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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty Drugseternalhealth Actimmune Prior Auth | OpenPayer
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    CurrenteternalhealthPolicy 26208

    Actimmune (interferon gamma-1b) coverage

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    This policy establishes prior authorization criteria for Actimmune injection. Coverage requires documentation of chronic granulomatous disease or severe malignant osteopetrosis, with approval available for continuation of prior therapy.

    Policy Summary
    Payereternalhealth
    PolicyActimmune (interferon gamma-1b) coverage
    Policy CodePolicy 26208
    Change TypeNo material change
    Effective DateNov 1, 2026
    Next Review DateN/A
    Key ActionSubmit documentation confirming a diagnosis of chronic granulomatous disease or severe malignant osteopetrosis.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2Covered diagnostic conditions
    12 monthsCoverage duration
    RequiredPrior authorization
    Not requiredPrerequisite Part D drug

    Medical Necessity and Covered Indications

    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.

    Covered Indications and Product-Specific Medical Necessity Criteria

    Coverage is available when the requested product, indication, and all applicable clinical requirements below are met.

    Actimmune covered indications: Diagnosis of chronic granulomatous disease (CGD) or severe malignant osteopetrosis (SMO).
    Pulmonary hypertension products: For Alyq, symptomatic PAH confirmed by right-heart catheterization or current PAH therapy. For Adempas, either symptomatic PAH meeting the same confirmation/current-therapy pathway or inoperable or persistent/recurrent symptomatic CTEPH, or current CTEPH therapy.

    Initial PAH therapy is prescribed by or in consultation with a pulmonologist or cardiologist.

    Afinitor indications: SEGA associated with TSC requiring therapeutic intervention; advanced RCC after SUTENT or NEXAVAR trial/failure, contraindication, or intolerance; progressive unresectable, locally advanced, or metastatic pNET; renal angiomyolipoma with TSC; advanced hormone-receptor-positive/HER2-negative breast cancer after FEMARA or ARIMIDEX trial/failure, contraindication, or intolerance; or progressive, well-differentiated, non-functional GI or lung NET that is unresectable, locally advanced, or metastatic.SEGA age at least 1 year
    Afinitor Disperz indications: SEGA associated with TSC requiring therapeutic intervention or TSC-associated partial-onset seizures.Age at least 1 year for SEGA; at least 2 years for seizures

    Seizure treatment requires neurologist prescribing or consultation.

    Migraine prevention: Episodic migraine with at least 4 migraine days per month, or chronic migraine with at least 8 migraine days per month after medication-overuse headache has been considered and potentially offending medication discontinued.Age at least 18 years

    Aimovig and Emgality must not be combined with another CGRP inhibitor as specified by the requested indication.

    Akeega: Metastatic prostate cancer with deleterious or suspected deleterious BRCA mutation; used with prednisone and a GnRH agent.
    Alecensa or Alunbrig: Diagnosis of non-small cell lung cancer; continuation of prior therapy may be approved.
    Prolastin-c: Congenital AAT deficiency with emphysema; continued conventional emphysema treatment; qualifying PiZZ, PiZ(null), Pi(null)(null), or other qualifying genotype; and pretreatment serum AAT below 11 µM/L.<11 µM/L, or <80 mg/dL by radial immunodiffusion
    Dalfampridine: Multiple sclerosis with documented difficulty walking and either EDSS score 7 or less, or no wheelchair restriction when EDSS is not measured.
    Arformoterol: COPD and maintenance treatment of bronchoconstriction, including chronic bronchitis or emphysema.
    Arikayce: MAC lung disease; combination antibacterial regimen; and failure to achieve at least two negative sputum cultures after at least 6 consecutive months of multidrug background therapy.

    Prescribed by or in consultation with an infectious disease specialist.

    Augtyro: Locally advanced or metastatic ROS1 rearrangement-positive NSCLC, or locally advanced, metastatic, or unresectable NTRK-fusion-positive solid tumor that progressed after treatment or has no satisfactory alternative.
    Austedo: Chorea associated with Huntington disease, or tardive dyskinesia with persistent symptoms despite dose reduction, tapering, or discontinuation of the offending drug, or when such a trial is inappropriate.
    Avmapki Fakzynja: KRAS mutation confirmed by an FDA-approved or CLIA-approved test and prior systemic therapy.
    Avtozma and Avtozma SC: Applicable active RA, SJIA, PJIA, GCA, CAR-T-associated CRS, hospitalized COVID-19 requiring systemic corticosteroids and respiratory support, or SSc-ILD pathway, including required conventional or biologic therapy, imaging, specialist, and treatment-setting criteria.
    Oncology and hematology indications: Covered product-specific indications include GIST, AdvSM/ISM, qualifying FGFR3-altered urothelial carcinoma, active SLE or lupus nephritis, polycythemia vera or essential thrombocythemia, Ph-positive CML, BRAF-mutated melanoma/colorectal cancer/NSCLC, lymphoma, aTTP, RCC/HCC/DTC or neuroendocrine tumors, MCL/CLL/SLL, thyroid cancer, Gaucher disease, bile-acid synthesis or peroxisomal disorders, AML, iron overload, pheochromocytoma, prostate cancer, basal cell carcinoma, IPF, and qualifying NSCLC biomarkers.

    Each product remains subject to its indication-specific disease status, biomarker, age, laboratory, combination, and prior-treatment requirements.

    Pulmonary, infectious, neurologic, and metabolic indications: Covered product-specific indications include cystic fibrosis with qualifying Pseudomonas or tolerance findings, invasive aspergillosis or mucormycosis, COPD, MS, partial-onset or syndrome-associated seizures, HAE prophylaxis or acute attacks, cerebrotendinous xanthomatosis, sickle cell disease with recurrent painful crises, Fabry disease, severe eosinophilic asthma, EGPA, HES, breakthrough cancer pain, and growth hormone deficiency or qualifying growth failure.

    Product-specific age, specialist, laboratory, prior-treatment, and response criteria apply.

    Inflammatory and gastrointestinal indications: Covered product-specific indications include RA, PJIA, PsA, plaque psoriasis, AS, nr-axSpA, ERA, HS, Crohn disease, UC, uveitis, EoE, atopic dermatitis, COPD with type 2 inflammation, bullous pemphigoid, CSU, AFRS, and peptic ulcer disease.

    Indication-specific severity, objective findings, prior therapy, specialist, and combination-treatment requirements apply.

    Other covered indications: Covered product-specific indications also include BPH, confirmed onychomycosis, toxoplasmosis treatment or prophylaxis, acute agitation associated with schizophrenia or bipolar disorder, glycopyrrolate-treated peptic ulcer disease, neurofibromatosis type 1 with inoperable plexiform neurofibromas, and inability to swallow generic imatinib for Imkeldi.
    Continuation of prior therapy: Continuation may be approved when the product-specific covered indication remains applicable and prior therapy is documented.

    Initial Authorization Requirements

    Initial Therapy Criteria

    Initial authorization requires the applicable diagnosis and every criterion in the requested product pathway.

    Alyq or Adempas PAH: Symptomatic PAH with right-heart catheterization confirmation or current PAH therapy.

    Pulmonologist or cardiologist prescribing or consultation required.

    Adempas CTEPH: Inoperable or persistent/recurrent symptomatic CTEPH, or current CTEPH therapy.
    Afinitor or Afinitor Disperz: Meet one covered SEGA, TSC seizure, RCC, pNET, renal angiomyolipoma, breast cancer, or GI/lung NET pathway, including age and prior-treatment requirements where applicable.
    Aimovig or Emgality: Episodic migraine with at least 4 migraine days monthly; chronic migraine with at least 8 migraine days monthly and medication-overuse assessment; or qualifying episodic cluster headache.Age at least 18 years
    Akeega: Metastatic deleterious or suspected deleterious BRCA-mutated prostate cancer, used with prednisone and a GnRH agent.
    Alecensa: Diagnosis of NSCLC.
    Prolastin-c: Congenital AAT deficiency, emphysema, conventional emphysema treatment, qualifying genotype, and serum AAT below 11 µM/L.<11 µM/L
    Dalfampridine: MS, difficulty walking, and EDSS 7 or less or no wheelchair restriction when EDSS is not measured.
    Austedo: Huntington disease chorea, or tardive dyskinesia with persistent symptoms after offending-medication reduction, tapering, or discontinuation, or documented inappropriateness of that trial.
    Avtozma or Avtozma SC: Meet the requested RA, SJIA, PJIA, GCA, CRS, COVID-19, or SSc-ILD pathway, including required prior therapy, hospitalization, respiratory support, imaging, and specialist criteria.
    Ayvakit through Calquence: Meet the requested disease, biomarker, stage, platelet, prior-treatment, combination-treatment, transplant, or specialist pathway for Ayvakit, Balversa, Benlysta, Besremi, Bosulif, Braftovi, Bronchitol, Brukinsa, Cablivi, Cabometyx, or Calquence.
    Caplyta through Ctexli: Meet the requested schizophrenia, bipolar depression, MDD, thyroid cancer, CF/Pseudomonas, Gaucher, bile-acid disorder, BPH, onychomycosis, HAE, CLL/SLL, Cosentyx, Cotellic, Cresemba, or cerebrotendinous xanthomatosis pathway.
    Daurismo through Dupixent: Meet the requested AML, iron-overload, pheochromocytoma, Dravet, thrombocytopenia/ITP, asthma, COPD, EoE, atopic dermatitis, bullous pemphigoid, CSU, AFRS, or other indication-specific diagnosis, laboratory, age/weight, prior-treatment, and specialist requirements.
    Ebglyss through Epidiolex: Meet the requested atopic dermatitis, migraine/cluster headache, PNH/C3G/primary IC-MPGN, inflammatory disease, sickle-cell, ALK-positive NSCLC, chronic HCV, or LGS/Dravet/TSC seizure pathway.
    Procrit through Evrysdi: Meet the applicable anemia scenario and laboratory thresholds; metastatic or qualifying locally advanced BCC; prostate cancer; IPF diagnostic and pulmonology criteria; mild-to-moderate AD with topical-therapy history; or SMA genetic, respiratory, motor-assessment, and therapy restrictions.
    Fabrazyme through Icatibant: Meet the applicable Fabry, severe eosinophilic asthma, EGPA, HES, breakthrough-cancer-pain/opioid-tolerance, Fintepla seizure, or acute HAE diagnostic and treatment pathway.
    Firmagon through Gilotrif: Meet the applicable advanced prostate cancer, relapsed/refractory RCC, metastatic colorectal cancer, immunization, RET-positive cancer, relapsing MS, or EGFR-mutated NSCLC pathway, including required treatment history and biomarkers.
    Glatiramer acetate through Humira: Meet the applicable relapsing-MS, peptic-ulcer/acid-suppression, neurofibromatosis, growth-hormone, HER2-mutated NSCLC, or Humira inflammatory bowel, rheumatologic, dermatologic, uveitis, or HS pathway.
    Products reviewed for all medically accepted indications: For Hyrnuo, Ibrance, Ibtrozi, Iclusig, Idhifa, Igalmi, Imbruvica, and Imkeldi, document the product-specific diagnosis and required medical information; meet any specified biomarker, prior-treatment, formulation, age, or combination requirement.

    Renewal and Continuation Requirements

    Continuation and Reauthorization Criteria

    Reauthorization requires continued appropriate use and the product-specific response, laboratory, treatment, or prior-therapy criteria below.

    Alyq or Adempas: Patient demonstrates positive clinical response to therapy.12-month reauthorization
    Aimovig or Emgality: Positive response; decreased acute migraine medication use; no prohibited concurrent CGRP inhibitor; and continued medication-overuse-headache monitoring for chronic migraine.
    Prolastin-c: Positive clinical response and continued conventional emphysema treatment.12 months
    Dalfampridine: Physician confirms improved walking and the applicable EDSS or wheelchair-use criterion remains met.
    Austedo, Avtozma, Benlysta, Bronchitol, Cayston, Ctexli, Roflumilast, Demser, Doptelet, Dulera, Ebglyss, Enbrel, Endari, Esbriet, Eucrisa, Fasenra, Humira, and related products: Patient demonstrates the positive clinical response required for the indication, such as improved symptoms, disease activity, laboratory values, function, joint counts, BSA/SCORAD, pulmonary exacerbations, platelet count, liver function, or sickle-cell complications.
    HAE prophylaxis: Positive clinical response and continued avoidance of combination with another approved HAE prophylaxis treatment.12 months
    Cosentyx and Cosentyx IV: Document indication-specific improvement from baseline, including joint counts, symptoms, BSA, disease activity, inflammatory markers, function, axial status, abscesses, nodules, sinus tracts, scarring, pain, or suppuration.12-month reauthorization
    Procrit: Meet the applicable disease-specific continuation pathway with positive response and required hemoglobin/hematocrit, ongoing chemotherapy or ribavirin, and other laboratory criteria.
    Evrysdi: Positive clinical response; no concomitant chronic SMN-modifying therapy; and applicable gene-therapy history and inadequate-response documentation.12 months
    Fabrazyme: Positive clinical response and no combination with another drug used for Fabry disease.12 months
    Icatibant: Positive clinical response and no concomitant use of another approved acute HAE treatment.12 months
    Fingolimod or glatiramer acetate: Positive clinical response, neurologist prescribing or consultation, and no combination with another MS disease-modifying therapy.12 months
    Glycopyrrolate tablets: Persistent or recurrent peptic ulcer, required PPI or H2-receptor antagonist therapy, reduced symptoms, and gastroenterology prescribing or consultation.3 months
    Growth hormone: For pediatric indications, expected adult height has not been attained and the height goal remains applicable; for AGHD or IGHDA, an IGF-1/somatomedin C level was documented within the prior 12 months.12 months
    Products requiring continuation of prior therapy: For Alunbrig, Augtyro, Avmapki Fakzynja, Afinitor, Afinitor Disperz, Akeega, Alecensa, oncology products, Epidiolex, Fintepla, and the listed products reviewed only for continuation, continuation of prior therapy is documented and the covered indication remains applicable.
    Product-specific continuation review: For Hyrnuo, Ibrance, Ibtrozi, Iclusig, Idhifa, Igalmi, Imbruvica, and Imkeldi, continuation of prior therapy is documented together with the product-specific diagnosis and required medical information.

    Prerequisite and Prior-Treatment Requirements

    ProductIndication or useRequired prerequisite or step therapyFailure, contraindication, or intolerance requirementMinimum duration or quantity
    AfinitorRenal cell carcinomaSUTENT (sunitinib) or NEXAVAR (sorafenib)Trial and failure, contraindication, or intoleranceNot specified
    AfinitorAdvanced hormone receptor-positive, HER2-negative breast cancerFEMARA (letrozole) or ARIMIDEX (anastrozole)Trial and failure, contraindication, or intoleranceNot specified
    AugtyroAll covered indicationsA prerequisite Part D drugNot specifiedNot specified
    Avmapki FakzynjaAll covered indicationsA prerequisite Part D drugNot specifiedNot specified
    Avtozma IVRheumatoid arthritisTwo of: Enbrel, a formulary adalimumab product, Orencia, Rinvoq, or Xeljanz/Xeljanz XRTrial and failure, contraindication, or intolerance; prescriber attestation may establish that a trial is inappropriateTwo therapies
    Avtozma IVSystemic juvenile idiopathic arthritisNSAID or systemic glucocorticoidTrial and failure, contraindication, or intoleranceNSAID: at least 1 month; systemic glucocorticoid: at least 2 weeks
    Avtozma IVPolyarticular juvenile idiopathic arthritisTwo of: Enbrel, a formulary adalimumab product, Orencia, Rinvoq/LQ, or XeljanzTrial and failure, contraindication, or intolerance; prescriber attestation may establish that a trial is inappropriateTwo therapies
    Avtozma SCRheumatoid arthritisTwo of: Enbrel, a formulary adalimumab product, Orencia, Rinvoq, or Xeljanz/Xeljanz XRTrial and failure, contraindication, or intolerance; prescriber attestation may establish that a trial is inappropriateTwo therapies
    Avtozma SCSystemic juvenile idiopathic arthritisNSAIDTrial and failure, contraindication, or intoleranceAt least 1 month at the maximally tolerated dose
    Avtozma SCPolyarticular juvenile idiopathic arthritisTwo of: Enbrel, a formulary adalimumab product, Orencia, Rinvoq/LQ, or XeljanzTrial and failure, contraindication, or intolerance; prescriber attestation may establish that a trial is inappropriateTwo therapies
    BalversaLocally advanced or metastatic urothelial carcinomaPrior systemic therapy and PD-1 or PD-L1 inhibitor therapy, or documentation that the patient is not a candidateDisease progression on or after at least one systemic therapy line; PD-1/PD-L1 therapy may be unsuitableAt least 1 systemic therapy line
    BesremiHigh-risk polycythemia veraHydroxyureaInadequate response, contraindication, or intoleranceNot specified
    BesremiEssential thrombocythemiaRequired prior therapyInadequate responseNot specified
    BraftoviColorectal cancerErbitux (cetuximab) plus prior therapy or fluorouracil-based chemotherapyPrior therapy required unless used with fluorouracil-based chemotherapyNot specified
    BrukinsaMantle cell lymphomaPrior therapyPrior treatment requiredAt least 1 prior therapy
    BrukinsaMarginal zone lymphomaPrior anti-CD20-based regimenRelapsed or refractory disease; prior regimen requiredAt least 1 prior anti-CD20 regimen
    BrukinsaFollicular lymphomaPrior systemic therapy; use with GazyvaRelapsed or refractory diseaseAt least 2 prior systemic therapy lines
    CabometyxHepatocellular carcinomaNEXAVAR (sorafenib)Trial and failure, contraindication, or intoleranceNot specified
    CabometyxDifferentiated thyroid cancerPrior VEGFR-targeted therapy, such as Lenvima or NEXAVARDisease progression; radioactive-iodine refractory or ineligibleNot specified
    CabometyxPancreatic or extra-pancreatic neuroendocrine tumorsPrevious treatment, such as octreotide, lanreotide, or chemotherapyPrevious treatment requiredNot specified
    CalquenceMantle cell lymphoma, treatment-naive pathwayBendamustine plus rituximabNo prior MCL therapy and patient ineligible for autologous HSCTNo prior therapy
    CalquenceMantle cell lymphoma, previously treated pathwayPrior MCL therapyPrior therapy requiredAt least 1 prior therapy
    CaplytaSchizophreniaTwo listed generic atypical antipsychoticsTrial and failure, contraindication, or intoleranceTwo agents
    CaplytaBipolar depressionQuetiapine IR/ER or olanzapineTrial and failure, contraindication, or intoleranceNot specified
    CaplytaMajor depressive disorderAripiprazole and quetiapine IR/ERTrial and failure, contraindication, or intoleranceBoth agents
    TadalafilBenign prostatic hyperplasiaAn alpha-blocker or 5-alpha reductase inhibitorTrial and failure, contraindication, or intoleranceNot specified
    CiclopiroxFingernail or toenail onychomycosisOral terbinafineTrial and failure, contraindication, or intoleranceFingernails: minimum 6-week supply; toenails: minimum 12-week supply
    CobenfyAll covered indicationsTwo listed oral generic formulary atypical antipsychoticsIntoleranceTwo agents
    CopiktraRelapsed or refractory CLL/SLLPrior CLL/SLL therapiesTrial and failure, contraindication, or intoleranceAt least 2 prior therapies
    CosentyxPlaque psoriasisOne topical corticosteroid, vitamin D analog, tazarotene, or calcineurin inhibitorTrial and failure, contraindication, or intoleranceAt least 4 weeks
    CosentyxAnkylosing spondylitisOne NSAID at the maximally tolerated doseTrial and failure, contraindication, or intoleranceAt least 1 month
    Cosentyxnr-axSpA or enthesitis-related arthritisTwo NSAIDs at maximally tolerated dosesTrial and failure, contraindication, or intoleranceAt least 1 month
    Cosentyx IVPsoriatic arthritisTwo listed formulary alternativesTrial and failure, contraindication, or intolerance, unless continuation of prior therapyNot specified
    Cosentyx IVAnkylosing spondylitisTwo listed formulary alternativesTrial and failure, contraindication, or intolerance, unless continuation of prior therapyNot specified
    Cosentyx IVnr-axSpACosentyx SC and RinvoqTrial and failure, contraindication, or intolerance, unless continuation of prior therapyBoth alternatives
    CyclobenzaprineAll covered indicationsA prerequisite Part D drugNot specifiedNot specified
    RoflumilastCOPDTwo prior COPD therapiesTrial and failure, intolerance, or contraindicationTwo therapies
    DemserPreoperative pheochromocytoma preparationAn alpha-adrenergic blocker and a beta-adrenergic blockerTrial and failure, contraindication, or intolerance to bothNot specified
    DopteletImmune thrombocytopeniaA corticosteroid, immunoglobulin, or splenectomyTrial and failure, contraindication, or intoleranceAt least 1 therapy
    DuleraAsthmaBreo ElliptaTrial, failure, contraindication, or intoleranceNot specified
    DupixentCRSwNPIntranasal corticosteroidInadequate response, contraindication, or intoleranceAt least 2 months
    DupixentAsthmaAge-appropriate inhaled corticosteroid and additional controller, or ICS/LABA combinationRequired therapy may be excepted for contraindication or intoleranceNot specified
    DupixentEosinophilic esophagitisProton-pump inhibitor or topical esophageal corticosteroidTrial and failure, contraindication, or intoleranceAt least 8 weeks
    DupixentAtopic dermatitisTopical corticosteroid, pimecrolimus, tacrolimus ointment, or crisaboroleFailure, contraindication, or intoleranceUsually at least 30 days; 14 days for topical corticosteroids
    DupixentCOPDMaximally tolerated triple therapy; LAMA plus LABA if ICS is contraindicatedICS may be omitted for contraindicationNot specified
    EbglyssModerate-to-severe atopic dermatitisMedium- or higher-potency topical corticosteroid, pimecrolimus, tacrolimus ointment, or crisaboroleFailure, contraindication, or intoleranceUsually at least 30 days; 14 days for topical corticosteroids
    EmpaveliC3G or primary IC-MPGNACE inhibitor, ARB, or SGLT2 inhibitorMaximally tolerated therapy must be used before initiation and continued for renewalAt least 12 weeks
    EnbrelRheumatoid arthritisMethotrexate, leflunomide, or sulfasalazineFailure, contraindication, or intoleranceAt least 3 months
    EnbrelPolyarticular juvenile idiopathic arthritisLeflunomide or methotrexateFailure, contraindication, or intoleranceAt least 6 weeks
    EnbrelAnkylosing spondylitisOne NSAID at the maximally tolerated doseFailure, contraindication, or intoleranceAt least 1 month
    EnbrelPlaque psoriasisAppropriate topical therapyFailure, contraindication, or intoleranceUsually at least 30 days; 14 days for topical corticosteroids
    EpidiolexLennox-Gastaut syndromeTwo formulary anticonvulsants, such as topiramate, lamotrigine, or valproateTrial, contraindication, or intoleranceTwo agents
    EucrisaAtopic dermatitisOne prescription-strength topical corticosteroidTrial and failure, contraindication, or intolerance; not required for sensitive areas such as the face, axillae, or groinNot specified
    FasenraSevere eosinophilic asthmaAge-appropriate inhaled corticosteroid and additional controller, or applicable ICS/LABA combinationRequired unless contraindicated or intolerableNot specified
    FasenraEGPACorticosteroid therapyRequired unless contraindicated or intolerableNot specified
    FasenraHESCorticosteroid or cytotoxic/immunosuppressive therapyTrial and failure, contraindication, or intoleranceNot specified
    FotivdaRelapsed or refractory advanced renal cell carcinomaAt least two prior systemic therapiesPrior therapies requiredAt least 2 therapies
    FruzaqlaMetastatic colorectal cancerFluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy plus anti-VEGF therapy; RAS wild-type also requires anti-EGFR therapy plus Lonsurf or StivargaPrior treatment requiredNot specified
    GilotrifAdvanced or metastatic NSCLCFirst-line qualifying EGFR-mutated pathway or post-platinum pathwayApplicable treatment-history requirementNot specified
    HumiraRheumatoid arthritisMethotrexate, leflunomide, or sulfasalazineFailure, contraindication, or intoleranceAt least 3 months
    HumiraPolyarticular juvenile idiopathic arthritisLeflunomide or methotrexateFailure, contraindication, or intoleranceAt least 6 weeks
    HumiraPlaque psoriasisCorticosteroid, vitamin D analog, tazarotene, or calcineurin inhibitorFailure, contraindication, or intoleranceUsually at least 30 days; 14 days for topical corticosteroids
    HumiraAnkylosing spondylitisOne NSAID at the maximally tolerated doseFailure, contraindication, or intoleranceAt least 1 month
    Glycopyrrolate tabletsPeptic ulcer diseaseConcomitant PPI; if contraindicated or intolerable, an H2-receptor antagonistPPI contraindication or intolerance required when using H2-receptor antagonist insteadNot specified
    HyrnuoLocally advanced or metastatic non-squamous NSCLCA prerequisite Part D drugPrior systemic therapy also requiredNot specified
    IgalmiAcute agitation associated with schizophrenia or bipolar I/II disorderA prerequisite Part D drug and acute-agitation productsTrial and failure, contraindication, or intolerance to at least two acute-agitation productsAt least 2 products
    ImbruvicaAll covered indicationsA prerequisite Part D drugFor cGVHD, trial and failure of one or more systemic therapy linesAt least 1 systemic therapy line for cGVHD

    Clinical Thresholds and Quantitative Requirements

    Quantitative clinical thresholds
    Migraine frequencyEpisodic migraine: greater than or equal to 4 migraine days per month; chronic migraine: greater than or equal to 8 migraine days per month.
    Alpha-1 antitrypsin levelPretreatment serum AAT less than 11 µM/L, corresponding to less than 80 mg/dL if measured by radial immunodiffusion.
    Dalfampridine functional criterionEDSS score less than or equal to 7, or the patient is not restricted to using a wheelchair when EDSS is not measured.
    Refractory MAC criterionAt least two negative sputum cultures after a minimum of 6 consecutive months of multidrug background regimen therapy.
    Iron-overload thresholdsTransfusional iron overload: ferritin greater than 1,000 mcg/L and at least 100 mL/kg packed red blood cell transfusion; NTDT: liver iron concentration at least 5 mg Fe/g liver dry weight and serum ferritin greater than 300 mcg/L.
    Eosinophilic disease thresholdsDupixent COPD requires blood eosinophils at least 300 cells/mcL; Fasenra HES requires pretreatment eosinophils at least 1,000 cells per microliter.
    Opioid toleranceFor fentanyl citrate oral transmucosal therapy, tolerance for at least one week is required at one qualifying regimen, including morphine at least 60 mg/day, transdermal fentanyl at least 25 micrograms/hour, oxycodone at least 30 mg/day, oral hydromorphone at least 8 mg/day, oral oxymorphone at least 25 mg/day, oral hydrocodone at least 60 mg/day, or oral methadone at least 20 mg/day.

    Prior Authorization and Submission Requirements

    Prior Authorization

    Complete prior authorization documentation before prescribing

    Prior authorization is required for Actimmune injection and the specialty products addressed in this policy. Submit the product-specific diagnosis, required clinical findings or laboratory/molecular results, prior-treatment history or exceptions, specialist involvement when required, and continuation response information; requests may be denied when these criteria are not documented.

    • Actimmune requests must document chronic granulomatous disease or severe malignant osteopetrosis.
    • Document indication-specific disease severity, diagnostic testing, treatment history, prerequisite therapy or documented contraindication/intolerance, and required prescriber specialty or consultation.
    • For reauthorization, document continuation of prior therapy or the required positive clinical response and any product-specific laboratory or treatment criteria.
    • Follow product-specific restrictions, including prohibited combination therapy, required concomitant therapy, and applicable authorization periods.

    Clinical and Policy Definitions

    Abbreviations and clinical definitions
    CGDChronic granulomatous disease.
    SMOSevere malignant osteopetrosis.
    TF/C/ITrial and failure, contraindication, or intolerance.
    SSc-ILDSystemic sclerosis-associated interstitial lung disease.
    FGFR3Fibroblast growth factor receptor 3.
    HAEHereditary angioedema, including type I or II disease associated with C1-inhibitor deficiency or dysfunction and HAE with normal C1-inhibitor associated with specified genetic findings or confirmed family history.
    SCORADAn atopic dermatitis severity measure; severity may be established by at least 10% body surface area involvement or a SCORAD index value of at least 25.

    Policy Scope and Specialty-Drug Context

    This policy establishes prior authorization criteria for specialty drugs across a broad range of clinical uses, including pulmonary hypertension, oncology, neurologic and movement disorders, migraine prevention, pulmonary disease, and alpha-1 antitrypsin deficiency. Coverage is generally based on the documented diagnosis and, when applicable, disease severity, molecular or laboratory findings, age, prior treatment history, specialist involvement, and demonstrated clinical response for reauthorization.

    Administration and Site-of-Care Requirements

    Billing Rule

    Administer the first Cablivi dose in the office

    The first Cablivi dose must be administered by a healthcare provider as a bolus intravenous injection. Document the administration plan or completed administration with the aTTP request, along with the required immunosuppressive therapy and plasma-exchange pathway.

    • Use with immunosuppressive therapy such as rituximab or glucocorticoids.
    • Use with plasma exchange, or administer after plasma exchange has been completed with fewer than 59 days elapsed.
    • Prescribing must be by or in consultation with a hematologist or oncologist.
    Policy Summary
    Payereternalhealth
    PolicyActimmune (interferon gamma-1b) coverage
    Policy CodePolicy 26208
    Change TypeNo material change
    Effective DateNov 1, 2026
    Next Review DateN/A
    Key ActionSubmit documentation confirming a diagnosis of chronic granulomatous disease or severe malignant osteopetrosis.
    SourceLink
    On This Page
    Medical Necessity and Covered IndicationsInitial Authorization RequirementsRenewal and Continuation RequirementsPrerequisite and Prior-Treatment RequirementsClinical Thresholds and Quantitative RequirementsPrior Authorization and Submission RequirementsClinical and Policy DefinitionsPolicy Scope and Specialty-Drug ContextAdministration and Site-of-Care Requirements