CurrentIndependent HealthPolicy N/A

Medicare Part D Prior Authorization Criteria (selected formulary drugs)

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Lists prior authorization requirements for drugs on Independent Health's 2025 Medicare Advantage C-SNP Part D formulary, including clinical, prescriber, age, documentation, step therapy, and site-of-care rules that affect coverage.

Policy Summary

PayerIndependent Health

PolicyMedicare Part D Prior Authorization Criteria (selected formulary drugs)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2025

Last ReviewJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization before dispensing for drugs listed with 'PA' on the 2025 Medicare Advantage C‑SNP Part D formulary to avoid denial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2025formulary year

MA C-SNP Part Daffected formulary

PAdesignation

1 yrtypical duration

~150distinct entries

Coverage Criteria — Product-level Requirements

OHTUVAYRE Initial Therapy

Covered when ALL of the following are met

OHTUVAYRE initial approval: Diagnosis of COPD with post-bronchodilator FEV1% predicted between 23% and 85%; FEV1/FVC ratio < 0.72; mMRC dyspnea score ≥ 2; currently receiving dual LABA-LAMA therapy (with or without inhaled corticosteroid) OR documentation that dual LABA-LAMA or triple LABA-LAMA-ICS therapy was ineffective, not tolerated, or contraindicated; attestation drug will not be used in combination with roflumilast; age ≥ 18 years; prescriber restricted to pulmonology; initial coverage 6 months then 1 year; PA applies when covered as a Part D benefit; reauthorization requires documentation of spirometry and/or symptom improvement and continued background LAMA-LABA therapy.

Spirometry and attestation required; Part B vs Part D determination may be requested.

ADEMPAS Initial Therapy

Covered when ALL of the following are met

ADEMPAS initial approval: Diagnosis consistent with covered use including WHO Group; submission of creatinine clearance (or serum creatinine, weight, and height) and pregnancy status for females of childbearing potential; for WHO Group 1 PAH, documentation of diagnosis confirmed by right heart catheterization; age ≥ 18 years; prescriber restricted to cardiology or pulmonology; PA applies to new starts only; coverage duration 1 year; exclusions include pregnancy, Child-Pugh class C hepatic impairment, CrCl < 15 mL/min or dialysis, and concurrent use with nitrates or phosphodiesterase inhibitors.

Right heart catheterization required for WHO Group 1 PAH documentation.

Alpha-1 PI Augmentation Criteria

Covered when ALL of the following are met

Alpha-1 PI therapy: Pre-treatment alpha-1 antitrypsin (AAT) level < 11 mmol/L (80 mg/dL); confirmation of clinically evident emphysema secondary to congenital alpha-1 PI deficiency by pulmonary function testing (spirometry or body plethysmography), radiography, or DLCO; age ≥ 18 years; prescriber restricted to pulmonology; PA applies to all; coverage duration 1 year; continuation requires objective documentation from the prescriber that the patient's symptoms have improved.

Individuals with IgA deficiency who have known anti-IgA antibodies are excluded.

ARIKAYCE Initial Therapy

Covered when ALL of the following are met

ARIKAYCE initial approval: Diagnosis of refractory Mycobacterium avium complex (MAC) lung disease; documentation that a multi-drug MAC regimen (eg, ethambutol, a macrolide, and a rifamycin) was tried and failed for at least a 6-month trial period; submission of a positive sputum culture obtained after treatment with the multi-drug regimen; age ≥ 18 years; prescriber restricted to infectious diseases or pulmonology; PA applies to all; coverage duration 1 year; medication may be covered under Part B for non-long-term care enrollees and under Part D when applicable.

Failure of ≥6 months multi-drug regimen and post-treatment positive sputum culture required.

Biologics Preferred-agent Step Requirement

Covered when ALL of the following are met

Preferred agent trials: For drugs in the biologics/immunomodulators group (except Otezla and Velsipity), patient must have tried and failed or been intolerant to at least two preferred agents (adalimumab biosimilar, Cosentyx, Enbrel, Humira, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz/XR) for the indication submitted where possible; submission of baseline latent TB screening (PPD or IGRA) is required; if TB screening is positive, latent TB must be treated before initiation; yearly TB screening or chest X-ray required for reauthorization when ongoing exposure risk exists; PA applies to all; coverage duration 1 year.

Otezla and Velsipity exempt from this preferred-agent requirement.

CAMZYOS Initial Therapy

Covered when ALL of the following are met

CAMZYOS initial approval: Attestation patient has exertional symptoms consistent with NYHA class II or III; confirmation of LV outflow tract obstruction gradient ≥ 50 mmHg at rest, with Valsalva, or after exercise; confirmation of LV wall thickness ≥ 15 mm or ≥ 13 mm if familial; LVEF documented ≥ 55%; age ≥ 18 years; prescriber restricted to cardiology; patient has tried and failed or is intolerant/contraindicated to both a beta-blocker and a non-DHP calcium channel blocker; pregnancy status submitted for females of childbearing potential; PA applies to all; initial coverage 6 months then 1 year; documentation of positive response required for reauthorization and annual attestation thereafter.LV outflow tract gradient ≥50 mmHg; LV wall thickness ≥15 mm (≥13 mm if familial)

Submit LVEF and prior/current therapy documentation.

CERDELGA Genotype-restricted coverage

Covered when ALL of the following are met

CERDELGA requirements: Diagnosis of covered use; submission of CYP2D6 metabolizer status by genotype testing and liver function testing or Child-Pugh score; age ≥ 18 years; prescriber restriction as specified; exclusions include pre-existing cardiac disease, moderate/severe hepatic impairment, long QT syndrome, coadministration with Class Ia or III antiarrhythmics; patients who are ultra-rapid CYP2D6 metabolizers will not be covered; PA applies to all; coverage duration 1 year; updated liver function testing or Child-Pugh score required for reauthorization.CYP2D6 genotype testing

Do not approve for ultra-rapid CYP2D6 metabolizers.

DOPTELET Indication-specific criteria

Covered when ALL of the following are met

DOPTELET indications: For thrombocytopenia in chronic liver disease scheduled for a procedure: platelet count < 50 x 10^9/L; For immune thrombocytopenia (ITP): platelet count < 30 x 10^9/L OR < 50 x 10^9/L with symptomatic bleeding AND documentation patient has undergone splenectomy and/or tried and failed two different ITP therapies (eg systemic corticosteroids, IVIG, danazol, fostamatinib, or cytotoxics/immunosuppressants such as rituximab); age ≥ 18 years; prescriber restricted to gastroenterology, hematology, hepatology, or surgery; coverage duration: 5 days for procedure use, initially 6 months then 1 year for ITP; PA applies to all.platelet thresholds as above

For ITP reauthorization, documentation of platelet improvement ≥50 x 10^9/L after ≥4 weeks on max tolerated dose required.

ITP and procedure-related thrombocytopenia

Covered when ALL of the following are met

ITP coverage for agent in chunk 37: Diagnosis of ITP with platelet count <30 x 10^9/L OR <50 x 10^9/L with symptomatic bleeding AND documentation patient has undergone splenectomy and/or tried and failed two different ITP therapies (systemic corticosteroids, immunoglobulins, danazol, fostamatinib, or cytotoxics/immunosuppressants such as rituximab); age ≥ 18 years; prescriber restricted to hematology or gastroenterology/hepatology as appropriate; initial approval durations and reauthorization requirements per product (initial 6–12 weeks then annual), with demonstrated platelet improvement required for continuation.platelets <30 x10^9/L (ITP)

Maintenance requires platelet improvement ≥50 x10^9/L after treatment.

Dupilumab coverage

Covered when indication-specific objective criteria are met

Covered dupilumab indications: Atopic dermatitis: BSA ≥10% or failed appropriate topical therapy; Asthma: pre-bronchodilator FEV1 <80% predicted (or <90% if <18) AND blood eosinophils and/or OCS-dependence per product criteria and inadequate control on inhaled corticosteroid plus at least one controller; COPD: FEV1/FVC <0.7 with post-bronchodilator FEV1 30–70% predicted and blood eosinophils ≥300 cells/mcL and symptomatic despite triple inhaled therapy; CRSwNP: evidence of nasal polyps and prior intranasal corticosteroid use; EoE: endoscopy with biopsy showing ≥15 eosinophils/HPF; prurigo nodularis per label. Age and prescriber restrictions per indication; PA applies to all; initial 6 months then 1 year for continuation; reauthorization requires objective documentation of positive clinical response.varies by indication (eg BSA≥10%, eos≥300 cells/mcL)

Submit disease-specific objective measures and prior therapy documentation.

Neupogen step requirement

Covered when ALL of the following are met

Neupogen prior to Zarxio trial: For approval of Neupogen for any indication other than Hematopoietic Syndrome of Acute Radiation Syndrome, patient must have tried and failed to have an adequate response to or had an intolerance to Zarxio (the biosimilar). Age and prescriber restrictions per indication; coverage duration 1 year; PA applies as indicated. Part B vs Part D coverage determination may be requested based on administration setting.trial of Zarxio

Biosimilar trial required except for radiation syndrome indication.

Initial Authorization (generalized)

Covered when ALL of the following are met for each specific product as detailed below:

diagnosis_and_testing: Diagnosis of covered use with submission of any required confirmatory testing (eg gene variant, mutation, biomarker, tumor testing, 24-hour UFC, HCV genotype and HCV RNA, AGXT mutation or CFTR mutation) as specified by the product-specific criteria.

See individual product entries for exact test/type and timing requirements.

age_and_prescriber: Age and prescriber restrictions met (eg minimum ages typically 18; some products require pediatric age ranges or specialist prescribers such as oncology, cardiology, nephrology, endocrinology, pulmonology, immunology).

Refer to product-specific chunk for exact age/prescriber restrictions.

exclusions: No exclusion conditions present (eg severe hepatic impairment Child-Pugh B/C where specified, severe renal impairment eGFR thresholds, congenital long QT syndrome, drug–drug interaction exclusions such as strong CYP3A4 inhibitors/inducers or dual strong CYP3A/P-gp inhibitors).

Examples appear in product-specific criteria (eg eGFR <30, QTcF thresholds, CYP interactions).

prior_authorization_scope: PA applies as indicated (often to new starts only); coverage duration commonly 1 year unless otherwise stated (some products initial shorter duration such as 6 months or 3 months with reauthorization requirements).

See each product for initial duration and reauthorization timing.

additional_documentation: Submission of baseline labs or other measurements when required (eg baseline blood pressure, LFTs, ECG including QTcF, ANC, ALC, platelet counts, pregnancy status) and documentation of prior therapies tried/failed when specified.

Product-specific lab and prior therapy lists available in corresponding entries.

JUXTAPID Initial Therapy

JUXTAPID (lomitapide) approval requires ALL of the following:

JUXTAPID approval: Documented diagnosis meeting HoFH criteria (eg functional mutations in both LDL receptor alleles OR skin fibroblast LDL receptor activity <20% OR untreated total cholesterol >500 mg/dL with both parents untreated TC >250 mg/dL); submission of baseline labs (ALT, AST, alkaline phosphatase, total bilirubin, baseline LDL-C, TC, apoB, non-HDL-C); pregnancy status for females of childbearing potential; documentation of contraindication to or treatment failure with evolocumab; age ≥ 18 years; prescriber restricted to cardiology, lipidology, or endocrinology experienced in lipid management; initial approval 6 months then 1 year with LDL response documentation required for reauthorization; exclusions include pregnancy and moderate/severe hepatic impairment; PA applies to all; not approved for heterozygous familial hypercholesterolemia.

Baseline liver tests required and LDL response required for continuation.

Kisqali Initial Therapy

Kisqali (ribociclib) approval requires ALL of the following:

Kisqali approval: Diagnosis of HR-positive, HER2-negative tumor confirmed by genetic tumor testing; submission of QTcF, serum potassium and magnesium within prior 6 months; no congenital long QT syndrome and QTcF <450 msec at initiation; no uncorrected hypokalemia or hypomagnesemia; no concomitant strong CYP3A4 inducers or QT-prolonging drugs; for Kisqali regimens confirm concomitant aromatase inhibitor or fulvestrant as appropriate; age ≥ 18 years; prescriber restricted to oncology; coverage duration 1 year; PA applies to new starts only.QTcF <450 msec

Baseline ECG and electrolytes required.

Ledipasvir-sofosbuvir Coverage Criteria

Ledipasvir-sofosbuvir (HCV) approval requires ALL of the following:

Ledipasvir-sofosbuvir approval: Laboratory confirmation of HCV genotype (1a, 1b, 4, 5, or 6) and baseline HCV RNA; documentation of cirrhosis status and compensation; documentation of treatment-naive vs experienced status; HBV testing (HBsAg and anti-HBc) completed; coverage duration per genotype and prior treatment (eg treatment-experienced genotype 1 with compensated cirrhosis 24 weeks; others typically 12 weeks; 8 weeks may be considered for select treatment-naive patients); PA applies to all.

Adhere to AASLD-IDSA guidance for duration as applicable.

MAVYRET Coverage Criteria

MAVYRET (glecaprevir/pibrentasvir) approval requires ALL of the following:

MAVYRET approval: Laboratory confirmation of HCV infection and documentation of cirrhosis status (compensated vs decompensated); HBV testing (HBsAg and anti-HBc) completed; no moderate or severe hepatic impairment (Child-Pugh B or C); no coadministration with rifampin or atazanavir; coverage duration applied consistent with current AASLD-IDSA guidance; PA applies to all.

Do not use in Child-Pugh B or C or with contraindicated concomitant drugs.

KERENDIA Coverage Criteria

KERENDIA (finerenone) approval requires ALL of the following for chronic kidney disease associated with type 2 diabetes:

KERENDIA CKD approval: Diagnosis of CKD associated with type 2 diabetes; submission of eGFR and baseline serum potassium; documentation of trial of Farxiga or Jardiance; age ≥ 18 years; exclusions include adrenal insufficiency, eGFR <25 mL/min/1.73 m2, serum potassium >5.0 mEq/L at initiation, severe hepatic impairment (Child-Pugh C), coadministration with strong CYP3A4 inhibitors or moderate/strong CYP3A4 inducers; PA applies to all; coverage duration 1 year.eGFR and serum potassium per requirements

For HF indication additional LVEF documentation required as specified.

JAYPIRCA Coverage Criteria

JAYPIRCA (pirtobrutinib) approval requires ALL of the following:

JAYPIRCA approval: Diagnosis of covered hematologic malignancy per product labeling; documentation patient has tried and failed at least two previous lines of systemic therapy (with indication-specific prior therapy composition, e.g., mantle cell lymphoma requiring prior BTK inhibitor; CLL/SLL requiring prior BTK and BCL-2 inhibitors); pregnancy status for females of childbearing potential submitted; age ≥ 18 years; prescriber restricted to hematology and oncology; coverage duration 1 year; PA applies to new starts only.

Provide prior therapy history and rationale for JAYPIRCA use.

LYTGOBI - Initial Therapy

Covered when ALL of the following are met

LYTGOBI initial criteria: Age ≥ 18 years; prescriber restricted to oncology; diagnosis of a medically-accepted indication; submission of test confirming FGFR2 fusion or rearrangement; documentation of previous systemic treatments tried; pregnancy status for females of childbearing potential; PA applies to new starts only; coverage duration 1 year; exclusion: coadministration with dual strong CYP3A4/P-glycoprotein inhibitors or inducers.

FGFR2 fusion/rearrangement testing required for coverage.

MAVYRET - Coverage Criteria

Covered when ALL of the following are met

MAVYRET criteria: Diagnosis of HCV confirmed by laboratory testing; documentation of cirrhosis status and compensation; completion of HBV testing (HBsAg and anti-HBc); no moderate or severe hepatic impairment (Child-Pugh B or C); no coadministration with rifampin or atazanavir; coverage duration per current AASLD-IDSA guidance; PA applies to all.

Provider must submit HCV genotype and baseline HCV RNA per product guidance.

Mepolizumab - Indication-Specific Criteria

Covered when ALL indication-specific criteria are met

Mepolizumab indications: Indications include severe eosinophilic asthma, CRSwNP, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and others as FDA-approved. Each indication requires specific objective documentation: for asthma—pre-bronchodilator FEV1 <80% predicted (or <90% if adolescent) and blood eosinophil count ≥150 cells/mcL within 6 weeks or ≥300 cells/mcL within 12 months and inadequate control on inhaled corticosteroid plus at least one additional controller; for CRSwNP—evidence of nasal polyps and prior intranasal corticosteroid trial; for EGPA and HES—disease-specific eosinophil thresholds and prior therapy failure documentation. Age and prescriber specialty restrictions apply; PA applies to all; continuation requires objective documentation of positive clinical response.FEV1 and eosinophil thresholds as specified

Submit baseline lung function and eosinophil counts as required.

ORSERDU — Coverage and Duration

Covered when ALL of the following are met

ORSERDU initial criteria: Patient is ≥18 years; prescriber restricted to endocrinology or gynecology; diagnosis of covered use provided; attestation patient is premenopausal where applicable and pregnancy status submitted for females of childbearing potential; submission of liver function testing or Child-Pugh score where required; no pregnancy, severe hepatic impairment (Child-Pugh C), known osteoporosis, or coadministration with OATP1B1 inhibitors; PA applies to all; coverage duration up to 24 months depending on indication (eg endometriosis with dyspareunia or moderate hepatic impairment 6 months; endometriosis without dyspareunia 150 mg daily for 24 months); use >2 years will not be approved.

Provide indication-specific duration and liver function information.

Oncology agents with tumor testing requirement

Covered when ALL of the following are met

Oncology agents with tumor testing requirement: Patient is ≥18 years; prescriber restricted to oncology; diagnosis of covered use with submission of tumor testing confirming required biomarker (eg ER-positive, HER2-negative, ESR1-mutated or PIK3CA-mutated depending on drug); submission of liver function/Child-Pugh score where required; documentation of prior endocrine or systemic therapies tried and failed as specified; PA applies to new starts only; coverage duration typically 1 year.

Provide tumor testing and prior therapy history per product.

Eltrombopag — Indication-specific criteria

Covered when ALL of the following are met

Eltrombopag ITP initial: Diagnosis of immune thrombocytopenia (ITP) AND submission of platelet count AND documentation patient has undergone splenectomy and/or tried and failed two different ITP therapies (eg systemic corticosteroids, IVIG, danazol, fostamatinib, or cytotoxics/immunosuppressants such as rituximab) AND platelet count <30 x 10^9/L or <50 x 10^9/L with increased bleeding risk; age and prescriber restrictions per product; initial approval durations vary by indication (eg ITP initially 12 weeks then 1 year) and documentation of platelet improvement required for reauthorization.platelet thresholds as specified

Submit prior therapy history and platelet counts.

Recorlev (levoketoconazole) — Coverage criteria

Covered when ALL of the following are met

Recorlev initial criteria: Diagnosis of Cushing's syndrome with 24-hour urine free cortisol (UFC) demonstrating baseline >1.5× upper limit of normal (50 micrograms or 145 nmol) AND attestation pituitary surgery is not an option or was not curative AND ECG including QTcF and liver function tests (AST/ALT) performed within 3 months AND documentation patient tried and failed at least one other therapy for Cushing's (eg mifepristone, osilodrostat, pasireotide); age ≥ 18 years; prescriber restricted to endocrinology; initial coverage 6 months then 1 year; PA applies to all; continuation requires documentation of clinically relevant response including 24-hour UFC improvement; exclusions include cirrhosis, baseline AST/ALT >3× ULN, prolonged QTcF >470 msec, and coadministration with QT-prolonging drugs associated with ventricular arrhythmias.24-hour UFC >1.5× ULN

ECG and LFTs required within 3 months prior to request.

Oncology product initial therapy

Covered when ALL of the following are met for oncology kinase inhibitor products (example):

Oncology product initial criteria: Diagnosis of covered oncologic use; submission of prior kinase inhibitor therapies tried and failed; baseline blood pressure reading; baseline left ventricular ejection fraction ≥ 50% where required; pregnancy status for females of childbearing potential; age ≥ 18 years; prescriber restricted to oncology; PA applies to new starts only; coverage duration 1 year.LVEF ≥50% where specified

Provide prior therapy history and baseline cardiovascular testing as required.

Recorlev initial and continuation

Covered when ALL of the following are met for Recorlev:

Recorlev initial criteria: Diagnosis of Cushing's syndrome with 24-hour UFC baseline >1.5× ULN; attestation pituitary surgery not an option or not curative; ECG including QTcF and LFTs within 3 months; documentation patient tried and failed at least one other Cushing therapy; age ≥ 18 years; prescriber restricted to endocrinology; initial coverage 6 months then 1 year; continuation requires documentation of clinically relevant response (eg 24-hour UFC improvement).24-hour UFC >1.5× ULN

Exclusion triggers include cirrhosis, AST/ALT >3× ULN, prolonged QTcF >470 msec.

Relistor initial therapy

Covered when ALL of the following are met for Relistor products:

Relistor initial criteria: Diagnosis of covered use; documentation patient tried and failed or had contraindication/intolerance to both lubiprostone and Movantik; for non-cancer pain, documentation of steady opioid dose for the previous 8 weeks; age ≥ 18 years; PA applies to all; coverage duration 1 year; confirmation patient remains on opioid required for reauthorization; exclusion for known or suspected mechanical GI obstruction or high risk of recurrent obstruction.

Submit prior therapy details and opioid use documentation where applicable.

Retacrit initial therapy

Covered when ALL of the following are met for Retacrit:

Retacrit initial criteria: Diagnosis of covered use; hemoglobin <10 g/dL at initial submission for non-surgery indications; assessment of serum iron, TIBC, and transferrin saturation within 30 days; documentation patient does not have uncontrolled hypertension; coverage duration for non-ESRD conditions 90 days and for ESRD-related conditions 1 year; PA applies to all.Hgb <10 g/dL

Submit iron studies and hemoglobin level with request.

RIVFLOZA initial and continuation

Covered when ALL of the following are met for RIVFLOZA:

RIVFLOZA initial criteria: Diagnosis of covered use with AGXT mutation confirmed by liver enzyme analysis or genetic testing; submission of 24-hour urinary oxalate (Uox) excretion ≥ 0.7 mmol (normalized to BSA if <18) and eGFR documentation; attestation patient has not received prior kidney or liver transplant and will not use in combination with lumasiran (Oxlumo); prescriber restricted to nephrology or urology; exclusion if eGFR <30 mL/min/1.73 m2; initial coverage 6 months then 1 year; PA applies to all; reauthorization requires documentation of clinically relevant response (reduced Uox or plasma oxalate).Uox ≥0.7 mmol; eGFR ≥30 mL/min/1.73 m2

Provide genetic/biochemical confirmation and renal function.

SCEMBLIX initial therapy

Covered when ALL of the following are met for SCEMBLIX:

SCEMBLIX mutation-based criteria: Diagnosis of covered use; submission of pregnancy status for females of childbearing potential; for patients with T315I mutation, documentation patient tried and failed or was intolerant to ponatinib; for patients without T315I, documentation of two or more other TKIs tried and failed; age ≥ 18 years; prescriber restricted to hematology and oncology; coverage duration 1 year; PA applies to new starts only.

Provide mutation testing and prior TKI history.

General product criteria (illustrative)

Coverage requires meeting all listed product-specific criteria (examples shown below).

Example: general product criteria: Diagnosis of covered use; submission of required baseline labs (eg serum potassium and magnesium, LFTs, ECG) where specified; pregnancy status for females of childbearing potential; prescriber specialty as required (eg oncology, cardiology); absence of exclusion conditions (eg uncorrected electrolyte abnormalities, drug interactions with strong CYP3A modulators); PA applies to new starts only for many products; coverage duration typically 1 year unless otherwise stated.

This node is illustrative — consult the product-specific entry for exact requirements.

ATTR cardiomyopathy

Covered when ALL of the following are met

ATTR cardiomyopathy coverage: Diagnosis of transthyretin amyloid cardiomyopathy (ATTRwt or ATTRm) confirmed by one of: cardiac biopsy with amyloid deposits, immunohistochemical confirmation of transthyretin precursor protein, technetium-99 SPECT/planar scintigraphy, or TTR genetic mutation plus cardiac involvement (increased interventricular septal wall thickness); documentation of heart failure history with at least one prior hospitalization for heart failure or signs/symptoms of volume overload requiring diuretic therapy; age ≥ 18 years; prescriber restricted to cardiology; PA applies to all; coverage duration 1 year; annual reauthorization requires documentation of positive clinical response.

Provide diagnostic confirmation by imaging/biopsy or genetic testing.

Tavalisse (fostamatinib)

Covered when ALL of the following are met

Tavalisse initial authorization: Diagnosis of ITP with platelet count <30 x 10^9/L OR <50 x 10^9/L with documented increased bleeding risk; documentation patient has undergone splenectomy and/or tried and failed two different ITP therapies (eg systemic corticosteroids, immunoglobulins, danazol, fostamatinib, or cytotoxics/immunosuppressants such as rituximab); age ≥ 18 years; PA applies to new starts only; initial coverage 12 weeks then 1 year; documentation of platelet improvement required for reauthorization.platelet thresholds as specified

Submit prior therapy history and platelet counts.

Tolvaptan

Covered when ALL of the following are met

Tolvaptan initiation: Diagnosis of clinically significant hyponatremia defined as serum sodium <125 mEq/L OR serum sodium <135 mEq/L that is symptomatic and resistant to fluid restriction; no underlying liver disease; patient able to sense and respond to thirst and not hypovolemic or anuric; no coadministration with strong CYP3A inhibitors/inducers or desmopressin; age ≥ 18 years; PA applies to all; treatment limited to 30 days with close monitoring of serum sodium to prevent liver injury; formulation for ADPKD with REMS is not approved under this policy.serum sodium thresholds as specified

Initiate where sodium monitoring is feasible; limited duration to mitigate hepatic risk.

Teriparatide/TYMLOS

Covered when ALL of the following are met

PTH analog initiation: Diagnosis of high fracture risk (history of osteoporotic fracture OR multiple risk factors OR failed/intolerant of other osteoporosis therapies); submission of baseline serum calcium and DEXA or fracture history; documentation that at least one bisphosphonate was tried and failed OR all bisphosphonates contraindicated; contraindications include pre-existing hypercalcemia and increased osteosarcoma risk; age and prescriber restrictions per product; coverage duration typically up to 2 years; continuation beyond 2 years requires evidence patient remains at high fracture risk.

Provide prior bisphosphonate trial documentation and baseline calcium.

Vanflyta

Covered when ALL of the following are met

Vanflyta initiation: Diagnosis of covered use with submission of test confirming presence of FLT3 mutation; baseline QTcF interval must be provided and ≤ 450 msec at initiation; baseline serum potassium and magnesium provided and corrected if needed; attestation no history of ventricular arrhythmias or torsades de pointes; no coadministration with moderate/strong CYP3A inducers; prescriber restricted to hematology and oncology; age ≥ 18 years; PA applies to new starts only; coverage duration 1 year.QTcF ≤450 msec

Correct electrolytes prior to initiation and provide ECG.

Initial Therapy

Covered when ALL of the following are met

Initial IgA nephropathy criteria: Biopsy-confirmed primary IgA nephropathy; 24-hour urine protein ≥ 1 g/day OR UPCR ≥ 0.8 g/g; age ≥ 18 years; prescriber restricted to immunology or nephrology; patient is currently using (or has contraindication to) a maximally-tolerated ACE inhibitor or ARB AND has tried and failed or is intolerant to at least one SGLT‑2 inhibitor (eg dapagliflozin, empagliflozin); PA applies to new starts only; coverage duration 1 year; reauthorization requires documentation of clinically relevant response (stabilization or improvement of UPCR or reduction in 24‑hour urine protein from baseline).24-hour urine protein ≥1 g/day or UPCR ≥0.8 g/g

Submit biopsy and prior therapy documentation.

HFrEF (Verquvo)

Covered when ALL of the following are met

Verquvo initiation: Diagnosis of HFrEF with left ventricular ejection fraction <45% AND hospitalization for HFrEF within prior 6 months OR outpatient IV diuretic use within prior 3 months; age ≥ 18 years; submission of pregnancy status if applicable; current HFrEF regimen includes a renin-angiotensin system inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist each at maximally‑tolerated doses (or documentation of contraindication/intolerance); if beta-blocker not one of bisoprolol, carvedilol, or metoprolol succinate provide rationale; PA applies to all; coverage duration 1 year; reauthorization requires updated HFrEF regimen documentation annually.LVEF <45%

Provide hospitalization/IV diuretic documentation and optimized background therapy.

Wegovy (semaglutide) indications

Covered when ALL of the following are met for indicated Wegovy uses

Wegovy MACE or MASH criteria: For MACE indication: documentation of established cardiovascular disease (prior MI, prior stroke, or symptomatic PAD per definitions) AND BMI ≥ 25 kg/m2 AND attestation no personal/family history of medullary thyroid carcinoma or MEN2 AND not receiving another GLP‑1 agonist; prescribers restricted to cardiology/gastroenterology/hepatology. For MASH indication: confirmation of F2 or F3 fibrosis by biopsy or elastography and plan for hepatic management; prescribers restricted to hepatology/gastroenterology. PA applies to all; initial duration 32 weeks then 1 year; product will not be approved for weight management under Medicare Part D.BMI ≥25 kg/m2 for MACE

Submit cardiovascular disease documentation for MACE and fibrosis staging for MASH.

Pulmonary arterial hypertension

Covered when ALL of the following are met

PAH therapy initiation: Diagnosis of pulmonary arterial hypertension with pulmonary capillary wedge pressure ≤ 15 mm Hg AND pulmonary vascular resistance ≥ 5 Wood units; submission of baseline 6‑minute walk distance, BNP and/or NT‑proBNP, and WHO/NYHA functional class (II or III); submission of background PAH therapy documenting use of drugs in at least two classes among nitric oxide pathway, endothelin receptor antagonist, and prostacyclin pathway unless contraindicated; age ≥ 18 years; prescriber restricted to cardiology or pulmonology; PA applies to all; initial coverage 6 months then 1 year; reauthorization after 6 months requires absence of unacceptable toxicity and evidence of response (functional class, RV function, 6MWD, or BNP/NT‑proBNP improvements).PCWP ≤15 mm Hg; PVR ≥5 Wood units

Right heart catheterization data typically required to document hemodynamics.

VIVJOA

Covered when ALL of the following are met

VIVJOA initiation: Diagnosis of recurrent vulvovaginal candidiasis with at least three episodes in the prior 12 months; patient is postmenopausal or infertile; submission of eGFR and confirmation patient does not have severe hepatic impairment; attestation patient is not of reproductive potential as required; age and prescriber restrictions per product; PA applies to all; coverage duration 12 weeks.

Provide eGFR and menopausal/infertility status documentation.

Product-specific PA criteria (selected entries)

Covered when ALL product-specific documentation, prescriber, age, and other listed criteria are met.

WELIREG: Diagnosis of covered use; submission of pregnancy status for females of childbearing potential; for VHL disease confirm germline VHL alteration and attest immediate surgery is not required; for advanced RCC confirm prior PD‑1/PD‑L1 inhibitor and VEGF TKI therapy tried/failed; age ≥18; prescriber restricted to oncology; PA applies to new starts only; coverage duration 1 year.

Provide genetic testing and prior therapy documentation as applicable.

XIFAXAN 550 mg: For hepatic encephalopathy (HE): prior trial and inadequate response to lactulose required; for IBS‑D: failure of at least one antidiarrheal/antispasmodic/tricyclic and documentation of prior 14‑day rifaximin courses; for SIBO: positive carbohydrate breath test and failure of at least two prior antibiotics; age ≥18; prescriber restricted to gastroenterology/hepatology; coverage durations: HE 1 year; IBS‑D and SIBO 14 days; quantity limits: IBS‑D max three 14‑day courses lifetime; SIBO max two 14‑day courses per 365 days; PA applies to all for 550 mg strength.

Submit prior therapy history and breath test results for SIBO.

XOLAIR: Diagnosis of covered use with indication-specific objective criteria (eg asthma: pre‑BD FEV1 <80% and pre‑treatment IgE 30–700 IU/mL and perennial aeroallergen sensitization and uncontrolled despite ICS plus another controller; CRSwNP: nasal polyps and IgE ≥30 IU/mL and prior intranasal corticosteroid use; chronic spontaneous urticaria: persistent severe symptoms despite H1 antihistamine ≥30 days; food allergy: IgE‑mediated food allergy with IgE ≥30 IU/mL and not using Palforzia); prescribers restricted to allergy/dermatology/immunology/ENT/pulmonology; initial coverage 6 months then 1 year; continuation requires objective documentation of response (food allergy requires attestation) and Xolair will not be approved for food allergy if patient is using Palforzia.IgE ≥30 IU/mL where specified

Provide indication‑specific objective measures.

XOLREMDI: Diagnosis of covered use with documentation of CXCR4 mutation; baseline ANC ≤ 400 cells/mcL and baseline ALC submitted; age ≥12; prescriber restricted to dermatology/hematology/immunology/genetic disease specialists; initial coverage 3 months then 1 year; initial reauthorization after 3 months requires improvements in ANC/ALC; PA applies to all.ANC ≤400 cells/mcL

Submit baseline hematologic labs and mutation testing.

Individuals with IgA deficiency who have known anti‑IgA antibodies are excluded from coverage for alpha‑1 antitrypsin (alpha‑1 PI) augmentation therapy. This exclusion accompanies the coverage requirements that include a pre‑treatment AAT level below 11 mmol/L (80 mg/dL) and confirmation of clinically evident emphysema by pulmonary function testing, imaging, or DLCO; prescriber must be a pulmonologist and PA applies to all requests.

ADEMPAS (riociguat) will be excluded for patients with pregnancy and for those with severe hepatic impairment (Child‑Pugh class C). Requests must include creatinine clearance information (or serum creatinine, weight and height to calculate CrCl) and pregnancy status; ADEMPAS is contraindicated when creatinine clearance is 15 mL/min or the patient is on dialysis. The drug also should not be used with concurrent nitrates or nitric oxide donors or with phosphodiesterase inhibitors. PA applies to new starts only and prescribers are restricted to cardiology or pulmonology.

ARIKAYCE (liposomal amikacin for inhalation) is excluded when the member’s Mycobacterium avium complex (MAC) lung disease is not refractory to guideline multi‑drug therapy. Coverage requires documentation that a multi‑drug MAC regimen (for example ethambutol plus a macrolide and a rifamycin) was tried and failed for at least a 6‑month trial and submission of a positive sputum culture obtained after that regimen; prescriber must be infectious diseases or pulmonology and PA applies when covered under Part D.

Coding, Clinical Thresholds and Lab Criteria

Listed products (partial segment)mixed

No codes listed

Document markers/datesmixed

12/1/2025

date marker appearing in product list

inv-85: LV outflow tract obstruction gradient — numeric threshold key/value

LV outflow tract obstruction gradient>= 50 mmHg

Measurement conditionsMeasured at rest, with Valsalva, or after exercise

Supporting documentationSubmit cardiology report documenting gradient at time of evaluation

inv-86: LV wall thickness — numeric threshold key/value

Left ventricular (LV) wall thickness>= 15 mm (or >= 13 mm if familial)

ContextRequirement applies to hypertrophic cardiomyopathy assessment for CAMZYOS

DocumentationSubmit imaging report (echocardiography or MRI) verifying maximal wall thickness

inv-87: QTcF interval — numeric threshold key/value

QTcF interval threshold (treatment initiation)<= 450 msec (QTcF >=450 msec is an exclusion for some products)

Contraindication noteProlonged QTcF (eg >470 msec) contraindicates therapy for select agents (see product-specific criteria)

Required testingSubmit baseline ECG including QTcF prior to initiation when specified

inv-88: ANC threshold — numeric threshold key/value

Absolute neutrophil count (ANC) requirement> 1.5 x 10^9/L

ExclusionRequests excluded if ANC is below 1.5 x 10^9/L

DocumentationSubmit recent ANC as part of baseline labs for affected products

inv-89: Platelet count for procedure — key/value

Platelet count for procedure-related thrombocytopenia< 50 x 10^9/L

Use caseApply when patient with chronic liver disease is scheduled to undergo a procedure

DocumentationSubmit platelet count prior to authorization for procedural use

inv-90: Platelet count for ITP — key/value

Platelet count threshold for ITP initial approval< 30 x 10^9/L (or < 50 x 10^9/L with symptomatic bleeding)

Prior therapy requirementDocumentation of splenectomy and/or failure of two different ITP therapies required

Reauthorization metricImprovement to >=50 x 10^9/L after >=4 weeks on max tolerated dose required for reauthorization

inv-93: Atopic dermatitis extent (BSA ≥10%) — key/value

Atopic dermatitis extent (BSA) for dupilumab>= 10% body surface area involvement

Supporting requirementPatient must have tried a moderate-strength topical corticosteroid for at least 4 weeks unless contraindicated

DocumentationSubmit dermatology notes documenting BSA and prior topical therapy

inv-94: Asthma pre-bronchodilator FEV1 threshold — key/value

Asthma pre-bronchodilator FEV1 threshold< 80% predicted in adults (or < 90% if under 18)

Additional asthma criteriaRequire blood eosinophil count >=150 cells/mcL within 6 weeks or daily OCS dependence

DocumentationSubmit pre-bronchodilator FEV1 and recent eosinophil count prior to authorization

inv-95: COPD eosinophil threshold — key/value

COPD blood eosinophil threshold for dupilumab>= 300 cells/mcL within 6 weeks of therapy initiation

COPD spirometry requirementPost-bronchodilator FEV1/FVC <0.7 and FEV1 30–70% predicted

Symptom requirementPatient must be symptomatic (mMRC >=2 or CAT >=10) despite optimized therapy

inv-96: Filgotinib/IgAN urine protein threshold — key/value

Filgotinib / IgAN proteinuria threshold24-hour urine protein >= 1 g/day OR UPCR >= 0.8 g/g

ContextRequired for initial authorization in IgA nephropathy indications

DocumentationSubmit 24-hour urine protein or UPCR result with biopsy-confirmed diagnosis

inv-97: IgAN proteinuria threshold for fabhalta — key/value

IgAN proteinuria threshold for FABHALTA24-hour UPCR >= 1.5 g/g

ContextApplies to patients evaluated for specific IgAN therapy where FABHALTA criteria referenced

DocumentationSubmit 24-hour UPCR measurement and biopsy confirmation as required

inv-98: eGFR threshold — key/value

eGFR threshold (exclusion)less than 30 mL/min/1.73 m2 is an exclusion for select products

Product examplesApplies to agents with renal function limits (eg GALAFOLD, RIVFLOZA) — check product-specific criteria

DocumentationSubmit most recent eGFR or creatinine clearance to support authorization

inv-100: Hemoglobin A1c threshold — key/value

Hemoglobin A1c threshold for type 2 diabetes confirmation>= 6.5%

Acceptable evidenceMedical record, chart notes, ICD-10 on claims, or lab results demonstrating HbA1c >=6.5% or qualifying glucose values

DocumentationSubmit recent HbA1c or qualifying glucose test when required for GLP-1 or diabetes-related approvals

inv-101: Age restrictions (many oncology drugs) — key/value

Typical age restriction for many oncology drugs18 years of age or older

Pediatric exceptionsSome products specify other minimum ages (eg pediatric oncology agents) — see product-specific entries

Prescriber restrictionMost oncology agents require oncology prescriber specialty for approval

inv-107: Mepolizumab eosinophil thresholds — key/value

Mepolizumab eosinophil thresholds>=150 cells/mcL within 6 weeks of therapy initiation OR >=300 cells/mcL within 12 months

Indication-specificityThresholds vary by mepolizumab indication (asthma, EGPA, HES); submit most recent eosinophil counts per indication requirements

DocumentationProvide blood eosinophil counts obtained within the specified timeframe when requesting authorization

inv-109: 24-hour urine free cortisol (UFC) baseline threshold — key/value

24-hour urine free cortisol (UFC) baseline thresholdBaseline > 1.5 times the upper limit of normal (50 micrograms or 145 nmol)

Use caseRequired for initial authorization of Recorlev for Cushing's syndrome

Supporting testsSubmit ECG including QTcF and LFTs within 3 months along with 24-hour UFC

Provider Actions — Prior Authorization, Documentation, Denial Triggers

Prior Authorization

Obtain prior authorization before dispensing

Prior authorization must be obtained before dispensing for drugs listed with 'PA' on the 2025 Independent Health Medicare Advantage C‑SNP Part D formulary; failure to obtain PA may result in the drug not being covered.

Prior Authorization

Bronchitol: provide passed tolerance test and pulmonologist prescriber

Submit documentation the patient has passed a Bronchitol Tolerance Test. PA for Bronchitol is limited to pulmonology prescribers, adults (≥18), applies to new starts only, and authorization is typically for 1 year.

Document passed Bronchitol Tolerance Test
Prescriber must be pulmonologist
Applies to new starts only; coverage duration 1 year

Prior Authorization

CABLIVI: submit diagnosis, concurrent plasma exchange/immunosuppression, and prescriber info

For CABLIVI, include diagnosis confirmation and documentation that therapy will be given with plasma exchange and immunosuppressive therapy. Prescriber must be in the permitted specialties and patient must be ≥18. PA applies to all uses; initial coverage noted as 3 months. Do not approve non‑first use if >2 recurrences of aTTP while on caplacizumab.

Confirm treatment given with plasma exchange and immunosuppression
Prescriber restricted to cardiology, hematology, or immunology; age ≥18
PA applies to all; coverage duration 3 months; recurrence >2 on caplacizumab excludes approval

Prior Authorization

CF modulators: submit CFTR mutation test and pulmonology prescriber

For CFTR modulators, submit CFTR mutation testing that confirms a mutation responsive per the drug’s prescribing information. Prescriber must be a pulmonologist; PA applies to new starts only and authorization is typically 1 year.

Provide drug‑specific CFTR mutation test result (per PI section 12.1 or in‑vitro data)
Prescriber must be pulmonology
PA applies to new starts only; usual duration 1 year

Prior Authorization

Digoxin: age- and dose-based PA (≥65 years)

For digoxin in patients aged ≥65, PA applies unless prescribed by cardiology or dose is ≤0.125 mg/day. Include updated creatinine clearance for annual reauthorization.

PA applies to patients ≥65 years
PA not required if prescriber is cardiology
PA not required for doses ≤0.125 mg/day; submit updated creatinine clearance for reauthorization

Prior Authorization

Dronabinol (SYNDROS): age, prescriber, and duration requirements

For dronabinol (Syndros) submit documentation that patient is ≥18 and that prescriber is in an allowed specialty; note indication‑specific durations (e.g., 5 days for procedure‑related thrombocytopenia; ITP initial 6 months then 1 year).

Patient age ≥18
Prescriber restrictions apply
Follow indication‑specific coverage durations (e.g., 5 days for procedure use; ITP: 6 months initial then 1 year)

Prior Authorization

Dupilumab: specialist prescriber, initial 6 months then annual reauthorization with objective response

Dupilumab requests must come from an appropriate specialist (allergy, dermatology, gastroenterology, immunology, otolaryngology, or pulmonology). Initial authorization is 6 months then 1 year; continuation requires objective documentation of a positive clinical response and indication‑specific objective measures.

Specialist prescriber required (listed specialties)
Initial 6 months then annual reauthorization
Submit objective disease measures (e.g., AD BSA ≥10%, asthma FEV1/eosinophils, COPD spirometry/eosinophils, CRSwNP/endoscopy findings) for continuation

Prior Authorization

PA commonly applies to new starts only — expect 1‑year authorizations

PA generally applies to new treatment starts for many products listed in this formulary; when noted, the typical coverage duration is 1 year.

Confirm request is for a new start when PA applies to new starts only
Expect typical authorization duration of 1 year unless product specifies otherwise

Prior Authorization

When PA is for new starts: document new‑start status and expect 1‑year durations

For products where PA applies to new starts, ensure the initial request documents prior treatment status; many oncology and diabetes drugs specify a 1‑year coverage period on approval.

Document whether patient is a new start
Anticipate 1‑year coverage duration for listed oncology/diabetes products

Documentation Required

IVIG: submit diagnosis and indication‑specific labs; PA often for new starts

For IVIG, submit the diagnosis of the covered use and indication‑specific data (e.g., ITP platelet count, CLL with IgG <600 mg/dL and infection history, unequivocal CIDP diagnosis). PA typically applies to new starts; durations vary (e.g., 3 months for acute/new starts, 1 year for chronic renewals).

Provide diagnosis and indication‑specific labs (e.g., platelet counts, IgG)
Note PA applies to new starts only for many IVIG indications
Coverage durations: variable (acute/new starts 3 months; chronic renewals commonly 1 year)

Prior Authorization

Confirm new‑start status when PA applies to new starts only

Many listed products require PA for new starts only; confirm the request is for a new start and include the product‑specific initial documentation requested.

Confirm new‑start status
Include product‑specific required documentation

Prior Authorization

LYTGOBI: oncology prescriber, FGFR2 testing, prior therapy, and interaction exclusion

For LYTGOBI, include test confirming FGFR2 fusion/rearrangement, prior systemic therapy history, prescriber specialty (oncology), patient ≥18, and note that PA applies to new starts only with typical 1‑year coverage; coadministration with dual strong CYP3A4/P‑gp modulators is an exclusion.

Submit FGFR2 fusion/rearrangement test
Document prior systemic treatments tried
Prescriber must be oncology; patient age ≥18
Exclusion: dual strong CYP3A4/P‑gp inhibitors or inducers

Prior Authorization

MAVYRET: confirm HCV, cirrhosis status, HBV testing; PA applies to all

For MAVYRET, submit laboratory confirmation of HCV, document cirrhosis presence/status, and confirm HBV testing (HBsAg and anti‑HBc). PA applies to all uses and coverage duration follows current AASLD‑IDSA guidance; exclude patients with moderate/severe hepatic impairment or specified contraindicated coadministrations.

Provide HCV laboratory confirmation and baseline HCV RNA
Document cirrhosis status and compensation
Confirm HBV testing (HBsAg and anti‑HBc) completed
Do not use in Child‑Pugh B/C or with rifampin/atazanavir coadministration

Prior Authorization

Mepolizumab: specialty prescriber and required lung/eosinophil documentation

Mepolizumab PA requires prescribers in specified specialties (allergy, hematology, ENT/otolaryngology, pulmonology, rheumatology). Include diagnosis, pre‑bronchodilator FEV1, blood eosinophil counts per thresholds, prior controller therapy history, and objective measures; continuation requires objective response documentation.

Prescriber restricted to listed specialties
Submit pre‑BD FEV1 and blood eosinophil count (≥150 cells/mcL within 6 weeks or ≥300 within 12 months as applicable)
Document inadequate control on inhaled corticosteroid plus at least one other controller
Continuation requires objective clinical response

Prior Authorization

ORSERDU: PA for all uses — submit pregnancy status and liver function; duration limits apply

ORSERDU prior authorization applies to all uses; include diagnosis, attestation patient is premenopausal where applicable, pregnancy status for females of childbearing potential, and liver function testing/Child‑Pugh score. Coverage durations vary up to 24 months by indication; requests >2 years will not be approved.

Submit diagnosis and premennopausal attestation when applicable
Provide pregnancy status for females of childbearing potential
Include liver function testing/Child‑Pugh score
Note duration limits (up to 24 months); therapy >2 years not approved

Prior Authorization

Oncology agents: new‑start PA, oncology prescriber, and tumor testing required

For oncology agents listed, confirm the request is a new start when required, prescriber is oncology, and include tumor testing or biomarker results as specified; PA for new starts only with typical 1‑year authorizations.

Ensure prescriber is oncology
Provide tumor biomarker testing (e.g., ER+/HER2‑/ESR1, PIK3CA, RET, ALK/ROS1 as applicable)
PA often applies to new starts only; anticipate 1‑year coverage

Prior Authorization

Narcolepsy agents: PA applies to all; prior wake‑promoting agent trials required in adults

Narcolepsy agents: PA applies to all formulations; authorization is 1 year. For adults with excessive daytime sleepiness, document prior failure/intolerance to armodafinil or modafinil and solriamfetol before approving other narcolepsy agents.

PA applies to all formulations; duration 1 year
For adults, document trials and failure/intolerance to armodafinil/modafinil and solriamfetol

Prior Authorization

Oncology product new‑start PA: include prior TKI history and baseline vitals

Many oncology products require PA for new starts only; ensure previous kinase inhibitor exposures and baseline vitals (BP, LVEF) are provided when requested and that prescriber is oncology.

Confirm this is a new start when PA applies to new starts only
Submit prior kinase inhibitor therapy history where specified
Provide baseline BP and LVEF (≥50%) when required

Prior Authorization

Recorlev: baseline UFC, ECG/QTcF, LFTs, and continuation response documentation

For Recorlev, submit a baseline 24‑hour urine free cortisol >1.5× ULN, ECG including QTcF, liver function tests within 3 months, and documentation that pituitary surgery is not an option or not curative. Initial approval is 6 months then 1 year; continuation requires documentation of clinically relevant response (e.g., improved 24‑hour UFC).

Submit 24‑hour UFC >1.5× ULN at baseline
Provide ECG including QTcF and LFTs (within 3 months)
Attest pituitary surgery is not an option or not curative
Initial 6 months then 1 year; continuation requires documented response

Prior Authorization

Relistor: document prior laxative/Movantik failure and ongoing opioid use

For Relistor, include documentation that the patient tried and failed (or had contraindication/intolerance to) lubiprostone and Movantik; for non‑cancer pain document steady opioid dose for prior 8 weeks. PA applies to all; coverage duration 1 year and confirmation of ongoing opioid use is required for reauthorization.

Document failure/intolerance to lubiprostone and Movantik
For non‑cancer pain, document stable opioid dose for prior 8 weeks
Confirmation patient remains on opioid required for reauthorization

Note

Follow product‑specific PA scope (new starts vs all uses)

Prior authorization is required as specified per product; confirm whether PA applies to new starts only or to all uses and follow the product‑specific PA scope.

Check product entry to determine whether PA is for new starts only or all uses
Follow product‑specific PA scope and duration

Note

Verify whether PA applies to all patients or new starts only

Some products listed under this policy require PA either for all patients or for new starts as noted — verify the product’s PA scope in the policy before submitting.

Verify whether PA applies to all patients or to new starts only per product entry

Prior Authorization

Oncology new‑start PA: document prior therapies and tumor testing; Part B not usually required

Many oncology products have PA that applies to new starts only and do not require a Part B prerequisite; document prior therapies and tumor testing as instructed.

Document prior systemic therapies and tumor testing as specified
No Part B prerequisite typically required for these new‑start oncology PAs

Prior Authorization

Xolair: 6‑month initial PA then annual; reauthorization requires objective response documentation

For Xolair, initial authorization is 6 months then 1 year. Reauthorization requires objective documentation of clinical response; for CRSwNP confirm continued intranasal corticosteroid use and for food allergy provide attestation of ongoing medical necessity (and note Xolair is not approved for food allergy if patient uses Palforzia).

Initial 6 months, then annual reauthorization
Submit objective documentation of response for reauthorization
CRSwNP: confirm maintenance intranasal corticosteroid use; food allergy: attest continued medical necessity; not approved if using Palforzia

Note

Index lists only — consult individual drug pages for PA requirements

The index portion lists drug names and page references only and does not by itself specify PA requirements; use the individual drug policy pages for PA actions.

Do not rely on index entries for PA specifics — consult the drug’s policy page

Step Therapy

Preferred‑agent trial: document failure of ≥2 preferred biologics (TB screening required)

For biologics and immunomodulators (except Otezla and Velsipity), document trial and inadequate response or intolerance to at least two preferred agents (list provided) before approval; submit baseline latent TB screening and follow yearly TB screening or chest X‑ray for reauthorization when exposure risk exists.

Document failed trials of ≥2 preferred agents (adalimumab biosimilar, Cosentyx, Enbrel, Humira, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz)
Submit baseline TB screening (PPD or IGRA) and yearly screening or chest X‑ray if indicated

Step Therapy

Migraine CGRP biologics: trial of two non‑CGRP alternatives required

For CGRP migraine prevention biologics, document failure of at least two non‑CGRP FDA‑approved or compendial alternatives (or one if contraindicated) and baseline headache days/month; Emgality requires prior failure of Aimovig and Ajovy.

Provide baseline headache days/month
Document failure of ≥2 non‑CGRP alternatives (or 1 if contraindicated)
Emgality: document failure of Aimovig and Ajovy

Step Therapy

Antipsychotic prior‑trial requirement: document aripiprazole + one other trial

For antipsychotic approvals (e.g., schizophrenia), document prior failure or intolerance to aripiprazole and at least one other generic second‑generation antipsychotic.

Document trials and failures/intolerance to aripiprazole and one other second‑generation antipsychotic

Step Therapy

Neupogen: trial of Zarxio required before Neupogen for most indications

For Neupogen (non‑radiation syndrome indications), document prior trial and inadequate response or intolerance to the biosimilar Zarxio; provide how the drug will be used/obtained to determine Part B vs Part D coverage.

Document trial and failure/intolerance to Zarxio for most indications
Describe intended site/use to establish Part B vs Part D coverage

Step Therapy

Document required prior systemic/TKI therapies per product-specific sequencing rules

Some agents (examples: ICLUSIG, JAYPIRCA, Itovebi) require documentation of prior systemic or kinase‑inhibitor therapies per the product entry; follow the product‑specific prior‑therapy sequencing rules when requesting PA.

Provide documentation of prior kinase inhibitor or systemic therapy trials as specified (e.g., ICLUSIG: ≥2 prior TKIs when not T315I; JAYPIRCA: ≥2 prior systemic therapies)

Step Therapy

MYCAPSSA: require prior injectable somatostatin analog trial and attestation

MYCAPSSA: submit documentation of prior use of injectable octreotide or lanreotide and attestation of successful treatment before approval.

Provide prior octreotide or lanreotide use and attestation of response

Step Therapy

Narcolepsy (adults): prior armodafinil/modafinil and solriamfetol required

For narcolepsy agents in adults, authorization requires prior trials and inadequate response/intolerance/contraindication to armodafinil or modafinil and solriamfetol.

Document prior trial and failure/intolerance to armodafinil/modafinil and solriamfetol

Step Therapy

PCSK9 step requirement: document statin + ezetimibe or prior statin failures

PCSK9 inhibitor approval (Repatha/Praluent) requires current statin + ezetimibe use or failure/intolerance to at least two statins or one statin + ezetimibe; at least one previously tried statin must be hydrophilic.

Document current statin + ezetimibe or failure of ≥2 statins or 1 statin + ezetimibe
Ensure at least one previously tried statin was hydrophilic

Step Therapy

SCEMBLIX: mutation‑specific prior TKI requirements

SCEMBLIX: for T315I mutation, document trial and failure or intolerance to ponatinib; for non‑T315I, document two or more other TKIs tried and failed.

If T315I: provide documentation trial/failure or intolerance to ponatinib
If not T315I: document ≥2 other TKIs tried and failed

Step Therapy

CAPLYTA: prior antipsychotic trial requirements per indication

CAPLYTA for schizophrenia or bipolar I requires documentation of failure or intolerance to aripiprazole and at least one other generic second‑generation antipsychotic; for bipolar I depression, failure/intolerance to at least two specified alternatives is required.

Document failed trials of aripiprazole + one other second‑generation antipsychotic for schizophrenia/acute mania
For bipolar I depression, document failure of two specified alternatives (cariprazine, lurasidone, olanzapine, or quetiapine)

Step Therapy

Solriamfetol: require prior armodafinil/modafinil trial

Solriamfetol will be authorized only after trial and inadequate response/intolerance to armodafinil or modafinil; document prior trial.

Provide documentation of prior armodafinil or modafinil trial and inadequate response/intolerance

Step Therapy

Teriparatide/TYMLOS: bisphosphonate trial required; duration limits apply

Teriparatide/TYMLOS require prior trial and failure or intolerance to at least one bisphosphonate (or contraindication to all); total duration is limited (typically 2 years) and continuation beyond 2 years requires evidence of ongoing high fracture risk.

Document prior bisphosphonate trial and failure or contraindication to bisphosphonates
Limit total therapy to 2 years unless high fracture risk is documented

Step Therapy

Primary IgA nephropathy: biopsy confirmation, proteinuria threshold, ACE/ARB and SGLT‑2 trial documented

For primary IgA nephropathy initial authorization, document biopsy‑confirmed diagnosis, 24‑hour urine protein ≥1 g/day or UPCR ≥0.8 g/g, and current use of or contraindication to maximally‑tolerated ACE inhibitor or ARB plus trial/intolerance to at least one SGLT‑2 inhibitor.

Submit biopsy confirmation and 24‑hour urine protein or UPCR
Document current ACE inhibitor/ARB use or contraindication and SGLT‑2 inhibitor trial/failure

Step Therapy

Pitolisant (adults): prior wake‑promoting agent trials required

For pitolisant in adults with narcolepsy, document prior inadequate response/intolerance/contraindication to armodafinil/modafinil and solriamfetol.

Provide documentation of trials and failure/intolerance to armodafinil/modafinil and solriamfetol

Step Therapy

Rifaximin 550 mg: lactulose failure for HE; prior therapy/testing and course limits for IBS‑D/SIBO

Rifaximin 550 mg for HE requires documentation of prior trial and failure of lactulose; for IBS‑D and SIBO, document required prior therapies or positive testing per indication and respect quantity limits (IBS‑D: max three 14‑day courses lifetime; SIBO: max two 14‑day courses per 365 days).

HE: document lactulose trial and failure
IBS‑D: document prior antidiarrheal/antispasmodic/tricyclic trial(s); limit 3 lifetime 14‑day courses
SIBO: positive breath test and ≥2 prior antibiotics tried; limit 2 courses per 365 days

Documentation Required

ADEMPAS: submit WHO Group, renal function, and pregnancy status (right heart catheterization for WHO Group 1)

For ADEMPAS, submit diagnosis including WHO Group, creatinine clearance (or serum creatinine, weight, and height) and pregnancy status; provide right heart catheterization documentation for WHO Group 1 PAH.

Provide WHO Group diagnosis and right heart catheterization for WHO Group 1
Submit creatinine clearance (or serum creatinine, weight, height) and pregnancy status

Documentation Required

Alpha‑1 PI therapy: submit low AAT level and objective emphysema evidence

For alpha‑1 antitrypsin augmentation, submit pre‑treatment AAT level <11 mmol/L (≈80 mg/dL) and confirm clinically evident emphysema by pulmonary function testing, imaging, or DLCO. Prescriber should be pulmonology; PA applies to all.

Pre‑treatment AAT level <11 mmol/L (80 mg/dL) required
Provide PFTs, imaging, or DLCO confirming emphysema
Prescriber restricted to pulmonology; PA applies to all

Documentation Required

OHTUVAYRE COPD: submit spirometry, mMRC, and prior dual therapy documentation

OHTUVAYRE COPD requests must include post‑bronchodilator FEV1 % predicted (23–85%), FEV1/FVC <0.72, mMRC ≥2, and evidence of current dual LAMA‑LABA therapy or documentation of failure/intolerance to such therapy; prescriber must be pulmonology.

Submit post‑bronchodilator FEV1% predicted and FEV1/FVC ratio
Document mMRC dyspnea score ≥2
Confirm current dual LAMA‑LABA therapy or prior failure/intolerance
Prescriber restricted to pulmonology

Documentation Required

CAMZYOS: submit LVOT gradient, wall thickness, NYHA class, LVEF, and pregnancy status

For CAMZYOS, include attestation of NYHA class II–III exertional symptoms, LVOT gradient ≥50 mmHg, LV wall thickness per criteria, current LVEF, prior/current therapies, and pregnancy status. Documentation of positive response is required for reauthorization.

Attest NYHA class II or III symptoms
Submit LVOT gradient (≥50 mmHg) and LV wall thickness (≥15 mm or ≥13 mm if familial)
Provide current LVEF and prior/current therapies
Pregnancy status for females of childbearing potential; positive response documentation required for reauthorization

Documentation Required

CF modulators: provide drug‑specific CFTR mutation test result

CFTR mutation testing is required for CF modulators — provide the specific mutation result that demonstrates the patient is responsive to the requested modulator per prescribing guidance.

Provide CFTR genotype confirming drug‑specific responsive mutation (per PI section 12.1 or in‑vitro data)
Prescriber restricted to pulmonology

Documentation Required

DOPTELET: submit platelet counts, prior ITP therapy history, and reauthorization platelet response

For DOPTELET, submit platelet counts and prior therapy history: for procedure‑related thrombocytopenia provide platelet count <50 ×10^9/L; for ITP submit platelet <30 ×10^9/L (or <50 ×10^9/L with bleeding) and documentation of splenectomy and failed ITP therapies; reauthorization for ITP requires platelet improvement ≥50 ×10^9/L after ≥4 weeks on max tolerated dose.

Procedure: platelet count <50 ×10^9/L
ITP: platelet <30 ×10^9/L or <50 ×10^9/L with symptomatic bleeding
Document splenectomy and failed ITP therapies; provide platelet improvement evidence for reauthorization

Documentation Required

Dupilumab and biologics: submit prior/current therapies and objective disease measures

For dupilumab and other indication‑specific biologics, submit prior and current therapies and objective disease measures appropriate to the indication (e.g., AD BSA ≥10%, asthma FEV1 and eosinophils, COPD spirometry and eosinophils, CRSwNP endoscopy/ polyp evidence, EoE biopsy thresholds).

List prior and current therapies
Provide indication‑specific objective measures (e.g., BSA, FEV1, eosinophil counts, biopsy results)

Documentation Required

Molecular testing and baseline vitals required for mutation‑directed agents (e.g., GAVRETO)

For GAVRETO and other fusion/mutation‑directed agents, submit molecular testing confirming the required alteration (e.g., RET fusion) and baseline vitals such as blood pressure and pregnancy status for females of childbearing potential.

Provide molecular test confirming required mutation/fusion (e.g., RET)
Submit baseline blood pressure and pregnancy status

Documentation Required

MAVYRET: submit HCV confirmation, cirrhosis status, and HBV testing

For MAVYRET, include laboratory confirmation of HCV, cirrhosis status, and HBV testing (HBsAg and anti‑HBc) when submitting PA requests.

Submit HCV laboratory confirmation and baseline HCV RNA
Document cirrhosis presence and compensation status
Confirm HBV testing completed (HBsAg and anti‑HBc)

Documentation Required

Mepolizumab: submit lung function and eosinophil documentation

Mepolizumab requests must include diagnosis, pre‑bronchodilator FEV1, and blood eosinophil counts meeting the specified thresholds; document inadequate control on inhaled corticosteroid plus another controller and confirm specialty prescriber.

Pre‑BD FEV1 and blood eosinophil count (e.g., ≥150 cells/mcL within 6 weeks or ≥300 within 12 months)
Document failed controller therapy and that mepolizumab will be added to chronic therapies
Prescriber restricted to listed specialties

Documentation Required

ORSERDU: submit premennopausal attestation, pregnancy status, and liver tests; duration capped

ORSERDU documentation must include diagnosis, attestation patient is premenopausal where applicable, pregnancy status for females of childbearing potential, and liver function information; follow specified duration limits per indication and do not approve therapy beyond 2 years.

Submit diagnosis and premennopausal attestation where applicable
Provide pregnancy status and liver function testing/Child‑Pugh score
Observe indication‑specific duration limits; therapy >2 years not approved

Denial Risk

No PA may cause coverage denial

If no prior authorization is obtained when 'PA' is required on the formulary, the request may be denied and the drug may not be covered.

Obtain PA before dispensing to avoid denial of coverage

Denial Risk

ARIKAYCE denial risk if failed MAC regimen or post‑treatment culture missing

For ARIKAYCE, include documentation that a multi‑drug MAC regimen (ethambutol, a macrolide, and a rifamycin) was tried and failed for at least 6 months and provide a positive sputum culture obtained after that regimen; missing this documentation risks denial.

Document ≥6‑month failed multi‑drug MAC regimen (ethambutol + macrolide + rifamycin)
Submit positive post‑treatment sputum culture

Denial Risk

CERDELGA: exclude ultra‑rapid CYP2D6 metabolizers (genotype required)

Do not approve CERDELGA for patients who are ultra‑rapid CYP2D6 metabolizers — submit CYP2D6 genotype testing and exclude ultra‑rapid metabolizers.

Provide CYP2D6 genotype testing
Exclude ultra‑rapid CYP2D6 metabolizers from coverage

Denial Risk

CAMZYOS: exclusion if cardiac parameters not met (LVEF <55% or missing LVOT/LV thickness)

CAMZYOS requests will be denied if cardiac parameter exclusions are present; verify LVEF is ≥55%, LVOT gradient and LV wall thickness meet thresholds, and provide required cardiac attestations.

Ensure LVEF ≥55%
Provide LVOT gradient ≥50 mmHg and LV wall thickness per criteria
Attest NYHA II–III symptoms and supply required cardiac documentation

Denial Risk

CABLIVI: recurrence exclusion — >2 recurrences on caplacizumab disqualifies non‑first use

CABLIVI will not be authorized for non‑first use patients who had more than 2 recurrences of aTTP while on caplacizumab; include prior recurrence history when applicable.

If non‑first use, document prior aTTP recurrences while on caplacizumab
Do not approve if >2 recurrences on caplacizumab

Denial Risk

Exclude therapy when dual strong CYP3A4/P‑gp interaction present

Avoid coadministration with dual strong CYP3A4 and P‑gp inhibitors/inducers for products listing that interaction (e.g., LYTGOBI, everolimus examples); such coadministration is an exclusion and will lead to denial.

Check for dual strong CYP3A4/P‑gp inhibitors or inducers before approval
Deny coverage if coadministration contraindicated per product

Denial Risk

Verify and document absence of clinical exclusion conditions (pregnancy, severe hepatic/renal impairment)

Clinical exclusions commonly trigger denial: pregnancy, severe hepatic impairment (Child‑Pugh C), severe renal impairment (eGFR <30 mL/min/1.73 m2), uncontrolled hypertension, or other product‑specified contraindications — verify and document absence of these conditions or provide rationale.

Confirm pregnancy status for females of childbearing potential
Check liver function/Child‑Pugh class and renal function (eGFR)
Identify and document contraindicated comedications or comorbidities

Denial Risk

GLP‑1: off‑label weight‑management excluded; document diabetes diagnosis per criteria

Do not approve GLP‑1 agonists for off‑label weight‑management under Medicare Part D; document type 2 diabetes per criteria when submitting requests for diabetes indications.

GLP‑1 products will not be approved for weight management under Medicare Part D
For diabetes, submit documentation meeting diagnostic criteria (e.g., HbA1c ≥6.5% or glucose thresholds)

Denial Risk

HAE acute‑attack requests excluded for some products — follow prophylaxis criteria

Requests for acute HAE attack therapy are excluded for specified HAE products; for prophylactic HAE therapy, follow product‑specific prophylaxis criteria and prior therapy requirements.

Acute HAE attack requests may be excluded for some products
For prophylaxis, submit objective disease burden and prior prophylactic therapy history as required

Denial Risk

JUXTAPID: will not be approved for HeFH; submit HoFH genetic/functional criteria and labs

Do not approve JUXTAPID for heterozygous familial hypercholesterolemia (HeFH); ensure required genetic/functional LDL receptor criteria and baseline labs are submitted for HoFH candidates.

JUXTAPID not approved for HeFH
Submit functional LDL receptor mutation documentation or fibroblast activity <20% and baseline lipid/liver labs for HoFH candidates

Denial Risk

Lidocaine patch: limit to FDA‑approved postherpetic neuralgia

Lidocaine patch requests for indications other than FDA‑approved postherpetic neuralgia will not be approved; ensure indication matches FDA‑approved use.

Approve only for FDA‑approved postherpetic neuralgia indication

Denial Risk

LODOCO: excluded for gout

LODOCO (example) will not be authorized for gout — do not submit requests for excluded indications.

Exclude off‑label gout use from PA submissions for LODOCO

Denial Risk

MAVYRET: exclude Child‑Pugh B/C and specified drug interactions

MAVYRET exclusions include moderate/severe hepatic impairment (Child‑Pugh B/C) and specified drug interactions (e.g., rifampin, atazanavir); do not submit PA requests if these exclusions apply.

Do not use in Child‑Pugh B or C
Avoid coadministration with rifampin or atazanavir

Denial Risk

Mepolizumab denial risk if lung function, eosinophils, or prior controller therapy not documented

For mepolizumab, missing required clinical documentation (lung function, eosinophil counts, prior inhaled‑corticosteroid‑based controller therapy, and specialty prescriber) may lead to denial — include all required data.

Provide pre‑BD FEV1 and eosinophil counts per thresholds
Document prior inhaled corticosteroid + another controller trial and specialist prescriber

Denial Risk

ORSERDU: check for pregnancy, severe hepatic impairment, osteoporosis, and OATP1B1 interactions

ORSERDU exclusion triggers include pregnancy, Child‑Pugh C hepatic impairment, known osteoporosis, and coadministration with OATP1B1 inhibitors — verify and document absence of these triggers.

Confirm no pregnancy and assess liver function/Child‑Pugh class
Do not approve if patient has osteoporosis or is on interacting OATP1B1 inhibitors

Denial Risk

Oncology agent denials when tumor marker testing or prior therapy documentation missing

Oncology agent requests may be denied if primary tumor testing does not confirm required markers (e.g., ER+/HER2‑/ESR1‑mutated); include tumor testing and prior therapy documentation.

Provide tumor testing confirming required biomarker profile
Document prior endocrine or systemic therapies tried and failed

Denial Risk

Recorlev: exclusion triggers include cirrhosis, high AST/ALT, prolonged QTcF, and QT‑prolonging drugs

Recorlev requests may be denied for cirrhosis, baseline AST/ALT >3× ULN, prolonged QTcF >470 msec, or coadministration with QT‑prolonging drugs — ensure these exclusions are evaluated and documented.

Exclude cirrhosis or extensive liver disease and AST/ALT >3× ULN
Provide baseline QTcF and avoid QT‑prolonging coadministrations

Denial Risk

RETACRIT/RETEVMO: avoid uncontrolled hypertension and strong CYP3A inducers

RETACRIT/RETEVMO examples: confirm no uncontrolled hypertension and avoid coadministration with strong CYP3A inducers per product entries to prevent denial.

Evaluate blood pressure control before approval
Avoid strong CYP3A inducers as coadministration exclusions

Denial Risk

RIVFLOZA: exclude if eGFR <30 mL/min/1.73 m2

RIVFLOZA is excluded for eGFR <30 mL/min/1.73 m2; confirm renal function and do not approve if eGFR is below threshold.

Provide eGFR and exclude therapy if eGFR <30 mL/min/1.73 m2

Denial Risk

Deny when product‑specific exclusion criteria are present (electrolyte, BP, interactions)

If product‑specific exclusion criteria are present (e.g., uncorrected hypokalemia/hypomagnesemia, severe/uncontrolled hypertension, interacting drugs), the request should be denied — identify and document these exclusions before submitting PA.

Screen for and document any product‑specific exclusions prior to PA submission
Deny requests when exclusions are present

Denial Risk

Tolvaptan: exclusion for inability to sense thirst, hypovolemia, anuria, or strong CYP3A interactions

Tolvaptan requests: deny if patient cannot sense/respond to thirst, is hypovolemic or anuric, or if strong CYP3A inhibitors/inducers or desmopressin are coadministered.

Confirm patient can sense/respond to thirst and is not hypovolemic/anuric
Avoid coadministration with strong CYP3A inhibitors/inducers or desmopressin

Denial Risk

Do not request therapy beyond product maximum durations (e.g., >2 years)

Requests for therapy beyond product‑specified maximum durations (e.g., >2 years where noted) will not be approved; ensure duration limits are observed in PA and reauthorization requests.

Adhere to product‑specific maximum therapy durations (do not request >2 years where prohibited)

Denial Risk

Exclude when QTcF exceeds product‑specific thresholds; include ECG/QTcF

Do not approve when QTcF interval exclusion thresholds are exceeded (product‑specific thresholds such as >450 msec or >470 msec apply); include ECG/QTcF in submissions when required.

Provide ECG including QTcF and exclude if QTcF exceeds product threshold (e.g., >450 or >470 msec)

Documentation Required

HFrEF: document background RAS inhibitor, beta‑blocker, and MRA regimen or rationale if omitted

For HFrEF agents, document the required background regimen (RAS inhibitor, beta‑blocker, MRA each at maximally‑tolerated doses) or provide rationale/contraindication if components are not used.

Submit current HFrEF regimen showing RAS inhibitor, beta‑blocker, and MRA at maximally‑tolerated doses or documented contraindications

Denial Risk

PAH: include hemodynamics and background PAH therapy or risk denial

For PAH products, failure to document background PAH therapy (drugs in at least two pathway classes) or hemodynamic criteria (PCWP ≤15 mm Hg and PVR ≥5 Wood units), WHO/NYHA class II–III, baseline 6‑minute walk and BNP/NT‑proBNP may lead to denial.

Submit PCWP and PVR hemodynamics and background PAH medications (≥2 classes unless contraindicated)
Provide WHO/NYHA class II–III, baseline 6MWD, and BNP/NT‑proBNP

Denial Risk

HE: require documentation of prior lactulose trial and failure before rifaximin approval

For hepatic encephalopathy (HE), lack of documentation of prior trial and failure of lactulose may lead to denial for rifaximin PA requests.

Document prior lactulose trial and failure for HE requests involving rifaximin

Initial Therapy Criteria — Authorization Logic

Continuation and Reauthorization Criteria

Step Therapy — Prior Trials and Failures Required

Drug / Step	Step Therapy Requirement	Notes
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Drug Group	Required Preferred-Agent Trial	Exceptions / Notes
Biologics / Immunomodulators (managed by this policy)	Patient must have tried and had inadequate response to or intolerance to at least two preferred agents (adalimumab biosimilar, Cosentyx, Enbrel, Humira, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz/XR) for the submitted indication before approval.	Otezla and Velsipity are exempt from the preferred-agent requirement; baseline latent TB screening required for most drugs; PA applies to all.

Drug/Class	Required Trial(s) Before CGRP Prevention Agent	Reauthorization / Notes
CGRP monoclonal antibodies for migraine prevention	Patient must have tried and failed at least two non‑CGRP FDA‑approved or compendial alternatives for migraine prevention (examples: propranolol, timolol, topiramate, valproic acid, amitriptyline, atenolol). One alternative required if contraindications to others exist.	Episodic migraine limited to <15 headache days/month; Emgality requires prior failure of Aimovig and Ajovy; initial trial period 3 months then 1 year for reauthorization with documented improvement.

Drug / Indication	Prior Antipsychotic Trials Required	Notes
Antipsychotic agents for schizophrenia (policy entry)	Approval requires failure or intolerance to aripiprazole and at least one other generic second‑generation atypical antipsychotic.	Prescriber restriction: psychiatry; PA applies to new starts only; age ≥18.

Scenario	Step Therapy Rule	Examples / Notes
General rule	Prior therapies must have been tried and failed or be contraindicated/intolerant before initiating the requested agent.	Examples: PNH agents require failure/intolerance to C5 inhibitors (eculizumab or ravulizumab); IgA nephropathy agents require trial of maximally‑tolerated ACE inhibitor/ARB prior to therapy.

Reference Product	Step Requirement	Exceptions / Notes
Neupogen (filgrastim)	For all indications other than Hematopoietic Syndrome of Acute Radiation Syndrome, patient must have tried and had inadequate response to or intolerance to Zarxio (filgrastim biosimilar) prior to Neupogen approval.	Coverage and Part B vs D determination may depend on administration setting and how drug is obtained; PA applies as noted.

Products	Prior Trial / Failure Requirement	Notes
Selected products with step requirements	Certain products require documented trial and failure (or intolerance/contraindication) of specific prior therapies before approval — e.g., Haegarda requires prior failure/intolerance to Takhzyro for patients ≥12 years, and other products list similar prerequisites.	Prescriber restrictions, documentation of prior therapies, and Part B/Part D site‑of‑care considerations apply per product.

Step 1 Example	Required Prior Therapies / Conditions	Product Notes
Hematology/Oncology and specialty examples	Many specialty agents require prior lines of therapy or specific prior agents: e.g., JAYPIRCA requires failure of at least two prior systemic therapy lines (with BTK/BCL‑2 specifics by diagnosis); JUXTAPID requires trial/intolerance/contraindication to evolocumab; certain oncology agents require prior progression on defined prior systemic regimens.	PA generally applies to new starts only; age and prescriber restrictions vary by product; coverage durations commonly 1 year (some initial shorter periods specified).

Therapy Area	Prior Trials Required	Notes
Insomnia / related CNS indications	Patient must have tried and failed or been intolerant to two covered alternative therapies recommended by AASM (examples include doxepin, eszopiclone, ramelteon, suvorexant, temazepam, zaleplon, zolpidem), including one non‑suvorexant for sleep maintenance when applicable.	PA applies to new starts only for older patients per entry; coverage duration 1 year.

Class / Product	Step Requirement	Details
PCSK9 inhibitors (Repatha, Praluent)	Patient must be currently using a statin plus ezetimibe OR have tried/failed at least two statins (or one statin plus ezetimibe) prior to PCSK9 initiation.	At least one previously tried statin should be hydrophilic where specified; documentation of prior statin therapy required.

Drug	Prior Wake‑Promoting Agents Required	Notes
Narcolepsy agents (policy entries e.g., pitolisant, solriamfetol coverage rules)	For adults with excessive daytime sleepiness associated with narcolepsy: must have tried and had inadequate response, intolerance, or contraindication to armodafinil or modafinil; for pitolisant authorization adults must try and fail armodafinil/modafinil and solriamfetol (as applicable).	Prescriber restrictions: neurology/sleep medicine; PA applies to all or new starts as specified; coverage duration commonly 1 year.

Drug	Prior ITP Therapies Required	Notes
Tavalisse (fostamatinib)	Approval requires documentation patient has tried and failed two different ITP therapies (examples: systemic corticosteroids, IVIG, danazol, fostamatinib, cytotoxics/immunosuppressants such as rituximab) and/or splenectomy prior to initiation.	Initial coverage 12 weeks then 1 year; documentation of platelet improvement required for reauthorization.

Condition	Required Prior Therapies	Notes
Primary IgA nephropathy	Initial authorization requires patient currently using (or with contraindication to) a maximally‑tolerated ACE inhibitor or ARB AND tried and failed or had intolerance to at least one SGLT‑2 inhibitor (eg dapagliflozin, empagliflozin).	Submit biopsy confirmation and 24‑hour urine protein ≥1 g/day or UPCR ≥0.8 g/g; reauthorization requires documentation of clinically relevant response (stabilization or improvement of UPCR).

Drug	Prior Trials Required	Notes
Pitolisant (for adult narcolepsy)	Authorization only if patient previously tried and had inadequate response, intolerance, or contraindication to armodafinil/modafinil and solriamfetol.	Updated serum potassium and magnesium may be required for reauthorization; prescriber restriction to neurology/sleep medicine; PA applies to all.

Requirement	Description	Policy Note
Documentation of prior therapies	Where specified in product entries, prior therapies must be documented as tried and failed, intolerant, or contraindicated before the requested therapy will be approved.	Examples: HE requires prior lactulose failure before rifaximin; IBS‑D requires failure of antidiarrheals/antispasmodics/TCA; SIBO requires positive breath test and failure of ≥2 antibiotics.

Quantity Limits and Refill Restrictions

inv-311: XIFAXAN 550 mg — IBS-D and SIBO course limits

XIFAXAN 550 mg — IBS-D course limitsMaximum three 14-day courses per patient's lifetime

XIFAXAN 550 mg — SIBO course limitsMaximum two 14-day courses per 365 days

Prior therapy requirementsIBS-D: try at least one antidiarrheal/antispasmodic/tricyclic; SIBO: positive breath test and failure of ≥2 antibiotics

inv-312: XOLAIR (food allergy) — not approved if patient is using Palforzia

XOLAIR (food allergy) exclusionNot approved if patient is using Palforzia

DocumentationSubmit prior therapy and current use of Palforzia to verify ineligibility for food allergy indication

Continuation requirementFood allergy reauthorization requires attestation of continued medical necessity

inv-313: ZURZUVAE — one 14-day course per plan year

ZURZUVAE quantity limitOne 14-day course per plan year

Indication windowFor postpartum depression within 12 months postpartum

ExclusionsNot for use during current pregnancy, bipolar disorder, schizophrenia, or schizoaffective disorder

Site of Care — Part B vs Part D Determinations

Note

Biosimilar Requirements and Step Rules

Note

Definitions and Clinical Terms

inv-238: WHO Group 1 (PAH) definition

WHO Group 1 (PAH) definitionPulmonary arterial hypertension confirmed by right heart catheterization

Age requirementPatients must be 18 years or older for ADEMPAS-related PAH indications

DocumentationSubmit right heart catheterization hemodynamics when WHO Group 1 PAH is claimed

inv-239: Refractory MAC — definition

Refractory MAC definitionFailure of a multi-drug MAC regimen (eg ethambutol, a macrolide, and a rifamycin) over at least a 6-month trial and positive sputum culture after treatment

Prescriber restrictionPrescriber must be infectious diseases or pulmonology for ARIKAYCE

DocumentationSubmit treatment history of multi-drug regimen and post-treatment sputum culture

inv-240: Symptomatic COPD — mMRC/CAT thresholds

Symptomatic COPD definition (dupilumab)mMRC dyspnea scale >=2 OR COPD Assessment Test (CAT) score >=10

Spirometry criteriaPost-bronchodilator FEV1/FVC <0.7 with FEV1 30–70% predicted where specified

Therapy requirementPatient must be on stable triple inhaler regimen or have documented contraindication/intolerance

inv-241: EoE confirmation — biopsy criteria

EoE confirmation criteriaUpper endoscopy with biopsy showing >=15 eosinophils per high-power field (or 60 eosinophils/mm2)

Prior therapy requirementDocumentation of failed at least 8-week PPI course to exclude GERD-related eosinophilia

Age restrictionMany EoE entries specify age >=11 years for certain products

inv-242: Primary biliary cholangitis (PBC) — definition

Primary biliary cholangitis (PBC) definitionEither elevated alkaline phosphatase (ALP) above the upper limit of normal OR histological evidence on liver biopsy

Required prior therapyDocumentation that elafibranor will be used with UDCA or that patient is intolerant to UDCA

Baseline testsSubmit baseline LFTs, ALP, and total bilirubin

inv-243: Type 2 diabetes confirmation — acceptable evidence

Type 2 diabetes confirmation — acceptable evidenceMedical record/chart notes, ICD-10 on claims, or laboratory results (HbA1c >=6.5% or qualifying glucose thresholds)

AttestationProvider must attest patient is not receiving another GLP-1 agonist when indicated

DocumentationSubmit HbA1c or qualifying glucose tests when required for authorization

inv-244: Homozygous familial hypercholesterolemia (HoFH) criteria

HoFH criteriaDocumented functional mutation(s) in both LDL receptor alleles OR skin fibroblast LDL receptor activity <20% OR untreated total cholesterol >500 mg/dL with parental criteria

Required labsSubmit baseline LDL-C, TC, apoB, non-HDL-C, and liver tests for JUXTAPID evaluation

Prescriber restrictionSpecialist in cardiology, lipidology, or endocrinology experienced in lipid management

inv-245: HCV baseline requirements — genotype, baseline RNA, cirrhosis status, HBV testing

HCV baseline requirementsLaboratory confirmation of HCV genotype and baseline HCV RNA; documentation of cirrhosis status (compensated vs decompensated); HBV testing (HBsAg and anti-HBc) completed

Treatment duration guidanceCoverage duration applied per AASLD-IDSA guidance or product-specific rules (eg 8–24 weeks)

DocumentationSubmit genotype, baseline HCV RNA, cirrhosis status, and HBV test results

inv-247: 24-hour urine free cortisol (UFC) — definition and use

24-hour urine free cortisol (UFC) — definition and useLaboratory test documenting baseline cortisol excretion; required baseline >1.5x upper limit of normal for Recorlev authorization

Complementary testingECG including QTcF and liver function tests within 3 months are required with UFC for Cushing's syndrome evaluations

DocumentationSubmit UFC result and prior therapy history (eg failure of mifepristone, osilodrostat) when requesting Recorlev

inv-248: Platelet count thresholds (ITP) — initial approval thresholds

Platelet count thresholds for ITP (initial approval)< 30 x 10^9/L OR < 50 x 10^9/L with documented increased bleeding risk

Initial approval documentationSubmit platelet count and prior therapies tried/failed (eg corticosteroids, IVIG, danazol, fostamatinib, rituximab) or splenectomy

Reauthorization metricImprovement in platelet count required for reauthorization (specified per agent)

inv-252: Optimized HFrEF therapy — definition of required background regimen

Optimized HFrEF therapy — required background regimenRenin-angiotensin system inhibitor, beta-blocker, and mineralocorticoid receptor antagonist each at maximally-tolerated doses

Clinical contextRequired when initiating Verquvo for HFrEF; if not used, prescriber must document contraindication or intolerance

DocumentationSubmit current HFrEF regimen, LVEF (<45%), and recent hospitalization or IV diuretic use evidence

Policy Summary

PayerIndependent Health

PolicyMedicare Part D Prior Authorization Criteria (selected formulary drugs)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2025

Last ReviewJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization before dispensing for drugs listed with 'PA' on the 2025 Medicare Advantage C‑SNP Part D formulary to avoid denial.

SourceLink

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Policy Summary

PayerIndependent Health

PolicyMedicare Part D Prior Authorization Criteria (selected formulary drugs)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2025

Last ReviewJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization before dispensing for drugs listed with 'PA' on the 2025 Medicare Advantage C‑SNP Part D formulary to avoid denial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2025formulary year

MA C-SNP Part Daffected formulary

PAdesignation

1 yrtypical duration

~150distinct entries

Coverage Criteria — Product-level Requirements

OHTUVAYRE Initial Therapy

Covered when ALL of the following are met

Spirometry and attestation required; Part B vs Part D determination may be requested.

ADEMPAS Initial Therapy

Covered when ALL of the following are met

Right heart catheterization required for WHO Group 1 PAH documentation.

Alpha-1 PI Augmentation Criteria

Covered when ALL of the following are met

Individuals with IgA deficiency who have known anti-IgA antibodies are excluded.

ARIKAYCE Initial Therapy

Covered when ALL of the following are met

Failure of ≥6 months multi-drug regimen and post-treatment positive sputum culture required.

Biologics Preferred-agent Step Requirement

Covered when ALL of the following are met

Otezla and Velsipity exempt from this preferred-agent requirement.

CAMZYOS Initial Therapy

Covered when ALL of the following are met

Submit LVEF and prior/current therapy documentation.

CERDELGA Genotype-restricted coverage

Covered when ALL of the following are met

Do not approve for ultra-rapid CYP2D6 metabolizers.

DOPTELET Indication-specific criteria

Covered when ALL of the following are met

For ITP reauthorization, documentation of platelet improvement ≥50 x 10^9/L after ≥4 weeks on max tolerated dose required.

ITP and procedure-related thrombocytopenia

Covered when ALL of the following are met

Maintenance requires platelet improvement ≥50 x10^9/L after treatment.

Dupilumab coverage

Covered when indication-specific objective criteria are met

Submit disease-specific objective measures and prior therapy documentation.

Neupogen step requirement

Covered when ALL of the following are met

Biosimilar trial required except for radiation syndrome indication.

Initial Authorization (generalized)

Covered when ALL of the following are met for each specific product as detailed below:

See individual product entries for exact test/type and timing requirements.

Refer to product-specific chunk for exact age/prescriber restrictions.

Examples appear in product-specific criteria (eg eGFR <30, QTcF thresholds, CYP interactions).

See each product for initial duration and reauthorization timing.

Product-specific lab and prior therapy lists available in corresponding entries.

JUXTAPID Initial Therapy

JUXTAPID (lomitapide) approval requires ALL of the following:

Baseline liver tests required and LDL response required for continuation.

Kisqali Initial Therapy

Kisqali (ribociclib) approval requires ALL of the following:

Baseline ECG and electrolytes required.

Ledipasvir-sofosbuvir Coverage Criteria

Ledipasvir-sofosbuvir (HCV) approval requires ALL of the following:

Adhere to AASLD-IDSA guidance for duration as applicable.

MAVYRET Coverage Criteria

MAVYRET (glecaprevir/pibrentasvir) approval requires ALL of the following:

Do not use in Child-Pugh B or C or with contraindicated concomitant drugs.

KERENDIA Coverage Criteria

KERENDIA (finerenone) approval requires ALL of the following for chronic kidney disease associated with type 2 diabetes:

For HF indication additional LVEF documentation required as specified.

JAYPIRCA Coverage Criteria

JAYPIRCA (pirtobrutinib) approval requires ALL of the following:

Provide prior therapy history and rationale for JAYPIRCA use.

LYTGOBI - Initial Therapy

Covered when ALL of the following are met

FGFR2 fusion/rearrangement testing required for coverage.

MAVYRET - Coverage Criteria

Covered when ALL of the following are met

Provider must submit HCV genotype and baseline HCV RNA per product guidance.

Mepolizumab - Indication-Specific Criteria

Covered when ALL indication-specific criteria are met

Submit baseline lung function and eosinophil counts as required.

ORSERDU — Coverage and Duration

Covered when ALL of the following are met

Provide indication-specific duration and liver function information.

Oncology agents with tumor testing requirement

Covered when ALL of the following are met

Provide tumor testing and prior therapy history per product.

Eltrombopag — Indication-specific criteria

Covered when ALL of the following are met

Submit prior therapy history and platelet counts.

Recorlev (levoketoconazole) — Coverage criteria

Covered when ALL of the following are met

ECG and LFTs required within 3 months prior to request.

Oncology product initial therapy

Covered when ALL of the following are met for oncology kinase inhibitor products (example):

Provide prior therapy history and baseline cardiovascular testing as required.

Recorlev initial and continuation

Covered when ALL of the following are met for Recorlev:

Exclusion triggers include cirrhosis, AST/ALT >3× ULN, prolonged QTcF >470 msec.

Relistor initial therapy

Covered when ALL of the following are met for Relistor products:

Submit prior therapy details and opioid use documentation where applicable.

Retacrit initial therapy

Covered when ALL of the following are met for Retacrit:

Submit iron studies and hemoglobin level with request.

RIVFLOZA initial and continuation

Covered when ALL of the following are met for RIVFLOZA:

Provide genetic/biochemical confirmation and renal function.

SCEMBLIX initial therapy

Covered when ALL of the following are met for SCEMBLIX:

Provide mutation testing and prior TKI history.

General product criteria (illustrative)

Coverage requires meeting all listed product-specific criteria (examples shown below).

This node is illustrative — consult the product-specific entry for exact requirements.

ATTR cardiomyopathy

Covered when ALL of the following are met

Provide diagnostic confirmation by imaging/biopsy or genetic testing.

Tavalisse (fostamatinib)

Covered when ALL of the following are met

Submit prior therapy history and platelet counts.

Tolvaptan

Covered when ALL of the following are met

Initiate where sodium monitoring is feasible; limited duration to mitigate hepatic risk.

Teriparatide/TYMLOS

Covered when ALL of the following are met

Provide prior bisphosphonate trial documentation and baseline calcium.

Vanflyta

Covered when ALL of the following are met

Correct electrolytes prior to initiation and provide ECG.

Initial Therapy

Covered when ALL of the following are met

Submit biopsy and prior therapy documentation.

HFrEF (Verquvo)

Covered when ALL of the following are met

Provide hospitalization/IV diuretic documentation and optimized background therapy.

Wegovy (semaglutide) indications

Covered when ALL of the following are met for indicated Wegovy uses

Submit cardiovascular disease documentation for MACE and fibrosis staging for MASH.

Pulmonary arterial hypertension

Covered when ALL of the following are met

Right heart catheterization data typically required to document hemodynamics.

VIVJOA

Covered when ALL of the following are met

Provide eGFR and menopausal/infertility status documentation.

Product-specific PA criteria (selected entries)

Covered when ALL product-specific documentation, prescriber, age, and other listed criteria are met.

Provide genetic testing and prior therapy documentation as applicable.

Submit prior therapy history and breath test results for SIBO.

Provide indication‑specific objective measures.

Submit baseline hematologic labs and mutation testing.

Coding, Clinical Thresholds and Lab Criteria

Listed products (partial segment)mixed

No codes listed

Document markers/datesmixed

12/1/2025

date marker appearing in product list

inv-85: LV outflow tract obstruction gradient — numeric threshold key/value

LV outflow tract obstruction gradient>= 50 mmHg

Measurement conditionsMeasured at rest, with Valsalva, or after exercise

Supporting documentationSubmit cardiology report documenting gradient at time of evaluation

inv-86: LV wall thickness — numeric threshold key/value

Left ventricular (LV) wall thickness>= 15 mm (or >= 13 mm if familial)

ContextRequirement applies to hypertrophic cardiomyopathy assessment for CAMZYOS

DocumentationSubmit imaging report (echocardiography or MRI) verifying maximal wall thickness

inv-87: QTcF interval — numeric threshold key/value

QTcF interval threshold (treatment initiation)<= 450 msec (QTcF >=450 msec is an exclusion for some products)

Contraindication noteProlonged QTcF (eg >470 msec) contraindicates therapy for select agents (see product-specific criteria)

Required testingSubmit baseline ECG including QTcF prior to initiation when specified

inv-88: ANC threshold — numeric threshold key/value

Absolute neutrophil count (ANC) requirement> 1.5 x 10^9/L

ExclusionRequests excluded if ANC is below 1.5 x 10^9/L

DocumentationSubmit recent ANC as part of baseline labs for affected products

inv-89: Platelet count for procedure — key/value

Platelet count for procedure-related thrombocytopenia< 50 x 10^9/L

Use caseApply when patient with chronic liver disease is scheduled to undergo a procedure

DocumentationSubmit platelet count prior to authorization for procedural use

inv-90: Platelet count for ITP — key/value

Platelet count threshold for ITP initial approval< 30 x 10^9/L (or < 50 x 10^9/L with symptomatic bleeding)

Prior therapy requirementDocumentation of splenectomy and/or failure of two different ITP therapies required

Reauthorization metricImprovement to >=50 x 10^9/L after >=4 weeks on max tolerated dose required for reauthorization

inv-93: Atopic dermatitis extent (BSA ≥10%) — key/value

Atopic dermatitis extent (BSA) for dupilumab>= 10% body surface area involvement

Supporting requirementPatient must have tried a moderate-strength topical corticosteroid for at least 4 weeks unless contraindicated

DocumentationSubmit dermatology notes documenting BSA and prior topical therapy

inv-94: Asthma pre-bronchodilator FEV1 threshold — key/value

Asthma pre-bronchodilator FEV1 threshold< 80% predicted in adults (or < 90% if under 18)

Additional asthma criteriaRequire blood eosinophil count >=150 cells/mcL within 6 weeks or daily OCS dependence

DocumentationSubmit pre-bronchodilator FEV1 and recent eosinophil count prior to authorization

inv-95: COPD eosinophil threshold — key/value

COPD blood eosinophil threshold for dupilumab>= 300 cells/mcL within 6 weeks of therapy initiation

COPD spirometry requirementPost-bronchodilator FEV1/FVC <0.7 and FEV1 30–70% predicted

Symptom requirementPatient must be symptomatic (mMRC >=2 or CAT >=10) despite optimized therapy

inv-96: Filgotinib/IgAN urine protein threshold — key/value

Filgotinib / IgAN proteinuria threshold24-hour urine protein >= 1 g/day OR UPCR >= 0.8 g/g

ContextRequired for initial authorization in IgA nephropathy indications

DocumentationSubmit 24-hour urine protein or UPCR result with biopsy-confirmed diagnosis

inv-97: IgAN proteinuria threshold for fabhalta — key/value

IgAN proteinuria threshold for FABHALTA24-hour UPCR >= 1.5 g/g

ContextApplies to patients evaluated for specific IgAN therapy where FABHALTA criteria referenced

DocumentationSubmit 24-hour UPCR measurement and biopsy confirmation as required

inv-98: eGFR threshold — key/value

eGFR threshold (exclusion)less than 30 mL/min/1.73 m2 is an exclusion for select products

Product examplesApplies to agents with renal function limits (eg GALAFOLD, RIVFLOZA) — check product-specific criteria

DocumentationSubmit most recent eGFR or creatinine clearance to support authorization

inv-100: Hemoglobin A1c threshold — key/value

Hemoglobin A1c threshold for type 2 diabetes confirmation>= 6.5%

Acceptable evidenceMedical record, chart notes, ICD-10 on claims, or lab results demonstrating HbA1c >=6.5% or qualifying glucose values

DocumentationSubmit recent HbA1c or qualifying glucose test when required for GLP-1 or diabetes-related approvals

inv-101: Age restrictions (many oncology drugs) — key/value

Typical age restriction for many oncology drugs18 years of age or older

Pediatric exceptionsSome products specify other minimum ages (eg pediatric oncology agents) — see product-specific entries

Prescriber restrictionMost oncology agents require oncology prescriber specialty for approval

inv-107: Mepolizumab eosinophil thresholds — key/value

Mepolizumab eosinophil thresholds>=150 cells/mcL within 6 weeks of therapy initiation OR >=300 cells/mcL within 12 months

Indication-specificityThresholds vary by mepolizumab indication (asthma, EGPA, HES); submit most recent eosinophil counts per indication requirements

DocumentationProvide blood eosinophil counts obtained within the specified timeframe when requesting authorization

inv-109: 24-hour urine free cortisol (UFC) baseline threshold — key/value

24-hour urine free cortisol (UFC) baseline thresholdBaseline > 1.5 times the upper limit of normal (50 micrograms or 145 nmol)

Use caseRequired for initial authorization of Recorlev for Cushing's syndrome

Supporting testsSubmit ECG including QTcF and LFTs within 3 months along with 24-hour UFC

Provider Actions — Prior Authorization, Documentation, Denial Triggers

Prior Authorization

Obtain prior authorization before dispensing

Prior Authorization

Bronchitol: provide passed tolerance test and pulmonologist prescriber

Document passed Bronchitol Tolerance Test
Prescriber must be pulmonologist
Applies to new starts only; coverage duration 1 year

Prior Authorization

CABLIVI: submit diagnosis, concurrent plasma exchange/immunosuppression, and prescriber info

Confirm treatment given with plasma exchange and immunosuppression
Prescriber restricted to cardiology, hematology, or immunology; age ≥18
PA applies to all; coverage duration 3 months; recurrence >2 on caplacizumab excludes approval

Prior Authorization

CF modulators: submit CFTR mutation test and pulmonology prescriber

Provide drug‑specific CFTR mutation test result (per PI section 12.1 or in‑vitro data)
Prescriber must be pulmonology
PA applies to new starts only; usual duration 1 year

Prior Authorization

Digoxin: age- and dose-based PA (≥65 years)

For digoxin in patients aged ≥65, PA applies unless prescribed by cardiology or dose is ≤0.125 mg/day. Include updated creatinine clearance for annual reauthorization.

PA applies to patients ≥65 years
PA not required if prescriber is cardiology
PA not required for doses ≤0.125 mg/day; submit updated creatinine clearance for reauthorization

Prior Authorization

Dronabinol (SYNDROS): age, prescriber, and duration requirements

Patient age ≥18
Prescriber restrictions apply
Follow indication‑specific coverage durations (e.g., 5 days for procedure use; ITP: 6 months initial then 1 year)

Prior Authorization

Dupilumab: specialist prescriber, initial 6 months then annual reauthorization with objective response

Specialist prescriber required (listed specialties)
Initial 6 months then annual reauthorization
Submit objective disease measures (e.g., AD BSA ≥10%, asthma FEV1/eosinophils, COPD spirometry/eosinophils, CRSwNP/endoscopy findings) for continuation

Prior Authorization

PA commonly applies to new starts only — expect 1‑year authorizations

PA generally applies to new treatment starts for many products listed in this formulary; when noted, the typical coverage duration is 1 year.

Confirm request is for a new start when PA applies to new starts only
Expect typical authorization duration of 1 year unless product specifies otherwise

Prior Authorization

When PA is for new starts: document new‑start status and expect 1‑year durations

For products where PA applies to new starts, ensure the initial request documents prior treatment status; many oncology and diabetes drugs specify a 1‑year coverage period on approval.

Document whether patient is a new start
Anticipate 1‑year coverage duration for listed oncology/diabetes products

Documentation Required

IVIG: submit diagnosis and indication‑specific labs; PA often for new starts

Provide diagnosis and indication‑specific labs (e.g., platelet counts, IgG)
Note PA applies to new starts only for many IVIG indications
Coverage durations: variable (acute/new starts 3 months; chronic renewals commonly 1 year)

Prior Authorization

Confirm new‑start status when PA applies to new starts only

Many listed products require PA for new starts only; confirm the request is for a new start and include the product‑specific initial documentation requested.

Confirm new‑start status
Include product‑specific required documentation

Prior Authorization

LYTGOBI: oncology prescriber, FGFR2 testing, prior therapy, and interaction exclusion

Submit FGFR2 fusion/rearrangement test
Document prior systemic treatments tried
Prescriber must be oncology; patient age ≥18
Exclusion: dual strong CYP3A4/P‑gp inhibitors or inducers

Prior Authorization

MAVYRET: confirm HCV, cirrhosis status, HBV testing; PA applies to all

Provide HCV laboratory confirmation and baseline HCV RNA
Document cirrhosis status and compensation
Confirm HBV testing (HBsAg and anti‑HBc) completed
Do not use in Child‑Pugh B/C or with rifampin/atazanavir coadministration

Prior Authorization

Mepolizumab: specialty prescriber and required lung/eosinophil documentation

Prescriber restricted to listed specialties
Submit pre‑BD FEV1 and blood eosinophil count (≥150 cells/mcL within 6 weeks or ≥300 within 12 months as applicable)
Document inadequate control on inhaled corticosteroid plus at least one other controller
Continuation requires objective clinical response

Prior Authorization

ORSERDU: PA for all uses — submit pregnancy status and liver function; duration limits apply

Submit diagnosis and premennopausal attestation when applicable
Provide pregnancy status for females of childbearing potential
Include liver function testing/Child‑Pugh score
Note duration limits (up to 24 months); therapy >2 years not approved

Prior Authorization

Oncology agents: new‑start PA, oncology prescriber, and tumor testing required

Ensure prescriber is oncology
Provide tumor biomarker testing (e.g., ER+/HER2‑/ESR1, PIK3CA, RET, ALK/ROS1 as applicable)
PA often applies to new starts only; anticipate 1‑year coverage

Prior Authorization

Narcolepsy agents: PA applies to all; prior wake‑promoting agent trials required in adults

PA applies to all formulations; duration 1 year
For adults, document trials and failure/intolerance to armodafinil/modafinil and solriamfetol

Prior Authorization

Oncology product new‑start PA: include prior TKI history and baseline vitals

Many oncology products require PA for new starts only; ensure previous kinase inhibitor exposures and baseline vitals (BP, LVEF) are provided when requested and that prescriber is oncology.

Confirm this is a new start when PA applies to new starts only
Submit prior kinase inhibitor therapy history where specified
Provide baseline BP and LVEF (≥50%) when required

Prior Authorization

Recorlev: baseline UFC, ECG/QTcF, LFTs, and continuation response documentation

Submit 24‑hour UFC >1.5× ULN at baseline
Provide ECG including QTcF and LFTs (within 3 months)
Attest pituitary surgery is not an option or not curative
Initial 6 months then 1 year; continuation requires documented response

Prior Authorization

Relistor: document prior laxative/Movantik failure and ongoing opioid use

Document failure/intolerance to lubiprostone and Movantik
For non‑cancer pain, document stable opioid dose for prior 8 weeks
Confirmation patient remains on opioid required for reauthorization

Note

Follow product‑specific PA scope (new starts vs all uses)

Prior authorization is required as specified per product; confirm whether PA applies to new starts only or to all uses and follow the product‑specific PA scope.

Check product entry to determine whether PA is for new starts only or all uses
Follow product‑specific PA scope and duration

Note

Verify whether PA applies to all patients or new starts only

Some products listed under this policy require PA either for all patients or for new starts as noted — verify the product’s PA scope in the policy before submitting.

Verify whether PA applies to all patients or to new starts only per product entry

Prior Authorization

Oncology new‑start PA: document prior therapies and tumor testing; Part B not usually required

Many oncology products have PA that applies to new starts only and do not require a Part B prerequisite; document prior therapies and tumor testing as instructed.

Document prior systemic therapies and tumor testing as specified
No Part B prerequisite typically required for these new‑start oncology PAs

Prior Authorization

Xolair: 6‑month initial PA then annual; reauthorization requires objective response documentation

Initial 6 months, then annual reauthorization
Submit objective documentation of response for reauthorization
CRSwNP: confirm maintenance intranasal corticosteroid use; food allergy: attest continued medical necessity; not approved if using Palforzia

Note

Index lists only — consult individual drug pages for PA requirements

The index portion lists drug names and page references only and does not by itself specify PA requirements; use the individual drug policy pages for PA actions.

Do not rely on index entries for PA specifics — consult the drug’s policy page

Step Therapy

Preferred‑agent trial: document failure of ≥2 preferred biologics (TB screening required)

Document failed trials of ≥2 preferred agents (adalimumab biosimilar, Cosentyx, Enbrel, Humira, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz)
Submit baseline TB screening (PPD or IGRA) and yearly screening or chest X‑ray if indicated

Step Therapy

Migraine CGRP biologics: trial of two non‑CGRP alternatives required

Provide baseline headache days/month
Document failure of ≥2 non‑CGRP alternatives (or 1 if contraindicated)
Emgality: document failure of Aimovig and Ajovy

Step Therapy

Antipsychotic prior‑trial requirement: document aripiprazole + one other trial

For antipsychotic approvals (e.g., schizophrenia), document prior failure or intolerance to aripiprazole and at least one other generic second‑generation antipsychotic.

Document trials and failures/intolerance to aripiprazole and one other second‑generation antipsychotic

Step Therapy

Neupogen: trial of Zarxio required before Neupogen for most indications

Document trial and failure/intolerance to Zarxio for most indications
Describe intended site/use to establish Part B vs Part D coverage

Step Therapy

Document required prior systemic/TKI therapies per product-specific sequencing rules

Provide documentation of prior kinase inhibitor or systemic therapy trials as specified (e.g., ICLUSIG: ≥2 prior TKIs when not T315I; JAYPIRCA: ≥2 prior systemic therapies)

Step Therapy

MYCAPSSA: require prior injectable somatostatin analog trial and attestation

MYCAPSSA: submit documentation of prior use of injectable octreotide or lanreotide and attestation of successful treatment before approval.

Provide prior octreotide or lanreotide use and attestation of response

Step Therapy

Narcolepsy (adults): prior armodafinil/modafinil and solriamfetol required

For narcolepsy agents in adults, authorization requires prior trials and inadequate response/intolerance/contraindication to armodafinil or modafinil and solriamfetol.

Document prior trial and failure/intolerance to armodafinil/modafinil and solriamfetol

Step Therapy

PCSK9 step requirement: document statin + ezetimibe or prior statin failures

Document current statin + ezetimibe or failure of ≥2 statins or 1 statin + ezetimibe
Ensure at least one previously tried statin was hydrophilic

Step Therapy

SCEMBLIX: mutation‑specific prior TKI requirements

SCEMBLIX: for T315I mutation, document trial and failure or intolerance to ponatinib; for non‑T315I, document two or more other TKIs tried and failed.

If T315I: provide documentation trial/failure or intolerance to ponatinib
If not T315I: document ≥2 other TKIs tried and failed

Step Therapy

CAPLYTA: prior antipsychotic trial requirements per indication

Document failed trials of aripiprazole + one other second‑generation antipsychotic for schizophrenia/acute mania
For bipolar I depression, document failure of two specified alternatives (cariprazine, lurasidone, olanzapine, or quetiapine)

Step Therapy

Solriamfetol: require prior armodafinil/modafinil trial

Solriamfetol will be authorized only after trial and inadequate response/intolerance to armodafinil or modafinil; document prior trial.

Provide documentation of prior armodafinil or modafinil trial and inadequate response/intolerance

Step Therapy

Teriparatide/TYMLOS: bisphosphonate trial required; duration limits apply

Document prior bisphosphonate trial and failure or contraindication to bisphosphonates
Limit total therapy to 2 years unless high fracture risk is documented

Step Therapy

Primary IgA nephropathy: biopsy confirmation, proteinuria threshold, ACE/ARB and SGLT‑2 trial documented

Submit biopsy confirmation and 24‑hour urine protein or UPCR
Document current ACE inhibitor/ARB use or contraindication and SGLT‑2 inhibitor trial/failure

Step Therapy

Pitolisant (adults): prior wake‑promoting agent trials required

For pitolisant in adults with narcolepsy, document prior inadequate response/intolerance/contraindication to armodafinil/modafinil and solriamfetol.

Provide documentation of trials and failure/intolerance to armodafinil/modafinil and solriamfetol

Step Therapy

Rifaximin 550 mg: lactulose failure for HE; prior therapy/testing and course limits for IBS‑D/SIBO

HE: document lactulose trial and failure
IBS‑D: document prior antidiarrheal/antispasmodic/tricyclic trial(s); limit 3 lifetime 14‑day courses
SIBO: positive breath test and ≥2 prior antibiotics tried; limit 2 courses per 365 days

Documentation Required

ADEMPAS: submit WHO Group, renal function, and pregnancy status (right heart catheterization for WHO Group 1)

Provide WHO Group diagnosis and right heart catheterization for WHO Group 1
Submit creatinine clearance (or serum creatinine, weight, height) and pregnancy status

Documentation Required

Alpha‑1 PI therapy: submit low AAT level and objective emphysema evidence

Pre‑treatment AAT level <11 mmol/L (80 mg/dL) required
Provide PFTs, imaging, or DLCO confirming emphysema
Prescriber restricted to pulmonology; PA applies to all

Documentation Required

OHTUVAYRE COPD: submit spirometry, mMRC, and prior dual therapy documentation

Submit post‑bronchodilator FEV1% predicted and FEV1/FVC ratio
Document mMRC dyspnea score ≥2
Confirm current dual LAMA‑LABA therapy or prior failure/intolerance
Prescriber restricted to pulmonology

Documentation Required

CAMZYOS: submit LVOT gradient, wall thickness, NYHA class, LVEF, and pregnancy status

Attest NYHA class II or III symptoms
Submit LVOT gradient (≥50 mmHg) and LV wall thickness (≥15 mm or ≥13 mm if familial)
Provide current LVEF and prior/current therapies
Pregnancy status for females of childbearing potential; positive response documentation required for reauthorization

Documentation Required

CF modulators: provide drug‑specific CFTR mutation test result

CFTR mutation testing is required for CF modulators — provide the specific mutation result that demonstrates the patient is responsive to the requested modulator per prescribing guidance.

Provide CFTR genotype confirming drug‑specific responsive mutation (per PI section 12.1 or in‑vitro data)
Prescriber restricted to pulmonology

Documentation Required

DOPTELET: submit platelet counts, prior ITP therapy history, and reauthorization platelet response

Procedure: platelet count <50 ×10^9/L
ITP: platelet <30 ×10^9/L or <50 ×10^9/L with symptomatic bleeding
Document splenectomy and failed ITP therapies; provide platelet improvement evidence for reauthorization

Documentation Required

Dupilumab and biologics: submit prior/current therapies and objective disease measures

List prior and current therapies
Provide indication‑specific objective measures (e.g., BSA, FEV1, eosinophil counts, biopsy results)

Documentation Required

Molecular testing and baseline vitals required for mutation‑directed agents (e.g., GAVRETO)

Provide molecular test confirming required mutation/fusion (e.g., RET)
Submit baseline blood pressure and pregnancy status

Documentation Required

MAVYRET: submit HCV confirmation, cirrhosis status, and HBV testing

For MAVYRET, include laboratory confirmation of HCV, cirrhosis status, and HBV testing (HBsAg and anti‑HBc) when submitting PA requests.

Submit HCV laboratory confirmation and baseline HCV RNA
Document cirrhosis presence and compensation status
Confirm HBV testing completed (HBsAg and anti‑HBc)

Documentation Required

Mepolizumab: submit lung function and eosinophil documentation

Pre‑BD FEV1 and blood eosinophil count (e.g., ≥150 cells/mcL within 6 weeks or ≥300 within 12 months)
Document failed controller therapy and that mepolizumab will be added to chronic therapies
Prescriber restricted to listed specialties

Documentation Required

ORSERDU: submit premennopausal attestation, pregnancy status, and liver tests; duration capped

Submit diagnosis and premennopausal attestation where applicable
Provide pregnancy status and liver function testing/Child‑Pugh score
Observe indication‑specific duration limits; therapy >2 years not approved

Denial Risk

No PA may cause coverage denial

If no prior authorization is obtained when 'PA' is required on the formulary, the request may be denied and the drug may not be covered.

Obtain PA before dispensing to avoid denial of coverage

Denial Risk

ARIKAYCE denial risk if failed MAC regimen or post‑treatment culture missing

Document ≥6‑month failed multi‑drug MAC regimen (ethambutol + macrolide + rifamycin)
Submit positive post‑treatment sputum culture

Denial Risk

CERDELGA: exclude ultra‑rapid CYP2D6 metabolizers (genotype required)

Do not approve CERDELGA for patients who are ultra‑rapid CYP2D6 metabolizers — submit CYP2D6 genotype testing and exclude ultra‑rapid metabolizers.

Provide CYP2D6 genotype testing
Exclude ultra‑rapid CYP2D6 metabolizers from coverage

Denial Risk

CAMZYOS: exclusion if cardiac parameters not met (LVEF <55% or missing LVOT/LV thickness)

CAMZYOS requests will be denied if cardiac parameter exclusions are present; verify LVEF is ≥55%, LVOT gradient and LV wall thickness meet thresholds, and provide required cardiac attestations.

Ensure LVEF ≥55%
Provide LVOT gradient ≥50 mmHg and LV wall thickness per criteria
Attest NYHA II–III symptoms and supply required cardiac documentation

Denial Risk

CABLIVI: recurrence exclusion — >2 recurrences on caplacizumab disqualifies non‑first use

CABLIVI will not be authorized for non‑first use patients who had more than 2 recurrences of aTTP while on caplacizumab; include prior recurrence history when applicable.

If non‑first use, document prior aTTP recurrences while on caplacizumab
Do not approve if >2 recurrences on caplacizumab

Denial Risk

Exclude therapy when dual strong CYP3A4/P‑gp interaction present

Check for dual strong CYP3A4/P‑gp inhibitors or inducers before approval
Deny coverage if coadministration contraindicated per product

Denial Risk

Verify and document absence of clinical exclusion conditions (pregnancy, severe hepatic/renal impairment)

Confirm pregnancy status for females of childbearing potential
Check liver function/Child‑Pugh class and renal function (eGFR)
Identify and document contraindicated comedications or comorbidities

Denial Risk

GLP‑1: off‑label weight‑management excluded; document diabetes diagnosis per criteria

Do not approve GLP‑1 agonists for off‑label weight‑management under Medicare Part D; document type 2 diabetes per criteria when submitting requests for diabetes indications.

GLP‑1 products will not be approved for weight management under Medicare Part D
For diabetes, submit documentation meeting diagnostic criteria (e.g., HbA1c ≥6.5% or glucose thresholds)

Denial Risk

HAE acute‑attack requests excluded for some products — follow prophylaxis criteria

Requests for acute HAE attack therapy are excluded for specified HAE products; for prophylactic HAE therapy, follow product‑specific prophylaxis criteria and prior therapy requirements.

Acute HAE attack requests may be excluded for some products
For prophylaxis, submit objective disease burden and prior prophylactic therapy history as required

Denial Risk

JUXTAPID: will not be approved for HeFH; submit HoFH genetic/functional criteria and labs

Do not approve JUXTAPID for heterozygous familial hypercholesterolemia (HeFH); ensure required genetic/functional LDL receptor criteria and baseline labs are submitted for HoFH candidates.

JUXTAPID not approved for HeFH
Submit functional LDL receptor mutation documentation or fibroblast activity <20% and baseline lipid/liver labs for HoFH candidates

Denial Risk

Lidocaine patch: limit to FDA‑approved postherpetic neuralgia

Lidocaine patch requests for indications other than FDA‑approved postherpetic neuralgia will not be approved; ensure indication matches FDA‑approved use.

Approve only for FDA‑approved postherpetic neuralgia indication

Denial Risk

LODOCO: excluded for gout

LODOCO (example) will not be authorized for gout — do not submit requests for excluded indications.

Exclude off‑label gout use from PA submissions for LODOCO

Denial Risk

MAVYRET: exclude Child‑Pugh B/C and specified drug interactions

MAVYRET exclusions include moderate/severe hepatic impairment (Child‑Pugh B/C) and specified drug interactions (e.g., rifampin, atazanavir); do not submit PA requests if these exclusions apply.

Do not use in Child‑Pugh B or C
Avoid coadministration with rifampin or atazanavir

Denial Risk

Mepolizumab denial risk if lung function, eosinophils, or prior controller therapy not documented

Provide pre‑BD FEV1 and eosinophil counts per thresholds
Document prior inhaled corticosteroid + another controller trial and specialist prescriber

Denial Risk

ORSERDU: check for pregnancy, severe hepatic impairment, osteoporosis, and OATP1B1 interactions

ORSERDU exclusion triggers include pregnancy, Child‑Pugh C hepatic impairment, known osteoporosis, and coadministration with OATP1B1 inhibitors — verify and document absence of these triggers.

Confirm no pregnancy and assess liver function/Child‑Pugh class
Do not approve if patient has osteoporosis or is on interacting OATP1B1 inhibitors

Denial Risk

Oncology agent denials when tumor marker testing or prior therapy documentation missing

Oncology agent requests may be denied if primary tumor testing does not confirm required markers (e.g., ER+/HER2‑/ESR1‑mutated); include tumor testing and prior therapy documentation.

Provide tumor testing confirming required biomarker profile
Document prior endocrine or systemic therapies tried and failed

Denial Risk

Recorlev: exclusion triggers include cirrhosis, high AST/ALT, prolonged QTcF, and QT‑prolonging drugs

Exclude cirrhosis or extensive liver disease and AST/ALT >3× ULN
Provide baseline QTcF and avoid QT‑prolonging coadministrations

Denial Risk

RETACRIT/RETEVMO: avoid uncontrolled hypertension and strong CYP3A inducers

RETACRIT/RETEVMO examples: confirm no uncontrolled hypertension and avoid coadministration with strong CYP3A inducers per product entries to prevent denial.

Evaluate blood pressure control before approval
Avoid strong CYP3A inducers as coadministration exclusions

Denial Risk

RIVFLOZA: exclude if eGFR <30 mL/min/1.73 m2

RIVFLOZA is excluded for eGFR <30 mL/min/1.73 m2; confirm renal function and do not approve if eGFR is below threshold.

Provide eGFR and exclude therapy if eGFR <30 mL/min/1.73 m2

Denial Risk

Deny when product‑specific exclusion criteria are present (electrolyte, BP, interactions)

Screen for and document any product‑specific exclusions prior to PA submission
Deny requests when exclusions are present

Denial Risk

Tolvaptan: exclusion for inability to sense thirst, hypovolemia, anuria, or strong CYP3A interactions

Tolvaptan requests: deny if patient cannot sense/respond to thirst, is hypovolemic or anuric, or if strong CYP3A inhibitors/inducers or desmopressin are coadministered.

Confirm patient can sense/respond to thirst and is not hypovolemic/anuric
Avoid coadministration with strong CYP3A inhibitors/inducers or desmopressin

Denial Risk

Do not request therapy beyond product maximum durations (e.g., >2 years)

Requests for therapy beyond product‑specified maximum durations (e.g., >2 years where noted) will not be approved; ensure duration limits are observed in PA and reauthorization requests.

Adhere to product‑specific maximum therapy durations (do not request >2 years where prohibited)

Denial Risk

Exclude when QTcF exceeds product‑specific thresholds; include ECG/QTcF

Do not approve when QTcF interval exclusion thresholds are exceeded (product‑specific thresholds such as >450 msec or >470 msec apply); include ECG/QTcF in submissions when required.

Provide ECG including QTcF and exclude if QTcF exceeds product threshold (e.g., >450 or >470 msec)

Documentation Required

HFrEF: document background RAS inhibitor, beta‑blocker, and MRA regimen or rationale if omitted

For HFrEF agents, document the required background regimen (RAS inhibitor, beta‑blocker, MRA each at maximally‑tolerated doses) or provide rationale/contraindication if components are not used.

Submit current HFrEF regimen showing RAS inhibitor, beta‑blocker, and MRA at maximally‑tolerated doses or documented contraindications

Denial Risk

PAH: include hemodynamics and background PAH therapy or risk denial

Submit PCWP and PVR hemodynamics and background PAH medications (≥2 classes unless contraindicated)
Provide WHO/NYHA class II–III, baseline 6MWD, and BNP/NT‑proBNP

Denial Risk

HE: require documentation of prior lactulose trial and failure before rifaximin approval

For hepatic encephalopathy (HE), lack of documentation of prior trial and failure of lactulose may lead to denial for rifaximin PA requests.

Document prior lactulose trial and failure for HE requests involving rifaximin

Initial Therapy Criteria — Authorization Logic

Continuation and Reauthorization Criteria

Step Therapy — Prior Trials and Failures Required

Drug / Step	Step Therapy Requirement	Notes
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Drug Group	Required Preferred-Agent Trial	Exceptions / Notes
Biologics / Immunomodulators (managed by this policy)	Patient must have tried and had inadequate response to or intolerance to at least two preferred agents (adalimumab biosimilar, Cosentyx, Enbrel, Humira, Rinvoq, Skyrizi, ustekinumab biosimilar, Xeljanz/XR) for the submitted indication before approval.	Otezla and Velsipity are exempt from the preferred-agent requirement; baseline latent TB screening required for most drugs; PA applies to all.

Drug/Class	Required Trial(s) Before CGRP Prevention Agent	Reauthorization / Notes
CGRP monoclonal antibodies for migraine prevention	Patient must have tried and failed at least two non‑CGRP FDA‑approved or compendial alternatives for migraine prevention (examples: propranolol, timolol, topiramate, valproic acid, amitriptyline, atenolol). One alternative required if contraindications to others exist.	Episodic migraine limited to <15 headache days/month; Emgality requires prior failure of Aimovig and Ajovy; initial trial period 3 months then 1 year for reauthorization with documented improvement.

Drug / Indication	Prior Antipsychotic Trials Required	Notes
Antipsychotic agents for schizophrenia (policy entry)	Approval requires failure or intolerance to aripiprazole and at least one other generic second‑generation atypical antipsychotic.	Prescriber restriction: psychiatry; PA applies to new starts only; age ≥18.

Scenario	Step Therapy Rule	Examples / Notes
General rule	Prior therapies must have been tried and failed or be contraindicated/intolerant before initiating the requested agent.	Examples: PNH agents require failure/intolerance to C5 inhibitors (eculizumab or ravulizumab); IgA nephropathy agents require trial of maximally‑tolerated ACE inhibitor/ARB prior to therapy.

Reference Product	Step Requirement	Exceptions / Notes
Neupogen (filgrastim)	For all indications other than Hematopoietic Syndrome of Acute Radiation Syndrome, patient must have tried and had inadequate response to or intolerance to Zarxio (filgrastim biosimilar) prior to Neupogen approval.	Coverage and Part B vs D determination may depend on administration setting and how drug is obtained; PA applies as noted.

Products	Prior Trial / Failure Requirement	Notes
Selected products with step requirements	Certain products require documented trial and failure (or intolerance/contraindication) of specific prior therapies before approval — e.g., Haegarda requires prior failure/intolerance to Takhzyro for patients ≥12 years, and other products list similar prerequisites.	Prescriber restrictions, documentation of prior therapies, and Part B/Part D site‑of‑care considerations apply per product.

Step 1 Example	Required Prior Therapies / Conditions	Product Notes
Hematology/Oncology and specialty examples	Many specialty agents require prior lines of therapy or specific prior agents: e.g., JAYPIRCA requires failure of at least two prior systemic therapy lines (with BTK/BCL‑2 specifics by diagnosis); JUXTAPID requires trial/intolerance/contraindication to evolocumab; certain oncology agents require prior progression on defined prior systemic regimens.	PA generally applies to new starts only; age and prescriber restrictions vary by product; coverage durations commonly 1 year (some initial shorter periods specified).

Therapy Area	Prior Trials Required	Notes
Insomnia / related CNS indications	Patient must have tried and failed or been intolerant to two covered alternative therapies recommended by AASM (examples include doxepin, eszopiclone, ramelteon, suvorexant, temazepam, zaleplon, zolpidem), including one non‑suvorexant for sleep maintenance when applicable.	PA applies to new starts only for older patients per entry; coverage duration 1 year.

Class / Product	Step Requirement	Details
PCSK9 inhibitors (Repatha, Praluent)	Patient must be currently using a statin plus ezetimibe OR have tried/failed at least two statins (or one statin plus ezetimibe) prior to PCSK9 initiation.	At least one previously tried statin should be hydrophilic where specified; documentation of prior statin therapy required.

Drug	Prior Wake‑Promoting Agents Required	Notes
Narcolepsy agents (policy entries e.g., pitolisant, solriamfetol coverage rules)	For adults with excessive daytime sleepiness associated with narcolepsy: must have tried and had inadequate response, intolerance, or contraindication to armodafinil or modafinil; for pitolisant authorization adults must try and fail armodafinil/modafinil and solriamfetol (as applicable).	Prescriber restrictions: neurology/sleep medicine; PA applies to all or new starts as specified; coverage duration commonly 1 year.

Drug	Prior ITP Therapies Required	Notes
Tavalisse (fostamatinib)	Approval requires documentation patient has tried and failed two different ITP therapies (examples: systemic corticosteroids, IVIG, danazol, fostamatinib, cytotoxics/immunosuppressants such as rituximab) and/or splenectomy prior to initiation.	Initial coverage 12 weeks then 1 year; documentation of platelet improvement required for reauthorization.

Condition	Required Prior Therapies	Notes
Primary IgA nephropathy	Initial authorization requires patient currently using (or with contraindication to) a maximally‑tolerated ACE inhibitor or ARB AND tried and failed or had intolerance to at least one SGLT‑2 inhibitor (eg dapagliflozin, empagliflozin).	Submit biopsy confirmation and 24‑hour urine protein ≥1 g/day or UPCR ≥0.8 g/g; reauthorization requires documentation of clinically relevant response (stabilization or improvement of UPCR).

Drug	Prior Trials Required	Notes
Pitolisant (for adult narcolepsy)	Authorization only if patient previously tried and had inadequate response, intolerance, or contraindication to armodafinil/modafinil and solriamfetol.	Updated serum potassium and magnesium may be required for reauthorization; prescriber restriction to neurology/sleep medicine; PA applies to all.

Requirement	Description	Policy Note
Documentation of prior therapies	Where specified in product entries, prior therapies must be documented as tried and failed, intolerant, or contraindicated before the requested therapy will be approved.	Examples: HE requires prior lactulose failure before rifaximin; IBS‑D requires failure of antidiarrheals/antispasmodics/TCA; SIBO requires positive breath test and failure of ≥2 antibiotics.