Prior authorization required for listed drugs

Prior authorization (PA) or step therapy (ST) is required for many listed drugs and products. Providers must request PA/ST prior to dispensing and supply supporting clinical documentation (diagnoses, prior therapies, treatment dates, and response). Include copies of relevant chart notes, specialty pharmacy documentation, and any prior authorization forms. Failure to submit required documentation may delay or result in denial of coverage.

• PA required for drugs and products listed in the formulary and policy (identified with PA/ST flags).
• When requested, submit full clinical notes showing diagnosis, medical necessity, prior treatments and response.
• Coverage duration requests (e.g., 1 year) and reauthorization requests require supporting evidence of benefit.

Prior authorization required per product

Some products have PA criteria that apply per specific product or formulation. Confirm the exact product (brand, strength, formulation, NDC) when submitting a request and include product-specific documentation.

• Prior authorization required per product (e.g., specific brand vs biosimilar, tablet vs injection).
• Indicate exact product name, strength, route, and NDC when requesting PA.
• If multiple formulations exist (e.g., tablet vs TBSO), supply rationale for chosen formulation.

Document prerequisite trials and responses

Requests must document prerequisite therapy trials and clinical responses where required. Provide specific trial medications, dates, duration, reason for discontinuation, and objective/subjective response to therapy.

• Document prerequisite trials and responses: list drug name, start/stop dates, dose, and reason for failure or intolerance.
• Document prior therapy trials (including generic or formulary alternatives) when step/ trial requirements are specified.
• Examples of required generic/formulary trials: trials of letrozole or anastrozole before everolimus+exemestane for HR+ breast cancer; trial of sunitinib or sorafenib before certain RCC agents.
• Reauthorization often requires documentation of positive clinical response to therapy (e.g., symptom improvement, reduced exacerbations, tumor response).

Provide diagnostic or lab evidence where specified

Some therapies require specific diagnostic or laboratory evidence to support approval. Submit pertinent lab values, imaging, or functional test results with the PA request.

• Provide diagnostic or lab evidence where specified (e.g., confirmatory imaging, genetic testing where required).
• Lab documentation for eosinophil counts: submit absolute eosinophil count values and dates when criteria reference eosinophilia.
• Timed walk test for Dalfampridine: include documented T25FW (Timed 25-Foot Walk) results showing baseline and treatment response as required.
• Examples of other lab/diagnostic evidence: A1C or OGTT results for metabolic indications, specific genetic test reports, pulmonary function tests (FEV1%), or pathology reports.

Combination-use requirements

Combination-use rules and step/trial requirements are enforced for certain oncology and specialty regimens. Indicate concomitant agents and prior required agents when applicable.

• Combination-use requirements: many products require use in combination with a specific agent (examples include Everolimus + exemestane; Akeega with prednisone; certain PARP or hormonal therapy combinations).
• Other example combination requirements: Cabometyx combined with nivolumab where specified, or PARP inhibitors paired with corticosteroids as noted in product criteria.
• Step/Trial requirements: list required prior trials of generics or formulary alternatives (e.g., trial of letrozole or anastrozole prior to coverage for certain breast cancer regimens; trial of sunitinib or sorafenib prior to some RCC therapies).
• When combination-use is an exclusion (e.g., cannot be used with another biologic or targeted DMARD for the same condition), include documentation confirming absence of concurrent biologic therapy.

Submit clinical documentation for Part B vs Part D determination

When a drug may be payable under Medicare Part B vs Part D, the plan may request additional information to make the determination. Submit treatment setting and administration details when requested.

• Submit clinical documentation indicating whether the drug is administered in a physician office/clinic (Part B) or self-administered/retail pharmacy (Part D).
• Include infusion/administration records, claim information, or provider attestation when requested to support Part B vs Part D determination.

Reauthorization requirements

Reauthorization requests commonly require evidence of ongoing benefit. Many biologics and specialty agents require documentation of positive clinical response and continued medical necessity for renewal.

• Reauthorization requirement: supply objective or clinician-documented evidence of improvement or stabilization since initiation (e.g., reduced symptom scores, improved labs, imaging, or functional tests).
• Reauthorization requirements: many products list a 1-year coverage duration and require renewal requests with supporting outcome documentation.
• Documented positive clinical response is frequently required for continuation of biologic therapies (e.g., Adbry reauthorization requires documentation of positive clinical response).