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Prior authorization and coverage criteria for specialty pharmacy products (partial)

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This document provides prior authorization requirements and coverage criteria for specific specialty pharmacy products for GlobalHealth Medicare Advantage plans; it affects prescribers and pharmacies submitting PA requests for the listed drugs.

Policy Summary

Payerglobalhealth

PolicyPrior authorization and coverage criteria for specialty pharmacy products (partial)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2026

Last ReviewJul 21, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests with required clinical documentation (e.g., disease severity measures, prior therapy trials, specialist consult notes) to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20+products shown (partial)

12 monthscommon PA duration

24TYMLOS duration limit

All FDA-approvedindication scope repeated

Coverage Criteria (Per-Product Summaries)

TYMLOS — Initial therapy

Covered when ALL of the following are met:

TYMLOS initial coverage: Patient meets an FDA‑approved indication for abaloparatide (TYMLOS) for osteoporosis; total cumulative duration of abaloparatide therapy will not exceed 24 months.24 MONTHS

ORENCIA — Initial and renewal

Covered when ALL of the following are met:

ORENCIA initial: Indication-specific prescriber: RA and PJIA prescribed by or in consultation with a rheumatologist; PsA prescribed by or in consultation with a dermatologist or rheumatologist. RA initial requires trial of or contraindication to 3 months of one conventional synthetic DMARD (if methotrexate tried, dose ≥20 mg/week or maximally tolerated). No concurrent use with another systemic biologic or targeted small molecule for the same indication.3 months DMARD trial; methotrexate >=20 mg/week if tried

ORENCIA renewal: Renewal requires documentation the member continues to benefit from therapy and that there is no concurrent use with another systemic biologic or targeted small molecule for the same indication.continued benefit

Oncology agents — Initial

Covered when the product‑specific PA criteria are met for FDA‑approved oncology indications:

Oncology agents (examples): Product is prescribed for an FDA‑approved oncology indication listed for the agent (e.g., VERZENIO, abiraterone products); required documentation and prescriber restrictions per the product entry are provided. Typical authorization duration is 12 months.12 MONTHS

ATTR-CM: Initial/Renewal

Initial authorization for ATTR‑CM is covered when ALL of the following are met:

ATTR-CM initial criteria: 1) Patient has NYHA class I, II, or III heart failure; AND 2) Diagnosis of transthyretin‑mediated amyloidosis confirmed by (A) strongly positive Tc‑99m‑PYP bone scan demonstrating myocardial uptake, OR (B) tissue biopsy with chemical typing confirming transthyretin (TTR) protein. Prescribed by or in consultation with a cardiologist, ATTR specialist, or medical geneticist; no concurrent use with other ATTR‑CM TTR stabilizers (e.g., tafamidis).

Adalimumab products: Initial

Initial authorization for adalimumab products is covered when ALL of the following are met (requirements vary by indication):

Psoriasis initial: Plaque psoriasis covering ≥3% body surface area OR psoriatic lesions affecting hands, feet, face, scalp, or genital area; plus required trials of topical/systemic therapies or phototherapy per product entry unless contraindicated or switching from another biologic.>=3% BSA

Rheumatoid arthritis initial: Trial of or contraindication to 3 months of one conventional synthetic DMARD (e.g., methotrexate); if methotrexate was tried, trial at ≥20 mg/week or maximally tolerated dose is required. Prescriber restrictions (e.g., rheumatologist) apply per indication.>=20 mg/week when methotrexate trialed

Initial and Renewal Criteria (examples)

Covered when ALL of the following are met (examples extracted from product entries):

RA initial example: Trial of or contraindication to 3 months of one conventional synthetic DMARD; if methotrexate tried, dose ≥20 mg/week or maximally tolerated dose required.

Psoriasis initial example: Plaque psoriasis covering ≥3% BSA or lesions affecting hands/feet/face/scalp/genitalia AND at least a 3‑month trial of one oral immunosuppressant (cyclosporine, methotrexate, tacrolimus) or PUVA unless contraindicated/intolerant.3% BSA

Ankylosing spondylitis initial example: Trial of or contraindication to an NSAID prior to biologic therapy.

Renewal example: For renewal (commonly 12 months), documentation that the member continues to benefit from the medication is required.12 months renewal interval typical

Per-product PA coverage summaries (partial)

Covered when the product‑specific PA criteria, prescriber restrictions, and documentation requirements are met:

ARIKAYCE initial/renewal: Initial and renewal requests must be prescribed by or in consultation with a pulmonologist or infectious disease specialist. Renewal requires microbiological response and symptomatic improvement (first renewal: ≥1 negative MAC sputum culture by 6 months; second/subsequent renewals: ≥3 negative MAC sputum cultures by 12 months).

Kineret (anakinra): Indications such as CAPS and DIRA require confirmatory genetic testing or inflammatory marker evidence plus clinical features; for RA initial therapy requires trial or contraindication to two preferred agents and no concurrent systemic biologic/targeted small molecule for the same indication.

Other listed agents (summary): Many specialty products require PA for FDA‑approved indications, with typical authorization durations of 12 months and potential prescriber restrictions; see individual product entry for detailed clinical criteria.12 MONTHS

Otezla initiation and renewal

Otezla initiation pack covered when ALL of the following are met:

Mild plaque psoriasis initial: Patient meets any of: psoriasis covering <3% BSA OR SPGA score of 2 OR PASI score 2–9; and trial of or contraindication to one conventional systemic therapy (e.g., methotrexate, acitretin, cyclosporine) OR one conventional topical therapy (e.g., topical corticosteroids).

Moderate-to-severe plaque psoriasis initial: Psoriasis covering ≥3% BSA OR lesions affecting hands/feet/face/scalp/genital area; AND at least a 3‑month trial of one oral immunosuppressant (cyclosporine, methotrexate, tacrolimus) or PUVA, or documented contraindication/intolerance.BSA >= 3%

General Otezla rules: No concurrent use with another systemic biologic or targeted small molecule for the same indication; renewal requires demonstrated continued benefit (renewal typically 12 months).

Asciminib (Scemblix) initial therapy

Covered when ALL of the following are met:

Scemblix (asciminib) initial: Indication: previously treated Ph+ CML or T315I mutation per product labeling; mutational analysis (BCR‑ABL1 profile) performed prior to initiation and therapy aligns with NCCN guideline recommendations based on mutation profile.

Miplyffa (NPC) initial and renewal

Covered when ALL of the following are met:

Miplyffa (NPC) initial: Prescribed by or in consultation with a neurologist or geneticist; initial authorization 6 months and renewal 12 months; renewal requires evidence of improvement or slowing of disease progression per product entry.

Qulipta coverage

Covered when ALL of the following are met:

Qulipta initial: Indication: migraine prevention as labeled; initial authorization 6 months, renewal 12 months; no concurrent use with other CGRP inhibitors for migraine.

Avacopan (Tavneos) coverage

Covered when ALL of the following are met:

Avacopan (Tavneos) initial: Indication: ANCA‑associated vasculitis (ANCA seropositive anti‑PR3 or anti‑MPO); prescribed by or in consultation with a rheumatologist or nephrologist; initial/renewal duration 6 months and renewal requires continued benefit documentation.

Ayvakit and AVMAPKI co-pack

Covered when the PA criteria for each product are met:

Ayvakit initial: Coverage per FDA‑approved indications; authorization duration commonly 12 months as listed in product entry.

AVMAPKI co‑pack initial: Coverage per FDA‑approved indications; authorization duration commonly 12 months as listed in product entry.

Per-product criteria (partial)

Per the product entries in this segment, coverage is allowed when the listed PA elements are satisfied:

General product PA attributes: PA record includes required clinical information, prescriber specialty (if specified), required prior therapy trials (if specified), and supports FDA‑approved indication; many entries list a typical authorization duration of 12 months.

REZUROCK - chronic GVHD: For chronic graft‑versus‑host disease: failure of at least two lines of systemic therapy is required, one of which must be a trial of or contraindication to JAKAFI.

BENLYSTA - SLE: Prescribed by or in consultation with a rheumatologist; initial authorization 6 months and renewal 12 months; initial SLE requires concurrent use of standard background therapies and renewal requires documented clinical improvement.

Per-product PA summaries (partial)

These product summaries list PA parameters; approval requires meeting the entry‑specific clinical and administrative requirements:

Sample listed products: Products in this window (e.g., REZUROCK, WELIREG, MEKTOVI, BORTEZOMIB) require PA for FDA‑approved indications with durations commonly 12 months; see individual product line for specific clinical criteria.

Bosentan: Initial Therapy

Covered when ALL of the following are met:

Bosentan initial PA criteria: Diagnosis of pulmonary arterial hypertension confirmed by right heart catheterization with mean PAP >20 mmHg, PCWP ≤15 mmHg, and PVR >2 Wood units; prescribed by or in consultation with a cardiologist or pulmonologist; baseline liver tests acceptable and no concurrent use of cyclosporine A or glyburide; avoid use if ALT/AST >3×ULN or bilirubin increase ≥2×ULN.see node text

Bosutinib: Initial Therapy

Covered when ALL of the following are met:

Bosutinib initial PA criteria: Diagnosis of previously treated Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML); mutational analysis (BCR‑ABL1 profile) performed prior to initiation and Bosulif appropriate per NCCN guideline table; prerequisite therapy required per product entry.

HAEGARDA: Initial Therapy

Covered when ALL of the following are met:

HAEGARDA initial PA criteria: Diagnosis of hereditary angioedema (Type III or Type I/II confirmed by complement testing: C1‑INH protein, C4, C1‑INH functional levels, C1q); prescribed by or in consultation with a hematologist, immunologist, allergist or pulmonologist; not on concurrent alternative prophylactic HAE agent.

General product PA stance

General PA coverage rules apply:

General product PA stance: Products listed in this formulary segment are subject to prior authorization; coverage generally limited to FDA‑approved indications and many entries indicate a default authorization period of 12 months unless otherwise specified.

EPIDIOLEX

Covered when ALL of the following are met:

EPIDIOLEX initial: Indication: Dravet syndrome, Lennox‑Gastaut syndrome, or tuberous sclerosis complex; prescribed by or in consultation with a neurologist; for LGS an initial trial of or contraindication to two therapies is required (example: clonazepam); initial/renewal durations and other prerequisites per product entry.

EPIDIOLEX renewal: Renewal: routinely 12 months; documentation of continued benefit required.

Carglumic acid

Covered when ALL of the following are met:

Carglumic acid indications: Covered for acute or chronic hyperammonemia due to NAGS deficiency (confirmed by biochemical or genetic testing), acute hyperammonemia due to propionic acidemia (confirmed by elevated methylcitric acid or genetic testing), or acute hyperammonemia due to methylmalonic acidemia (confirmed by elevated methylmalonic/methylcitric acid or genetic testing).

Carglumic acid duration rules: Acute hyperammonemia due to NAGS/PA/MMA: up to 7 days; chronic HA due to NAGS: initial authorization 6 months with renewal 12 months contingent on documented clinical improvement.7 DAYS; 6 MOS initial; 12 MOS renewal

CIMZIA-STARTER: Initial and Renewal Coverage Criteria

Covered when ALL of the following are met for specified indications:

CIMZIA‑STARTER plaque psoriasis: Plaque psoriasis covering ≥3% BSA OR lesions affecting hands/feet/face/scalp/genital area.BSA >= 3%

CIMZIA‑STARTER NR‑axSpA: Non‑radiographic axial spondyloarthritis: objective support with elevated CRP above ULN OR sacroiliitis on MRI.

Prescriber restriction: For certain diagnoses (RA, AS, NR‑axSpA, PJIA) prescription must be by or in consultation with a specialist (e.g., rheumatologist).

Step therapy: Initial approval requires trial of or contraindication to specified preferred agents (number and agents vary by indication); step requirement waived if patient is pregnant, breastfeeding, or trying to become pregnant.

No concurrent therapy: No concurrent use with another systemic biologic or targeted small molecule for the same indication.

Duration: Initial duration may be 6 months for some indications; renewals typically 12 months with documentation of continued benefit.6 months initial (some), 12 months renewal

Product-level general coverage statements

Covered when consistent with product labeling and required documentation:

FDA indication alignment: Request supports an FDA‑approved indication for the product and required clinical documentation (labs, imaging, prior therapy trials, prescriber specialty) is provided as specified in the product entry.

Default duration: Where the product entry specifies a default authorization period, the usual duration is 12 months unless otherwise noted.12 months

General PA coverage for listed products

Coverage summarized per product entries in this segment; approval requires meeting the per‑product PA elements:

General PA coverage rules: Most listed specialty products require prior authorization for FDA‑approved indications; when specified, authorization durations are commonly 12 months and Part B applicability is noted per entry.

Dasatinib specific coverage criterion

Covered when ALL of the following are met:

Dasatinib prerequisites: For previously treated Philadelphia chromosome‑positive CML: mutational analysis (BCR‑ABL1 profile) performed prior to initiation and dasatinib use is appropriate per NCCN guideline recommendations based on mutation profile.

Dalfampridine ER specific coverage criterion

Covered when ALL of the following are met:

Dalfampridine ER initial: Prescribed by or in consultation with a neurologist and documentation of walking disability symptoms (e.g., mild to moderate bilateral lower extremity impairment) is provided.

TAFINLAR soluble tablet criterion

Covered when ALL of the following are met:

TAFINLAR soluble tablet authorization: Soluble tablet formulation authorized when patient is unable to swallow TAFINLAR capsules; PA criteria apply and authorization duration typically 12 months.

Deferasirox — Initial and Renewal Coverage Criteria

Covered when ALL of the following are met for the specified indications:

Transfusion‑dependent chronic iron overload (initial): Serum ferritin consistently >1000 mcg/L; prescribed by or in consultation with a hematologist or hematologist/oncologist; initial authorization 6 months.serum ferritin >1000 mcg/L

NTDT initial: Serum ferritin consistently >300 mcg/L (at least two lab values in prior 3 months) AND liver iron concentration (LIC) ≥5 mg Fe/g dry weight; prescribed by or in consultation with a hematologist; initial authorization 6 months.ferritin >300 mcg/L; LIC >=5 mg Fe/g

Renewal criteria: Transfusion‑dependent renewal: serum ferritin consistently >500 mcg/L. NTDT renewal: ferritin >300 mcg/L (two labs) OR LIC ≥3 mg Fe/g dry weight; renewal authorization 12 months.

Diclofenac topical — OA knee

Covered when ALL of the following are met:

Topical diclofenac for OA knee: Documented diagnosis of osteoarthritis of the knee and trial of alternative agents where required per product entry; authorization durations vary (example entry lists 6 months).

General product coverage

Covered when the claim meets product‑specific criteria listed in the formulary:

General product coverage: Request supports an FDA‑approved indication and required clinical documentation (prescriber specialty, labs, prior trials) is provided as specified; many entries state a default authorization period of 12 months.

Droxidopa Initial/Renewal

Covered when ALL of the following are met:

Droxidopa initial criteria: Baseline blood pressure readings while sitting and within 3 minutes of standing are documented; orthostatic drop of ≥20 mmHg systolic or ≥10 mmHg diastolic within 3 minutes after standing demonstrated; prescribed by or in consultation with a neurologist or cardiologist.>=20 mmHg systolic or >=10 mmHg diastolic within 3 minutes of standing

Droxidopa renewal: Renewal authorization: 12 months if patient continues to benefit from therapy.

DUPIXENT Initial/Renewal/Exclusions

DUPIXENT is covered when ALL indication‑specific diagnostic and prior therapy requirements are met:

Eosinophilic asthma initial: Blood eosinophil count 150–1500 cells/mcL within the past 12 months; concurrent therapy with an appropriate dose of inhaled corticosteroid and one other maintenance medication; evidence of poor control (e.g., corticosteroid burst ≥3 days within past 12 months or serious exacerbation) as specified in product entry.eosinophils 150-1500 cells/mcL

CRSwNP initial: 56‑day trial of one topical nasal corticosteroid AND evidence of nasal polyps by exam/endoscopy/CT AND inadequately controlled disease per product entry.

General exclusion: No concurrent use with another systemic biologic or targeted small molecule for the same indication.

Dronabinol Coverage

Covered when ALL of the following are met:

Dronabinol initial (nausea/vomiting): Indication: nausea and vomiting associated with cancer; prior authorization required; authorization duration commonly 6 months per product entry.

ADA‑SCID coverage (REVCOVI)

Covered when ALL of the following are met:

REVCOVI initial for ADA‑SCID: Confirmatory genetic test OR suggestive laboratory findings (e.g., elevated deoxyadenosine nucleotide levels, lymphopenia) plus hallmark clinical signs/symptoms (recurrent infections, failure to thrive, persistent diarrhea); prescribed by or in consultation with an immunologist, hematologist/oncologist, or physician specializing in inherited metabolic disorders. Initial authorization 6 months; renewal 12 months contingent on improvement or maintenance of immune function.

CFTR modulator coverage (TRIKAFTA)

Covered when ALL of the following are met:

TRIKAFTA initial: Prescribed by or in consultation with a pulmonologist or cystic fibrosis expert; not used concurrently with another CFTR modulator; initial authorization 6 months (renewal per product entry, often lifetime thereafter).

Multiple myeloma coverage (ELREXFIO)

Covered when ALL of the following are met:

ELREXFIO initial: Initial approval for relapsed/refractory multiple myeloma as listed in the product entry; initial authorization 6 months. Renewal requires documentation of clinical response; for relapsed/refractory disease renewal requires at least 24 weeks of prior treatment and response for at least 2 months.

Eltrombopag coverage (ITP and other indications)

Covered when ALL of the following are met for ITP and other indications:

Eltrombopag initial for ITP: Platelet count <30 x10^9/L OR platelet count <50 x10^9/L with a prior bleeding event; trial of or contraindication to one corticosteroid or IVIG or insufficient response to splenectomy; prescribed by or in consultation with a hematologist or immunologist; no concurrent use with other thrombopoietin receptor agonists. Initial authorization 6 months.

Eltrombopag formulation preference: For oral suspension packets, trial of a formulary tablet version is required OR documentation that the patient cannot tolerate the tablet formulation.

Eltrombopag renewal: Renewal: improvement in platelet counts from baseline or reduction in bleeding events AND no concurrent use with other TPO‑RAs; renewal authorization 12 months.

ORSERDU coverage

Covered when ALL specified PA elements are met:

ORSERDU coverage: PA required for FDA‑approved indications; authorization duration commonly 12 months per product entry.

Initial therapy (ITP)

Covered when ALL of the following are met:

ITP initial coverage: 1) Platelet count <30 x10^9/L OR platelet count <50 x10^9/L with a prior bleeding event; 2) Trial of or contraindication to splenectomy; 3) Prescribed by or in consultation with a hematologist or immunologist; 4) No concurrent use with other TPO‑RAs; 5) For oral suspension packets, trial of a formulary tablet version or documented inability to tolerate/swallow tablets.

Continuation / renewal (ITP)

Covered when ALL of the following are met for continuation:

ITP renewal: 1) Demonstrated improvement in platelet counts from baseline or reduction in bleeding events; 2) No concurrent use with other thrombopoietin receptor agonists; 3) Prescriber remains a hematologist or immunologist. Renewal authorization: 12 months.

Abaloparatide (TYMLOS) is subject to prior authorization and is covered only for FDA‑approved osteoporosis indications with a maximum cumulative treatment duration of 24 months. Requests that would result in total therapy beyond 24 months are excluded and may be denied.

Several product entries explicitly prohibit concurrent use of multiple agents for the same indication. Examples include: ATTR‑CM agents (e.g., ATTRUBY) — no concurrent use with other ATTR‑CM TTR stabilizers (e.g., tafamidis); and multiple biologic/targeted therapies for inflammatory indications (e.g., adalimumab family and related starters) — no concurrent use with another systemic biologic or targeted small molecule (for the same indication). These concurrent‑use exclusions are enforced at initial authorization and renewal.

For uveitis indications the policy excludes isolated anterior uveitis in the listed adalimumab/related product entries: if the request is for isolated anterior uveitis it does not meet the documented initial criteria and is not eligible for coverage under that indication.

Initial Therapy — Criteria by Drug

inv-246: TYMLOS initial

TYMLOS initial: Coverage allowed for FDA‑approved osteoporosis indications provided cumulative use does not exceed 24 months.24 MONTHS

inv-247: ATTR-CM initial

ATTR‑CM initial: NYHA class I–III AND diagnostic confirmation by strongly positive Tc‑99m‑PYP bone scan OR tissue biopsy with transthyretin typing; prescribed by or in consultation with appropriate specialist; no concurrent use with other ATTR‑CM TTR stabilizers.

inv-248: Adalimumab initial

Adalimumab initial (summary): Indication‑specific criteria: e.g., plaque psoriasis ≥3% BSA or other listed features; RA requires trial of or contraindication to 3 months of a conventional synthetic DMARD (methotrexate ≥20 mg/week if tried).>=3% BSA; methotrexate >=20 mg/week if tried

inv-249: Initial therapy prerequisites

Initial therapy prerequisites (examples): Indication‑specific prerequisite therapy is required (e.g., psoriasis: 3‑month trial of an oral immunosuppressant or PUVA; RA: 3‑month DMARD trial at appropriate dose), or documentation of contraindication/intolerance.

inv-250: ARIKAYCE initial

ARIKAYCE initial: Prescribed by or in consultation with a pulmonologist or infectious disease specialist; initial authorization 6 months; patient meets MAC lung disease criteria per product entry.

inv-251: Kineret initial

Kineret initial: For RA: prescribed by or in consultation with a rheumatologist and trial of or contraindication to two preferred agents required; CAPS/DIRA require genetic or inflammatory marker confirmation and clinical features.

inv-252: Onapgo initial

Onapgo initial: Initial prescription by or in consultation with a neurologist for Parkinson disease; initial/renewal duration 12 months; renewal requires documented improvement in motor symptoms.

inv-253: Otezla initial therapy

Otezla initiation: Meets criteria for mild or moderate‑to‑severe plaque psoriasis as defined (BSA, SPGA, PASI) and prior therapy trials or contraindications documented; no concurrent systemic biologic/targeted small molecule for same indication.

inv-254: Scemblix initial therapy

Scemblix initial: Mutational analysis prior to initiation and alignment with NCCN treatment recommendations for BCR‑ABL1 mutation profile; coverage duration commonly 12 months.

inv-255: BENLYSTA initial therapy

BENLYSTA initial: Prescribed by or in consultation with a rheumatologist for SLE; initial authorization 6 months; patient receiving standard background SLE therapies; renewal 12 months with documented clinical improvement.

inv-256: Prerequisite therapy notes (partial)

Prerequisite therapy notes: Some product entries indicate prerequisite therapy (Prerequisite Therapy: Yes) or specific prior agent trials; details are product specific and must be documented.

inv-257: Bosentan initial therapy

Bosentan initial: PAH diagnosis confirmed by right heart catheterization (mean PAP >20 mmHg, PCWP ≤15 mmHg, PVR >2 Wood units); prescribed by or in consultation with appropriate specialist; baseline LFTs acceptable and no concurrent use with cyclosporine A or glyburide; avoid if ALT/AST >3×ULN or bilirubin ≥2×ULN.

inv-258: EPIDIOLEX Initial Therapy

EPIDIOLEX initial: Prescribed by or in consultation with a neurologist for DS, LGS, or TSC; for LGS initial trial of or contraindication to two therapies required (example clonazepam); initial/renewal durations per product entry.

inv-259: Initial therapy requirements

CIMZIA‑STARTER initial requirements: Initial: trial of or contraindication to preferred agents as specified by indication; prescriber specialty requirements for certain diagnoses; documentation of disease severity and prior therapy required; initial durations vary (commonly 6 months for some indications).

inv-260: Deferasirox — Initial Therapy

Deferasirox initial: Transfusion‑dependent: serum ferritin consistently >1000 mcg/L. NTDT: serum ferritin >300 mcg/L (two values in prior 3 months) AND LIC ≥5 mg Fe/g dry weight. Prescribed by or in consultation with a hematologist; initial authorization 6 months.see node text

inv-261: DUPIXENT initial

DUPIXENT initial (AD example): For atopic dermatitis: intractable pruritus or skin breakdown AND trial of or contraindication to one topical agent (topical corticosteroid, calcineurin inhibitor, PDE‑4 inhibitor, or JAK inhibitor) as specified.

inv-262: Initial therapy requirements

Select initial coverage durations and prescriber requirements: Examples: REVCOVI initial 6 months with specialist prescribing and diagnostic confirmation; TRIKAFTA initial 6 months with pulmonologist/CF expert and no concurrent CFTR modulator; ELREXFIO initial 6 months; eltrombopag initial 6 months for ITP with platelet thresholds and prior therapy trial documented.

inv-263: Initial therapy (ITP)

ITP initial (eltrombopag): Platelet count <30 x10^9/L OR platelet count <50 x10^9/L with prior bleeding; trial of or contraindication to splenectomy; prescribed by or in consultation with a hematologist or immunologist; no concurrent use with other TPO‑RAs; for suspension packets, trial of tablet formulation or inability to tolerate tablets is required. Initial duration: 6 months.

Renewal / Continuation Criteria

inv-264: Abatacept continuation

Abatacept continuation: Renewal for abatacept (ORENCIA) requires documentation that the member continues to benefit from therapy and no concurrent use with another systemic biologic or targeted small molecule for the same indication.

inv-265: Renewal criteria

Renewal criteria (general): Renewal requests require evidence the patient continues to benefit from therapy; renewal intervals commonly 12 months where specified.

inv-266: Renewal/Continuation

Renewal/continuation: Demonstration of continued clinical benefit is required for renewal across many products; documentation of symptom improvement or laboratory/imaging response as specified in the product entry is expected.

inv-267: ARIKAYCE continuation

ARIKAYCE continuation: Renewal requires no positive MAC sputum culture after consecutive negative cultures AND symptom improvement; first renewal: ≥1 negative MAC sputum culture by 6 months; second/subsequent renewals: ≥3 negative MAC sputum cultures by 12 months.

inv-268: Kineret continuation

Kineret continuation: Renewal intervals: RA initial 6 months, renewal 12 months; CAPS/DIRA may have lifetime authorization for some indications; renewal requires continued benefit documentation.

inv-269: Otezla renewal

Otezla renewal: Renewal requires documentation that the patient continues to benefit from therapy; renewal duration commonly 12 months.

inv-270: Renewal criteria (partial)

Renewal notes (partial): Bosentan renewal: continued avoidance of contraindicated concurrent medications (e.g., cyclosporine A, glyburide) and acceptable liver tests; HAEGARDA renewal: not on concurrent alternative prophylactic HAE agent. Renewal durations commonly 12 months.

inv-271: CIMZIA-STARTER renewal

CIMZIA‑STARTER renewal: Renewal requires documentation that the patient continues to benefit from the medication for the indicated condition; renewal duration typically 12 months.

inv-272: Deferasirox — Continuation Therapy

Deferasirox continuation: Transfusion‑dependent renewal: serum ferritin consistently >500 mcg/L. NTDT renewal: ferritin >300 mcg/L (two labs) OR LIC ≥3 mg Fe/g dry weight. Renewal duration: 12 months.

inv-273: Droxidopa renewal

Droxidopa renewal: Renewal: 12 months if patient continues to benefit from therapy, with required documentation of clinical response as specified.

inv-274: DUPIXENT renewal

DUPIXENT renewal: Indication‑specific improvement on therapy required for renewal (examples: reduction in exacerbations or rescue med use, increased FEV1, or symptom reduction for asthma; improvement in pruritus/lesions for PN); renewal durations per product entry (commonly 12 months).

inv-275: Renewal/continuation therapy requirements

Renewal/continuation summary: Examples: REVCOVI renewal 12 months contingent on improvement or maintenance of immune function; ELREXFIO renewal 12 months with specified response/time‑on‑therapy requirements; eltrombopag renewal 12 months with improvement in platelet counts and no concurrent TPO‑RA use.

inv-276: Renewal (ITP)

ITP renewal: Improvement in platelet counts from baseline or reduction in bleeding events AND no concurrent use with other TPO‑RAs; renewal duration typically 12 months.

Prior Authorization and Documentation — Actions for Prescribers/Pharmacies

Prior Authorization

TYMLOS prior authorization

Prior authorization required for TYMLOS (abaloparatide). Total cumulative coverage is limited to 24 months; requests exceeding a cumulative 24-month treatment duration will not be approved.

Coverage duration limit: 24 MONTHS

Prior Authorization

ORENCIA prior authorization

Prior authorization required for ORENCIA (IV and SC). Initial requests for RA/PJIA must be prescribed by or in consultation with a rheumatologist (PsA by or in consultation with a dermatologist or rheumatologist); RA initial requires trial of or contraindication to 3 months of one conventional synthetic DMARD (if methotrexate tried, ≥20 mg/week or maximally tolerated dose). Renewal requires documentation of continued benefit and no concurrent use with another systemic biologic or targeted small molecule.

Prescriber restriction: rheumatologist for RA/PJIA; dermatologist or rheumatologist for PsA
RA prerequisite: 3-month trial of one conventional synthetic DMARD (methotrexate ≥20 mg/week if tried)
No concurrent use with another systemic biologic or targeted small molecule
Renewal: document continued benefit

Prior Authorization

Oncology agents prior authorization

Prior authorization is required for listed oncology agents (e.g., VERZENIO, abiraterone products). Coverage durations are commonly set to 12 months; approval must align with the product’s PA criteria and indication-specific requirements.

Typical coverage duration: 12 MONTHS
Indications limited to All FDA‑approved Indications unless otherwise specified

Prior Authorization

CALQUENCE (acalabrutinib) – PA required

Prior authorization required for CALQUENCE (acalabrutinib) oral tablet. PA entries list a 12‑month coverage duration and require adherence to the product-specific PA criteria in the formulary entry.

Coverage duration: 12 MONTHS
Follow product PA criteria as listed in formulary

Prior Authorization

ATTRUBY (acoramidis) – PA required

Prior authorization required for ATTRUBY (acoramidis) for transthyretin‑mediated amyloid cardiomyopathy (ATTR‑CM). Initial requests must document NYHA class I–III and diagnosis confirmed by a strongly positive Tc‑99m‑PYP bone scan or tissue biopsy with transthyretin typing; requests must be prescribed by or in consultation with a cardiologist, ATTR specialist, or medical geneticist. Concurrent use with other ATTR‑CM TTR stabilizers is not allowed.

Diagnostic documentation: NYHA class I–III AND positive Tc‑99m‑PYP scan OR biopsy with TTR chemical typing
Prescriber: cardiologist, ATTR specialist, or medical geneticist
No concurrent use with other ATTR‑CM TTR stabilizers
Initial/renewal duration: 12 MONTHS

Prior Authorization

Adalimumab products – PA required

Prior authorization required for adalimumab products. Initial approvals require indication‑specific documentation (e.g., plaque psoriasis ≥3% BSA or lesions on hands/feet/face/scalp/genitalia) and required prior therapy trials such as conventional systemic/topical therapies or immunosuppressants; concurrent use with another systemic biologic or targeted small molecule for the same indication is prohibited.

Psoriasis severity: ≥3% BSA or involvement of hands/feet/face/scalp/genitalia
RA prerequisite: trial of or contraindication to 3 months of one conventional synthetic DMARD (methotrexate ≥20 mg/week if tried)
No concurrent use with another systemic biologic or targeted small molecule

Step Therapy

Prior authorization with prerequisite therapy

Prior authorization often requires evidence of prerequisite therapy; the specific prerequisite varies by indication (for example, RA requires a 3‑month trial of a conventional synthetic DMARD, and psoriasis commonly requires trials of topical/systemic therapies or phototherapy).

Document trials of specified prior therapies or contraindications per indication (e.g., methotrexate ≥20 mg/week when used)
Step therapy requirements differ by indication — confirm applicable list in product entry

Prior Authorization

Prior authorization required

Prior authorization is required for the listed specialty products; approval durations and other criteria are specified per product entry — many products have a common 12‑month authorization period.

Confirm product‑specific PA criteria and stated coverage duration (commonly 12 months)

Prior Authorization

ARIKAYCE PA specifics

ARIKAYCE (amikacin liposomal) PA requires prescribing by or in consultation with a pulmonologist or infectious disease specialist. Renewal requires microbiological and clinical response: first renewal requires at least one negative MAC sputum culture by 6 months; second and subsequent renewals require at least three negative MAC sputum cultures by 12 months, plus symptomatic improvement.

Prescriber restriction: pulmonologist or infectious disease specialist
Renewal evidence: ≥1 negative MAC sputum culture by 6 months for first renewal; ≥3 negative cultures by 12 months for subsequent renewals
Renewal also requires clinical improvement in symptoms

Documentation Required

PA requires disease severity and prior therapy documentation

Prior authorization requests must include disease severity measures and documentation of prior therapies or contraindications when required (examples: psoriasis BSA/SPGA/PASI scores, prior systemic or topical treatment trials for Otezla). Failure to provide these objective severity or prior‑therapy records may lead to denial.

Provide BSA, SPGA, or PASI scores for psoriasis where requested
Include documented trials of prior therapies or contraindications per indication

Documentation Required

PA requires mutational analysis

Prior authorization for certain targeted agents (e.g., Scemblix/asciminib) requires mutational analysis prior to initiation and alignment with NCCN treatment recommendations based on BCR‑ABL1 mutation profile.

Submit mutational analysis (BCR‑ABL1) demonstrating appropriateness of therapy per NCCN guidance

Prior Authorization

Prior authorization required (12-month durations noted)

Prior authorization is required for many listed products and commonly provides a 12‑month approval interval; verify Part B applicability in the product entry (often 'No').

Common coverage duration: 12 MONTHS
Confirm Part B applicability per entry

Prior Authorization

BENLYSTA PA timing

BENLYSTA (belimumab) PA: initial authorization is for 6 months and renewal for 12 months; initial requests should be prescribed by or in consultation with a rheumatologist and include documentation of concurrent standard SLE therapy and clinical improvement on renewal.

Initial duration: 6 months; renewal: 12 months
Prescriber: rheumatologist or in consultation with rheumatology
Initial: evidence of concomitant SLE therapy (corticosteroids, antimalarials, NSAIDs, or immunosuppressive agents); renewal: clinical improvement required

Prior Authorization

Prior authorization required (multiple products)

Prior authorization is required for many additional products in the formulary; most entries indicate a 12‑month coverage duration and product‑specific PA criteria must be met.

Confirm product‑specific PA criteria and documentation requirements
Typical authorization period: 12 MONTHS

Prior Authorization

MEKTOVI prior authorization

MEKTOVI (binimetinib) requires prior authorization with a coverage duration listed as 12 months and coverage limited to FDA‑approved indications per the formulary entry.

Coverage duration: 12 MONTHS
Indications: All FDA‑approved Indications

Prior Authorization

Bortezomib prior authorization

Bortezomib products require prior authorization; the formulary lists a 12‑month coverage duration and coverage is limited to FDA‑approved indications.

Coverage duration: 12 MONTHS
Indications: All FDA‑approved Indications

Prior Authorization

Bosentan prior authorization

Bosentan prior authorization requires diagnostic confirmation of PAH by right heart catheterization (mean PAP >20 mmHg; PCWP ≤15 mmHg; PVR >2 Wood units), prescriber specialty involvement, baseline liver tests, and no concurrent use with cyclosporine A or glyburide. Coverage/renewal durations are listed as 12 months.

RHC confirmation with mean PAP >20 mmHg; PCWP ≤15 mmHg; PVR >2 Wood units
Do not authorize if ALT/AST >3x ULN or bilirubin increase ≥2x ULN
No concurrent use with cyclosporine A or glyburide
Coverage duration: 12 MONTHS

Prior Authorization

Bosutinib prior authorization

Bosutinib (Bosulif) requires prior authorization with prior mutational analysis (BCR‑ABL1 mutation profile) before initiation and indicates prerequisite therapy; coverage duration is 12 months.

Submit BCR‑ABL1 mutational analysis prior to initiation
Prerequisite therapy indicated (see product entry)
Coverage duration: 12 MONTHS

Prior Authorization

HAEGARDA prior authorization

HAEGARDA prior authorization required for hereditary angioedema (HAE). Initial requests must include complement testing to confirm Type I/II HAE (C1‑INH protein, C4, C1‑INH function, C1q) or documentation consistent with Type III HAE, be prescribed by or in consultation with an appropriate specialist, and note no concurrent prophylactic HAE agent; initial/renewal duration: 12 months.

Required labs: C1‑INH protein, C4, C1‑INH functional levels, C1q
Prescriber: hematologist, immunologist, allergist, or pulmonologist
No concurrent use with alternative prophylactic HAE agent
Coverage duration: 12 MONTHS

Prior Authorization

Cometriq prior authorization

Cometriq products are listed as subject to prior authorization in the formulary; consult the product PA entry for specific criteria.

Check the product entry for detailed PA criteria

Prior Authorization

Prior authorization required

Prior authorization is required for many listed products; review each product entry for detailed PA criteria and typical 12‑month coverage periods.

Confirm product‑specific PA criteria and documentation

Prior Authorization

EPIDIOLEX prior auth specifics

EPIDIOLEX requires prior authorization with specialist prescription (neurologist) for DS, LGS, and TSC; for LGS an initial trial of or contraindication to two therapies (one example: clonazepam) is required. Initial/renewal durations are noted (initial and renewal as specified in entry).

Prescriber: neurologist or in consultation with neurologist
LGS prerequisite: trial of or contraindication to two therapies (example: clonazepam)
Initial/renewal durations per product entry

Prior Authorization

Carglumic acid prior auth specifics

Carglumic acid prior authorization requires diagnostic confirmation for acute or chronic hyperammonemia etiologies (e.g., NAGS gene mutation by biochemical or genetic testing); durations vary by indication (acute: 7 days; chronic NAGS initial 6 months, renewal 12 months).

Diagnostic confirmation: genetic or biochemical testing per listed etiology
Duration: acute HA due to NAGS/PA/MMA = 7 DAYS; chronic NAGS initial = 6 MOS, renewal = 12 MOS

Prior Authorization

CIMZIA-STARTER prior authorization requirements

CIMZIA‑STARTER requires prior authorization with indication‑specific initial requirements and step therapy in many indications (trials of or contraindication to preferred agents); step requirements are waived for pregnancy/breastfeeding/trying to conceive. Initial durations may be 6 months with renewals typically 12 months.

Document trials of specified preferred agents per indication or contraindication
Step waiver: pregnancy, breastfeeding, or trying to become pregnant
Initial duration commonly 6 months for some indications; renewal: 12 months

Prior Authorization

PA required; typical 12-month duration

Prior authorization is commonly required for listed specialty products with a typical 12‑month approval period; confirm product‑specific PA criteria and prescriber requirements in the formulary entry.

Default coverage duration often 12 MONTHS
Verify prescriber restrictions per product

Prior Authorization

TAFINLAR soluble tablet — PA for inability to swallow capsules

TAFINLAR soluble tablet (dabrafenib) soluble formulation may be prior authorized when the patient is unable to swallow capsules; PA criteria apply and coverage is typically listed as 12 months.

Authorization condition: inability to swallow TAFINLAR capsules
Coverage duration: 12 MONTHS

Prior Authorization

INQOVI — PA required

INQOVI (decitabine/cedazuridine) is subject to prior authorization with a coverage duration of 12 months and indications per All FDA‑approved Indications.

Coverage duration: 12 MONTHS
Indications: All FDA‑approved Indications

Prior Authorization

Deferasirox — PA required

Deferasirox products require prior authorization. Initial authorization is 6 months with renewal 12 months and documented laboratory thresholds (transfusion‑dependent: serum ferritin consistently >1000 mcg/L; NTDT: ferritin >300 mcg/L with LIC thresholds); trial of or contraindication to generic deferasirox formulations is required.

Transfusion‑dependent initial: ferritin >1000 mcg/L
NTDT initial: ferritin >300 mcg/L (two labs) AND LIC ≥5 mg Fe/g dry weight
Initial duration: 6 MONTHS; renewal: 12 MONTHS
Prerequisite: trial of or contraindication to generic deferasirox tablet or suspension

Prior Authorization

OSENVELT — PA required

OSENVELT is subject to prior authorization with a coverage duration commonly listed as 12 months and indication scope per FDA labeling.

Coverage duration: 12 MONTHS
Indications: All FDA‑approved Indications

Prior Authorization

Topical and oral agents — PA required

Topical and oral agents (e.g., diclofenac formulations, dimethyl fumarate) require prior authorization; typical authorization duration is 12 months and indications are listed as All FDA‑approved or All Medically‑accepted Indications where specified.

Typical coverage duration: 12 MONTHS
Confirm indication scope per product entry (FDA‑approved or medically accepted)

Prior Authorization

PA required; typical duration 12 months

Prior authorization is commonly required across many formulary entries with a typical 12‑month coverage period (e.g., VUMERITY); verify product‑specific criteria when submitting a PA.

Confirm PA criteria and documentation per product entry
Typical duration: 12 MONTHS

Prior Authorization

Dronabinol PA and duration

Dronabinol (oral capsule) requires prior authorization for nausea and vomiting associated with cancer with an initial coverage period of 6 months.

Coverage duration: 6 MONTHS for the listed indication (nausea/vomiting associated with cancer)
PA required

Prior Authorization

Prior authorization required for ORSERDU

Prior authorization required for ORSERDU oral tablets; coverage duration listed as 12 months for FDA‑approved indications.

Coverage duration: 12 MONTHS
Indications: All FDA‑approved Indications

Prior Authorization

PA and duration for REVCOVI

REVCOVI (elapegademase‑lvlr) requires prior authorization with initial approval for 6 months and renewal typically 12 months; initial requests must include confirmatory genetic testing or suggestive laboratory findings with hallmark signs/symptoms for ADA‑SCID and specialist prescribing.

Initial duration: 6 MONTHS; renewal: 12 MONTHS with evidence of improvement or maintenance of immune function
Diagnostic requirement: confirmatory genetic test OR suggestive labs (e.g., elevated deoxyadenosine nucleotide, lymphopenia) plus clinical signs/symptoms
Prescriber: immunologist, hematologist/oncologist, or metabolic disorder specialist

Prior Authorization

PA and prescriber restriction for TRIKAFTA

TRIKAFTA (elexacaftor‑tezacaftor‑ivacaftor) requires prior authorization. Initial approval is for 6 months and renewal may be lifetime; initial requests must be prescribed by or in consultation with a pulmonologist or CF expert and the drug must not be used concurrently with another CFTR modulator.

Initial duration: 6 MONTHS; renewal: LIFETIME per entry
Prescriber: pulmonologist or cystic fibrosis expert
No concurrent use with another CFTR modulator

Prior Authorization

PA and renewal rules for ELREXFIO

ELREXFIO (elranatamab‑bcmm) requires prior authorization with an initial 6‑month approval and 12‑month renewals; for relapsed/refractory multiple myeloma, renewal requires at least 24 weeks of treatment and documented response for at least 2 months.

Initial: 6 MONTHS; Renewal: 12 MONTHS
Renewal requirement for relapsed/refractory MM: ≥24 weeks treatment and response ≥2 months

Prior Authorization

PA and durations for PROMACTA

Eltrombopag (PROMACTA/ALVAIZ) requires prior authorization for ITP and other indications. Initial ITP approvals are for 6 months with renewals of 12 months; initial requests must document platelet counts (<30 x10^9/L or <50 x10^9/L with prior bleeding), trial of or contraindication to corticosteroid or IVIG or insufficient response to splenectomy, and no concurrent use with other TPO‑RAs. For oral suspension packets, a trial of the formulary tablet or documentation of inability to tolerate tablets is required.

Initial ITP platelet criteria: <30 x10^9/L OR <50 x10^9/L with prior bleeding
Initial duration: 6 MONTHS; Renewal: 12 MONTHS
Document trial/contraindication to corticosteroid or IVIG or insufficient response to splenectomy
No concurrent use with other TPO‑RAs
For suspension packets: trial of tablet formulation or intolerance to tablets required

Prior Authorization

Eltrombopag prior authorization

Prior authorization is required for eltrombopag products; initial ITP approvals are 6 months and renewals 12 months, contingent on meeting platelet thresholds and other specified criteria.

Ensure required baseline platelet counts and prior therapy documentation are submitted
No concurrent TPO‑RA use

Step Therapy

Abatacept (ORENCIA) step therapy

Step therapy for abatacept (ORENCIA) in RA: trial of or contraindication to 3 months of one conventional synthetic DMARD (e.g., methotrexate at ≥20 mg/week or maximally tolerated dose) is required before approval.

Document trial duration (3 months) and dosing if methotrexate was used (≥20 mg/week or maximally tolerated)

Step Therapy

Prerequisite therapy trials

Prerequisite therapy trials are required for many indications (e.g., RA, psoriasis, ankylosing spondylitis). Providers must document trials of conventional synthetic DMARDs, topical/systemic therapies, phototherapy, NSAIDs, or other specified agents, or document contraindications/intolerance.

Provide documentation of prior therapy trials and durations per indication (e.g., 3 months for DMARDs, 3 months for oral immunosuppressants for moderate‑severe psoriasis)

Step Therapy

Step or prerequisite therapy details

Step therapy details vary by product and indication; examples include trials of oral immunosuppressants or phototherapy for psoriasis and an NSAID trial for ankylosing spondylitis prior to biologic approval.

Confirm required prior agents (e.g., cyclosporine, methotrexate, tacrolimus, PUVA for psoriasis) and document failure, intolerance, or contraindication

Step Therapy

Kineret step therapy

Kineret (anakinra) step therapy: for RA an initial trial of or contraindication to two preferred agents is required prior to initiation.

Document trials of two preferred agents or contraindications

Step Therapy

Step therapy / prerequisite trials for Otezla

Otezla initiation requires trials of or contraindications to specified conventional systemic or topical therapies or phototherapy for the indicated psoriasis severity; document these prior therapies when submitting a PA.

For mild PSO: trial of one conventional systemic OR one topical therapy
For moderate‑severe PSO: ≥3‑month trial of one oral immunosuppressant or PUVA, or contraindication/intolerance

Step Therapy

Step therapy requirement for specific indications

Certain indications require failure of multiple prior systemic therapies (example: chronic graft‑vs‑host disease requires failure of at least two systemic therapy lines, one being JAKAFI); document prior systemic therapy history accordingly.

Provide history of prior systemic therapy lines and reason for failure/intolerance

Step Therapy

Prerequisite therapy noted

Prerequisite therapy requirements are noted in several product entries (field 'Prerequisite Therapy: Yes'); ensure documentation of trials or contraindications per the product’s PA entry.

Check the product entry for the number and identity of prerequisite agents required

Step Therapy

Bosutinib step therapy note

Bosutinib lists prerequisite therapy as required; submit documentation of prior therapy as indicated by the product entry when requesting prior authorization.

Ensure prior therapy documentation is submitted (product entry notes Prerequisite Therapy: Yes)

Coding and Billing Identifiers

Products Listedmixed

CALQUENCE ORAL TABLET

acalabrutinib product listing

Products Listedmixed

ATTRUBY

acoramidis product listing

Products Listedmixed

HUMIRA	adalimumab branded product and starter kits
adalimumab-aaty	adalimumab-aaty biosimilar presentations (various pen/syringe configurations)
YUFLYMA	adalimumab biosimilar product presentations

Adalimumab product identifiers listedmixed

adalimumab-aaty	1 pen auto-injector kit 40 mg/0.4ml or 80 mg/0.8ml
adalimumab-adbm
adalimumab-bwwd

Products Affected (Cyltezo and starters)mixed

CYLTEZO (2 PEN)
CYLTEZO (2 SYRINGE)
CYLTEZO-CD/UC/HS STARTER
CYLTEZO-PSORIASIS/UV STARTER

Hadlima productsmixed

HADLIMA
HADLIMA PUSHTOUCH

Piqray dosing products affectedmixed

PIQRAY (200 MG DAILY DOSE)
PIQRAY (300 MG DAILY DOSE)

Formulary Identifiersmixed

Formulary ID: 26380

Formulary identifier shown for Otezla/ Otezla XR initiation pack

Covered product identifiers (trade names) shownmixed

MEKTOVI

Product name listed under 'Products Affected'

Covered product identifiersmixed

bortezomib injection solution reconstituted 1 mg, 2.5 mg, 3.5 mg

Bortezomib formulations listed

Covered product identifiersmixed

bosentan oral tablet

Covered product identifiersmixed

BOSULIF ORAL TABLET 100 MG, 400 MG, 500 MG

bosutinib oral tablet

Covered product identifiersmixed

HAEGARDA SUBCUTANEOUS SOLUTION RECONSTITUTED 2000 UNIT, 3000 UNIT

C1 esterase inhibitor - HAEGARDA

Covered product identifiersmixed

COMETRIQ (100 MG DAILY DOSE) ORAL KIT 80 & 20 MG	Cometriq product listing
COMETRIQ (140 MG DAILY DOSE) ORAL KIT 3 X 20 MG & 80 MG	Cometriq product listing

Products Affected (example)mixed

COMETRIQ (100 MG DAILY DOSE) ORAL KIT 80 & 20 MG

Product listing text

Products Affected (example)mixed

COMETRIQ (140 MG DAILY DOSE) ORAL KIT 3 X 20 MG & 80 MG

Product listing text

Products Affectedmixed

TABRECTA

Product name as listed

Products Affectedmixed

EPIDIOLEX

Product name as listed

Products Affectedmixed

carglumic acid oral tablet soluble

Product name as listed

Formulary identifiersmixed

Formulary ID: 26380

Identifier for CIMZIA-STARTER entry

Drugs listed in segment (no billing codes provided)mixed

No codes listed

Products listed by namemixed

INQOVI	Product name listed (decitabine/cedazuridine)
OSENVELT	denosumab-bmwo
VUMERITY	diroximel fumarate

Deferasirox formulationsmixedCovered

deferasirox granules	deferasirox formulation
deferasirox oral tablet	deferasirox formulation

Topical diclofenac productsmixedCovered

diclofenac sodium external solution 2%	topical diclofenac product
diclofenac epolamine external	topical diclofenac patch/agent

Neurology / MS related productsmixedCovered

AUSTEDO	deutetrabenazine formulations
dimethyl fumarate oral capsule delayed release	dimethyl fumarate formulations

Products listed (examples)mixed

ORSERDU ORAL TABLET 345 MG, 86 MG

Product strengths listed in formulary entry

CFTR modulator productmixed

TRIKAFTA ORAL TABLET THERAPY PACK

Elexacaftor‑tezacaftor‑ivacaftor therapy pack

Multiple myeloma productmixed

ELREXFIO SUBCUTANEOUS SOLUTION 44 MG/1.1ML, 76 MG/1.9ML

Elranatamab‑bcmm formulations

Eltrombopag formulationsmixed

eltrombopag olamine oral tablet 12.5 mg, 25 mg, 50 mg, 75 mg	PROMACTA tablet strengths
eltrombopag olamine oral packet 12.5 mg, 25 mg	PROMACTA suspension packets

ADA‑SCID therapymixed

REVCOVI

Elapegademase‑lvlr product name

Covered drug productsNDCCovered

eltrombopag olamine oral tablet 12.5 mg	Listed product affected
eltrombopag oral suspension packets	Listed formulation with trial requirement

Maximum cumulative duration for abaloparatide (TYMLOS)

Maximum cumulative duration24 MONTHS (total treatment duration for abaloparatide [TYMLOS] must not exceed 24 months)

Indication scopeAll FDA‑approved indications for abaloparatide

Prerequisite therapyNone required

Coverage duration for listed oncology products

Typical coverage duration12 MONTHS (coverage duration listed for multiple oncology agents, e.g., VERZENIO, abiraterone products)

Indication scopeAll FDA‑approved indications (per product entries)

Part B applicabilityCommonly: No

Psoriasis body surface area

Psoriasis BSA threshold for systemic biologic initiation>= 3% body surface area OR lesions affecting hands/feet/face/scalp/genital area

Mild disease definition<3% BSA or SPGA score of 2 or PASI score 2–9

Documentation requiredBSA, SPGA or PASI score must be provided with PA request

NYHA class for ATTR-CM

NYHA class requirementNYHA class I, II, or III heart failure required for initial ATTR‑CM authorization

Diagnostic confirmationStrongly positive Tc‑99m‑PYP bone scan OR tissue biopsy with chemical typing confirming transthyretin

Prescriber requirementPrescribed by or in consultation with a cardiologist, ATTR specialist, or medical geneticist

Methotrexate dosing trial

Methotrexate dosing for DMARD trial>= 20 mg per week OR maximally tolerated dose when methotrexate was tried

Duration of DMARD trialTrial of or contraindication to 3 months of one conventional synthetic DMARD for RA initial requests

Alternate DMARD documentationIf methotrexate not used, document trial of another conventional synthetic DMARD or contraindication

Step Therapy Requirements

Requirement	Details
Required prior DMARD trial before initiating abatacept for RA
Trial of or contraindication to 3 months of one conventional synthetic DMARD (e.g., methotrexate). If methotrexate was tried, it must have been at ≥20 mg/week or the maximally tolerated dose.

Requirement	Details
Requires prior trials of conventional therapies or documented contraindication
For plaque psoriasis and related indications: at least a 3-month trial of one oral immunosuppressant (cyclosporine, methotrexate, tacrolimus) or phototherapy (PUVA), or contraindication/intolerance; topical/systemic therapies or phototherapy required per indication.

Requirement	Details
Trial of specified agents prior to biologic therapy
Examples include a trial of oral immunosuppressants or PUVA for psoriasis and trial of an NSAID for ankylosing spondylitis; documentation of trial and inadequate response or contraindication required.

Requirement	Details
step
For rheumatoid arthritis (Kineret) a trial of or contraindication to two preferred agents is required prior to initiation.

Requirement	Details
Trial of specified prior therapies required before Otezla initiation
Mild plaque psoriasis: trial of or contraindication to one conventional systemic therapy (e.g., methotrexate, acitretin, cyclosporine) or one conventional topical therapy. Moderate-to-severe: at least a 3-month trial of one oral immunosuppressant (cyclosporine, methotrexate, tacrolimus) or PUVA, or contraindication/intolerance.

Requirement	Details
Required before coverage for CGVHD indications
For chronic graft‑versus‑host disease (cGVHD): failure of at least two lines of systemic therapy is required, one of which must be a trial of or contraindication to JAKAFI.

Requirement	Details
Prerequisite therapy references in entries
Some product entries indicate 'Prerequisite Therapy: Yes' or list required prior agents; specific sequencing may vary by product and indication.

Requirement	Details
Prerequisite therapy required for bosutinib
Bosutinib (Bosulif) lists 'Prerequisite Therapy: Yes' and requires mutational analysis prior to initiation per NCCN recommendations; specific prior therapy details are referenced in the product entry.

Requirement	Details
Must document trial or contraindication
EPIDIOLEX LGS indication: initial trial of or contraindication to two specified therapies (example: clonazepam) must be documented.

Requirement	Details
Step agents required for many indications unless exception applies
CIMZIA‑STARTER and similar entries require trials of specified preferred agents (number varies by indication); step requirements are waived for patients who are pregnant, breastfeeding, or trying to conceive.

Requirement	Details
Prescribed by or in consultation with a neurologist required for initial dalfampridine ER
Dalfampridine ER initial requests must be prescribed by or in consultation with a neurologist and include documentation of walking disability symptoms (e.g., bilateral lower extremity impairment).

Requirement	Details
Trial or documentation of contraindication required prior to approval
Examples: deferasirox requires trial of or contraindication to generic deferasirox oral tablet or suspension; topical diclofenac for OA knee requires trial of alternative agents per product entry.

Requirement	Details
Prerequisite therapy required for some DUPIXENT indications
For atopic dermatitis: trial of topical agents (e.g., corticosteroid, calcineurin inhibitor, PDE‑4 or JAK inhibitor) or documentation of contraindication. For eosinophilic asthma: evidence of concurrent ICS and another maintenance med plus eosinophil thresholds and prior exacerbation/control criteria.

Requirement	Details
Trial of formulary tablet required before approving oral suspension packets
Eltrombopag oral suspension packets require a trial of a formulary tablet version or documentation that the patient cannot tolerate the tablet formulation or has difficulty swallowing.

Requirement	Details
Trial of or contraindication to splenectomy required for ITP; formulation trial rules
Initial ITP: document platelet count thresholds (<30 x10^9/L or <50 x10^9/L with prior bleeding), trial of or contraindication to splenectomy, and no concurrent use of other TPO‑RAs. For suspension packets, trial of tablet formulation or inability to tolerate tablets is required.

Background and Scope

This document provides prior authorization requirements and coverage criteria for multiple specialty pharmacy products used by GlobalHealth Medicare Advantage plans. It covers products across therapeutic areas — for example, osteoporosis (abaloparatide/TYMLOS), transthyretin‑mediated amyloidosis (ATTRUBY), and numerous biologic and oncology agents — and specifies required clinical documentation, prescriber restrictions, prerequisite therapy trials, and standard authorization durations (commonly 6 or 12 months). Notable policy limits include a 24‑month cumulative duration cap for abaloparatide (TYMLOS), diagnostic confirmation and specialist prescribing requirements for ATTR‑CM, and restrictions prohibiting concurrent use of multiple systemic biologic or targeted small‑molecule therapies for the same indication.

Definitions and Diagnostic Thresholds

Conventional synthetic DMARD definition

DefinitionConventional synthetic DMARDs are traditional disease‑modifying antirheumatic drugs (example: methotrexate)

Role in step therapyRequired prerequisite therapy before many biologics (document trial of at least 3 months or contraindication)

Example agent and dosingMethotrexate — if tried, at least 20 mg/week or maximally tolerated dose

ATTR-CM diagnostic confirmation

Confirmatory testsStrongly positive Tc‑99m‑PYP bone scan OR tissue biopsy with chemical typing confirming transthyretin (TTR)

Clinical requirementNYHA class I, II, or III heart failure documented

PrescriberPrescribed by or in consultation with cardiologist, ATTR specialist, or medical geneticist

Conventional synthetic DMARD trial for RA

Required trial durationTrial of or contraindication to 3 months of one conventional synthetic DMARD is required prior to biologic for RA

Methotrexate standardIf methotrexate tried, trial at >=20 mg/week or maximally tolerated dose is expected

Prescriber documentationPrescribed by or in consultation with a rheumatologist for RA/PJIA

Plaque psoriasis severity

Plaque psoriasis severity threshold>= 3% body surface area OR lesions affecting hands, feet, face, scalp, or genital area

Mild disease criteria<3% BSA OR SPGA score of 2 OR PASI score 2–9

Prior therapy requirementFor moderate‑to‑severe: at least a 3‑month trial of one oral immunosuppressant (e.g., cyclosporine, methotrexate, tacrolimus) or PUVA unless contraindicated

RA DMARD trial requirement

RA DMARD trial requirementTrial of or contraindication to 3 months of one conventional synthetic DMARD; if methotrexate tried, dose >=20 mg/week or maximally tolerated dose

DocumentationProvide dosing history and reason for intolerance/contraindication if applicable

No concurrent biologicNo concurrent use with another systemic biologic or targeted small molecule for same indication

CAPS / DIRA diagnostic criteria

Diagnostic evidence for CAPS/DIRAGenetic testing for gain‑of‑function mutations OR objective inflammatory markers (elevated CRP/ESR/SAA) plus characteristic clinical features

Clinical features examplesUrticarial‑like rash, cold‑triggered episodes, sensorineural hearing loss, musculoskeletal symptoms, chronic aseptic meningitis (CAPS); pustular psoriasis‑like rash, osteomyelitis (DIRA)

PrescriberSpecialist involvement (e.g., rheumatologist) expected for initial requests

Mild vs Moderate-to-Severe Psoriasis

Mild psoriasisPsoriasis covering <3% BSA OR SPGA score of 2 OR PASI score 2–9

Moderate-to-severe psoriasisPsoriasis covering >=3% BSA or lesions affecting hands/feet/face/scalp/genitalia (qualifies for systemic biologic therapy)

Assessment measuresBSA, SPGA, or PASI scores required for PA submission

Ph+ CML with T315I or previously treated

Ph+ CML populations coveredPreviously treated Ph+ CML and Ph+ CML with T315I mutation

Required testingMutational analysis (BCR‑ABL1 mutation profile) prior to initiation

Guideline alignmentTherapy appropriateness per NCCN treatment recommendations

Initial / Renewal durations example (BENLYSTA)

Example initial/renewal durationsBENLYSTA: Initial authorization 6 months; renewal 12 months with documentation of clinical improvement for SLE

Prescriber requirementPrescribed by or in consultation with a rheumatologist for SLE; lupus nephritis requires rheumatologist or nephrologist

Concurrent therapyRenewal requires ongoing background therapy (corticosteroids, antimalarials, NSAIDs, or immunosuppressives) and documented benefit

Coverage duration of service authorized (commonly 12 MONTHS)

Common default coverage duration12 MONTHS (commonly listed for many products)

ExceptionsSome products have 6‑month initial approvals with 12‑month renewals (e.g., BENLYSTA, deferasirox initial 6 months)

Part B notePart B applicability commonly listed as 'No' for many specialty drugs in this extract

PAH diagnostic criteria (right heart catheterization thresholds)

RHC diagnostic thresholds for PAHmean PAP >20 mmHg; PCWP ≤15 mmHg; PVR >2 Wood units (required for bosentan PA)

Prescriber requirementPrescribed by or in consultation with a cardiologist or pulmonologist

Safety exclusionsDo not initiate if ALT/AST >3x ULN or bilirubin increase ≥2x ULN; no concurrent use with cyclosporine A or glyburide

Hereditary angioedema (HAE) confirmation

HAE confirmation testingType I or II HAE: complement testing (C1‑INH protein, C4, C1‑INH functional levels, C1q) required; Type III documented clinically

PrescriberPrescribed by or in consultation with hematologist, immunologist, allergist, or pulmonologist

Concurrent prophylaxisNot on concurrent alternative prophylactic HAE agent for initial/renewal

NAGS-related hyperammonemia

NAGS-related HA confirmationBiochemical or genetic confirmation of NAGS gene mutation required for acute or chronic hyperammonemia due to NAGS

Duration for acute vs chronicAcute HA due to NAGS/PA/MMA: 7 days; Chronic HA due to NAGS: initial 6 months, renewal 12 months

Renewal evidenceChronic NAGS renewal requires documented clinical improvement

NR-axSpA diagnostic support

NR‑axSpA diagnostic supportElevated CRP above ULN OR sacroiliitis on MRI supports diagnosis for NR‑axSpA initial approval

PrescriberSpecialist involvement (rheumatologist) expected for initial requests

Related criteriaInitial duration typically 6 months; renewal 12 months with documented benefit

Ph+ CML definition

DefinitionPhiladelphia chromosome‑positive chronic myeloid leukemia (Ph+ CML)

Required testingMutational analysis (BCR‑ABL1 mutation profile) required prior to initiation for previously treated patients

Coverage duration12 MONTHS (as listed)

dalfampridine ER indication definition

IndicationImprovement in walking ability for patients with multiple sclerosis

Prescriber requirementPrescribed by or in consultation with a neurologist; documentation of walking disability (e.g., bilateral lower extremity impairment)

Coverage duration12 MONTHS (initial/renewal listed)

NTDT definition

NTDT definition (laboratory)Serum ferritin consistently above 300 mcg/L (at least two values in prior 3 months) with LIC thresholds specified

Initial LIC thresholdLIC >= 5 mg Fe/g dry weight for NTDT initial authorization

PrescriberPrescribed by or in consultation with a hematologist or hematologist/oncologist

NOH orthostatic BP drop

Orthostatic BP drop criterion>=20 mmHg systolic OR >=10 mmHg diastolic within 3 minutes of standing (documented)

Measurement requirementsBaseline seated and standing blood pressure readings required

PrescriberPrescribed by or in consultation with neurologist or cardiologist

ADA‑SCID definition

ADA‑SCID confirmationConfirmatory genetic test OR suggestive labs (e.g., elevated deoxyadenosine nucleotide levels, lymphopenia) plus hallmark signs/symptoms (recurrent infections, failure to thrive, persistent diarrhea)

PrescriberPrescribed by or in consultation with immunologist, hematologist/oncologist, or metabolic disorder specialist

Initial/renewal durationsInitial: 6 months; Renewal: 12 months contingent on improved/maintained immune function

ITP definition

ITP diagnostic definitionPersistent or chronic immune thrombocytopenia (ITP) with platelet thresholds and prior therapy requirements specified for eltrombopag

Initial platelet thresholdsPlatelet count <30 x10^9/L OR <50 x10^9/L with a prior bleeding event

Prerequisite therapyTrial of or contraindication to splenectomy and trial/contraindication to one corticosteroid or IVIG as specified

ITP (persistent or chronic)

Persistent/chronic ITP criteriaITP requiring platelet count thresholds and prior therapy documentation for eltrombopag coverage

Initial versus renewal durationsInitial approval: 6 months; Renewal: 12 months (requires improvement in platelet counts or reduced bleeding)

Formulation trialFor oral suspension packets, trial of formulary tablet version is required or documentation patient cannot tolerate tablets

Revision History

Policy Summary

Payerglobalhealth

PolicyPrior authorization and coverage criteria for specialty pharmacy products (partial)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2026

Last ReviewJul 21, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests with required clinical documentation (e.g., disease severity measures, prior therapy trials, specialist consult notes) to support approval.

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Policy Summary

Payerglobalhealth

PolicyPrior authorization and coverage criteria for specialty pharmacy products (partial)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 1, 2026

Last ReviewJul 21, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests with required clinical documentation (e.g., disease severity measures, prior therapy trials, specialist consult notes) to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20+products shown (partial)

12 monthscommon PA duration

24TYMLOS duration limit

All FDA-approvedindication scope repeated

Coverage Criteria (Per-Product Summaries)

TYMLOS — Initial therapy

Covered when ALL of the following are met:

TYMLOS initial coverage: Patient meets an FDA‑approved indication for abaloparatide (TYMLOS) for osteoporosis; total cumulative duration of abaloparatide therapy will not exceed 24 months.24 MONTHS

ORENCIA — Initial and renewal

Covered when ALL of the following are met:

Oncology agents — Initial

Covered when the product‑specific PA criteria are met for FDA‑approved oncology indications:

ATTR-CM: Initial/Renewal

Initial authorization for ATTR‑CM is covered when ALL of the following are met:

Adalimumab products: Initial

Initial authorization for adalimumab products is covered when ALL of the following are met (requirements vary by indication):

Initial and Renewal Criteria (examples)

Covered when ALL of the following are met (examples extracted from product entries):

RA initial example: Trial of or contraindication to 3 months of one conventional synthetic DMARD; if methotrexate tried, dose ≥20 mg/week or maximally tolerated dose required.

Ankylosing spondylitis initial example: Trial of or contraindication to an NSAID prior to biologic therapy.

Renewal example: For renewal (commonly 12 months), documentation that the member continues to benefit from the medication is required.12 months renewal interval typical

Per-product PA coverage summaries (partial)

Covered when the product‑specific PA criteria, prescriber restrictions, and documentation requirements are met:

Otezla initiation and renewal

Otezla initiation pack covered when ALL of the following are met:

Asciminib (Scemblix) initial therapy

Covered when ALL of the following are met:

Miplyffa (NPC) initial and renewal

Covered when ALL of the following are met:

Qulipta coverage

Covered when ALL of the following are met:

Qulipta initial: Indication: migraine prevention as labeled; initial authorization 6 months, renewal 12 months; no concurrent use with other CGRP inhibitors for migraine.

Avacopan (Tavneos) coverage

Covered when ALL of the following are met:

Ayvakit and AVMAPKI co-pack

Covered when the PA criteria for each product are met:

Ayvakit initial: Coverage per FDA‑approved indications; authorization duration commonly 12 months as listed in product entry.

AVMAPKI co‑pack initial: Coverage per FDA‑approved indications; authorization duration commonly 12 months as listed in product entry.

Per-product criteria (partial)

Per the product entries in this segment, coverage is allowed when the listed PA elements are satisfied:

REZUROCK - chronic GVHD: For chronic graft‑versus‑host disease: failure of at least two lines of systemic therapy is required, one of which must be a trial of or contraindication to JAKAFI.

Per-product PA summaries (partial)

These product summaries list PA parameters; approval requires meeting the entry‑specific clinical and administrative requirements:

Bosentan: Initial Therapy

Covered when ALL of the following are met:

Bosutinib: Initial Therapy

Covered when ALL of the following are met:

HAEGARDA: Initial Therapy

Covered when ALL of the following are met:

General product PA stance

General PA coverage rules apply:

EPIDIOLEX

Covered when ALL of the following are met:

EPIDIOLEX renewal: Renewal: routinely 12 months; documentation of continued benefit required.

Carglumic acid

Covered when ALL of the following are met:

CIMZIA-STARTER: Initial and Renewal Coverage Criteria

Covered when ALL of the following are met for specified indications:

CIMZIA‑STARTER plaque psoriasis: Plaque psoriasis covering ≥3% BSA OR lesions affecting hands/feet/face/scalp/genital area.BSA >= 3%

CIMZIA‑STARTER NR‑axSpA: Non‑radiographic axial spondyloarthritis: objective support with elevated CRP above ULN OR sacroiliitis on MRI.

Prescriber restriction: For certain diagnoses (RA, AS, NR‑axSpA, PJIA) prescription must be by or in consultation with a specialist (e.g., rheumatologist).

No concurrent therapy: No concurrent use with another systemic biologic or targeted small molecule for the same indication.

Duration: Initial duration may be 6 months for some indications; renewals typically 12 months with documentation of continued benefit.6 months initial (some), 12 months renewal

Product-level general coverage statements

Covered when consistent with product labeling and required documentation:

Default duration: Where the product entry specifies a default authorization period, the usual duration is 12 months unless otherwise noted.12 months

General PA coverage for listed products

Coverage summarized per product entries in this segment; approval requires meeting the per‑product PA elements:

Dasatinib specific coverage criterion

Covered when ALL of the following are met:

Dalfampridine ER specific coverage criterion

Covered when ALL of the following are met:

TAFINLAR soluble tablet criterion

Covered when ALL of the following are met:

TAFINLAR soluble tablet authorization: Soluble tablet formulation authorized when patient is unable to swallow TAFINLAR capsules; PA criteria apply and authorization duration typically 12 months.

Deferasirox — Initial and Renewal Coverage Criteria

Covered when ALL of the following are met for the specified indications:

Diclofenac topical — OA knee

Covered when ALL of the following are met:

General product coverage

Covered when the claim meets product‑specific criteria listed in the formulary:

Droxidopa Initial/Renewal

Covered when ALL of the following are met:

Droxidopa renewal: Renewal authorization: 12 months if patient continues to benefit from therapy.

DUPIXENT Initial/Renewal/Exclusions

DUPIXENT is covered when ALL indication‑specific diagnostic and prior therapy requirements are met:

CRSwNP initial: 56‑day trial of one topical nasal corticosteroid AND evidence of nasal polyps by exam/endoscopy/CT AND inadequately controlled disease per product entry.

General exclusion: No concurrent use with another systemic biologic or targeted small molecule for the same indication.

Dronabinol Coverage

Covered when ALL of the following are met:

Dronabinol initial (nausea/vomiting): Indication: nausea and vomiting associated with cancer; prior authorization required; authorization duration commonly 6 months per product entry.

ADA‑SCID coverage (REVCOVI)

Covered when ALL of the following are met:

CFTR modulator coverage (TRIKAFTA)

Covered when ALL of the following are met:

Multiple myeloma coverage (ELREXFIO)

Covered when ALL of the following are met:

Eltrombopag coverage (ITP and other indications)

Covered when ALL of the following are met for ITP and other indications:

Eltrombopag formulation preference: For oral suspension packets, trial of a formulary tablet version is required OR documentation that the patient cannot tolerate the tablet formulation.

Eltrombopag renewal: Renewal: improvement in platelet counts from baseline or reduction in bleeding events AND no concurrent use with other TPO‑RAs; renewal authorization 12 months.

ORSERDU coverage

Covered when ALL specified PA elements are met:

ORSERDU coverage: PA required for FDA‑approved indications; authorization duration commonly 12 months per product entry.

Initial therapy (ITP)

Covered when ALL of the following are met:

Continuation / renewal (ITP)

Covered when ALL of the following are met for continuation:

Initial Therapy — Criteria by Drug

inv-246: TYMLOS initial

TYMLOS initial: Coverage allowed for FDA‑approved osteoporosis indications provided cumulative use does not exceed 24 months.24 MONTHS

inv-247: ATTR-CM initial

inv-248: Adalimumab initial

inv-249: Initial therapy prerequisites

inv-250: ARIKAYCE initial

ARIKAYCE initial: Prescribed by or in consultation with a pulmonologist or infectious disease specialist; initial authorization 6 months; patient meets MAC lung disease criteria per product entry.

inv-251: Kineret initial

inv-252: Onapgo initial

Onapgo initial: Initial prescription by or in consultation with a neurologist for Parkinson disease; initial/renewal duration 12 months; renewal requires documented improvement in motor symptoms.

inv-253: Otezla initial therapy

inv-254: Scemblix initial therapy

Scemblix initial: Mutational analysis prior to initiation and alignment with NCCN treatment recommendations for BCR‑ABL1 mutation profile; coverage duration commonly 12 months.

inv-255: BENLYSTA initial therapy

inv-256: Prerequisite therapy notes (partial)

Prerequisite therapy notes: Some product entries indicate prerequisite therapy (Prerequisite Therapy: Yes) or specific prior agent trials; details are product specific and must be documented.

inv-257: Bosentan initial therapy

inv-258: EPIDIOLEX Initial Therapy

inv-259: Initial therapy requirements

inv-260: Deferasirox — Initial Therapy

inv-261: DUPIXENT initial

inv-262: Initial therapy requirements

inv-263: Initial therapy (ITP)

Renewal / Continuation Criteria

inv-264: Abatacept continuation

inv-265: Renewal criteria

Renewal criteria (general): Renewal requests require evidence the patient continues to benefit from therapy; renewal intervals commonly 12 months where specified.

inv-266: Renewal/Continuation

inv-267: ARIKAYCE continuation

inv-268: Kineret continuation

Kineret continuation: Renewal intervals: RA initial 6 months, renewal 12 months; CAPS/DIRA may have lifetime authorization for some indications; renewal requires continued benefit documentation.

inv-269: Otezla renewal

Otezla renewal: Renewal requires documentation that the patient continues to benefit from therapy; renewal duration commonly 12 months.

inv-270: Renewal criteria (partial)

inv-271: CIMZIA-STARTER renewal

CIMZIA‑STARTER renewal: Renewal requires documentation that the patient continues to benefit from the medication for the indicated condition; renewal duration typically 12 months.

inv-272: Deferasirox — Continuation Therapy

inv-273: Droxidopa renewal

Droxidopa renewal: Renewal: 12 months if patient continues to benefit from therapy, with required documentation of clinical response as specified.

inv-274: DUPIXENT renewal

inv-275: Renewal/continuation therapy requirements

inv-276: Renewal (ITP)

ITP renewal: Improvement in platelet counts from baseline or reduction in bleeding events AND no concurrent use with other TPO‑RAs; renewal duration typically 12 months.

Prior Authorization and Documentation — Actions for Prescribers/Pharmacies

Prior Authorization

TYMLOS prior authorization

Prior authorization required for TYMLOS (abaloparatide). Total cumulative coverage is limited to 24 months; requests exceeding a cumulative 24-month treatment duration will not be approved.

Coverage duration limit: 24 MONTHS

Prior Authorization

ORENCIA prior authorization

Prescriber restriction: rheumatologist for RA/PJIA; dermatologist or rheumatologist for PsA
RA prerequisite: 3-month trial of one conventional synthetic DMARD (methotrexate ≥20 mg/week if tried)
No concurrent use with another systemic biologic or targeted small molecule
Renewal: document continued benefit

Prior Authorization

Oncology agents prior authorization

Typical coverage duration: 12 MONTHS
Indications limited to All FDA‑approved Indications unless otherwise specified

Prior Authorization

CALQUENCE (acalabrutinib) – PA required

Coverage duration: 12 MONTHS
Follow product PA criteria as listed in formulary

Prior Authorization

ATTRUBY (acoramidis) – PA required

Diagnostic documentation: NYHA class I–III AND positive Tc‑99m‑PYP scan OR biopsy with TTR chemical typing
Prescriber: cardiologist, ATTR specialist, or medical geneticist
No concurrent use with other ATTR‑CM TTR stabilizers
Initial/renewal duration: 12 MONTHS

Prior Authorization

Adalimumab products – PA required

Psoriasis severity: ≥3% BSA or involvement of hands/feet/face/scalp/genitalia
RA prerequisite: trial of or contraindication to 3 months of one conventional synthetic DMARD (methotrexate ≥20 mg/week if tried)
No concurrent use with another systemic biologic or targeted small molecule

Step Therapy

Prior authorization with prerequisite therapy

Document trials of specified prior therapies or contraindications per indication (e.g., methotrexate ≥20 mg/week when used)
Step therapy requirements differ by indication — confirm applicable list in product entry

Prior Authorization

Prior authorization required

Confirm product‑specific PA criteria and stated coverage duration (commonly 12 months)

Prior Authorization

ARIKAYCE PA specifics

Prescriber restriction: pulmonologist or infectious disease specialist
Renewal evidence: ≥1 negative MAC sputum culture by 6 months for first renewal; ≥3 negative cultures by 12 months for subsequent renewals
Renewal also requires clinical improvement in symptoms

Documentation Required

PA requires disease severity and prior therapy documentation

Provide BSA, SPGA, or PASI scores for psoriasis where requested
Include documented trials of prior therapies or contraindications per indication

Documentation Required

PA requires mutational analysis

Submit mutational analysis (BCR‑ABL1) demonstrating appropriateness of therapy per NCCN guidance

Prior Authorization

Prior authorization required (12-month durations noted)

Prior authorization is required for many listed products and commonly provides a 12‑month approval interval; verify Part B applicability in the product entry (often 'No').

Common coverage duration: 12 MONTHS
Confirm Part B applicability per entry

Prior Authorization

BENLYSTA PA timing

Initial duration: 6 months; renewal: 12 months
Prescriber: rheumatologist or in consultation with rheumatology
Initial: evidence of concomitant SLE therapy (corticosteroids, antimalarials, NSAIDs, or immunosuppressive agents); renewal: clinical improvement required

Prior Authorization

Prior authorization required (multiple products)

Prior authorization is required for many additional products in the formulary; most entries indicate a 12‑month coverage duration and product‑specific PA criteria must be met.

Confirm product‑specific PA criteria and documentation requirements
Typical authorization period: 12 MONTHS

Prior Authorization

MEKTOVI prior authorization

MEKTOVI (binimetinib) requires prior authorization with a coverage duration listed as 12 months and coverage limited to FDA‑approved indications per the formulary entry.

Coverage duration: 12 MONTHS
Indications: All FDA‑approved Indications

Prior Authorization

Bortezomib prior authorization

Bortezomib products require prior authorization; the formulary lists a 12‑month coverage duration and coverage is limited to FDA‑approved indications.

Coverage duration: 12 MONTHS
Indications: All FDA‑approved Indications

Prior Authorization

Bosentan prior authorization

RHC confirmation with mean PAP >20 mmHg; PCWP ≤15 mmHg; PVR >2 Wood units
Do not authorize if ALT/AST >3x ULN or bilirubin increase ≥2x ULN
No concurrent use with cyclosporine A or glyburide
Coverage duration: 12 MONTHS

Prior Authorization

Bosutinib prior authorization

Bosutinib (Bosulif) requires prior authorization with prior mutational analysis (BCR‑ABL1 mutation profile) before initiation and indicates prerequisite therapy; coverage duration is 12 months.

Submit BCR‑ABL1 mutational analysis prior to initiation
Prerequisite therapy indicated (see product entry)
Coverage duration: 12 MONTHS

Prior Authorization

HAEGARDA prior authorization

Required labs: C1‑INH protein, C4, C1‑INH functional levels, C1q
Prescriber: hematologist, immunologist, allergist, or pulmonologist
No concurrent use with alternative prophylactic HAE agent
Coverage duration: 12 MONTHS

Prior Authorization

Cometriq prior authorization

Cometriq products are listed as subject to prior authorization in the formulary; consult the product PA entry for specific criteria.

Check the product entry for detailed PA criteria

Prior Authorization

Prior authorization required

Prior authorization is required for many listed products; review each product entry for detailed PA criteria and typical 12‑month coverage periods.

Confirm product‑specific PA criteria and documentation

Prior Authorization

EPIDIOLEX prior auth specifics

Prescriber: neurologist or in consultation with neurologist
LGS prerequisite: trial of or contraindication to two therapies (example: clonazepam)
Initial/renewal durations per product entry

Prior Authorization

Carglumic acid prior auth specifics

Diagnostic confirmation: genetic or biochemical testing per listed etiology
Duration: acute HA due to NAGS/PA/MMA = 7 DAYS; chronic NAGS initial = 6 MOS, renewal = 12 MOS

Prior Authorization

CIMZIA-STARTER prior authorization requirements

Document trials of specified preferred agents per indication or contraindication
Step waiver: pregnancy, breastfeeding, or trying to become pregnant
Initial duration commonly 6 months for some indications; renewal: 12 months

Prior Authorization

PA required; typical 12-month duration

Default coverage duration often 12 MONTHS
Verify prescriber restrictions per product

Prior Authorization

TAFINLAR soluble tablet — PA for inability to swallow capsules

TAFINLAR soluble tablet (dabrafenib) soluble formulation may be prior authorized when the patient is unable to swallow capsules; PA criteria apply and coverage is typically listed as 12 months.

Authorization condition: inability to swallow TAFINLAR capsules
Coverage duration: 12 MONTHS

Prior Authorization

INQOVI — PA required

INQOVI (decitabine/cedazuridine) is subject to prior authorization with a coverage duration of 12 months and indications per All FDA‑approved Indications.

Coverage duration: 12 MONTHS
Indications: All FDA‑approved Indications

Prior Authorization

Deferasirox — PA required

Transfusion‑dependent initial: ferritin >1000 mcg/L
NTDT initial: ferritin >300 mcg/L (two labs) AND LIC ≥5 mg Fe/g dry weight
Initial duration: 6 MONTHS; renewal: 12 MONTHS
Prerequisite: trial of or contraindication to generic deferasirox tablet or suspension

Prior Authorization

OSENVELT — PA required

OSENVELT is subject to prior authorization with a coverage duration commonly listed as 12 months and indication scope per FDA labeling.

Coverage duration: 12 MONTHS
Indications: All FDA‑approved Indications

Prior Authorization

Topical and oral agents — PA required

Typical coverage duration: 12 MONTHS
Confirm indication scope per product entry (FDA‑approved or medically accepted)

Prior Authorization

PA required; typical duration 12 months

Prior authorization is commonly required across many formulary entries with a typical 12‑month coverage period (e.g., VUMERITY); verify product‑specific criteria when submitting a PA.

Confirm PA criteria and documentation per product entry
Typical duration: 12 MONTHS

Prior Authorization

Dronabinol PA and duration

Dronabinol (oral capsule) requires prior authorization for nausea and vomiting associated with cancer with an initial coverage period of 6 months.

Coverage duration: 6 MONTHS for the listed indication (nausea/vomiting associated with cancer)
PA required

Prior Authorization

Prior authorization required for ORSERDU

Prior authorization required for ORSERDU oral tablets; coverage duration listed as 12 months for FDA‑approved indications.

Coverage duration: 12 MONTHS
Indications: All FDA‑approved Indications

Prior Authorization

PA and duration for REVCOVI

Initial duration: 6 MONTHS; renewal: 12 MONTHS with evidence of improvement or maintenance of immune function
Diagnostic requirement: confirmatory genetic test OR suggestive labs (e.g., elevated deoxyadenosine nucleotide, lymphopenia) plus clinical signs/symptoms
Prescriber: immunologist, hematologist/oncologist, or metabolic disorder specialist

Prior Authorization

PA and prescriber restriction for TRIKAFTA

Initial duration: 6 MONTHS; renewal: LIFETIME per entry
Prescriber: pulmonologist or cystic fibrosis expert
No concurrent use with another CFTR modulator

Prior Authorization

PA and renewal rules for ELREXFIO

Initial: 6 MONTHS; Renewal: 12 MONTHS
Renewal requirement for relapsed/refractory MM: ≥24 weeks treatment and response ≥2 months

Prior Authorization

PA and durations for PROMACTA

Initial ITP platelet criteria: <30 x10^9/L OR <50 x10^9/L with prior bleeding
Initial duration: 6 MONTHS; Renewal: 12 MONTHS
Document trial/contraindication to corticosteroid or IVIG or insufficient response to splenectomy
No concurrent use with other TPO‑RAs
For suspension packets: trial of tablet formulation or intolerance to tablets required

Prior Authorization

Eltrombopag prior authorization

Prior authorization is required for eltrombopag products; initial ITP approvals are 6 months and renewals 12 months, contingent on meeting platelet thresholds and other specified criteria.

Ensure required baseline platelet counts and prior therapy documentation are submitted
No concurrent TPO‑RA use

Step Therapy

Abatacept (ORENCIA) step therapy

Document trial duration (3 months) and dosing if methotrexate was used (≥20 mg/week or maximally tolerated)

Step Therapy

Prerequisite therapy trials

Provide documentation of prior therapy trials and durations per indication (e.g., 3 months for DMARDs, 3 months for oral immunosuppressants for moderate‑severe psoriasis)

Step Therapy

Step or prerequisite therapy details

Confirm required prior agents (e.g., cyclosporine, methotrexate, tacrolimus, PUVA for psoriasis) and document failure, intolerance, or contraindication

Step Therapy

Kineret step therapy

Kineret (anakinra) step therapy: for RA an initial trial of or contraindication to two preferred agents is required prior to initiation.

Document trials of two preferred agents or contraindications

Step Therapy

Step therapy / prerequisite trials for Otezla

For mild PSO: trial of one conventional systemic OR one topical therapy
For moderate‑severe PSO: ≥3‑month trial of one oral immunosuppressant or PUVA, or contraindication/intolerance

Step Therapy

Step therapy requirement for specific indications

Provide history of prior systemic therapy lines and reason for failure/intolerance

Step Therapy

Prerequisite therapy noted

Prerequisite therapy requirements are noted in several product entries (field 'Prerequisite Therapy: Yes'); ensure documentation of trials or contraindications per the product’s PA entry.

Check the product entry for the number and identity of prerequisite agents required

Step Therapy

Bosutinib step therapy note

Bosutinib lists prerequisite therapy as required; submit documentation of prior therapy as indicated by the product entry when requesting prior authorization.

Ensure prior therapy documentation is submitted (product entry notes Prerequisite Therapy: Yes)

Coding and Billing Identifiers

Products Listedmixed

CALQUENCE ORAL TABLET

acalabrutinib product listing

Products Listedmixed

ATTRUBY

acoramidis product listing

Products Listedmixed

HUMIRA	adalimumab branded product and starter kits
adalimumab-aaty	adalimumab-aaty biosimilar presentations (various pen/syringe configurations)
YUFLYMA	adalimumab biosimilar product presentations

Adalimumab product identifiers listedmixed

adalimumab-aaty	1 pen auto-injector kit 40 mg/0.4ml or 80 mg/0.8ml
adalimumab-adbm
adalimumab-bwwd

Products Affected (Cyltezo and starters)mixed

CYLTEZO (2 PEN)
CYLTEZO (2 SYRINGE)
CYLTEZO-CD/UC/HS STARTER
CYLTEZO-PSORIASIS/UV STARTER

Hadlima productsmixed

HADLIMA
HADLIMA PUSHTOUCH

Piqray dosing products affectedmixed

PIQRAY (200 MG DAILY DOSE)
PIQRAY (300 MG DAILY DOSE)

Formulary Identifiersmixed

Formulary ID: 26380

Formulary identifier shown for Otezla/ Otezla XR initiation pack

Covered product identifiers (trade names) shownmixed

MEKTOVI

Product name listed under 'Products Affected'

Covered product identifiersmixed

bortezomib injection solution reconstituted 1 mg, 2.5 mg, 3.5 mg

Bortezomib formulations listed

Covered product identifiersmixed

bosentan oral tablet

Covered product identifiersmixed

BOSULIF ORAL TABLET 100 MG, 400 MG, 500 MG

bosutinib oral tablet

Covered product identifiersmixed

HAEGARDA SUBCUTANEOUS SOLUTION RECONSTITUTED 2000 UNIT, 3000 UNIT

C1 esterase inhibitor - HAEGARDA

Covered product identifiersmixed

COMETRIQ (100 MG DAILY DOSE) ORAL KIT 80 & 20 MG	Cometriq product listing
COMETRIQ (140 MG DAILY DOSE) ORAL KIT 3 X 20 MG & 80 MG	Cometriq product listing

Products Affected (example)mixed

COMETRIQ (100 MG DAILY DOSE) ORAL KIT 80 & 20 MG

Product listing text

Products Affected (example)mixed

COMETRIQ (140 MG DAILY DOSE) ORAL KIT 3 X 20 MG & 80 MG

Product listing text

Products Affectedmixed

TABRECTA

Product name as listed

Products Affectedmixed

EPIDIOLEX

Product name as listed

Products Affectedmixed

carglumic acid oral tablet soluble

Product name as listed

Formulary identifiersmixed

Formulary ID: 26380

Identifier for CIMZIA-STARTER entry

Drugs listed in segment (no billing codes provided)mixed

No codes listed

Products listed by namemixed

INQOVI	Product name listed (decitabine/cedazuridine)
OSENVELT	denosumab-bmwo
VUMERITY	diroximel fumarate

Deferasirox formulationsmixedCovered

deferasirox granules	deferasirox formulation
deferasirox oral tablet	deferasirox formulation

Topical diclofenac productsmixedCovered

diclofenac sodium external solution 2%	topical diclofenac product
diclofenac epolamine external	topical diclofenac patch/agent

Neurology / MS related productsmixedCovered

AUSTEDO	deutetrabenazine formulations
dimethyl fumarate oral capsule delayed release	dimethyl fumarate formulations

Products listed (examples)mixed

ORSERDU ORAL TABLET 345 MG, 86 MG

Product strengths listed in formulary entry

CFTR modulator productmixed

TRIKAFTA ORAL TABLET THERAPY PACK

Elexacaftor‑tezacaftor‑ivacaftor therapy pack

Multiple myeloma productmixed

ELREXFIO SUBCUTANEOUS SOLUTION 44 MG/1.1ML, 76 MG/1.9ML

Elranatamab‑bcmm formulations

Eltrombopag formulationsmixed

eltrombopag olamine oral tablet 12.5 mg, 25 mg, 50 mg, 75 mg	PROMACTA tablet strengths
eltrombopag olamine oral packet 12.5 mg, 25 mg	PROMACTA suspension packets

ADA‑SCID therapymixed

REVCOVI

Elapegademase‑lvlr product name

Covered drug productsNDCCovered

eltrombopag olamine oral tablet 12.5 mg	Listed product affected
eltrombopag oral suspension packets	Listed formulation with trial requirement

Maximum cumulative duration for abaloparatide (TYMLOS)

Maximum cumulative duration24 MONTHS (total treatment duration for abaloparatide [TYMLOS] must not exceed 24 months)

Indication scopeAll FDA‑approved indications for abaloparatide

Prerequisite therapyNone required

Coverage duration for listed oncology products

Typical coverage duration12 MONTHS (coverage duration listed for multiple oncology agents, e.g., VERZENIO, abiraterone products)

Indication scopeAll FDA‑approved indications (per product entries)

Part B applicabilityCommonly: No

Psoriasis body surface area

Psoriasis BSA threshold for systemic biologic initiation>= 3% body surface area OR lesions affecting hands/feet/face/scalp/genital area

Mild disease definition<3% BSA or SPGA score of 2 or PASI score 2–9

Documentation requiredBSA, SPGA or PASI score must be provided with PA request

NYHA class for ATTR-CM

NYHA class requirementNYHA class I, II, or III heart failure required for initial ATTR‑CM authorization

Diagnostic confirmationStrongly positive Tc‑99m‑PYP bone scan OR tissue biopsy with chemical typing confirming transthyretin

Prescriber requirementPrescribed by or in consultation with a cardiologist, ATTR specialist, or medical geneticist

Methotrexate dosing trial

Methotrexate dosing for DMARD trial>= 20 mg per week OR maximally tolerated dose when methotrexate was tried

Duration of DMARD trialTrial of or contraindication to 3 months of one conventional synthetic DMARD for RA initial requests

Alternate DMARD documentationIf methotrexate not used, document trial of another conventional synthetic DMARD or contraindication

Step Therapy Requirements

Requirement	Details
Required prior DMARD trial before initiating abatacept for RA
Trial of or contraindication to 3 months of one conventional synthetic DMARD (e.g., methotrexate). If methotrexate was tried, it must have been at ≥20 mg/week or the maximally tolerated dose.

Requirement	Details
Requires prior trials of conventional therapies or documented contraindication
For plaque psoriasis and related indications: at least a 3-month trial of one oral immunosuppressant (cyclosporine, methotrexate, tacrolimus) or phototherapy (PUVA), or contraindication/intolerance; topical/systemic therapies or phototherapy required per indication.

Requirement	Details
Trial of specified agents prior to biologic therapy
Examples include a trial of oral immunosuppressants or PUVA for psoriasis and trial of an NSAID for ankylosing spondylitis; documentation of trial and inadequate response or contraindication required.

Requirement	Details
step
For rheumatoid arthritis (Kineret) a trial of or contraindication to two preferred agents is required prior to initiation.

Requirement	Details
Trial of specified prior therapies required before Otezla initiation
Mild plaque psoriasis: trial of or contraindication to one conventional systemic therapy (e.g., methotrexate, acitretin, cyclosporine) or one conventional topical therapy. Moderate-to-severe: at least a 3-month trial of one oral immunosuppressant (cyclosporine, methotrexate, tacrolimus) or PUVA, or contraindication/intolerance.

Requirement	Details
Required before coverage for CGVHD indications
For chronic graft‑versus‑host disease (cGVHD): failure of at least two lines of systemic therapy is required, one of which must be a trial of or contraindication to JAKAFI.

Requirement	Details
Prerequisite therapy references in entries
Some product entries indicate 'Prerequisite Therapy: Yes' or list required prior agents; specific sequencing may vary by product and indication.

Requirement	Details
Prerequisite therapy required for bosutinib
Bosutinib (Bosulif) lists 'Prerequisite Therapy: Yes' and requires mutational analysis prior to initiation per NCCN recommendations; specific prior therapy details are referenced in the product entry.

Requirement	Details
Must document trial or contraindication
EPIDIOLEX LGS indication: initial trial of or contraindication to two specified therapies (example: clonazepam) must be documented.

Requirement	Details
Step agents required for many indications unless exception applies
CIMZIA‑STARTER and similar entries require trials of specified preferred agents (number varies by indication); step requirements are waived for patients who are pregnant, breastfeeding, or trying to conceive.

Requirement	Details
Prescribed by or in consultation with a neurologist required for initial dalfampridine ER
Dalfampridine ER initial requests must be prescribed by or in consultation with a neurologist and include documentation of walking disability symptoms (e.g., bilateral lower extremity impairment).

Requirement	Details
Trial or documentation of contraindication required prior to approval
Examples: deferasirox requires trial of or contraindication to generic deferasirox oral tablet or suspension; topical diclofenac for OA knee requires trial of alternative agents per product entry.

Requirement	Details
Prerequisite therapy required for some DUPIXENT indications
For atopic dermatitis: trial of topical agents (e.g., corticosteroid, calcineurin inhibitor, PDE‑4 or JAK inhibitor) or documentation of contraindication. For eosinophilic asthma: evidence of concurrent ICS and another maintenance med plus eosinophil thresholds and prior exacerbation/control criteria.

Requirement	Details
Trial of formulary tablet required before approving oral suspension packets
Eltrombopag oral suspension packets require a trial of a formulary tablet version or documentation that the patient cannot tolerate the tablet formulation or has difficulty swallowing.

Requirement	Details
Trial of or contraindication to splenectomy required for ITP; formulation trial rules
Initial ITP: document platelet count thresholds (<30 x10^9/L or <50 x10^9/L with prior bleeding), trial of or contraindication to splenectomy, and no concurrent use of other TPO‑RAs. For suspension packets, trial of tablet formulation or inability to tolerate tablets is required.