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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsHarvard Pilgrim prior auth drug coverage | OpenPay…
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    Currentharvard pilgrim health carePolicy N/A

    Tufts Medicare Preferred Prior Authorization Medical Necessity Guidelines (drug-specific PA rules)

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    Compilation of prior authorization and medical necessity criteria for numerous pharmacy and specialty drugs describing required diagnoses, prescriber restrictions, prerequisite therapies, monitoring, and coverage durations where specified.

    Policy Summary
    Payerharvard pilgrim health care
    PolicyTufts Medicare Preferred Prior Authorization Medical Necessity Guidelines
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateJun 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization with documented diagnosis, required prescriber specialty, and supporting test results or prior therapy history as specified for the drug.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    20+drug product entries in this partial document
    2 yearstypical coverage duration listed
    prescriber restrictionsspecialist prescriber often required
    variesprerequisite Part D drug

    Drug-specific Coverage Criteria

    inv-01: Abilify Mycite — product-specific criteria summaries (partial document)

    Product-specific criteria summaries (partial document):

    Abilify Mycite: Member must have documented diagnosis of bipolar I disorder, major depressive disorder, or schizophrenia; documentation of worsening symptoms with oral aripiprazole; prescribing physician must be a psychiatrist; coverage duration 2 years; prerequisite Part D drug required.
    Abiraterone products (Yonsa, Abirtega): Member must have documented diagnosis of metastatic castration-resistant prostate cancer (CRPC) or metastatic high-risk castration-sensitive prostate cancer; abiraterone must be used in combination with prednisone; prescribing physician must be an oncologist or urologist; coverage duration 2 years; no prerequisite Part D drug required.

    inv-02: Abiraterone (Yonsa, Abirtega) — 1 top-level node

    Abiraterone products:
    Policy Summary
    Payerharvard pilgrim health care
    PolicyTufts Medicare Preferred Prior Authorization Medical Necessity Guidelines
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateJun 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization with documented diagnosis, required prescriber specialty, and supporting test results or prior therapy history as specified for the drug.
    SourceLink
    On This Page
    Drug-specific Coverage CriteriaPrior Authorization, Documentation, and Billing GuidanceInitial Authorization RequirementsReauthorization and Continuation RulesRequired Prior Trials and Step Therapy RulesMonitoring, Age Limits, and Key Clinical CodesPolicy Background and ScopeKey Terms and AbbreviationsBilling Setting and Coverage Determination
    Member must have documented diagnosis of metastatic castration-resistant prostate cancer (CRPC) or metastatic high-risk castration-sensitive prostate cancer; abiraterone used in combination with prednisone; prescribing physician must be oncologist or urologist; coverage duration 2 years; no prerequisite Part D drug required.

    inv-03: Adalimumab/Humira family — 1 top-level node

    Adalimumab / Humira family: Indications: medically accepted indications as listed (e.g., ankylosing spondylitis, Crohn's disease, ulcerative colitis, hidradenitis suppurativa, plaque psoriasis with failure of topical/systemic therapies, psoriatic arthritis, RA with trial/failure/intolerance to one conventional therapy); prescribing physician must be specialist (dermatologist, gastroenterologist, ophthalmologist, or rheumatologist); coverage duration 2 years; prerequisite Part D drug may be required per indication.

    inv-04: Aimovig — 1 top-level node

    Aimovig: Initial: documented diagnosis of migraine; subsequent approvals require clinically significant reduction in migraine days per month as determined by the prescriber; initial approval 6 months, subsequent approvals 2 years; no prerequisite Part D drug required.

    inv-05: Armodafinil / Modafinil — 1 top-level node

    Armodafinil / Modafinil: Member must have documented diagnosis of narcolepsy, excessive sleepiness associated with obstructive sleep apnea, or shift-work sleep disorder; coverage will not be approved for generalized fatigue, jet lag, or sleep-deprivation not associated with a covered diagnosis; coverage duration 2 years; no prerequisite Part D drug required.

    inv-06: Benlysta — 1 top-level node

    Benlysta (belimumab): Member must have documented diagnosis of active, autoantibody-positive systemic lupus erythematosus (SLE) or active lupus nephritis and be on concurrent standard therapy; prescribing physician must be a nephrologist or rheumatologist; Benlysta will not be approved as monotherapy, for members with severe active lupus nephritis or severe active central nervous system lupus, for autoantibody-negative members, or in combination with other biologics or IV cyclophosphamide; coverage duration 2 years; no prerequisite Part D drug required.

    inv-07: Examples: Medullary thyroid cancer (Cometriq/related) — Product-specific medical necessity and prescriber requirements (examples below).

    Product-specific medical necessity and prescriber requirements (examples below).

    Cometriq/Cometin (medullary thyroid cancer): Member must have documented symptomatic or progressive medullary thyroid cancer with unresectable locally advanced or metastatic disease; prescribing physician must be an endocrinologist or oncologist; coverage duration 2 years.

    inv-08: Cystic fibrosis — Cayston — 1 top-level node

    Cayston (aztreonam for inhalation): Diagnosis of cystic fibrosis AND evidence of Pseudomonas aeruginosa in the lungs; coverage duration 2 years; no prerequisite Part D drug required.

    inv-09: Inflammatory indications requiring prior topical/systemic therapy — Anti-TNF/biologic products require diagnosis and prior therapy trials.

    Anti-TNF/biologic products (e.g., Cosentyx, Enbrel) require diagnosis and prior therapy trials.

    Plaque psoriasis (biologics): Documented moderate-to-severe plaque psoriasis AND failure or intolerance to topical therapies (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, or coal tar); prescribed by or in consultation with a dermatologist; coverage duration 2 years.
    Non-radiographic axial spondyloarthritis: Documented diagnosis with objective signs of inflammation AND minimum one-month trial and failure, contraindication, or intolerance to two NSAIDs at maximally indicated doses; prescribed by or in consultation with a rheumatologist; coverage duration 2 years.

    inv-10: ALK-positive NSCLC — Ensacove — 1 top-level node

    Ensacove (ALK-positive NSCLC): Diagnosis of NSCLC that is locally advanced or metastatic AND ALK rearrangement-positive AND patient has not previously received an ALK-inhibitor; prescribing physician must be an oncologist; coverage duration 2 years; approve continuation of prior therapy as noted.

    inv-11: Dupixent — Indication-specific coverage criteria — 1 top-level node

    Dupixent (indication-specific): Indication-specific documentation required (e.g., atopic dermatitis with trial and failure of topical therapy; asthma with eosinophilic phenotype or oral steroid dependence; CRSwNP inadequately controlled on current treatment; prurigo nodularis; eosinophilic esophagitis; COPD with eosinophilic phenotype; bullous pemphigoid; allergic fungal rhinosinusitis); prescribed by or in consultation with relevant specialists; Dupixent will not be approved for relief of acute bronchospasm or status asthmaticus; coverage duration 2 years; prerequisite Part D drug required.

    inv-12: Product-specific initial coverage criteria (selected)

    Product-specific coverage criteria (representative examples from this chunk):

    Exkivity (EGFR exon 20 insertion NSCLC): Documented locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation and progression on or after platinum-based chemotherapy; prescribing physician must be an oncologist; coverage duration 2 years; no prerequisite Part D drug required.
    Everolimus for TSC-related indications: Documented partial-onset seizures associated with TSC or SEGA associated with TSC (patient not a candidate for surgical resection); prescribing physician must be a neurologist or oncologist; coverage duration 2 years; no prerequisite Part D drug required.
    Fasenra (example): Severe eosinophilic asthma despite inhaled corticosteroid plus additional controller OR eosinophilic granulomatosis with polyangiitis; prescribing physician must be an asthma specialist or rheumatologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-13: Jaypirca — covered indications and requirements — 1 top-level node

    Covered when ALL of the following are met:

    Jaypirca criteria: Member has documented diagnosis appropriate to product (chronic GVHD after failure of one or two lines of systemic therapy; myelofibrosis intermediate or high-risk; polycythemia vera with inadequate response/contraindication/intolerance to hydroxyurea; steroid-refractory acute GVHD).

    Coverage duration 2 years; subsequent authorization for myelofibrosis requires documentation of spleen size reduction or symptomatic improvement.

    inv-14: Jubbonti — relapsed/refractory MCL or CLL/SLL — 1 top-level node

    Covered when ALL of the following are met:

    Jubbonti indications: 1) Relapsed or refractory mantle cell lymphoma with >=2 prior systemic therapies including a BTK inhibitor OR 2) CLL/SLL previously treated with a covalent BTK inhibitor; prescribed by or in consultation with an oncologist; coverage duration 2 years.

    inv-15: Jubbonti (denosumab) for osteoporosis — Covered when ANY of the following are met

    Covered when ANY of the following are met:

    Jubbonti (denosumab) — osteoporosis indications: 1) Member at high risk of fracture OR 2) inadequate response/intolerance to at least one traditional osteoporosis treatment OR 3) female on adjuvant aromatase inhibitor therapy receiving denosumab to increase bone mass OR 4) men at high risk receiving androgen deprivation therapy for non-metastatic prostate cancer OR 5) treatment for glucocorticoid-induced osteoporosis in high-risk men/women; coverage duration 2 years; prerequisite Part D drug required.

    inv-16: Jynarque (tolvaptan) — ADPKD initial and reauthorization

    Initial and reauthorization criteria include diagnosis and safety monitoring:

    Jynarque initiation: Diagnosis of rapidly progressing ADPKD AND either: (A) patient receiving Jynarque <=18 months AND ALT/AST/bilirubin measured prior to initiation, at 2 and 4 weeks after initiation, then monthly for the first 18 months OR (B) patient receiving Jynarque >18 months AND ALT/AST/bilirubin measured at least every 3 months; patient must not have history of significant liver impairment (excluding uncomplicated polycystic liver disease); coverage duration 1 year.
    Jynarque reauthorization: For reauthorizations: patient demonstrates positive clinical response to therapy and no signs or symptoms consistent with hepatic injury OR has only uncomplicated polycystic liver disease.

    inv-17: Kalydeco (ivacaftor) — cystic fibrosis genotype requirement

    Covered when ALL of the following are met:

    Kalydeco (ivacaftor): Documented diagnosis of cystic fibrosis and at least one CFTR mutation responsive to ivacaftor based on clinical and/or in vitro assay data; if genotype unknown, use FDA-cleared mutation test and verify per test instructions; Kalydeco ineffective in patients homozygous for F508del; granules formulation age >=1 month; coverage duration 2 years.

    inv-18: Kesimpta — relapsing forms of multiple sclerosis — 1 top-level node

    Covered when ALL of the following are met:

    Kesimpta: Documented diagnosis of relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing-remitting, active secondary progressive); prescribing physician must be a neurologist; coverage duration 2 years; no prerequisite Part D drug required.

    inv-19: Kineret — RA and NOMID specific criteria — 1 top-level node

    Covered when specified confirmation and prior therapy requirements are met:

    Kineret — RA: Moderately to severely active RA AND either trial and failure, contraindication, or intolerance to two listed agents (etanercept, a formulary adalimumab product, abatacept, upadacitinib, tofacitinib) or attestation that trial may be inappropriate OR continuation of prior therapy; prescribed by or in consultation with a rheumatologist; reauth requires documented clinical response; coverage duration 1 year; prerequisite Part D drug required.
    Kineret — NOMID: Diagnosis of NOMID with either NLRP3 mutation OR two characteristic clinical symptoms plus elevated acute phase reactants; prescribed by or in consultation with allergist/immunologist, rheumatologist, or pediatrician; reauth requires clinical response; coverage duration 1 year; prerequisite Part D drug required.

    inv-20: Krazati — KRAS G12C indications — 1 top-level node

    Covered when ALL of the following are met:

    Krazati (KRAS G12C): NSCLC: locally advanced/metastatic KRAS G12C-mutated disease and prior systemic therapy; CRC: KRAS G12C-mutated locally advanced/metastatic CRC with prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and when used in combination with cetuximab; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-21: Lapatinib ditosylate — HER2+ breast cancer criteria — 1 top-level node

    Covered when ALL of the following are met:

    Lapatinib ditosylate: HER2 overexpressing advanced/metastatic breast cancer AND failed prior anthracycline and taxane AND failed prior trastuzumab AND concurrently treated with capecitabine (or letrozole in HR+ postmenopausal metastatic setting); prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-22: Lazcluze / Lenalidomide / Lenvima — oncology indications

    Covered when indicated disease-specific prior therapy and combination requirements are met:

    Lazcluze: Used as first-line treatment of NSCLC in combination with amivantamab for EGFR exon 19 deletion or exon 21 L858R mutations in locally advanced/metastatic disease; prescribing physician must be an oncologist; coverage duration 2 years; continuation of prior therapy allowed.
    Lenalidomide: Indications include previously treated follicular lymphoma in combination with rituximab, mantle cell lymphoma relapsed/progressed after two prior therapies including bortezomib, marginal zone lymphoma previously treated in combination with rituximab, multiple myeloma in combination with dexamethasone or maintenance post-autologous transplant, and transfusion-dependent anemia due to 5q-deletion MDS; prescribing physician must be a hematologist or oncologist; coverage duration 2 years; prerequisite Part D drug required.
    Lenvima: Indications include advanced endometrial carcinoma pMMR after prior systemic therapy (with pembrolizumab), ARCC with prior antiangiogenic therapy (or first-line with pembrolizumab), unresectable HCC, and radioactive iodine-refractory differentiated thyroid cancer; prescribing physician must be an oncologist; coverage duration 2 years.

    inv-23: Lidocaine transdermal patches — pain indications — 1 top-level node

    Covered when ALL of the following are met:

    Lidocaine transdermal patches (5%): For postherpetic neuralgia or diabetic neuropathy, member must have had failure, adverse reaction, or contraindication to gabapentin; approved for members not candidates for opioid or other oral pain management; new members must have pain currently well-controlled on patches to continue coverage; coverage duration 2 years; prerequisite Part D drug required.

    inv-24: Livtencity — post-transplant CMV infection/disease — 1 top-level node

    Covered when ALL of the following are met:

    Livtencity — post-transplant CMV infection/disease: Member >=35 kg with documented post-transplant CMV infection/disease refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet (with or without genotypic resistance); coverage duration 2 years; prerequisite Part D drug required.

    inv-25: Lonsurf — metastatic colorectal and gastric/GEJ cancer — 1 top-level node

    Covered when ALL of the following are met:

    Lonsurf indications: mCRC: previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and if RAS wild-type, anti-EGFR therapy; metastatic gastric/GEJ adenocarcinoma: previously treated with at least two prior lines including fluoropyrimidine, platinum, and taxane or irinotecan and HER2 therapy if appropriate; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-26: Lorbrena — ALK-positive metastatic NSCLC — 1 top-level node

    Covered when ALL of the following are met:

    Lorbrena (lorlatinib): Documented metastatic NSCLC with ALK-positive tumor status; prescribing physician must be an oncologist; coverage duration 2 years; no prerequisite Part D drug required.

    inv-27: Lumakras — KRAS G12C indications — 1 top-level node

    Covered when ANY of the following are met:

    Lumakras: 1) KRAS G12C-mutated locally advanced or metastatic NSCLC with at least one prior systemic therapy OR 2) KRAS G12C-mutated mCRC when used with panitumumab after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-28: Lybalvi — schizophrenia or Bipolar I disorder — 1 top-level node

    Covered when ALL of the following are met:

    Lybalvi: Documented diagnosis of schizophrenia or Bipolar I disorder; prescribing physician must be a psychiatrist; coverage duration 2 years; no prerequisite Part D drug required.

    inv-29: Lynparza — multiple tumor-specific indications — 1 top-level node

    Covered when disease- and biomarker-specific criteria are met:

    Lynparza (olaparib): Breast, ovarian, pancreatic, and prostate cancer indications tied to BRCA/HRR/HRD status and prior therapies as specified: e.g., metastatic HER2-negative breast cancer with deleterious/suspected deleterious gBRCA mutation after chemotherapy (and prior endocrine therapy if HR+); maintenance for BRCA-mutated ovarian cancer in response to platinum chemo; metastatic pancreatic adenocarcinoma with gBRCA mutation with no progression after >=16 weeks first-line platinum chemo; HRR gene-mutated mCRPC progressed after enzalutamide or abiraterone or BRCA-mutated mCRPC in combination with abiraterone and prednisone; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-30: Lynparza (olaparib) - Indication-specific criteria

    Lynparza — covered when ALL of the following per indication:

    Lynparza indications (detailed): Indication-specific eligibility as listed (see Lynparza summary): metastatic HER2-negative gBRCA-mutated breast cancer with prior chemotherapy and prior endocrine therapy if HR+; high-risk early breast cancer after neoadjuvant/adjuvant chemo; maintenance for BRCA-mutated ovarian cancer in response to first-line platinum chemo; maintenance with bevacizumab for HRD-positive disease responding to first-line platinum chemo; maintenance for recurrent ovarian cancer responding to platinum chemo; metastatic pancreatic adenocarcinoma with gBRCA mutation and no progression after >=16 weeks first-line platinum chemo; HRR gene-mutated mCRPC progressed after enzalutamide or abiraterone; BRCA-mutated mCRPC in combination with abiraterone and prednisone; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-31: Lytgobi (futibatinib) - FGFR2 fusion positive cholangiocarcinoma

    Lytgobi — covered when ALL of the following are met:

    Lytgobi (futibatinib): Documented diagnosis of previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or rearrangements; prescribed by or in consultation with an oncologist; coverage duration 2 years; no prerequisite Part D drug required.

    inv-32: Pulmonary hypertension drugs - diagnostic confirmation requirement

    Pulmonary arterial hypertension agents (examples) — covered when ALL of the following are met:

    PAH agents: Documented diagnosis of pulmonary arterial hypertension confirmed by right heart catheterization OR diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) where indicated; prescribing physician must be a cardiologist or pulmonologist; coverage duration 2 years; no prerequisite Part D drug required.

    inv-33: Mekinist (trametinib) - single agent and combination criteria

    Mekinist (trametinib) — covered when ALL of the following apply:

    Mekinist single-agent or combination: Single agent: unresectable or metastatic melanoma with BRAF V600E or V600K mutation (will not be approved as single agent for members who have received prior BRAF-inhibitor therapy). Combination with Tafinlar: multiple BRAF V600E/V600K indications as listed. Prescribing physician must be an oncologist; coverage duration 2 years; no prerequisite Part D drug required for many uses.

    inv-34: Nerlynx - adjuvant and advanced disease criteria

    Nerlynx (neratinib) — covered when ALL apply:

    Nerlynx indications: Extended adjuvant treatment: early-stage HER2-positive breast cancer with prior Herceptin-based adjuvant therapy OR advanced/metastatic HER2-positive breast cancer in combination with capecitabine after two or more prior anti-HER2 regimens; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-35: Nexletol / Nexlizet - LDL-C management criteria

    Nexletol / Nexlizet — covered when ALL of the following are met:

    Nexletol/Nexlizet criteria: Elevated LDL-C on maximally tolerated statin therapy or statin contraindication/intolerance AND documented diagnosis of HeFH, atherosclerotic cardiovascular disease, established CVD, or high risk for CVD event; must be prescribed by or in consultation with cardiologist, endocrinologist, lipidologist, or neurologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-36: Ofev - ILD indications

    Ofev (nintedanib) — covered when ALL of the following are met:

    Ofev indications: Diagnosis of idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated interstitial lung disease (SSc-ILD), or chronic fibrosing interstitial lung diseases with a progressive phenotype; prescribing physician must be a pulmonologist or rheumatologist; coverage duration 2 years; no prerequisite Part D drug required.

    inv-37: Onureg - AML maintenance criteria

    Onureg (azacitidine oral) — covered when ALL of the following are met:

    Onureg criteria: Documented diagnosis of acute myeloid leukemia (AML) and achievement of first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and inability to complete intensive curative therapy; prescribing physician must be a hematologist or oncologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-38: Otezla - dermatologic and Behcet's indications

    Otezla (apremilast) — covered when ALL of the following are met depending on indication:

    Otezla indications: Psoriatic arthritis: documented diagnosis of PsA. Plaque psoriasis: documented diagnosis and failure or intolerance to at least one topical therapy listed (e.g., corticosteroid, vitamin D analog, tazarotene, calcineurin inhibitors, anthralin, coal tar). Oral ulcers in Behcet's disease: documented diagnosis with active oral ulcers. Prescribed by or in consultation with dermatologist or rheumatologist; coverage duration 2 years; prerequisite Part D drug required for certain indications.

    inv-39: Orserdu (elacestrant) — advanced/metastatic ER+/HER2- breast cancer with ESR1 mutation

    Covered when ALL of the following are met

    Orserdu initial: 1) Diagnosis of advanced or metastatic ER-positive, HER2-negative breast cancer; 2) Documentation of ESR1 mutation; 3) Disease progression following at least one line of endocrine therapy; 4) Prescribed by or in consultation with an oncologist; coverage duration 2 years.

    inv-40: Otezla — Psoriatic arthritis, plaque psoriasis, Behcet's oral ulcers — Covered when ALL of the following are met (indication-specific)

    Covered when ALL of the following are met (indication-specific)

    Otezla — Psoriatic arthritis, plaque psoriasis, Behcet's oral ulcers: Psoriatic arthritis: documented diagnosis. Plaque psoriasis: documented diagnosis and failure/intolerance to at least one topical therapy listed. Oral ulcers (Behcet's): documented diagnosis and active oral ulcers. Prescribed by or in consultation with dermatologist or rheumatologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-41: Pemazyre — FGFR-altered cholangiocarcinoma or FGFR1-rearranged MLNs — 1 top-level node

    Covered when ALL of the following are met

    Pemazyre indications: 1) Unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement and previously treated OR 2) Relapsed/refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-42: Pirfenidone — idiopathic pulmonary fibrosis — 1 top-level node

    Covered when ALL of the following are met

    Pirfenidone (IPF): Documented diagnosis of idiopathic pulmonary fibrosis (IPF); prescribing physician must be a pulmonologist; coverage duration 2 years; no prerequisite Part D drug required.

    inv-43: Pomalidomide (Pomalyst) — Kaposi sarcoma or multiple myeloma — 1 top-level node

    Covered when ALL of the following are met (indication-specific)

    Pomalidomide (Pomalyst): Kaposi sarcoma: documented KS after HAART failure. Multiple myeloma: documented multiple myeloma with ≥2 prior therapies including lenalidomide and a proteasome inhibitor, disease progression on or within 60 days of last therapy, and use in combination with dexamethasone; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required for some uses.

    inv-44: PCSK9 inhibitors (Praluent, Repatha) — elevated LDL-C — 1 top-level node

    Covered when ALL of the following are met

    PCSK9 inhibitors (Praluent, Repatha): Elevated LDL-C while on high-intensity statin therapy OR elevated LDL-C with contraindication/intolerance to statins AND documented diagnosis of cardiovascular disease, primary hyperlipidemia (including HeFH) or HoFH confirmed by genetic testing or clinical criteria; coverage duration 2 years; prerequisite Part D drug required.

    inv-45: Prevymis — CMV prophylaxis in transplant recipients — 1 top-level node

    Covered when ANY of the following are met

    Prevymis indications: 1) Had or scheduled to receive allogeneic HSCT and at risk for CMV infection, OR 2) Had or scheduled to receive a kidney transplant and at risk for CMV infection; coverage duration 2 years.

    inv-46: Prolastin-c — alpha-1 antitrypsin deficiency with emphysema — 1 top-level node

    Covered when ALL of the following are met

    Prolastin-c (alpha-1 antitrypsin deficiency): Documented diagnosis of hereditary deficiency of alpha-1 antitrypsin with clinical evidence of emphysema; coverage duration 2 years.

    inv-47: Qulipta — migraine — 1 top-level node

    Covered when ALL of the following are met

    Qulipta: Documented diagnosis of migraine; coverage duration 2 years; no prerequisite Part D drug required.

    inv-48: Rinvoq — multiple inflammatory indications — 1 top-level node

    Covered when ALL of the following (indication-specific) are met

    Rinvoq indications: Indications include ankylosing spondylitis, atopic dermatitis (refractory moderate-severe with topical/systemic therapy trials), psoriatic arthritis (inadequate response/intolerance to TNF inhibitors), rheumatoid arthritis (trial/failure/intolerance of one conventional DMARD and inadequate response/intolerance to TNF inhibitors), ulcerative colitis and Crohn's disease with inadequate response/intolerance to TNF inhibitors or other specified systemic therapies, non-radiographic axial spondyloarthritis with inadequate response to TNF blockers, and others as listed; prescribed by or in consultation with appropriate specialist; coverage duration 2 years; prerequisite Part D drug required.

    inv-49: Rezdiffra — MASH/NASH with F2-F3 fibrosis — 1 top-level node

    Covered when ALL of the following are met

    Rezdiffra (MASH/NASH): Diagnosis of metabolic dysfunction-associated steatohepatitis (MASH) without cirrhosis AND fibrosis stage F2 or F3 confirmed by combined serum and imaging biomarkers or specified imaging/biopsy tests (FAST, MAST, MEFIB, or liver biopsy within 12 months) AND presence of ≥1 metabolic risk factor (e.g., T2DM, hypertension, obesity); prescribed by gastroenterologist or hepatologist; coverage duration 2 years; reauth requires positive response and no progression to cirrhosis; no prerequisite Part D drug required.

    inv-50: Rozlytrek — ROS1+ NSCLC or NTRK fusion solid tumors — 1 top-level node

    Covered when ALL of the following are met

    Rozlytrek indications: NSCLC: metastatic NSCLC with ROS1-positive tumors. Solid tumors: NTRK gene fusion without known acquired resistance mutation, metastatic or where resection would cause severe morbidity, progressed after treatment or no satisfactory alternatives; prescribing physician must be an oncologist; coverage duration 2 years; no prerequisite Part D drug required.

    inv-51: Rubraca — BRCA-mutated recurrent ovarian cancer maintenance; mCRPC BRCA-mutated — 1 top-level node

    Covered when ALL of the following are met

    Rubraca indications: Recurrent ovarian cancer (deleterious BRCA germline and/or somatic) in complete or partial response to platinum-based chemotherapy for maintenance, OR BRCA-mutated mCRPC previously treated with AR-directed therapy and taxane-based chemotherapy; prescribing physician must be an oncologist; coverage duration 2 years; not approved with concurrent chemotherapy; prerequisite Part D drug required.

    inv-52: Rydapt — FLT3+ AML induction and other hematologic indications — 1 top-level node

    Covered when ALL of the following are met

    Rydapt (midostaurin): AML: FLT3 mutation-positive AML and used as first-line therapy in combination with cytarabine and daunorubicin induction and cytarabine consolidation; Mast Cell Leukemia and Systemic Mastocytosis indications as specified; prescribing physician must be a hematologist/oncologist or allergist; coverage duration 2 years; Rydapt will not be approved as single-agent induction therapy for AML; no prerequisite Part D drug required.

    inv-53: Zelvysia — hyperphenylalaninemia due to BH4-responsive PKU — 1 top-level node

    Covered when ALL of the following are met

    Zelvysia (sapropterin) — BH4-responsive PKU: Documented diagnosis of hyperphenylalaninemia due to BH4-responsive PKU; prescribing physician must be a specialist in metabolic diseases or a geneticist; initial authorization 8 weeks, subsequent authorizations 2 years; coverage for continuing therapy if member experienced improvement; no prerequisite Part D drug required.

    inv-54: Rydapt - covered indications with restrictions

    Rydapt — covered indications with restrictions

    Rydapt coverage conditions: Member has documented diagnosis of FLT3 mutation-positive AML and Rydapt is being used as first-line therapy in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation; for MCL and systemic mastocytosis, documented diagnosis required; prescribing physician must be a hematologist, oncologist, or allergist; coverage duration 2 years; Rydapt will not be approved as single-agent induction therapy for AML.

    inv-55: Sapropterin - covered indication

    Sapropterin — covered indication

    Sapropterin coverage conditions: Member has documented diagnosis of hyperphenylalaninemia due to BH4-responsive PKU; prescriber must be a specialist in metabolic diseases or a geneticist; initial authorization 8 weeks, subsequent 2 years; coverage authorized for continuing therapy if member experienced improvement; no prerequisite Part D drug required.

    inv-56: Skyrizi - covered indications with prior therapy requirement

    Skyrizi / plaque psoriasis and related indications

    Skyrizi psoriasis criteria: For plaque psoriasis: documented moderate-to-severe disease and failure or intolerance to at least one topical agent (examples listed); prescriber is dermatologist, rheumatologist, or gastroenterologist; coverage duration 2 years; prerequisite Part D drug required; also covers psoriatic arthritis, Crohn's disease, and ulcerative colitis per documented diagnoses.

    inv-57: TIRF - covered only for cancer breakthrough pain

    Transmucosal Immediate-Release Fentanyl (TIRF)

    TIRF coverage conditions: Covered for breakthrough pain in adult cancer patients who are opioid tolerant and receiving around-the-clock opioid therapy; pediatric approval for lozenges for patients 16 years and older; must remain on around-the-clock opioids when taking fentanyl transmucosal; prescribing physician must be an oncologist or pain management specialist; TIRF products will not be covered for any non-cancer pain indication.

    inv-58: Trikafta - CF initial and reauthorization criteria

    Trikafta (Cystic Fibrosis)

    Trikafta coverage conditions: Diagnosis of cystic fibrosis and at least one responsive CFTR mutation (F508del or other responsive mutation); age-specific formulation restrictions (granule packets for 2 to <6 years; tablets for >=6 years); prescribed by or in consultation with a pulmonologist or CF care center specialist; coverage duration 2 years; reauthorization requires demonstrated positive clinical response; no prerequisite Part D drug required.

    inv-59: Tibsovo - covered indications

    Tibsovo — covered indications

    Tibsovo indications: Relapsed/refractory AML with susceptible IDH1 mutation; new diagnosis AML with susceptible IDH1 when monotherapy or with azacitidine for patients >=75 years or unfit for intensive chemo; cholangiocarcinoma previously treated; relapsed/refractory MDS; prescribing physician must be a hematologist or oncologist; coverage duration 2 years; prerequisite Part D drug required for some indications.

    inv-60: Truqap — Initial therapy

    Truqap (CF) — Covered when ALL of the following are met:

    Truqap initial: Diagnosis of cystic fibrosis AND at least one CFTR mutation (F508del OR another CFTR mutation responsive based on clinical/in vitro data) AND age criteria met (granule packets: 2 to <6 years; tablets: ≥6 years) AND prescribed by or in consultation with a pulmonologist or CF care center; coverage duration 2 years; no prerequisite Part D drug required.

    inv-61: Tukysa — Indication criteria

    Tukysa — Covered when ALL of the following are met:

    Tukysa for breast cancer: Documented diagnosis of locally advanced or metastatic breast cancer that is HR-positive and HER2-negative AND taking in combination with fulvestrant AND presence of one or more PIK3CA/AKT1/PTEN alterations AND disease progression after at least one endocrine-based regimen in metastatic setting OR recurrence on/within 12 months of completing adjuvant therapy; coverage duration 2 years; prerequisite Part D drug required; prescribing physician must be an oncologist.

    inv-62: Turalio — Indication criteria

    Turalio CAPS 125MG — Covered when ALL of the following are met:

    Turalio (TGCT): Documented symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations AND condition not amenable to improvement with surgery; coverage duration 2 years; no prerequisite Part D drug required.

    inv-63: Selected autoimmune/arthritis criteria

    Ubrelvy, biologics, and immunomodulators — Selected criteria:

    Ubrelvy: Documented diagnosis of migraines AND inadequate response, intolerance, or contraindication to at least one triptan medication; coverage duration 2 years.
    Selected RA criteria (example): Diagnosis of moderately to severely active rheumatoid arthritis AND either trial and failure/contraindication/intolerance to two specified agents (etanercept, a formulary adalimumab product, abatacept, upadacitinib, tofacitinib) OR continuation of prior therapy; prescribed by/consultation with rheumatologist; reauth requires positive clinical response; coverage duration 1 year for some indications.

    inv-64: Voquezna — GERD and H. pylori criteria

    Voquezna (vonoprazan-containing regimens) — Covered when:

    H. pylori (Dual/Triple Pak): Diagnosis of H. pylori infection AND trial and failure, contraindication, or intolerance to bismuth quadruple therapy; coverage duration for H. pylori/NERD 1 month.
    HRH (erosive esophagitis): Diagnosis of erosive esophagitis AND trial and inadequate response, contraindication, or intolerance to two generic PPIs; coverage duration HRH 2 months, MHRH 6 months.

    inv-65: Vyndamax — Indication criteria

    Vyndamax (tafamidis) — Covered when ALL of the following are met:

    Vyndamax (ATTR-CM): Diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy AND either presence of a TTR mutation OR tissue biopsy showing TTR amyloid deposits OR imaging suggestive of amyloidosis plus absence of light-chain amyloidosis AND documentation patient has NYHA Functional Class I, II, or III heart failure; prescriber: cardiologist; coverage duration: plan year; reauth requires continued NYHA class I-III.

    inv-66: Welireg — Indication criteria

    Welireg (belzutifan) — Covered when ALL of the following are met:

    Welireg indications: von Hippel-Lindau disease requiring therapy for associated RCC, CNS hemangioblastomas, or pancreatic NET not requiring immediate surgery OR advanced RCC following PD-1/PD-L1 inhibitor and VEGF-TKI OR locally advanced/unresectable/metastatic pheochromocytoma or paraganglioma; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required for some indications.

    inv-67: Wyost — Indication criteria

    Wyost (denosumab) — Covered when ONE of the following is met:

    Wyost (denosumab) indications: 1) Prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors OR 2) Treatment of unresectable giant cell tumor of bone (GCTB) where surgical resection likely causes severe morbidity OR 3) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy; coverage duration 2 years; prerequisite Part D drug required.

    inv-68: Example oncology criteria (Wyost) — Product-specific medical necessity and prescriber requirements (examples below).

    Product-specific medical necessity requirements (examples extracted):

    Wyost (oncology examples): Member must have documented von Hippel-Lindau disease requiring therapy for associated RCC, CNS hemangioblastomas, or pancreatic NET not requiring immediate surgery OR advanced RCC post PD-1/PD-L1 and VEGF-TKI OR locally advanced/unresectable/metastatic PPGL; prescriber must be an oncologist; coverage duration 2 years; prerequisite Part D drug may be required.

    inv-69: Denosumab bone-related indications

    Denosumab (Wyost) specific indications for bone-related uses (separate entry in part):

    Wyost denosumab bone indications: Prevention of skeletal-related events in multiple myeloma or bone metastases from solid tumors; unresectable giant cell tumor of bone where resection likely causes severe morbidity; hypercalcemia of malignancy refractory to bisphosphonate therapy; coverage duration 2 years; prerequisite Part D drug required.

    inv-70: Xalkori indications

    Xalkori (crizotinib) requirements:

    Xalkori indications: Metastatic NSCLC that is ALK-positive or ROS1-positive; relapsed/refractory systemic ALCL that is ALK-positive; unresectable/recurrent/refractory IMT that is ALK-positive; prescribing physician must be an oncologist; coverage duration 2 years; no prerequisite Part D drug required.

    inv-71: Xeljanz required prior therapies

    Xeljanz family therapy rules (examples):

    Xeljanz (rheumatologic indications): Ankylosing spondylitis, RA, PJIA, psoriatic arthritis: diagnosis of active disease AND inadequate response or intolerance to one or more TNF inhibitors; for RA and PJIA additional requirement: trial and failure, contraindication, or intolerance to one conventional therapy (methotrexate, leflunomide, or sulfasalazine); prescriber must be gastroenterologist or rheumatologist for some indications; coverage duration 2 years; prerequisite Part D drug required.

    inv-72: Xermelo criteria

    Xermelo indication rule:

    Xermelo: Carcinoid syndrome diarrhea inadequately controlled by somatostatin analog therapy and Xermelo is to be used in combination with an SSA; prescriber must be a gastroenterologist, hematologist, or oncologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-73: Xolair criteria

    Xolair (omalizumab) criteria summary:

    Xolair: Asthma: moderate-to-severe persistent asthma with failure of treatment regimen including two or more controller medications or intolerance and definitive sensitivity to perennial allergens and pre-treatment serum IgE 30–1,300 IU/mL; CSU symptomatic despite H1 antihistamine; nasal polyps inadequate response to nasal corticosteroids; prescriber must be allergist, dermatologist, immunologist, otolaryngologist, or pulmonologist; coverage duration 2 years; prerequisite Part D drug required.

    inv-74: Xpovio criteria

    Xpovio (selinexor) combination and refractory multiple myeloma criteria:

    Xpovio combinations: In combination with dexamethasone: relapsed/refractory multiple myeloma with at least four prior therapies and disease refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody. In combination with bortezomib and dexamethasone: multiple myeloma with at least one prior therapy. Relapsed/refractory DLBCL: at least 2 lines of systemic therapy; prescriber hematologist/oncologist; coverage 2 years; prerequisite Part D drug required.

    inv-75: Xtandi indications

    Xtandi (enzalutamide) indications:

    Xtandi indications: Non-metastatic castration-resistant prostate cancer OR metastatic hormone-sensitive prostate cancer when used with docetaxel; prescriber must be oncologist or urologist; coverage 2 years; prerequisite Part D drug not required.

    inv-76: Biologic product criteria

    Biosimilars or biologic examples (selected):

    Steqeyma/Yesintek (examples): Indications include Crohn's disease, plaque psoriasis (failed topical therapies), psoriatic arthritis, ulcerative colitis; prescriber must be dermatologist, gastroenterologist, or rheumatologist; coverage 2 years; prerequisite Part D drug required.

    inv-77: Zejula criteria

    Zejula (niraparib) ovarian cancer maintenance criteria:

    Zejula: Advanced or recurrent epithelial ovarian/fallopian tube/primary peritoneal cancer in complete or partial response to platinum-based chemotherapy OR recurrent disease with deleterious/suspected deleterious germline BRCA mutation in response to platinum chemotherapy; prescribing physician must be an oncologist; coverage 2 years; prerequisite Part D drug required.

    Benlysta (belimumab) is covered only when used as an adjunct to standard therapy for systemic lupus erythematosus (SLE). The member must have a documented diagnosis of active, autoantibody-positive SLE (for example, positive ANA, anti-dsDNA, or anti-Sm) or active lupus nephritis, and be on concurrent standard therapy (such as antimalarials, corticosteroids, or immunosuppressives). Prescriptions must be by a nephrologist or rheumatologist. Benlysta will not be approved as monotherapy, for members with severe active lupus nephritis or severe active central nervous system lupus, for autoantibody‑negative members, or in combination with other biologics or intravenous cyclophosphamide. Coverage duration is generally set to 2 years.

    Cotellic (cobimetinib) is covered only for its indicated uses in BRAF V600–mutant disease and must be prescribed by an oncologist. Cotellic is not indicated for treatment of patients with wild-type BRAF melanoma. Coverage duration is typically 2 years.

    Icatibant is covered for hereditary angioedema when the member has a documented diagnosis and meets laboratory confirmation requirements as specified. Coverage is limited by exclusion criteria: icatibant will not be approved for members with acquired angioedema or for members concurrently taking an ACE inhibitor. Prescribers should be an allergist, hematologist, or immunologist; coverage duration is generally 2 years.

    Kalydeco (ivacaftor) is authorized only for cystic fibrosis patients with a CFTR mutation known to be responsive to ivacaftor based on clinical or in vitro data. If genotype is unknown, an FDA‑cleared mutation test should be used and verified per instructions. Kalydeco is not effective and is excluded for patients homozygous for the F508del CFTR mutation. Age- and formulation-specific rules apply (granules for infants as noted); coverage duration is typically 2 years.

    Mekinist (trametinib) coverage depends on indication and combination use. For single‑agent use it is for unresectable or metastatic melanoma with BRAF V600E or V600K mutations; for combination use with dabrafenib there are additional labeled indications. Importantly, Mekinist will not be approved as a single agent for members who have received prior BRAF‑inhibitor therapy. Prescribing physician must be an oncologist; coverage duration is commonly 2 years.

    Quinine sulfate is not covered for the treatment or prevention of nocturnal leg cramps. Quinine may be approvable for appropriate, labeled infectious disease indications (e.g., uncomplicated Plasmodium falciparum malaria) when documentation supports the use. Coverage will not be approved for nocturnal leg cramps.

    Rydapt (midostaurin) is covered for FLT3‑mutation–positive acute myeloid leukemia (AML) when used as first‑line therapy in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation, and for other labeled hematologic indications. Requests for single‑agent use as induction for AML are explicitly excluded: Rydapt will not be approved as single‑agent induction therapy for the treatment of patients with AML. Prescribing physician must be a hematologist/oncologist or allergist; coverage duration is generally 2 years.

    Transmucosal immediate‑release fentanyl (TIRF) products are restricted to breakthrough cancer pain in opioid‑tolerant patients and require specialist prescriber involvement. They are covered only for management of breakthrough pain in adult cancer patients who are already tolerant to around‑the‑clock opioid therapy (and selected pediatric approvals as specified). TIRF products will not be covered for any non‑cancer pain indication.

    Tadalafil formulations included in the document are not covered for treatment of erectile dysfunction under these criteria. Tadalafil is excluded from coverage for the treatment of Erectile Dysfunction.

    Many product entries in this extract state that there are no additional off‑label or exclusion criteria to report. In numerous listings the fields for off‑label uses or exclusion criteria are populated as 'Off‑Label Uses = N/A' or 'Exclusion Criteria = N/A'; where specific exclusions exist they are called out per product (for example, Kalydeco, Cotellic, Benlysta, etc.). Review each product section for any product‑specific exclusions or explicit noncoverage statements.

    Zelboraf (vemurafenib) is indicated for tumors with BRAF V600 mutations and must be prescribed by an oncologist or hematologist. Zelboraf is not indicated for treatment of patients with wild‑type BRAF melanoma; coverage is for BRAF V600–mutant disease as specified, with typical coverage duration of 2 years.

    Armodafinil and modafinil are covered only for labeled diagnoses such as narcolepsy, excessive sleepiness associated with obstructive sleep apnea, or shift‑work sleep disorder and require documentation of the diagnosis. Coverage will not be approved for generalized fatigue, jet lag, or sleep‑deprivation not associated with a covered diagnosis.

    Dupixent (dupilumab) and other biologic agents are limited to their labeled indications with required documentation of diagnosis and prior therapy where applicable. For Dupixent specifically, it is not approved for acute bronchospasm or status asthmaticus: Dupixent will not be approved for the relief of acute bronchospasm or status asthmaticus. Requests lacking required documented diagnosis or required prescriber specialty are at risk for denial.

    The extract focuses on covered indications, required diagnostic confirmation, and documentation rather than enumerating every possible not‑medically‑necessary (NMN) scenario. Several entries include explicit NMN/exclusion statements (e.g., armodafinil/modafinil, Dupixent, quinine sulfate), but many products simply list labeled indications, required prior therapies, prescriber specialty, and coverage duration without separate NMN language. Absence of explicit NMN wording in a product entry does not imply unrestricted coverage; adherence to the listed indication, diagnostic confirmation, and prerequisite therapy requirements is required.

    Jynarque (tolvaptan) — Liver monitoring schedule
    Monitoring scheduleMeasure ALT, AST, and bilirubin prior to initiation, at 2 weeks and 4 weeks after initiation, then monthly for the first 18 months; thereafter measure at least every 3 months if on therapy >18 months
    Initial safety requirementPatient must not have a history of significant liver impairment or injury (excluding uncomplicated polycystic liver disease)
    Indication for useAutosomal dominant polycystic kidney disease (ADPKD) — diagnosis of rapidly progressing ADPKD required
    Coverage durationInitial coverage duration: 1 year
    Reauthorization criteriaReauthorization requires positive clinical response and absence of hepatic injury signs — and continued liver monitoring per schedule
    Koselugo — Age and prescribing requirements
    Approved age>= 1 year
    IndicationNeurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
    Prescriber restrictionPrescribing physician must be a neurologist or an oncologist
    Coverage duration2 years
    Prerequisite therapyCriteria does not require prior use of a prerequisite Part D drug

    Prior Authorization, Documentation, and Billing Guidance

    Prior Authorization

    Prior authorization required — submit diagnosis, prescriber specialty, and indication-specific info

    Many products listed in this document require prior authorization. Submit documentation of the member's diagnosis, the prescriber's specialty when specified, and any indication-specific supporting information noted in the product entry. Coverage durations are commonly specified (often 2 years).

    • Provide documented diagnosis matching the product-specific indication.
    • Include prescriber specialty or consultation notes when the entry requires a specialist.
    • Attach prior therapy history or prerequisite Part D drug use when specified.
    Prior Authorization

    Aimovig prior authorization and duration

    Aimovig requests require initial authorization for 6 months; subsequent approvals are for 2 years. Initial submission must document a diagnosis of migraine; reauthorization must document clinically significant reduction in migraine days per month as determined by the prescriber.

    • Initial approval period: 6 months.
    • Subsequent approval period: 2 years.
    • Document baseline migraine diagnosis and prescriber-assessed clinical benefit for reauthorization.
    Prior Authorization

    Cometriq / Cometin prior authorization for medullary thyroid cancer

    Cometriq/Cometin prior authorization requires documentation of symptomatic or progressive medullary thyroid cancer that is unresectable locally advanced or metastatic. Prescribing physician must be an oncologist.

    • Provide documented diagnosis of progressive, symptomatic medullary thyroid cancer.
    • Include oncologist prescriber information.
    Prior Authorization

    Cayston prior authorization

    Cayston prior authorization requires documentation of cystic fibrosis and evidence of Pseudomonas aeruginosa in the lungs.

    • Submit CF diagnosis documentation.
    • Provide microbiology or clinical evidence of Pseudomonas aeruginosa in the lungs.
    Prior Authorization

    Dupixent prior authorization — diagnosis-specific documentation required

    Dupixent requires indication‑specific documentation (for example, moderate‑to‑severe atopic dermatitis with trial and failure of topical therapies; eosinophilic asthma or oral steroid dependence; CRSwNP inadequately controlled on current treatment). Requests must be prescribed by or in consultation with the relevant specialist.

    • Provide indication-specific trial/failure documentation (e.g., topical therapy trial for atopic dermatitis).
    • Include specialist prescriber or consultation documentation (allergist, dermatologist, immunologist, otolaryngologist, pulmonologist, or gastroenterologist as applicable).
    Prior Authorization

    Product-specific prior authorization requirements

    Product entries require prior authorization with submission of the specific diagnosis, prescriber specialty when specified, and notation of prerequisite Part D drug use where required; many entries state a standard coverage duration of 2 years.

    • Include the exact diagnosis and any required biomarker or test results.
    • Provide prescriber specialty or consultation when the drug entry mandates it.
    • Note whether a prerequisite Part D drug was used when the product requires it.
    Prior Authorization

    Prior authorization required for listed specialty drugs — include diagnosis and prior therapy history

    Prior authorization is required for the listed specialty drugs; most require a documented diagnosis and prior therapy history. Coverage durations are commonly set to 2 years (some products list 1 year).

    • Document prior therapy trials and failures where specified.
    • Check each product entry for stated coverage duration (commonly 2 years; some 1 year).
    Prior Authorization

    Prior authorization and coverage duration — Part D specialty drugs often 2-year approvals

    Many Part D specialty drugs require prior authorization and specify coverage durations (frequently 2 years); several entries additionally require certain prescriber specialties for approval.

    • Confirm and document the prescriber specialty when required (e.g., oncologist, pulmonologist).
    • Note that standard coverage duration in many entries is 2 years.
    Documentation Required

    Therapy prerequisites and diagnostic proof — submit prior therapy and mutation status

    Some products require documentation of prior specific therapies or tumor/mutation status; for example, Lynparza requires documentation of prior chemotherapy and relevant BRCA/HRR status depending on the indication.

    • Submit tumor biomarker or mutation test results (e.g., BRCA, FGFR2, ALK) when required.
    • Provide prior chemotherapy or endocrine therapy history where the indication specifies it.
    Prior Authorization

    Orserdu authorization — ESR1 mutation and prior endocrine therapy required

    Orserdu prior authorization requires documentation of advanced or metastatic ER-positive, HER2‑negative breast cancer with an ESR1 mutation and progression after at least one line of endocrine therapy; prescriber must be or consult an oncologist. Coverage duration is 2 years.

    • Provide ESR1 mutation test results and documentation of endocrine therapy progression.
    • Include oncologist prescriber or consultation note.
    Prior Authorization

    Pomalidomide authorization — diagnosis and prior therapy lines required

    Pomalidomide (Pomalyst) authorization requires diagnosis‑specific criteria: Kaposi sarcoma after HAART failure or multiple myeloma after at least two prior therapies including lenalidomide and a proteasome inhibitor; prescriber must be an oncologist. Coverage duration commonly 2 years.

    • Document prior HAART failure for Kaposi sarcoma or history of ≥2 prior therapies including lenalidomide and a proteasome inhibitor for multiple myeloma.
    • Include oncologist prescriber information.
    Prior Authorization

    Rydapt prior authorization — meet diagnostic and prescriber requirements

    Rydapt requires prior authorization for listed indications and must meet diagnostic criteria (FLT3 mutation‑positive AML for first‑line in combination with standard induction/consolidation) and prescriber requirements (hematologist/oncologist/allergist).

    • Provide FLT3 mutation test results and documentation that Rydapt will be used with cytarabine and daunorubicin induction and cytarabine consolidation when for AML.
    • Include hematologist/oncologist or allergist prescriber details.
    Prior Authorization

    TIRF prior authorization — covered only for breakthrough cancer pain in opioid‑tolerant patients

    Transmucosal Immediate‑Release Fentanyl (TIRF) products require prior authorization and are covered only for breakthrough cancer pain in opioid‑tolerant adults (and certain pediatric lozenge approvals for age ≥16); prescriber must be an oncologist or pain management specialist.

    • Document opioid‑tolerant status (around‑the‑clock opioid equivalent dosing as defined in the entry).
    • Confirm ongoing around‑the‑clock opioid therapy and oncologist or pain specialist prescriber.
    Prior Authorization

    Trikafta prior authorization — CF diagnosis and responsive CFTR mutation required

    Trikafta prior authorization requires documentation of a cystic fibrosis diagnosis and at least one responsive CFTR mutation; age‑specific formulation restrictions and prescriber affiliation with a pulmonologist or CF care center apply.

    • Submit CF diagnosis and CFTR mutation(s) demonstrating responsiveness (F508del or other responsive mutation).
    • Indicate age‑appropriate formulation (granules for 2 to <6 years; tablets for ≥6 years) and pulmonologist/CF center prescriber or consultation.
    Prior Authorization

    Ubrelvy — prior authorization after triptan failure/intolerance

    Ubrelvy requires prior authorization for migraine treatment only after inadequate response, intolerance, or contraindication to at least one triptan medication.

    • Document prior triptan trial and failure, intolerance, or contraindication.
    • Provide migraine diagnosis per product entry.
    Prior Authorization

    Voquezna — prior authorization with documented prior trial/failure

    Voquezna (including dual/triple pak) requires prior authorization for H. pylori and erosive esophagitis indications; submit documentation of trial and failure, contraindication, or intolerance to bismuth quadruple therapy for H. pylori or two generic PPIs for erosive esophagitis as specified.

    • For H. pylori: document trial and failure, intolerance, or contraindication to bismuth quadruple therapy.
    • For erosive esophagitis: document trial and inadequate response, intolerance, or contraindication to two generic PPIs.
    Prior Authorization

    Prior authorization requirement — submit diagnosis, prescriber specialty, and prior/concomitant therapy evidence

    Prior authorization is required broadly across products with instructions to submit the specific diagnosis, prescriber specialty when specified, and evidence of required prior or concomitant therapies; many entries list a 2‑year coverage duration.

    • Ensure required diagnostic tests and prior therapy documentation are attached.
    • Include prescriber specialty where the product entry mandates it.
    • Check product entry for stated coverage duration (commonly 2 years).
    Note

    Part B vs Part D determination — submit use and setting information

    To determine Medicare billing under Part B versus Part D, submit information describing the drug's use and the care setting; coverage determination may depend on those details.

    • Include documentation that clarifies whether the drug is being administered in a physician office, outpatient facility (Part B), or as a pharmacy benefit (Part D).
    • Provide clinical context of use to aid Part B vs Part D determination.
    Step Therapy

    Prerequisite therapy notes — confirm and document prior Part D drug use when required

    Some oncology and specialty products require prior use of specific Part D drugs or other prerequisite therapies before approval; check the product entry for whether a prerequisite Part D drug is required.

    • If the product entry lists 'Criteria DOES require use of a prerequisite Part D drug,' submit evidence of that prior Part D drug trial.
    • If the entry indicates no prerequisite, do not include unrelated prior Part D therapies.
    Step Therapy

    NSAID trial requirement — one‑month trials of two NSAIDs required for select spondyloarthritis indications

    For non‑radiographic axial spondyloarthritis and enthesitis‑related arthritis, document a minimum one‑month trial and failure, contraindication, or intolerance to two NSAIDs at maximally indicated doses before authorization.

    • Provide documentation of two NSAID trials (e.g., ibuprofen, naproxen) at maximally indicated doses for at least one month each or justification for intolerance/contraindication.
    • Include objective signs of inflammation (e.g., elevated CRP or sacroiliitis on MRI) as required.
    Note

    Prerequisite Part D drug rules — confirm per product entry

    Some products explicitly require or explicitly do not require prior use of a Part D drug; verify the product line entry and submit documentation accordingly.

    • If the entry states 'Criteria DOES require use of a prerequisite Part D drug,' attach documentation of that prior drug.
    • If the entry states 'Criteria DOES NOT require,' no prerequisite Part D evidence is needed.
    Step Therapy

    Prior therapy requirements — document prior trials, failures, and reasons

    Many products require documented trials and failures of specified prior therapies; include dates, agents used, and reason for discontinuation (failure, intolerance, or contraindication) when applicable.

    • List prior agents, treatment durations, and objective evidence of failure or intolerance.
    • For genotype‑ or biomarker‑driven indications, include test results in addition to prior therapy history.
    Documentation Required

    Prerequisite Part D drug requirements — submit prior Part D therapy evidence when specified

    Several products explicitly require prior or prerequisite Part D drugs; when a product entry states this requirement, submit prior Part D therapy records to support the request.

    • Attach pharmacy claims or clinical notes documenting prior Part D drug use when the product mandates it.
    • If prerequisite therapy was not used, provide clinical rationale why a trial was inappropriate.
    Step Therapy

    Otezla step — topical therapy trial and failure required for plaque psoriasis

    For plaque psoriasis, Otezla requires trial and failure or intolerance to at least one topical agent (e.g., medium‑or higher‑potency topical corticosteroid, pimecrolimus, tacrolimus, or crisaborole) before authorization.

    • Provide documentation of topical agent trial(s), duration, and reason for failure/intolerance.
    • Include prescriber specialty or consultation (dermatologist or rheumatologist) when applicable.
    Step Therapy

    Stelara prerequisite therapy — Yesintek/Steqeyma trial required before coverage

    Stelara (and certain biologics) require documentation of trial, intolerance, or contraindication to Yesintek or Steqeyma prior to coverage; include proof of those trials or a clinician attestation if inappropriate.

    • Submit records of Yesintek or Steqeyma use and outcome, or attestation explaining why trial is inappropriate.
    • Include prescriber specialty as specified (dermatologist, gastroenterologist, or rheumatologist).
    Step Therapy

    Biologic/prerequisite therapy — document prior topical/alternative or biologic trials

    Many biologics require prior trials of topical or alternative therapies or specific prior biologics; document prior agents, durations, and reasons for discontinuation as required by the product entry.

    • Provide trial/failure documentation for topical/systemic therapies or prior biologics as listed in the product entry.
    • Include specialty prescriber documentation (dermatologist, gastroenterologist, or rheumatologist) when required.
    Step Therapy

    Ustekinumab — prerequisite biologic (Yesintek/Steqeyma) required

    Ustekinumab requires a trial, intolerance, or contraindication to Yesintek or Steqeyma prior to approval; submit trial documentation or a clinician attestation if the trial is inappropriate.

    • Attach records of Yesintek/Steqeyma trials and outcomes or an attestation why a trial is inappropriate.
    • Include prescriber specialty (dermatologist, gastroenterologist, or rheumatologist).
    Step Therapy

    Step or prerequisite therapy — document trials and failures of specified prior agents

    Several products require trial and failure of specified prior agents (examples include multiple biologic/DMARD requirements for rheumatologic indications and multiple prior systemic therapies for oncology agents); submit prior therapy documentation exactly as the product entry specifies.

    • List each prior agent, treatment dates, and documented reason for discontinuation.
    • If a mandated prior agent was not used, include a clear clinical rationale or contraindication.
    Note
    Documentation Required

    Required medical information — abiraterone

    Provide required medical information per product entry (examples): abiraterone requires metastatic CRPC or metastatic high‑risk castration‑sensitive prostate cancer diagnosis and use with prednisone; include oncologist or urologist prescriber details.

    • Attach documentation of metastatic CRPC or metastatic high‑risk castration‑sensitive prostate cancer.
    • Confirm abiraterone is prescribed in combination with prednisone and include prescriber specialty.
    Documentation Required

    Required medical information — adalimumab/Humira family

    For adalimumab/Humira family products, submit documentation of the diagnosis appropriate to the indication (e.g., RA, Crohn's, UC, psoriasis) and prior failure or intolerance to specified conventional therapies where required; include specialist prescriber details.

    • Provide diagnosis documentation and record of trial/failure/intolerance to conventional therapies when indicated (e.g., methotrexate for RA).
    • Include prescriber specialty (dermatologist, gastroenterologist, ophthalmologist, or rheumatologist).
    Documentation Required

    Required diagnosis documentation for Cometriq/related

    For Cometriq/related agents, submit documentation of progressive, metastatic medullary thyroid cancer; include oncologist prescriber details as required by the entry.

    • Provide documentation the disease is symptomatic or progressive and unresectable locally advanced or metastatic.
    • Include oncologist prescriber information.
    Documentation Required

    Tumor mutation and prior therapy documentation for biomarker‑driven therapies

    For biomarker‑driven therapies (e.g., Ensacove, Lynparza), submit tumor mutation testing and prior therapy history as specified (for example ALK rearrangement status for Ensacove and no prior ALK‑inhibitor use).

    • Attach validated test results confirming the required mutation (e.g., ALK rearrangement).
    • Document prior therapy lines and confirm absence of disallowed prior agents where specified.
    Documentation Required

    Required documentation — include diagnosis, prior therapies, response measures, and monitoring

    Provide product‑specific required documentation such as diagnosis, prior therapy history, objective response measures, and safety monitoring results where specified in the entry.

    • Include objective response data when reauthorization requires it (e.g., spleen size reduction for myelofibrosis).
    • Supply laboratory or imaging monitoring per product requirements (e.g., liver tests for Jynarque).
    Documentation Required

    Required documentation and response data — supply prior therapy history and objective response where specified

    Providers must supply diagnoses, prior therapy history (including trials and failures), and where specified objective response measures (e.g., spleen size reduction for myelofibrosis or lab monitoring results for Jynarque) to support authorization.

    • Attach documentation of prior systemic therapies and outcomes.
    • Provide specified objective response data when required for continuation or reauthorization.
    Documentation Required

    Disease‑specific confirmatory documentation required (NOMID, RA examples)

    Document disease‑specific confirmatory information when required (e.g., NLRP3 mutation or clinical criteria for NOMID; TF/C/I to specified biologic/DMARD therapies for RA).

    • Attach genetic test results or clinical confirmation per the product's diagnostic criteria.
    • Include specialist prescriber notes confirming diagnosis and prior therapy trials.
    Documentation Required

    Required clinical documentation for biomarker‑driven therapies

    For biomarker‑driven therapies, submit required clinical documentation such as BRCA mutation for Lynparza, FGFR2 fusion for Lytgobi, or right heart catheterization data for PAH agents as specified in each product entry.

    • Attach mutation or biomarker test results (BRCA, FGFR2, etc.).
    • Provide diagnostic test reports (e.g., right heart catheterization for PAH).
    Documentation Required

    Orserdu required information — ESR1 mutation and prior endocrine therapy documentation

    For Orserdu, include documentation of advanced or metastatic ER‑positive, HER2‑negative breast cancer, ESR1 mutation, progression after at least one line of endocrine therapy, and that the prescriber is an oncologist or consulted with one.

    • Provide ESR1 mutation test report and prior endocrine therapy progression documentation.
    • Include oncologist prescriber or consultation note.
    Documentation Required

    Rezdiffra required information — fibrosis stage and metabolic risk documentation

    For Rezdiffra (MASH/NASH), submit documentation of diagnosis without cirrhosis, fibrosis stage F2 or F3 confirmed by specified biomarkers/imaging/biopsy, and presence of at least one metabolic risk factor; prescriber should be a gastroenterologist or hepatologist.

    • Attach fibrosis confirmation by approved biomarker panels or imaging tests (FAST, MAST, MEFIB, or liver biopsy within 12 months).
    • Document metabolic risk factors (e.g., T2DM, hypertension, obesity).
    Documentation Required

    Rydapt required medical information — FLT3 mutation and combination therapy documentation

    For Rydapt, provide documentation of FLT3 mutation‑positive AML and that Rydapt is being used as first‑line therapy in combination with cytarabine and daunorubicin induction and cytarabine consolidation; include hematologist/oncologist prescriber details.

    • Submit FLT3 mutation testing and treatment plan demonstrating combination use with induction/consolidation agents.
    • Include treating hematologist/oncologist details.
    Documentation Required

    Sapropterin required medical information — BH4‑responsive PKU diagnosis

    For sapropterin, document a diagnosis of hyperphenylalaninemia due to BH4‑responsive PKU and include specialist prescriber details (metabolic disease specialist or geneticist).

    • Attach diagnostic confirmation of BH4‑responsive PKU.
    • Include metabolic disease specialist or geneticist prescriber information.
    Documentation Required

    Tibsovo required medical information — IDH1 mutation documentation

    For Tibsovo, include documentation of a susceptible IDH1 mutation for the relevant AML indication and indicate whether the request is for initial or relapsed setting per the product criteria.

    • Attach IDH1 mutation test results and clinical context (new diagnosis vs relapsed/refractory).
    • Provide prescriber specialty (hematologist/oncologist).
    Documentation Required

    Truqap required information — CF diagnosis and CFTR mutation documentation

    Truqap (CF) authorization requires documentation of cystic fibrosis and at least one CFTR mutation (F508del or another responsive mutation), prescriber affiliation with a pulmonologist or CF care center, and age‑appropriate formulation details.

    • Provide CF diagnosis and CFTR mutation test results confirming responsiveness.
    • Include pulmonologist or CF center prescriber/consultation and age/formulation information.
    Documentation Required

    Ustekinumab required information — diagnosis and prior biologic trial documentation

    Ustekinumab requires documentation of diagnosis and trial, intolerance, or contraindication to Yesintek or Steqeyma for listed indications; include prescriber specialty (dermatologist, gastroenterologist, or rheumatologist).

    • Attach records of Yesintek/Steqeyma trial or a clinician attestation if a trial was inappropriate.
    • Include prescriber specialty documentation.
    Documentation Required

    Required diagnosis documentation — disease‑specific tests and prescriber specialty

    Provide diagnosis documentation specific to the drug's indication (examples include von Hippel‑Lindau disease for Welireg or ALK/ROS1 status for Xalkori) when requested; include prescriber specialty when specified.

    • Attach disease‑specific diagnostic tests or reports per the product entry.
    • Include prescriber specialty (e.g., oncologist) when required.
    Documentation Required

    Prior therapy documentation — list prior agents, dates, and failure/refractory evidence

    Document prior therapies and lines of therapy where required (for example, Xpovio and Xeljanz entries) including dates, agents, and evidence of refractory disease or treatment failure.

    • List prior therapies, treatment durations, and objective evidence of failure or refractory status.
    • Include oncology or specialty prescriber details where required.
    Billing Rule

    Submit drug use and setting information to determine Part B vs Part D

    Submit information describing the drug's clinical use and the setting of administration to allow determination of Medicare coverage under Part B versus Part D.

    • State whether the drug is administered in a physician office/infusion setting (possible Part B) or dispensed via pharmacy (Part D).
    • Provide clinical indication and treatment intent to support the billing determination.
    Denial Risk

    Benlysta exclusion risks — do not request for excluded conditions

    Benlysta is not approved as monotherapy, for members with severe active lupus nephritis or severe active CNS lupus, for autoantibody‑negative members, or in combination with other biologics or IV cyclophosphamide; do not submit requests that meet these exclusion conditions.

    • Confirm member is autoantibody‑positive SLE and on concurrent standard therapy before requesting Benlysta.
    • Do not request Benlysta as monotherapy or in combination with other biologics or IV cyclophosphamide.
    Denial Risk

    Exclusion risk — armodafinil/modafinil not covered for generalized fatigue or jet lag

    Armodafinil/modafinil will not be approved for generalized fatigue, jet lag, or sleep‑deprivation not associated with a covered diagnosis; ensure the request documents an approved diagnosis such as narcolepsy or shift‑work sleep disorder.

    • Provide diagnosis documentation for narcolepsy, excessive sleepiness with OSA, or shift‑work sleep disorder.
    • Avoid requesting coverage for generalized fatigue, jet lag, or non‑diagnosis‑related sleep deprivation.
    Denial Risk

    Dupixent denial risk — not for acute bronchospasm/status asthmaticus

    Dupixent will not be approved for relief of acute bronchospasm or status asthmaticus; ensure submitted asthma indications are for chronic eosinophilic or oral steroid‑dependent asthma per the product criteria.

    • Document chronic eosinophilic asthma or oral steroid dependence rather than acute bronchospasm.
    • Include eosinophil phenotype data or steroid dependence documentation when applicable.
    Denial Risk

    Denial risk — missing required diagnosis or prescriber specialty

    Requests lacking the required documented diagnosis or prescriber specialty (when specified) may be denied; ensure all required diagnosis and specialty fields are provided in the submission.

    • Attach clear diagnostic documentation that matches the product‑specific indication.
    • Include specialist prescriber or consultation notes when the entry requires it (e.g., oncologist, pulmonologist).
    Denial Risk

    Denial risk — missing required diagnosis or prior therapy documentation

    Requests missing required diagnosis confirmation or documentation of prior prerequisite therapies are at risk for denial (examples include chronic GVHD, myelofibrosis, and other specialty indications); include specific prior therapy failure documentation where the product requires it.

    • Provide records showing failure, intolerance, or contraindication to required prior therapies.
    • Attach relevant clinical notes and dates to support prior therapy history.
    Documentation Required

    Jynarque monitoring — document ALT/AST/bilirubin per schedule to avoid denial

    For Jynarque, failure to document ALT/AST/bilirubin monitoring per the scheduled intervals (prior, 2 and 4 weeks, then monthly for first 18 months; thereafter at least every 3 months) or a history of significant liver impairment may lead to non‑authorization.

    • Submit baseline and scheduled liver enzyme and bilirubin test results per the monitoring schedule.
    • Document absence of significant liver impairment (excluding uncomplicated polycystic liver disease).
    Denial Risk

    Denial risk — missing required diagnostic information for biomarker‑driven therapies

    Requests that do not document required disease‑specific diagnostic criteria (e.g., BRCA mutation for Lynparza, FGFR2 fusion for Lytgobi, right heart catheterization for PAH agents) are at risk for denial; attach the specified test results.

    • Include genetic or molecular test reports when the product requires a mutation/fusion.
    • Provide diagnostic procedure reports (e.g., right heart catheterization) where specified.
    Denial Risk

    Explicit noncoverage — Quinine Sulfate not approved for nocturnal leg cramps

    Coverage will not be approved for the treatment or prevention of nocturnal leg cramps with quinine sulfate; do not submit prior authorization requests for this non‑covered use.

    • Ensure the indication for quinine use is a medically accepted indication (e.g., malaria) and not nocturnal leg cramps.
    • Do not submit requests for nocturnal leg cramps as these are explicitly non‑covered.
    Denial Risk

    Concurrent chemotherapy exclusion for Rubraca — do not request concurrent chemo use

    Rubraca will not be approved for concurrent use with other chemotherapy agents; if Rubraca is requested, document that it will not be used concurrently with other chemotherapy.

    • Provide treatment plan indicating Rubraca will be used as monotherapy or in allowed combinations per the product entry, and not concurrently with other chemotherapy agents.
    • Include oncologist prescriber documentation.
    Denial Risk

    Rydapt exclusion — not approved as single‑agent induction for AML

    Rydapt will not be approved as single‑agent induction therapy for AML; documentation must show Rydapt is being used as first‑line therapy in combination with standard induction and consolidation agents when requested for AML.

    • Attach treatment plan showing Rydapt will be combined with cytarabine and daunorubicin induction and cytarabine consolidation for AML.
    • Do not request Rydapt as single‑agent induction for AML.
    Denial Risk

    TIRF exclusion — not covered for non‑cancer pain

    TIRF products will not be covered for any non‑cancer pain indication; ensure requests document cancer breakthrough pain in opioid‑tolerant patients with appropriate opioid use documentation.

    • Provide documentation of opioid‑tolerant status and that the indication is cancer breakthrough pain.
    • Include oncologist or pain management specialist prescriber information.
    Denial Risk

    Documentation risk — Trikafta/Truqap require CF diagnosis and responsive CFTR mutation

    Trikafta and Truqap requests risk denial if cystic fibrosis diagnosis or CFTR mutation responsive to therapy is not documented; include mutation test reports and prescriber consultation with a pulmonologist or CF care center.

    • Attach CFTR mutation test results demonstrating responsiveness (F508del or other responsive mutation).
    • Include pulmonologist or CF care center prescriber/consultation documentation.
    Denial Risk

    Documentation risk — Tukysa requires tumor alteration and prior endocrine therapy documentation

    Tukysa requests may be denied if documentation does not demonstrate HR‑positive, HER2‑negative locally advanced or metastatic breast cancer with the required PIK3CA/AKT1/PTEN alterations and prior endocrine‑based regimen progression or early recurrence; submit molecular testing and prior therapy history.

    • Provide molecular alteration test results and documentation of prior endocrine therapy progression or recurrence.
    • Include oncologist prescriber details.
    Billing Rule

    Part B vs Part D documentation risk — clarify use and setting to avoid coverage issues

    If the drug's billing as Medicare Part B versus Part D is not clarified with supporting information about use and setting, coverage determination may be affected; submit complete use and setting information with the request.

    • Include setting of administration (physician office, outpatient facility, or pharmacy) and intended route of administration.
    • Provide clinical justification to support Part B or Part D billing.
    Billing Rule

    Documentation affects Part B vs D determination — submit clinical use and setting details

    Failure to submit information describing the drug's clinical use and setting may prevent determination of whether Medicare Part B or Part D applies and could delay or alter coverage decisions; include these details with the authorization request.

    • Provide documentation of how and where the drug will be administered (infusion, in‑office injection, or pharmacy dispensed).
    • State the clinical purpose (e.g., acute inpatient administration vs chronic outpatient therapy).
    Note

    Initial Authorization Requirements

    Reauthorization and Continuation Rules

    Required Prior Trials and Step Therapy Rules

    ScopeStep therapy / prerequisite requirement
    Biologic and specialty products listed across the document (e.g., adalimumab/Humira family, ustekinumab, various oncology and immunologic agents).Prerequisite or prior therapy requirements are specified per-product in each entry (see individual product lines for exact requirements).
    Indication / product examplesRequired prior trial(s) before biologic coverage
    Adalimumab/Humira family — inflammatory indications (RA, PsA, plaque psoriasis, ankylosing spondylitis, Crohn's, UC, hidradenitis suppurativa).Failure, contraindication, or intolerance to one conventional therapy (e.g., methotrexate, leflunomide, or sulfasalazine) for RA/PJIA; for plaque psoriasis failure or intolerance to topical therapies as listed; many biologic indications require prior topical/systemic therapy trials before biologic coverage.
    Product examplesExplicit systemic/Part D prerequisite
    Calquence (selected oncology examples).Criteria indicates a prerequisite Part D drug is required for specified indications (documented in product entry).
    Exkivity (EGFR exon 20 insertion NSCLC).Product entry explicitly states Criteria DOES NOT require use of a prerequisite Part D drug for Exkivity (see product line).
    Xpovio (selinexor) for relapsed/refractory multiple myeloma).Product entry notes Criteria DOES require use of a prerequisite Part D drug for specified combinations/indications.
    Product / indicationPrior trials & failures documented
    Kineret — RA and NOMID indications.RA initial: TF/C/I to two listed biologic/targeted agents or attestation that trial is inappropriate; NOMID requires genetic confirmation or clinical criteria plus elevated acute phase reactants.
    Lidocaine 5% patches — postherpetic neuralgia or diabetic neuropathy.Member must have had failure, adverse reaction, or contraindication to gabapentin; continuity criteria for members already controlled on patches.
    Lynparza — multiple tumor-specific indications.Prerequisites include prior chemotherapy or endocrine therapy per indication; product lines document required prior therapies and whether Part D prerequisite applies.
    What to documentExamples of required prior therapy documentation
    Document prior therapies, dates, and reason for discontinuation (failure, intolerance, or contraindication).For osteoporosis: prior inadequate response or intolerance to at least one traditional osteoporosis treatment is required before teriparatide or denosumab uses are approved (see product line).
    Document prior lines of therapy and objective response when specified (e.g., spleen size reduction for myelofibrosis).Jaypirca reauthorization requires documentation of spleen size reduction or symptomatic improvement for continued coverage in myelofibrosis.
    Document whether prerequisite Part D drug was used where entry requires it (or explicitly state when not required).Exkivity and other entries explicitly state whether prerequisite Part D drug is required; include this in documentation per product line.
    IndicatorPrior therapies and failures to record
    Plaque psoriasis (biologics such as Cosentyx, Enbrel, Stelara, ustekinumab).Failure or intolerance to topical therapies (listed agents) and for some biologics prior trial/intolerance/contraindication to specified biologics (e.g., Yesintek or Steqeyma for ustekinumab/Stelara) must be documented.
    Non-radiographic axial spondyloarthritis/ERA.Minimum one-month trial and failure, contraindication, or intolerance to two NSAIDs at maximally indicated doses required prior to biologic approval.
    Crohn's disease/Ulcerative colitis for various biologics.Document inadequate response or intolerance to TNF inhibitors or other specified systemic therapies per product entry before approval of alternate biologics.
    ProductRequired prior trial before Stelara coverage
    Stelara (ustekinumab).Requires trial, intolerance, or contraindication to Yesintek or Steqeyma prior to coverage; prescriber must be dermatologist, gastroenterologist, or rheumatologist.
    ProductRequired prior trial before Teriparatide coverage
    Teriparatide (for osteoporosis).Member must have documentation of postmenopausal osteoporosis, male primary/hypogonadal osteoporosis, or glucocorticoid-associated osteoporosis at high fracture risk and inadequate response or intolerance to at least one traditional osteoporosis treatment prior to approval.
    General rulePer-drug requirement
    Most specialty products state whether a prior trial/failure/intolerance/contraindication is required — review product-specific entry for precise requirement.Examples: Ubrelvy requires inadequate response/intolerance/contraindication to at least one triptan; lidocaine patches require failure/adverse reaction/contraindication to gabapentin; many biologics require trials of topical/systemic therapies.
    When specifiedRequired prior trial and documented failure/intolerance agents
    Rheumatologic and inflammatory agents (e.g., Xeljanz, Xermelo, Xolair examples).Require prior trial and documented failure/intolerance to listed agents such as TNF inhibitors, conventional DMARDs, or other named biologics per product entry; documentation of trials and reasons for discontinuation must be provided.
    Oncology agents (e.g., Xpovio, Rydapt, Tibsovo).Require documentation of prior lines of therapy and failure/intolerance as specified (e.g., Xpovio: at least four prior therapies and refractory status; Rydapt: used in combination per induction requirements), with prescriber specialty noted.

    Monitoring, Age Limits, and Key Clinical Codes

    Jynarque liver test frequency — schedule for ALT/AST/bilirubin monitoring
    Tests to monitorAlanine transaminase (ALT), aspartate transaminase (AST), and bilirubin must be measured per schedule.
    Initial monitoring timingMeasure at 2 weeks and 4 weeks after initiation in addition to baseline.
    Long-term monitoringAfter first 18 months on therapy, measure ALT/AST/bilirubin at least every 3 months.
    Koselugo age restriction — >= 1 year
    Minimum age>= 1 year
    Indication citedSpecified for patients with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas.
    Prescriber requirementPrescribing physician must be a neurologist or an oncologist.

    Policy Background and Scope

    This partial extract compiles drug‑specific prior authorization criteria used to determine medical necessity for specialized and specialty pharmacy products. The entries emphasize documented diagnosis, required prescriber specialty where specified, prerequisite or prior therapy trials (when required), and stated coverage durations (commonly 2 years for many products). Providers should submit the supporting medical information identified in each product entry to facilitate authorization and to determine whether use is billed under Medicare Part B or Part D when applicable.

    Key Terms and Abbreviations

    Prerequisite Part D drug — Indicates whether prior use of a Part D-covered medication is required before approval of the listed product.
    DefinitionIndicates whether prior use of a Part D-covered medication is required before approval of the listed product.
    ApplicationUsed in product entries to denote prerequisite Part D drug requirements for specialty therapies.
    Provider actionCheck product-specific entry to determine if prior Part D drug use must be documented for authorization.
    Autoantibody positive SLE — Serology requirement for Benlysta eligibility
    Serology requirementActive, autoantibody-positive SLE (e.g., ANA, anti-dsDNA, anti-Sm) is required for Benlysta eligibility.
    Concurrent therapyMember must be on concurrent standard therapy (antimalarials, corticosteroids, or immunosuppressives).
    ExclusionsBenlysta will not be approved for autoantibody-negative members or as monotherapy, or combined with other biologics/IV cyclophosphamide.
    Objective signs of inflammation — e.g., elevated CRP or sacroiliitis on MRI
    ExamplesObjective signs include elevated C-reactive protein (CRP) above the upper limit of normal and/or sacroiliitis on MRI.
    ContextUsed to support diagnoses such as non-radiographic axial spondyloarthritis that require objective inflammation evidence.
    Provider actionDocument CRP results or MRI findings when required by the product-specific criteria.
    SEGA — Subependymal Giant Cell Astrocytoma associated with TSC
    DefinitionSEGA = Subependymal Giant Cell Astrocytoma associated with tuberous sclerosis complex; member must not be a candidate for surgical resection when specified.
    Indication contextAppears in product entries for TSC-related therapies where SEGA is an approved indication.
    PrescriberPrescribing physician must be a neurologist or oncologist for SEGA-associated indications.
    TSC — Tuberous Sclerosis Complex
    DefinitionTSC = Tuberous Sclerosis Complex; diagnosis must be documented for TSC-related therapy approvals.
    Associated conditionsTSC entries reference partial-onset seizures and SEGA as specific indications.
    PrescriberPrescribing physician typically must be a neurologist or oncologist for TSC indications.
    Jynarque (tolvaptan) monitoring — ADPKD liver enzyme monitoring schedule
    Monitoring scheduleALT, AST, and bilirubin must be measured prior to initiation, at 2 and 4 weeks after initiation, then monthly for the first 18 months; thereafter at least every 3 months.
    Baseline and ongoing riskPatient must not have history of significant liver impairment/injury (excluding uncomplicated polycystic liver disease).
    ReauthorizationReauthorization requires demonstration of clinical benefit and absence of hepatic injury signs; continue monitoring per schedule.
    NOMID diagnostic confirmation — NLRP3 mutation or clinical criteria plus elevated acute phase reactants
    Diagnostic confirmationNOMID diagnosis must be confirmed by NLRP3 gene mutation OR by clinical criteria (two characteristic symptoms) plus elevated acute phase reactants (e.g., ESR, CRP, SAA).
    Clinical symptoms examplesCharacteristic symptoms may include urticaria-like rash, sensorineural hearing loss, chronic aseptic meningitis, musculoskeletal symptoms, and skeletal abnormalities.
    PrescriberPrescribed by or in consultation with an allergist/immunologist, rheumatologist, or pediatrician for NOMID indications.
    BRCA-mutated — germline or somatic BRCA mutation documentation
    Mutation documentationDeleterious or suspected deleterious germline or somatic BRCA mutation must be documented in the member's cancer for BRCA-targeted indications.
    Indication examplesUsed for Lynparza in breast, ovarian, pancreatic, and prostate cancer indications tied to BRCA/HRR/HRD status.
    PrescriberPrescribing physician must be an oncologist for BRCA-mutated indications.
    FGFR2 fusion/rearrangement — required molecular alteration in cholangiocarcinoma
    Required alterationPresence of FGFR2 gene fusions or rearrangements in intrahepatic cholangiocarcinoma must be documented.
    Indication contextApplies to Lytgobi (futibatinib) coverage for previously treated unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma.
    PrescriberPrescribing physician must be an oncologist.
    FGFR2 fusion — Pemazyre coverage requirement
    Molecular requirementFGFR2 fusion (or rearrangement) is required for Pemazyre coverage in unresectable, locally advanced or metastatic cholangiocarcinoma.
    Prior therapy noteApplies to previously treated disease per product-specific criteria.
    PrescriberPrescribing physician must be an oncologist.
    RET fusion — genetic alteration required for Retevmo coverage
    Genetic requirementRET fusion-positive tumor must be documented for Retevmo coverage in NSCLC, medullary thyroid cancer, and other solid tumors.
    Indication examplesIncludes metastatic RET fusion-positive NSCLC and advanced or metastatic RET-mutant medullary thyroid cancer when systemic therapy is required.
    PrescriberPrescribing physician must be an oncologist.
    Opioid tolerant — definition for TIRF coverage
    Opioid tolerant definitionPatients considered opioid tolerant are those taking around-the-clock opioids equivalent to morphine 60 mg/day or more, fentanyl transdermal 25 mcg/hr or more, oxycodone 30 mg/day or more, hydromorphone 8 mg/day or more, or an equianalgesic opioid daily for a week or longer.
    Coverage scopeTIRF products covered only for breakthrough cancer pain in opioid-tolerant adult cancer patients (some pediatric lozenge approval ≥16 years).
    PrescriberPrescribing physician must be an oncologist or pain management specialist.
    SSc-ILD — Systemic sclerosis-associated ILD diagnostic definition
    Diagnostic definitionSSc-ILD is systemic sclerosis-associated interstitial lung disease documented by exclusion of other causes of ILD and supportive HRCT or surgical lung biopsy findings.
    PrescriberPrescribed by or in consultation with a pulmonologist or rheumatologist.
    Use in criteriaApplied for coverage of ILD therapies such as nintedanib (Ofev) where SSc-ILD is an approved indication.
    ATTR-CM — Transthyretin-mediated amyloidosis with cardiomyopathy diagnostic criteria
    Diagnostic criteriaTransthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM) requires diagnostic confirmation via TTR mutation, tissue biopsy showing TTR amyloid deposits, or imaging suggestive of amyloidosis plus absence of light-chain amyloidosis, and documentation of NYHA class I–III heart failure.
    PrescriberPrescribing physician must be a cardiologist for ATTR-CM indications.
    ReauthorizationReauthorization requires continued NYHA Functional Class I–III status for ongoing therapy coverage.
    Submission of use and setting information — Medicare Part B vs Part D determination
    RequirementSubmit information describing the use and setting of the drug to determine whether coverage falls under Medicare Part B or Part D.
    ImpactFailure to submit this information may prevent determination of Part B vs Part D coverage and affect coverage decisions.
    Provider actionInclude site-of-care and intended use details with the authorization request when applicable.

    Billing Setting and Coverage Determination

    Note