Drugs That Require Prior Authorization — Pharmacy & Specialty Drugs
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Lists specialty drugs requiring prior authorization from HMSA Akamai Advantage (PPO) and summarizes required documentation, indication-specific criteria, exclusions, step therapy, quantity limits, and coverage durations.
No material clinical or coverage changes in this revision.
Drug-Specific Coverage Criteria
Example: ABIRATERONE
Each listed drug is covered only when PA criteria specific to that drug are met (examples below from the extract).
Example: ALBENDAZOLE
Example PA coverage rules for ALBENDAZOLE.
Example: ALDURAZYME
Example PA criteria for ALDURAZYME (enzyme replacement).
Example: ITP / AA criteria
Example criteria for thrombopoietic agents (ITP/AA).
Example: Molecular marker–dependent oncology criteria
Example oncology molecular marker requirements.
Dupixent — indication-specific initial and continuation criteria
Covered when ALL of the following indication‑specific criteria are met (per indication):
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Cosentyx — psoriasis, axial spondyloarthritis, PsA, hidradenitis (new starts)
Covered for new starts when ALL of the following are met (by disease):
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Pyrimethamine (Daraprim) — prophylaxis and treatment exceptions
Covered when ALL specified conditions for prophylaxis/treatment are met:
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Dalfampridine ER — multiple sclerosis
Covered when specified objective walking criteria are met:
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Cystinosis agents — diagnostic confirmation
Covered when diagnostic confirmation and corneal involvement are documented:
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Deferasirox — chronic iron overload
Covered when the following laboratory threshold is met:
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DHE nasal — migraine
Coverage criteria include prior trial of a triptan and interaction exclusions:
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CEQUR insulin delivery systems
Covered when ALL listed conditions are met:
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Doxorubicin/DAURISMO/Cancer agents — combination and prior therapy requirements
Examples of oncology-specific combination or prior‑therapy requirements.
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Atopic dermatitis (AD) — Initial and continuation
Covered when specified criteria are met.
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Asthma — Severe and oral corticosteroid dependent
Covered when ALL of the following are met for initial therapy (per indication variant).
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Eosinophilic esophagitis (EoE)
Covered when ALL of the following are met for initial therapy.
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COPD
Covered when ALL of the following are met for initial therapy.
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Chronic rhinosinusitis with nasal polyposis (CRSwNP)
Covered when ALL of the following are met.
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Chronic spontaneous urticaria (CSU)
Covered when ALL of the following are met for initial therapy.
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Bullous pemphigoid (BP)
Covered when ALL of the following are met for initial therapy.
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HCV (EPCLUSA)
Coverage consistent with current AASLD‑IDSA guidance and requires laboratory and staging documentation.
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RET-positive non-small cell lung cancer
Required Medical Information for RET‑positive NSCLC
Age restriction: 18 years or older
Pediatric growth hormone criteria
Pediatric growth hormone therapy (Genotropin) medical necessity
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Harvoni coverage criteria
Harvoni (ledipasvir/sofosbuvir) coverage conditions
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High-risk medication older-adult criteria
High‑risk medications (HRM) prior authorization for older adults.
Some PAs apply to cumulative days per year (e.g., >30 or >90 days)
HRM geriatric PA
PA applies when ALL of the following are met for promethazine (and similar HRM entries):
Applies to promethazine and related HRM groups.
Adalimumab (HUMIRA) coverage criteria
Covered when ALL of the following for specified indications (new starts unless otherwise noted):
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Icatibant (acute HAE) criteria
Covered when ONE of the following is met:
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IVIG coverage criteria
IVIG covered for medically‑accepted indications when indication‑specific laboratory or clinical criteria are met:
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Imatinib (and alternatives) criteria
Coverage requires diagnosis confirmation and prior therapy conditions depending on indication:
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IVIG / immunoglobulin-related indications (selected)
Covered when ALL of the following are met for the specific indication:
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JAKAFI (ruxolitinib) coverage conditions (selected)
Coverage considered for multiple indications when indication‑specific criteria are met:
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JAYPIRCA (pirtobrutinib) coverage conditions (selected)
Coverage when BOTH of the following are met for CLL/SLL:
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Ketoconazole (oral) coverage conditions
Coverage considered when ALL of the following are documented:
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LORBRENA (lorlatinib) coverage conditions (selected)
For recurrent/advanced/metastatic NSCLC coverage when the following apply:
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MAVYRET (glecaprevir/pibrentasvir) coverage conditions
Coverage requires confirmation of HCV infection and documentation aligned with AASLD‑IDSA guidance:
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LYNPARZA (olaparib) coverage conditions (selected)
Coverage depends on disease‑specific biomarker and prior therapy:
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LYTGOBI (futibatinib) coverage conditions
Coverage for extrahepatic cholangiocarcinoma when ALL are met:
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BRAF V600 mutation — combination with encorafenib
Covered when ALL of the following are met
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Atovaquone (Mepron) PA criteria
Covered when ALL of the following are met
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Myelofibrosis — coverage criteria
Covered when ALL of the following are met
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Posaconazole (Noxafil) — OPC criteria
Covered when ALL of the following are met
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Omnipod (insulin pump) initial criteria
Covered when ALL of the following are met
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Pulmonary arterial hypertension — documentation requirement
Covered when ALL of the following are met
New starts only per document.
Drug-specific coverage criteria (selected examples)
Covered when the specified drug‑specific criteria are met as listed below (selected examples):
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RINVOQ (selected oncology indications)
Covered when ALL of the following are met for specific disease indications, per subsection:
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CML indication requirements (example)
Coverage for chronic myeloid leukemia in chronic phase requires all of the following:
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Plaque psoriasis biologic therapy (example)
For moderate to severe plaque psoriasis (new starts only) coverage requires ALL of the following:
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TABRECTA (NSCLC) requirement example
For recurrent, advanced, or metastatic NSCLC coverage:
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BRAF-targeted therapy requirements (TAFINLAR and similar)
Coverage requires tumor BRAF V600 activating mutation documentation and indication‑specific usage:
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Teriparatide (postmenopausal and other osteoporosis)
Initial coverage criteria (one of the following) plus additional requirements:
Initial: 24 months; continuation: Plan Year
Terbinafine (onycomycosis)
Covered when ALL are met:
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TEPMETKO (tepotinib) — recurrent/advanced/metastatic NSCLC
Covered when ALL of the following are met
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Parathyroid hormone analogs — initial and continuation
Covered when ALL of the following apply (initial and continuation rules differ)
Initial authorization: 24 months; continuation requires ongoing high fracture risk and benefit outweighs risks.
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Tetrabenazine — tardive dyskinesia and chorea
Covered when ALL of the following are met
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TOBI/TOBRAMYCIN inhaled — cystic fibrosis and non-CF bronchiectasis
Covered when ANY of the following are met
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TREMFYA — moderate to severe plaque psoriasis (new starts)
Covered when ALL of the following are met
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Vanflyta — relapsed/refractory AML
Covered when ALL of the following are met
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VENCLEXTA — multiple indications
Covered when the indication‑specific criteria are met
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VERQUVO — symptomatic chronic heart failure
Covered when ALL of the following are met
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Vigabatrin — complex partial seizures and infantile spasms
Covered when ALL of the following are met
Age restrictions: infantile spasms 1 month–2 years; complex partial seizures ≥2 years (chunk 181).
VITRAKVI — NTRK gene fusion-positive tumors
Covered when ALL of the following are met
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Chronic heart failure (symptomatic) criteria
Covered when ANY of the following are met for initial therapy and LVEF <45%:
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Vigabatrin (complex partial seizures / infantile spasms)
Covered when ALL of the following are met for complex partial seizures:
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Hepatitis C therapy (Vosevi) criteria
Covered when ALL of the following documentation items are provided:
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Pulmonary arterial hypertension / PH-ILD (Yutrepia)
For WHO Group 1 PAH or PH with interstitial lung disease, new starts only:
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Sodium oxybate (narcolepsy) initial therapy
Covered when ALL of the following are met for initial requests:
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Biologics for inflammatory conditions (new starts)
Covered for new starts when ALL of the following are met:
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ZEJULA: Uterine leiomyosarcoma
ZEJULA — uterine leiomyosarcoma
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ZELBORAF: Indication-specific criteria
ZELBORAF — multiple indications
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ZONISADE: Authorization criteria
ZONISADE — adjunctive treatment of partial‑onset (focal) seizures
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ZURZUVAE: Diagnostic confirmation required
ZURZUVAE — treatment of postpartum depression (PPD)
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ZYPREXA RELPREVV: Prerequisite tolerability and indication-specific notes
ZYPREXA RELPREVV — long‑acting olanzapine
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ALDURAZYME (for mucopolysaccharidosis type I) requires diagnostic confirmation by enzyme assay demonstrating alpha-L-iduronidase deficiency or by genetic testing. Patients with the attenuated Scheie form of MPS I are excluded from ALDURAZYME coverage unless they have moderate to severe symptoms documented in the medical record.
DHE nasal (dihydroergotamine mesylate) is not eligible for coverage when prescribed concurrently with potent CYP3A4 inhibitors. Requests will be denied if the member is using a potent CYP3A4 inhibitor; prior documentation must show absence of such interacting therapy for coverage to be considered.
Ergotamine-containing products are excluded when used in combination with potent CYP3A4 inhibitors. The policy specifies that coverage will be denied for ergotamine use in the setting of such drug–drug interaction (examples of potent CYP3A4 inhibitors are listed elsewhere in the clinical record).
When a medication is appropriately covered under Medicare Part A or Part B based on the setting or administration, the request for coverage under Part D will be denied. Providers must document the site-of-care and administration setting to support a Part D claim; absence of that documentation or evidence that Part A/B covers the service will result in denial under Part D.
Requests for ivermectin will be excluded when the drug is prescribed for the prevention or treatment of COVID‑19. The requested use must be for an FDA‑approved or other covered indication; documentation showing a non‑COVID indication is required for consideration.
Intravenous immunoglobulin (IVIG) may be covered only when clinical criteria for a medically‑accepted indication are met and when coverage is not instead provided under Medicare Part A or Part B. If the IVIG administration is furnished in a setting or manner that makes it payable by Part A or Part B, a Part D request will be denied; providers should document the administration setting and relevant laboratory or clinical thresholds (e.g., serum IgG) to support a Part D claim.
Certain combination exclusions and biosimilar‑intolerance rules are applied across agents. Some drugs are explicitly excluded when given in combination with specific products (for example, ivacaftor‑containing medications are not to be combined), and select biosimilar or reference‑product intolerance must be documented for alternative product coverage (for example, intolerable adverse events to Trazimera that were not attributed to the active ingredient are required before KANJINTI may be used). Providers must supply documentation of the prior adverse event and attribution as part of the prior authorization request.
Initial Authorization Requirements
Initial: AIMOVIG
Initial therapy examples where present.
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Dupixent initial therapy
Initial Dupixent criteria (examples):
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CEQUR initial therapy
CEQUR initial criteria:
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Initial therapy conditions (examples)
Initial therapy authorization requires diagnostic confirmation and prior therapy trials or specified lab thresholds depending on indication.
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Tasimelteon initial
Tasimelteon initial therapy
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Initial therapy biologics
Initial therapy requirements for biologics such as adalimumab:
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Initial clinical thresholds
Initial clinical thresholds (examples):
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Omnipod initial therapy
Initial Omnipod eligibility
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Ofev (idiopathic pulmonary fibrosis) initial diagnostics
Initial Ofev for idiopathic pulmonary fibrosis (new starts only)
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Initial therapy requirements (examples)
Examples of initial therapy requirements:
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Initial therapy examples
Initial therapy coverage conditions for selected drugs:
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Initial therapy durations
Initial therapy rules where specified
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TREMFYA initial
TREMFYA initial requirements
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Initial therapy examples
Initial therapy prerequisites provided for multiple drugs.
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Vigabatrin initial
Vigabatrin initial therapy
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Reauthorization / Continuation Requirements
Continuation: AIMOVIG
Continuation criteria examples where present in the extract.
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Continuation: ITP/AA agents
Continuation platelet response criteria example.
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Continuation therapy rules (examples)
Continuation approvals require documented clinical benefit as specified per drug.
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Continuation therapy rules (general)
Continuation approval generally requires documented clinical benefit or maintained positive response.
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Continuation therapy
Continuation requirements for ongoing therapy where stated
Continuation therapy
Continuation criteria where present:
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Continuation therapy examples
Continuation requirements when specified
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Testosterone products — continuation
Continuation requirements for testosterone products
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Continuation criteria
Examples of continuation criteria present in the excerpt:
Continuation therapy examples
Continuation coverage examples require evidence of benefit or maintained response.
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Parathyroid hormone analog continuation
Continuation rules for parathyroid hormone analogs
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Testosterone continuation
Testosterone continuation
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Continuation therapy examples
Continuation of therapy criteria where specified (examples include asthma, CSU, narcolepsy, and other indications).
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Sodium oxybate continuation
Sodium oxybate continuation:
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How to Request and Document Prior Authorization
How to request prior authorization
Prior authorization requests must be made to HMSA at 1 (855) 479-3659, available 24 hours a day, 7 days a week; TTY/TDD users should call 711.
Provide Part B vs Part D setting information when requested
For some drugs the provider must supply setting/use information so HMSA can determine Medicare Part B vs Part D responsibility before processing coverage.
Prior authorization required for listed drugs
Prior authorization is required for the specialty drugs listed in this document; coverage is granted only when the drug‑specific PA criteria are met.
Dalfampridine: document sustained impairment for new starts; benefit for continuation
For dalfampridine ER (multiple sclerosis) new starts, the prescriber must document sustained walking impairment prior to initiation; continuation requests must show improvement in walking or another objective walking measure since starting therapy.
Follow indication‑specific PA criteria (e.g., atopic dermatitis)
Prior authorization approvals for many agents are indication‑specific; for example, atopic dermatitis entries require moderate‑to‑severe disease and inadequate response to topical corticosteroid or calcineurin inhibitor, with continuation requiring documented clinical benefit.
FASENRA: eosinophil or steroid‑dependent criteria required
For FASENRA and similar severe asthma biologics, document either baseline blood eosinophils ≥150 cells/µL or systemic corticosteroid dependence plus history of severe asthma despite medium‑to‑high‑dose inhaled corticosteroid and an additional controller.
RET‑positive NSCLC: document RET fusion/rearrangement and disease stage
Requests for RET‑positive NSCLC require documentation that the tumor is RET fusion‑positive or RET rearrangement‑positive and that disease is recurrent, advanced, or metastatic (NSCLC requests limited to patients ≥18 years).
Harvoni: submit AASLD‑IDSA‑aligned HCV documentation
Harvoni (ledipasvir/sofosbuvir) requests must include documentation consistent with AASLD‑IDSA guidance, including presence of HCV RNA, planned regimen, genotype, prior treatment history, cirrhosis status, HIV coinfection status, and transplant status where applicable.
HRM PA: applies to older adults (typically ≥70 years)
Prior authorization applies to certain high‑risk medications (HRM) for older adults—these PA rules generally apply to patients age 70 years or older.
Promethazine and geriatric HRM: age, cumulative therapy, and trial requirements
For promethazine and related HRM entries in older adults, PA is required when the patient is ≥70 years old and cumulative therapy exceeds the specified days per year; prescriber must acknowledge benefits outweigh risks and document trials of non‑HRM alternatives when indicated.
- PA applies to cumulative therapy thresholds (e.g., >30 or >90 days/year) where listed
- For rhinitis, document trial/failure of two non‑HRM alternatives
HUMIRA: indication‑specific prior therapy documentation required
Adalimumab (HUMIRA) products require prior authorization with indication‑specific criteria; for rheumatoid arthritis new starts document inadequate response/intolerance to methotrexate or prior biologic/targeted synthetic DMARD as specified.
Icatibant: HAE diagnostic confirmation required
Icatibant for acute hereditary angioedema attacks requires laboratory confirmation of HAE subtype (C1 inhibitor deficiency/dysfunction or HAE with normal C1 inhibitor with supporting mutation or family history) and documentation of antihistamine trial where applicable.
Submit drug‑specific clinical documentation (labs, imaging, mutation status)
Many specialty drug PAs require submission of drug‑specific clinical documentation (examples: lab values, imaging, mutation/biomarker testing, and prior‑therapy history) to support medical necessity.
- Examples include HCV RNA for hepatitis C, serum IgG for IVIG indications, and mutation testing for targeted oncology agents.
PA may include drug‑specific coverage duration limits
Some agents have specified initial coverage durations that must be requested (examples in the document include initial approvals of defined months for select drugs).
BRAF‑mutant tumor: document BRAF V600 mutation when used with encorafenib
BRAF‑targeted therapy requests used in combination with encorafenib require documentation of a tumor BRAF V600 activating mutation (e.g., V600E or V600K) and indication‑specific disease stage.
Atovaquone (Mepron): prior‑therapy and combination requirements
Atovaquone (Mepron) PA for pediatric opportunistic infection indications requires documentation of intolerance/contraindication to SMX‑TMP where specified and immunocompromised status for prophylaxis; babesiosis treatment must be used concurrently with azithromycin.
- Secondary toxoplasmosis prophylaxis: 6 months; other indications: 3 months
Neratinib: must be combined with GnRH analog or after orchiectomy
When neratinib (Nubeqa/Nerlynx) is indicated per the document, it must be used in combination with a GnRH analog or after bilateral orchiectomy for the listed indication.
PA required for all listed specialty drugs and indications
Prior authorization is required for the specialty drugs listed; each entry includes indication‑specific criteria, age and prescriber restrictions, coverage duration, and other requirements that must be met for approval.
Provide diagnosis, biomarker/mutation status, and prior‑therapy evidence with PA
Many drugs require specific clinical documentation with PA requests—diagnosis, relevant biomarker/mutation testing when indicated, and documentation of prior therapy or intolerance must be provided per drug section.
Include required information, exclusions, and duration per drug
Prior authorization requests must include the required medical information, exclusion criteria, and any specified durations for the requested drug as listed in each drug section.
Parathyroid hormone analogs: 24‑month initial authorization and continuation criteria
Parathyroid hormone analogs (e.g., teriparatide) initial authorizations are granted for 24 months; continuation requires documentation that the patient remains at high fracture risk and that benefits outweigh risks.
- Initial authorization: 24 months
General prior authorization reminder
Prior authorization is required for the specialty drugs and indications listed; providers must follow each entry's required medical information and criteria for approval.
Vigabatrin: document failure of ≥2 AEDs and meet age limits
Vigabatrin PA for complex partial seizures requires documentation that the patient had inadequate response to at least two antiepileptic drugs; age‑specific restrictions apply (infantile spasms: month to 2 years; complex partial seizures: ≥2 years).
Xyrem: sleep‑lab confirmed diagnosis and age‑specific requirements
Initial sodium oxybate (Xyrem) requests require diagnosis confirmed by sleep laboratory evaluation; age and prior‑treatment prerequisites differ for patients ≤17 vs ≥18 years and prescribing should involve or consult a sleep disorder specialist or neurologist.
ZEJULA: second‑line use in BRCA‑altered uterine leiomyosarcoma
ZEJULA requests for uterine leiomyosarcoma must document that use is as second‑line therapy and that the patient has BRCA‑altered disease.
ZELBORAF: document BRAF V600 mutation and indication‑specific use
ZELBORAF prior authorization requires documentation of tumor BRAF V600 activating mutation (e.g., V600E) and indication‑specific use (CNS, melanoma, NSCLC) including intended combination with cobimetinib where required.
ZONISADE: prior treatment failure or swallowing impairment required (age ≥16)
ZONISADE authorization for adjunctive partial‑onset seizures requires documentation of prior inadequate response/intolerance/contraindication to a generic anticonvulsant AND to Aptiom, Xcopri, or Spritam, or documentation that the patient has difficulty swallowing solid oral dosage forms; limited to ages ≥16 years.
ZTALMY: PA required; age ≥2 years
ZTALMY requires prior authorization for its FDA‑approved indications and is limited to patients aged 2 years and older as specified.
ZIRABEV: prior authorization required for listed indications
ZIRABEV is listed as requiring prior authorization for FDA‑approved and some medically‑accepted indications; include indication‑specific documentation with the PA request.
ZOLINZA: PA required for MF and Sézary syndrome
ZOLINZA prior authorization is required for mycosis fungoides and Sézary syndrome for FDA‑approved and some medically‑accepted indications; include indication‑specific documentation.
ZURZUVAE: standardized‑scale confirmation and duration
ZURZUVAE prior authorization requires standardized‑scale confirmation of postpartum depression diagnosis (e.g., HDRS, EPDS, PHQ‑9, MADRS, BDI); coverage duration noted as month in the document.
ZYDELIG: PA required for SLL and related indications
ZYDELIG prior authorization is required for small lymphocytic lymphoma (SLL) and related indications—submit disease‑specific documentation with the PA.
ZYPREXA RELPREVV: document oral olanzapine tolerability before LAI
ZYPREXA RELPREVV requires prior authorization and documentation that tolerability with oral olanzapine has been established prior to administration of the long‑acting injectable.
Prior TKI therapy required for some oncology agents
Certain oncology approvals require prior trial and failure/intolerance to earlier tyrosine kinase inhibitors (TKIs); for example, BOSULIF‑class indications require prior TKI therapy (imatinib, dasatinib, nilotinib) as specified.
Biologic/targeted agent step requirements (e.g., Cosentyx)
Some biologic/targeted agents require documented prior failure, intolerance, or contraindication to listed biologics/targeted agents before approval (Cosentyx example for new starts).
Step therapy: document failure/intolerance to methotrexate or alternatives
For many rheumatologic and dermatologic biologic PAs (new starts) the provider must document inadequate response, intolerance, or contraindication to methotrexate or other specified systemic/phototherapy options as required by indication.
Document trials of alternative drugs when step therapy requires it
Providers must document trials of specified alternative drugs and inadequate response or intolerance where step therapy requires it (examples across CNS, sleep, and other indications are listed).
RA step: methotrexate or prior biologic/tsDMARD required
For rheumatoid arthritis biologic starts, the PA commonly requires prior use or intolerance to methotrexate or prior biologic/targeted synthetic DMARD as applicable.
Document prior‑line oncology therapies per indication
Several oncology and hematology drugs require documentation of prior specific therapies (e.g., JAYPIRCA requires prior BTK and BCL‑2 inhibitors for CLL/SLL); include prior‑therapy records with PA.
PAH agents: require right heart catheterization hemodynamic confirmation
Opsumit (macitentan) new starts for pulmonary arterial hypertension require right heart catheterization confirmation with pretreatment hemodynamics (mPAP >20 mmHg, PCWP ≤15 mmHg, PVR ≥3 Wood units) documented prior to initiation.
- Document pretreatment mPAP, PCWP, and PVR from right heart catheterization
REMICADE/RENFLEXIS: new‑start step therapy and documentation required
For infusion/injectable biologics such as REMICADE/RENFLEXIS, new starts often require documentation of inadequate response or intolerance to methotrexate (or combination therapy) and/or prior biologic or targeted synthetic DMARD as specified.
Document prior therapy failure/intolerance per drug‑specific step rules
Providers must document failure, intolerance, or contraindication to specified prior therapies when required for approval across many agents (psoriasis biologics, osteoporosis agents, BPH, etc.).
TREMFYA: phototherapy/systemic therapy trial required unless contraindicated
TREMFYA new starts for plaque psoriasis require prior failure or intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) unless contraindicated or severe disease justifies biologic first‑line.
TNF inhibitor step: document prior TNF trial/failure where required
Some biologic approvals require prior inadequate response, intolerance, or contraindication to at least one TNF inhibitor before approval for new starts in specified indications.
ZYPREXA RELPREVV: document prior adequate trials/intolerance per indication
For ZYPREXA RELPREVV and similar entries that list step requirements, providers must document prior adequate trials/intolerances per the indication section.
Coding and Clinical Thresholds
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Required Prior Trials and Step Therapy Rules
| Step | Requirement |
|---|---|
| Prior TKI requirement (BOSULIF example) | Patient must have experienced resistance or intolerance to prior tyrosine kinase inhibitors (for example: imatinib, dasatinib, or nilotinib) and be negative for specified mutations when required before BOSULIF is approved. |
| Coverage label | Covered with criteria |
| Supporting documentation | Diagnosis confirmed by detection of Philadelphia chromosome or BCR‑ABL; documentation of prior TKI resistance/intolerance. |
| Step | Requirement |
|---|---|
| Antidepressant step requirement | Trial and inadequate response or intolerance to two different classes of antidepressants prior to approval. |
| Coverage label | Covered with criteria |
| Supporting documentation | Medical record evidence of trials of two antidepressant classes and outcomes. |
| Step | Requirement |
|---|---|
| Biologic/targeted agent step | For Cosentyx (new starts for psoriasis, axial spondyloarthritis, PsA, hidradenitis): patient must have had inadequate response, intolerance, or contraindication to specified listed biologics/agents prior to approval. |
| Coverage label | Covered with criteria (new starts only for some indications) |
| Supporting documentation | Records documenting prior biologic/targeted therapy trials, intolerance, or contraindication (list per policy). |
| Step | Requirement |
|---|---|
| Generic/therapy trial requirement | Trial of listed generics or standard therapies (e.g., methotrexate, phototherapy, generic anticonvulsants, triptans) is required before PA approval for many agents. |
| Coverage label | Covered with criteria |
| Supporting documentation | Documentation of prior trials and inadequate response or intolerance to listed generics/therapies. |
| Step | Requirement |
|---|---|
| Alternative therapy trial requirement | Patient must have tried specified alternative(s) (non‑HRM alternatives, amantadine, doxepin, etc.) and demonstrated inadequate response or intolerance prior to approval when listed. |
| Coverage label | Covered with criteria |
| Supporting documentation | Records showing trials of the specified alternatives and reasons for failure/intolerance or contraindication. |
| Step | Requirement |
|---|---|
| Biologic alternatives trial and failure | For many biologic indications (e.g., RA, psoriasis): trial and failure or intolerance to specified alternatives such as methotrexate, phototherapy, cyclosporine, or conventional systemic agents required before biologic approval. |
| Coverage label | Covered with criteria |
| Supporting documentation | Documentation of prior systemic therapy trials, phototherapy, or methotrexate use and outcomes. |
| Step | Requirement |
|---|---|
| Document prior use and failure/intolerance | Many oncology and hematology indications require documentation of prior use and failure or intolerance to listed agents (e.g., prior BTK and BCL‑2 inhibitors for JAYPIRCA in CLL/SLL). |
| Coverage label | Covered with criteria |
| Supporting documentation | Medical records listing prior agents used, treatment duration, and reason for discontinuation (progression, intolerance). |
| Step | Requirement |
|---|---|
| Right heart catheterization confirmation | For Opsumit new starts in PAH: diagnosis must be confirmed by right heart catheterization with pretreatment mPAP >20 mmHg, PCWP ≤15 mmHg, and PVR ≥3 Wood units before initiation. |
| Coverage label | Covered with criteria (new starts only) |
| Supporting documentation | Right heart catheterization hemodynamic report documenting mPAP, PCWP, and PVR values meeting thresholds. |
| Step | Requirement |
|---|---|
| Trial and failure/intolerance to listed alternatives | Coverage for some drugs (e.g., atovaquone indications, certain psychiatric/antipsychotic formulations) requires trial and failure or intolerance to listed alternatives such as SMX‑TMP or specified generic/brand products. |
| Coverage label | Covered with criteria |
| Supporting documentation | Evidence of prior therapy trials and rationale for intolerance/contraindication; concurrent-use requirements where applicable (e.g., azithromycin with atovaquone for babesiosis). |
| Step | Requirement |
|---|---|
| Prior-line therapies step requirement | New starts of many biologics/targeted agents require trial and failure, intolerance, or contraindication to specified prior‑line therapies (e.g., MTX, TNF inhibitors) before approval. |
| Coverage label | Covered with criteria (new starts) |
| Supporting documentation | Documentation showing prior‑line therapy trials and outcomes per indication (e.g., failure of at least one TNF inhibitor for RINVOQ in RA). |
| Step | Requirement |
|---|---|
| Step 1 placeholder | Initial step: document prior trial(s) or meet listed entry‑specific prerequisites before advancing to specialty therapy (details vary by agent). |
| Coverage label | Covered with criteria |
| Supporting documentation | See individual drug sections for specific prior therapy requirements and documentation. |
| Step | Requirement |
|---|---|
| TREMFYA phototherapy/systemic therapy trial | For TREMFYA (plaque psoriasis new starts): failure or intolerance to phototherapy or methotrexate/cyclosporine/acitretin is required unless contraindicated or severe disease justifies biologic first‑line. |
| Coverage label | Covered with criteria (new starts) |
| Supporting documentation | Documentation of prior phototherapy or systemic therapy trials, intolerance, contraindication, or justification for biologic first‑line use. |
| Step | Requirement |
|---|---|
| Deutetrabenazine trial required | For tetrabenazine use in tardive dyskinesia or chorea associated with Huntington disease: patient must have experienced inadequate response or intolerable adverse event to deutetrabenazine prior to approval. |
| Coverage label | Covered with criteria |
| Supporting documentation | Medical record showing prior deutetrabenazine trial and reason for discontinuation (inefficacy or adverse event). |
| Step | Requirement |
|---|---|
| New‑start prerequisites for biologics/immunomodulators | Many biologics and immunomodulators require prior inadequate response, intolerance, or contraindication to specified conventional therapies or prior biologics before approval for new starts. |
| Coverage label | Covered with criteria (new starts) |
| Supporting documentation | Provider must supply disease‑specific diagnostic confirmation and prior‑treatment history as specified per drug. |
| Step | Requirement |
|---|---|
| Pazopanib step before GIST use | For GIST: pazopanib use is preceded by requirement that disease progressed after at least two FDA‑approved therapies (e.g., imatinib, sunitinib, regorafenib, ripretinib) unless SDH‑deficient. |
| Coverage label | Covered with criteria |
| Supporting documentation | Documentation of prior GIST therapies and progression, or evidence of SDH‑deficiency where applicable. |
| Step | Requirement |
|---|---|
| Prior ALK inhibitor failure required | For certain ALK‑positive NSCLC indications (e.g., ZYPREXA RELPREVV entries), prior failure, intolerance, or contraindication to specified ALK inhibitors (e.g., alectinib or brigatinib) is required before coverage. |
| Coverage label | Covered with criteria |
| Supporting documentation | Medical records documenting prior ALK inhibitor therapy and reason for discontinuation (progression, intolerance). |
Quantity Limits and Threshold Triggers
Required Documentation and Diagnostic Evidence
Submit enzyme assay or genetic testing for enzyme‑replacement therapies
For some enzyme replacement and rare‑disease therapies (e.g., ALDURAZYME), submit required diagnostic confirmation such as enzyme assay or genetic testing as supporting documentation with the PA request.
CEQUR: document insulin management and self‑testing/CGM use
CEQUR insulin delivery system PAs must include documentation that the patient requires insulin management and is self‑testing glucose levels or using a continuous glucose monitor, plus evidence of prior trial or inability to use bolus injections as specified.
Cystinosis: submit leukocyte cystine, genetic testing, or slit‑lamp evidence
For cystinosis agents (CYSTADROPS, CYSTAGON, CYSTARAN) the provider must submit confirmatory diagnostic documentation (increased leukocyte cystine, genetic testing, or slit‑lamp demonstration of corneal cystine crystals) and evidence of corneal crystal accumulation where specified.
HCV PAs: provide HCV RNA, genotype, staging, prior treatments, and related labs
HCV therapy PAs (e.g., EPCLUSA, Harvoni, MAVYRET) require documentation of HCV RNA prior to treatment, planned regimen, genotype, prior treatment history, cirrhosis staging, HIV coinfection status, resistance‑associated substitutions where applicable, and transplant status when relevant.
GATTEX: document parenteral support dependence and prescriber specialty
For GATTEX in short bowel syndrome, document dependence on parenteral support (adults: dependent ≥12 months; pediatric: dependent) and include prescriber specialty (GI surgeon, gastroenterologist, or nutrition support specialist).
Harvoni: include AASLD‑IDSA required documentation
Harvoni PA requests must include the items aligned with AASLD‑IDSA guidance (HCV RNA, regimen, genotype, prior treatments, cirrhosis status, HIV coinfection, RAS where applicable, and transplant status).
Growth hormone: submit stimulation tests, IGF‑1, height/velocity data
Growth hormone (Genotropin) PAs must include diagnostic criteria such as age, height/velocity thresholds, failed GH stimulation tests (peak <10 ng/mL), IGF‑1 levels, and karyotype for Turner syndrome when applicable.
Document prior therapy failure/intolerance for biologics/biosimilars
For biologic PAs (e.g., adalimumab/HUMIRA and biosimilars), document prior therapy trials showing inadequate response or intolerance to specified conventional therapies and prior biologics as required by indication.
Icatibant: lab confirmation or genetic/family history required
Icatibant PAs for HAE require laboratory confirmation of HAE type (C1 inhibitor deficiency/dysfunction) or genetic/family history and evidence of antihistamine trial failure as applicable.
IVIG: provide serum IgG and infection history per indication
IVIG prior authorization must include relevant laboratory IgG levels and/or history of recurrent bacterial infections; transplant and pediatric HIV criteria specify serum IgG thresholds and timing post‑transplant.
MAVYRET/Vosevi: HCV RNA, regimen, staging, and related documentation required
For hepatitis C PAs (MAVYRET, Vosevi, etc.) include HCV RNA confirmation, planned regimen, genotype, prior treatment history, cirrhosis (Child‑Pugh) status, HIV coinfection, RAS when applicable, and transplant status; durations follow AASLD‑IDSA guidance.
Immunodeficiency: document IgG thresholds or recurrent infection history
For immunodeficiency or transplant‑related IVIG requests, document serum IgG thresholds or a history of recurrent bacterial infections as specified by indication.
Myelofibrosis: risk category, hemoglobin/transfusion history, and prior ruxolitinib info
Myelofibrosis PAs must include documentation of intermediate or high‑risk primary or secondary myelofibrosis, hemoglobin <10 g/dL or transfusion‑dependent anemia, and prior inadequate response/intolerance to ruxolitinib or hemoglobin <8 g/dL as alternative criteria.
Posaconazole (Noxafil): document fluconazole failure/intolerance; age ≥13
Posaconazole oral PA for oropharyngeal candidiasis requires documentation of inadequate response, intolerance, or contraindication to fluconazole and age ≥13 years.
Common required documentation: diagnosis tests, prior therapy history, lab thresholds
Typical PA documentation often includes diagnosis‑specific test results (e.g., HCV RNA), prior treatment history demonstrating inadequate response or intolerance to specified agents, and laboratory thresholds relevant to the drug (e.g., hemoglobin, TSAT).
Supply disease‑specific diagnostic confirmation and prior‑therapy history per drug
Providers must supply disease‑specific diagnostic confirmation and prior‑treatment history as specified per drug (examples include mutation status for BRCA, BRAF, MET, EGFR; confirmation of PAH by right heart catheterization; pretreatment IGF‑1 for acromegaly).
Include required medical information per drug (biomarkers, labs, prior trials)
PA requests must include required medical information that varies by drug and indication such as biomarker/mutation status, prior treatment trials, lab thresholds, and exclusion criteria.
Vigabatrin documentation: ≥2 AED failures and age‑specific criteria
For vigabatrin (complex partial seizures) document inadequate response to at least two antiepileptic drugs; age‑specific documentation is required for infantile spasms versus complex partial seizures.
HCV documentation: HCV RNA and staging details required
Hepatitis C PAs must show HCV infection confirmed by HCV RNA in serum prior to therapy and provide cirrhosis status, HIV coinfection, RAS where applicable, and transplant status per guidance.
PAH documentation: right heart cath hemodynamics required
For PAH or PH‑ILD indications, diagnosis must be confirmed by right heart catheterization with pretreatment mPAP >20 mmHg, PCWP ≤15 mmHg, and PVR ≥3 Wood units documented prior to initiation.
ZEJULA: document second‑line use and BRCA‑altered status
For ZEJULA in uterine leiomyosarcoma, document that the request is for second‑line therapy and that the patient has BRCA‑altered disease.
ZELBORAF (CNS): document BRAF V600E mutation and combination intent
For ZELBORAF in CNS cancers, document tumor BRAF V600E mutation status and intended use with cobimetinib or for pediatric diffuse high‑grade glioma as applicable.
ZELBORAF (melanoma): BRAF V600 mutation and indication stage required
For melanoma using ZELBORAF, document tumor BRAF V600 activating mutation and that therapy is for unresectable/limited resectable/metastatic disease or adjuvant systemic therapy as indicated.
ZONISADE: prior anticonvulsant failures or swallowing impairment documentation
For ZONISADE adjunctive partial‑onset seizures, document prior inadequate response/intolerance/contraindication to a generic anticonvulsant and to Aptiom/Xcopri/Spritam or document difficulty swallowing solid oral dosage forms.
ZYPREXA RELPREVV: document oral olanzapine tolerability
For ZYPREXA RELPREVV, the provider must document established tolerability with oral olanzapine prior to coverage of the long‑acting injectable.
ZURZUVAE: standardized rating‑scale confirmation required for PPD
For ZURZUVAE in postpartum depression, submit confirmation of diagnosis using standardized rating scales (e.g., HDRS, EPDS, PHQ‑9, MADRS, BDI) as required by the PA criteria.
Policy Background and Scope
This prior‑authorization (PA) list covers a broad range of therapeutic areas and high‑cost specialty drugs. It includes oncology targeted therapies, biologic and immunomodulatory agents, enzyme replacement and metabolic therapies, antiviral regimens, pulmonary arterial hypertension agents, immunoglobulin products, neurologic and rare‑disease treatments, and selected high‑risk medications for older adults. For many entries the PA requires disease‑specific diagnostic confirmation (laboratory, biopsy, or genetic/molecular testing), documentation of prior trials and failures or documented intolerance to specified alternatives, and applicable laboratory or physiologic thresholds. Some drugs have age or prescriber restrictions, specified initial coverage durations (for example, initial duration vs plan‑year renewals), and site‑of‑care considerations (including Part A/B versus Part D coverage determinations).
Biosimilar Substitution and Intolerance Notes
Document prior‑therapy trials and failures per step‑therapy rules
Providers must document that prior trials required by step‑therapy rules were completed and that the patient had inadequate response, intolerance, or contraindication before advanced agents are approved.
Biosimilar preference/intolerance documentation required
For biosimilar substitution or reference biologic exceptions (e.g., Remicade/Renflexis; KANJINTI/Trazimera), document an intolerable adverse event to the reference product that was not attributed to the active ingredient when claiming an exception.
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