HealthPartners Medicare Part D Prior Auth Policy Update

Drug-specific Coverage Criteria

Abiraterone (250 mg, 500 mg)

Covered when ALL of the following are met:

Abiraterone initial coverage: Patient has a diagnosis of metastatic high-risk castration-sensitive prostate cancer (mCSPC) OR metastatic castration-resistant prostate cancer (mCRPC); patient does not have an FDA‑labeled limitation of use or contraindication to therapy; dose limited to FDA‑labeled dosing guidelines; if 500 mg tablet requested, provide rationale why 250 mg tablet cannot be used

Coverage duration: six months

Actemra (all formulations)

Covered when ANY of the following indications are met:

Actemra indications: Diagnosis of one of: (1) rheumatoid arthritis with medical contraindication or inadequate response to at least two preferred drugs; (2) polyarticular juvenile idiopathic arthritis with medical contraindication or inadequate response to at least two preferred drugs; (3) giant cell arteritis with medical contraindication or inadequate response to at least one preferred drug; (4) systemic juvenile idiopathic arthritis; (5) systemic sclerosis‑associated ILD with inadequate response or contraindication to mycophenolate for early diffuse SSc with ILD and early evidence of ILD progression

May not be used concurrently with other biologic therapies; prescriber is or in consultation with rheumatologist or pulmonologist; coverage duration 12 months

Adbry

Covered when ALL of the following are met:

Adbry initial criteria: Diagnosis of an FDA‑approved indication not excluded from Part D (e.g., moderate‑to‑severe atopic dermatitis); for atopic dermatitis: ≥10% BSA or involvement of face/neck/hands/feet/genitals/intertriginous areas, intractable pruritus or significant skin breakdown, and inadequate response or contraindication to one prescription‑strength topical corticosteroid or one topical calcineurin inhibitor (tacrolimus or pimecrolimus); may not be used concurrently with another monoclonal antibody therapy; prescriber is or in consultation with allergist, immunologist, or dermatologist

Coverage duration 12 months

Adbry renewal: Provider attests treatment goals have been met

Renewal coverage 12 months

Adempas

Covered when ALL of the following are met:

Adempas initial criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; for Group 1 PAH: diagnosis confirmed by right heart catheterization with mean PAP ≥20 mmHg, PCWP ≤15 mmHg, and PVR >2 Wood units; for WHO Group 4 CTEPH: WHO FC II–IV symptoms and either inoperable disease, not a surgical candidate, or persistent/recurrent disease after surgery; avoid concurrent use with nitrates, nitric oxide donors, PDE inhibitors, or non‑specific PDE inhibitors; prescriber is or in consultation with cardiologist or pulmonologist

Coverage duration 12 months

Alpha-1 antitrypsin augmentation

Covered when ALL of the following are met:

AAT augmentation initial criteria: Diagnosis of alpha‑1 antitrypsin deficiency with clinically evident emphysema; pretreatment serum AAT level <11 micromoles/L (or <80 mg/dL by radial immunodiffusion or <57 mg/dL by nephelometry); patient will continue conventional emphysema treatment (e.g., bronchodilators); dose limited to FDA‑labeled dosing

Renewal: seen within past 12 months and positive response; coverage duration 12 months

ATTRUBY

Covered when ALL of the following are met:

ATTRUBY initial criteria: Patient diagnosed with wild‑type or hereditary transthyretin‑mediated amyloidosis cardiomyopathy (ATTR‑CM); diagnosis confirmed by either (A) cardiac biopsy with positive Congo red stain and ATTR confirmation by mass spectrometry or immunofluorescence, OR (B) ALL of: serum kappa/lambda free light chain ratio 0.26–1.65, absence of monoclonal protein on serum immunofixation, absence of monoclonal protein on urine immunofixation, and myocardial uptake on 99mTc‑PYP with heart‑to‑contralateral ratio >1.5 or visual grade ≥2; patient has clinical history of heart failure (prior hospitalization or symptomatic cardiomyopathy), is negative for light‑chain amyloidosis, and has NYHA class I–III heart failure; prescriber is or in consultation with a cardiologist

Coverage duration 12 months; may not be used concurrently with ONPATTRO or TEGSEDI

ATTRUBY renewal criteria: Patient has been seen by prescriber within past 12 months; medication has demonstrated efficacy; patient continues to have NYHA class I–III heart failure

Coverage duration 12 months

Erythropoiesis-stimulating agents

Covered when ANY of the following are met (indications and renewal thresholds summarized):

ESAs (Aranesp) criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; for CKD (adults not on dialysis): hemoglobin <10 g/dL or dose reduction/interruption when Hgb reaches 10 g/dL to decrease transfusion needs; pediatric CKD: hemoglobin approaches or exceeds 12 g/dL guiding dose reduction; cancer chemotherapy contexts align with avoiding RBC transfusion per clinical thresholds; setting may affect Part B vs Part D coverageHgb <10 g/dL (adult CKD)

Coverage duration 12 months; dosing limited to FDA labeling

Initial therapy for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM)

Covered when ALL of the following diagnostic and clinical criteria are met:

ATTR-CM initial criteria: (1) Diagnosis of wild‑type or hereditary transthyretin‑mediated amyloidosis cardiomyopathy (ATTR‑CM); AND (2) Diagnostic confirmation by EITHER (A) cardiac biopsy with Congo red stain and ATTR confirmation by mass spectrometry or immunofluorescence OR (B) ALL of: serum kappa/lambda free light chain ratio 0.26–1.65; absence of monoclonal protein on serum immunofixation; absence of monoclonal protein on urine immunofixation; myocardial uptake on 99mTc‑PYP with heart‑to‑contralateral ratio >1.5 or visual grade ≥2; AND (3) Clinical history of heart failure with documentation of either prior hospitalization for HF or symptomatic cardiomyopathy (dyspnea, fatigue, syncope, edema); AND (4) Negative for light‑chain amyloidosis; AND (5) NYHA class I, II, or III heart failure

Prescriber: cardiologist; coverage duration 12 months

Renewal criteria for ATTR-CM therapy

Renewal covered when ALL of the following are met:

ATTR-CM renewal criteria: (1) Patient seen by prescriber within past 12 months; (2) Medication has demonstrated efficacy; (3) Patient continues to have NYHA class I, II, or III heart failure

Coverage duration 12 months

Antipsychotics (selected agents) - new start criteria

Covered for new‑start patients when ALL of the following are met:

Antipsychotic new start: (1) Diagnosis of an FDA‑approved indication not excluded from Part D; AND (2) Inadequate response or medical contraindication to two of the following alternatives: lurasidone, risperidone, ziprasidone, olanzapine, quetiapine (IR), quetiapine (XR), or aripiprazole

Prescriptions limited to FDA labeled dosing; coverage duration 12 months

Benlysta (subcutaneous) initial criteria

Covered when ALL of the following are met for active SLE or lupus nephritis:

Benlysta SLE criteria: For active, autoantibody‑positive SLE without severe active CNS disease: diagnosis supported by anti‑dsDNA >30 IU/mL OR low complement (C3/C4) OR positive anti‑Smith; patient will continue standard‑of‑care therapy (antimalarials, corticosteroids, or immunosuppressants) in combination with Benlysta; inadequate response or contraindication to two of: hydroxychloroquine, immunosuppressive agents (mycophenolate, azathioprine, methotrexate, oral cyclophosphamide), or oral corticosteroids; for active lupus nephritis: continue standard of care and inadequate response or contraindication to mycophenolate mofetil or cyclophosphamide

Renewal requires positive response and visit within last 14 months; prescriber rheumatologist/nephrologist/dermatologist; coverage 12 months

Bosentan (oral) initial criteria for Group 1 PAH

Covered when ALL of the following are met for Group 1 PAH:

Bosentan PAH criteria: (1) Diagnosis of an FDA‑approved indication not excluded from Part D; AND (2) For Group 1 PAH: right heart catheterization confirming mean PAP ≥20 mmHg, PCWP ≤15 mmHg, and PVR >2 Wood units; AND (3) Patient does not have ALT/AST >3× ULN or bilirubin increase ≥2× ULNALT/AST <=3×ULN; bilirubin <2×ULN

Prescriber cardiologist or pulmonologist; coverage 12 months; contraindicated with cyclosporine A or glyburide

Cayston (aztreonam) initial criteria

Covered when ALL of the following are met:

Cayston CF criteria: (1) Diagnosis of an FDA‑approved indication not excluded from Part D; AND (2) Patient with cystic fibrosis documented to have Pseudomonas aeruginosa in the lungs

Renewal requires visit within last 12 months and positive response; prescriber from CF center, infectious disease, or pulmonology; coverage 12 months

Cimzia (certolizumab) initial criteria

Covered when ALL of the following are met for the listed autoimmune diseases:

Cimzia criteria: Diagnosis of the indicated condition (psoriatic arthritis, RA, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, non‑radiographic axial disease) with medical contraindication or inadequate response to at least two preferred drugs as specified per indication

May not be used concurrently with other biologic therapies; prescriber rheumatologist/dermatologist/gastroenterologist; coverage 12 months

Oncology/targeted oral agents - general initial criteria

Covered when ALL of the following are met:

Oncology oral agents criteria: (1) Diagnosis of an FDA‑approved indication not excluded from Part D; AND (2) Genetic testing completed if required and results indicate appropriateness; AND (3) No unsupported FDA‑labeled limitation of use for the indication; AND (4) Agent is FDA‑labeled or compendia‑supported as first‑line OR there is inadequate response/contraindication to first‑line therapy OR patient currently/previously benefited from agent

Renewal requires positive response; typical initial coverage six months; dosing limited to FDA labeling

Example: Corlanor

Corlanor (ivabradine): Patient does not have an FDA‑labeled limitation or contraindication to therapy; prerequisite therapy as specified per indication; dose limited to FDA labeling

Coverage duration 12 months

Cosentyx

Cosentyx: Diagnosis of an FDA‑approved indication; may not be used concurrently with other biologic therapies; prescribed by or in consultation with dermatologist or rheumatologist; dose limited to FDA labeling

Prerequisite therapy required; coverage 12 months

Cresemba

Cresemba: Prescribed by disease/transplant/hematology or oncology specialist; initial coverage three months then six months if positive response; dose limited to FDA labeling

Prerequisite therapy not required

Deferasirox

Deferasirox initial criteria: Either (1) chronic iron overload due to non‑transfusion‑dependent thalassemia with LIC ≥5 mg Fe/g dry weight AND serum ferritin >300 mcg/L, OR (2) chronic iron overload due to transfusions with regular transfusions AND serum ferritin >1000 mcg/L; prescriber hematologist/oncologist; renewal requires visit within past 12 months and positive responseLIC >=5 mg Fe/g; ferritin thresholds as stated

Coverage duration 12 months; dose limited to FDA labeling

Deferiprone

Deferiprone: Diagnosis of FDA‑approved indication; for transfusion‑induced iron overload ensure ANC >1.5 x10^9/L; prior inadequate response or contraindication to other chelators (e.g., deferasirox); renewal requires visit within past 12 months and positive response; prescriber hematologist/oncologistANC >1.5 x10^9/L

Coverage 12 months; dose limited to FDA labeling

Dihydroergotamine

Dihydroergotamine for acute migraine: Diagnosis of acute migraine (with/without aura); inadequate response or contraindication to two triptans (e.g., sumatriptan, naratriptan, rizatriptan); may not be used concurrently with another acute migraine agent such as a triptan or acute CGRP antagonist; prescriber neurologist/pain/headache specialistFailure of two triptans

Renewal requires positive response; coverage 12 months

Dronabinol

Dronabinol (CINV): For CINV: inadequate response or contraindication to a 5‑HT3 receptor antagonist AND inadequate response or contraindication to prochlorperazine AND patient is receiving chemotherapy; may be Part B or Part D depending on setting; dose limited to FDA labeling

Coverage duration pending CMS review; prerequisite therapy required

Dupixent

Dupixent: May not be used concurrently with another monoclonal antibody; for atopic dermatitis: moderate‑to‑severe disease with ≥10% BSA or involvement of special areas and inadequate response or contraindication to one topical corticosteroid or topical calcineurin inhibitor; for asthma: eosinophilic or steroid‑dependent moderate‑to‑severe asthma with pretreatment eosinophils ≥150 cells/µL and inadequate control despite inhaled steroid plus another maintenance med; for eosinophilic esophagitis: EGD with biopsy and inadequate response or contraindication to one PPI or swallowed topical steroids; prescriber specialty required; coverage 12 monthsEosinophils >=150 cells/µL for eosinophilic asthma

Prerequisite therapy required; dose limited to FDA labeling

Emgality

Emgality: May not be used concurrently with other CGRP antagonists for migraine prevention; patients age ≥18 for listed indications; initial coverage: migraine prevention 6 months, episodic cluster headache 3 months; renewals 12 months; dose limited to FDA labelingAge >=18

Prerequisite therapy required

Enbrel

Enbrel: Diagnosis‑specific prior inadequate response or contraindication to required therapies (e.g., methotrexate for RA; NSAID for ankylosing spondylitis; topical/systemic therapies for psoriasis) and medical contraindication or inadequate response to at least one preferred adalimumab biosimilar (Hadlima or Simlandi); prescriber specialty required; dose limited to FDA labelingPrior failure of preferred adalimumab biosimilar

Renewal: treatment goals met; coverage 12 months

Glutamine (sickle cell)

Glutamine (sickle cell): Diagnosis of sickle cell disease and ≥2 painful crises in prior 12 months despite hydroxyurea unless hydroxyurea is contraindicated; age ≥5 years; prescriber specialist required>=2 painful crises in prior 12 months

Coverage duration 12 months; dose limited to FDA labeling

Epidiolex

Epidiolex: New starts: diagnosis of seizures associated with Lennox‑Gastaut, Dravet, or tuberous sclerosis complex AND inadequate response or contraindication to two antiseizure medications; prescriber neurologyFailure of two antiseizure medications

Coverage duration 12 months; dose limited to FDA labeling

Erleada

Erleada: Indication per FDA (NMCRPC high risk or MCSPC) with documentation of castrate testosterone <50 ng/dL or bilateral orchiectomy or concurrent GnRH analog; dose limited to FDA labelingTestosterone <50 ng/dL

Coverage duration six months

Eucrisa

Eucrisa: Diagnosis of mild‑to‑moderate atopic dermatitis and inadequate response or contraindication to two of: prescription‑strength topical corticosteroid, pimecrolimus cream, or tacrolimus ointment (pimecrolimus/tacrolimus not required for <2 years)Failure of two topical therapies

Coverage duration 12 months

Specialty antimicrobials and related agents

Default specialty antimicrobial and related agent coverage:

Specialty antimicrobials default: Diagnosis of an FDA‑approved indication not excluded from Part D; patient must not have an FDA‑labeled limitation of use or contraindication to therapy; dose limited to FDA labeling; renewal requires positive response to therapy

Coverage duration typically 12 months; setting may affect Part B vs Part D determination

Default product criteria

Default coverage applied to many products in this section:

Default requirements: (1) Diagnosis of an FDA‑approved indication not otherwise excluded from Part D; (2) Patient must not have an FDA‑labeled limitation of use or contraindication to therapy; (3) Dose limited to within FDA‑labeled dosing guidelines; (4) Renewal requires positive response to therapy; (5) Coverage duration typically 12 months

Applies to many listed products

FINTEPLA criteria

Covered when ALL of the following are met for new starts:

FINTEPLA new start: Diagnosis of an FDA‑approved indication not excluded from Part D; for Lennox‑Gastaut syndrome (LGS): medical contraindication or inadequate response to at least two other seizure medications (e.g., felbamate, lamotrigine, topiramate, clobazam, rufinamide)

Renewal for Dravet requires positive response; coverage 12 months

GATTEX criteria

Covered when ALL of the following are met:

GATTEX initial: Treatment of short bowel syndrome in patients dependent on parenteral nutrition for ≥1 year with inability to taper parenteral support; adults require recent colonoscopy with polyp removal as applicable; pediatric FOBT/colonoscopy requirements; dose limited to 0.05 mg/kg/day0.05 mg/kg/day

Initial coverage three months then 12 months if renewal criteria met; prescriber gastroenterologist

Concurrency/exclusion rules

Concurrency/exclusion rules (examples):

Hadlima concurrency: Hadlima may not be used concurrently with other biologic therapies

Prescriber in consultation with appropriate specialist; coverage 12 months

Haegarda concurrency: Haegarda may not be used concurrently with another HAE prophylaxis agent

Prescribed by or in consultation with hematology/allergy/immunology; coverage six months

INBRIJA criteria

INBRIJA initial authorization covered when ALL of the following are met:

INBRIJA initial: (1) Diagnosis of Parkinson's disease with OFF episodes; (2) Provider attestation patient has or will receive inhaler technique education; (3) Patient is taking carbidopa/levodopa; (4) Patient has tried and failed at least one adjunct agent (rasagiline, ropinirole, entacapone, pramipexole, rotigotine, or selegiline) for ≥4 weeks in combination with carbidopa/levodopa; (5) Patient has no underlying lung disease OR if FEV1 <50% provider attests benefits outweigh risks and INBRIJA was not ineffective due to inspiratory capacity

Age ≥18; prescriber neurologist; renewal requires positive response; dose limited to FDA labeling

IMBRUVICA criteria

Covered when ANY of the following diagnosis‑specific conditions are met:

IMBRUVICA indications: Diagnosis of an FDA‑approved indication (e.g., CLL/SLL, Waldenstrom's, chronic GVHD after failure of ≥1 systemic therapy); for certain tablet strengths document intolerance or contraindication to preferred strengths/forms

Coverage duration six months; renewal requires positive response; prescriber specialty as indicated

INBRIJA Initial Therapy

Initial authorization covered when ALL of the following are met:

INBRIJA initial criteria: See INBRIJA criteria: Parkinson's disease with OFF episodes, education attestation, carbidopa/levodopa use, prior adjunct agent trial/failure, pulmonary assessment

Prescriber: neurologist or in consultation with neurologist; age ≥18; renewal requires positive response

JAYPIRCA Initial Therapy

JAYPIRCA — Initial authorization covered when ALL of the following are met:

JAYPIRCA initial criteria: (1) Diagnosis of an FDA‑approved indication not excluded from Part D; AND (2) For CLL/SLL: patient has received ≥2 prior therapies including a BTK inhibitor and a BCL‑2 inhibitor; OR for MCL: patient has received ≥2 prior systemic therapies including a BTK inhibitor

Coverage duration six months; renewal requires positive response; dose limited to FDA labeling

Tolvaptan Initial Therapy

Tolvaptan — Initial authorization covered when ALL of the following are met:

Tolvaptan initial criteria: (1) Diagnosis of an FDA‑approved indication not excluded from Part D; AND (2) For rapidly‑progressing ADPKD prescriber attests to characteristics such as reduced/declining renal function or high/increasing height‑adjusted total kidney volume

Exclusions: concurrent use with SAMSCA (tolvaptan tablets) and use in stage 5 CKD; prescriber nephrologist; coverage 12 months

KALYDECO Initial Therapy

KALYDECO — Initial authorization covered when ALL of the following are met:

KALYDECO initial criteria: (1) Diagnosis of cystic fibrosis; AND (2) Patient has at least one CFTR mutation responsive to the prescribed drug based on in vitro assay data; AND (3) Patient is not homozygous for the F508del mutation

Prescriber CF center specialist or pulmonologist; may not be used concurrently with another CFTR modulator for requested indication; renewal: seen within last 12 months and positive response; coverage 12 months

KINERET Initial Therapy

KINERET — Initial authorization covered when ANY of the following diagnoses are met:

KINERET indications: Diagnosis of CAPS (FCAS, Muckle‑Wells, NOMID), OR rheumatoid arthritis with contraindication or inadequate response to at least two preferred drugs, OR deficiency of interleukin‑1 receptor antagonist (DIRA) with genetic confirmation

May not be used concurrently with other biologic therapies; prescriber specialist required; coverage 12 months

Linezolid Initial Therapy

Linezolid (including IV formulations) — Initial authorization covered when ANY of the following are met:

Linezolid criteria set: (A) Vancomycin‑resistant Enterococcus faecium infection; OR (B) pneumonia caused by susceptible bacteria with inadequate response/contraindication/resistance to two antibiotic classes (beta‑lactams, macrolides, clindamycin, tetracyclines, co‑trimoxazole) OR inadequate response/contraindication/resistance to vancomycin; OR (C) skin and skin structure infection including diabetic foot infection caused by susceptible bacteria with inadequate response/contraindication/resistance to two listed antibiotic classes or vancomycin

Prescriber: infectious disease/transplant/hematology/oncology; coverage duration three months; dose limited to FDA labeling

LIVTENCITY Initial Therapy

LIVTENCITY — Initial authorization covered when ALL of the following are met:

LIVTENCITY criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; for HSCT or SOT patients with active CMV infection: medical contraindication or inadequate response to ganciclovir, valganciclovir, foscarnet, or cidofovir; prescriber transplant or infectious disease specialist or oncologist

Exclusions: may not be used concurrently with ganciclovir, valganciclovir, foscarnet or cidofovir; coverage eight weeks; dose limited to FDA labeling

MAVYRET Initial Therapy

MAVYRET — Initial authorization covered when ALL of the following are met:

MAVYRET criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; prescribed by or in consultation with gastroenterology/hepatology, infectious disease, or transplant specialist

Coverage duration 8–16 weeks per diagnosis or FDA labeling; dose limited to FDA labeling

LYNPARZA Initial Therapy

LYNPARZA — Initial authorization covered when ANY of the following FDA‑approved indications are met:

LYNPARZA multiple indication criteria: Indications include maintenance for BRCA‑mutated ovarian/fallopian tube/primary peritoneal cancer after platinum response; combination with bevacizumab for HRD‑positive first‑line maintenance; adjuvant therapy for high‑risk early BRCA‑mutated HER2‑negative breast cancer after chemo; treatment for metastatic BRCA‑mutated HER2‑negative breast cancer after prior chemo; HRR‑mutated mCRPC after progression on enzalutamide or abiraterone; others per FDA labeling

Coverage duration six months; dose limited to FDA labeling; renewal requires positive response

Nucala (mepolizumab) — Initial and Renewal Coverage

Covered when ALL of the following are met:

Nucala initial criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; for severe asthma: pretreatment eosinophil ≥150 cells/µL within prior 12 months; inadequate control despite medium/high‑dose inhaled steroid plus at least one other maintenance medication; inadequate control defined as ≥1 exacerbation requiring systemic corticosteroids ≥3 days in past 12 months OR ≥1 serious exacerbation requiring hospitalization/ER visit in past 12 months; prescriber specialist requiredEosinophils >=150 cells/µL

Coverage duration 12 months; renewal requires positive response and visit within specified interval

Ofev (nintedanib) — IPF and other fibrosing ILD Coverage

Covered when ALL of the following are met:

Ofev IPF criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; for IPF: exclusion of other ILD causes, HRCT pattern consistent with UIP or supportive histopathology, baseline FVC ≥50%, baseline %DLCO ≥30%; inadequate response or contraindication to pirfenidone where applicable; prescriber rheumatologist or pulmonologist; must not have underlying liver diseaseFVC >=50%; %DLCO >=30%

Renewal requires visit within last 14 months and positive response; coverage 12 months

Nexletol (bempedoic acid) — Hyperlipidemia Coverage

Covered when ALL of the following are met:

Nexletol criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; for HeFH or ASCVD with LDL above thresholds: trial of one high‑intensity statin plus ezetimibe concomitantly for specified weeks with LDL remaining >70 mg/dL OR documented statin intolerance (rhabdomyolysis to one statin or intolerance to both atorvastatin and rosuvastatin); prescriber cardiologist/endocrinologist or lipid specialistLDL > 70 mg/dL

Coverage duration 12 months; dose limited to FDA labeling

IGF-1 therapy for growth failure — Initial and Renewal Coverage

Covered when ALL of the following are met:

IGF-1 deficiency criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; for severe primary IGF‑1 deficiency or GH gene deletion with neutralizing antibodies to GH: height SDS ≤‑3.0 AND basal IGF‑1 SDS ≤‑3.0; prescriber endocrinologistheight SDS <= -3.0; basal IGF-1 SDS <= -3.0

Renewal requires positive response; coverage 12 months

Nitazoxanide — Giardiasis/Cryptosporidium

Covered when ALL of the following are met:

Nitazoxanide criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; for diarrhea due to Giardia lamblia or Cryptosporidium parvum; patient age ≥12 yearsAge >= 12

Coverage duration 10 days; dose limited to FDA labeling

Mifepristone (300 mg) — Endogenous Cushing's Disease

Covered when ALL of the following are met:

Mifepristone criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; for endogenous Cushing's disease: patient has type 2 diabetes or glucose intolerance by 2‑hour GTT and has failed surgical resection or is not a surgical candidate; prescriber endocrinologist

Initial coverage six months then 12 months if renewal criteria met; dose limited to FDA labeling

Nuedexta — Pseudobulbar affect

Covered when ALL of the following are met:

Nuedexta criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; structural neurological condition causing pseudobulbar affect; prescriber psychiatrist or neurologist

Coverage duration 12 months

Droxidopa — Neurogenic orthostatic hypotension (NOH)

Covered when ALL of the following are met:

Droxidopa criteria: Diagnosis of symptomatic neurogenic orthostatic hypotension (NOH) due to primary autonomic failure, dopamine beta‑hydroxylase deficiency, or non‑diabetic autonomic neuropathy; documented orthostatic BP drop ≥20 mmHg systolic or ≥10 mmHg diastolic within 3 minutes of standing; trial and failure or contraindication to at least two first‑line therapies (e.g., fludrocortisone and midodrine); prescriber cardiologist or neurologistBP drop >=20 systolic or >=10 diastolic

Initial one month then three months if renewal criteria met; dose limited to FDA labeling

Nurtec ODT — Migraine

Covered when ALL of the following are met:

Nurtec criteria: Diagnosis of an FDA‑approved migraine indication not excluded from Part D; patient age ≥18; not used concurrently with other CGRP antagonists for migraine prevention; prior therapy requirements per CMS review/policy where notedAge >=18

Initial six months then 12 months if positive response; dose limited to FDA labeling

Initial criteria for oncology/specialty drugs

General initial coverage for oncology/specialty agents:

Oncology/specialty agent initial criteria: (1) Diagnosis of an FDA‑approved indication not otherwise excluded from Part D; (2) Genetic testing completed if required and results indicate appropriateness; (3) No unsupported FDA‑labeled limitation of use; (4) Agent is FDA‑labeled or compendia‑supported as first‑line OR inadequate response/contraindication to first‑line therapy OR patient currently/previously benefited from agent

Typical initial coverage: six months; renewal requires positive response; dosing limited to FDA labeling

ORKAMBI

ORKAMBI — Initial authorization covered when ALL of the following are met:

ORKAMBI initial criteria: Diagnosis of cystic fibrosis AND patient is homozygous for the F508del CFTR mutation; not used concurrently with another CFTR modulator for the requested indication; prescriber CF specialist or pulmonologist

Renewal: seen within last 12 months and positive response; coverage 12 months; dose limited to FDA labeling

OPSUMIT (PAH)

OPSUMIT — Initial authorization covered when ALL of the following are met:

OPSUMIT initial criteria: Diagnosis of Group 1 pulmonary arterial hypertension confirmed by right heart catheterization with mean PAP ≥20 mmHg, PCWP ≤15 mmHg, and PVR >2 Wood units; prescriber cardiologist or pulmonologist

Coverage duration 12 months; dose limited to FDA labeling

Pirfenidone / IPF

Pirfenidone — Initial authorization covered when ALL of the following are met:

Pirfenidone initial criteria: Diagnosis of IPF with exclusion of other ILD causes and HRCT/histopathology consistent with IPF; baseline FVC ≥50% and DLCO ≥30%; patient does not have underlying liver diseaseFVC >=50%; DLCO >=30%

Coverage duration 12 months; renewal requires follow‑up visit and positive response

PLEGRIDY

PLEGRIDY — Initial authorization covered when ALL of the following are met:

PLEGRIDY initial criteria: Diagnosis of a relapsing form of multiple sclerosis (clinically isolated syndrome, relapsing‑remitting, active secondary progressive) AND medical contraindication or inadequate response to one of: teriflunomide, dimethyl fumarate, fingolimod, or glatiramer acetate

Coverage duration 12 months; specialist involvement required

REPATHA (PCSK9 inhibitors)

REPATHA — Initial coverage when ALL of the following are met:

REPATHA initial: Diagnosis of an FDA‑approved indication not excluded from Part D; for HeFH or adults with ASCVD on lipid‑lowering therapy with LDL >70 mg/dL: trial of one high‑intensity statin plus ezetimibe concomitantly for specified minimum weeks with LDL remaining >70 mg/dL OR documented statin intolerance (rhabdomyolysis to one statin or intolerance to both atorvastatin and rosuvastatin); prescriber cardiologist/endocrinologist or lipid specialist; not used concurrently with PRALUENT or LEQVIO; dose limited to FDA labelingLDL > 70 mg/dL

Document duration of statin/ezetimibe trial; coverage duration 12 months

REPATHA (PCSK9 inhibitor) — Initial coverage criteria

REPATHA — Initial coverage criteria (expanded):

REPATHA initial coverage criteria: As above: documented diagnosis; trial of high‑intensity statin + ezetimibe for specified weeks with LDL >70 mg/dL OR documented statin intolerance; prescriber specialty required; not concurrent with PRALUENT or LEQVIO; dosing per FDALDL > 70 mg/dL

Coverage duration and documentation of trials required

REZDIFFRA (NASH agent) — Initial and renewal criteria

REZDIFFRA — Initial and renewal coverage:

REZDIFFRA initial: Diagnosis of MASH/NASH with moderate–advanced fibrosis; confirmation by liver biopsy (NAS ≥4 with component scores) OR elastography/transient elastography/MRI/CT demonstrating staging consistent with F2 or F3 fibrosis; used in combination with diet and exercise counseling; dose limited to FDA labelingStage F2 or F3 fibrosis

Renewal requires ≥1 year of therapy, no worsening of fibrosis or progression to F4, and prescriber confirmation of ongoing diet/exercise counseling

RETACRIT

RETACRIT — Coverage conditions vary by clinical circumstance:

RETACRIT coverage: Coverage may be under Medicare Part B or Part D depending on setting and indication; initial/renewal durations vary by indication (e.g., anemia from chemo/CKD without dialysis/zidovudine: initial/renewal 12 months; surgery: 1 month)

Documentation of use and setting may be required to determine Part B vs Part D coverage

RUBRACA

RUBRACA — Initial authorization covered when ALL of the following are met:

RUBRACA initial: Diagnosis of an FDA‑approved indication not excluded from Part D; examples: MCRPC with deleterious germline/somatic BRCA mutation after AR‑directed therapy and taxane chemotherapy; maintenance for recurrent epithelial ovarian/FT/primary peritoneal cancer with deleterious BRCA mutation after platinum response; no FDA‑labeled contraindication; dose limited to FDA labeling

Coverage duration six months; renewal requires evidence of positive response

Biologic agents with specialist prescriber and concurrent therapy restrictions

Biologic agents with specialist prescriber and concurrent therapy restrictions — covered when ALL of the following are met:

General biologic criteria: Diagnosis of an FDA‑approved indication; prescribed by or in consultation with specified specialists depending on agent; not used concurrently with other biologic therapies where specified; dose limited to FDA‑labeled dosing; coverage duration commonly 12 months

Applies to multiple biologic agents listed in this section

Sodium oxybate (narcolepsy)

Covered when ALL of the following are met:

Sodium oxybate criteria: Diagnosis of an FDA‑approved indication (e.g., narcolepsy); patient age ≥7 years; prescribed by provider experienced in management of narcolepsy (neurologist/sleep specialist); not used concurrently with sedative hypnotics; dose limited to FDA labeling

Coverage duration 12 months

General initial coverage criteria

General initial coverage language applied per product:

General initial criteria: Diagnosis of an FDA‑approved indication not otherwise excluded from Part D; patient must not have an FDA‑labeled limitation of use or contraindication to therapy; product‑specific diagnostic confirmations or prior therapy requirements apply per product entry

Coverage duration and other specifics vary by product

TRIKAFTA

TRIKAFTA — Initial authorization covered when ALL of the following are met:

Trikafta initial criteria: Diagnosis of cystic fibrosis; patient has at least one F508del CFTR mutation (homozygous or heterozygous) OR a CFTR mutation responsive in vitro; not used concurrently with other CFTR modulators (concurrent CFTR modulators discontinued prior to initiation)

Patients age ≥2 years; prescriber pulmonologist or CF center specialist; coverage 12 months

Tadalafil (PAH)

Tadalafil (PAH) — Initial authorization covered when ALL of the following are met:

Tadalafil 20 mg PAH initial criteria: Diagnosis of WHO Group 1 PAH confirmed by right heart catheterization with mean PAP ≥20 mmHg, PCWP ≤15 mmHg, and PVR ≥3 Wood units; negative acute vasodilator test or trial/failure/contraindication to calcium channel blocker therapy; prescriber pulmonologist or cardiologist

Coverage duration 12 months; dose limited to FDA labeling

Fentanyl buccal lozenge on a handle

Fentanyl buccal lozenge on a handle — Initial authorization covered when ALL of the following are met:

Fentanyl buccal lozenge initial criteria: Diagnosis of breakthrough chronic cancer pain in active cancer; patient has difficulty swallowing or mucositis or related indications; patient is opioid tolerant and has been treated with a long‑acting opioid within past 90 days and has at least one week history of around‑the‑clock opioid therapy demonstrating tolerance (examples: ≥60 mg oral morphine/day; ≥25 mcg/hr transdermal fentanyl; ≥30 mg oral oxycodone/day; ≥60 mg oral hydrocodone/day or equianalgesic dose)Opioid tolerance thresholds as defined

Coverage duration 12 months

Trientine

Trientine — Initial authorization covered when ALL of the following are met:

Trientine initial criteria: Diagnosis of Wilson's disease confirmed by at least two diagnostic criteria (e.g., ATP7B mutation, Kayser‑Fleischer rings, neurological symptoms, hepatic abnormality, low ceruloplasmin <20 mg/dL, urinary copper >40 mcg/24h, hepatic parenchymal copper >40 mcg/g dry weight); intolerance or contraindication to penicillamine; prescriber specialist in genetics/metabolism or hepatology

Initial six months then 12 months if renewal criteria met; dose limited to FDA labeling

Venclexta

Venclexta — Covered when ANY of the following qualifying indications are met:

Venclexta initial eligible indications: (1) Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); OR (2) In combination with azacitidine, decitabine, or low‑dose cytarabine for newly diagnosed AML in adults ≥75 years or with comorbidities precluding intensive induction chemotherapy

Initial approval six months; renewal requires positive response

Talzenna

Talzenna — Initial authorization covered when ANY of the following are met:

Talzenna initial indications: Single‑agent for deleterious or suspected deleterious germline BRCA‑mutated HER2‑negative locally‑advanced or metastatic breast cancer; OR in combination with enzalutamide for HRR gene‑mutated mCRPC; diagnosis must be FDA‑approved indication not excluded from Part D

Coverage duration six months; dose limited to FDA labeling

Somavert

Somavert — Initial authorization covered when ALL of the following are met:

Somavert initial criteria: Diagnosis of acromegaly with confirmation by GH level criteria after OGTT or appropriate clinical/histopathologic confirmation; inadequate response or contraindication to octreotide; prescriber specialty as indicated

Initial six months then 12 months if renewal met; dose limited to FDA labeling

Valchlor

Valchlor — Covered when ALL of the following are met:

Valchlor initial criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; patient has received at least one prior skin‑directed therapy (e.g., topical corticosteroids, bexarotene gel)

Approvals limited to two 60 g tubes per month; initial six months then 12 months if renewal criteria met

VALCHLOR — Initial and Renewal Criteria

VALCHLOR — Initial and renewal criteria:

VALCHLOR initial criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; patient has received at least one prior skin‑directed therapy (topical corticosteroids, bexarotene topical gel)

Quantity limited to two 60‑gram tubes per month; initial 6 months then 12 months if renewal criteria met

VENCLEXTA — Initial and Renewal Criteria

VENCLEXTA — Initial and renewal coverage:

VENCLEXTA initial criteria: Diagnosis of an FDA‑approved indication not otherwise excluded from Part D AND (a) for CLL/SLL treatment of adults OR (b) in combination with azacitidine, decitabine, or low‑dose cytarabine for newly diagnosed AML in adults ≥75 or with comorbidities precluding intensive induction chemotherapy

Dose limited to FDA‑labeled dosing; initial coverage six months; renewal requires positive response

VERQUVO — Initial and Renewal Criteria

VERQUVO — Covered when ALL of the following are met:

VERQUVO initial criteria: Diagnosis of an FDA‑approved indication not excluded from Part D; ejection fraction <45%; AND one of: ≥1 prior HF hospitalization in last 6 months OR outpatient IV diuretic within last 3 months; AND inadequate response or contraindication to at least two guideline therapy classes (ACEi/ARB/ARNI, beta‑blockers, aldosterone antagonists, or SGLT2 inhibitor)EF <45%

Prescriber cardiologist or consult; coverage 12 months; renewal requires positive response

VOWST — Initial Criteria

VOWST — Initial authorization covered when ALL of the following are met:

VOWST initial criteria: Diagnosis of recurrent Clostridioides difficile infection defined as three or more prior CDI episodes treated with antibiotics (e.g., vancomycin); patient completed antibiotic therapy 2–4 days prior to initiating VOWST; patient completed magnesium citrate bowel prep the day before and at least 8 hours prior to initiating VOWST

Limited to a single treatment course; duration 10 days; dose limited to FDA labeling

WINREVAIR (PAH) — Initial Criteria

WINREVAIR (PAH) — Initial authorization covered when ALL of the following are met:

WINREVAIR initial criteria: Diagnosis of Group 1 PAH confirmed by right heart catheterization with mean PAP ≥20 mmHg, PCWP ≤15 mmHg, and PVR >2 Wood units; inadequate response or contraindication to two of the following oral therapies: PDE5 inhibitors, endothelin receptor antagonists, or other specified agents; prescriber pulmonologist or cardiologist

Coverage 12 months; dosing limited to FDA labeling

XALKORI — Initial and Renewal Criteria

XALKORI — Initial and renewal coverage (ANY of the listed qualifying diagnoses):

XALKORI qualifying criteria: ROS1‑positive metastatic NSCLC; anaplastic large cell lymphoma (ALCL); inflammatory myofibroblastic tumor (IMT); metastatic NSCLC ALK‑positive with intolerance/contraindication to alectinib; or patient currently receiving or previously benefited from XALKORI for cancer treatment

Genetic testing completed if applicable; coverage 6 months; renewal requires positive response

XELJANZ — Initial Criteria by Indication (step therapy required)

XELJANZ — Covered when ALL of the following are met per indication (step therapy required):

XELJANZ for Psoriatic Arthritis: Diagnosis of psoriatic arthritis AND medical contraindication or inadequate response to at least two preferred drugs as listed

May not be used concurrently with other biologic therapies; prescriber or consult required; coverage 12 months

XELJANZ for Rheumatoid Arthritis: Diagnosis of rheumatoid arthritis AND medical contraindication or inadequate response to at least two preferred drugs as listed

Prescribed by or in consultation with rheumatologist; coverage 12 months

XELJANZ for Ulcerative Colitis: Diagnosis of ulcerative colitis AND medical contraindication or inadequate response to at least two preferred drugs as listed

Prescribed by or in consultation with gastroenterologist; coverage 12 months

XERMELO — Initial and Renewal Criteria

XERMELO — Covered when ALL of the following are met:

XERMELO initial: Diagnosis of an FDA‑approved indication not excluded from Part D; diarrhea inadequately controlled with a somatostatin analog (SSA) such as octreotide for at least 3 months; used in combination with SSA therapy

Renewal requires positive response (reduction in daily stools); initial six months then 12 months if renewed

XIFAXAN — Indication-specific Criteria and Limits

XIFAXAN — Indication‑specific criteria and limits:

XIFAXAN indications: Hepatic encephalopathy when lactulose dose limited by side effects; travelers' diarrhea due to noninvasive E. coli with trial/failure or documented resistance to specified antibiotics; moderate‑to‑severe IBS‑D without constipation with inadequate response to first‑line therapy; dosing and duration per indication (e.g., 550 mg TID x14 days for IBS‑D; retreatment limited)

Coverage durations: hepatic encephalopathy 12 months, IBS‑D 14 days (retreatment limits), travelers' diarrhea 3 days

XOLAIR — Initial Criteria by Indication

XOLAIR — Initial criteria by indication (examples):

XOLAIR severe asthma criteria: Severe asthma with positive skin prick or blood test to a perennial aeroallergen and baseline IgE ≥30 IU/mL; inadequate asthma control despite medium/high‑dose inhaled corticosteroid plus at least one other maintenance med; inadequate control defined as ≥1 exacerbation requiring oral systemic corticosteroids for ≥3 days in past 12 months OR ≥1 serious exacerbation requiring hospitalization/ER visit in past 12 monthsIgE >=30 IU/mL

May not be used concurrently with another monoclonal antibody; prescriber specialist required; coverage 12 months

XOLAIR Coverage Criteria

XOLAIR — Initial and renewal coverage elements:

XOLAIR initial severe asthma: Positive allergen testing and baseline IgE ≥30 IU/mL; inadequate control despite inhaled corticosteroid + another maintenance med; inadequate control defined by exacerbation/hospitalization criteria

Renewal requires evidence of positive response (decreased exacerbations, decreased rescue med use, symptom reduction, or improved FEV1); coverage 12 months

XOLAIR other indications: Chronic urticaria: inadequate response to maximally tolerated H1 antihistamine; chronic rhinosinusitis with nasal polyps: ongoing intranasal corticosteroid use or failure/contraindication to intranasal corticosteroids

May not be used concurrently with another monoclonal antibody

XTANDI Coverage Criteria

XTANDI — Initial and renewal coverage criteria:

XTANDI initial criteria: Diagnosis of NMCRPC with high‑risk features or other indicated prostate cancer state; patient has bilateral orchiectomy OR castrate testosterone <50 ng/dL OR concurrent GnRH analog therapyCastration‑level testosterone <50 ng/dL

Coverage duration six months; dose limited to FDA labeling; renewal requires continued castrate status

ZEJULA Coverage Criteria

ZEJULA — Initial and renewal coverage criteria:

ZEJULA initial maintenance: First‑line maintenance for adult patients with advanced epithelial ovarian/fallopian tube/primary peritoneal cancer in complete or partial response to first‑line platinum chemotherapy; OR maintenance for recurrent deleterious/suspected deleterious gBRCA‑mutated disease in response to platinum chemotherapy

Coverage duration six months; renewal requires positive response; dosing limited to FDA labeling

YESINTEK Coverage Criteria

YESINTEK — Covered when ALL of the following are met:

YESINTEK general: Diagnosis of an FDA‑approved indication not excluded from Part D; prescriber is or in consultation with rheumatologist/dermatologist/gastroenterologist as appropriate; may not be used concurrently with other biologic therapies; dose limited to FDA labeling

Coverage duration 12 months; required medical information pending CMS review

ZURZUVAE Coverage Criteria

ZURZUVAE — Covered when ALL of the following are met:

ZURZUVAE initial: Diagnosis per FDA‑approved indication not excluded from Part D; required medical information and prerequisites as noted in the policy; dose limited to FDA labeling

Coverage duration 14 days; further documentation pending CMS review

Many biologic and monoclonal antibody products in this policy are subject to concurrent‑use prohibitions. Examples across product entries include: Actemra, Cimzia, Cosentyx, Benlysta, Enbrel, Hadlima, Haegarda, Kineret, and other listed biologics which may not be used concurrently with other biologic or monoclonal antibody therapies. In addition, several products specify that concurrent use with other agents in the same mechanistic class is disallowed (for example, REPATHA concurrent use with PRALUENT or LEQVIO is prohibited). These concurrency restrictions are enforced as exclusion criteria and may trigger denial if concurrent therapy is documented.

Adempas (riociguat) has an explicit drug‑interaction exclusion: it must not be used concurrently with nitrates, nitric oxide donors, phosphodiesterase (PDE) inhibitors, or non–specific PDE inhibitors. This interaction is listed as an exclusion and may trigger denial if concurrent use is present; prescribers must document absence of these concomitant agents in the medical record.

Adbry (tralokinumab) is contraindicated for concurrent use with another monoclonal antibody therapy per the policy. Requests documenting simultaneous monoclonal antibody treatment may be denied unless the provider demonstrates a compelling, documented rationale and that such use is consistent with FDA labeling or other policy exceptions.

For the transthyretin amyloid therapy listed (ATTRUBY), the policy specifies an exclusion for combined therapy with RNA‑targeting agents: ATTRUBY may not be used concurrently with Onpattro (patisiran) or Tegsedi (inotersen). Concurrent use is an explicit exclusion and may result in denial.

Where CFTR modulators are addressed (including Trikafta and other CFTR agents), the policy requires that concurrent CFTR modulator therapy is not permitted. Specifically, CFTR modulators must be discontinued prior to initiation of another CFTR modulator product; concurrent use is listed as an exclusion and may lead to denial.

The policy repeatedly states that certain biologic treatments are not to be combined with other biologics. Examples include Benlysta, Cimzia, Cosentyx, and similar agents — each entry notes that the product may not be used concurrently with other biologic therapies. Providers should document discontinuation of other biologics prior to initiation or risk denial.

Bosentan (oral) carries product‑specific concurrency exclusions: it is contraindicated with cyclosporine A and glyburide. In addition, monitoring and lab thresholds (liver enzymes and bilirubin) are required per the bosentan entry; concurrent contraindicated medications or unacceptable lab values are exclusionary.

Cosentyx (secukinumab) is listed with a clear concurrency prohibition: it may not be used concurrently with other biologic therapies. The entry directs specialist prescribing and limits dosing to FDA‑labeled regimens; concurrent biologic use is an exclusion that may trigger denial.

Dupixent (dupilumab) is explicitly restricted from concurrent use with other monoclonal antibody therapies. Indication‑specific prerequisites and specialist involvement are required, and documentation of absence of concurrent monoclonal therapy should accompany requests.

Emgality (galcanezumab) for migraine prevention is subject to a class concurrency exclusion: the policy states Emgality may not be used concurrently with other CGRP antagonists for migraine prevention. Age and prerequisite therapy requirements also apply for initial approvals.

Enbrel (etanercept) is identified as a biologic that may not be used concurrently with other biologic therapies. The Enbrel criteria also require prior inadequate response or contraindication to a preferred adalimumab biosimilar (e.g., Hadlima or Simlandi) before approval in many indications.

Dihydroergotamine for acute migraine is listed with a concurrency exclusion against other acute migraine agents: it may not be used concurrently with triptans or acute CGRP antagonists. Prior triptan trials and specialist prescribing are required elements of initial authorization.

The policy contains a broad exclusion that any product will not be approved when the patient has an FDA‑labeled limitation of use or contraindication. This is applied across many entries — requests documenting an FDA‑labeled contraindication or limitation to the requested therapy are excluded and may be denied.

Initial Authorization / Start-of-Therapy Criteria

Renewal / Ongoing Therapy Criteria

Required Prior / Alternative Therapy (Step) Rules

Step therapy requirement	Required prior trial(s) / documentation	Notes
Antidepressant agents (new starts)
Inadequate response or medical contraindication to two preferred alternative antidepressants (examples: citalopram, escitalopram, fluoxetine, paroxetine, sertraline, venlafaxine, duloxetine)
Required for new-start patients; coverage duration typically 12 months

Step therapy requirement	Required prior trial(s) / documentation	Notes
Actemra (selected indications)
Inadequate response or medical contraindication to at least two preferred drugs (examples: Hadlima, Simlandi, Rinvoq) depending on indication; prescriber is or in consultation with rheumatologist or pulmonologist
May not be used concurrently with other biologic therapies; coverage duration 12 months

Step therapy requirement	Required prior trial(s) / documentation	Notes
General step therapy for listed agents (examples: antipsychotics, Cimzia)
Inadequate response or medical contraindication to two specified preferred alternative therapies (lists provided per indication)
Applies to new-start patients; prescriber specialty and 12-month coverage common

Step therapy requirement	Required prior trial(s) / documentation	Notes
Enbrel (etanercept)
Prior inadequate response or contraindication to at least one preferred adalimumab biosimilar (preferred agents include Hadlima or Simlandi)
May not be used concurrently with other biologic therapies; prescriber specialty required; coverage duration 12 months

Step therapy requirement	Required prior trial(s) / documentation	Notes
Dronabinol (for CINV)
Inadequate response or contraindication to a 5-HT3 receptor antagonist (e.g., ondansetron) AND inadequate response or contraindication to prochlorperazine; patient is receiving chemotherapy
May be covered under Part B or Part D depending on setting; coverage pending CMS review

Step therapy requirement	Required prior trial(s) / documentation	Notes
FINTEPLA and similar agents
Prior inadequate response or medical contraindication to specified alternatives (e.g., for LGS: failure of ≥2 other antiseizure medications)
Prerequisite therapy required; prescriber specialty often required; coverage duration commonly 12 months

Step therapy requirement	Required prior trial(s) / documentation	Notes
INBRIJA (inhaled levodopa)
Trial and failure of at least one adjunct agent for ≥4 weeks in combination with carbidopa/levodopa (examples: rasagiline, ropinirole, entacapone, pramipexole, rotigotine, selegiline); provider attestation of inhaler education and pulmonary assessment
Patient must be taking carbidopa/levodopa; age ≥18; prescriber neurologist or consult; renewal requires positive response

Step therapy requirement	Required prior trial(s) / documentation	Notes
JAYPIRCA (zanubrutinib)
For CLL/SLL: prior exposure to at least two prior therapies including a BTK inhibitor and a BCL-2 inhibitor; for MCL: ≥2 prior systemic therapies including a BTK inhibitor
Documentation required; coverage duration six months; dose limited to FDA-labeled dosing; prerequisite therapy requirement noted pending CMS review

Step therapy requirement	Required prior trial(s) / documentation	Notes
KISQALI (ribociclib) regimens
Medical contraindication or inadequate response to at least one preferred drug (examples: Verzenio or Ibrance) prior to approval
Prescriber specialty and documentation required; typical initial coverage six months; renewal with positive response

Step therapy requirement	Required prior trial(s) / documentation	Notes
Nexletol (bempedoic acid)
Trial of one high-intensity statin plus ezetimibe concomitantly for specified minimum weeks with LDL remaining >70 mg/dL OR documented statin intolerance (rhabdomyolysis to one statin or intolerance to both atorvastatin and rosuvastatin)
Prescribed by or in consultation with cardiology/endocrinology; documentation of statin/ezetimibe trial duration required; coverage 12 months

Step therapy requirement	Required prior trial(s) / documentation	Notes
Trial and failure documentation (general)
Documentation that prior therapies were tried and failed or were contraindicated (examples: trials of first-line agents with clinical response noted)
Required prior therapy documentation is necessary for initial authorization decisions

Step therapy requirement	Required prior trial(s) / documentation	Notes
Documentation of prior therapy or contraindication
Provide documentation of prior therapy trials and outcomes or documented medical contraindications to those therapies (examples vary by product)
Documentation often required to demonstrate failure of preferred alternatives prior to approval

Step therapy requirement	Required prior trial(s) / documentation	Notes
REPATHA (PCSK9 inhibitor)
Trial of one high-intensity statin plus ezetimibe concomitantly for specified minimum weeks with LDL remaining >70 mg/dL OR documented statin intolerance as defined; prescriber specialty documentation required
May not be used concurrently with Praluent or Leqvio; document duration of statin/ezetimibe trial; dose limited to FDA labeling

Step therapy requirement	Required prior trial(s) / documentation	Notes
TYENNE (example biologic) prior therapy requirement
Inadequate response or medical contraindication to preferred drugs (usually at least two preferred agents such as Hadlima, Simlandi, Rinvoq depending on indication)
Prescribed by or in consultation with rheumatologist; coverage duration 12 months; not to be used concurrently with other biologics

Step therapy requirement	Required prior trial(s) / documentation	Notes
Valchlor (topical mechlorethamine)
Patient must have received at least one prior skin-directed therapy (examples: topical corticosteroids or bexarotene topical gel)
Approvals limited to two 60 g tubes per month; initial 6 months then 12 months if renewal criteria met

Step therapy requirement	Required prior trial(s) / documentation	Notes
XELJANZ (tofacitinib) step therapy
Prior inadequate response or medical contraindication to at least two preferred drugs (lists provided by indication) before approval
May not be used concurrently with other biologic therapies; prescriber specialty required; coverage duration 12 months

Step therapy requirement	Required prior trial(s) / documentation	Notes
Prerequisite therapy for several products (examples aggregated)
Many products require prior or concomitant use of standard therapies before approval (examples: Xolair requires inadequate control despite inhaled steroid plus at least one other maintenance med; other agents require prior specific drug trials)
Prescriber specialty and diagnostic documentation often required; coverage and step details product-specific

Index and Code Listings

Product listingsmixed

VENCLEXTA ORAL TABLET 10 MG	VENCLEXTA product listing
VENCLEXTA STARTING PACK	VENCLEXTA starting pack
100 MG	VENCLEXTA strength
50 MG	VENCLEXTA strength

Products listed in this sectionmixed

VALCHLOR	Product affected
VERQUVO	Product affected
VERZENIO	Product affected
VOSEVI	Product affected
VOWST	Product affected
VUMERITY	Product affected
WINREVAIR	Product affected
XALKORI	Product affected
XATMEP	Product affected
XDEMVY	Product affected

1–10 of 15

1/2

Product list (no billing codes provided in this section)mixed

No codes listed

Indexed product listingsNDC | mixed

INTRALIPID 20%	Intralipid intravenous emulsion 20% (indexed entries)
INTRALIPID 30%	Intralipid intravenous emulsion 30% (indexed entries)

Indexed drug: ipratropium bromide 0.02%NDC

ipratropium bromide inhalation solution 0.02%

Index entries listing ipratropium bromide inhalation solution 0.02% across many index numbers

Indexed drug: ipratropium-albuterolNDC

ipratropium-albuterol inhalation solution

Index entries listing ipratropium-albuterol inhalation solution across many index numbers

Indexed ml entriesmixed

ml	multiple numeric index entries referencing milliliters (ml) across index

Indexed drug namesNDC

ITOVEBI ORAL TABLET 3 MG, 9 MG

Index entry for Itovebi oral tablet strengths 3 mg and 9 mg

Actions, Documentation & Denial Risks for Providers

Prior Authorization

Abiraterone prior authorization & dose substitution

Abiraterone (oral) prior authorization: PA required. Initial requests must document diagnosis of metastatic high‑risk castration‑sensitive prostate cancer (MCSPC) or metastatic castration‑resistant prostate cancer (mCRPC). If the request is for the 500 mg tablet, the provider must document why the 250 mg tablet cannot be used (dose‑substitution rationale). Limit approvals limited to FDA‑labeled dosing. Coverage duration: 6 months. Note: patient must not have any FDA‑labeled contraindication or limitation of use.

Coverage duration: 6 months
If 500 mg tablet requested, provide rationale why 250 mg tablet unsuitable
Limited to FDA‑labeled dosing

Prior Authorization

Actemra prior authorization and preferred‑alternative requirements

Actemra (tocilizumab) — prior authorization required. Initial criteria: document applicable FDA‑approved diagnosis (e.g., rheumatoid arthritis, polyarticular JIA, giant cell arteritis, systemic juvenile idiopathic arthritis, systemic sclerosis–associated ILD) and medical contraindication or inadequate response to required preferred agents (examples include Hadlima, Simlandi, Rinvoq as applicable). Do not use Actemra concurrently with other biologic therapies. Prescriber should be or consult with a rheumatologist or pulmonologist when indicated. Coverage duration: 12 months. Limited to FDA‑labeled dosing.

Quantity, Duration and Refill Limits

GATTEX quantity limit

GATTEX dosing limitDose limited to FDA-approved 0.05 mg/kg/day

Initial coverage duration3 months initial, then 12 months if renewal criteria met

Indication requirementShort bowel syndrome with ≥1 year dependence on parenteral nutrition and inability to taper

insulin administration supplies — 12 months supply

Supply limitInsulin administration supplies covered as a 12 months supply

Coverage conditionOnly covered under Part D when used concurrently with insulin

Examples

Where Therapy is Administered / Coverage Setting

Note

Biosimilar Preferences and Requirements

Note

Clinical Thresholds and Key Numeric Criteria

Hemoglobin thresholds for ESAs

Adult CKD ESA thresholdHemoglobin < 10 g/dL (adults with CKD not on dialysis)

Pediatric CKD threshold guidancePediatric CKD: hemoglobin approaches or exceeds 12 g/dL — guide dose reduction/interruption to decrease transfusions

Cancer/chemotherapy contextHemoglobin thresholds aligned with avoiding RBC transfusion per indication

Alpha-1 antitrypsin level

Pretreatment AAT levelSerum alpha-1 antitrypsin (AAT) level < 11 micromoles/L

Equivalent unitsOr <80 mg/dL by radial immunodiffusion or <57 mg/dL by nephelometry

Policy Background

This policy excerpt summarizes Medicare Part D prior authorization standards for selected specialty and pharmacy drugs: coverage generally requires documentation of an FDA‑approved diagnosis (or acceptable diagnostic confirmation), evidence of prior trial(s) or contraindication to preferred alternatives when specified, absence of FDA‑labeled contraindications, and dosing limited to FDA‑labeled guidelines. Many biologic agents require specialist prescribing or consultation, and typical initial coverage durations are 6 to 12 months depending on the product; renewals commonly require evidence of clinical benefit and a recent prescriber visit.

OpenPayer

2026 Medicare Part D Prior Authorization Requirements (selected drugs)

Drug-specific Coverage Criteria

Initial Authorization / Start-of-Therapy Criteria

Renewal / Ongoing Therapy Criteria

Required Prior / Alternative Therapy (Step) Rules

Index and Code Listings

Actions, Documentation & Denial Risks for Providers

Quantity, Duration and Refill Limits

Where Therapy is Administered / Coverage Setting

Biosimilar Preferences and Requirements

Clinical Thresholds and Key Numeric Criteria

Policy Background