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

    Prior Authorization Criteria for Specialty Drugs

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    This document lists Priority Health Medicare Dual Premier prior authorization requirements for covered prescription drugs, including required documentation, clinical criteria, exclusions, prescriber restrictions, prerequisite therapy, and coverage duration. It applies to members of the 2026 Priority Medicare Dual Premier HMO D-SNP.

    Policy Summary
    PayerPriority Health Medicare
    PolicyPrior Authorization Criteria for Specialty Drugs
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit the applicable clinical documentation and obtain prior authorization before prescribing covered specialty drugs.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    8Drug criteria entries identified
    2 yearsCommon coverage duration
    6 monthsAnti-obesity coverage duration
    5%Adult weight-management renewal threshold

    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.

    Nov 2026
    Policy update shown

    Drug-Specific Coverage Criteria

    Drug-specific medical necessity framework and exclusions

    The listed products require prior authorization and are covered only when the requested use is an FDA-approved or medically accepted indication and all applicable product-specific clinical, safety, sequencing, prescriber, dosing, administration, and duration requirements are met.

    Acthar: Use is not for acute gouty arthritis, severe psoriasis, or atopic dermatitis; for every covered indication except infantile spasms, the patient has had a therapeutic trial of a parenteral glucocorticoid; and dosage is supported by the FDA-approved label.

    Coverage is limited to six weeks.

    Actimmune: The requested use is a medically accepted indication and the patient's body surface area is submitted.

    Coverage is limited to two years.

    Adalimumab-adaz: The requested use is medically accepted; prior therapies and responses are documented; the prescriber is a specialist or has consulted a specialist; dosing follows FDA-approved labeling or approved Part D compendia; the drug is not used with another biologic, Otezla, or a JAK inhibitor; and the applicable condition-specific prerequisite is satisfied.

    For juvenile idiopathic arthritis, an allowed exception may apply when treatment is started with methotrexate, sulfasalazine, or leflunomide, or when the prescriber documents aggressive disease.

    Adempas qualifying diagnosis

    • PAH: WHO Group 1 pulmonary arterial hypertension is confirmed by right heart catheterization.
    • CTEPH: WHO Group 4 chronic thromboembolic pulmonary hypertension is inoperable or persistent/recurrent after pulmonary endarterectomy.
    Aimovig: For initial migraine prevention, the patient has at least 4 migraine days per month; for reauthorization, a decrease in migraine days per month is documented; dosing follows FDA labeling; and Aimovig is not combined with another CGRP antagonist.
    Actimmune, Akeega, Alecensa, Alunbrig, Avonex, Ayvakit, Balversa, Betaseron, Bilprevda, Bosulif, bosutinib, Cabometyx, Calquence, Caprelsa, carglumic acid, Cayston, Cotellic, Cystadrops, Cystaran, Danziten, dasatinib, Daurismo, dichlorphenamide, dimethyl fumarate, Ensacove, Erivedge, Erleada, erlotinib, everolimus, fingolimod, Fotivda, Fruzaqla, Gavreto, gefitinib, Gilotrif, glatiramer acetate, Glatopa, Gomekli, Hernexeos, Hyrnuo, Ibrance, Ibtrozi, Iclusig, imatinib, Impavido: The request is for an applicable FDA-approved or medically accepted indication and product-specific prior authorization requirements are satisfied.
    Ambrisentan and bosentan: The patient has confirmed WHO Group 1 pulmonary arterial hypertension by right heart catheterization with supporting medical-record documentation.
    Amitriptyline: For a patient age 65 years or older, the prescriber acknowledges that benefit outweighs potential risk and has considered therapy changes if more than one anticholinergic drug is used.

    Amvuttra pathways

    • HATTR-PN: The patient is at least 18 years old, has a TTR mutation, baseline PND score IIIb or less, and clinical signs or symptoms of HATTR-PN.
    • ATTR-CM: The patient is at least 18 years old; has failed, not tolerated, or has a contraindication to tafamidis; has NYHA class 1, 2, or 3 heart failure with current manifestations or prior hospitalization; has ECHO or CMR evidence of cardiac involvement; and diagnosis is confirmed by biopsy, genetic testing, or qualifying radionuclide imaging, with Grade 2 or 3 uptake when radionuclide imaging is used.
    Cetirizine exception: A preferred second-generation antihistamine cannot be used because of allergy, contraindication, interaction, or unacceptable adverse effects; one preferred agent was tried and failed; or the prescriber provides clinical rationale why preferred therapy cannot be tried.
    Anti-obesity safety and treatment plan: The patient will not use more than one weight-loss drug in the same class concurrently; contributing metabolic or other causes are ruled out or treated; eating-disorder treatment is optimized when applicable; no listed contraindication is present; treatment is part of an appropriate diet and activity plan; other appropriate interventions have failed; the patient has been counseled about weight regain after discontinuation; and an anti-obesity GLP-1 agonist is not used with a DPP-4 inhibitor.

    Anti-obesity eligibility

    • Preferred products: Age 12 to less than 18 years with BMI at or above the 95th CDC percentile, or BMI at the 85th to 94th percentile with diabetes, sleep apnea, hypertension, or dyslipidemia; or age 18 years or older with BMI at least 30 kg/m2, or BMI 27 to less than 30 kg/m2 with hypertension, coronary artery disease, diabetes, dyslipidemia, or sleep apnea.
    • Nonpreferred products: Age 12 to less than 18 years with CDC-defined morbid obesity, or age 18 years or older with BMI at least 40 kg/m2.
    Nonpreferred anti-obesity prerequisite: The patient has allergy, contraindication, interaction, unacceptable adverse effects, or trial and failure involving all five preferred medication types: benzphetamine, diethylpropion, orlistat, phendimetrazine, and phentermine products.
    Weight-management age criteria: The patient meets the product-specific age requirement: at least 12 years for phentermine/topiramate or Xenical/orlistat, at least 17 years for phentermine, or at least 18 years for benzphetamine, diethylpropion, or phendimetrazine.
    Aprepitant: Use is for an FDA-approved indication and not for established nausea and vomiting treatment or chronic continuous use.

    Postoperative nausea/vomiting is limited to one 30-day fill and requires the surgery date.

    Arcalyst: For recurrent pericarditis, the patient has tried and failed an NSAID in combination with colchicine.
    Arikayce: A sputum culture supports Mycobacterium avium complex lung disease; treatment is prescribed by or in consultation with an infectious disease specialist or pulmonologist; and negative sputum cultures were not obtained after at least 6 months of multidrug background therapy.
    Aripiprazole oral tablet dispersible: Documentation supports inability to use generic aripiprazole tablet.
    Aripiprazole oral solution: The patient tried aripiprazole tablet and either olanzapine ODT or risperidone ODT, with documented intolerance or contraindication.
    Asenapine: The patient tried and failed two of aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, or lurasidone, using each for at least 28 days.
    Austedo TD initial pathway: Tardive dyskinesia is not associated with dopamine receptor blocking; or symptoms persisted despite stopping or reducing the dopamine-blocking agent; or stopping or reducing that agent is not possible.

    Do not combine with tetrabenazine or Ingrezza.

    Austedo continuation: For TD or chorea associated with Huntington disease, the provider attests that symptoms improved or stabilized with Austedo.
    Auvelity: For major depressive disorder, the patient tried and failed one SSRI after at least 4 weeks; dosing follows FDA labeling.
    Avtozma: The patient failed two of a preferred adalimumab product, Rinvoq, tofacitinib/tofacitinib XR, or Enbrel; failure means intolerance or inability to improve symptoms; prior therapies and responses are documented; dosing follows FDA labeling or Part D compendia; and the drug is not combined with another biologic, Otezla, or a JAK inhibitor.
    Benlysta: The drug is not used with another biologic or Lupkynis; the prescriber is a specialist or has consulted a specialist; and the applicable SLE or lupus nephritis pathway is met.

    Benlysta disease pathways

    • SLE: SELENA-SLEDAI is at least 6 before treatment and anti-dsDNA is greater than 30 IU/mL or ANA is greater than 1:80.
    • Lupus nephritis: SLE is confirmed and kidney biopsy shows class 3, 4, and/or 5 disease; standard therapy includes mycophenolate or azathioprine plus a steroid.
    Besremi: The patient tried and failed hydroxyurea; failure means intolerance and/or persistence or recurrence of disease; dosing follows FDA labeling.
    Braftovi: BRAF V600 mutation status is documented.
    Brivaracetam: The patient tried and failed generic levetiracetam and at least one other generic anticonvulsant, with failure defined as inadequate seizure control.
    Brukinsa: The use is medically accepted; for CLL/SLL, marginal zone lymphoma, mantle cell lymphoma, or Waldenström macroglobulinemia where Calquence or Imbruvica have the same NCCN recommendation category, the prescriber provides rationale why those alternatives cannot be used.
    Bysanti: Diagnosis and prior therapies are documented and the patient tried and failed two listed generic drugs, ziprasidone or lurasidone.
    Calcipotriene-betamethasone suspension: The patient tried and failed a generic topical scalp steroid, such as fluocinonide solution, clobetasol solution, or clobetasol shampoo, in combination with generic calcipotriene solution.
    Caplyta: The patient is at least 18 years old and prior therapies and responses are documented.

    Caplyta indication-specific failures

    • Schizophrenia: Two listed generic atypical antipsychotics failed.
    • Bipolar I depression: Quetiapine or olanzapine with fluoxetine failed and generic lurasidone failed.
    • Bipolar II depression: Quetiapine failed.
    • Adjunctive MDD: Two generic atypical antipsychotics, such as aripiprazole and quetiapine ER, failed.
    Cavhanza: Diagnosis and prior therapies are documented for a medically accepted indication.
    Clobazam: The patient first tried one generic anticonvulsant; the requested use is FDA approved, and any formulation contraindication such as dysphagia is documented.
    Clozapine ODT: The patient had a prior trial of generic clozapine tablets and has a documented contraindication such as dysphagia to the tablet formulation.
    Cobenfy: The patient is at least 18 years old, receives specialist prescribing or consultation, and tried and failed two generic atypical antipsychotics for at least 28 days each.
    Colistimethate sodium: The drug is not administered IV, IM, or by nebulization; the infection is proven or strongly suspected to involve susceptible bacteria based on culture and susceptibility information or local epidemiology; and an infectious-disease specialist prescribes or is consulted.
    Cortrophin: The request is for an FDA-approved or specified medically accepted indication; required indication-specific prerequisite trials are completed and documented; supporting records show inadequate response, intolerance, or FDA-labeled contraindication; and dosing remains within FDA labeling. Infantile spasms does not require prerequisite trials.
    Cosentyx: The request is for a medically accepted indication; prior therapies and responses are documented; a specialist prescribes or is consulted; dosing follows FDA labeling or approved Part D compendia; and the drug is not combined with another biologic, Otezla, or a JAK inhibitor.
    Cosentyx prerequisites: For ankylosing spondylitis or non-radiographic axial spondyloarthritis, one NSAID failed; for psoriasis, one traditional non-biologic immunomodulator failed; for enthesitis-related arthritis, another condition-specific drug failed or aggressive disease is documented; or for hidradenitis suppurativa, another condition-specific drug failed.
    Cresemba: The request is for an FDA-approved indication; for invasive aspergillosis, documentation supports inability to use generic voriconazole.
    Dalfampridine ER: The patient has no seizure history, creatinine clearance is greater than 50 mL/min, and the patient is ambulatory.
    Dextromethorphan-quinidine: The patient has pseudobulbar affect caused by an underlying neurologic condition, medical records support the diagnosis, and a neurologist prescribes the drug.
    Diabetic supplies: The prescriber confirms the requested supply is directly associated with delivering insulin to the body.
    Diacomit: The patient has Dravet syndrome seizures, is not controlled on current therapy with a generalized tonic-clonic or clonic seizure within the past 28 days, is taking concomitant clobazam, and receives specialist neurologic prescribing or consultation.
    Dihydroergotamine: The patient tried and failed one non-oral triptan and Nurtec ODT.
    Drizalma: The patient cannot use duloxetine and tried and failed one other generic antidepressant.
    Droxidopa: The patient first tried midodrine; reauthorization requires positive clinical response.
    Dupixent general requirements: The applicable diagnosis-specific pathway is met, a specialist prescribes or is consulted, dosing follows FDA labeling or Part D compendia, and the drug is not combined with another biologic or JAK inhibitor.
    Dupixent indications: For asthma, the oral-corticosteroid-dependent or eosinophilic pathway is met; for eosinophilic esophagitis, biopsy, weight, symptoms, and prerequisite therapy criteria are met; for prurigo nodularis, atopic dermatitis, chronic rhinosinusitis with nasal polyps, COPD, chronic urticaria, bullous pemphigoid, or allergic fungal rhinosinusitis, the applicable diagnosis, prerequisite, surgery, and response requirements are met.
    Ebglyss: Moderate-to-severe atopic dermatitis is confirmed, Rinvoq and Dupixent have produced inadequate responses, a specialist prescribes or is consulted, and the drug is not combined with another biologic or JAK inhibitor.

    Eltrombopag initial pathways

    • ITP: Platelet count is below 30,000/mcL, or below 50,000/mcL with bleeding or bleeding-risk factors; steroids or immunoglobulins and rituximab or splenectomy have failed or were not tolerated; and prohibited maintenance combinations are absent.
    • Hepatitis C thrombocytopenia: Thrombocytopenia prevents initiation or maintenance of interferon-based therapy.
    • Aplastic anemia: The drug is used with antithymocyte globulin and cyclosporine for first-line treatment, or after insufficient response to cyclosporine for later-line treatment.

    Emgality initial pathways

    • Migraine prevention: At least 4 migraine days per month.
    • Cluster headache: Verapamil was tried and was not tolerated or did not improve the condition.
    Emsam: Two of the following generic antidepressant categories were tried and failed: SNRIs, SSRIs, mirtazapine, or bupropion.
    Enbrel and Enbrel Mini: A specialist prescribes or is consulted; prior therapies and responses are documented; dosing follows FDA labeling or approved Part D compendia; combination with another biologic, Otezla, or a JAK inhibitor is absent; and the condition-specific prerequisite or juvenile idiopathic arthritis exception is met.
    Endari: The requested use is FDA approved and hydroxyurea was tried and failed, with continued intolerance qualifying as failure.
    Eohilia: The patient is at least 11 years old; eosinophilic esophagitis is biopsy confirmed with at least 15 eosinophils per high-power field; symptoms persisted after at least 2 months of a proton pump inhibitor and at least 2 months of one topical generic corticosteroid; and a gastroenterologist or allergist prescribes or is consulted.
    Epclusa: The patient has chronic hepatitis C infection and documentation supports use consistent with current AASLD/IDSA guidance.
    Epidiolex: The request is for an FDA-approved indication and at least two generic anticonvulsants were tried and failed.
    Eslicarbazepine: The request is for a medically accepted indication and at least two generic anticonvulsants were tried and failed because of inadequate seizure control.
    Eucrisa prerequisite: A prescription-strength topical steroid failed, or, when a topical steroid is inappropriate, a generic topical calcineurin inhibitor failed for the current condition.
    Eulexin: The patient tried generic flutamide or bicalutamide.

    Evenity pathways

    • Standard pathway: Alendronate, risedronate, or ibandronate and either zoledronic acid or Prolia failed, were not tolerated, or were contraindicated.
    • Very high fracture risk is documented, including T-score at or below -3.0, T-score at or below -2.5 with a fragility fracture, or a history of severe fracture.
    Evrysdi: For SMA, genetic testing confirms the diagnosis; a neurologist prescribes or is consulted; and the patient is not receiving concurrent Spinraza.
    Exxua: The patient is at least 18 years old; for MDD, mirtazapine was tried; and prior therapies and responses are documented.
    Fanapt: Two qualifying generic antipsychotics were tried and failed, each for at least 28 days, selected from aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, or lurasidone.

    Fasenra pathways

    • Severe eosinophilic asthma: Eosinophils are at least 150 cells/microliter within 6 weeks before treatment or at least 300 cells/microliter in the previous 12 months, and one ICS/LABA inhaler failed after at least 4 weeks.
    • EGPA: Non-severe eosinophilic granulomatosis with polyangiitis is documented, defined as absence of life- or organ-threatening manifestations.
    • HES: Hypereosinophilic syndrome is documented and eosinophils are at least 1,000 cells/microliter.
    Fintepla: Two of clobazam, valproic acid, and topiramate were tried and failed because of inadequate seizure control.
    Gattex: The patient depends on parenteral support because unable to be weaned from parenteral nutrition.
    Growth hormone products: The patient meets the applicable pediatric growth hormone deficiency, Turner syndrome, pre-transplant chronic renal insufficiency, or adult growth hormone deficiency criteria; the prescriber is an endocrinologist, gastroenterologist, or nephrologist; pediatric treatment excludes constitutional growth delay and acute or chronic catabolic illness; adult treatment is not for aging-related reduction, Turner syndrome, or cystinosis.
    Haegarda: The patient is at least 6 years old; C4, C1-inhibitor protein, and C1-inhibitor function results confirm hereditary angioedema; an appropriately experienced specialist prescribes or is consulted; and treatment is preventive, not for an acute attack or concurrent with an ACE inhibitor or another preventive HAE therapy.
    Icatibant acetate/Sajazir: The patient is at least 18 years old; the use is FDA approved; C4, C1-INH protein, and C1-INH function results confirm HAE; an experienced specialist prescribes; and there is no concurrent ACE inhibitor use.
    IDHIFA: The requested use is medically accepted and IDH2 mutation documentation is submitted.
    Imbruvica: The requested use is medically accepted, dosing follows FDA labeling, and criteria are applied consistent with current NCCN guidance.
    Imkeldi: The requested use is medically accepted and the patient is unable to swallow or appropriately use generic imatinib tablets.

    Initial Authorization Criteria

    Initial therapy criteria

    Initial authorization is covered when ALL applicable criteria below are met. Where an indication has alternative pathways, meeting ONE complete pathway is sufficient.

    Acthar: Covered indication; prior therapies and responses documented; parenteral glucocorticoid trial completed for every covered indication except infantile spasms; and dosing supported by the FDA-approved label.

    Six-week coverage.

    Actimmune: Medically accepted indication and patient's body surface area submitted.

    Two-year coverage.

    Adalimumab-adaz: Medically accepted indication; specialist prescriber or consultation; prior therapies and responses documented; FDA-label or approved Part D compendia dosing; no combination with another biologic, Otezla, or JAK inhibitor; and applicable disease-specific prerequisite met.

    Adempas

    Reauthorization and Continuation Criteria

    Continuation and reauthorization criteria

    Continuation or reauthorization is covered when the patient remains eligible and the required response, laboratory, safety, and monitoring criteria are documented.

    Aimovig: A decrease in migraine days per month is documented with use and dosing follows FDA labeling.
    Amvuttra: Positive response from baseline is documented: improved neuropathy symptoms, motor function, quality of life, or slowed progression for HATTR-PN; or reduced cardiovascular hospitalizations, improved function, or improved quality of life for ATTR-CM.

    Anti-obesity and weight-management renewal

    • Adults: At least 5% weight loss from baseline at treatment initiation is maintained.

    Prerequisite Therapy Requirements

    Drug or productRequired prerequisite therapyFailure or exception definitionCondition-specific sequencing rule
    ActharTherapeutic trial of a parenteral glucocorticoid, except for infantile spasms.A therapeutic trial is required; no separate failure definition is stated.For all covered indications other than infantile spasms; dosage must follow the FDA-approved label.
    Adalimumab-adazRheumatoid arthritis: one traditional non-biologic immunomodulator; ankylosing spondylitis: one NSAID; psoriasis: one traditional non-biologic immunomodulator; hidradenitis suppurativa, uveitis, or juvenile idiopathic arthritis: one other drug for the condition.Intolerance or inability to improve symptoms.For juvenile idiopathic arthritis, the prerequisite may be replaced by concurrent methotrexate, sulfasalazine, or leflunomide initiation, or aggressive disease determined by the prescriber.
    CetirizineOne preferred second-generation antihistamine.Allergy, contraindication, drug interaction, unacceptable adverse effects, or trial and failure; clinical rationale may support inability to try the preferred agent.Preferred therapy must be tried or clinically ruled out before cetirizine.
    Nonpreferred anti-obesity productsAll five preferred medication types: benzphetamine, diethylpropion, orlistat, phendimetrazine, and phentermine products.Allergy, contraindication, interaction, unacceptable adverse effects, or trial and failure with each preferred type.All five preferred types must be tried or otherwise established as unusable before the nonpreferred product.
    Amvuttra for ATTR-CMTafamidis.Failure or intolerance of tafamidis, or a contraindication to tafamidis.Tafamidis is required before Amvuttra for ATTR-CM unless contraindicated.
    Arcalyst for recurrent pericarditisAn NSAID used in combination with colchicine.Inadequate response.The NSAID-plus-colchicine trial precedes Arcalyst.
    Aripiprazole oral solutionAripiprazole tablet plus either olanzapine ODT or risperidone ODT.Documented intolerance or contraindication to the required prior products.Both prior product trials are required before the oral solution.
    AsenapineTwo of: aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, or lurasidone.Inadequate response after using each selected generic for at least 28 days.Two qualifying generic antipsychotics must be tried before asenapine.
    Auvelity for major depressive disorderOne SSRI.Inability to improve depressive symptoms after at least 4 weeks of treatment.The SSRI trial precedes Auvelity.
    AvtozmaTwo of: a preferred adalimumab product, Rinvoq, tofacitinib or tofacitinib XR, or Enbrel.Intolerance or inability to improve symptoms.Two preferred therapies must fail before Avtozma; combination with another biologic, Otezla, or a JAK inhibitor is not permitted.
    BesremiHydroxyurea.Intolerance and/or persistence or recurrence of disease.Hydroxyurea must be tried and failed before Besremi.
    Bexarotene externalPrerequisite therapy is required; the source does not specify the medication in this section.Not specified.Prerequisite therapy must precede topical bexarotene.
    BrivaracetamGeneric levetiracetam and at least one other generic anticonvulsant for the condition.Inadequate seizure control.Both prerequisite anticonvulsant components must be tried before brivaracetam.
    BysantiTwo listed generic drugs: ziprasidone or lurasidone.Inadequate response.Two qualifying generic trials precede Bysanti.
    Calcipotriene-betamethasone external suspensionA generic topical scalp steroid, such as fluocinonide solution, clobetasol solution, or clobetasol shampoo, in combination with generic calcipotriene solution.Inadequate response.The combination topical regimen must be tried before the suspension.
    CaplytaIndication-specific generic atypical antipsychotics.Taking the medication as prescribed without an adequate response or with intolerance.Schizophrenia: fail two of aripiprazole, ziprasidone, olanzapine, risperidone, or quetiapine; bipolar I depression: fail quetiapine or olanzapine with fluoxetine and generic lurasidone; bipolar II depression: fail quetiapine; adjunctive MDD: fail two generic atypical antipsychotics.
    ClobazamOne generic anticonvulsant.No separate failure definition is stated.The generic anticonvulsant trial precedes clobazam.
    Clozapine ODTGeneric clozapine tablets.A documented contraindication to the tablet formulation, such as dysphagia.Try the tablet formulation and document why it cannot be used before clozapine ODT.
    CobenfyTwo generic atypical antipsychotics, each used for at least 28 days.Inadequate response.Both generic antipsychotic trials precede Cobenfy.
    CosentyxAnkylosing spondylitis or non-radiographic axial spondyloarthritis: one NSAID; psoriasis: one traditional non-biologic immunomodulator; enthesitis-related arthritis: one other condition-specific drug; hidradenitis suppurativa: one other condition-specific drug.Try and fail means inadequate response; aggressive disease may qualify for enthesitis-related arthritis.The applicable condition-specific therapy must be tried before Cosentyx; dosing must follow the FDA label or approved Part D compendia.
    Cresemba for invasive aspergillosisGeneric voriconazole.Documented inability to use generic voriconazole is an allowed exception.Use voriconazole or document why it cannot be used before Cresemba.
    DiacomitConcomitant clobazam therapy.No separate failure definition is stated.The patient must be taking clobazam with Diacomit.
    Dihydroergotamine nasal sprayOne non-oral triptan and Nurtec ODT.Inability to improve symptoms or the condition.Both therapies must be tried and failed before dihydroergotamine.
    DrizalmaDuloxetine cannot be used, plus one other generic antidepressant.Inability to use duloxetine and inability to improve the condition with the other antidepressant.Document inability to use duloxetine and failure of the other antidepressant before Drizalma.
    DroxidopaMidodrine.Initial therapy requires a prior trial; reauthorization requires positive clinical response.Midodrine must be tried before droxidopa.
    DupixentIndication-specific therapy, including ICS/LABA, proton pump inhibitor or swallowed topical steroid, topical steroid or calcineurin inhibitor, intranasal steroid management, LABA/LAMA-containing dual or triple therapy, H1 antihistamine, or specified steroid and steroid-sparing therapy.Inability to improve the condition, inadequate response, or exacerbation despite prescribed therapy, as applicable.The prerequisite varies by diagnosis: asthma, eosinophilic esophagitis, atopic dermatitis, chronic rhinosinusitis with nasal polyps, COPD, chronic urticaria, bullous pemphigoid, or allergic fungal rhinosinusitis.
    Dupixent—additional dermatologic and respiratory indicationsThe required topical, antihistamine, inhaled, steroid, or steroid-sparing therapy for the diagnosis.Inability to improve symptoms, inadequate response, or exacerbation despite prescribed therapy.Chronic urticaria requires an H1 antihistamine; bullous pemphigoid requires an oral or high-potency topical steroid and a steroid-sparing drug; allergic fungal rhinosinusitis requires a history of sinonasal surgery.
    EbglyssRinvoq followed by Dupixent for moderate-to-severe atopic dermatitis.Inadequate response to each therapy.Rinvoq must be tried before Dupixent, and both must fail before Ebglyss.
    Eltrombopag for ITPSteroids or immunoglobulins, followed by rituximab or splenectomy.Inadequate response or intolerance.The ITP sequence is initial therapy with steroids or immunoglobulins, followed by rituximab or splenectomy.
    Emgality for cluster headacheVerapamil.Intolerance or inability to improve the condition.Verapamil must be tried before Emgality for cluster headache.
    EmsamTwo generic antidepressant categories selected from SNRIs, SSRIs, mirtazapine, or bupropion.Inadequate improvement in depressive symptoms.Two qualifying antidepressant categories must fail before Emsam.
    Enbrel or Enbrel MiniRheumatoid arthritis or psoriasis: one traditional non-biologic immunomodulator; ankylosing spondylitis: one NSAID; hidradenitis suppurativa: another treatment; juvenile idiopathic arthritis: another treatment.Intolerance or inability to improve symptoms.For juvenile idiopathic arthritis, alternatives include concurrent methotrexate, sulfasalazine, or leflunomide initiation, or aggressive disease determined by the prescriber.
    EndariHydroxyurea.Continued intolerance to hydroxyurea.Hydroxyurea must be tried and failed before Endari.
    EndariHydroxyurea.Intolerance qualifies as failure.Try and fail hydroxyurea before Endari; use must be FDA-approved.
    EpidiolexAt least two generic anticonvulsants for the condition.Failure of therapy for the condition being treated.At least two generic anticonvulsants must be tried before Epidiolex.
    EslicarbazepineAt least two generic anticonvulsants for the condition.Inadequate seizure control.At least two generic anticonvulsants must be tried before eslicarbazepine.
    EucrisaA prescription-strength topical steroid; if inappropriate, a generic topical calcineurin inhibitor.Failure of the prior topical therapy for the current condition.Use the topical steroid pathway first; the calcineurin-inhibitor pathway applies when a topical steroid is inappropriate.
    EucrisaPrescription-strength topical steroid, or generic topical calcineurin inhibitor when a topical steroid is inappropriate.Tried and failed therapy for the current condition.The applicable topical therapy must precede Eucrisa.
    EulexinGeneric flutamide or bicalutamide.Prior trial required; no separate failure definition is stated.Try generic flutamide or bicalutamide before Eulexin.
    EvenityAlendronate, risedronate, or ibandronate, followed by either zoledronic acid or Prolia.Trial and failure, intolerance, or contraindication; an alternative very-high-fracture-risk pathway may apply.The standard sequence is an oral bisphosphonate followed by zoledronic acid or Prolia, unless very high fracture risk is documented.
    Exxua for major depressive disorderMirtazapine.Prior trial required; no separate failure definition is stated.Try mirtazapine before Exxua.
    FanaptTwo of: aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, or lurasidone.Inadequate response after at least 28 days of each selected drug.Two qualifying generic antipsychotics must be tried before Fanapt.
    Fasenra for severe eosinophilic asthmaOne ICS/LABA inhaler within the prior 6 months.Inability to improve the condition after at least 4 weeks on the required therapy.The ICS/LABA trial applies to initial severe eosinophilic asthma coverage; it does not replace the separate EGPA or HES pathways.
    FinteplaTwo of clobazam, valproic acid, and topiramate.Inadequate seizure control.Two specified antiseizure therapies must be tried and failed before Fintepla.
    HadlimaRheumatoid arthritis or psoriasis: one traditional non-biologic immunomodulator; ankylosing spondylitis: one NSAID; hidradenitis suppurativa, uveitis, or juvenile idiopathic arthritis: another treatment.Intolerance or inability to improve symptoms.For juvenile idiopathic arthritis, concurrent methotrexate, sulfasalazine, or leflunomide initiation, or aggressive disease may qualify instead of prior failure.
    HumiraRheumatoid arthritis or psoriasis: one traditional non-biologic immunomodulator; ankylosing spondylitis: one NSAID; hidradenitis suppurativa, uveitis, or juvenile idiopathic arthritis: another treatment.Intolerance or inability to improve symptoms.For juvenile idiopathic arthritis, concurrent methotrexate, sulfasalazine, or leflunomide initiation, or aggressive disease may qualify instead of prior failure.

    Coverage Duration and Quantity Limits

    Quantity and treatment-duration limits
    AprepitantOne 30-day fill for post-operative nausea/vomiting.
    CortrophinQuantity limited to dosage supported by the FDA-approved label.
    Ebglyss4 doses in the first month, then 2 doses each month thereafter.
    Eohilia12 weeks of treatment.
    EvenityUp to 12 months total therapy.
    EucrisaOne year coverage period.
    EulexinOne year coverage period.

    Prior Authorization and Documentation Requirements

    Prior Authorization

    Obtain prior authorization before prescribing

    Submit prior authorization before dispensing any listed product. Approval periods and product-specific requirements vary, including six weeks for Acthar, one year for several products, two years for many products, and six months for selected therapies; follow the applicable indication, dosing, specialist, and renewal requirements.

    • Prior authorization is required for the listed products and is limited to the applicable FDA-approved or medically accepted indication.
    • Submit product-specific clinical information, treatment history, laboratory or diagnostic evidence, prescriber qualifications, and dosing information when required.
    • Track the authorization period and submit reauthorization evidence when continued coverage requires documented response or benefit.
    Step Therapy

    Complete required prerequisite therapy

    Complete the required prerequisite therapy before requesting coverage when the product has a step-therapy requirement. Failure may be defined as intolerance, inability to improve symptoms, inadequate response, inadequate seizure control, persistence or recurrence of disease, or continued intolerance, depending on the product.

    Policy Definitions and Clinical Terms

    Definitions and policy terms
    PAHPulmonary arterial hypertension classified as WHO Group 1 and confirmed by right heart catheterization.
    CTEPHChronic thromboembolic pulmonary hypertension classified as WHO Group 4 that is inoperable or persistent/recurrent after pulmonary endarterectomy.
    Try and failFor adalimumab-adaz, treatment failure means intolerance or inability to improve symptoms.
    HATTR-PNA transthyretin mutation with polyneuropathy-related clinical manifestations; the policy uses a baseline PND score of IIIb or less.
    ATTR-CMTransthyretin amyloid cardiomyopathy demonstrated by cardiac imaging and confirmed by biopsy, genetic testing, or qualifying radionuclide imaging.
    Mycobacterium avium complex lung diseaseA chronic pulmonary infection caused by Mycobacterium avium complex requiring diagnostic sputum culture support and prior multidrug therapy history.

    Administration and Site-of-Care Restrictions

    Billing Rule

    Verify the administration route before billing

    Do not bill colistimethate sodium under these criteria when it is administered intravenously, intramuscularly, or by nebulization. The request must instead document that the infection is proven or strongly suspected to involve susceptible bacteria and must meet the specialist-prescriber requirement.

    • Excluded routes: intravenous (IV), intramuscular (IM), and nebulized administration.
    • Required susceptibility support: culture and susceptibility information, or local epidemiology and susceptibility patterns.
    • The drug must be prescribed by or in consultation with an infectious disease specialist.
    Policy Summary
    PayerPriority Health Medicare
    PolicyPrior Authorization Criteria for Specialty Drugs
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit the applicable clinical documentation and obtain prior authorization before prescribing covered specialty drugs.
    SourceLink
    On This Page
    Drug-Specific Coverage CriteriaInitial Authorization CriteriaReauthorization and Continuation CriteriaPrerequisite Therapy RequirementsCoverage Duration and Quantity LimitsPrior Authorization and Documentation RequirementsPolicy Definitions and Clinical TermsAdministration and Site-of-Care Restrictions
    • WHO Group 1 PAH confirmed by right heart catheterization.
    • WHO Group 4 CTEPH is inoperable or persistent/recurrent after pulmonary endarterectomy.
    Aimovig: Migraine prevention requested; at least 4 migraine days per month; dosing follows FDA labeling; and no concurrent CGRP antagonist.
    Akeega, Alecensa, and Alunbrig: The request is for a medically accepted indication and drug-specific prior authorization requirements are met.

    Amvuttra

    • HATTR-PN: Age at least 18 years, TTR mutation, PND score IIIb or less, and clinical signs or symptoms documented.
    • ATTR-CM: Age at least 18 years; tafamidis failure, intolerance, or contraindication; NYHA class 1-3 heart failure; ECHO or CMR cardiac involvement; diagnostic confirmation by biopsy, genetic testing, or qualifying radionuclide imaging; and Grade 2-3 uptake when applicable.
    Anti-obesity agents: Applicable age and BMI eligibility is met; safety and diet/activity-plan attestations are completed; no contraindication or prohibited combination exists; and, for nonpreferred products, all five preferred medication types have failed, are contraindicated, caused interaction, allergy, or unacceptable adverse effects.
    Arcalyst: For recurrent pericarditis, NSAID plus colchicine trial failed because of inadequate response.
    Arikayce: MAC lung disease supported by sputum culture; negative cultures not obtained after at least 6 months of multidrug background therapy; and infectious-disease specialist or pulmonologist prescribes or consults.
    Aripiprazole ODT: Documentation supports inability to use generic aripiprazole tablet.
    Aripiprazole oral solution: Aripiprazole tablet and either olanzapine ODT or risperidone ODT were tried, with intolerance or contraindication documented.
    Asenapine: Two listed generic antipsychotics were tried and failed, each for at least 28 days.
    Austedo: TD is not associated with dopamine receptor blocking, or symptoms persisted despite dose reduction/discontinuation, or dose reduction/discontinuation is not possible.
    Auvelity: For MDD, one SSRI failed after at least 4 weeks; dosing follows FDA labeling.
    Avtozma: Two preferred therapies failed; prior therapies and responses documented; specialist prescriber or consultation; label/compendia dosing; and no prohibited combination.
    Benlysta: SLE pathway with SELENA-SLEDAI at least 6 and anti-dsDNA greater than 30 IU/mL or ANA greater than 1:80; or lupus nephritis pathway with confirmed SLE and biopsy class 3, 4, and/or 5 disease.
    Besremi: Hydroxyurea trial and failure documented.
    Bosentan: WHO Group 1 PAH confirmed by right-heart catheterization and documented in the medical record.
    Braftovi: BRAF V600 mutation status documented.
    Brivaracetam: Generic levetiracetam and at least one other generic anticonvulsant failed because of inadequate seizure control.
    Brukinsa specified indications: For specified lymphoma indications where Calquence or Imbruvica have the same NCCN recommendation category, rationale explains why those alternatives cannot be used.
    Bysanti: Diagnosis and prior therapies documented; ziprasidone or lurasidone prerequisites failed.
    Calcipotriene-betamethasone suspension: Generic topical scalp steroid plus generic calcipotriene solution failed because of inadequate response.
    Caplyta: Age at least 18 years, prior therapies/responses documented, and indication-specific generic atypical antipsychotic failures met.
    Cavhanza: Diagnosis and prior therapies documented.
    Clobazam: One generic anticonvulsant was tried before clobazam.
    Clozapine ODT: Generic clozapine tablets were tried and a tablet contraindication such as dysphagia is documented.
    Cobenfy: Age at least 18 years; specialist prescribing or consultation; and two generic atypical antipsychotics failed after at least 28 days each.
    Colistimethate sodium: Administration is not IV, IM, or nebulized; susceptible bacterial infection is documented; and infectious-disease specialist prescribing or consultation is present.
    Cortrophin: Covered indication, indication-specific prerequisite trials, supporting documentation of inadequate response/intolerance/contraindication, and FDA-labeled dosing/quantity.
    Cosentyx: Specialist involvement, prior therapies and responses, applicable condition-specific prerequisite, approved dosing, and no prohibited combination.
    Dalfampridine ER: No seizure history, creatinine clearance greater than 50 mL/min, and ambulatory status.
    Dextromethorphan-quinidine: Pseudobulbar affect due to an underlying neurologic condition, neurologist prescriber, and supporting medical records.
    Diacomit: Dravet syndrome seizures, seizure within past 28 days despite current therapy, concomitant clobazam, and neurologist/epileptologist prescribing or consultation.
    Dihydroergotamine, Drizalma, and droxidopa: Dihydroergotamine requires failed non-oral triptan and Nurtec ODT; Drizalma requires inability to use duloxetine plus failed generic antidepressant; droxidopa requires prior midodrine.
    Dupixent: Diagnosis-specific pathway, specialist involvement, prerequisite therapy, approved dosing, and no combination with another biologic or JAK inhibitor.
    Ebglyss: Moderate-to-severe atopic dermatitis with inadequate responses to Rinvoq and Dupixent; specialist prescriber or consultation; no biologic/JAK combination.
    Eltrombopag: ITP, hepatitis C thrombocytopenia, or aplastic anemia pathway is satisfied, including the applicable platelet, prior-treatment, and combination criteria.
    Emgality: Migraine prevention with at least 4 migraine days per month, or cluster headache with failed/intolerant verapamil.
    Emsam: Two generic antidepressant categories failed: SNRIs, SSRIs, mirtazapine, or bupropion.
    Enbrel and Enbrel Mini: Specialist involvement, prior-treatment documentation, approved dosing, no prohibited combination, and condition-specific prerequisite or juvenile idiopathic arthritis exception.
    Endari: FDA-approved indication and hydroxyurea failure, including continued intolerance.
    Eohilia: Age at least 11 years; biopsy-confirmed EoE with at least 15 eosinophils/HPF; persistent symptoms after at least 2 months of PPI and 2 months of topical generic corticosteroid; and gastroenterologist/allergist involvement.
    Epclusa: Chronic hepatitis C infection and use consistent with AASLD/IDSA guidance.
    Epidiolex: FDA-approved indication and failure of at least two generic anticonvulsants.
    Eslicarbazepine: Medically accepted indication and failure of at least two generic anticonvulsants because of inadequate seizure control.
    Eucrisa: Prescription-strength topical steroid failed, or, if inappropriate, generic topical calcineurin inhibitor failed.
    Eulexin: Generic flutamide or bicalutamide trial completed.
    Evenity: Required osteoporosis treatment failures/intolerance/contraindication are documented, or very high fracture risk is documented; endocrinologist prescriber required.
    Exxua: Age at least 18 years; for MDD, mirtazapine trial; prior therapies and responses documented.
    Fanapt: Two qualifying generic antipsychotics failed, each used at least 28 days.
    Fasenra: Severe eosinophilic asthma, non-severe EGPA, or HES pathway is met, including applicable eosinophil, prior-therapy, or disease-severity documentation.
    Fintepla: Two of clobazam, valproic acid, and topiramate failed because of inadequate seizure control.
    Gattex: The patient cannot be weaned from parenteral nutrition and is dependent on parenteral support.
    Growth hormone: Pediatric growth hormone deficiency, Turner syndrome, pre-transplant chronic renal insufficiency, or adult growth hormone deficiency pathway is documented; required growth, bone-age, stimulation-test, IGF-1/IGF-PB3, and exclusion criteria are met.
    Haegarda: Age at least 6 years, laboratory-confirmed HAE, experienced specialist prescriber, preventive use, and no ACE inhibitor or concurrent preventive HAE therapy.
    Icatibant acetate/Sajazir: Age at least 18 years, FDA-approved indication, laboratory-confirmed HAE, qualified specialist prescriber, and no concurrent ACE inhibitor.
    IDHIFA: Medically accepted indication and documented IDH2 mutation.
    Imbruvica: Medically accepted indication, FDA-label dosing, and criteria consistent with current NCCN guidance.
    Imkeldi: Medically accepted indication and inability to swallow or appropriately use generic imatinib tablets.
    Adolescents: BMI percentile is maintained or improved from baseline according to CDC growth charts.
    Austedo: The provider attests that TD or Huntington disease chorea symptoms improved or stabilized with Austedo.
    Benlysta: Clinical improvement is documented; for lupus nephritis, eGFR is improved or stable and standard therapy continues.
    Cortrophin: Previously authorized therapy demonstrates clinical benefit and requested quantity remains within FDA-labeled dosing.
    Dalfampridine ER: The patient remains ambulatory and stability or improvement in walking speed is documented.
    Droxidopa: Positive clinical response is documented, such as a sustained decrease in dizziness.
    Dupixent: Indication-specific clinical benefit compared with baseline is documented, such as fewer exacerbations, improved symptoms, reduced steroid use, reduced eosinophils, less dysphagia, fewer lesions or blisters, reduced pruritus, or fewer COPD exacerbations.
    Ebglyss: Positive response compared with baseline is documented and maintenance dosing is every 4 weeks, or every 2 weeks because every-4-week dosing was inadequate.
    Eltrombopag: Current platelet count is below 400 x 10^9/L and positive response to therapy is documented.
    Emgality: Migraine days decreased, or cluster-headache frequency or intensity decreased.
    Evrysdi: Reauthorization occurs every 12 months; SMA requirements remain met; and concurrent Spinraza is absent.
    Fasenra: For severe eosinophilic asthma, EGPA, or HES, clinical benefit compared with baseline is documented.
    Gattex: Parenteral support has sustainably decreased from baseline with an actual change in volume.
    Growth hormone: Ongoing clinical management is documented; if IGF-1 is above normal, the provider attests that the dose will be decreased and managed to achieve an IGF-1 within the normal range.
    Haegarda: A decrease in hereditary-angioedema attack frequency is documented.
    Icatibant acetate/Sajazir: Previously approved syringes were used and favorable clinical response is documented, such as decreased attack duration, rapid relief, symptom resolution, or decreased frequency or severity.
    Imbruvica for GVHD: Clinical benefit is documented and dosing continues to follow FDA-approved labeling.
    Everolimus
    Two years coverage period.
    Exxua, Fanapt, and fingolimodTwo years coverage period.
    FasenraOne year initial; two years reauthorization.
    Evrysdi12 months initial and 12 months reauthorization.
    • Condition-specific examples include parenteral glucocorticoid therapy before Acthar, tafamidis failure or intolerance before Amvuttra for ATTR-CM, and hydroxyurea failure before Besremi or Endari.
    • Other required sequences include preferred antihistamine therapy before cetirizine, generic anticonvulsants before selected antiseizure drugs, and conventional therapy before biologic products.
    • Document any permitted exception, such as aggressive disease or inability to use the prerequisite therapy, when the criteria allow it.
    Documentation Required

    Submit complete supporting documentation

    Include the clinical, diagnostic, laboratory, and treatment-history records needed for the requested product. Incomplete documentation can prevent approval even when the medication is being prescribed for a covered indication.

    • Provide diagnosis and indication details, prior therapies and responses, and specialist prescribing or consultation documentation when required.
    • Submit applicable objective evidence, such as right-heart catheterization for WHO Group 1 pulmonary arterial hypertension, mutation testing, sputum culture and susceptibility information, biopsy findings, platelet counts, eosinophil counts, or hereditary-angioedema laboratory results.
    • For renewals, document clinical benefit or response compared with baseline, such as decreased migraine days, improved symptoms, maintained weight loss, improved walking speed, or decreased attack frequency.
    Denial Risk

    Prevent common denial conditions

    Requests may be denied when a covered indication, prerequisite therapy, required diagnosis, safety condition, specialist requirement, dosing rule, or response criterion is not met. Denial also applies to prohibited combinations and uses specifically excluded from coverage.

    • Do not request excluded indications, including Acthar for acute gouty arthritis, severe psoriasis, or atopic dermatitis; aprepitant for established nausea and vomiting or chronic continuous use; or eltrombopag solely to normalize platelet counts.
    • Avoid prohibited combinations, including specified biologic, JAK-inhibitor, CGRP-antagonist, TTR-directed, ACE-inhibitor, Spinraza, or other maintenance-therapy combinations.
    • Verify product-specific safety and eligibility criteria, such as seizure history and renal function for dalfampridine ER, age and prior-treatment requirements for Caplyta, and inability to use generic imatinib tablets for Imkeldi.
    Tardive dyskinesiaA movement disorder indication for Austedo that may be associated with dopamine receptor blocking agents.
    Tardive dyskinesia (TD)A condition for which Austedo may be covered when it is not associated with dopamine receptor blocking therapy or when symptoms persist after dose reduction or discontinuation is attempted or not possible.
    Lupus nephritis (LN)Confirmed systemic lupus erythematosus with kidney biopsy confirmation of class 3, 4, and/or 5 disease.
    WHO Group 1 PAHPulmonary arterial hypertension classified as World Health Organization Group 1 and confirmed by right-heart catheterization.
    Trial and failureFor prerequisite anticonvulsant therapy, failure is defined as inadequate seizure control.
    Trial and failureFailure is defined as an inadequate response; for Caplyta, it additionally means taking the medication as prescribed without an adequate response or with intolerance.
    FailureAn inadequate response to a medication is treated as treatment failure for the Cobenfy prerequisite.
    Clinical benefitFor Cortrophin reauthorization, previously authorized therapy must demonstrate clinical benefit.
    Not currently controlledFor Diacomit, inadequate control means a generalized tonic-clonic or clonic seizure within the past 28 days.
    Trial and failureTrial and failure means inability to improve symptoms or the condition.
    Dupixent treatment failureFailure or inadequate response is defined according to the indication-specific requirement, including inability to improve the condition, inadequate response, or an exacerbation despite prescribed therapy.
    Treatment failureFailure or inadequate response may mean inability to improve symptoms or the condition, inadequate improvement in depressive symptoms, intolerance, or continued intolerance to hydroxyurea.
    Bleeding risk factorsExamples include a history of bleeding, peptic ulcer disease, history of falling, or anticoagulation therapy.
    Biopsy-confirmed eosinophilic esophagitisEosinophilic esophagitis confirmed by esophageal biopsy with at least 15 eosinophils per high-power field.
    FailureFor eslicarbazepine, failure of prior anticonvulsants means inadequate seizure control.
    FailureAn inadequate response is documented failure of a drug to adequately treat the requested condition.
    Elevated eosinophil countFor severe eosinophilic asthma, at least 150 cells per microliter within 6 weeks before treatment or at least 300 cells per microliter during the previous 12 months.
    ICS/LABA failureInability to improve the condition after at least 4 weeks on the required therapy.
    Non-severe EGPAAbsence of life-threatening or organ-threatening manifestations.
    Trial and failureInadequate seizure control after treatment with a specified medication.
    Dependence on parenteral supportInability to be weaned from parenteral nutrition.
    Sustained decreased parenteral supportA sustained decrease in parenteral support from baseline demonstrated by an actual change in volume.
    Try and failFailure means intolerance or inability to improve symptoms.
    Adult growth hormone deficiency confirmationConfirmation may include a suboptimal response to an appropriate growth hormone stimulation test, persistent childhood-onset deficiency, or documented pituitary or hypothalamic disease with at least three pituitary hormone deficiencies and low IGF-1.
    Hereditary angioedemaA diagnosis supported by C4, C1-INH protein, and C1-INH function laboratory results.
    IDH2 mutationA mutation in the isocitrate dehydrogenase-2 gene that must be documented for IDHIFA coverage.