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Prior Authorization Medical Necessity Guidelines — Pharmacy & Specialty Drugs

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Defines prior authorization medical necessity criteria for many specialty and pharmacy drugs, including required medical information, prescriber restrictions, coverage duration, and prerequisite therapy requirements for Harvard Pilgrim Health Care members.

Policy Summary

Payerharvard pilgrim health care

PolicyPrior Authorization Medical Necessity Guidelines — Pharmacy & Specialty Drugs

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documented diagnosis, required prior therapy history or mutation testing, and prescriber specialty when specified.

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 stated for many products

prescriber restriction presentmany oncology/immunology drugs require specialist prescriber

Per-Product Coverage Criteria

Product-specific criteria (example: Abilify Mycite)

Covered when ALL of the following product-specific criteria are met:

Abilify Mycite: Member has a documented diagnosis of bipolar I disorder, major depressive disorder, or schizophrenia; AND documentation of worsening symptoms while on oral aripiprazole; AND prescribing physician is a psychiatrist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 1

Product-specific criteria (example: Abiraterone)

Covered when ALL of the following product-specific criteria are met:

Abiraterone: Member has documented metastatic castration-resistant prostate cancer (CRPC) or metastatic high-risk castration-sensitive prostate cancer; AND abiraterone will be used in combination with prednisone; AND prescribing physician is an oncologist or urologist; coverage duration 2 years; no prerequisite Part D drug required.

From chunk 1

Product class criteria (Adalimumab)

What Providers Must Submit / Do

Prior Authorization

Prior authorization required for listed products — provider summary

Prior authorization is required for the specialty pharmacy products listed in this policy; submit an authorization request with the requested drug, indication, and duration. Many product entries additionally require documentation of prescriber specialty, diagnosis, and prior therapy where specified.

Prior authorization applies to the listed specialty and Part D drugs.
Typical coverage duration noted in many entries is 2 years unless otherwise specified.

Prior Authorization

Prior authorization — submit diagnosis, testing, prior therapy, and prescriber specialty

For each product-level PA request, provide the specific clinical documentation the policy lists: a documented diagnosis matching the indication, required molecular/genetic test results when applicable, prior therapy trials or failures, and the prescribing specialist when required.

If the product entry lists molecular testing (eg, BRCA/HRR, EGFR exon 20, FLT3, IDH1), include the test result in the submission.

Initial Authorization Requirements

Reauthorization / Continuation Requirements

Required Prior Trials / Step Therapy

Requirement	Details
Must document trial and failure/contraindication/intolerance to conventional therapies
For RA and PJIA: trial and failure, contraindication, or intolerance to ONE of methotrexate, leflunomide, or sulfasalazine (documented)

Indication group	Required prior trials/failure
Plaque psoriasis / Psoriatic arthritis / Ankylosing spondylitis
Plaque psoriasis: failed topical/systemic agents (e.g., corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar). Ankylosing spondylitis: documented active disease. Non-radiographic axial spondyloarthritis/ERA: trial and failure, contraindication, or intolerance to TWO NSAIDs at maximally indicated doses

Product / Example	Prerequisite Part D drug required?
Exkivity (EGFR exon 20 insertion NSCLC)
Criteria DOES NOT require use of a prerequisite Part D drug

Kineret use case	Required prior trials
Rheumatoid arthritis — initial
Trial and failure, contraindication, or intolerance to TWO of: etanercept (Enbrel), a formulary adalimumab product, Orencia (abatacept), Rinvoq (upadacitinib), or Xeljanz (tofacitinib), OR attestation that trials are inappropriate

Product	Prerequisite Part D required
Exkivity
Criteria DOES NOT require use of a prerequisite Part D drug (Exkivity)
Fasenra
Criteria DOES require use of a prerequisite Part D drug (Fasenra)

Requirement	Rezurock prior therapy
Condition
Chronic graft-versus-host disease (cGVHD): trial and failure of two or more lines of systemic therapy (e.g., corticosteroids, mycophenolate) prior to approval

Rinvoq indication examples	Prior therapy requirement
Rheumatoid arthritis
Trial and failure, contraindication, or intolerance to ONE conventional therapy (methotrexate, leflunomide, or sulfasalazine) AND inadequate response or intolerance to one or more TNF inhibitors

Testing, Monitoring, and Coding Notes

Jynarque liver monitoring schedule — ALT/AST/bilirubin testing timeline

Monitoring scheduleALT, AST, and bilirubin measured prior to initiation; at 2 weeks and 4 weeks after initiation; then monthly for the first 18 months; thereafter at least every 3 months if on therapy >18 months

Reauthorization monitoring requirementFor reauthorization, same monitoring schedule applies based on duration of prior therapy (≤18 months vs >18 months)

Liver impairment exclusionPatient must not have a history of significant liver impairment or injury (excluding uncomplicated polycystic liver disease)

Jynarque coverage duration — 1 year noted

Coverage duration1 year

Reauthorization basisReauthorization requires documentation of positive clinical response and absence of hepatic injury (or uncomplicated polycystic liver disease)

Setting & Medicare Part B vs Part D Determination

Note

Key Definitions and Acronyms

FGFR3 alteration definition — susceptible FGFR3 genetic alteration for Balversa

Susceptible FGFR3 alterationDocumented susceptible FGFR3 genetic alterations in locally advanced or metastatic urothelial carcinoma required for Balversa coverage

Therapy contextMember progressed during or following at least one line of prior systemic therapy and had prior PD-1/PD-L1 inhibitor or is not a candidate for such therapy

Prescriber requirementPrescribing physician must be an oncologist or urologist

Generalized fatigue exclusion definition — armodafinil/modafinil noncoverage contexts

Generalized fatigue exclusionArmodafinil and modafinil will not be approved for generalized fatigue, jet lag, or sleep-deprivation not associated with a covered diagnosis

Covered diagnoses example

Policy Scope and Background

This document provides drug‑specific prior authorization medical necessity criteria for a broad range of specialty and pharmacy drugs used across oncology, immunology, pulmonology, neurology, and other areas. It defines required medical information (diagnosis, mutation or pathogen testing when applicable), prescriber specialty requirements, coverage durations (commonly 2 years), and prerequisite therapy or step‑therapy requirements. For certain agents (for example, tolvaptan/Jynarque) the policy specifies monitoring schedules (liver tests) and duration‑specific monitoring obligations prior to authorization.

Policy Summary

Payerharvard pilgrim health care

PolicyPrior Authorization Medical Necessity Guidelines — Pharmacy & Specialty Drugs

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documented diagnosis, required prior therapy history or mutation testing, and prescriber specialty when specified.

SourceLink

On This Page

Adalimumab products: Member has a documented diagnosis corresponding to the requested indication (e.g., active ankylosing spondylitis; Crohn's disease; moderately to severely active ulcerative colitis; moderate-to-severe plaque psoriasis with failure or intolerance to specified topical therapies; psoriatic arthritis; rheumatoid arthritis with trial and failure/contraindication/intolerance to one conventional therapy); AND prescribed by or in consultation with relevant specialist as indicated (dermatologist, gastroenterologist, ophthalmologist, or rheumatologist); coverage duration 2 years; prerequisite Part D drug required for some entries.

From chunks 2-3

Per-product prior authorization criteria (excerpt)

Products are covered when ALL of the following product-specific criteria are met

Cometriq: Documented diagnosis of progressive, metastatic medullary thyroid cancer with unresectable locally advanced or metastatic disease; prescribing physician is an oncologist; coverage duration 2 years.

From chunks 18-19

Cayston: Diagnosis of cystic fibrosis AND evidence of Pseudomonas aeruginosa in the lungs; coverage duration 2 years.

From chunk 19

Copiktra: Documented diagnosis of relapsed or refractory CLL or SLL AND received at least two prior therapies; prescribing physician is a hematologist or oncologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 20

Cosentyx/Enbrel/Etc (class examples): Indications including ankylosing spondylitis, plaque psoriasis (failed topical/systemic therapies), psoriatic arthritis, non-radiographic axial spondyloarthritis (objective inflammation with failed NSAID trials), enthesitis-related arthritis (failed NSAID trials); prescribed by or in consultation with dermatologist or rheumatologist; coverage duration 2 years; prerequisite Part D drug required where specified.

From chunks 21,31

Dupixent: Indication-specific documented diagnosis (e.g., moderate-to-severe atopic dermatitis with trial/failure of topical therapies, severe eosinophilic asthma despite inhaled corticosteroid plus additional controller, CRSwNP inadequately controlled, EGPA, etc.); prescribed by or in consultation with appropriate specialist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 28

Everolimus: Diagnosis consistent with labeled oncologic or TSC-related indications (eg, advanced HR+ breast cancer with exemestane after aromatase inhibitor failure; ARCC after sorafenib or sunitinib; progressive pNET; renal angiomyolipoma with TSC; SEGA associated with TSC not candidate for surgery); prescribing physician is a neurologist or oncologist; coverage duration 2 years; prerequisite Part D drug may be required for some formulations.

From chunk 35-36

Exkivity: Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations AND progressed on or after platinum-based chemotherapy; prescribing physician is an oncologist; coverage duration 2 years.

From chunk 36

Fasenra: Either (1) severe asthma with eosinophilic phenotype despite inhaled corticosteroid plus an additional controller OR (2) eosinophilic granulomatosis with polyangiitis (EGPA); prescribing physician is an asthma specialist or rheumatologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 37

Exkivity (EGFR exon 20 insertions)

Coverage criteria for Exkivity

Exkivity: locally advanced or metastatic NSCLC with EGFR exon 20 insertion: Member must have documented locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutation; AND disease has progressed on or after platinum-based chemotherapy; AND prescribing physician is an oncologist; coverage duration 2 years.

From chunk 36

Fasenra

Coverage criteria for Fasenra

Fasenra indications: 1) Severe asthma with eosinophilic phenotype despite current treatment with inhaled corticosteroid plus an additional controller (LABA, leukotriene modifier, or theophylline) OR 2) Eosinophilic granulomatosis with polyangiitis (EGPA).

Prescriber must be an asthma specialist or rheumatologist; coverage duration 2 years; prerequisite Part D drug required. From chunk 37

GLP-1 / Type 2 Diabetes

Coverage criteria for GLP-1 receptor agonists / Type 2 Diabetes (selected products listed)

Type 2 Diabetes (initial): Diagnosis of Type 2 Diabetes confirmed by prescriber documentation OR record of a trial with a minimum 90-day supply of one product from a specified class (metformin-containing agent, DPP-4 inhibitor, SGLT2 inhibitor, alpha-glucosidase inhibitor, meglitinide, or sulfonylurea); coverage duration 2 years; reauthorization requires documentation of positive clinical response.>= 90 days

From chunk 40

Icatibant Acetate

Coverage criteria and exclusion for Icatibant Acetate

Icatibant for Hereditary Angioedema (HAE): Documented diagnosis of hereditary angioedema (HAE) with history of at least one severe attack in the past 6 months; for HAE Types 1 and 2 diagnosis must be confirmed by laboratory testing (low C4 and reduced C1 esterase inhibitor level or function); prescribing physician must be an allergist, hematologist, or immunologist; will not be approved for acquired angioedema or for members concurrently taking an ACE inhibitor; coverage duration 2 years.

From chunk 45

Selected hematology/immune drug criteria (Jaypirca and related)

Coverage is subject to drug-specific clinical criteria as follows.

Selected hematology/immune agents (example: Jaypirca): Member must have a documented diagnosis appropriate to the listed indication (e.g., relapsed/refractory mantle cell lymphoma with ≥2 prior systemic therapies including a BTK inhibitor; chronic GVHD after failure of one or two systemic therapies; intermediate/high-risk myelofibrosis); prescribing physician is a hematologist or oncologist as applicable; coverage duration 2 years; prerequisite Part D drug required where specified.

From chunk 54

Selected hematology/immune drug criteria (Jaypirca and related)

Oncology oral agents — covered when the following indication-specific criteria are met:

Jubbonti (oral oncology agent): Indication 1: Relapsed/refractory mantle cell lymphoma with ≥2 prior systemic therapies including a BTK inhibitor; OR Indication 2: CLL/SLL previously treated with a covalent BTK inhibitor; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 55

Jubbonti (denosumab noted elsewhere) criteria

Jubbonti (denosumab) for osteoporosis — authorized when ONE of the following is met:

Denosumab for osteoporosis: 1) Member at high risk of fracture; OR 2) Inadequate response to or intolerance of at least one traditional osteoporosis agent (eg, alendronate, risedronate, zoledronic acid); OR 3) Female at high risk receiving adjuvant aromatase inhibitor therapy and using denosumab to increase bone mass; OR 4) Men at high fracture risk receiving androgen deprivation for non-metastatic prostate cancer; OR 5) Glucocorticoid-induced osteoporosis in those at high fracture risk; prescribing physician must be hematologist/oncologist as appropriate; coverage duration 2 years; prerequisite Part D drug required where specified.

From chunk 56

Jubbonti (denosumab) osteoporosis indications

Covered when ALL of the following are met:

Denosumab (osteoporosis indications): Member meets one of the denosumab osteoporosis indications as specified (high fracture risk, prior treatment failure/intolerance to traditional agents, aromatase inhibitor–associated bone loss, androgen deprivation–associated high fracture risk, or glucocorticoid-induced osteoporosis); coverage duration 2 years; prerequisite Part D drug required.

From chunk 56

Jynarque (tolvaptan) ADPKD

Tolvaptan (Jynarque) for ADPKD — initial and reauthorization criteria:

Jynarque initial: Documented diagnosis of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD); AND either (A) patient has received Jynarque ≤18 months AND ALT, AST, and bilirubin measured prior to initiation, at 2 and 4 weeks after initiation, then monthly for the first 18 months, OR (B) patient has received Jynarque >18 months AND ALT, AST, and bilirubin measured at least every 3 months; AND no history of significant liver impairment or injury (excluding uncomplicated polycystic liver disease); coverage duration 1 year.

From chunk 57 and threshold details in chunk 110

Jynarque reauthorization: Patient demonstrates positive clinical response to therapy and has no signs or symptoms consistent with hepatic injury OR has uncomplicated polycystic liver disease; ongoing liver monitoring as per duration on therapy required; coverage duration 1 year.

From chunk 57

Kalydeco (ivacaftor)

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 or in vitro data; if genotype unknown perform an FDA-cleared CF mutation test with verification as recommended; granules formulation: age ≥1 month; exclusion: not effective for patients homozygous for F508del mutation; coverage duration 2 years.

From chunk 58

Kesimpta criteria

Covered when ALL of the following are met:

Kesimpta (ofatumumab): Documented diagnosis of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive disease; prescribing physician must be a neurologist; coverage duration 2 years.

From chunk 59

Kineret indications and reauthorization

Covered when the following indication-specific criteria are met:

Kineret — Rheumatoid arthritis (initial): Documented diagnosis of moderately to severely active rheumatoid arthritis AND either (a) trial and failure, contraindication, or intolerance to two of the listed agents (etanercept, a formulary adalimumab product, abatacept, upadacitinib, tofacitinib) OR (b) continuation of prior therapy; prescribed by or in consultation with a rheumatologist; coverage duration 1 year; prerequisite Part D drug required.

From chunks 60-61

Kineret — NOMID (initial): Documented diagnosis of neonatal-onset multisystem inflammatory disease (NOMID) AND confirmation by either NLRP3/CIAS1 mutation OR presence of two listed clinical symptoms plus elevated acute phase reactants; prescribed by or in consultation with appropriate specialist; coverage duration 1 year.

From chunks 60-61

Lazcluze NSCLC criteria

Covered when ALL of the following are met:

Lazcluze with amivantamab: Documented diagnosis of locally advanced or metastatic non-small cell lung cancer AND use as first-line treatment in combination with amivantamab AND presence of EGFR exon 19 deletion or exon 21 L858R substitution mutation; coverage duration 2 years; continuation of prior therapy approved.

From chunk 65

Lenalidomide indications

Covered when ANY of the following indication-specific criteria are met:

Lenalidomide by indication: Follicular lymphoma previously treated — lenalidomide used with rituximab; Mantle cell lymphoma relapsed/progressed after two prior therapies including bortezomib; Marginal zone lymphoma previously treated — lenalidomide with rituximab; Multiple myeloma — lenalidomide with dexamethasone or as post-autologous HSCT maintenance; MDS transfusion-dependent anemia with 5q deletion — lenalidomide indicated; prescribing physician must be hematologist/oncologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 66

Lidocaine patch (postherpetic neuralgia/diabetic neuropathy)

Covered when ANY of the following are met:

Lidocaine 5% patch: For postherpetic neuralgia or diabetic neuropathy: member has failed, had adverse reaction to, or is contraindicated for gabapentin; patches may be approved for members not candidates for opioid or other oral pain management therapy; new members approved if pain currently well-controlled on lidocaine patches; coverage duration 2 years.

From chunk 68

Livtencity (post-transplant CMV)

Covered when ALL of the following are met:

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

From chunk 68

Lonsurf criteria

Covered when ANY of the following indication-specific criteria are met:

Lonsurf (trifluridine‑tipiracil): mCRC: metastatic colorectal cancer 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 a fluoropyrimidine and a platinum and either a taxane or irinotecan and, if appropriate, HER2-targeted therapy; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 69

Lorbrena criteria

Covered when ALL of the following are met:

Lorbrena (lorlatinib): Documented metastatic non‑small cell lung cancer with ALK‑positive tumor; prescribing physician must be an oncologist; coverage duration 2 years; no prerequisite Part D drug required.

From chunk 70

Lumakras indications

Covered when ANY of the following are met:

Lumakras (sotorasib): 1) KRAS G12C‑mutated locally advanced or metastatic NSCLC with at least one prior systemic therapy; OR 2) KRAS G12C‑mutated metastatic colorectal cancer used in combination 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.

From chunk 70

Lybalvi criteria

Covered when ALL of the following are met:

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

From chunk 71

Lynparza (olaparib) indications

Lynparza — Covered when ALL of the following are met:

Lynparza — breast/ovarian/pancreas/prostate indications: Breast: deleterious/suspected deleterious gBRCA‑mutated HER2‑negative metastatic breast cancer treated with chemotherapy in neoadjuvant/adjuvant/metastatic setting and if HR+ prior endocrine therapy or contraindication/intolerance, OR high‑risk early breast cancer treated with neoadjuvant/adjuvant chemo; Ovarian: maintenance for deleterious/suspected deleterious germline or somatic BRCA‑mutated advanced epithelial ovarian/fallopian tube/primary peritoneal cancer in complete/partial response to first‑line platinum chemo OR maintenance with bevacizumab for HRD‑positive cancers in response to first‑line platinum chemo OR maintenance for recurrent disease in response to platinum chemo; Pancreatic: deleterious/suspected deleterious germline BRCA‑mutated metastatic pancreatic adenocarcinoma with no progression after ≥16 weeks of first‑line platinum chemo; Prostate: deleterious/suspected deleterious germline or somatic HRR‑mutated mCRPC progressed following enzalutamide or abiraterone OR deleterious/suspected deleterious BRCA‑mutated mCRPC in combination with abiraterone and prednisone/prednisolone; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

From chunks 72-73

Lynparza — Medical necessity criteria

Lynparza — Covered when ALL of the following are met:

Lynparza medical necessity: Member meets the specific, labeled criteria for the requested Lynparza indication (see indication‑specific requirements for BRCA/HRR mutation status, prior therapy and line‑of‑therapy requirements); prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 72

Lytgobi — Medical necessity criteria

Lytgobi — Covered when ALL of the following are met:

Lytgobi (FGFR2 fusion cholangiocarcinoma): Documented 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.

From chunk 74

Mavyret — Guideline-based criteria

Coverage applied consistent with guideline-based criteria:

Mavyret (HCV): Coverage criteria applied consistent with current AASLD‑IDSA guidance for hepatitis C indications; prescribing physician must be a gastroenterologist, hepatologist, or infectious disease specialist; duration per guidance.

From chunk 74

Pulmonary hypertension and CTEPH — Medical necessity criteria

Pulmonary hypertension agents — Covered when ALL of the following are met:

Pulmonary arterial hypertension (PAH): Documented diagnosis of pulmonary arterial hypertension confirmed by right heart catheterization; prescribing physician must be a cardiologist or pulmonologist; coverage duration 2 years.

From chunk 75

CTEPH: Diagnosis of persistent or recurrent chronic thromboembolic pulmonary hypertension after surgical treatment or inoperable disease; prescribing physician must be a cardiologist or pulmonologist; coverage duration 2 years.

From chunk 75

Mekinist — Medical necessity criteria

Mekinist — Covered when ALL of the following are met:

Mekinist single agent: Unresectable or metastatic melanoma with BRAF V600E or V600K mutation used as single agent when appropriate; Mekinist will not be approved as single agent for members who have received prior BRAF‑inhibitor therapy; prescribing physician must be an oncologist; coverage duration 2 years.

From chunk 76

Mekinist with Tafinlar: Indications for Mekinist in combination with Tafinlar include unresectable/metastatic melanoma with BRAF V600E/K, melanoma with lymph node involvement post‑resection, metastatic NSCLC with BRAF V600E, locally advanced/metastatic anaplastic thyroid cancer with BRAF V600E lacking satisfactory locoregional options, unresectable/metastatic solid tumors with BRAF V600E after prior treatment, and low‑grade glioma with BRAF V600E requiring systemic therapy; prescribing physician must be an oncologist; coverage duration 2 years.

From chunk 76

Mektovi — Medical necessity criteria

Mektovi — Covered when ALL of the following are met:

Mektovi (with encorafenib): Documented unresectable or metastatic melanoma with BRAF V600E or V600K mutation to be taken in combination with encorafenib OR metastatic NSCLC with BRAF V600E to be taken in combination with encorafenib; prescribing physician must be an oncologist; coverage duration 2 years.

From chunk 77

Modeyso — Medical necessity criteria

Modeyso — Covered when ALL of the following are met:

Modeyso (diffuse midline glioma): Documented diagnosis of diffuse midline glioma confirmed by presence of H3 K27M mutation and disease progressed following prior therapy; coverage duration 2 years; continuation of prior therapy approved; prerequisite Part D drug required as noted.

From chunks 77-78

Nayzilam — Medical necessity criteria

Nayzilam — Covered when ALL of the following are met:

Nayzilam (acute seizure treatment): Documented diagnosis of a seizure disorder requiring acute treatment; prescribing physician must be a neurologist; coverage duration 2 years.

From chunk 78

Nerlynx — Medical necessity criteria

Nerlynx — Covered when ALL of the following are met:

Nerlynx indications: Extended adjuvant treatment of early‑stage HER2‑positive breast cancer after 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.

From chunk 79

Nexletol/Nexlizet — Medical necessity criteria

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

LDL‑C elevation criteria: Patient has elevated LDL‑C while on maximally tolerated statin therapy or has contraindication/intolerance to statins; AND diagnosis of HeFH, atherosclerotic cardiovascular disease, or established CVD or high risk for a CVD event; medication prescribed by or in consultation with cardiology/endocrine/lipid specialist; prerequisite Part D drug required; coverage duration 2 years.

From chunks 79‑81

Nilotinib — Medical necessity criteria

Covered when ALL of the following are met:

Nilotinib: Documented diagnosis of Philadelphia chromosome‑positive chronic myeloid leukemia (Ph+ CML); prescribing physician must be a hematologist or oncologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 81

Ninlaro — Medical necessity criteria

Ninlaro — Covered when ALL of the following are met:

Ninlaro (multiple myeloma): Documented diagnosis of multiple myeloma and use in combination with lenalidomide and dexamethasone in patients who have received at least one prior therapy; prescribing physician must be an oncologist; prerequisite Part D drug required; coverage duration 2 years.

From chunk 81

Nitisinone — Medical necessity criteria

Nitisinone — Covered when ALL of the following are met:

Nitisinone (HT‑1): Documented diagnosis of hereditary tyrosinemia type‑1 (HT‑1); coverage duration 2 years.

From chunk 81

Nubeqa — Medical necessity criteria

Nubeqa — Covered when ANY of the following are met:

Nubeqa indications: Diagnosis of non‑metastatic castration‑resistant prostate cancer OR metastatic castration‑sensitive prostate cancer (monotherapy or with docetaxel); prescribing physician must be an oncologist or urologist; coverage duration 2 years; no prerequisite Part D drug required.

From chunk 82

Nuedexta — Medical necessity criteria

Nuedexta — Covered when ALL of the following are met:

Nuedexta (PBA): Documented diagnosis of pseudobulbar affect (PBA); coverage duration 2 years; no prerequisite Part D drug required.

From chunk 82

Nuplazid — Medical necessity criteria

Nuplazid — Covered when ALL of the following are met:

Nuplazid (Parkinson's disease psychosis): Documented diagnosis of Parkinson's disease with hallucinations and delusions associated with Parkinson's disease psychosis; medication prescribed by or in consultation with a neurologist or psychiatrist; coverage duration 2 years.

From chunk 84 (Nuplazid entry referenced in chunk 83)

Nurtec — Medical necessity criteria

Nurtec — Covered when ANY of the following are met:

Nurtec indications: 1) Acute migraine with inadequate response/intolerance/contraindication to at least one triptan medication; OR 2) episodic migraine; prerequisite Part D drug required for some pathways; coverage duration 2 years.

From chunk 84 (Nurtec entry referenced in chunk 83)

Odomzo — Medical necessity criteria

Odomzo — Covered when ALL of the following are met:

Odomzo (locally advanced BCC): Locally advanced basal cell carcinoma with disease recurrence after surgery/radiation OR patient not a candidate for surgery/radiation; prescribing physician must be an oncologist; coverage duration 2 years.

From chunk 85 (Odomzo entry referenced in chunk 84)

Ofev/Nintedanib — Medical necessity criteria

Ofev/Nintedanib — Covered when ANY of the following are met:

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

From chunk 85

Ogsiveo — Medical necessity criteria

Ogsiveo — Covered when ALL of the following are met:

Ogsiveo (desmoid tumors): Diagnosis of progressing desmoid tumors AND patient requires systemic treatment; prescribing physician must be an oncologist or sarcoma specialist; coverage duration 2 years.

From chunk 86 (Ogsiveo entry referenced in chunk 85)

Ojemda — Medical necessity criteria

Ojemda — Covered when ALL of the following are met:

Ojemda (pediatric low‑grade glioma): Diagnosis of relapsed or refractory pediatric low‑grade glioma with BRAF fusion/rearrangement or BRAF V600 mutation; coverage duration 2 years.

From chunk 86 (Ojemda entry referenced in chunk 85)

Ojjaara — Medical necessity criteria

Ojjaara — Covered when ALL of the following are met:

Ojjaara (myelofibrosis): Diagnosis of intermediate‑ or high‑risk myelofibrosis (primary or secondary) in adults with anemia; coverage duration 2 years.

From chunk 87 (Ojjaara entry referenced in chunk 86)

Onureg — Medical necessity criteria

Onureg — Covered when ALL of the following are met:

Onureg (AML maintenance): Documented diagnosis of acute myeloid leukemia with first complete remission (CR) or CRi after intensive induction chemotherapy and not able to complete intensive curative therapy; prescribing physician must be a hematologist or oncologist; prerequisite Part D drug required; coverage duration 2 years.

From chunks 86‑87

Opipza — Medical necessity criteria

Opipza — Covered when ANY of the following are met:

Opipza indications: Schizophrenia OR major depressive disorder as adjunctive therapy OR irritability associated with autistic disorder in pediatric patients OR Tourette's disorder in pediatric patients; prescribing physician must be a psychiatrist or neurologist; continuation of prior therapy approved; coverage duration 2 years; no prerequisite Part D drug required.

From chunks 86‑87

Orencia — Medical necessity criteria

Orencia — Covered when ALL of the following are met:

Orencia indications: Rheumatoid arthritis with trial/failure/contraindication/intolerance to conventional DMARDs (eg methotrexate, leflunomide, sulfasalazine), polyarticular juvenile idiopathic arthritis with trial/failure to conventional therapies, or psoriatic arthritis; prescribing physician must be dermatologist, rheumatologist, oncologist, or transplant specialist; prerequisite Part D drug required; coverage duration 2 years.

From chunk 88

Orgovyx — Medical necessity criteria

Orgovyx — Covered when ALL of the following are met:

Orgovyx (advanced prostate cancer): Documented diagnosis of advanced prostate cancer; prescribing physician must be an oncologist or urologist; coverage duration 2 years; no prerequisite Part D drug required.

From chunk 88

Orkambi — Medical necessity criteria

Orkambi — Covered when ALL of the following are met:

Orkambi (CF F508del homozygous): Documented diagnosis of cystic fibrosis and documentation that the member is homozygous for the F508del mutation; coverage duration 2 years; no prerequisite Part D drug required.

From chunk 90 (Orkambi entry referenced in chunk 89)

Orserdu — Medical necessity criteria

Orserdu — Covered when ALL of the following are met:

Orserdu (ESR1‑mutated breast cancer): Documented advanced or metastatic ER‑positive, HER2‑negative breast cancer in a postmenopausal woman or adult man with documented ESR1 mutation and disease progression following at least one line of endocrine therapy; prescribing physician must be an oncologist; prerequisite Part D drug required; coverage duration 2 years.

From chunk 90 (Orserdu entry referenced in chunk 89)

Otezla — Medical necessity criteria

Otezla — Covered when ANY of the following are met:

Otezla indications: 1) Psoriatic arthritis with documented diagnosis; OR 2) Plaque psoriasis with documented diagnosis and failure/intolerance to at least one topical agent (examples listed); OR 3) Oral ulcers associated with Behcet's disease with active oral ulcers; prescribing physician must be dermatologist or rheumatologist; prerequisite Part D drug required for some indications; coverage duration 2 years.

From chunks 90‑91

Orserdu — CF indication

Orserdu — Cystic fibrosis indication (product‑specific coverage):

Orserdu (CF): Documented diagnosis of cystic fibrosis AND documentation member is homozygous for the F508del mutation; coverage duration 2 years; no prerequisite Part D drug required.

From chunk 90

Otezla indications

Otezla (summary): Psoriatic arthritis, plaque psoriasis with prior topical therapy failure, or Behcet's oral ulcers as specified; prescribed by or in consultation with dermatologist or rheumatologist; coverage duration 2 years; prerequisite Part D drug required where noted.

From chunk 90

Piqray criteria

Piqray (alpelisib): Documented HR‑positive, HER2‑negative, PIK3CA‑mutated advanced or metastatic breast cancer; disease progressed on or after an endocrine‑based regimen; Piqray used in combination with fulvestrant; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 92

Pomalidomide indications

Pomalidomide (Pomalyst): Kaposi sarcoma after HAART failure OR multiple myeloma after ≥2 prior therapies including lenalidomide and a proteasome inhibitor with progression within 60 days of last therapy and used with dexamethasone; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 93

PCSK9 inhibitor criteria

PCSK9 inhibitors (Praluent/Repatha): Member has elevated LDL‑C while on a high‑intensity statin or has contraindication/intolerance to statins; AND documented diagnosis of atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia (HeFH), or homozygous familial hypercholesterolemia (HoFH) confirmed by testing or clinical criteria; coverage duration 2 years; prerequisite Part D drug required for some products.

From chunks 98‑99

Rezdiffra initial and reauthorization criteria

Rezdiffra (MASH): Diagnosis of metabolic dysfunction‑associated steatohepatitis (MASH) without cirrhosis; fibrosis stage F2 or F3 confirmed by specified biomarker/imaging or liver biopsy within 12 months; presence of ≥1 metabolic risk factor (e.g., type 2 diabetes, hypertension, obesity); prescribed by or in consultation with a gastroenterologist or hepatologist; reauthorization requires positive response and no progression to cirrhosis; coverage duration 2 years.Fibrosis F2 or F3

From chunk 102

Rinvoq coverage rules

Rinvoq (upadacitinib): Indication‑specific documented diagnosis AND prior trial/failure of particular conventional therapies as required per indication (e.g., RA requires trial/failure/contraindication/intolerance to one conventional therapy and inadequate response/intolerance to one or more TNF inhibitors); prescribed by or in consultation with appropriate specialist (allergist/immunologist, dermatologist, gastroenterologist, or rheumatologist); coverage duration 2 years; prerequisite Part D drug required where specified.

From chunks 104‑105

Revuforj indications

Revuforj: Diagnosis of relapsed or refractory acute leukemia with a KMT2A translocation OR relapsed/refractory AML with a susceptible NPM1 mutation; coverage duration 2 years; continuation of prior therapy approved.

From chunk 101

Rozlytrek indications

Rozlytrek: Metastatic NSCLC with ROS1‑positive tumors OR solid tumors with an NTRK gene fusion without known acquired resistance mutation that are metastatic or where surgery would cause severe morbidity and have progressed following treatment or have no satisfactory alternative therapy; prescribing physician must be an oncologist; coverage duration 2 years.

From chunk 106

Rydapt (midostaurin) — Initial/required criteria

Rydapt (midostaurin) — Covered when ALL of the following are met

Rydapt (midostaurin) initial therapy: Member has documented diagnosis of AML that is FLT3 mutation‑positive AND Rydapt is being used as first‑line therapy in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation; prescribing physician must be a hematologist or oncologist; coverage duration 2 years.

From chunk 108

TIRF (Fentanyl transmucosal) — Coverage criteria

TIRF products — Covered when ALL of the following are met

TIRF coverage: Used for management of breakthrough pain in adult cancer patients who are already receiving and are tolerant to around‑the‑clock opioid therapy for persistent cancer pain; pediatric approval (lozenges) for ≥16 years; patient must remain on around‑the‑clock opioids when taking TIRF; patients considered opioid tolerant per opioid‑tolerance definition; TIRF not covered for any non‑cancer pain indication.

From chunk 125

Trikafta — Initial and continuation

Trikafta — Covered when ALL of the following are met

Trikafta initial: Diagnosis of cystic fibrosis AND at least one CFTR mutation responsive to therapy (e.g., F508del or other responsive mutation supported by clinical/in vitro data); age restrictions by formulation (granules 2 to <6 years; tablets ≥6 years); prescribing physician is a pulmonologist or CF center specialist; coverage duration 2 years; reauthorization requires documentation of positive clinical response (eg, PPFEV1 improvement or fewer pulmonary exacerbations).

From chunk 126

Scemblix — Indications

Scemblix — Covered when ANY of the labeled indications are met

Scemblix indications: Diagnosis of Philadelphia chromosome‑positive chronic myeloid leukemia (Ph+ CML) in chronic phase and is newly diagnosed, previously treated, or has documented T315I mutation; prescribing physician must be a hematologist/oncologist; coverage duration 2 years; prerequisite Part D drug required where specified.

From chunk 109

Stelara — Required prior therapy

Stelara — Covered when ALL of the following are met

Stelara requirements: Diagnosis consistent with product labeling (eg, Crohn's disease, plaque psoriasis, psoriatic arthritis, ulcerative colitis) AND trial, intolerance, or contraindication to Yesintek or Steqeyma for the indication; prescribed by or in consultation with appropriate specialist; coverage duration 2 years; prerequisite Part D drug required.

From chunks 113‑114

Truqap — Cystic Fibrosis initial and reauthorization

Covered when the following criteria are met:

Truqap initial (CF): Diagnosis of cystic fibrosis AND at least one CFTR mutation (F508del or CFTR mutation responsive based on clinical/in vitro data); age/formulation restrictions apply (granules 2 to <6 years; tablets ≥6 years); prescribed by or in consultation with pulmonologist or CF care center specialist; coverage duration 2 years.age: granule packets 2 to <6 years; tablets ≥6 years

From chunk 126

Truqap reauthorization: Patient demonstrates positive clinical response to therapy (eg, improvement in PPFEV1 or decreased pulmonary exacerbations); reauthorization requires documentation of clinical benefit.

From chunk 126

Tukysa — HR-positive, HER2-negative breast cancer with PIK3CA/AKT1/PTEN alteration

Covered when ALL of the following are met:

Tukysa (HR‑positive, HER2‑negative with PIK3CA/AKT1/PTEN alteration): Documented diagnosis of locally advanced or metastatic HR‑positive, HER2‑negative breast cancer AND presence of one or more PIK3CA/AKT1/PTEN alterations; AND therapy will be taken in combination with fulvestrant; AND either progression on at least one endocrine‑based regimen in the metastatic setting OR recurrence on or within 12 months of completing adjuvant therapy; prerequisite Part D drug required; coverage duration 2 years.

From chunk 127

Tukisa/Turalio — oncology indications

Covered when ALL of the following are met:

Tukisa/Turalio (oncology indications): Tukisa: documented advanced unresectable or metastatic HER2‑positive breast cancer who have received one or more prior anti‑HER2 regimens in the metastatic setting and will be used in combination with trastuzumab and capecitabine; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required. Turalio: symptomatic tenosynovial giant cell tumor (TGCT) with severe morbidity or functional limitation not amenable to surgery; coverage duration 2 years.

From chunk 128

Rheumatology and related immunomodulatory agents (e.g., Ubrelvy, agents for RA, GCA, SJIA, PJIA, SSc-ILD)

Covered when criteria specific to indication are met:

Rheumatology agents — RA initial: Diagnosis of moderately to severely active RA AND trial and failure, contraindication, or intolerance to two listed alternatives (eg, Enbrel, a formulary adalimumab product, Orencia, Rinvoq, Xeljanz) OR continuation of prior therapy; prescriber rheumatologist or in consultation; reauthorization requires evidence of clinical response.

From chunks 129‑130

SJIA initial: Diagnosis of active systemic juvenile idiopathic arthritis AND trial and failure/contraindication/intolerance to conventional therapies at specified minimum durations (NSAID 1 month, methotrexate 3 months, systemic glucocorticoid 2 weeks); prescriber rheumatologist; coverage duration and reauth per policy.

From chunk 130

SSc‑ILD initial: Diagnosis of systemic sclerosis‑associated interstitial lung disease with exclusion of other causes AND HRCT or biopsy evidence consistent with SSc‑ILD; prescribed by or in consultation with pulmonologist or rheumatologist.

From chunk 130

Hematology/Oncology targeted agents (Vanflyta, Venclexta, Vorinigo, Vizimpro, Vonjo, etc.)

Covered when indication‑specific diagnostic and treatment‑context criteria are met:

Vanflyta (AML): Documented newly diagnosed AML that is FLT3 ITD positive; prescribing physician must be an oncologist or hematologist; coverage duration 2 years.

From chunk 133

Venclexta (AML/CLL): For AML: used as first‑line therapy in combination with azacitidine/decitabine/low‑dose cytarabine in patients ≥75 years or with comorbidities precluding intensive chemotherapy; For CLL/SLL: documented diagnosis as specified; prescribing physician must be a hematologist or oncologist; coverage duration 2 years.

From chunk 134

Voquezna (Voquezna/Voquezna Dual/Triple Pak) — H. pylori and erosive esophagitis indications

Covered when ALL of the following (indication‑specific) criteria are met:

Voquezna — H. pylori: Diagnosis of H. pylori infection AND trial and failure, contraindication, or intolerance to bismuth quadruple therapy (for Dual/Triple Pak) OR used in combination with amoxicillin ± clarithromycin as specified; coverage duration 1 month for H. pylori; prerequisite Part D drug required.

From chunk 138

Voquezna — erosive esophagitis (HRH) and maintenance (MHRH): Diagnosis of erosive esophagitis AND trial and inadequate response/intolerance/contraindication to TWO generic PPIs; coverage durations HRH 2 months, MHRH 6 months; prerequisite Part D drug required.

From chunk 139

Voquezna — NERD: History of heartburn ≥6 months with symptoms ≥4 days in any consecutive 7‑day period AND trial and inadequate response/intolerance/contraindication to TWO generic PPIs; coverage per criterion; prerequisite Part D drug required.

From chunk 139

Vowst — recurrent C. difficile infection

Covered when the following are met:

Vowst (recurrent C. difficile infection): Documented recurrent Clostridioides difficile infection AND completion of oral vancomycin or fidaxomicin 2–4 days prior to initiating Vowst; prescribing physician is a gastroenterologist or infectious disease specialist; coverage duration 14 days.

From chunk 142

Vyndamax — transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM)

Covered when ALL of the following are met:

Vyndamax (ATTR‑CM initial): Documented transthyretin‑mediated amyloidosis with cardiomyopathy (ATTR‑CM) AND one of: presence of a TTR mutation, biopsy demonstrating TTR amyloid, OR cardiac imaging suggestive of amyloidosis with absence of light‑chain disease; documentation of NYHA functional class I–III; prescribing physician must be a cardiologist; coverage duration: plan year.NYHA I–III

From chunk 143

Vyndamax reauthorization: Patient continues to have NYHA functional class I–III heart failure to support ongoing therapy; coverage for reauth: plan year.

From chunk 143

Wyost (denosumab) — skeletal-related events, GCTB, hypercalcemia of malignancy

Covered when ONE of the following is met:

Wyost — prevention of skeletal‑related events: Prevention of skeletal‑related events in patients with multiple myeloma or bone metastases from solid tumors.

From chunk 145

Wyost — unresectable GCTB: Treatment of unresectable giant cell tumor of bone (GCTB) or when surgical resection likely to result in severe morbidity.

From chunk 145

Wyost — hypercalcemia of malignancy: Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

From chunk 145

Wyost (denosumab)

Coverage authorized if ONE of the following is met

Wyost indications (summary): 1) Prevention of skeletal‑related events in multiple myeloma or bone metastases from solid tumors; OR 2) Treatment of unresectable giant cell tumor of bone (GCTB) or when surgical resection likely causes severe morbidity; OR 3) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required where specified.

From chunk 145

Xalkori

Coverage requires documented diagnosis of one of the following

Xalkori indications: Metastatic NSCLC that is ALK‑positive or ROS1‑positive; relapsed/refractory systemic ALCL that is ALK‑positive; unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK‑positive; prescribing physician must be an oncologist; coverage duration 2 years.

From chunk 146 (Xalkori entry referenced in chunk 145)

Xdemvy

Coverage requirement

Xdemvy: Documented diagnosis of Demodex blepharitis; must be prescribed by or in consultation with an ophthalmologist or optometrist; coverage duration 2 years.

From chunk 146

Xeljanz / Xeljanz XR

Coverage requires criteria depending on indication

Xeljanz / Xeljanz XR indications: Indication‑specific criteria such as: for RA/PJIA/psoriatic arthritis/ankylosing spondylitis — diagnosis plus prior trial/failure/intolerance to listed conventional therapies and inadequate response/intolerance to one or more TNF inhibitors; for UC and other indications similar prior therapy requirements apply; prescribed by or in consultation with gastroenterologist or rheumatologist; coverage duration 2 years; prerequisite Part D drug required where specified.

From chunk 147

Xermelo

Coverage criteria

Xermelo (carcinoid syndrome diarrhea): Documented diagnosis of carcinoid syndrome diarrhea inadequately controlled by somatostatin analog (SSA) therapy alone AND Xermelo used in combination with an SSA; prescribing physician must be a gastroenterologist, hematologist, or oncologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 148

Xifaxan TABS 550MG

Coverage criteria

Xifaxan 550 mg indications: Hepatic encephalopathy: documented diagnosis and inadequate response or contraindication to lactulose; OR IBS‑D: documented diagnosis of IBS‑D; coverage duration 2 years; prerequisite Part D drug required.

From chunk 148

Xolair

Coverage requires condition‑specific criteria

Xolair indications: Asthma: moderate‑to‑severe persistent asthma with prior treatment failure including two or more listed medication classes AND perennial allergen sensitivity and pretreatment IgE 30–1300 IU/mL; CSU: documented chronic spontaneous urticaria symptomatic despite H1 antihistamine; nasal polyps: inadequate response to nasal corticosteroids; prescribing physician must be allergist, dermatologist, immunologist, otolaryngologist, or pulmonologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 149

Xospata

Coverage criteria

Xospata indication: Relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation; prescribing physician must be a hematologist or oncologist; coverage duration 2 years.

From chunk 150

Xpovio (selinexor)

Multiple indication‑specific criteria

Xpovio (selinexor) indications: In combination with dexamethasone: relapsed or refractory multiple myeloma with at least four prior therapies and refractory to at least two proteasome inhibitors, at least 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 after at least 2 lines of systemic therapy (criteria noted); prescribing physician must be a hematologist or oncologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 151

Xtandi

Coverage criteria

Xtandi indications: Non‑metastatic castration‑resistant prostate cancer OR metastatic hormone‑sensitive prostate cancer when used in combination with docetaxel; prescribing physician must be an oncologist or urologist; coverage duration 2 years.

From chunk 152

Steqeyma / Yesintek (biosimilars) and related agents

Coverage criteria

Steqeyma / Yesintek (biosimilars): Indication‑specific criteria for inflammatory and GI diseases (eg, Crohn's disease, plaque psoriasis, psoriatic arthritis, ulcerative colitis) including documented diagnosis and prior therapy failures as specified; prescribed by or in consultation with dermatologist, gastroenterologist or rheumatologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 153

Zejula

Coverage criteria

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

From chunk 154

Zelboraf

Coverage criteria

Zelboraf indications: Erdheim‑Chester Disease (ECD) with BRAF V600 mutation OR unresectable or metastatic melanoma that is BRAF V600E mutation‑positive; not indicated for wild‑type BRAF melanoma; prescribing physician must be an oncologist or hematologist; coverage duration 2 years.

From chunk 155

Zolinza

Coverage criteria

Zolinza (CTCL): Cutaneous T‑cell lymphoma with progressive, persistent or recurrent disease AND documented current or prior treatment or failure with at least two systemic chemotherapeutic agents for CTCL; prescribing physician must be an oncologist; coverage duration 2 years; prerequisite Part D drug required.

From chunk 155

Ztalmy

Coverage criteria

Ztalmy indication: Seizures associated with cyclin‑dependent kinase‑like 5 (CDKL5) deficiency disorder (CDD); prescribed by or in consultation with a neurologist; coverage duration 2 years.

From chunk 156

Zurzuvae

Coverage criteria

Zurzuvae (postpartum depression): Documented diagnosis of postpartum depression (PPD); coverage duration 14 days; no prerequisite Part D drug required.

From chunk 156

Zydelig

Coverage criteria

Zydelig (CLL): Documented diagnosis of relapsed chronic lymphocytic leukemia (CLL) and use in combination with rituximab; prescribing physician must be a hematologist or oncologist; coverage duration 2 years; no prerequisite Part D drug required.

From chunk 157

Coverage will be denied when a drug request falls within an explicitly listed exclusion. For example, Benlysta (belimumab) is not approved as monotherapy, is not approved for members with severe active lupus nephritis or severe active CNS lupus, is not approved for members who are autoantibody negative, and is not approved for use in combination with other biologics or intravenous cyclophosphamide. When an exclusion applies, authorization should not be granted regardless of other supporting documentation.

Armodafinil and modafinil are subject to an explicit coverage exclusion: requests for these agents will be denied when the indication is generalized fatigue, jet lag, or sleep-deprivation not associated with a covered diagnosis. Approvals are limited to the labeled indications such as narcolepsy, excessive sleepiness associated with obstructive sleep apnea, or shift-work sleep disorder and require documentation of the qualifying diagnosis.

Certain BRAF-targeted agents are limited to patients with activating BRAF mutations. For example, Braftovi is not indicated for patients with wild-type BRAF melanoma or wild-type BRAF colorectal cancer; coverage requires documentation of an appropriate BRAF V600E or V600K mutation per the product labeling.

Requests for Dupixent for acute respiratory emergencies will be denied: Dupixent will not be approved for relief of acute bronchospasm or status asthmaticus. Approvals are limited to the chronic, labeled indications (e.g., atopic dermatitis, eosinophilic asthma, CRSwNP) with the required preauthorization documentation.

Cotellic (cobimetinib) is indicated only in tumors with the appropriate BRAF mutation context and is not indicated for treatment of patients with wild-type BRAF melanoma. Coverage requires documentation of a BRAF V600E or V600K mutation and, where applicable, use in combination with the specified companion BRAF inhibitor.

Icatibant requests are excluded for members with acquired angioedema or for those taking an ACE inhibitor: icatibant will not be approved for members with acquired angioedema or concurrently taking an ACE inhibitor. Approvals require documented hereditary angioedema and confirmatory laboratory testing for Types 1 and 2 when indicated.

Iclusig (ponatinib) has a treatment-setting exclusion: it will not be approved for members with newly diagnosed chronic phase CML. Coverage is limited to the labeled settings such as T315I-positive disease or chronic/accelerated/blast phase CML with resistance or intolerance to prior kinase inhibitors, per required documentation.

Ivacaftor (Kalydeco) is genotype-specific and is not effective for patients homozygous for the F508del CFTR mutation. Coverage requires documentation that the member has at least one CFTR mutation responsive to ivacaftor based on clinical or in vitro data (or appropriate genetic testing when genotype is unknown).

Mekinist (trametinib) single-agent use is restricted after prior BRAF-directed therapy: specifically, Mekinist will not be approved as a single agent for members who have received prior BRAF-inhibitor therapy. Coverage for Mekinist should follow the product-specific single-agent versus combination guidance and documentation of prior therapies.

Quinine sulfate has an explicit noncoverage statement in this policy: coverage will not be approved for the treatment or prevention of nocturnal leg cramps. Requests for quinine for that purpose should be denied.

Concurrent chemotherapy is a specific exclusion for some PARP inhibitors: for example, Rubraca will not be approved for concurrent use with other chemotherapy agents. Prior authorization must document intended regimen and concurrent therapy status to confirm eligibility.

Rydapt (midostaurin) is not approvable as single‑agent induction therapy for AML: Rydapt will not be approved as single-agent induction therapy for the treatment of patients with AML. Coverage for Rydapt requires use as first-line therapy in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation for FLT3‑mutated disease, as specified in the criteria.

Certain indication-based exclusions are policy-level and apply across products: for example, TIRF (transmucosal immediate‑release fentanyl) products are not covered for any non‑cancer pain indication, and tadalafil is excluded from coverage for the treatment of erectile dysfunction. Requests should include documentation supporting a covered indication to be considered.

Off‑label uses for products in this segment are generally not listed and are marked as not applicable or N/A in the source. Where no explicit exclusion is present, coverage decisions rely on whether the requested use meets the product‑specific labeled criteria and supporting documentation; absence of a listed exclusion does not itself establish medical necessity.

Several oncology targeted therapies are limited to tumors with activating BRAF mutations; for instance, Zelboraf (vemurafenib) and Braftovi are explicitly not indicated for wild‑type BRAF melanoma. Authorization requires molecular documentation of the relevant BRAF V600 mutation per the product label.

Include prior therapy history or evidence of trial/failure as specified (e.g., prior platinum-based chemotherapy, TNF inhibitors, or specified conventional agents).

If a specialist prescriber is required (oncologist, pulmonologist, CF specialist, neurologist, etc.), document that the prescriber meets the requirement.

Prior Authorization

Exkivity prior authorization — oncology-specific PA example

When requesting PA for Exkivity, document locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation and that the patient progressed on or after platinum-based chemotherapy; the prescriber must be an oncologist.

Indication: locally advanced or metastatic NSCLC with EGFR exon 20 insertion.
Document prior progression on platinum-based chemotherapy.
Prescriber must be an oncologist.
Coverage duration typically 2 years.

Prior Authorization

Fasenra prior authorization — prescriber, prior therapy, Part D prerequisite

For Fasenra PA requests, document severe eosinophilic asthma despite inhaled corticosteroid plus an additional controller, or a diagnosis of EGPA; include specialist prescriber information and note that the criteria require use of a prerequisite Part D drug.

Indication options: severe eosinophilic asthma despite inhaled corticosteroid + additional controller OR eosinophilic granulomatosis with polyangiitis (EGPA).
Prescriber must be an asthma specialist (allergist/immunologist/pulmonologist) or a rheumatologist.
Policy specifies that Fasenra criteria DO require use of a prerequisite Part D drug.

Prior Authorization

Type 2 diabetes (GLP‑1) PA — diagnosis confirmation or prior metformin trial

For GLP-1 agents used for Type 2 Diabetes initial therapy, submit either prescriber confirmation of Type 2 Diabetes or a record of a ≥90‑day trial with metformin or another listed antidiabetic class; reauthorization requires documentation of clinical response.

Initial documentation: prescriber confirmation of Type 2 Diabetes OR ≥90-day trial with metformin-containing product, DPP‑4, SGLT2, alpha‑glucosidase inhibitor, meglitinide, or sulfonylurea.
Reauthorization: evidence of positive clinical response to therapy.
Coverage duration typically 2 years.

Prior Authorization

Part D specialty drug prior authorization — drug‑specific clinical criteria required

Part D specialty drugs in this policy require prior authorization and must meet product‑specific clinical criteria; for several products the policy also requires documentation of prerequisite Part D drug use.

Each Part D specialty drug entry lists the clinical criteria that must be met for approval.
Where noted, include documentation of prior Part D drug therapy as a prerequisite.

Prior Authorization

PA requirement — submit diagnosis, molecular testing, prior therapy, prescriber

Prior authorization approvals require submission of the specified diagnosis, relevant molecular/genetic testing results when applicable, prior therapy history or failures, and the prescriber specialty if required by the product entry.

Examples: BRCA/HRR testing for Lynparza, CFTR mutation documentation for CF modulators, FLT3/IDH1 results for AML agents.
Include prior lines of systemic therapy or failure documentation where product entry requires it.
Confirm prescriber specialty (eg, oncologist, pulmonologist, CF specialist) when the policy mandates it.

Prior Authorization

Orserdu product‑specific PA — ESR1 mutation and prior endocrine therapy

Orserdu requires prior authorization for all medically accepted indications; include documentation of the ESR1 mutation and prior endocrine therapy history where applicable. The policy notes a standard coverage duration of 2 years for Orserdu.

Document ESR1 mutation for advanced/metastatic ER‑positive, HER2‑negative disease.
Provide evidence of progression following at least one line of endocrine therapy.
Prescriber should be an oncologist when indicated; coverage duration typically 2 years.

Prior Authorization

Rinvoq prior authorization and step requirements — prior therapy documentation required

Rinvoq PA requests must include the product‑specific indication and documentation of prior therapy trials/failures as defined by indication (for example, conventional therapy trial and inadequate response and, where required, TNF inhibitor trials).

For RA: trial/failure/contraindication/intolerance to one conventional therapy and inadequate response/intolerance to one or more TNF inhibitors as specified.
Prescriber must be or consult with the appropriate specialty (eg, rheumatologist, dermatologist, gastroenterologist).
Document prior therapy trials, exceptions, or attestation if trials are inappropriate.

Prior Authorization

General PA reminder — include diagnosis, prescriber specialty, prior therapy, duration

This policy reiterates that many specialty drugs listed require prior authorization; ensure PA submission includes diagnosis, prescriber specialty when required, prior therapies, and requested duration per product entry.

Use the product‑level entry to determine exact documentation required for each drug.
Typical coverage duration noted for many products is 2 years; exceptions have shorter durations (eg, Vowst 14 days, Jynarque 1 year, some Voquezna indications shorter).

Prior Authorization

Skyrizi PA — document indication and prior therapy failures

Skyrizi PA must include documentation of the specific labeled diagnosis (plaque psoriasis, psoriatic arthritis, Crohn's disease, or ulcerative colitis) and prior therapy failures or intolerances relevant to the skin or GI indication.

For plaque psoriasis: document moderate‑to‑severe disease and failure/intolerance to listed topical/systemic therapies.
For GI indications: document diagnosis and prior therapies per product entry.
Prescriber specialty per indication (eg, dermatologist, gastroenterologist) should be documented.

Prior Authorization

Truqap prior authorization — CF diagnosis, CFTR mutation, prescriber, reauth evidence

Truqap PA for cystic fibrosis requires documentation of CF diagnosis, CFTR mutation(s) responsive to therapy, prescriber specialty (pulmonologist or CF specialist), and age/formulation where applicable; reauthorization requires evidence of clinical response.

Initial: documented CF diagnosis and at least one CFTR mutation responsive to therapy (eg, F508del or other responsive mutation).
Document prescriber is a pulmonologist or specialist affiliated with a CF care center; note age restrictions for formulations (granules vs tablets).
Reauthorization: evidence of positive clinical response (eg, improved PPFEV1 or fewer exacerbations).
Standard coverage duration typically 2 years.

Prior Authorization

Ustekinumab prior authorization — diagnosis and prior biologic trial requirement

Ustekinumab (Stelara) prior authorization requires a documented diagnosis for the labeled indication and evidence of trial, intolerance, or contraindication to Yesintek or Steqeyma (where specified); prescriber specialty and a 2‑year coverage duration apply.

Document the labeled diagnosis (eg, Crohn's disease, plaque psoriasis, psoriatic arthritis, ulcerative colitis).
Provide evidence of trial and failure/intolerance/contraindication to the specified comparator biologic (Yesintek/Steqeyma) when required.
Prescriber specialty per indication should be documented.

Prior Authorization

Voquezna prior authorization — document H. pylori or erosive esophagitis and PPI/bismuth trials

Voquezna PA requires documentation of H. pylori infection or erosive esophagitis/NERD as appropriate, and evidence of trial and failure/intolerance/contraindication to specified regimens (bismuth quadruple therapy for H. pylori; two generic PPIs for HRH/MHRH/NERD).

H. pylori Dual/Triple Pak: document H. pylori infection and trial/failure/contraindication to bismuth quadruple therapy.
HRH/MHRH/NERD: document erosive esophagitis or heartburn history and trial/inadequate response/intolerance/contraindication to TWO generic PPIs.
Coverage durations vary by indication (H. pylori 1 month; HRH 2 months; MHRH 6 months).

Prior Authorization

PA requirements — products Wyost through Zykadia (diagnosis, prescriber, prior therapy)

For products in the Wyost–Zykadia range, PA requires documentation of the product‑specific diagnosis, prescriber specialty when required (often oncologist or hematologist), and prior therapy trials or molecular testing as specified by each entry; coverage durations are typically 2 years unless noted otherwise.

Follow the product entry for required diagnostic proof (eg, VHL, ALK, ROS1, FLT3).
Include prior therapy history where required (eg, prior PD‑1/PD‑L1 + VEGF‑TKI for Wyost).
Confirm prescriber specialty when the entry mandates an oncologist/hematologist.

Note

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

Some drugs may be billed under Medicare Part B or Part D depending on how and where they are used; include documentation describing the drug use and administration setting to allow the payer to determine Part B vs Part D coverage.

Submit information about the intended use (eg, infusion vs oral outpatient use) and the setting (infusion center, office, hospital outpatient, home).
Failure to submit setting/use information can impede correct Part B vs Part D adjudication and may lead to denial or misbilling.

Step Therapy

Prerequisite conventional therapy — document trials or provide attestation

Some products require trial and failure of specified conventional therapies before biologic or advanced therapy approval; include documentation of those trials or a clinician attestation explaining why trials are inappropriate.

Examples: RA and PJIA often require trial/failure of methotrexate, leflunomide, or sulfasalazine.
Provide dates, doses, and duration of prior conventional therapy trials when available.
If trials are clinically inappropriate, include an attestation explaining the reason.

Step Therapy

Required conventional therapy trials — dermatology and rheumatology step requirements

For rheumatologic and dermatologic indications, document trials and failures of specified topical/systemic conventional therapies or NSAIDs as required by product entries prior to approval of biologic therapy.

Plaque psoriasis: document failure or intolerance to listed topical agents before biologic approval.
Non‑radiographic axial spondyloarthritis and ERA: document minimum trial and failure/contraindication/intolerance to two NSAIDs at maximally indicated doses.
Include durations of trials per entry when specified.

Step Therapy

Fasenra prerequisite Part D — include prior Part D drug documentation

Fasenra’s criteria explicitly require prior use of a prerequisite Part D drug; when submitting PA for Fasenra, include documentation of that prerequisite Part D therapy per the product entry.

Document the specific Part D agent(s) used as prerequisites and the trial/failure/intolerance details.
Ensure overall PA submission also includes diagnosis and prescriber specialty.

Step Therapy

Oncology prerequisite Part D drugs — document prior Part D drug use when required

Certain oncology entries require prior use of a specified Part D agent before approval (product‑specific); include documentation of that prior Part D drug use when indicated by the product entry.

Examples include some targeted oncology agents where prior Part D drug use is listed as prerequisite.
Follow the product‑specific notes to determine whether a prerequisite Part D drug is required.

Step Therapy

Kineret RA prerequisite therapies — document two prior therapy trials or attestation

For Kineret initial use in rheumatoid arthritis, document trial and failure, contraindication, or intolerance to two specified agents (eg, etanercept, a formulary adalimumab product, abatacept, upadacitinib, tofacitinib) unless a clinical attestation explains why trials are inappropriate.

Provide dates and outcomes of trials with the two specified alternative agents.
If trials are inappropriate, include clinician attestation explaining medical rationale.

Step Therapy

Prerequisite therapy requirement — include prior Part D therapy where stated

Some product entries explicitly require prior or prerequisite Part D drug therapy; check each product’s entry and include the required documentation of prior Part D agent trials or failures when specified.

The policy lists multiple examples where prerequisite Part D drug use is required; follow the individual product notes.
When prerequisite Part D therapy is indicated, include supporting documentation (agent, dose, duration, response).

Step Therapy

Rezurock step therapy — require two or more prior systemic therapy lines

Rezurock for chronic GVHD requires documentation of trial and failure of two or more lines of systemic therapy prior to approval; include prior systemic therapy details and prescriber specialty.

Document prior systemic therapies tried (eg, corticosteroids, mycophenolate) and reason for failure.
Prescriber should be a hematologist/oncologist or physician experienced in transplant management.

Step Therapy

Prerequisite Part D drug requirements — attach prior Part D therapy records

Several products in the policy explicitly require use of prerequisite Part D drugs (examples include Scemblix, Stelara, Sunitinib, Tazverik, Tibsovo, Truqap); when applicable, include documentation of those prerequisite Part D therapies in the PA submission.

Verify product entry to confirm whether prerequisite Part D drug is required.
Attach prior Part D therapy records (agent, dates, reason for discontinuation) to support the PA.

Step Therapy

Voquezna step therapy — bismuth quadruple therapy or two PPI trials required

Voquezna step therapy: for H. pylori Dual/Triple Pak entries document trial/failure/intolerance to bismuth quadruple therapy; for HRH/MHRH/NERD document trial and inadequate response/intolerance/contraindication to TWO generic PPIs.

H. pylori: evidence of prior bismuth quadruple therapy trial and inadequate response or intolerance.
Erosive esophagitis/NERD: document trials of two generic PPIs (omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, dexlansoprazole) and inadequate response or intolerance.

Step Therapy

Ubrelvy — step therapy requires prior triptan trial

Ubrelvy PA requires documentation that the member has migraine and has had inadequate response, intolerance, or contraindication to at least one triptan medication prior to approval.

Provide documentation of migraine diagnosis and prior triptan trial(s) and outcomes.
If triptan trial is inappropriate, include clinician attestation explaining rationale.

Documentation Required

Required medical information — diagnosis, tests, prior and concomitant therapy

Across multiple products, prior authorization requires submission of the listed required medical information: a documented diagnosis supporting the requested drug, relevant test results (genetic/molecular/pathogen), prior therapy history, and concomitant therapy details where applicable.

Examples: metastatic CRPC for abiraterone; CFTR mutation for CF modulators; PIK3CA mutation for Piqray; LDL‑C/ statin history for PCSK9 inhibitors.
When concomitant therapy is required (eg, abiraterone with prednisone; Tukysa with fulvestrant), document combination therapy use.

Documentation Required

Concomitant therapy documentation — include required combination agents

Where concomitant therapy is a criterion (eg, abiraterone with prednisone; Tukysa or Piqray to be used with fulvestrant), include documentation that the patient is receiving the required concomitant agent.

List the concomitant medication, dose, start date, and indication.
If combination therapy is planned, document the treatment plan and rationale.

Documentation Required

Required clinical documentation — diagnosis, molecular tests, prior therapy, prescriber

Provide the specific clinical documentation the policy requires: indication‑specific diagnosis documentation, molecular/genetic test results when specified, prior therapy history with dates and outcomes, and specialist prescriber information when required.

Examples: medullary thyroid cancer diagnosis for Cometriq; cystic fibrosis + Pseudomonas for Cayston; ALK/ROS1 testing for Xalkori/Xykadia.
For AML/oncology agents, include molecular marker testing (eg, FLT3, IDH1) and line‑of‑therapy context.

Documentation Required

Required diagnostic documentation for select neurologic indications

For select neurologic indications (eg, partial‑onset seizures associated with TSC or SEGA associated with TSC), include the diagnostic documentation specified by the product entry (eg, TSC diagnosis, SEGA status and surgical candidacy).

Document TSC diagnosis and that the patient is not a candidate for surgical resection when seeking therapy for SEGA.
Include neurologist prescriber information where the policy specifies.

Documentation Required

Prior therapy documentation — Fruzaqla (mCRC) and oncology examples

For Fruzaqla (metastatic colorectal cancer) and similar oncology agents, include documentation of prior systemic therapies as specified (eg, fluoropyrimidine-, oxaliplatin-, irinotecan‑based chemotherapy; anti‑VEGF; anti‑EGFR when RAS wild‑type).

List prior chemotherapy regimens with dates and responses.
Document RAS status and prior biologic therapy where applicable.

Documentation Required

Hematology/oncology documentation — diagnosis, molecular markers, regimen details

Document diagnosis and prior therapy history for hematology/oncology agents (eg, FLT3 ITD for Vanflyta; venetoclax combinations for AML/CLL) and include molecular markers or combination regimen details as required by the product entry.

Include molecular testing results (eg, FLT3, IDH1) and line‑of‑therapy context.
For combination regimens, document concurrent agents and intent (eg, venetoclax + azacitidine for first‑line AML in older/comorbid patients).

Documentation Required

Jynarque — liver monitoring and impairment risk for PA and reauth

For Jynarque (tolvaptan) PA and reauthorization, document the scheduled liver tests (ALT/AST/bilirubin) per monitoring schedule and absence of significant liver injury; noncompliance with monitoring or significant liver impairment may preclude coverage.

Initial monitoring: ALT/AST/bilirubin measured prior to initiation, at 2 and 4 weeks after initiation, then monthly for first 18 months.
If on therapy >18 months, document ALT/AST/bilirubin measured at least every 3 months.
Document no history of significant liver impairment or symptoms of hepatic injury.

Documentation Required

Truqap — required medical information, formulation age, prescriber, reauth evidence

Truqap PA requires CF diagnosis and at least one CFTR mutation responsive to therapy; for granules vs tablets document age appropriate to formulation, prescriber specialty (pulmonologist/CF center), and evidence of clinical response for reauthorization.

Initial: CF diagnosis and responsive CFTR mutation (eg, F508del or other supportive clinical/in‑vitro data).
Granules: age 2 to <6 years; tablets: ≥6 years — document age for formulation.
Reauth: clinical response evidence (PPFEV1 improvement or fewer pulmonary exacerbations).

Documentation Required

Tukysa — required medical information and prior endocrine therapy documentation

Tukysa (Tukysa/Tualio entries) PA requires documentation of locally advanced or metastatic HR‑positive, HER2‑negative breast cancer with PIK3CA/AKT1/PTEN alteration, documentation of progression on/after endocrine therapy or recurrence timing, and that the drug will be used in combination with fulvestrant.

Submit molecular testing demonstrating PIK3CA/AKT1/PTEN alteration.
Document prior endocrine‑based regimen progression or recurrence within 12 months of adjuvant therapy.
Document planned combination with fulvestrant and prescriber specialty (oncologist).

Documentation Required

Hematology/oncology — required documentation of diagnosis and molecular markers

For hematology/oncology agents, include the diagnosis and the specific molecular marker testing required (eg, FLT3 ITD for Vanflyta, IDH1 for Tibsovo) and the line‑of‑therapy context specified by the product entry.

Attach molecular/genetic test results and dates.
Document whether agent is used as first‑line, maintenance, or later‑line therapy as required.

Documentation Required

Documentation impacts Part B vs Part D determination — include setting/use details

When Part B vs Part D determination may apply, include information describing the drug’s use and the setting of administration (infusion center, office, hospital outpatient, home) so the payer can adjudicate coverage under the correct Medicare part.

Provide clinical rationale for administration route and setting.
Failure to supply setting/use information may prevent correct adjudication and lead to denial or misbilling.

Denial Risk

Denial triggers — explicit exclusions and common noncoverage examples

Coverage will be denied where the request falls under explicit policy exclusions or lacks the required documentation—examples include: benlysta as monotherapy or for autoantibody‑negative SLE, armodafinil/modafinil for generalized fatigue/jet lag, TIRF products for non‑cancer pain, and tadalafil for erectile dysfunction.

Benlysta: will not be approved as monotherapy, for autoantibody‑negative SLE, or in combination with other biologics or IV cyclophosphamide.
Armodafinil/Modafinil: will not be approved for generalized fatigue, jet lag, or sleep‑deprivation not associated with a covered diagnosis.
TIRF products: not covered for any non‑cancer pain indication; opioid‑tolerant cancer patients only.
Tadalafil: excluded for treatment of erectile dysfunction.

Denial Risk

Missing documented diagnosis or test results — denial risk

Denials will result if a required diagnosis or specific supporting documentation is missing (eg, missing documented CF diagnosis and Pseudomonas culture for Cayston, missing mutation testing for targeted oncology agents).

Cayston: submit documented CF diagnosis and evidence of Pseudomonas aeruginosa in the lungs.
Targeted oncology drugs: provide required mutation test results (EGFR, ALK, ROS1, BRCA/HRR, FLT3, IDH1) as specified.
If diagnosis or test results are absent, authorization may be denied.

Denial Risk

Explicit exclusion leading to denial — examples (Icatibant, Iclusig)

Explicit exclusions stated in product entries (for example, Icatibant exclusion for acquired angioedema or ACE inhibitor co‑use; Iclusig exclusion for newly diagnosed chronic‑phase CML) are denial triggers—do not submit for excluded uses.

Icatibant: will not be approved for acquired angioedema or for members concurrently taking an ACE inhibitor.
Iclusig: will not be approved for newly diagnosed chronic phase CML.

Denial Risk

Jynarque — liver monitoring noncompliance or hepatic impairment may preclude coverage

Failure to meet Jynarque’s liver monitoring schedule or presence of significant liver impairment may preclude coverage; include ALT/AST/bilirubin test dates and results per the policy monitoring schedule.

Monitoring schedule: prior to initiation, at 2 and 4 weeks after initiation, then monthly for first 18 months; thereafter at least every 3 months if on therapy >18 months.
Document absence of significant liver injury or history of significant hepatic impairment.

Denial Risk

Genotype exclusions — Kalydeco F508del homozygous example

Genotype exclusions are denial triggers where specified—e.g., Kalydeco is not effective for patients homozygous for the F508del CFTR mutation and such patients do not meet criteria.

If policy states a genotype exclusion (eg, Kalydeco in F508del homozygotes), do not submit PA for excluded genotypes.
Provide CFTR genotype documentation where required to determine eligibility.

Denial Risk

Lynparza — potential denial triggers for missing mutation or prior therapy documentation

Lynparza PA denials may occur when required BRCA/HRR mutation status or prior therapy documentation is missing; include mutation test results and prior chemotherapy or endocrine therapy history where indicated.

For Lynparza indications, submit deleterious or suspected deleterious germline/somatic BRCA or HRR testing results.
Document prior chemotherapy or endocrine therapy lines as specified for the breast, ovarian, pancreatic, and prostate indications.

Denial Risk

TIRF — explicit noncoverage for non‑cancer pain

Transmucosal Immediate‑Release Fentanyl (TIRF) products are not covered for any non‑cancer pain indication; PA for non‑cancer pain will be denied.

TIRF coverage limited to management of breakthrough pain in adult cancer patients tolerant to around‑the‑clock opioid therapy.
Patients must remain on around‑the‑clock opioids when receiving TIRF; pediatric lozenges approvable ≥16 years for cancer pain.

Denial Risk

Tadalafil exclusion — ED excluded; document BPH prior therapy when applicable

Tadalafil is excluded from coverage for the treatment of erectile dysfunction; for PA related to BPH indications, document BPH diagnosis and prior trials of at least two specified agents.

Do not submit PA for tadalafil for erectile dysfunction; it's excluded.
For BPH indications, document failure/adverse reaction/contraindication to a 30‑day trial of at least two listed BPH medications.

Denial Risk

Tafinlar — indication restriction for BRAF V600 mutations only

Tafinlar is not indicated for patients with wild‑type BRAF mutations; do not request PA for Tafinlar in wild‑type BRAF disease and include BRAF V600 mutation documentation when applicable.

Submit BRAF V600E or V600K mutation documentation for Tafinlar use as required by indication.
Requests for wild‑type BRAF disease will not meet policy criteria.

Documentation Required

Cystic Fibrosis PA — ensure CF diagnosis, CFTR mutation, age/formulation, and prescriber documented

For cystic fibrosis entries (Truqap, Trikafta, Orkambi, Kalydeco), PA will be denied if CF diagnosis, age/formulation restrictions, prescriber specialty, or required CFTR mutation documentation are missing or if the genotype is excluded by the policy.

Truqap/Trikafta: document CF diagnosis, CFTR mutation responsive to therapy, prescriber specialty, and age appropriate to formulation.
Orkambi: document homozygous F508del status where required.
Kalydeco: requests for patients homozygous for F508del do not meet criteria.

Documentation Required

Tukysa — document molecular alteration and prior endocrine therapy progression

For Tukysa (breast cancer) PA, include documentation of the required molecular alteration (PIK3CA/AKT1/PTEN) and prior endocrine‑based regimen progression or recurrence timing; missing either item may trigger denial.

Provide molecular testing demonstrating PIK3CA/AKT1/PTEN alteration.
Document prior progression on an endocrine regimen or recurrence within 12 months of adjuvant therapy as required.

Documentation Required

Oncology agents — prescriber and diagnosis documentation required to avoid denial

Oncology agents frequently require specialist prescribers and specific diagnostic documentation; absence of an oncologist prescriber or required diagnostic proof (eg, metastatic, unresectable, advanced disease) may result in denial.

Confirm prescriber is an oncologist when the product entry mandates it.
Attach imaging, pathology, or molecular reports demonstrating the advanced/unresectable/metastatic diagnosis as required.

Documentation Required

Wyost — required diagnosis and oncologist prescriber to support PA

Wyost (denosumab) PA will be denied if the required documented diagnosis (eg, prevention of skeletal‑related events in multiple myeloma or bone metastases, unresectable GCTB, or refractory hypercalcemia of malignancy) or oncologist prescriber information is not provided.

Provide documentation of the specific Wyost indication being requested.
Confirm prescriber specialty (oncologist) when required by the entry.

Products (examples)	Prerequisite Part D drug required?
Stelara (ustekinumab)
Criteria DOES require use of a prerequisite Part D drug (Yesintek/Steqeyma) per product entry
Sunitinib
Criteria DOES require use of a prerequisite Part D drug
Tibsovo (IDH1) / Tukysa
Entries note prerequisite Part D drug required for some indications (product-specific)

Documentation option	When trial inappropriate
Prior trials documented
Documented trial and inadequate response, intolerance, or contraindication to specified agents (e.g., triptan for Ubrelvy; two generic PPIs for Voquezna) per product criteria
Attestation
Provider attestation acceptable when trials are clinically inadvisable or inappropriate (per product-specific language)

Product examples	Required prior trials (examples)
Ankylosing spondylitis / RA / Psoriatic arthritis
Inadequate response/intolerance to one or more TNF inhibitors (e.g., Enbrel, Humira) and trial/failure of conventional DMARDs where specified
Carcinoid syndrome diarrhea (Xermelo)
Inadequate control on somatostatin analog (SSA) therapy prior to addition of Xermelo

Initial vs maintenance noteInitial and reauthorization both reference same monitoring schedule tied to duration on therapy

Fibrosis stage — F2 or F3 (Rezdiffra initial therapy eligibility)

Required fibrosis stageFibrosis stage F2 or F3

Indication contextDiagnosis of metabolic dysfunction-associated steatohepatitis (MASH) without cirrhosis

Documentation windowFibrosis confirmation by specified biomarker/imaging or liver biopsy within past 12 months

Opioid tolerance example — definition for opioid-tolerant patients (TIRF example)

Opioid-tolerant examplePatients taking around-the-clock opioids such as morphine 60 mg oral daily or greater; fentanyl transdermal 25 mcg/hour or greater; oxycodone 30 mg oral daily or greater; hydromorphone 8 mg oral daily or greater, or an equianalgesic dose of another opioid daily for a week or longer

Clinical contextTIRF products covered only for adult cancer patients already tolerant to around-the-clock opioid therapy for persistent cancer pain

Pediatric noteFentanyl lozenges approvable for pediatric patients 16 years and older

MASH definition and other coding-adjacent key terms where applicable

TermMASH (metabolic dysfunction-associated steatohepatitis)

Contextual definitionFormerly known as NASH; diagnosis requires absence of cirrhosis for initial therapy and presence of fibrosis stage F2 or F3

Required specialistsPrescribed by or in consultation with a gastroenterologist or hepatologist

Covered only for narcolepsy, excessive sleepiness associated with obstructive sleep apnea, or shift-work sleep disorder (documented)

Prerequisite Part D drugCriteria does not require use of a prerequisite Part D drug for armodafinil/modafinil

Non-radiographic axial spondyloarthritis definition as used in policy

DefinitionNon-radiographic axial spondyloarthritis with objective signs of inflammation: active disease with elevated CRP and/or sacroiliitis on MRI without definitive radiographic structural damage

Prior therapy requirementMinimum one month trial and failure, contraindication, or intolerance to two NSAIDs at maximally indicated doses required

Specialist involvementPrescriber restrictions typically involve consultation with a rheumatologist or relevant specialist

BRAF V600E/V600K mutation — definition for Cotellic combination eligibility

Mutation requiredBRAF V600E or V600K mutation required to qualify for Cotellic use in combination with vemurafenib

Indication contextUnresectable or metastatic melanoma with BRAF V600E or V600K mutation or histiocytic neoplasm for monotherapy

Prescriber requirementPrescribing physician must be an oncologist

SEGA definition — Subependymal Giant Cell Astrocytoma context for TSC indications

SEGA termSubependymal Giant Cell Astrocytoma (SEGA): a TSC-associated brain tumor included as an indication when the patient is not a candidate for surgical resection

Associated conditionSEGA occurs in tuberous sclerosis complex (TSC)

Prescriber requirementPrescribing physician should be a neurologist or oncologist as specified

RET fusion–positive disease — definition for Gavreto eligibility

RET fusion–positive diseaseDocumented RET fusion–positive NSCLC or thyroid cancer required for Gavreto coverage

Prior therapy noteEntry context indicates criteria may require prior therapies as specified per product entry

Prescriber requirementPrescribing physician must be an oncologist

deleterious or suspected deleterious BRCA/HRR mutation — definition for Lynparza/related agents

Deleterious or suspected deleterious BRCA/HRR mutationA molecular genetic test result indicating a pathogenic or likely pathogenic variant in BRCA or homologous recombination repair (HRR) genes required for Lynparza and similar indications

Indication examplesApplies to ovarian, breast, pancreatic, and prostate cancer indications as specified in product criteria

Prescriber requirementPrescribing physician must be an oncologist

MASH definition and coding-adjacent note

MASH termMASH = metabolic dysfunction-associated steatohepatitis

Clinical noteFormerly known as NASH; used in Rezdiffra criteria for patients without cirrhosis

Diagnostic requirementFibrosis stage and biomarker/imaging confirmation required as specified

Opioid-tolerant definition — examples of morphine/fentanyl/oxycodone/hydromorphone thresholds

Opioid-tolerant examplesMorphine ≥60 mg/day; fentanyl transdermal ≥25 mcg/hour; oxycodone ≥30 mg/day; hydromorphone ≥8 mg/day; or equianalgesic dosing for a week or longer

ApplicationDefinition used to determine eligibility for TIRF products for breakthrough cancer pain

RequirementPatients must remain on around-the-clock opioids when taking TIRF

PPFEV1 — percent predicted FEV1 definition used in CF response assessment

PPFEV1 definitionPercent predicted forced expiratory volume in one second (PPFEV1) used as objective measure of lung function for cystic fibrosis response assessment

Reauthorization useImprovement in PPFEV1 cited as example of clinical response for CF drug reauthorization (e.g., Trikafta/Truqap)

Specialist requirementPrescriber usually a pulmonologist or CF center specialist for CF modulators

Part B vs Part D determination — definition and process for deciding coverage under Medicare parts

DefinitionPart B vs Part D determination: process to decide whether a drug is billed and covered under Medicare Part B or Part D based on how and where the drug is used

Provider actionInformation describing the use and setting of the drug may need to be submitted to make the determination

Setting examplesInfusion center, office, hospital outpatient, or home — setting determines Part B vs Part D coverage