Abaloparatide (Tymlos) — Prior Authorization and Coverage Criteria
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Defines prior authorization and coverage restrictions for abaloparatide (TYMLOS) for San Francisco Health Plan members, including a 24-month cumulative parathyroid-class treatment limit, prescriber and documentation requirements where specified, and typical authorization durations.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy — Covered when the following high-level conditions are met
Covered when the following high-level conditions are met
See exclusion: cumulative parathyroid treatment limit applies; prior authorization required.
Initial/renewal authorization common criteria — Covered when ALL of the following are met (as specified per product)
Covered when ALL of the following are met (as specified per product):
Product lines indicate prescriber requirement per indication
Product-specific variations apply
Applies across many product entries
See product-specific lines for exact durations
Summary coverage behavior
Summary coverage statements as listed in the excerpt
Product-specific PA criteria (selected explicit items) — Summarized product-level requirements
Summarized product-level requirements (selected explicit items from the excerpt)
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This policy requires prior authorization for abaloparatide (TYMLOS) and applies coverage limits and exclusions specific to the parathyroid class. Coverage is limited to All FDA‑approved indications for the product when PA criteria are met. A key authorization condition is the cumulative treatment cap: the member must not have received a total of 24 months cumulative treatment with any parathyroid agent. Requests that would exceed this 24‑month cumulative limit may be denied.
The document includes indication‑specific exclusions and concurrent‑use restrictions. For example, the uveitis indication excludes patients with isolated anterior uveitis. Several biologic and targeted therapy entries prohibit concurrent use with another systemic biologic or targeted small molecule for the same indication (e.g., no concurrent CGRP inhibitors for migraine prevention). These concurrent‑therapy exclusions apply to both initial and renewal requests.
Exclusion criteria are specified for individual products and may include diagnostic or safety exclusions. KINERET lists multiple exclusions (e.g., COVID‑19 in hospitalized adults and sensorineural hearing loss) and corticotropin is explicitly noted as not approved for diagnostic purposes in initial use. For metabolic/genetic agents (for example, carglumic acid) initial use may require genetic test confirmation as part of exclusion/eligibility determinations.
The policy enforces no concurrent use rules for certain therapies. Atogepant (QULIPTA) and other CGRP inhibitors are not to be used concurrently for migraine prevention. Similarly, entries for chronic graft‑versus‑host disease therapies (NIKTIMVO, REZUROCK) prohibit concurrent use with specified agents such as JAKAFI, REZUROCK, and IMBRUVICA.
Some products include explicit concurrent‑use exclusions with named agents. NIKTIMVO requires failure of at least two prior systemic therapy lines and states no concurrent use with JAKAFI, REZUROCK, or IMBRUVICA. REZUROCK likewise lists no concurrent use with JAKAFI, NIKTIMVO, or IMBRUVICA. Bosentan (for PAH) has safety exclusions tied to hepatic labs; see lab‑based exclusions and prescriber requirements.
Age and prescriber restrictions are applied where clinically appropriate. CAYSTON carries an age restriction: 7 years of age or older. Several agents (for example BENLYSTA, corticotropin, and neurologic agents) require prescribing by or consultation with a relevant specialist (rheumatologist, nephrologist, neurologist, movement‑disorder specialist) as part of initial authorization.
Certain products specify prescriber specialty requirements and documentation expectations. BENLYSTA subcutaneous initial therapy must be prescribed by or in consultation with a rheumatologist (and nephrologist for lupus nephritis) with documentation of concomitant therapies and clinical improvement for renewal. Prescriber specialty requirements are common across multiple specialty drug entries.
The policy reiterates multiple concurrent‑use exclusions for safety and therapeutic duplication. REZUROCK and NIKTIMVO entries both forbid concurrent administration with overlapping targeted agents, and migraine prevention therapies such as AIMOVIG/QULIPTA disallow concurrent CGRP inhibitor use to avoid duplication of mechanism.
Bosentan PAH initial criteria require diagnostic confirmation by right heart catheterization (mean PAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR > 2 Wood units) and prescriber involvement (cardiologist or pulmonologist). Bosentan also includes laboratory exclusion thresholds: ALT/AST > 3× ULN or bilirubin increase ≥ 2× ULN will exclude use.
Initial use of metabolic or genetic therapies may require confirmatory testing. For carglumic acid, genetic testing confirming NAGS (or other specified gene mutations for related disorders) is part of the initial eligibility criteria. Similarly, some product entries note required diagnostic or genetic confirmation before approval.
SYMPAZAN (clobazam) and other neurologic agents include prescriber‑specialty requirements: initial therapy for Lennox‑Gastaut Syndrome must be prescribed by or in consultation with a neurologist. Dalfampridine also requires initial prescribing by or consultation with a neurologist for multiple sclerosis patients with walking disability.
Corticotropin is explicitly noted as not approved for diagnostic purposes in initial use and includes prescriber and prerequisite therapy considerations depending on indication. Part B/Part D applicability is also addressed for certain indications and MA‑PD plan considerations.
VIZIMPRO (dacomitinib) coverage carries an exclusion for metastatic NSCLC when the patient is receiving concurrent EGFR tyrosine kinase inhibitor therapy. Prior authorization and a 12‑month authorization period are typical for this product.
The policy notes Part B coverage status for many listed products. Unless explicitly specified, entries typically indicate Part B: No. Part B applicability is called out only where relevant (for example, corticotropin has Part B entries in some indications).
A recurring coverage rule across entries is the prohibition on concurrent use with another systemic biologic or targeted small molecule for the same indication. This is stated for initial and renewal requests and applies broadly to avoid duplication of therapy and safety risks.
For immune thrombocytopenia (ITP) treatments, concurrent use with other thrombopoietin receptor agonists (TPO‑RAs) is not allowed. Eltrombopag entries require platelet thresholds and prior therapy documentation for initial approval and explicitly prohibit concurrent TPO‑RA use at initiation and renewal.
Some product listings indicate that additional exclusion criteria are required though the excerpt does not list them in full. The policy notes Exclusion Criteria Required for several products, implying that specific contraindications or safety exclusions must be verified for authorization.
Initial Therapy Criteria
Epoetin alfa-epbx Initial and Renewal Criteria
Epoetin alfa-epbx (RETACRIT) coverage and exclusion summary
Renewal documentation and dose‑reduction evidence required for renewal
AIMOVIG Authorization Criteria
AIMOVIG (erenumab‑aeoe) coverage timing and renewal expectations
Renewal: 12 months with demonstrated reduction in migraine frequency/severity/duration
Etanercept Coverage Criteria
Etanercept products coverage and prerequisite therapy
See indication‑specific lines for specialties
No concurrent use with another systemic biologic/targeted small molecule for same indication
Applies across etanercept product listings
VOWST Coverage
Fecal microbiota capsules (VOWST) coverage notes
See VOWST entry for prior treatment constraints and definitions of treatment failure
INREBIC initial therapy
INREBIC (fedratinib) coverage notes
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FINTEPLA
FINTEPLA (fenfluramine) coverage notes
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Fentanyl citrate buccal lozenge
Fentanyl citrate buccal lozenge on a handle
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VEOZAH
VEOZAH (fezolinetant) coverage notes
Initial/renewal duration 12 months
Initial therapy/authorization
Initial authorization details
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Continuation / Renewal Criteria
Continuation Therapy
Renewal/continuation restrictions
Policy exclusion applies to additional parathyroid coverage
Typical renewal duration: 12 months where specified
Renewal requirements
Renewal criteria (common across several biologics):
Renewal intervals often set to 12 months
Applies to many biologic policies
Renewal/Continuation rules
Renewal criteria examples present in excerpt
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Continuation / renewal
Renewal criteria commonly require demonstrated benefit and set renewal durations (typically 12 months).
See product entries for evidence required
Standard continuation/renewal
Many products list initial/renewal duration of 12 months and indicate coverage for all FDA‑approved indications; continuation follows same duration where renewal is allowed.
Applies broadly across multiple product entries
Dalfampridine continuation
Dalfampridine renewal
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Deferasirox continuation
Deferasirox renewal
See initial thresholds for initiation criteria
Continuation therapy notes
Renewal/continuation requirements are indicated for some agents (example renewal durations and continued benefit statements).
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Renewal / continuation therapy
Renewal requires clinical improvement or maintenance evidence.
Specific renewal evidence varies by indication
ITP Continuation
Renewal/continuation rules for ITP therapy with eltrombopag
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Step Therapy / Prerequisite Trials
| Prerequisite therapy | Notes |
|---|---|
| No prerequisite therapy required | |
| Document lists 'Prerequisite Therapy, 1 = No' for abaloparatide (TYMLOS); Part B prerequisite: No; cumulative parathyroid-class duration limit applies (see policy). |
| Requirement | Example / Details |
|---|---|
| Trial of conventional synthetic DMARD(s) or documented contraindication | |
| RA initial: trial of or contraindication to ≥3 months of a conventional synthetic DMARD (e.g., methotrexate at ≥20 mg/week or maximally tolerated dose). | |
| Prior trials of specified agents per indication | |
| For psoriatic disease/psoriasis/others: required trials of listed preferred agents (see product-specific entries for agent lists and exceptions). |
| Step requirement | KINERET example / Details |
|---|---|
| Trial of preferred agents or documented contraindication required | |
| Example: KINERET and similar biologics require trial of or contraindication to specified preferred agents (lists include agents such as HUMIRA, XELJANZ, RINVOQ, ORENCIA, etc.); no concurrent use with another systemic biologic or targeted small molecule for same indication. |
| Prior therapy required | NIKTIMVO (chronic GVHD) details |
|---|---|
| Failure of prior systemic therapies required | |
| Chronic GVHD: failure of at least two lines of systemic therapy is required; one must be a trial of or contraindication to JAKAFI; no concurrent use with JAKAFI, REZUROCK, or IMBRUVICA; coverage duration 12 months. |
| Documentation required | REZUROCK (belumosudil) prior treatment failures |
|---|---|
| Document failure of prior lines of therapy | |
| REZUROCK for chronic GVHD: requires documentation of failure of at least two lines of systemic therapy, one of which must be a trial of or contraindication to JAKAFI; also must not be used concurrently with JAKAFI, NIKTIMVO, or IMBRUVICA; prior authorization required (12 months). |
| Prerequisite therapy | Bosutinib (Bosulif) note |
|---|---|
| Prior therapy required (per product entry) | |
| Bosutinib entry indicates 'Prerequisite Therapy: Yes' for previously treated Ph+ CML; mutational analysis prior to initiation is required and documentation per NCCN treatment recommendations expected; coverage duration typically 12 months. |
| Step therapy requirement | Indications / Notes |
|---|---|
| Trials of preferred agents or documented contraindications required | |
| For multiple autoimmune indications (RA, PSA, PSO, AS, CD, PJIA): trial of or contraindication to specified preferred agents is required; pregnancy/breastfeeding/trying to conceive exceptions apply. Specific agent lists and trial lengths are product-dependent (see entries). |
| Prerequisite therapy / Part B/Part D | Corticotropin details |
|---|---|
| Prerequisite therapy required for some indications; Part B considerations noted | |
| Corticotropin: initial criteria note prerequisite therapy (e.g., trial of or contraindication to IV corticosteroids for many indications); Part B/Part D step therapy considerations apply for MA-PD plans; durations vary by indication (e.g., 28 days for some, 12 months for others). |
| Step requirement | Deferasirox formulations |
|---|---|
| Trial of or contraindication to generic deferasirox required before coverage of other formulations | |
| Deferasirox: initial coverage requires trial of or documented contraindication to generic deferasirox oral tablet or tablet for oral suspension before authorization of other deferasirox formulations; initial and renewal lab thresholds and prescriber specialty requirements also apply. |
| Prior trial required | Diclofenac topical (knee OA) example |
|---|---|
| Trial of formulary/topical options required prior to higher-line agent authorization | |
| Diclofenac topical solution (knee osteoarthritis): trial of or contraindication to a formulary version is required prior to authorization; coverage duration initial: 6 months. |
| Documented trial required | Examples (topicals, antihistamines, corticosteroids, immunoglobulin) |
|---|---|
| Documented trial or contraindication to specified prior agents required | |
| Examples: dermatologic conditions often require trial of topical corticosteroid/calcineurin inhibitor/PDE4/JAK inhibitor; chronic spontaneous urticaria requires trial of a second-generation H1 antihistamine; ITP initial therapy requires trial of or contraindication to corticosteroid or IVIG (or insufficient response to splenectomy). |
| Formulation-specific step | Eltrombopag oral suspension packets |
|---|---|
| Trial of formulary tablet formulation required before packet formulation | |
| Eltrombopag oral suspension packets: trial of a formulary version of eltrombopag tablet is required unless the patient is unable to tolerate the tablet formulation. |
| Prerequisite therapy | Etanercept (ENBREL) example |
|---|---|
| Trial of or contraindication to specified therapies required | |
| Etanercept initial criteria: RA requires trial of or contraindication to ≥3 months of a conventional synthetic DMARD (methotrexate ≥20 mg/week if tried); AS requires trial of or contraindication to an NSAID; PSO requires prior trial of immunosuppressant or PUVA or switching from another advanced therapy. Initial duration typically 6 months; renewal 12 months. |
| Step requirement | FINTEPLA (LGS) details |
|---|---|
| Trial of or contraindication to two specified agents required | |
| FINTEPLA for Lennox-Gastaut syndrome: initial requires trial of or contraindication to two specified agents (examples listed include felbamate, clobazam, topiramate, lamotrigine, clonazepam); prescribed by or in consultation with a neurologist for LGS. |
| Prerequisite therapy | KERENDIA (finerenone) for CKD with T2D |
|---|---|
| History of and continued use of, contraindication to, or intolerance to an ACE inhibitor or ARB required | |
| KERENDIA initial criteria for CKD associated with T2D: patient must have history of and continue on, or have contraindication/intolerance to, an ACE inhibitor or ARB prior to coverage; initial/renewal duration 12 months. |
| Prerequisite therapy | General note |
|---|---|
| No prerequisite therapy required | |
| Several product entries explicitly state 'Prerequisite Therapy, 1 = No' (e.g., abaloparatide/TYMLOS and FRUZAQLA). When 'No' is listed, PA may still be required and other criteria (duration limits, exclusions) apply. |
Provider Actions & Denial Risks
TYMLOS — prior authorization and 24‑month cumulative limit
Prior authorization is required for TYMLOS (abaloparatide). Requests must demonstrate the drug is for an FDA‑approved indication and that the patient has not received a total of 24 months cumulative treatment with any parathyroid agent; Prerequisite Therapy: No. Part B prerequisite: No. Coverage duration: 24 months cumulative limit across parathyroid agents.
- Medication: TYMLOS (abaloparatide)
- Indication: All FDA‑approved indications
- Cumulative parathyroid‑class treatment must be < 24 months
PA required for listed specialty products; observe product durations
Prior authorization is required for the listed specialty products; each product entry specifies initial and renewal coverage durations (examples: many products list 12 months; some list initial 6 months with 12‑month renewals). Providers must follow the PA Criteria referenced for each product.
- Follow product‑specific PA Criteria and durations
- Common durations: initial 6 months (some products), renewal 12 months; many products list 12 months
PA applies — 'All FDA‑approved Indications' and typical 12‑month durations
Prior authorization criteria apply to many listed specialty products; multiple entries state coverage for 'All FDA‑approved Indications' and commonly authorize for 12 months unless otherwise specified.
- Indication scope often: All FDA‑approved Indications
- Typical authorization duration: 12 MONTHS (unless product notes different initial/renewal durations)
PA duration pattern — 6‑month initial then 12‑month renewal (example: MIPLYFFA)
Prior authorization required; for several products initial approval is commonly 6 months with renewals to 12 months (example: MIPLYFFA initial 6 months, renewal 12 months). Providers must document continued benefit for renewals where indicated.
- Initial coverage often 6 months (product‑dependent)
- Renewal commonly 12 months with evidence of continued benefit
SCEMBLIX (asciminib) — PA with 12‑month authorization
SCEMBLIX (asciminib) requires prior authorization and is authorized for 12 months. For previously treated or T315I‑mutant Ph+ CML, mutational analysis prior to initiation is required per the product entry.
- Coverage duration: 12 MONTHS
- Required documentation: mutational analysis (BCR‑ABL1) prior to initiation for previously treated/T315I‑mutant Ph+ CML
INLYTA (axitinib) — PA required with 12‑month coverage
INLYTA (axitinib) requires prior authorization; coverage period is specified as 12 months per the product entry.
- Coverage duration: 12 MONTHS
- Follow PA Criteria referenced in product entry
ONUREG — PA required; 12‑month coverage
ONUREG (oral azacitidine) requires prior authorization; the product entry lists a coverage duration of 12 months. Providers must meet the PA Criteria referenced for approval.
- Coverage duration: 12 MONTHS
- PA Criteria: see product entry
CAYSTON — PA required; age ≥7 years
CAYSTON (aztreonam inhaled) requires prior authorization and is restricted to patients aged 7 years or older; coverage duration listed as 12 months.
- Age restriction: 7 years of age or older
- Coverage duration: 12 MONTHS
BENLYSTA SC — PA: initial 6 months, renewal 12 months; prescriber restrictions
BENLYSTA SUBCUTANEOUS requires prior authorization with an initial authorization of 6 months and renewal of 12 months. Initial therapy for SLE must be prescribed by or in consultation with a rheumatologist and documentation of concomitant therapies is expected.
- Initial duration: 6 MONTHS; Renewal: 12 MONTHS
- Prescriber restriction for SLE: rheumatologist or consultation with rheumatologist; LN: rheumatologist or nephrologist
- Document current use of corticosteroids, antimalarials, NSAIDs, or immunosuppressives for initial approval
REZUROCK — PA with step‑therapy requirement and 12‑month coverage
REZUROCK (belumosudil) requires prior authorization with a coverage duration of 12 months and a prerequisite that the patient has failed at least two lines of systemic therapy, one of which must be a trial of or contraindication to JAKAFI.
- Coverage duration: 12 MONTHS
- Prerequisite therapy: failure of ≥2 systemic therapy lines (one must be trial of or contraindication to JAKAFI)
- No concurrent use with JAKAFI, NIKTIMVO, or IMBRUVICA
Betaine — PA required; 12‑month coverage for FDA‑approved indications
Betaine requires prior authorization; the product entry lists coverage for all FDA‑approved indications and a typical coverage duration of 12 months. No Part B prerequisite and no prerequisite therapy are noted.
- Indications: All FDA‑approved Indications
- Coverage duration: 12 MONTHS
- Prerequisite Therapy: No; Part B Prerequisite: No
Bevacizumab‑bvzr (ZIRABEV) — PA with 12‑month coverage
Bevacizumab‑bvzr (ZIRABEV) requires prior authorization; the entry covers all FDA‑approved indications with a coverage duration of 12 months and lists no Part B prerequisite or prerequisite therapy.
- Indications: All FDA‑approved Indications
- Coverage duration: 12 MONTHS
- Prerequisite Therapy: No; Part B Prerequisite: No
Bexarotene — PA required; 12‑month coverage
Bexarotene requires prior authorization; the product entry indicates coverage for all FDA‑approved indications with a 12‑month duration and no prerequisite therapy or Part B prerequisite.
- Indications: All FDA‑approved Indications
- Coverage duration: 12 MONTHS
- Prerequisite Therapy: No; Part B Prerequisite: No
Binimetinib (Mektovi) — PA required; 12‑month coverage
Binimetinib (Mektovi) requires prior authorization; the product entry lists coverage for all FDA‑approved indications and a coverage duration of 12 months with no prerequisite therapy noted.
- Indications: All FDA‑approved Indications
- Coverage duration: 12 MONTHS
- Prerequisite Therapy: No
Bortezomib — PA required; 12‑month coverage
Bortezomib (including BORUZU) requires prior authorization; entries list coverage for all FDA‑approved indications with a 12‑month duration and no prerequisite therapy or Part B prerequisite noted.
- Indications: All FDA‑approved Indications
- Coverage duration: 12 MONTHS
- Prerequisite Therapy: No; Part B Prerequisite: No
Bosentan (PAH) — PA with hemodynamic confirmation and hepatic lab exclusions
Bosentan (oral tablet) requires prior authorization for pulmonary arterial hypertension; initial requests must include right heart catheterization confirming mean PAP >20 mmHg, PCWP ≤15 mmHg, and PVR >2 Wood units, and the prescriber must be or consult with a cardiologist or pulmonologist. Baseline hepatic labs must not show ALT/AST >3x ULN or bilirubin increase ≥2x ULN. Duration: initial/renewal 12 months.
- Required diagnostic confirmation: right heart catheterization with mean PAP >20 mmHg, PCWP ≤15 mmHg, PVR >2 Wood units
- Prescriber: cardiologist or pulmonologist (or consultation)
- Laboratory exclusion: ALT/AST >3x ULN or bilirubin increase ≥2x ULN
- Coverage duration: 12 MONTHS (initial/renewal)
Bosutinib — PA: mutational analysis required and prior therapy indicated
Bosutinib (Bosulif) requires prior authorization; for previously treated Ph+ CML mutational analysis prior to initiation is required and a prerequisite therapy is indicated for at least some indications. Coverage duration is typically 12 months.
- Required documentation: mutational analysis prior to initiation (BCR‑ABL1 mutation profile)
- Prerequisite Therapy: Yes (per product entry)
- Coverage duration: 12 MONTHS
Brigatinib (Alunbrig) — PA required; 12‑month coverage
Brigatinib (Alunbrig) requires prior authorization; product entry lists coverage for all FDA‑approved indications with a typical 12‑month duration and no prerequisite therapy noted.
- Indications: All FDA‑approved Indications
- Coverage duration: 12 MONTHS
- Prerequisite Therapy: No
HAEGARDA — PA with diagnostic confirmation and prescriber specialty
HAEGARDA (C1 esterase inhibitor) requires prior authorization for hereditary angioedema; initial criteria include type III HAE or laboratory confirmation of type I/II (C1‑INH protein, C4, C1‑INH functional levels, C1Q). Prescriber must be or consult with a hematologist, immunologist, allergist, or pulmonologist. Coverage: initial/renewal 12 months; no concurrent treatment at initiation/renewal.
- Diagnostic requirements: type III HAE OR type I/II HAE confirmed by complement testing (C1‑INH protein, C4, C1‑INH function, C1Q)
- Prescriber restriction: hematologist, immunologist, allergist, or pulmonologist (or consult)
- Coverage duration: 12 MONTHS (initial/renewal)
- Concurrent treatment: not on concurrent treatment at initiation/renewal
Cabozantinib (Cometriq) — PA required; 12‑month coverage
Cabozantinib (Cometriq) capsule entries require prior authorization; product entries list coverage for all FDA‑approved indications with a typical 12‑month duration. Dosing examples for Cometriq are provided in the product entry.
- Indications: All FDA‑approved Indications
- Coverage duration: 12 MONTHS
- PA Criteria: see product entry (Cometriq dosing examples included)
PA required — many specialty products with 12‑month coverage and PA Criteria
Many specialty products listed require prior authorization and commonly list 'All FDA‑approved Indications' with a 12‑month coverage period; providers must follow each product's PA Criteria and any exclusion criteria referenced as 'Criteria Details.'
- Common duration: 12 MONTHS
- Indications frequently: All FDA‑approved Indications
- Follow PA Criteria/Exclusion Criteria 'Criteria Details' per product
Certolizumab pegol — PA with indication‑dependent durations and prescriber restrictions
Certolizumab pegol requires prior authorization with specified initial and renewal durations and prescriber restrictions that vary by indication; follow the product entry for exact initial/renewal timing and documentation requirements.
- Initial/renewal durations as specified per indication (example initial 6 months, renewal 12 months for some entries)
- Prescriber restrictions depend on indication (dermatology, rheumatology, gastroenterology, etc.)
PA required — typical 12‑month durations and documented PA Criteria
Prior authorization is required for many listed products; duration is commonly specified as 12 months and PA Criteria/Exclusion Criteria are referenced as 'Criteria Details' on each product line.
- Typical authorization duration: 12 MONTHS
- PA Criteria and Exclusion Criteria specified per product line ('Criteria Details')
VIZIMPRO — PA required; 12‑month limit and exclusion for concurrent EGFR TKI
VIZIMPRO (dacomitinib) requires prior authorization with a 12‑month coverage limit; it is not covered for metastatic NSCLC if the patient is on concurrent therapy with an EGFR tyrosine kinase inhibitor.
- Coverage duration: 12 MONTHS
- Exclusion: metastatic NSCLC patients receiving concurrent EGFR tyrosine kinase inhibitor therapy
Dasatinib — PA: mutational analysis required; 12‑month coverage
Dasatinib oral tablets require prior authorization; for previously treated Ph+ CML, mutational analysis prior to initiation is required and dasatinib must be appropriate per NCCN BCR‑ABL1 mutation‑based recommendations. Coverage duration is typically 12 months.
- Required documentation: mutational analysis prior to initiation (BCR‑ABL1 profile)
- Coverage duration: 12 MONTHS
Deferasirox — PA with specific ferritin/LIC thresholds and prescriber specialty
Deferasirox requires prior authorization with initial and renewal criteria that include specific laboratory thresholds (e.g., transfusion‑related ferritin >1000 mcg/L; NTDT ferritin >300 mcg/L on ≥2 labs and LIC ≥5 mg Fe/g dry weight). Prescriber must be or consult with a hematologist/hematologist‑oncologist. Initial duration 6 months; renewal 12 months.
- Transfusion‑related initial: serum ferritin consistently >1000 mcg/L
- NTDT initial: serum ferritin >300 mcg/L on ≥2 labs in prior 3 months AND LIC ≥5 mg Fe/g dry weight
- Prescriber: hematologist or hematologist/oncologist (or consultation)
- Initial duration: 6 MONTHS; Renewal: 12 MONTHS
Dalfampridine — PA: neurologist involvement and 12‑month coverage
Dalfampridine requires prior authorization; initial and renewal coverage are listed as 12 months, and initial prescribing must be by or in consultation with a neurologist for multiple sclerosis patients with walking disability. Renewal requires documented improvement in walking ability.
- Coverage duration: INITIAL/RENEWAL: 12 MONTHS
- Prescriber: neurologist or consultation required for initial
- Renewal requirement: documented improvement in walking ability
PA required — 12‑month coverage common across listed products
Prior authorization is required for listed products; where specified, coverage durations are commonly 12 months. Providers must supply required clinical documentation and meet the product‑specific PA Criteria.
- Common coverage duration: 12 MONTHS
- Follow product PA Criteria and supply required documentation
Diclofenac topical solution — PA: 6‑month coverage and prerequisite trial
Diclofenac sodium topical solution (metered pump) requires prior authorization; coverage duration is 6 months and a trial of or contraindication to a formulary version is required prior to approval.
- Coverage duration: 6 MONTHS
- Prerequisite therapy: trial of or contraindication to a formulary version required
PA requirement — document indication‑specific criteria, labs, prior therapy, prescriber specialty
Prior authorization is required with indication‑specific criteria, prescriber restrictions, and defined initial and renewal durations; providers must document required labs, diagnostics, prior therapy trials or contraindications, and specialist involvement when specified.
- Document diagnosis, labs/imaging, prior therapy trials/contraindications, and prescriber specialty/consultation as specified
- Initial/renewal durations vary by product (commonly 6 or 12 months)
ITP (eltrombopag/Alvaiz) — PA requires platelet thresholds and prior therapy documentation
For immune thrombocytopenia (ITP) prior authorization is required; initial approvals require documented platelet counts meeting thresholds (<30 x10^9/L or <50 x10^9/L with prior bleeding) and trial of or contraindication to one corticosteroid or IVIG or insufficient response to splenectomy. Renewals require demonstrated improvement and no concurrent use with other TPO‑RAs.
- Initial platelet thresholds: <30 x10^9/L OR <50 x10^9/L with prior bleeding event
- Initial prerequisite: trial of or contraindication to corticosteroid or IVIG, or insufficient response to splenectomy
- No concurrent use with other TPO‑RAs
- Renewal: improvement in platelet counts from baseline or reduction in bleeding events
Epoetin alfa‑epbx (RETACRIT) — PA with hemoglobin thresholds and 12‑month coverage
Epoetin alfa‑epbx (RETACRIT) requires prior authorization; initial hemoglobin thresholds include <10 g/dL for CKD/anemia related to zidovudine or chemotherapy, and elective non‑cardiac/non‑vascular surgery criteria use ≤13 g/dL. Renewal requires meeting renewal hemoglobin criteria; coverage duration for most indications is 12 months.
- Initial hemoglobin threshold: <10 g/dL for CKD, zidovudine, or chemotherapy‑related anemia
- Elective surgery threshold: ≤13 g/dL
- Renewal: hemoglobin <10 g/dL or reached 10 g/dL with dose reduction/interruption evidence
- Coverage duration: 12 MONTHS (most indications); 1 month for surgery
AIMOVIG — PA: initial 6 months, renewal 12 months; no concurrent CGRP inhibitors
AIMOVIG (erenumab) requires prior authorization with initial coverage of 6 months and renewal of 12 months. Concurrent use with other CGRP inhibitors for migraine prevention is not allowed.
- Initial duration: 6 MONTHS; Renewal: 12 MONTHS
- Concurrent CGRP inhibitors: not allowed
Etanercept — PA: 6‑month initial, 12‑month renewal; DMARD prerequisite for RA
Etanercept products require prior authorization; initial approval is commonly 6 months with renewal 12 months. Prescriber restrictions and prerequisite DMARD trials apply for RA and other indications as specified.
- Initial duration: 6 MONTHS; Renewal: 12 MONTHS
- RA prerequisite: trial of or contraindication to ≥3 months of a conventional synthetic DMARD (e.g., methotrexate ≥20 mg/week)
- Prescriber restrictions vary by indication (rheumatologist/dermatologist)
VOWST — PA required; 30‑day coverage and exclusion/prerequisite conditions
VOWST (fecal microbiota capsules) requires prior authorization; coverage duration is 30 days and approvals depend on recurrent CDI definitions or prior VOWST treatment failure per the product entry.
- Coverage duration: 30 DAYS
- Indications include recurrent CDI (≥3 episodes) or prior VOWST treatment failure meeting the specified conditions
INREBIC — PA: 6‑month initial, 12‑month renewal; JAKAFI trial required
INREBIC (fedratinib) requires prior authorization; initial duration is 6 months with renewal 12 months and a prerequisite trial of or contraindication to JAKAFI (ruxolitinib) for myelofibrosis.
- Initial duration: 6 MONTHS; Renewal: 12 MONTHS
- Prerequisite therapy: trial of or contraindication to JAKAFI (ruxolitinib) for myelofibrosis
FRUZAQLA — PA required; 12‑month coverage
FRUZAQLA (fruquintinib) requires prior authorization; the product entry lists coverage for all FDA‑approved indications with a coverage duration of 12 months and no prerequisite therapy noted.
- Indications: All FDA‑approved Indications
- Coverage duration: 12 MONTHS
- Prerequisite Therapy: No
Prerequisite therapy — 'No' indicated for select products (verify per product)
Some PA entries explicitly indicate 'Prerequisite Therapy: No' — providers do not need to document prior therapy trials for those products. Confirm on the product line whether prerequisite therapy is required.
- If 'Prerequisite Therapy: No' is shown on product entry, no prior trial documentation is required
- Always verify product‑specific PA Criteria for exceptions
RA — DMARD trial required prior to biologic PA
For rheumatoid arthritis, prior authorization requires documentation of a trial of or contraindication to at least 3 months of a conventional synthetic DMARD (e.g., methotrexate at ≥20 mg/week or maximally tolerated dose) before approval of many biologics.
- Trial duration: ≥3 months
- If methotrexate tried, dose must be ≥20 mg/week or maximally tolerated
Step therapy — document trials or contraindications to preferred agents
Some biologics and specialty agents require documented trials of preferred agents or contraindications before approval (examples include KINERET and similar biologics). Providers must document trial history or contraindications as specified.
- Document trials of preferred agents or reasons for contraindication
- Follow product‑specific step therapy requirements listed in PA Criteria
NIKTIMVO — step‑therapy: ≥2 prior lines including JAKAFI
NIKTIMVO requires prior authorization with a prerequisite that the patient failed at least two lines of systemic therapy, one of which must be a trial of or contraindication to JAKAFI; concurrent use with JAKAFI, REZUROCK, or IMBRUVICA is not allowed.
- Failure of ≥2 lines of systemic therapy, including trial of or contraindication to JAKAFI
- No concurrent use with JAKAFI, REZUROCK, or IMBRUVICA
REZUROCK — step‑therapy: ≥2 prior systemic therapies including JAKAFI
REZUROCK requires failure of at least two lines of systemic therapy (one must include trial of or contraindication to JAKAFI) before approval; providers must document prior therapies and cannot prescribe concurrently with JAKAFI, NIKTIMVO, or IMBRUVICA.
- Failure of ≥2 systemic therapy lines; one must be trial of or contraindication to JAKAFI
- No concurrent use with JAKAFI, NIKTIMVO, or IMBRUVICA
Bosutinib — prerequisite therapy required (document prior treatments)
Bosutinib's product entry indicates Prerequisite Therapy: Yes; providers must document prior therapy as required by the product‑specific PA Criteria.
- Document prior therapy per PA Criteria
- Mutational analysis required for previously treated Ph+ CML
Deferasirox — trial of generic tablet required before other formulations
A trial of generic deferasirox tablet or documented contraindication is required prior to coverage of other deferasirox formulations; providers must document the trial or contraindication and meet lab thresholds.
- Trial of or contraindication to generic deferasirox tablet/oral suspension required
- Also provide required ferritin/LIC lab values per initial/renewal criteria
PA documentation — provide clinical evidence matching PA Criteria and exclusions
Prior authorization requires documentation consistent with the PA Criteria and any listed exclusion criteria (example: TYMLOS PA entry notes documentation and exclusion criteria are required). Providers must supply the clinical data specified on each product line.
- Supply clinical documentation matching PA Criteria and exclusion criteria
- Verify product‑specific required medical information fields
Duration limit — denial risk if cumulative parathyroid treatment ≥24 months
A request may be denied if the patient has received a total of 24 months cumulative treatment with any parathyroid agent; providers must document cumulative prior parathyroid‑class exposure to avoid denial.
- Cumulative parathyroid‑class treatment must be < 24 months
- Document prior parathyroid agent use and total duration
Concurrent therapy prohibition — avoids denial
Concurrent use of another systemic biologic or targeted small molecule for the same indication is prohibited and may trigger denial; providers must confirm no concurrent systemic biologic or targeted therapy is being used for the same indication.
- No concurrent systemic biologic or targeted small molecule (e.g., JAK inhibitors, PDE‑4 inhibitors) for the same indication
- Document medication history to confirm absence of concurrent therapy
Bosentan — hepatic lab exclusions (ALT/AST >3× ULN or bilirubin ≥2× ULN)
For bosentan (PAH) requests, exclusion applies if ALT/AST are more than 3× ULN or bilirubin increase is ≥2× ULN; providers must supply baseline hepatic function labs to demonstrate eligibility.
- Do not initiate if ALT/AST > 3× ULN or bilirubin increase ≥ 2× ULN
- Provide baseline and relevant hepatic labs with PA request
Duration limits — typical 12‑month authorization; exceeding may trigger denial
Coverage durations for many listed products are commonly limited to 12 months; requests exceeding the stated coverage period or lacking required criteria may be denied.
- Most products list coverage duration: 12 MONTHS
- Ensure requests adhere to product‑specific duration limits
Prescriber specialty — specialist prescribing/consultation often required
Select products require that initial prescriptions be made by or in consultation with a specialist (examples: SYMPAZAN, BENLYSTA, HAEGARDA, deferasirox); providers must ensure prescriber specialty or consultation is documented in the PA request.
- Document specialist involvement (e.g., neurologist for SYMPAZAN; rheumatologist for BENLYSTA; hematologist/immunologist for HAEGARDA; hematologist for deferasirox)
- Include consult notes or co‑signature when applicable
Documentation missing — lack of required labs/trials risks denial
Failure to document required prior therapy trials, diagnostic confirmation, or required labs (e.g., platelet counts for ITP, mutational analysis for Ph+ CML, ferritin/LIC for deferasirox) may result in denial; include all required results and trial histories with the PA.
- Provide platelet counts and prior therapy history for ITP
- Provide mutational analysis (BCR‑ABL1) for dasatinib/bosutinib/asciminib when required
- Provide serum ferritin and/or LIC values for deferasirox per thresholds
- Document required trials (topical steroids, DMARDs, JAKAFI, etc.) or contraindications
Product Codes & Key Values
| BORUZU | bortezomib branded product name listed |
| ZIRABEV | bevacizumab‑bvzr brand name listed |
| HAEGARDA | C1 esterase inhibitor product |
| cladribine 10 mg x 10 tab pk outer | Product affected (packaging/detail) from document |
| ERBITUX | Cetuximab product name listed |
| SYMPAZAN | Clobazam product name listed |
Background
Abaloparatide (TYMLOS) is listed among the products affected in this policy. Coverage is available for FDA‑approved indications, but the policy imposes a cumulative treatment cap: prior authorization is required and the member must not have received a total of 24 months cumulative treatment with any parathyroid agent. This cumulative duration limit is enforced across the parathyroid class.
Definitions & Thresholds
Biosimilar References
Adalimumab and biosimilars — same PA criteria apply
Multiple adalimumab reference and biosimilar products are listed with similar PA criteria and requirements; providers should apply the same PA expectations and documentation to biosimilars and reference products.
- Biosimilars and reference adalimumab products share PA Criteria
- Apply identical prerequisite therapy and prescriber documentation where specified
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