CurrentAlign Powered by Sanford Health PlanPolicy 26213
Actimmune Coverage Criteria
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This policy governs prior authorization for Actimmune injection. Coverage applies to members diagnosed with chronic granulomatous disease or severe malignant osteopetrosis, with approval for continuation of prior therapy.
Policy Summary
PayerAlign Powered by Sanford Health Plan
PolicyActimmune Coverage Criteria
Policy CodePolicy 26213
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.
No material clinical or coverage changes in this revision.
2Covered diagnostic indications
12 monthsCoverage duration
NoPrerequisite Part D drug required
Product Coverage Criteria
Actimmune through Prolastin-C
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Covered when the applicable product-specific criteria are met.
Actimmune
Diagnosis of chronic granulomatous disease (CGD) or severe malignant osteopetrosis (SMO).
Continuation of prior therapy is approved.
Coverage duration: 12 months.
Alyq
Initial PAH therapy: diagnosis of symptomatic pulmonary arterial hypertension (PAH), confirmed by right-heart catheterization or current PAH therapy; prescribed by or in consultation with a pulmonologist or cardiologist.
Initial coverage is 6 months; renewal coverage is 12 months.
Adempas
Initial PAH
Diagnosis of symptomatic PAH confirmed by right-heart catheterization.
Diagnosis of symptomatic PAH and current therapy for PAH.
Initial CTEPH
ALL of the following
Inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH).
CTEPH is symptomatic.
Current therapy for CTEPH.
Afinitor covered indications
Subependymal giant cell astrocytoma associated with tuberous sclerosis complex requiring therapeutic intervention; age 1 year or older.
Advanced renal cell carcinoma after failure, contraindication, or intolerance to sunitinib or sorafenib.
Progressive, unresectable, locally advanced, or metastatic pancreatic neuroendocrine tumor.
Renal angiomyolipoma associated with tuberous sclerosis complex.
Advanced hormone receptor-positive, HER2-negative breast cancer after failure, contraindication, or intolerance to letrozole or anastrozole.
Progressive, well-differentiated, nonfunctional gastrointestinal or lung neuroendocrine tumor that is unresectable, locally advanced, or metastatic.
Afinitor Disperz covered indications
Subependymal giant cell astrocytoma associated with tuberous sclerosis complex requiring therapeutic intervention; age 1 year or older.
Tuberous-sclerosis-complex-associated partial-onset seizures; age 2 years or older and prescribed by or in consultation with a neurologist.
Coverage duration: 12 months; continuation of prior therapy approved.
Aimovig initial therapy
ANY of the following
Episodic migraine with at least 4 migraine days per month.
Chronic migraine with at least 8 migraine days per month; medication-overuse headache considered and offending medication discontinued.
Patient is 18 years or older.
Not used with another CGRP inhibitor for migraine prevention.
Aimovig continuation therapy
Positive response to therapy and decreased use of acute migraine medicines.
Chronic migraine patients continue to be monitored for medication-overuse headache.
Not used with another CGRP inhibitor for migraine prevention.
Initial coverage is 6 months; renewal coverage is 12 months.
Akeega
Metastatic prostate cancer with deleterious or suspected deleterious BRCA mutation.
Used in combination with prednisone and a GnRH agonist/antagonist.
Coverage duration: 12 months; continuation of prior therapy approved.
Alecensa
Diagnosis of non-small-cell lung cancer (NSCLC).
Coverage duration: 12 months; continuation of prior therapy approved.
Prolastin-C initial therapy
Congenital alpha-1 antitrypsin deficiency with emphysema and continued conventional treatment, such as bronchodilators.
PiZZ, PiZ(null), Pi(null)(null), or another rare AAT genotype associated with pretreatment serum AAT below 11 µM/L (less than 80 mg/dL by radial immunodiffusion).
Prolastin-C continuation therapy
Positive clinical response to therapy.
Continued conventional treatment for emphysema.
Coverage duration for initial and renewal therapy: 12 months.
Avtozma through Calquence
Covered when the applicable product-specific criteria are met.
Avtozma initial coverage
Moderately to severely active rheumatoid arthritis after trial/failure, contraindication, or intolerance to two specified biologic or targeted therapies, unless a trial is inappropriate or treatment is continuation therapy.
Active systemic juvenile idiopathic arthritis after a one-month NSAID or two-week systemic corticosteroid trial.
Active polyarticular juvenile idiopathic arthritis after failure, contraindication, or intolerance to two specified therapies, unless a trial is inappropriate or treatment is continuation therapy.
Giant cell arteritis.
Cytokine release syndrome in a patient receiving or about to receive CAR-T therapy.
Hospitalized COVID-19 with systemic corticosteroid treatment and need for oxygen, noninvasive or invasive ventilation, or ECMO.
Avtozma continuation therapy
Positive clinical response, including reduced active joint count or improved symptoms for RA/PJIA/SJIA, and positive response for GCA or SSc-ILD.
Initial coverage is 6 months; renewal coverage is 12 months.
Avtozma SSc-ILD coverage
Systemic-sclerosis-associated interstitial lung disease with other causes excluded.
High-resolution CT, with or without surgical lung biopsy, shows SSc-ILD or probable SSc-ILD pattern.
Prescribed by or in consultation with a rheumatologist or appropriate specialist.
Avtozma SSc-ILD continuation
Positive clinical response to therapy.
Renewal coverage: 12 months.
Ayvakit
Unresectable or metastatic GIST with PDGFRA exon 18 mutation, including D842V.
Advanced systemic mastocytosis: aggressive SM, SM with associated hematologic neoplasm, or mast-cell leukemia; platelet count at least 50 × 10^9/L.
Indolent systemic mastocytosis with platelet count at least 50 × 10^9/L.
Balversa
Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 alteration confirmed by an FDA-approved or CLIA test.
Disease progressed after at least one systemic therapy and patient received, or is not a candidate for, PD-1/PD-L1 inhibitor therapy.
Benlysta
ANY of the following
Active SLE with positive ANA or anti-dsDNA and current standard-of-care treatment.
Active lupus nephritis with standard-of-care corticosteroid plus mycophenolate or cyclophosphamide.
For initial therapy, patient is at least 5 years old and treatment is prescribed by or in consultation with a rheumatologist or nephrologist as applicable.
Renewal requires positive clinical response; coverage is 6 months.
Besremi
Polycythemia vera; for high-risk disease, age at least 60 or prior thrombosis and inadequate response, contraindication, or intolerance to hydroxyurea.
Essential thrombocythemia after inadequate response, contraindication, or intolerance to required prior therapy.
Essential-thrombocythemia therapy is prescribed by or in consultation with a hematologist/oncologist.
Relapsed or refractory marginal-zone lymphoma after an anti-CD20 regimen.
CLL/SLL with contraindication or intolerance to acalabrutinib.
Relapsed or refractory follicular lymphoma, used with obinutuzumab, after at least two prior systemic lines.
Cablivi
Acquired thrombotic thrombocytopenic purpura.
Used with immunosuppressive therapy and plasma exchange, or after plasma exchange for fewer than 59 days.
First dose administered by a healthcare provider; prescribed by or in consultation with a hematologist/oncologist; coverage 3 months.
Cabometyx
Renal cell carcinoma.
Hepatocellular carcinoma after failure, contraindication, or intolerance to sorafenib.
Progressive differentiated thyroid cancer after VEGFR-targeted therapy and radioactive-iodine refractory or ineligible; age at least 12.
Well-differentiated, unresectable, locally advanced, or metastatic pancreatic or extra-pancreatic neuroendocrine tumor after prior treatment.
Calquence qualifying indications
MCL: untreated and transplant-ineligible with bendamustine/rituximab, or at least one prior therapy.
Chronic lymphocytic leukemia or small lymphocytic lymphoma.
Caplyta through Daurismo
Covered when the applicable product-specific criteria are met.
Caplyta psychiatric indications
Schizophrenia after trial/failure, contraindication, or intolerance to two listed generic atypical antipsychotics.
Bipolar I or II depression, as monotherapy or adjunctive lithium/valproate, after trial/failure, contraindication, or intolerance to quetiapine or olanzapine.
Major depressive disorder as adjunctive therapy with an antidepressant after trial/failure, contraindication, or intolerance to aripiprazole and quetiapine.
Caprelsa thyroid cancer
Metastatic or unresectable locally advanced medullary thyroid cancer with symptomatic or progressive disease.
Cayston pulmonary infection
Evidence of Pseudomonas aeruginosa in the lungs in cystic fibrosis; initial therapy requires age at least 7 years.
Renewal requires benefit, such as fewer pulmonary exacerbations.
Cerdelga Gaucher disease
Type 1 Gaucher disease with CYP2D6 extensive, intermediate, or poor metabolizer status confirmed by an FDA-cleared test.
Patient is at least 18 years old.
Cholbam metabolic disorders
Bile-acid-synthesis disorder due to a single enzyme defect confirmed by urinary bile-acid analysis or molecular genetic testing.
Peroxisomal disorder confirmed by testing, with liver disease, steatorrhea, or fat-soluble-vitamin malabsorption complications, and used as adjunctive treatment.
Ciclopirox onychomycosis
No lunula/matrix involvement; confirmed fingernail or toenail onychomycosis by KOH, culture, or histology.
Toenail disease is mild to moderate and involves at least one target nail.
Failure, contraindication, or intolerance to oral terbinafine after at least 6 weeks for fingernails or 12 weeks for toenails.
Coverage duration: 48 weeks.
Cinryze hereditary angioedema prophylaxis
Hereditary angioedema confirmed by appropriate C4/C1-INH abnormalities or normal C4/C1-INH with qualifying mutation or family history.
Used for HAE prophylaxis, not with another approved prophylactic treatment; patient is at least 6 years old.
Prescribed by or in consultation with an allergist or immunologist.
Renewal requires positive clinical response; coverage is 12 months.
Continuation therapy
For products whose source criteria specify continuation, the patient may continue previously authorized therapy when the product-specific diagnosis remains present.
Where renewal criteria are specified, documentation of positive clinical response is required.
Cotellic initial coverage
Unresectable or metastatic melanoma with BRAF V600E or V600K mutation, used with vemurafenib.
Histiocytic neoplasm indication may also qualify.
Cresemba
Invasive aspergillosis or invasive mucormycosis.
Coverage duration: 6 months.
Ctexli initial therapy
Cerebrotendinous xanthomatosis confirmed by pathogenic CYP27A1 variant.
Initial therapy prescribed by or in consultation with a neurologist, geneticist, metabolic-disease specialist, or endocrinologist.
Ctexli continuation therapy
Positive clinical response to therapy.
Initial and renewal coverage: 12 months.
Cyclobenzaprine coverage
Muscle spasm associated with an acute, painful musculoskeletal condition.
Off-label fibromyalgia-related symptoms, such as difficulty sleeping.
Acute temporomandibular disorder with jaw-muscle tenderness and concurrent NSAID use.
For patients age 65 or older, prescriber acknowledges anticholinergic risks and will consider dose reduction or discontinuation of unnecessary medicines.
Daliresp initial therapy
COPD with exacerbations requiring systemic corticosteroids, antibiotics, or hospitalization.
Trial and failure, intolerance, or contraindication to two prior COPD therapies.
Coverage duration: 12 months; continuation of prior therapy approved.
Daraprim
Active, secondary-prophylaxis, or congenital toxoplasmosis; or primary prophylaxis when TMP-SMX is intolerable despite desensitization or caused a life-threatening reaction.
Malaria treatment or prophylaxis is not authorized.
Toxoplasmosis treatment is prescribed by or in consultation with an infectious-disease specialist.
General indication and response requirements
The requested product must be used for a covered, medically accepted indication documented in the record.
Renewal generally requires continued diagnosis and positive clinical response when specified by the product criteria.
Eosinophilic conditions through Fintepla
Covered when the applicable product-specific criteria are met.
Eosinophilic esophagitis initial therapy
Eosinophilic esophagitis with esophageal dysfunction, at least 15 intraepithelial eosinophils per high-power field, and exclusion of other causes.
Patient weighs at least 15 kg and has failed, cannot tolerate, or has a contraindication to an 8-week PPI or topical esophageal corticosteroid trial.
Atopic dermatitis initial therapy
Moderate to severe atopic dermatitis with at least 10% BSA involvement or SCORAD at least 25.
Failure, contraindication, or intolerance to medium/high-potency topical corticosteroid, pimecrolimus, tacrolimus, or crisaborole as applicable.
COPD initial therapy
COPD with type 2 inflammation and baseline eosinophils at least 300 cells/mcL.
Receiving maximal triple therapy (ICS/LAMA/LABA), or LAMA/LABA when ICS is contraindicated.
At least two exacerbations requiring systemic corticosteroids or a COPD hospitalization in the preceding 12 months.
Epclusa preferred
Chronic hepatitis C treated consistently with current AASLD/IDSA guidance.
Not used with another HCV direct-acting antiviral.
Prescribed by or in consultation with an eligible hepatology, gastroenterology, infectious-disease, HIV, or liver-transplant specialist unless the stated exception applies.
Procrit indication-specific criteria
CKD anemia with Hgb below 10 g/dL or Hct below 30%, with dialysis/ESRD status or declining hemoglobin likely to require transfusion.
Chemotherapy-associated anemia in nonmyeloid cancer with Hgb below 10 g/dL or Hct below 30%.
Preoperative noncardiac, nonvascular surgery with Hgb above 10 and no more than 13 g/dL and high transfusion risk.
Ribavirin/interferon-associated HCV anemia with Hgb below 12 or Hct below 36%.
HIV-associated anemia with Hgb below 12 or Hct below 36% and erythropoietin no more than 500 mU/mL.
MDS with erythropoietin no more than 500 mU/mL or transfusion dependence.
Eucrisa initial and continuation therapy
Initial: mild to moderate atopic dermatitis and failure, contraindication, or intolerance to a prescription topical corticosteroid, unless the site is sensitive.
Renewal: positive clinical response, such as improved severity.
Evrysdi initial therapy
SMA type I, II, or III with qualifying 5q SMN1 mutation/deletion and at least two SMN2 copies.
Not dependent on invasive ventilation/tracheostomy and noninvasive ventilation beyond naps/nighttime sleep.
Baseline motor assessment completed; no concomitant chronic SMN-modifying therapy.
No prior gene replacement, or inadequate response to prior gene therapy documented.
Prescribed by or in consultation with a neurologist experienced in SMA.
Evrysdi continuation therapy
Positive clinical response.
No concomitant chronic SMN-modifying therapy and applicable prior-gene-therapy requirements continue to be met.
Initial and renewal coverage: 12 months.
Fabrazyme initial and continuation therapy
Initial: Fabry disease confirmed by GLA pathogenic mutation, deficient alpha-galactosidase A activity, or significant clinical manifestations; patient is at least 2 years old.
Renewal: positive clinical response and no combination with another Fabry disease drug.
Coverage duration: 12 months.
Fasenra asthma initial therapy
Severe eosinophilic asthma with baseline eosinophils at least 150 cells/mcL and at least two systemic-steroid exacerbations or an asthma hospitalization in the prior 12 months.
Patient is receiving required age-appropriate medium/high-dose ICS plus controller therapy or maximally dosed ICS/LABA unless contraindicated.
Fasenra EGPA and HES therapy
EGPA with current corticosteroid therapy unless contraindicated or intolerant.
HES after ruling out secondary causes, FIP1L1-PDGFRA negativity, eosinophils at least 1,000 cells/mcL, and failure, contraindication, or intolerance to corticosteroid or cytotoxic/immunosuppressive therapy.
Renewal for asthma, EGPA, or HES requires positive clinical response.
Fentanyl citrate oral transmucosal therapy
Breakthrough cancer pain while taking a long-acting opioid around the clock.
At least one week of opioid tolerance at qualifying dose, including morphine 60 mg/day, fentanyl patch 25 mcg/hour, oxycodone 30 mg/day, or equianalgesic alternative.
Prescribed by or in consultation with pain, oncology, hematology, hospice, or palliative-care specialist.
Fintepla initial and continuation therapy
Seizures associated with Dravet syndrome or Lennox-Gastaut syndrome; patient is at least 2 years old.
Prescribed by or in consultation with a neurologist.
Continuation of prior therapy approved; coverage duration 12 months.
Icatibant through Imkeldi
Covered when the applicable product-specific criteria are met.
Icatibant acetate acute HAE therapy
Acute hereditary angioedema attack with diagnosis confirmed by qualifying C4/C1-INH findings or qualifying mutation/family history.
For treatment of an acute HAE attack; not used with another approved acute-attack treatment.
Initial therapy requires age at least 18 and consultation with an allergist or immunologist.
Renewal requires positive clinical response; coverage is 12 months.
Icatibant initial therapy
Same qualifying HAE diagnosis and acute attack criteria as above.
Patient is at least 18 years old and treatment is prescribed by or in consultation with an allergist/immunologist.
Icatibant continuation
Positive clinical response.
Not used with another approved acute HAE treatment.
Firmagon
Advanced or metastatic prostate cancer.
Coverage duration: 12 months; continuation of prior therapy approved.
Fotivda
Advanced renal cell carcinoma that is relapsed or refractory after at least two systemic therapies.
Coverage duration: 12 months; continuation of prior therapy approved.
Fruzaqla
Metastatic colorectal cancer after fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and anti-VEGF therapy.
RAS-mutant disease, or RAS-wild-type disease after anti-EGFR therapy and Lonsurf or Stivarga.
Gamastan
Intramuscular immune globulin administered at the minimum effective dose and appropriate frequency for the diagnosis and required immunization.
Coverage duration: 14 days.
Gavreto
Metastatic RET-fusion-positive NSCLC.
Advanced or metastatic RET-fusion-positive thyroid cancer requiring systemic therapy and radioactive iodine refractory or inappropriate; age at least 12.
Gilenya initial therapy
Relapsing form of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease.
Prescribed by or in consultation with a neurologist.
Not used with another MS disease-modifying therapy.
Gilenya continuation
Positive clinical response, such as stable radiologic disease, fewer relapses, or stable/improved function.
Not used with another MS disease-modifying therapy; coverage is 12 months.
Gilotrif
Advanced or metastatic NSCLC with non-resistant EGFR mutation confirmed by FDA-approved or CLIA test, used first line, or progression after platinum chemotherapy.
Glatiramer acetate initial therapy
Relapsing form of MS.
Not used with another MS disease-modifying therapy and prescribed by or in consultation with a neurologist.
Glatiramer acetate continuation
Positive clinical response and no concurrent MS disease-modifying therapy.
Coverage duration: 12 months.
Gleevec
One qualifying indication: Ph-positive/BCR-ABL-positive CML or ALL, GIST, unresectable/recurrent/metastatic dermatofibrosarcoma protuberans, hypereosinophilic syndrome/chronic eosinophilic leukemia, MDS/myeloproliferative disease, or another listed covered indication.
Coverage duration: 12 months; continuation of prior therapy approved.
Glycopyrrolate
Initial: peptic ulcer with concurrent PPI, or PPI contraindication/intolerance with H2 antagonist therapy.
Renewal: ulcer not healed or new ulcer, continued acid-suppression therapy, and reduced symptoms.
Prescribed by or in consultation with a gastroenterologist; coverage 3 months.
Gomekli
Neurofibromatosis type 1 with inoperable plexiform neurofibromas.
Coverage duration: 12 months; continuation of prior therapy approved.
Preferred growth hormone
Qualifying pediatric growth hormone deficiency, Turner syndrome, Noonan syndrome, idiopathic short stature, SHOX deficiency, small for gestational age without catch-up growth, chronic renal insufficiency, or other listed pediatric indication with required growth/bone-age documentation.
Qualifying adult growth hormone deficiency confirmed by stimulation testing or pituitary hormone/IGF-1 findings.
Renewal requires expected adult height not reached, documented goal, or monitoring such as IGF-1 as applicable; prescribed by or in consultation with an endocrinologist or nephrologist.
Hernexeos
Unresectable or metastatic nonsquamous NSCLC with HER2 tyrosine-kinase-domain activating mutation confirmed by FDA-approved or CLIA test.
Coverage duration: 12 months; continuation of prior therapy approved.
Humira
Qualifying active RA, SJIA, PJIA, PsA, plaque psoriasis, AS, Crohn disease, ulcerative colitis, hidradenitis suppurativa, uveitis, or other listed indication with the specified disease severity and prior-treatment requirements.
Renewal requires positive clinical response documented by disease-specific measures.
Hyrnuo initial and continuation criteria
Locally advanced or metastatic nonsquamous NSCLC with activating HER2 mutation confirmed by FDA-approved or CLIA test and prior systemic therapy.
Continuation of prior therapy approved; coverage duration is 12 months.
Ibrance criteria
Diagnosis of breast cancer.
Coverage duration: 12 months; continuation of prior therapy approved.
Ibtrozi criteria
Locally advanced or metastatic NSCLC with ROS1 rearrangement-positive tumor confirmed by FDA-approved or CLIA test.
Coverage duration: 12 months; continuation of prior therapy approved.
Iclusig criteria
Chronic myelogenous leukemia.
Philadelphia-chromosome-positive acute lymphoblastic leukemia treated with chemotherapy for up to 20 cycles or as monotherapy when no other kinase inhibitor is indicated or disease is resistant/intolerant.
Idhifa criteria
Relapsed or refractory AML with IDH2 mutation confirmed by FDA-approved or CLIA test.
Coverage duration: 12 months; continuation of prior therapy approved.
Igalmi criteria
Schizophrenia or bipolar I/II disorder with acute agitation.
Failure, contraindication, or intolerance to at least two products used for acute agitation and ongoing maintenance therapy for the underlying disorder.
Coverage duration: 14 days; continuation of prior therapy approved.
Imbruvica criteria
CLL, Waldenström macroglobulinemia/lymphoplasmacytic lymphoma, or SLL.
Chronic graft-versus-host disease after failure of at least one systemic therapy; age at least 1 year.
Coverage duration: 12 months; continuation of prior therapy approved.
Imkeldi criteria
Ph-positive/BCR-ABL-positive CML or ALL, MDS/MPD, aggressive systemic mastocytosis, HES/CEL, unresectable/recurrent/metastatic DFSP, or GIST.
Patient cannot swallow generic imatinib tablets because of age, physical impairment, dysphagia, or feeding/nasogastric tube use.
Coverage duration: 12 months; continuation of prior therapy approved.
Tadalafil/Cialis: concurrent use with nitrates is excluded. Where specified, documentation of contraindication, intolerance, or failure of an alpha-blocker or 5-alpha-reductase inhibitor is required.
Cinryze: do not use in combination with another approved treatment for hereditary-angioedema prophylaxis.
Icatibant acetate: do not use in combination with another approved treatment for acute HAE attacks.
Epclusa/sofosbuvir-velpatasvir: do not use with another HCV direct-acting antiviral.
Aimovig and Emgality: do not combine with another CGRP inhibitor for preventive migraine treatment; Emgality cluster-headache therapy also must not be combined with another injectable CGRP inhibitor.
Evrysdi: do not use concomitantly with chronic survival-motor-neuron-modifying therapy such as Spinraza; prior gene therapy requires documented inadequate response when applicable.
Fabrazyme: do not use in combination with other drugs for Fabry disease.
Gilenya and glatiramer acetate: do not use in combination with another disease-modifying therapy for multiple sclerosis.
Coverage determinations must also apply the general requirement that the requested product be used for a documented covered indication and that renewal requests demonstrate the product-specific response requirements.
Initial Authorization Criteria
Initial therapy criteria: Actimmune through Daurismo
Initial authorization requires all applicable product-specific requirements.
Pulmonary and early oncology products: For Actimmune, document CGD or SMO. For Alyq or Adempas, document symptomatic PAH with right-heart-catheterization confirmation or current PAH therapy, or qualifying symptomatic inoperable/persistent/recurrent CTEPH. For Afinitor, Afinitor Disperz, Aimovig, Akeega, Alecensa, and Prolastin-c, document the indication-specific diagnosis, age, biomarker, prior therapy, combination therapy, or laboratory requirements stated for the product.
Avtozma through Calquence: Document the qualifying diagnosis, disease activity or stage, biomarker or laboratory findings, specialist involvement, required prior therapies or combinations, and administration requirements for Avtozma, Ayvakit, Balversa, Benlysta, Besremi, Bosulif, Braftovi, Briviact, Bronchitol, Brukinsa, Cablivi, Cabometyx, and Calquence.
Caplyta through Daurismo: Document the applicable psychiatric, oncologic, infectious, metabolic, pulmonary, laboratory, genetic, age, specialist, and prior-treatment criteria for Caplyta, Caprelsa, Cayston, Cerdelga, Cholbam, tadalafil, ciclopirox, Cinryze, Cotellic, Cresemba, Ctexli, cyclobenzaprine, Daliresp, Danziten, Daraprim, and Daurismo.
Ebglyss through Fintepla: Document the applicable disease severity, laboratory, genetic, motor, opioid-tolerance, specialist, and prerequisite-therapy requirements for Ebglyss, Emgality, Empaveli, Enbrel, L-glutamine, Ensacove, sofosbuvir/velpatasvir, Epidiolex, Procrit, Erivedge, Erleada, pirfenidone, Eucrisa, Evrysdi, Fabrazyme, Fasenra, fentanyl citrate, and Fintepla.
Icatibant through Imkeldi: Document the applicable HAE diagnostic pathway, cancer diagnosis and biomarker, prior systemic therapy, relapsed or refractory status, specialist involvement, MS combination exclusion, disease-specific response measures, or inability to swallow generic imatinib for Icatibant, Firmagon, Fotivda, Fruzaqla, Gamastan, Gavreto, Gilenya, Gilotrif, glatiramer acetate, Gleevec, glycopyrrolate, Gomekli, growth hormone, Hernexeos, Humira, Hyrnuo, Ibrance, Ibtrozi, Iclusig, Idhifa, Igalmi, Imbruvica, and Imkeldi.
Initial therapy criteria: Ebglyss through Imkeldi
Initial authorization requires all applicable disease-specific, laboratory, prior-treatment, specialist, and formulation criteria.
Indication-specific medical necessity: For eosinophilic esophagitis, require esophageal dysfunction, at least 15 eosinophils per high-power field, exclusion of other causes, weight at least 15 kg, and an 8-week PPI or topical esophageal corticosteroid trial. For atopic dermatitis, require moderate to severe disease, at least 10% BSA or SCORAD at least 25, and qualifying topical-therapy failure. For COPD, require eosinophils at least 300 cells/mcL, maximally tolerated maintenance therapy, and qualifying exacerbation or hospitalization history.
Ebglyss through Epidiolex: Require Ebglyss severity, age, weight, and topical-therapy criteria; Emgality headache frequency and age criteria; Empaveli diagnosis, age, renal prerequisites, and transplant restriction; Enbrel indication-specific conventional-therapy trials; at least two sickle-cell crises for L-glutamine; ALK-positive NSCLC without prior ALK inhibitor for Ensacove; chronic HCV regimen and specialist criteria for sofosbuvir/velpatasvir; and qualifying seizure syndrome, age, neurologist, and anticonvulsant criteria for Epidiolex.
Procrit through Fintepla: Require indication-specific anemia and laboratory criteria for Procrit; qualifying BCC for Erivedge; prostate cancer for Erleada; IPF diagnostic findings and pulmonologist involvement for pirfenidone; mild to moderate atopic dermatitis and topical-corticosteroid exception for Eucrisa; SMN1/SMN2 genetics, ventilatory status, motor baseline, specialist, and combination restrictions for Evrysdi; Fabry confirmation and age for Fabrazyme; disease-specific eosinophil and background-therapy criteria for Fasenra; opioid tolerance and specialist involvement for transmucosal fentanyl; and Dravet or Lennox-Gastaut syndrome, age, and neurologist involvement for Fintepla.
Renewal and Reauthorization Criteria
Continuation and reauthorization criteria
Reauthorization requires continuation of the approved indication and the applicable response, laboratory, therapy-continuation, and combination-use conditions.
Continuation of prior therapy may be approved for products whose original indication remains applicable, including Actimmune, Afinitor, Afinitor Disperz, Akeega, Alecensa, Ayvakit, Balversa, Besremi, Bosulif, Briviact, Brukinsa, Cabometyx, Calquence, Caplyta, Caprelsa, Cotellic, Danziten, Daurismo, Erivedge, Erleada, Fintepla, Firmagon, Fotivda, Fruzaqla, Gavreto, Gleevec, Gomekli, Hernexeos, Hyrnuo, Ibrance, Ibtrozi, Iclusig, Idhifa, Igalmi, Imbruvica, and Imkeldi.
Positive clinical response: Where required, the patient demonstrates positive clinical response. Response may include reduced migraine days or acute medication use; reduced joint counts, symptoms, BSA, SCORAD, exacerbations, pulmonary infections, disease activity, relapses, objective laboratory or functional measures, or other indication-specific improvement.
Product-specific continuation: Prolastin-c requires positive response and continued conventional emphysema therapy; Bronchitol requires positive response; Cayston requires benefit; Cholbam requires improved liver function; Ctexli and Daliresp require positive response; Benlysta, Enbrel, L-glutamine, Fasenra, Esbriet, Eucrisa, and Humira require positive response; glycopyrrolate requires ongoing ulcer disease, acid suppression, and symptom reduction.
Combination and prerequisite restrictions: Do not combine Aimovig or Emgality with prohibited CGRP therapy; Cinryze or Actimmune with another HAE prophylaxis treatment; Evrysdi with chronic SMN-modifying therapy; Fabrazyme with another Fabry drug; icatibant with another acute HAE treatment; or Gilenya/fingolimod or glatiramer acetate with another MS disease-modifying therapy. Continue applicable Empaveli renal background therapy and required disease-specific therapy where specified.
Procrit continuation: Positive response plus indication-specific laboratory and treatment criteria: chemotherapy requires Hgb below 10 g/dL or Hct below 30% and ongoing chemotherapy; HCV requires Hgb at or below 12 g/dL or Hct at or below 36% with response; MDS requires Hgb/Hct criteria with response.
Evrysdi continuation: Positive response, no concomitant chronic SMN-modifying therapy, and applicable gene-therapy inadequate-response documentation; continued neurologist involvement.
Prerequisite and Step-Therapy Requirements
Product or indication
Prerequisite therapy requirement
Trial duration or qualifying condition
Imbruvica
A prerequisite Part D drug.
Required; cGVHD additionally requires failure of at least 1 line of systemic therapy.
Prior Authorization and Submission Requirements
Prior Authorization
Initial Prior Authorization: Actimmune Through Daurismo
Prior authorization is required for the following products. Submit the diagnosis, indication-specific clinical criteria, prescriber information when applicable, treatment history, and continuation response documentation. Unless otherwise noted, approval is for 12 months and continuation of prior therapy requires documented clinical benefit.
Actimmune: chronic granulomatous disease or severe malignant osteopetrosis; 12-month authorization; continuation of prior therapy may be approved; no prerequisite Part D drug.
Alyq: symptomatic pulmonary arterial hypertension (PAH), confirmed by right-heart catheterization or supported by current PAH therapy; initial prescriber is a pulmonologist or cardiologist; initial authorization 6 months and reauthorization 12 months with positive response; no prerequisite drug.
Adempas: symptomatic PAH confirmed by right-heart catheterization or supported by current PAH therapy, or symptomatic inoperable/persistent/recurrent CTEPH or current CTEPH therapy; pulmonologist/cardiologist involvement; initial 6 months and reauthorization 12 months with positive response; no prerequisite drug.
Afinitor tablets: submit the applicable SEGA/TSC, advanced RCC, progressive unresectable/locally advanced/metastatic pNET or GI/lung NET, renal angiomyolipoma with TSC, or advanced hormone-receptor-positive/HER2-negative breast cancer indication and required failed/intolerant SUTENT, NEXAVAR, FEMARA, or ARIMIDEX therapy; 12 months; prerequisite Part D therapy required.
Afinitor Disperz: SEGA associated with TSC requiring intervention or TSC-associated partial-onset seizures; minimum age 1 year for SEGA and 2 years for seizures; neurologist involvement for seizures; 12 months; no prerequisite drug.
Aimovig: episodic migraine with at least 4 migraine days/month or chronic migraine with at least 8 days/month after considering medication-overuse headache; adults only; initial 6 months and reauthorization 12 months with positive response, reduced acute-migraine medication use, and no concurrent CGRP preventive therapy.
Akeega: metastatic prostate cancer with deleterious or suspected deleterious BRCA mutation, used with prednisone and GnRH therapy; 12 months; no prerequisite drug.
Prolastin-C: congenital alpha-1 antitrypsin deficiency with emphysema, continued conventional treatment, qualifying Pi phenotype/genotype, and pretreatment serum AAT below 11 µM/L; 12 months; reauthorization requires positive response and continued conventional treatment.
Avtozma: initial authorization requires the applicable active RA, SJIA, PJIA, GCA, CRS, COVID-19, or SSc-ILD indication and required conventional therapy or clinical exception; initial and acute-indication documentation must be submitted; reauthorization requires positive response and applicable ongoing therapy; specialty prescriber requirements apply.
Ayvakit: unresectable/metastatic GIST with PDGFRA exon 18 mutation, advanced systemic mastocytosis, or indolent systemic mastocytosis with platelet count at least 50 × 10^9/L; 12 months; continuation permitted; no prerequisite drug.
Balversa: locally advanced/metastatic urothelial carcinoma with susceptible FGFR3 alteration, progression after systemic therapy, and prior PD-1/PD-L1 therapy or ineligibility; 12 months; prerequisite systemic therapy required.
Benlysta: active SLE with positive autoantibodies and standard-of-care treatment, or active lupus nephritis with standard therapy; minimum age 5 years; rheumatology/nephrology involvement; 6-month initial and reauthorization periods with positive response.
Besremi: polycythemia vera, with hydroxyurea trial/inadequate response, contraindication, or intolerance for high-risk disease, or essential thrombocythemia with prerequisite therapy; hematology/oncology involvement for essential thrombocythemia; 12 months; prerequisite therapy required.
Bosulif: Philadelphia chromosome-positive CML; 12 months; continuation permitted; no prerequisite drug.
Cotellic: unresectable/metastatic BRAF V600E/V600K melanoma used with Zelboraf, or qualifying histiocytic neoplasm; 12 months; continuation permitted; no prerequisite drug.
Cresemba: invasive aspergillosis or invasive mucormycosis; 6 months; no prerequisite drug.
Ctexli: genetically confirmed cerebrotendinous xanthomatosis with specialist involvement; initial and reauthorization 12 months; reauthorization requires positive response.
Cyclobenzaprine: covered for acute painful muscle spasm, qualifying fibromyalgia, or acute temporomandibular disorder; age 65 years or older; prescriber must acknowledge anticholinergic risk; 4 weeks for muscle spasm/TMD and 12 months for fibromyalgia; prerequisite therapy required.
Daliresp: COPD with exacerbation history requiring systemic steroids, antibiotics, or hospitalization and failure/intolerance/contraindication to two COPD therapies; 12 months with positive response on reauthorization; prerequisite therapy required.
Danziten: Philadelphia chromosome-positive CML; 12 months; continuation permitted; no prerequisite drug.
Daraprim/pyrimethamine: active, secondary-prophylaxis, or qualifying congenital toxoplasmosis; primary prophylaxis only with TMP-SMX intolerance and failed desensitization or life-threatening reaction; malaria treatment or prophylaxis is excluded; infectious-disease consultation and 12-month toxoplasmosis authorization.
Daurismo: newly diagnosed AML used with low-dose cytarabine in patients age 75 or older or with comorbidities precluding intensive chemotherapy; 12 months; continuation permitted; no prerequisite drug.
Prior Authorization
Initial and Product-Specific Prior Authorization: Ebglyss Through Imkeldi
Submit product-specific prior authorization requests with the qualifying diagnosis, biomarker or laboratory evidence, age and specialist requirements, prior treatment history, formulation rationale, and continuation response. Initial and reauthorization durations vary by product and indication as summarized below.
Ebglyss: moderate-to-severe atopic dermatitis, age at least 12 years and weight at least 40 kg, at least 10% BSA or SCORAD at least 25, and failure/intolerance/contraindication to qualifying topical therapy; dermatologist or allergist/immunologist; initial 6 months, reauthorization 12 months with reduced BSA or SCORAD; prerequisite therapy required.
Emgality: episodic migraine, chronic migraine, or episodic cluster headache with required frequency and age criteria; no concurrent CGRP therapy; initial 6 months for migraine, 3 months for cluster headache, reauthorization 12 months with response and reduced acute-medication use where applicable.
Empaveli: PNH, C3G, or primary IC-MPGN; for primary IC-MPGN no kidney transplant; proteinuria reduction and at least 12 weeks of maximally tolerated ACE inhibitor, ARB, or SGLT2 inhibitor; minimum age 12 years for C3G/primary IC-MPGN; 12 months with response and continued prerequisite therapy.
Enbrel: indication-specific RA, PJIA, PsA, plaque psoriasis, AS, Crohn’s disease, UC, HS, or uveitis criteria; conventional or topical therapy trials are required where specified, with specialist involvement and clinical-response documentation for reauthorization; initial periods are generally 6 months (12 weeks for UC) and reauthorization 12 months.
Endari/L-glutamine: sickle cell disease with at least two painful crises in the preceding 12 months; reauthorization requires positive clinical response; no prerequisite drug.
Ensacove: locally advanced or metastatic ALK rearrangement-positive NSCLC, with no prior ALK inhibitor; 12 months; continuation permitted; no prerequisite drug.
Step Therapy
Step Therapy and Prerequisite Provider Actions
Before submitting a specialty-drug request, document whether prerequisite therapy is required, not required, or clinically excepted. Step therapy must be satisfied with adequate trials, failure, contraindication, or intolerance unless the policy permits an attestation or exception.
Avtozma: RA requires a 3-month trial/failure, contraindication, or intolerance to qualifying conventional therapy or an accepted exception; PJIA requires at least 6 weeks of leflunomide or methotrexate; SJIA requires at least 1 month of NSAID or 2 weeks of systemic glucocorticoid; document rheumatology step therapy when applicable.
Balversa: prior systemic therapy and required PD-1/PD-L1 treatment or documented ineligibility are prerequisites.
Besremi: hydroxyurea prerequisite is required for high-risk polycythemia vera and essential thrombocythemia requests as applicable.
Braftovi: indication and combination requirements must be met; prior therapy or fluorouracil-based chemotherapy is required for applicable colorectal cancer use and Mektovi combination for BRAF V600E NSCLC; prerequisite therapy required.
Brukinsa: MCL requires at least one prior therapy; MZL requires a prior anti-CD20 regimen; CLL/SLL requires contraindication or intolerance to Calquence; FL requires at least two prior systemic lines and Gazyva combination; prerequisite therapy required.
Calquence: MCL requires either specified untreated, transplant-ineligible combination therapy or at least one prior therapy; prerequisite therapy required.
Documentation Required
Provider Documentation Checklist
The request must contain sufficient clinical documentation to establish the diagnosis, disease severity, qualifying laboratory or biomarker results, prior treatment history, prescriber qualifications, and response to therapy. Use the product-specific checklist below and include continuation documentation for every reauthorization.
Laboratory, diagnostic, and biomarker evidence: submit PAH right-heart catheterization or current therapy; AAT phenotype/genotype and serum level; FGFR3, PDGFRA, BRAF, ALK, RET, EGFR, ROS1, IDH2, HER2/ERBB2, BRCA, CYP27A1, CYP2D6, GLA, SMN1/SMN2, or other required molecular results; CBC/platelets; eosinophil counts; hemoglobin/hematocrit; erythropoietin; ferritin and TSAT; HCV, HAE complement/C1-INH, Fabry enzyme/genetic, CT/HRCT/biopsy, serology, and other product-specific testing.
Specialist and prescriber documentation: document consultation or prescribing by the required pulmonologist, cardiologist, rheumatologist, dermatologist, allergist/immunologist, neurologist, oncologist/hematologist, gastroenterologist, hepatologist, infectious-disease specialist, nephrologist, endocrinologist, ophthalmologist, otolaryngologist, pain/oncology/hospice/palliative specialist, or other designated specialist.
Denial Risk
Denial-Risk Rules
Deny or pend the request when the submitted records do not establish the requested indication, required biomarker or laboratory threshold, age or formulation requirement, prior-treatment history, specialist involvement, combination restriction, or continuation response. The following denial-risk rules apply across the listed products.
Indication or continuation criteria not met: deny when the diagnosis, disease stage, severity, qualifying indication, or required positive response is absent; this includes Actimmune through Daurismo and Ebglyss through Imkeldi product-specific criteria.
Alyq/Adempas: deny when PAH/CTEPH eligibility is not established, symptoms or required catheterization/current therapy evidence are absent, specialist involvement is missing, or reauthorization lacks positive response.
Biomarker or diagnostic evidence missing: deny Balversa, Ayvakit, Braftovi, Cotellic, Ctexli, Ensacove, Gavreto, Gilotrif, Hernexeos, Ibtrozi, Idhifa, Akeega, Prolastin-C, Evrysdi, Fabrazyme, Cerdelga, or other biomarker-dependent requests without the required test, mutation, genotype, enzyme, imaging, or laboratory evidence.
Laboratory, age, or disease-status failure: deny when required platelet, eosinophil, hemoglobin/hematocrit, erythropoietin, iron-store, serum AAT, SMN2, weight, age, BSA/SCORAD, migraine-day, HAE, or other threshold is not met.
Prior-treatment failure: deny Balversa, Besremi, Braftovi, Brukinsa, Cabometyx, Calquence, Caplyta, Ciclopirox, Daliresp, Epidiolex, Eucrisa, Fasenra, Fotivda, Fruzaqla, Gilotrif, Humira, Hyrnuo, Igalmi, Imbruvica, and other step-therapy products when the required prerequisite trial, treatment history, contraindication, intolerance, or approved exception is not documented.
Clinical Thresholds and Measurement Requirements
Numeric and Clinical Thresholds
Migraine and cluster-headache thresholdsEpisodic migraine: ≥4 migraine days per month; chronic migraine: ≥8 migraine days per month; episodic cluster headache: at least 2 cluster periods lasting 7 to 365 days, separated by pain-free periods of at least 3 months.
Alpha-1 antitrypsin deficiencyPretreatment serum AAT <11 µM/L, corresponding to <80 mg/dL if measured by radial immunodiffusion.
Hematologic and autoimmune thresholdsAyvakit platelet count ≥50 x 10^9/L; Benlysta ANA titer ≥1:80 or anti-dsDNA ≥30 IU/mL; high-risk polycythemia vera age ≥60 years.
Dermatology, gastroenterology, and pulmonary thresholdsEosinophilic esophagitis: at least 15 intraepithelial eosinophils per high-power field; atopic dermatitis: at least 10% BSA or SCORAD ≥25; COPD: baseline eosinophils ≥300 cells/mcL; plaque psoriasis: at least 3% BSA, severe scalp disease, or palmoplantar, facial, or genital involvement; Crohn's disease: CDAI >220.
Sickle cell and anemia thresholdsEndari or L-glutamine: at least 2 painful sickle cell crises within the past 12 months; CKD or chemotherapy anemia: Hct <30% or Hgb <10 g/dL; HCV/ribavirin or HIV anemia: Hct <36% or Hgb <12 g/dL; preoperative hemoglobin: >10 to ≤13 g/dL.
Procrit laboratory thresholdsMDS: serum erythropoietin ≤500 mU/mL or transfusion-dependent MDS; adequate iron stores: ferritin >100 mcg/L and TSAT >20%; off-label anemia is not approved when Hgb >10 g/dL or Hct >30%, except MDS and HCV.
Neurologic, opioid, and growth thresholdsFasenra asthma eosinophils ≥150 cells/microliter; Fasenra HES eosinophils ≥1000 cells/microliter; Evrysdi SMN2 ≥2 copies; Fabrazyme and Fintepla minimum age 2 years; initial icatibant minimum age 18 years; qualifying opioid tolerance includes morphine ≥60 mg/day, transdermal fentanyl ≥25 micrograms/hour, oxycodone ≥30 mg/day, oral hydromorphone ≥8 mg/day, oral oxymorphone ≥25 mg/day, oral hydrocodone ≥60 mg/day, or oral methadone ≥20 mg/day; pediatric growth and growth-failure criteria include the specified height, growth-velocity, skeletal-age, percentile, and standard-deviation thresholds; adult growth hormone deficiency testing requires peak GH ≤5 mcg/L with insulin tolerance testing, ≤3 mcg/L with glucagon, or ≤2.8 ng/mL with macimorelin; ulcerative colitis includes greater than 6 stools per day, frequent blood or urgency, ulcers, abnormal laboratory values, or corticosteroid-dependent/refractory disease.
Policy Definitions and Abbreviations
Definitions and Abbreviations
Pulmonary and neurologic termsCTEPH: chronic thromboembolic pulmonary hypertension. SEGA associated with TSC: subependymal giant cell astrocytoma associated with tuberous sclerosis complex. EM: episodic migraine. CM: chronic migraine. SSc-ILD: systemic sclerosis-associated interstitial lung disease.
Treatment and acute-care abbreviationsTF/C/I: trial and failure, contraindication, or intolerance. CRS: chimeric antigen receptor T-cell immunotherapy-associated cytokine release syndrome. aTTP: acquired thrombotic thrombocytopenic purpura. HSCT: autologous hematopoietic stem cell transplantation.
Disease and biomarker definitionsAAT deficiency: alpha-1 antitrypsin deficiency. AdvSM: advanced systemic mastocytosis, including aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, or mast cell leukemia. BRAF mutation testing requires an FDA-approved test or testing at a CLIA-approved facility. ALK rearrangement-positive and RET fusion-positive status likewise require FDA-approved or CLIA-approved testing.
Oncology and lymphoma terminologyMCL: mantle cell lymphoma. WM: Waldenstrom's macroglobulinemia. LPL: lymphoplasmacytic lymphoma. MZL: marginal zone lymphoma. CLL: chronic lymphocytic leukemia. SLL: small lymphocytic lymphoma. FL: follicular lymphoma. Ph+/BCR-ABL-positive refers to Philadelphia chromosome-positive or BCR-ABL-positive leukemia.
Metabolic and formulation termsEM, IM, or PM: extensive, intermediate, or poor metabolizer of cytochrome P450 2D6. BAS: bile acid synthesis disorders due to single enzyme defects. IR or ER: immediate-release or extended-release quetiapine. Cerebrotendinous xanthomatosis is also identified as cholestanol storage disease.
Hereditary angioedema terminology and confirmationHAE: hereditary angioedema, including type I or II disease associated with C1-INH deficiency or dysfunction and HAE with normal C1-INH. C1-INH: C1 inhibitor. Type I or II HAE is supported by low C4 with low or dysfunctional C1-INH. HAE-nl-C1INH is supported by normal C4 and C1-INH plus an eligible gene mutation or confirmed family history of recurrent angioedema.
Disease-specific testing and assessmentEosinophilic esophagitis requires esophageal dysfunction and at least 15 intraepithelial eosinophils per high-power field after exclusion of other causes. COPD triple therapy consists of an inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta agonist. SMN2 is the survival motor neuron 2 gene copy number; HINE-2, HFMSE, and RULM are accepted baseline motor assessments for SMA. Idiopathic pulmonary fibrosis requires exclusion of other known ILD causes and specified HRCT or biopsy findings. Growth hormone deficiency or growth failure is assessed with standardized growth charts, standard-deviation scores, growth velocity, skeletal age, laboratory, stimulation, or genetic testing as applicable.
Initial PAH/CTEPH therapy must be prescribed by or in consultation with a pulmonologist or cardiologist.
Initial coverage is 6 months; renewal coverage is 12 months with positive clinical response.
Coverage duration: 12 months; continuation of prior therapy approved.
Renewal requires applicable laboratory thresholds, positive response, and adequate iron stores.
Icatibant through Imkeldi: Require confirmed HAE and acute attack criteria for icatibant; advanced or metastatic prostate cancer for Firmagon; relapsed/refractory RCC after at least two therapies for Fotivda; specified chemotherapy and biologic history for Fruzaqla; immunization need and IM immune globulin for Gamastan; RET-positive cancer pathways for Gavreto; relapsing MS without combination disease-modifying therapy for Gilenya or glatiramer; EGFR-positive NSCLC pathway for Gilotrif; covered leukemia, solid-tumor, lymphoma, psychiatric, or cGVHD diagnoses for the remaining products; and inability to swallow generic imatinib for Imkeldi.
Epclusa (sofosbuvir/velpatasvir): chronic hepatitis C treated consistently with current AASLD/IDSA guidance; do not combine with another HCV direct-acting antiviral; specialist involvement as required; 12–24 weeks; no prerequisite drug.
Epidiolex: seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex; age at least 1 year, neurologist involvement, and trial/contraindication/intolerance to two formulary anticonvulsants; 12 months; prerequisite anticonvulsant therapy required.
Procrit: qualifying anemia associated with CKD, chemotherapy, preoperative transfusion reduction, ribavirin/interferon-treated HCV, HIV, or MDS; submit required hemoglobin/hematocrit, erythropoietin, iron-store, cancer, dialysis, treatment, or surgical documentation; duration ranges from 1 month to 12 months by indication; reauthorization requires laboratory and clinical response.
Erivedge: metastatic or qualifying locally advanced basal cell carcinoma; 12 months; continuation permitted; no prerequisite drug.
Erleada: prostate cancer; 12 months; continuation permitted; no prerequisite drug.
Esbriet/pirfenidone: idiopathic pulmonary fibrosis documented by exclusion of other ILD causes and appropriate HRCT/biopsy findings; pulmonologist involvement; initial and reauthorization 12 months with positive response; no prerequisite drug.
Eucrisa: mild-to-moderate atopic dermatitis; initial failure, contraindication, or intolerance to prescription-strength topical corticosteroid unless the site is sensitive; reauthorization requires positive response; topical corticosteroid prerequisite required.
Evrysdi: SMA type I, II, or III with qualifying 5q SMN1 mutation/deletion and at least two SMN2 copies, no prohibited ventilatory dependence, baseline motor assessment, no concomitant chronic SMN-modifying therapy, and required gene-therapy history documentation; neurologist with SMA expertise; 12 months; reauthorization requires response and continued noncombination use.
Fabrazyme: Fabry disease confirmed by GLA mutation, deficient alpha-galactosidase A activity, or significant clinical manifestations; age at least 2 years; 12 months; reauthorization requires response and no other Fabry drug combination.
Fasenra: severe eosinophilic asthma with eosinophil and exacerbation/hospitalization criteria, EGPA with corticosteroid therapy, or HES with exclusion of secondary causes, FIP1L1-PDGFRA negativity, eosinophil count at least 1,000 cells/µL, and failed/intolerant corticosteroid or cytotoxic/immunosuppressive therapy; specialist requirements apply; asthma initial 6 months and otherwise 12 months, with positive response for reauthorization.
Transmucosal fentanyl: breakthrough cancer pain while receiving around-the-clock long-acting opioid therapy; document at least one week of opioid tolerance at qualifying dose or equianalgesic dose and specialist involvement; 12 months; no prerequisite drug.
Fintepla: seizures associated with Dravet or Lennox-Gastaut syndrome; age at least 2 years and neurologist involvement; 12 months; continuation permitted; no prerequisite drug.
Icatibant: acute HAE attacks in adults, with laboratory/genetic or family-history confirmation and allergist/immunologist involvement; initial and reauthorization 12 months, with response documentation; do not combine with another approved acute HAE treatment.
Firmagon: advanced or metastatic prostate cancer; 12 months; continuation permitted; no prerequisite drug.
Fotivda: advanced relapsed/refractory renal cell carcinoma after at least two prior systemic therapies; 12 months; continuation permitted; prerequisite therapy required.
Fruzaqla: metastatic colorectal cancer after fluoropyrimidine/oxaliplatin/irinotecan and anti-VEGF therapy, with required RAS and anti-EGFR/Lonsurf/Stivarga history where applicable; 12 months; continuation permitted; prerequisite therapy required.
Gamastan: intramuscular immune globulin at minimum effective dose/frequency for required immunization; 14 days; no prerequisite drug.
Gavreto: metastatic RET fusion-positive NSCLC or advanced/metastatic RET fusion-positive thyroid cancer requiring systemic therapy and qualifying radioactive-iodine status; age at least 12 years for thyroid cancer; 12 months; continuation permitted; no prerequisite drug.
Gilenya/fingolimod: relapsing MS, neurologist involvement, positive response for reauthorization, and no concurrent MS disease-modifying therapy; 12 months; no prerequisite drug.
Gilotrif: advanced/metastatic NSCLC with non-resistant EGFR mutation for first-line use or progression after platinum chemotherapy; 12 months; continuation permitted; prerequisite therapy required.
Glatiramer acetate: relapsing MS, neurologist involvement, positive response for reauthorization, and no concurrent MS disease-modifying therapy; 12 months; no prerequisite drug.
Gleevec/imatinib: qualifying Ph+/BCR-ABL CML or ALL, GIST, DFSP, HES/CEL, MDS/MPD, or other approved indication; 12 months; continuation permitted; no prerequisite drug.
Glycopyrrolate tablets: peptic ulcer with concomitant PPI therapy or documented PPI contraindication/intolerance and H2-antagonist therapy; gastroenterologist involvement; 3 months initially and for reauthorization, with symptom response; no prerequisite drug.
Growth hormone: submit diagnosis-specific growth-failure or adult/idiopathic GHD evidence, growth charts, bone age, genetic or stimulation-test results, IGF-1, expected-height goals, and endocrinology/nephrology involvement; 12 months with required monitoring and response.
Hernexeos: unresectable or metastatic nonsquamous NSCLC with HER2/ERBB2 activating tyrosine-kinase-domain mutation; 12 months; continuation permitted; no prerequisite drug.
Humira: indication-specific RA, PJIA, PsA, plaque psoriasis, AS, Crohn’s disease, UC, HS, or uveitis criteria; document required conventional, topical, NSAID, or other formulary trials, specialist involvement, and response; initial and reauthorization periods follow the indication-specific schedule.
Caplyta: schizophrenia requires failure, contraindication, or intolerance to two formulary generic atypical antipsychotics; bipolar depression requires quetiapine or olanzapine trial; MDD adjunctive use requires aripiprazole and quetiapine trials; prerequisite therapy required.
Tadalafil tablets: requires contraindication or intolerance to an alpha-blocker or 5-alpha-reductase inhibitor; concurrent nitrate use is excluded; prerequisite therapy required, with documentation of the exception.
Ciclopirox products: confirmed onychomycosis without lunula involvement and mild-to-moderate target-toenail disease where applicable; oral terbinafine trial/failure, contraindication, or intolerance is required—6 weeks for fingernails and 12 weeks for toenails; 48-week authorization.
Cyclobenzaprine: required prerequisite therapy applies, while the prescriber must address anticholinergic risk and age 65-or-older criteria.
Daliresp: failure, intolerance, or contraindication to two prior COPD therapies is required; submit COPD exacerbation history and prerequisite therapy.
Required prerequisite therapy: document the drug, dose, duration, dates, response, failure, contraindication, or intolerance; when a clinical exception is permitted, include the rationale and supporting records.
Epidiolex: trial, contraindication, or intolerance to two formulary anticonvulsants is required.
Eucrisa/Ebglyss: document the required topical corticosteroid or other topical-therapy trial, unless a sensitive-site exception or contraindication applies.
Fotivda: document at least two prior systemic therapies for advanced RCC.
Fruzaqla: document fluoropyrimidine-, oxaliplatin-, irinotecan-, anti-VEGF-, and, when applicable, anti-EGFR/Lonsurf or Stivarga exposure.
Gilotrif: document first-line EGFR-positive use or progression after platinum-based chemotherapy.
Humira/Enbrel: document conventional therapy trials required by the requested indication, including methotrexate, leflunomide, sulfasalazine, NSAIDs, topical therapies, or other indication-specific prerequisites.
Hyrnuo: prior systemic therapy for locally advanced/metastatic HER2-mutated NSCLC is required.
Igalmi: trial/failure, contraindication, or intolerance to at least two acute-agitation products and ongoing maintenance therapy are required.
Imbruvica: cGVHD requires failure of at least one systemic therapy; other indications require disease-specific treatment history where applicable.
Caplyta, tadalafil, Ciclopirox, Cyclobenzaprine, Daliresp, Epidiolex, Eucrisa, Fotivda, Fruzaqla, Gilotrif, Hyrnuo, Igalmi, and Imbruvica: requests without the applicable prerequisite therapy or a documented exception are subject to denial.
No-prerequisite status: Actimmune, Alyq, Adempas, Afinitor Disperz, Aimovig, Akeega, Alecensa, Prolastin-C, Benlysta, Bosulif, Cotellic, Cresemba, Ctexli, Danziten, Daraprim, Daurismo, Emgality, Ensacove, Epclusa, Procrit, Erivedge, Erleada, Esbriet, Evrysdi, Fabrazyme, Fintepla, Icatibant, Firmagon, Gamastan, Gavreto, Gilenya, Glatiramer acetate, Gleevec, Glycopyrrolate, Hernexeos, Ibrance, Ibtrozi, Iclusig, Idhifa, Imkeldi, and other products expressly identified above do not require a prerequisite Part D drug, but still require their product-specific criteria.
Prior-treatment documentation: provide drug names, dates, doses, duration, adherence, response, failure, contraindication, or intolerance for conventional RA/PJIA/SJIA therapy; topical corticosteroids; oral terbinafine; COPD therapy; anticonvulsants; atypical antipsychotics; acid suppression; alpha-blockers/5-alpha-reductase inhibitors; cancer systemic therapy; biologics; and all other required prerequisites.
Response and continuation documentation: report symptom improvement, migraine days and acute-medication use, BSA/SCORAD, joint counts, pulmonary exacerbations, lung function or imaging where applicable, laboratory response, tumor response/stability, ulcer response, seizure or agitation control, HAE response, motor scores, growth/IGF-1 monitoring, and any other product-specific positive clinical response; document that prohibited combination therapy is not being used.
Product-specific documentation: submit Actimmune diagnosis; Alyq and Adempas PAH/CTEPH eligibility and response; Afinitor and Afinitor Disperz indication/prerequisite records; Aimovig migraine-frequency records; Akeega BRCA and combination records; Alecensa NSCLC records; Prolastin-C AAT and emphysema records; Avtozma initial, acute-indication, SSc-ILD, prerequisite, rheumatology-step, and reauthorization records; Bosulif diagnosis; Braftovi combination/clinical history; Briviact diagnosis and age; Bronchitol tolerance test; Brukinsa prior-line records; Cablivi bolus, plasma exchange, and immunosuppression records; Cabometyx prior therapy; Calquence diagnosis and treatment history; Caplyta formulary trials; Caprelsa thyroid cancer; Cayston Pseudomonas and response; Cerdelga Gaucher/CYP2D6; Cholbam diagnostic testing; tadalafil exception; Ciclopirox fungal confirmation and terbinafine trial; Cinryze/HAE confirmation where applicable; and required clinical/continuation documentation.
Additional records: include COPD documentation for Daliresp, sofobuvir/velpatasvir guideline-based regimen documentation, Evrysdi diagnostic and baseline motor testing, Fabrazyme diagnostic testing, Fasenra asthma/EGPA/HES records, fentanyl opioid-tolerance records, Icatibant HAE confirmation and reauthorization response, Firmagon prostate cancer, Fotivda RCC, Fruzaqla colorectal cancer, Gamastan immunization, Gavreto RET-positive cancer, Gilenya/glatiramer MS, Gilotrif NSCLC, glatiramer initial documentation, Gleevec indication, glycopyrrolate acid-suppression records, growth-hormone diagnostic and stimulation-test records, Gomekli NF1/inoperable plexiform neurofibroma, Hernexeos biomarker, Humira indication, Hyrnuo systemic therapy and biomarker, Ibrance breast cancer, Ibtrozi ROS1, Iclusig leukemia, Idhifa IDH2, Igalmi acute agitation, Imbruvica disease-specific records, and Imkeldi formulation-specific inability to swallow generic imatinib.
Formulation-specific requirements: Imkeldi requires documentation that the patient cannot swallow generic imatinib tablets because of age, physical impairment, dysphagia, feeding tube, or nasogastric tube; Evrysdi requires baseline motor testing and gene-therapy history; Afinitor Disperz requires the TSC/SEGA or seizure indication; and product-specific prior authorization documentation is required even when no prerequisite Part D drug is required.
RA/SSc-ILD criteria: deny Avtozma when required RA conventional therapy or rheumatology step therapy is absent, or when SSc-ILD diagnostic evidence excluding other ILD causes and appropriate HRCT/biopsy documentation is missing.
Concurrent or prohibited therapy: deny or pend Aimovig/Emgality for concurrent CGRP preventive therapy; Icatibant for concurrent acute-HAE treatment; Evrysdi for concurrent chronic SMN-modifying therapy or prohibited ventilatory support; Gilenya or glatiramer for concurrent MS disease-modifying therapy; Fabrazyme for combination Fabry therapy; Epclusa for combination HCV direct-acting antiviral therapy; Empaveli for kidney-transplant or prerequisite-therapy conflict; and tadalafil for concurrent nitrate use.
Combination and formulation requirements: deny Akeega without prednisone and GnRH combination, Cotellic without required combination, Braftovi without required combination, Daurismo without low-dose cytarabine, Fasenra EGPA without corticosteroid therapy unless excepted, Gomekli without NF1 with inoperable plexiform neurofibroma, and Imkeldi without documentation supporting the formulation-specific inability to swallow generic imatinib.
Fentanyl: deny transmucosal fentanyl when breakthrough cancer pain, around-the-clock long-acting opioid use, qualifying opioid tolerance, or required prescriber documentation is absent.
Fintepla and Igalmi: deny Fintepla without a qualifying Dravet/Lennox-Gastaut diagnosis, age, or neurologist; deny Igalmi without acute agitation from schizophrenia/bipolar disorder, two failed/intolerant acute-agitation products, and maintenance therapy.
HAE products: deny prophylactic or acute icatibant requests without HAE confirmation, appropriate age/indication, specialist documentation, or response; avoid combination prophylaxis or acute-attack therapy as applicable.
Malaria exclusion: pyrimethamine/Daraprim requests for malaria treatment or prophylaxis are not authorized; qualifying toxoplasmosis documentation and infectious-disease involvement are required.
Clinical documentation failure: deny or pend when the request lacks required medical records, laboratory dates, diagnostic reports, treatment history, specialist documentation, baseline measurements, response evidence, or product-specific medical information.
Failure to meet initial or reauthorization requirements: an initial approval does not override missing reauthorization evidence; deny when continuation response, ongoing prerequisite therapy, required laboratory monitoring, or noncombination attestations are not submitted.
Product-specific criteria: deny requests that do not meet the applicable clinical, biomarker, laboratory, age, specialist, treatment-history, formulation, combination, or authorization-duration requirements for any product listed in this section.