least 3 months each.
      • Hidradenitis suppurativa: at least one other agent and at least two of Cosentyx, adalimumab, or infliximab for at least 3 months each.
      • Ankylosing spondylitis: at least two of adalimumab, Cosentyx, Enbrel, or Xeljanz/XR for at least 3 months each.
      • Non-radiographic axial spondyloarthritis: objective inflammation by elevated CRP and/or MRI sacroiliitis, plus at least two of Cimzia or Cosentyx for at least 3 months each.
      • Psoriatic arthritis: traditional non-biologic systemic agent for at least 3 months and at least two of adalimumab, Cosentyx, Enbrel, Otezla/XR, ustekinumab, or Xeljanz/XR for at least 3 months each.
    • Cablivi initial therapy

      • Age at least 18 years and diagnosis of acquired TTP with thrombocytopenia and microscopic red-cell fragmentation.
      • Administered with plasma exchange and immunosuppressive therapy and continued for 30 days after plasma exchange ends.
    • Initial cardiac myosin inhibitor therapy

      • Symptomatic NYHA class II or III obstructive hypertrophic cardiomyopathy, age at least 18 years, LVEF at least 55%, and prescribed by or in consultation with a cardiologist.
      • Trial and failure for at least 30 days, intolerance, or contraindication to both a beta blocker and a calcium-channel blocker.
    • Initial carglumic acid therapy

      • Deficiency of N-acetylglutamate synthase and acute or chronic hyperammonemia.
    • Initial Cayston therapy

      • Cystic fibrosis with appropriate documentation, age at least 7 years, and Pseudomonas aeruginosa confirmed by positive airway culture.
      • Aztreonam is the only sensitive inhaled antibiotic, or tobramycin inhalation solution was unsuccessful, not tolerated, contraindicated, or the isolate is resistant.
    • Cholbam initial therapy

      • Bile-acid synthesis disorder due to a single-enzyme defect or peroxisomal disorder; serum VLCFA and baseline liver-function tests submitted.
    • Cibinqo initial therapy

      • Specialist involvement; moderate-to-severe atopic dermatitis; medium/high-potency topical corticosteroid or topical calcineurin inhibitor for at least 3 months; and at least two of Dupixent, Adbry, or Nemluvio for at least 3 months each.
    • Cimzia initial therapy

      • Specialist involvement and diagnosis-specific criteria: ankylosing spondylitis requires at least two of adalimumab, Cosentyx, Enbrel, or Xeljanz/XR; nr-axSpA requires objective inflammation; Crohn's disease requires moderate-to-severe disease, failed or contraindicated conventional therapy, and at least one of adalimumab, infliximab, or ustekinumab; juvenile idiopathic arthritis requires at least two of adalimumab, Enbrel, tocilizumab, or Xeljanz/XR; psoriatic arthritis, rheumatoid arthritis, and plaque psoriasis require the specified traditional systemic agent plus at least two preferred biologic/targeted agents.
    • Cobenfy initial therapy

      • Schizophrenia, age at least 18 years, failed or cannot use two atypical antipsychotics for at least 28 days each, and specialist involvement.
    • Cosentyx initial therapy

      • Specialist involvement; plaque psoriasis or psoriatic arthritis requires a traditional non-biologic systemic agent for at least 3 months; ankylosing spondylitis has no specific induction criterion beyond general criteria; nr-axSpA requires objective inflammation; hidradenitis suppurativa requires at least one other agent.
    • Crenessity initial therapy

      • Genetically confirmed classic CAH due to 21-hydroxylase deficiency; age at least 4 years; stable and compliant glucocorticoid dose for at least 1 month exceeding 13 mg/m2/day hydrocortisone equivalents; inability and medical necessity to lower the dose; and specialist involvement.
    • Cresemba initial therapy

      • Invasive aspergillosis or mucormycosis; failed, intolerant of, or contraindicated to voriconazole or itraconazole; and specialist involvement.
    • CFTR modulator initial therapy

      • Cystic fibrosis documented within the prior 12 months using an approved CF diagnosis code, and the requested formulation matches the FDA-labeled age formulation.
    • Dalfampridine ER initial therapy

      • Multiple sclerosis, age 18-70 years, receiving immunomodulatory therapy unless not indicated, and significant continuous walking impairment despite optimal MS treatment.
      • Does not require a wheelchair; can walk 20 meters without resting; baseline T25FW is 8-45 seconds or EDSS is at least 4.5 and less than 7.
    • Initial therapy for multiple sclerosis walking impairment

      • Meets the MS diagnosis, age, treatment, ambulation, T25FW/EDSS, and functional-impairment requirements above.
    • Initial Daybue therapy

      • Classic/typical Rett syndrome with MECP2 mutation; baseline objective severity assessment; in-depth behavioral assessment by an appropriate specialist; age at least 2 years; and specialist involvement.
    • Initial Diacomit therapy

      • Dravet syndrome, age at least 2 years, adjunctive use with clobazam, and failure of valproate and clobazam.
    • Initial Droxidopa therapy

      • Symptomatic neurogenic orthostatic hypotension from primary autonomic failure, dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy, excluding other causes.
      • Tried at least two non-pharmacologic interventions and trial/failure, intolerance, or contraindication to both midodrine and fludrocortisone; specialist involvement.
    • Dupixent atopic dermatitis

      • Moderate-to-severe atopic dermatitis and trial of a medium/high-potency topical corticosteroid or topical calcineurin inhibitor for at least 3 months.
    • Dupixent moderate-to-severe asthma

      • Eosinophilic asthma with eosinophils over 150 cells/mcL in the prior 12 months or daily oral-corticosteroid dependence; ICS plus another controller; and at least one exacerbation in the prior year.
    • Dupixent CRSwNP

      • Used as add-on maintenance treatment for inadequately controlled chronic rhinosinusitis with nasal polyposis.
    • Dupixent moderate-to-severe COPD

      • COPD with FEV1/FVC less than 0.7 and FEV1 30-70%, eosinophils over 300 cells/mcL, symptoms, failure of LABA/LAMA or triple therapy after at least 3 months, continued background therapy, qualifying exacerbation, and current non-smoking status.
    • Dupixent prurigo nodularis

      • Moderate-to-severe disease with WI-NRS at least 7 and at least 20 nodules, after medium/high-potency topical corticosteroid and topical calcineurin inhibitor each for at least 3 months.
    • Dupixent eosinophilic esophagitis

      • Biopsy-confirmed EoE with at least 15 eos/hpf and failure of dietary modification, a proton-pump inhibitor for at least 2 months, and topical corticosteroid for at least 2 months.
    • Dupixent chronic urticaria

      • Age at least 12 years and failure of either two or more H1 antihistamines or one H1 antihistamine plus an H2 antihistamine, oral corticosteroid, or leukotriene modifier.
    • Dupixent bullous pemphigoid

      • Moderate-to-severe disease with BPDAI at least 24 and weekly Peak Pruritus NRS at least 4; failure of medium/high-potency topical corticosteroid, oral corticosteroid, and a traditional non-biologic systemic agent, each for at least 3 months.
    • Enbrel general initiation

      • Prescriber is a specialist or has consulted a specialist for the condition.
    • Enbrel indication-specific therapy

      • Plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis require the specified traditional non-biologic systemic agent for at least 3 months; ankylosing spondylitis has no additional specific induction criterion.
      • Juvenile idiopathic arthritis requires one other agent, concurrent methotrexate/sulfasalazine/leflunomide, or aggressive disease.
    • Enbrel initial therapy

      • General and diagnosis-specific Enbrel criteria are met.
    • Enspryng initial therapy

      • NMOSD documented, AQP4 antibody positive, at least one attack requiring rescue therapy in the prior year or two in the prior 2 years, specialist neurologist involvement, progressive disease on a rituximab trial, and EDSS no greater than 7.
    • Entyvio SC initial therapy

      • Specialist involvement; moderate-to-severe Crohn's disease or ulcerative colitis; failed or contraindicated conventional therapy; and failed at least two specified biologic/targeted agents for the applicable indication.
    • Eohilia initial therapy

      • Biopsy-confirmed EoE with at least 15 eos/hpf; failure of dietary modification, PPI for at least 2 months, and topical corticosteroid for at least 2 months; age at least 1 year; and gastroenterologist or allergist involvement.
    • Epidiolex initial therapy

      • Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex; adjunctive seizure treatment; age at least 1 year; and failure, intolerance, or contraindication to at least two generic anticonvulsants.
    • Evrysdi initial therapy

      • SMA diagnosed by genetic testing with biallelic SMN1 mutations, no more than two SMN2 copies or symptoms before 6 months, symptomatic but not advanced disease, baseline validated motor assessment, and prescription by or consultation with an SMA-experienced neurologist.
    • Fasenra initial therapy

      • Severe eosinophilic asthma with eosinophils over 150 cells/mcL, ICS plus another controller, and an exacerbation in the prior year.
      • EGPA with eosinophils over 1,000 cells/mcL or at least 10% and trial of systemic corticosteroid or immunosuppressive therapy.
      • HES without an identifiable secondary non-hematologic cause, at least two flares in 12 months or eosinophils at least 1,000 cells/mcL, and stable standard therapy.
    • Fentanyl citrate lozenge initial therapy

      • Age at least 16 years; breakthrough cancer pain; and tolerance of around-the-clock opioid therapy for persistent cancer pain.
      • Quantity limited to 120 lozenges per 30 days; quantity-limit exception requires the designated request form.
    • Filsuvez initial therapy

      • Recessive dystrophic epidermolysis bullosa with genetic confirmation, open partial-thickness wounds, application only to such wounds during dressing changes, and specialist involvement.
    • Fintepla initial therapy

      • Seizures associated with Lennox-Gastaut or Dravet syndrome, age at least 2 years, failed two of clobazam, valproate/divalproex, or topiramate, and failed or contraindicated to Diacomit for Dravet syndrome.
    • Firdapse initial therapy

      • LEMS confirmed by qualifying electrodiagnostic findings and positive anti-P/Q-type VGCC antibody; symptomatic proximal lower-extremity weakness interfering with daily activities; ambulatory; baseline QMG or 3TUG score; adults failed pyridostigmine; and associated cancer appropriately treated before therapy.

    Continuation Therapy

    Continuation coverage requires the applicable response, adherence, safety, and monitoring criteria below.

    Continuation therapy criteria

    • Accrufer continuation therapy

      • Documentation of improvement from baseline, such as improved tolerance or increased hemoglobin and ferritin.
    • Adbry continuation therapy

      • Positive clinical response, such as reduced BSA, pruritus, flares, or improved activities of daily living.
      • Approval duration is 12 months.
    • Migraine continuation therapy

    Exclusions, Non-Covered Combinations, and Operational Restrictions

    The following exclusions, non-covered combinations, unsupported-use restrictions, and operational limits apply in addition to the applicable criteria.

    Exclusions and denial-risk criteria

    • Acthar is not medically necessary for corticosteroid-responsive acute MS exacerbations; rheumatic disorders including psoriatic or rheumatoid arthritis and ankylosing spondylitis; collagen diseases including SLE and dermatomyositis; severe erythema multiforme or Stevens-Johnson syndrome; serum sickness; listed ophthalmic inflammatory diseases; symptomatic sarcoidosis; or edematous states. Acthar approval is 1 month, up to 75 units/m2 twice daily for 2 weeks followed by taper.
    • Adalimumab, Arcalyst, Bimzelx, Cimzia, Cosentyx, Enbrel, and other specified biologic therapies are not covered in combination with another biologic. Unlisted diagnoses, doses, intervals, or indications require case-by-case rationale and pertinent clinical information.
    • Adbry, Cibinqo, Dupixent, Fasenra, and similar biologics are not covered in combination with other biologic therapy; Dupixent is also not covered with Rhapsido or Ohtuvayre, and Fasenra is not covered with another biologic.

    Prior Authorization and Documentation Requirements

    Prior Authorization

    Request Authorization and Submit Complete Documentation

    Use the Approved Drug List (ADL) to determine whether a medication requires prior authorization. Submit the applicable Pharmacy Prior Authorization form (for retail pharmacy drugs), Oncology Pharmacy Drug Request form (for oncology drugs under the pharmacy or medical benefit), or electronic prior authorization (ePA); use the Opioid Quantity/Dose Limit exception form for opioid exceptions. Requests for formulary exceptions, quantity-limit exceptions, age-limit exceptions, or other ADL limitations must include the applicable exception rationale and supporting clinical information.

    • General request: Submit the diagnosis, requested drug/product, dose, route, quantity, duration, treatment history, relevant laboratory or diagnostic results, response or failure documentation, and prescriber/specialist information.
    • Off-label or unlisted indication, dose, or route: Provide rationale, all pertinent patient information, and two published peer-reviewed literature articles supporting the requested use. FDA-approved indications, dosing, and routes, or uses recognized in CMS-accepted compendia, do not require this literature exception package.
    • Step therapy: Document a therapeutic trial and failure, intolerance, or contraindication to each required preferred or prerequisite drug. Trials must involve drugs covered or preferred by the plan; nonformulary and nonpreferred products do not satisfy a preferred-drug prerequisite.
    • Continuation: Coverage may be discontinued for noncompliance, absence of demonstrable clinically significant improvement, or failure to continue meeting initial criteria. Submit adherence and objective response documentation at renewal.

    Preferred Product and Treatment Sequencing

    Medication or indicationStepRequired prior therapyDuration or failure requirement
    Accrufer — iron deficiency anemia1Two different generic oral iron therapiesInadequate response; if intolerant, attempt every-other-day dosing and lifestyle or dietary strategies to improve tolerability
    Adalimumab — Crohn’s disease1Adequate conventional therapy, such as steroids or immunomodulators such as azathioprineSteroids for 7 days or immunomodulators for at least 2 months; failure, intolerance, or contraindication required
    Adalimumab — plaque psoriasis, psoriatic arthritis, or rheumatoid arthritis1One traditional non-biologic systemic agentAt least 3 months; failure or required treatment history must be documented
    Adalimumab — uveitis or hidradenitis suppurativa1One other agent for the conditionPrior trial required; duration not specified
    Adalimumab — juvenile idiopathic arthritis1One other agent; or concurrent methotrexate, sulfasalazine, or leflunomide; or physician-determined aggressive diseaseOne prior agent where applicable; alternative pathways may apply
    Adbry — atopic dermatitis1One medium- to high-potency topical corticosteroid or one topical calcineurin inhibitor (tacrolimus or pimecrolimus)At least 3 months
    PCSK9 inhibitor1One high-intensity statin, such as atorvastatin or rosuvastatinAtorvastatin at least 40 mg daily or rosuvastatin at least 20 mg daily for at least 8 continuous weeks; LDL-C remains above goal
    Non-preferred PCSK9 inhibitor2Preferred Repatha and an additional statin drugTrial and failure, intolerance, or contraindication; specialist prescriber required
    Acute migraine therapy1One triptan drugPrior trial required
    Non-preferred acute migraine product2Preferred Ubrelvy and an additional triptan drugTrial and failure, intolerance, or contraindication to Ubrelvy; additional triptan trial required
    Non-preferred preventive antimigraine product1Aimovig, Emgality, and AjovyEach for 3 continuous months without adequate migraine reduction; failure, intolerance, or contraindication required
    Non-preferred miscellaneous antiretroviral product1Preferred SunlencaTrial and failure, intolerance, or contraindication required
    Arikayce — MAC lung disease1Multidrug background regimen, such as clarithromycin or azithromycin, rifampin, and ethambutolAt least 6 consecutive months with failure to obtain a negative sputum culture
    Benlysta — active SLE1Standard therapy, such as corticosteroids, immunosuppressants, or hydroxychloroquineAt least 12 weeks; active SLE remains demonstrated despite therapy
    Besremi — high-risk polycythemia vera1Hydroxyurea and pegylated interferon-alfa 2aTrial and failure of both required
    Bimzelx — plaque psoriasis1One traditional non-biologic systemic agent and at least two of adalimumab, Cosentyx, Enbrel, Otezla/XR, or ustekinumabSystemic agent and each listed advanced agent for at least 3 months
    Bimzelx — hidradenitis suppurativa1One other agent and at least two of Cosentyx, adalimumab, or infliximabEach listed advanced agent for at least 3 months
    Bimzelx — ankylosing spondylitis1At least two of adalimumab, Cosentyx, Enbrel, or Xeljanz/XREach for at least 3 months
    Bimzelx — non-radiographic axial spondyloarthritis1At least two of Cimzia or CosentyxEach for at least 3 months; objective inflammation also required
    Bimzelx — psoriatic arthritis1One traditional non-biologic systemic agent and at least two of adalimumab, Cosentyx, Enbrel, Otezla/XR, ustekinumab, or Xeljanz/XRSystemic agent and each listed advanced agent for at least 3 months
    Camzyos or Myqorzo1Beta blocker and calcium channel blockerAt least 30 days; trial and failure, intolerance, or contraindication to both
    Cayston1Tobramycin inhalation solution, unless aztreonam is the only sensitive inhaled antibioticQualifying adverse reaction, unsatisfactory response, contraindication, intolerance, or tobramycin resistance required
    Cibinqo — atopic dermatitis1One topical corticosteroid or calcineurin inhibitor, and at least two of Dupixent, Adbry, or NemluvioTopical therapy for at least 3 months; each advanced therapy for at least 3 months
    Cimzia — ankylosing spondylitis or juvenile idiopathic arthritis1At least two indication-specific agentsEach for at least 3 months
    Cimzia — Crohn’s disease1Conventional therapy plus at least one of adalimumab, infliximab, or ustekinumabConventional therapy failure, intolerance, or contraindication; biologic for at least 3 months
    Cimzia — psoriatic arthritis, rheumatoid arthritis, or plaque psoriasis2Required conventional systemic therapy and the specified number of biologic or targeted agentsGenerally at least 3 months per agent; failure, intolerance, or contraindication where specified
    Cosentyx — plaque psoriasis or psoriatic arthritis1One traditional non-biologic systemic agentAt least 3 months
    Cosentyx — hidradenitis suppurativa1At least one other agent, such as corticosteroids, systemic antibiotics, or isotretinoinPrior treatment trial required; duration not specified
    Cobenfy1Two atypical antipsychotic drugsEach used for at least 28 days with failure, intolerance, or contraindication
    Cresemba1Voriconazole or itraconazoleTrial and failure, intolerance, or contraindication required
    Diacomit — Dravet syndrome1Valproate and clobazam; Diacomit used with clobazamTrial and failure of valproate and clobazam required
    Droxidopa1At least two non-pharmacologic interventionsPrior interventions required; medication step also required
    Droxidopa1Midodrine and fludrocortisoneEach for at least 30 days with failure, intolerance, or contraindication
    Dupixent — COPD1LABA/LAMA or triple therapy containing LABA/LAMA/ICSTry and fail after at least 3 months of consistent use; continue background therapy with Dupixent
    Enbrel — plaque psoriasis, psoriatic arthritis, or rheumatoid arthritis1One traditional non-biologic systemic agentAt least 3 months
    Enbrel — juvenile idiopathic arthritis1One other agent; or concurrent methotrexate, sulfasalazine, or leflunomide; or aggressive diseaseAlternative pathways may apply; duration not specified
    Entyvio — Crohn disease or ulcerative colitis1Adequate conventional therapy plus at least two listed biologic or targeted therapiesConventional therapy failure, intolerance, or contraindication; each prior listed therapy for at least 3 months
    Eohilia1Dietary modification, one proton pump inhibitor, and one topical corticosteroidPPI and topical corticosteroid each for at least 2 months; failure required
    Epidiolex1At least two generic anticonvulsantsTrial and failure, intolerance, or contraindication required
    Fasenra — severe eosinophilic asthma1One inhaled corticosteroid and one additional asthma controllerPrior trials required; at least one exacerbation in the previous year
    Fasenra — EGPA1One systemic corticosteroid or one immunosuppressive therapyPrior trial required
    Fintepla1Two of clobazam, valproate/divalproex, or topiramate; Diacomit for Dravet syndromeFailure of two antiseizure drugs; failure or contraindication to Diacomit for Dravet syndrome
    Firdapse — adults1PyridostigmineFailure after use as prescribed at an appropriate dose

    Quantity, Dose, and Treatment Duration Limits

    Quantity and Dosing Limits
    Opioid medications120 MEqD per day
    ActharUp to 75 units/m2 twice daily for two weeks, followed by a tapering schedule for an additional two weeks
    VyeptiInitial dosing of 100 mg every 3 months; one-time authorization for 300 mg may be made for patients unresponsive to 100 mg and assessed for incremental efficacy
    CabliviInitial: 31 vials per 30 days; continuation: 28 vials per 28 days
    CaystonUse for 28 days followed by 28 days off treatment
    Fentanyl citrate lozenge (generic Actiq)120 lozenges per 30 days

    Coding and Reference Codes

    Referenced diagnosis codingICD-10
    ICD-10Cystic fibrosis diagnosis code; the specific code is not provided in the document.
    Approved cystic fibrosis ICD-10 codesICD-10Covered
    E84.0Cystic fibrosis with pulmonary manifestations
    E84.11Cystic fibrosis with meconium ileus
    E84.19Cystic fibrosis with other intestinal manifestations
    E84.8Cystic fibrosis with other manifestations
    E84.9Cystic fibrosis, unspecified
    Clinical Thresholds and Operational Criteria
    Opioid exception thresholdRequests exceeding 120 MEqD per day require an exception review; approved treatment may be authorized for up to 12 months
    Acute migraine minimum ageAt least 18 years, with a trial of one triptan drug
    Migraine frequency for preventive therapyAt least 4 migraine days per month
    Migraine continuation responseMore than 50% reduction in monthly migraine days
    Baseline HIV-1 RNAAt least 400 copies/mL
    Benlysta active SLE responseMeet at least 3 of 6 continuation response requirements
    Benlysta lupus nephritis renal function

    Site-of-Care and Administration Rules

    Billing Rule

    Follow Entyvio site-of-care rules

    For Crohn disease or ulcerative colitis, Entyvio induction consists of two IV doses covered under the medical benefit at weeks 0 and 2. After induction, maintenance may continue as IV dosing under the medical benefit or use subcutaneous pens under the pharmacy benefit.

    • Initial induction: IV doses at week 0 and week 2 in an infusion-center setting.
    • Maintenance: continued IV dosing under the medical benefit or subcutaneous Entyvio pens under the pharmacy benefit.

    Definitions and Abbreviations

    Definitions and Abbreviations
    ASCVDAtherosclerotic cardiovascular disease.
    Multidrug-resistant HIV-1 infectionDocumented resistance to two or more agents from three of the four main antiretroviral classes.
    CAPSCryopyrin-Associated Periodic Syndromes, including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome.
    SELENA-SLEDAISafety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index.
    T25FWTimed 25-foot walk test used to assess walking speed and impairment.
    Eosinophilic esophagitis confirmationBiopsy showing at least 15 intraepithelial eosinophils per high-power field.
    LEMS

    Policy Background

    This manual establishes prior authorization requirements for pharmacy medications covered under Priority Health benefits. Authorization may be required when specified clinical criteria must be met before coverage, or when a request exceeds coverage limits listed on the plan’s Approved Drug List (ADL).

    Use this manual with the member’s plan-specific Approved Drug List and the applicable pharmacy or oncology drug request form. Requirements may include coverage criteria, quantity-limit exceptions, step therapy, and continuation requirements; coverage may be discontinued if the member is noncompliant, does not show clinically significant improvement, or no longer meets the initial criteria.

    Preferred Adalimumab Biosimilars

    Billing Rule

    Use a preferred adalimumab biosimilar

    Use the preferred adalimumab biosimilar products listed by Priority Health when clinically appropriate: adalimumab-adaz, adalimumab-adbm, adalimumab-bwwd (Hadlima), adalimumab-ryvk (Simlandi), or adalimumab-aaty.

    • Adalimumab-adaz — unbranded by Sandoz.
    • Adalimumab-adbm — unbranded by Boehringer Ingelheim.
    • Adalimumab-bwwd — Hadlima by Organon.
    • Adalimumab-ryvk — Simlandi by Teva.
    • Adalimumab-aaty — unbranded by Celltrion.
    Policy Summary
    PayerPriority Health Medicare
    PolicyPharmacy Drug Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit the applicable pharmacy drug request form or electronic prior authorization after confirming coverage and requirements in the plan-specific Approved Drug List.
    SourceLink
    On This Page
    Medication Coverage CriteriaPrior Authorization and Documentation RequirementsPreferred Product and Treatment SequencingQuantity, Dose, and Treatment Duration LimitsCoding and Reference CodesSite-of-Care and Administration RulesDefinitions and AbbreviationsPolicy BackgroundPreferred Adalimumab Biosimilars
    Migraine prevention demonstrates more than 50% reduction in monthly migraine days.
  1. Emgality cluster headache continuation

    • Significant decrease in cluster-headache frequency and/or intensity and patient is in a current cluster period.
  2. Antiretroviral continuation therapy

    • Clinically significant viral response and continued optimized background ARV regimen.
  3. Arikayce continuation therapy

    • Negative sputum culture obtained within the prior 30 days, adherence, tolerability, and response.
    • Treatment generally continues until cultures are negative for 1 year; treatment after 1 year of negative cultures is not approved. Duration is 12 months.
  4. Benlysta active SLE continuation

    • At least 3 of 6: SELENA-SLEDAI reduction of at least 4; Physician Global Assessment showing no progression; BILAG A score zero and B score no greater than 1 in the prior 4 weeks; reduced steroid dose; negative seroconversion or 20% autoantibody reduction; or no significant flares requiring steroid boost.
  5. Benlysta lupus nephritis continuation

    • Efficacy shown by urine protein-creatinine ratio no greater than 0.7 and eGFR no more than 20% below pre-flare or at least 60 mL/min/1.73m2, with no rescue therapy for treatment failure.
  6. Besremi continuation therapy

    • Positive clinical response shown by disease stability or improvement; approval duration is 12 months.
  7. Cablivi continuation therapy

    • Received with plasma exchange and immunosuppressive therapy during plasma exchange and for 30 days afterward; persistent underlying disease such as suppressed ADAMTS13; extension no longer than 28 days.
  8. Continuation cardiac myosin inhibitor therapy

    • Positive response compared with baseline, such as improved symptoms, NT-proBNP, or dyspnea, plus pVO2 improvement of at least 1.5 mL/kg/min with at least one NYHA-class reduction, or pVO2 improvement of at least 3 mL/kg/min with stable NYHA class.
  9. Continuation carglumic acid therapy

    • Chart documentation of disease stability or improvement.
  10. Continuation Cayston therapy

    • Continued need to treat Pseudomonas aeruginosa and stabilization or improvement documented by a pulmonologist or CF specialist.
  11. Cayston continuation therapy

    • Continued treatment need and specialist-documented stabilization or improvement.
  12. Cholbam continuation therapy

    • Weight increased 10% or remains at least the 50th percentile; ALT/AST below 50 U/L or reduced 80% from baseline; bilirubin no greater than 1 mg/dL; and no cholestasis on biopsy.
  13. Cibinqo continuation therapy

    • Positive clinical response, such as reduced BSA, pruritus, flares, or improved activities of daily living; approval duration is 12 months.
  14. Dalfampridine ER continuation therapy

    • At least 85% adherence by fill history; functional impairment resolves through improved ambulation and instrumental activities; and at least 20% improvement in T25FW walking speed from baseline.
  15. Continuation therapy for multiple sclerosis walking impairment

    • Meets the dalfampridine adherence, functional-improvement, and T25FW response requirements.
  16. Continuation Daybue therapy

    • Positive clinical response documented with an objective Rett syndrome severity or functional measure.
  17. Droxidopa continuation therapy

    • Positive response, sustained decrease in dizziness, and maintained increase in systolic and diastolic blood pressure within 3 minutes of standing.
  18. Dupixent continuation therapy

    • Atopic dermatitis: positive clinical response.
    • Asthma: fewer exacerbations, improved symptoms, or reduced oral corticosteroids.
    • CRSwNP: improved congestion, polyps, smell, rhinorrhea, inflammation, or reduced oral corticosteroids.
    • COPD: fewer symptoms and/or exacerbations and continued LABA/LAMA or triple therapy.
    • Prurigo nodularis: adherence and improved WI-NRS and nodular lesions.
    • EoE: adherence, histologic remission at no more than 6 eos/hpf, and improved DSQ.
    • Chronic urticaria: reduced symptoms.
    • Bullous pemphigoid: adherence and reduced disease severity.
  19. Continuation therapy

    • For Enbrel, continuation requires ongoing clinical benefit under the applicable diagnosis-specific criteria.
  20. Enspryng continuation therapy

    • Positive clinical response shown by a documented decrease in relapse rate.
  21. Evrysdi continuation therapy

    • Repeat validated motor assessment shows maintenance or improvement; HINE shows improvement in more motor-milestone categories than worsening; members over 2 years show clinically significant improvement, stabilization, or reduced decline compared with expected natural history.
  22. Fasenra continuation therapy

    • Asthma: positive response with fewer exacerbations, improved symptoms, or reduced oral corticosteroids.
    • EGPA: BVAS 0 and prednisolone/prednisone no greater than 4 mg/day.
    • HES: fewer flares or reduced corticosteroid use and improved symptoms.
  23. Filsuvez continuation therapy

    • Clinical benefit such as complete wound closure, smaller wounds, reduced wound BSA, increased granulation tissue, reduced pain, or reduced infection.
  24. Benlysta is not covered with other biologic therapy, Lupkynis, or for central nervous system manifestations. Arikayce is not approved as monotherapy. Camzyos and Myqorzo are not covered together.
  25. Migraine restrictions: Ubrelvy, Nurtec, Zavzpret, and dihydroergotamine are not combined with one another or another branded acute agent; Vyepti and Qulipta are not combined with Botox or another branded preventive; Qulipta is not combined with Ubrelvy or Nurtec. Vyepti generally starts at 100 mg every 3 months, with one assessed 300-mg authorization if inadequate response. Needle phobia or fatigue is not an exception to step therapy.
  26. Crenessity is not covered with CYP3A4 inducers. Oral solution is not covered above 55 kg unless inability to swallow capsules is documented.
  27. Dalfampridine is not covered for spinal cord injury, myasthenia gravis, demyelinating peripheral neuropathy including Guillain-Barre syndrome, Alzheimer's disease, or Lambert-Eaton myasthenic syndrome.
  28. Daybue is not covered for atypical or variant Rett syndrome. Evrysdi is experimental for non-5q SMA, is not authorized after Zolgensma, is not combined with Spinraza, and is limited to FDA-approved SMA dosing.
  29. Eohilia is not combined with biologic therapy; approval is 12 weeks and failure means inability to achieve and maintain low or mild disease activity.
  30. Filsuvez is not combined with Vyjuvek or Zevaskyn. Initial approval is 3 months and continuation approval is 6 months.
  31. Arikayce approval is 12 months. Benlysta initial approval is 6 months and continuation 12 months. Camzyos initial approval is 6 months and continuation 12 months. Crenessity initial approval is 6 months and continuation 12 months. Evrysdi approval is 6 months. Fasenra approval is 12 months.
  32. Cayston and other CF therapies require documentation of CF and culture results as specified. CFTR formulation must match the FDA-labeled age.
  33. Firdapse requires ambulatory status and baseline disease-severity testing; if LEMS is associated with cancer, the cancer must be appropriately treated before initiation.
  34. Opioid quantity/dose exception: The standard limit is 120 MEqD. For a request above 120 MEqD, document an opioid treatment agreement; chronic pain from a documented medical condition; a taper or attempted taper or valid rationale for not tapering; routine validated pain/function assessments showing sustained improvement; recent non-drug therapy or contraindication; concurrent non-opioid therapy unless contraindicated; safety rationale for benzodiazepine, sedative-hypnotic, barbiturate, or other interacting therapy; and naloxone education. Individual quantity limits and step therapy also apply; nonpreferred long-acting opioids require authorization. Approved treatment may be authorized up to 12 months.
  35. Accrufer: Document iron deficiency anemia, baseline hemoglobin and ferritin, and inadequate response to two different generic oral iron therapies. If oral iron intolerance is claimed, document every-other-day dosing and lifestyle/dietary tolerability strategies. Continuation requires improved tolerance and/or increased hemoglobin or ferritin; approval is 12 months.
  36. Acthar: Approval requires infantile spasms in a patient younger than 2 years. Approval is 1 month, up to 75 units/m² twice daily for 2 weeks followed by a taper for 2 additional weeks. Acthar is not medically necessary for acute multiple-sclerosis exacerbations; rheumatic, collagen, dermatologic, allergic, ophthalmic, respiratory, or edematous conditions listed in the policy.
  37. Step Therapy

    Document Preferred-Product Sequencing and Step Therapy

    Document required preferred-product sequencing and prior treatment history for nonpreferred products. The requested drug must be used with the required optimized background regimen, and prohibited combinations or failure to meet continuation criteria may result in denial.

    • Generic oral iron: Try two generic oral iron therapies before Accrufer; document every-other-day dosing and food, stool-softener, and other tolerability measures when applicable.
    • PCSK9 inhibitors: Document at least 8 continuous weeks of high-intensity atorvastatin 40 mg or rosuvastatin 20 mg with LDL-C above goal. For a nonpreferred product, document cardiology, endocrinology, or board-certified lipidology involvement and failure, intolerance, or contraindication to the preferred PCSK9 product plus additional statin therapy. Sequence statin therapy and the preferred PCSK9 product first.
    • Acute migraine products: Document migraine with or without aura, age 18 years or older, and a trial of one triptan. For a nonpreferred product, document failure, intolerance, or contraindication to the preferred product and an additional triptan. Do not combine Ubrelvy, Nurtec, Zavzpret, dihydroergotamine, or another branded acute treatment agent.
    • Preventive migraine therapy: For migraine, document at least 4 migraine days per month and trials of two oral preventive classes, such as an antidepressant, beta blocker, or antiepileptic. For nonpreferred products, document failure, intolerance, or contraindication to Aimovig, Emgality, and Ajovy for 3 continuous months each. Do not combine Vyepti or Qulipta with Botox or another branded preventive agent; do not combine Qulipta with Ubrelvy or Nurtec. Needle phobia or needle fatigue is not an exception to step therapy.
    • Antiretroviral agents: Document heavily treatment-experienced multidrug-resistant HIV-1, failure of the current regimen with HIV-1 RNA at least 400 copies/mL, resistance across the required classes, full susceptibility to at least one other agent, and use with an optimized background regimen. For a nonpreferred product, document failure, intolerance, or contraindication to the preferred product. Initial approval is 6 months and continuation is 12 months.
    • MAC therapy: Before Arikayce, document failure to achieve a negative sputum culture after at least 6 consecutive months of multidrug MAC therapy, including an appropriate macrolide, rifampin, and ethambutol regimen. Document failure or intolerance of the multidrug regimen, not monotherapy, and infectious-disease involvement.
    • SLE standard therapy: Before Benlysta, document at least 12 weeks of standard therapy, such as corticosteroids, immunosuppressants, or hydroxychloroquine. For other biologic indications, document the required conventional systemic-agent or biologic trials for the diagnosis.
    • Cardiac myosin inhibitor: Before Camzyos, document at least 30 days of beta-blocker and calcium-channel-blocker therapy, unless intolerance or contraindication is documented. Continuation requires a positive clinical response and the required pVO2 and NYHA improvement.
    • Cayston: Document prior tobramycin inhalation solution use with clinically significant adverse reaction or inadequate response, contraindication/intolerance, or culture resistance to tobramycin.
    • Drug-specific sequencing: Document required prior therapy for Besremi (hydroxyurea and pegylated interferon alfa-2a); Cibinqo (topical therapy and at least two of Dupixent, Adbry, or Nemluvio); Cimzia, Cosentyx, Enbrel, Bimzelx, and Entyvio (diagnosis-specific conventional and biologic trials); Cobenfy (two atypical antipsychotics for at least 28 days each); Cresemba (voriconazole or itraconazole); Diacomit (valproate and clobazam); Droxidopa (midodrine and fludrocortisone); Dupixent (indication-specific topical, controller, dietary, antihistamine, or systemic therapy); Epidiolex (two generic anticonvulsants); Fasenra (ICS plus another controller); Fintepla (two antiseizure drugs and Diacomit when applicable); and Firdapse (pyridostigmine in adults).
    Documentation Required

    Drug-Specific Clinical Criteria and Supporting Records

    The request must establish the diagnosis-specific criteria, required specialist involvement, baseline testing, and treatment history for the requested product. Include objective measures and supporting records rather than diagnosis codes alone.

    • Adbry: Use a specialist or specialist consultation; document moderate-to-severe atopic dermatitis and at least 3 months of medium/high-potency topical corticosteroid or topical calcineurin inhibitor therapy. For an off-label request, provide published literature and rationale for the indication or dose.
    • Arcalyst: Document CAPS, DIRA, or recurrent pericarditis, including age/weight requirements. For an exception or unlisted use, provide rationale and pertinent information; document specialist involvement when applicable.
    • Arikayce: Submit MAC sputum culture supporting diagnosis, at least 6 months of multidrug-regimen history, infectious-disease consultation, adherence and tolerability, and continuation response. A negative sputum culture obtained within 30 days is required for continuation; treatment is not authorized beyond 1 year of negative cultures.
    • Benlysta: Submit age, ANA or anti-dsDNA results, SELENA-SLEDAI activity, standard-therapy history, renal biopsy and renal-function data for lupus nephritis, and continuation evidence such as score reduction, steroid reduction, BILAG/PGA findings, serology, flare status, urinary protein/creatinine ratio, and eGFR. Initial approval is 6 months and continuation is 12 months.
    • Besremi: Submit high-risk polycythemia vera diagnosis, hematology/oncology documentation, hydroxyurea and pegylated interferon alfa-2a history, ECOG 0–2, and eGFR at least 30 mL/min/1.73 m².
    • Bimzelx: Submit specialist documentation and diagnosis-specific treatment history: plaque psoriasis requires a traditional nonbiologic systemic agent and two qualifying biologics; hidradenitis suppurativa requires one other agent and two qualifying biologics; ankylosing spondylitis requires two qualifying agents; nr-axSpA requires elevated CRP and/or MRI sacroiliitis plus two qualifying agents; psoriatic arthritis requires a traditional systemic agent plus two qualifying agents. Provide exception rationale for unlisted use.
    • Cablivi: Document acute acquired TTP with thrombocytopenia and red-cell fragmentation, age 18 years or older, and concurrent plasma exchange and immunosuppressive therapy through 30 days after plasma exchange ends.
    • Carglumic acid: Document NAGS deficiency and acute or chronic hyperammonemia; for continuation, submit chart notes showing stability or improvement. Approval is 12 months.
    • Cayston: Submit CF diagnosis and code, age, positive Pseudomonas sputum culture, susceptibility results, and pulmonologist/CF-specialist continuation documentation. Initial approval is 6 months and continuation is 12 months; use 28 days on followed by 28 days off.
    • Cholbam: Submit SED or peroxisomal-disorder diagnosis, serum VLCFA, baseline liver tests, and continuation weight, ALT/AST, bilirubin, and liver-biopsy findings.
    • Cibinqo: Document moderate-to-severe atopic dermatitis, topical treatment, two qualifying biologic trials, specialist involvement, and rationale for an exception or unlisted use. Approval is 12 months.
    • Cimzia and Cosentyx: Submit specialist documentation, diagnosis-specific conventional or biologic treatment history, CRP/MRI evidence for nr-axSpA, and exception rationale where criteria are not met.
    • Cobenfy: Submit schizophrenia diagnosis, age 18 years or older, two failed or contraindicated atypical antipsychotic trials of at least 28 days, and specialist involvement. Approval is 12 months.
    • Crenessity: Submit genetic confirmation of classic CAH due to 21-hydroxylase deficiency, age, glucocorticoid dose and compliance, androgen results, medical necessity to reduce glucocorticoid exposure, and specialist documentation. Continuation requires reduced daily glucocorticoid dose; approval is 6 months initially and 12 months thereafter.
    • Cresemba: Submit invasive aspergillosis or mucormycosis diagnosis, prior azole failure/intolerance/contraindication, and specialist involvement. Continuation requires disease stability or improvement.
    • CFTR modulators: Submit CF diagnosis and qualifying ICD-10 code within 12 months and verify that granule or tablet formulation matches the FDA-labeled age.
    • Dalfampridine ER: Submit MS diagnosis, immunomodulatory treatment or rationale, age 18–70, walking impairment, wheelchair status, baseline T25FW or EDSS, and continuation adherence and response. Approval is 6 months initially and 12 months for continuation.
    • Daybue: Submit classic/typical Rett syndrome with MECP2 mutation, objective baseline severity assessment, in-depth neurologic/genetic/developmental evaluation, age at least 2 years, and specialist involvement. Atypical or variant Rett syndrome is excluded.
    • Diacomit: Submit Dravet syndrome, age at least 2 years, adjunctive use with clobazam, and failed valproate and clobazam therapy.
    • Droxidopa: Submit symptomatic neurogenic orthostatic hypotension, exclusion of other causes, at least two nonpharmacologic measures, cardiology/neurology/nephrology involvement, failed or contraindicated midodrine and fludrocortisone, and continuation response. Initial approval is 3 months and continuation is 6 months.
    • Dupixent: Submit indication-specific diagnosis and therapy history for atopic dermatitis, asthma, COPD, CRSwNP, prurigo nodularis, EoE, chronic urticaria, or bullous pemphigoid, including required topical, controller, dietary, antihistamine, PPI, corticosteroid, or systemic-agent trials and objective severity results.
    • Enspryng: Submit NMOSD diagnosis, AQP4 antibody positivity, qualifying attacks, neurologist involvement, progressive disease despite rituximab, and EDSS ≤7.
    • Entyvio SC: Submit specialist documentation, Crohn’s disease or ulcerative colitis diagnosis, conventional therapy failure, and two required biologic or targeted-therapy trials. Document whether IV induction and maintenance are billed under the medical benefit or SC maintenance under the pharmacy benefit.
    • Eohilia: Submit biopsy-confirmed EoE with at least 15 eos/hpf, failed dietary modification, PPI for at least 2 months, topical corticosteroid for at least 2 months, age at least 1 year, and gastroenterology/allergy consultation. Approval is 12 weeks.
    • Epidiolex: Submit Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex diagnosis, adjunctive seizure use, age at least 1 year, and failure, intolerance, or contraindication to at least two generic anticonvulsants.
    • Evrysdi: Submit neurologist involvement, SMA diagnosis, SMN1 bi-allelic mutation testing, qualifying SMN2 copy number or early symptoms, symptomatic but not advanced disease, and baseline MFM-32, HINE, or validated measure. Continuation requires repeat objective assessment and clinically significant stability or improvement.
    • Fasenra: Submit eosinophilic asthma, EGPA, or HES criteria; required eosinophil counts or flare history; standard therapy; and continuation response. Approval is 12 months.
    • Fentanyl citrate lozenge: Submit age at least 16 years, breakthrough cancer pain, tolerance of around-the-clock opioid therapy, and quantity justification. The standard limit is 120 lozenges per 30 days; use the opioid quantity/dose exception form when exceeding it.
    • Filsuvez: Submit genetic confirmation of recessive dystrophic epidermolysis bullosa, open partial-thickness wounds, specialist involvement, application limited to wounds during dressing changes, and continuation wound response. Initial approval is 3 months and continuation is 6 months.
    • Fintepla: Submit Lennox-Gastaut or Dravet syndrome, age at least 2 years, failed clobazam, valproate/divalproex, or topiramate trials, and failed or contraindicated Diacomit for Dravet syndrome.
    • Firdapse: Submit electrodiagnostic confirmation of LEMS, positive P/Q-type VGCC antibody, clinically significant proximal weakness, ambulatory status, baseline QMG or 3TUG, failed pyridostigmine for adults, and appropriate treatment of associated cancer before initiation.
    Denial Risk

    Denial Risks, Exclusions, and Continuation Rules

    Before submission, verify each product’s initial and continuation requirements, specialist role, dose and route, treatment duration, and objective response measures. Requests that omit required diagnostic confirmation, baseline assessment, treatment history, or renewal response are at high risk of denial.

    • General denial risks: Unsupported indication, dose, or route; unlisted or off-label use without published evidence and rationale; failure to meet diagnosis-specific or general criteria; missing specialist consultation; missing laboratory, genetic, culture, imaging, pathology, or baseline functional documentation; and failure to document required prior treatment.
    • Continuation denial risks: Nonadherence, lack of clinically significant improvement, failure to maintain the initial diagnosis or criteria, missing renewal response measures, or inability to demonstrate benefit.
    • Combination exclusions: Do not request concurrent biologic therapy for Adbry, Arcalyst, Bimzelx, Cibinqo, Cimzia, Cosentyx, Dupixent, Enbrel, Entyvio, Fasenra, or Eohilia. Do not combine Benlysta with another biologic, Lupkynis, or therapy for CNS manifestations; do not combine Filsuvez with Vyjuvek or Zevaskyn; and do not combine Evrysdi with Spinraza or authorize it after Zolgensma.
    • Arcalyst, Bimzelx, Cimzia, Cosentyx, and Enbrel: Unlisted diagnoses and non-label uses require case-by-case exception rationale, pertinent patient information, and supporting literature where applicable. Combination biologic therapy is excluded.
    • Arikayce: Monotherapy is excluded. Treatment beyond one year after negative cultures is excluded; continuation requires a recent negative culture, adherence, tolerability, and response.
    • Benlysta: Combination biologic therapy, Lupkynis, and CNS manifestations are excluded; lupus nephritis requests with eGFR below 30 mL/min/1.73 m² are excluded.
    • Besremi: eGFR below 30 mL/min/1.73 m² is excluded.
    • Cardiac myosin inhibitors: Camzyos and Myqorzo may not be used together. Deny when NYHA class, LVEF, cardiology involvement, or beta-blocker/calcium-channel-blocker criteria are not met; continuation requires the specified response.
    • Carglumic acid and Cholbam: Deny when NAGS/hyperammonemia or SED/PD diagnosis criteria are not met, or when continuation laboratory and clinical targets are not documented.
    • Cayston: Deny without CF confirmation, Pseudomonas culture, required susceptibility or tobramycin history, or continuation documentation. The regimen is 28 days on and 28 days off.
    • Crenessity: Exclude CYP3A4 inducer coadministration. Oral solution is excluded above 55 kg unless inability to swallow capsules is documented.
    • Cresemba: Deny when invasive aspergillosis or mucormycosis, prior azole failure/intolerance/contraindication, specialist involvement, or continuation response is not documented.
    • Dalfampridine ER: Exclude spinal-cord injury, myasthenia gravis, demyelinating peripheral neuropathy including Guillain-Barré syndrome, Alzheimer’s disease, and Lambert-Eaton myasthenic syndrome. Continuation requires at least 85% adherence and a 20% improvement in T25FW.
    • Daybue: Atypical or variant Rett syndrome is excluded; submit MECP2 confirmation and objective baseline severity.
    • Diacomit: Monotherapy is excluded; it must be adjunctive to clobazam for Dravet syndrome and requires prior valproate and clobazam trials.
    • Droxidopa: Deny when alternative causes of orthostatic hypotension are not excluded, nonpharmacologic measures are absent, midodrine/fludrocortisone trials are undocumented, or continuation response is not shown.
    • Dupixent: Prohibited combinations include other biologics, Fasenra, Tezspire, Xolair, Rhapsido, and Ohtuvayre. COPD requests require continued LABA/LAMA or triple therapy; EoE requests require histologic remission and symptom response for continuation.
    • Enbrel and Entyvio: Deny combination biologic therapy and unlisted/non-label use without exception rationale. Entyvio dosing or intervals outside the FDA label require rationale; Crohn’s and ulcerative-colitis induction includes two IV doses at weeks 0 and 2.
    • Eohilia: Biologic combination therapy is excluded; failure means inability to achieve and maintain low or mild disease activity.
    • Evrysdi: Non-5q SMA is experimental/investigational, non-FDA dosing is excluded, prior Zolgensma use is excluded, and combination with Spinraza is excluded.
    • Fasenra: Combination biologic therapy is excluded; continuation requires documented response for asthma, EGPA, or HES.
    • Fentanyl: Deny outside breakthrough cancer pain in an opioid-tolerant patient or above 120 lozenges per 30 days without an approved exception.
    • Filsuvez: Limit use to open partial-thickness RDEB wounds during dressing changes; combination with Vyjuvek or Zevaskyn is excluded.
    • Fintepla and Firdapse: Deny without the required seizure diagnosis, step therapy, and Diacomit history for Fintepla, or without electrodiagnostic, antibody, functional, pyridostigmine, and cancer-treatment documentation for Firdapse.
    Documentation Required

    Submission Checklist and Exception Documentation

    Attach supporting literature, exception rationale, clinical history, specialist notes, prior treatment records, laboratory and diagnostic results, and objective response measures to the prior authorization submission. Use the pharmacy prior authorization request for drugs dispensed through the pharmacy benefit and identify whether medical-benefit administration or pharmacy-benefit dispensing applies.

    • Supporting literature: For FDA-unapproved or compendia-unrecognized indication, dose, or route, submit two published peer-reviewed articles and a clinical rationale explaining appropriateness for the identified patient.
    • Clinical history: Include diagnosis date, disease severity, symptoms, prior and current therapies, adherence, treatment duration, response, adverse effects, contraindications, and reason for selecting the requested product.
    • Specialist documentation: Include the relevant specialist’s notes or consultation, especially for Adbry, Arikayce, Besremi, Crenessity, Cresemba, Daybue, Droxidopa, Enspryng, Eohilia, Evrysdi, Filsuvez, cardiac myosin inhibitors, and Firdapse.
    • Objective evidence: Submit laboratory results, cultures and susceptibility testing, genetic or antibody testing, biopsy and pathology, MRI or imaging, disease-activity scores, pulmonary function, eGFR, liver tests, hemoglobin/ferritin, VLCFA, echocardiographic measures, T25FW/EDSS, MFM-32/HINE, QMG/3TUG, and other measures specified for the drug.
    • Continuation evidence: Provide fill-history adherence, clinical response, disease stability or improvement, reduced exacerbations or steroid use, improved function, remission or laboratory targets, and the product-specific renewal measurement. Failure to provide these records may cause loss of continuation coverage.
    • Exception documentation: When general or diagnosis-specific criteria are not met, explain why the exception is medically necessary, identify the unlisted indication or dosing, provide alternatives considered and failed, and attach all pertinent patient information and supporting literature.
    • Pharmacy submission: Complete and submit the Pharmacy Prior Authorization form or ePA for retail pharmacy products. Complete the Oncology Pharmacy Drug Request form for qualifying oncology products. Identify quantity, dose, route, and benefit pathway, and submit the opioid quantity/dose exception form when the request exceeds the applicable limit.
    • Product-specific submission reminders: Include migraine frequency and preventive/acute treatment history; antiretroviral resistance and optimized background regimen; MAC sputum culture and multidrug-regimen history; CF diagnosis and culture data; dermatology and rheumatology treatment history; neurologic genetic and baseline motor assessments; and documented continuation response for every renewal.
    • Approval-duration tracking: Record the applicable authorization period: Acthar 1 month; Carglumic acid, Accrufer, Cibinqo, Cobenfy, Dupixent, Fasenra, and Arcalyst when specified 12 months; antiretroviral initial 6 months/continuation 12 months; Camzyos initial 6 months/continuation 12 months; Cayston initial 6 months/continuation 12 months; Crenessity initial 6 months/continuation 12 months; Dalfampridine ER initial 6 months/continuation 12 months; Droxidopa initial 3 months/continuation 6 months; Eohilia 12 weeks; Evrysdi 6 months; Filsuvez initial 3 months/continuation 6 months; and opioid treatment up to 12 months.
    eGFR must not be less than 30 mL/min/1.73m2
    Lambert-Eaton myasthenic syndrome; the criteria require objective electrodiagnostic confirmation and positive anti-P/Q type VGCC antibody testing.