Prior authorization must document that all approval criteria are met

Prior authorization requests must include evidence that the member meets all approval criteria for apalutamide: the specific prostate cancer diagnosis subgroup (non‑metastatic CRPC with PSADT ≤ 10 months; non‑metastatic castration‑sensitive with biochemical recurrence and PSADT ≤ 9 months, PSA ≥ 0.5 ng/mL, and prior/unsuitable radiotherapy; or metastatic castration‑sensitive), prescriber specialty (oncologist or urologist), age ≥ 18, and documentation of concurrent GnRH analog use or prior bilateral orchiectomy. For metastatic disease, include documentation of prior failure of generic abiraterone unless contraindicated or a state redirection prohibition applies. Also document dose does not exceed 240 mg/day (1 tablet/day) or provide guideline/literature support for off‑label dosing.

• Include diagnosis details and relevant PSADT values where applicable (PSADT ≤ 10 months for non‑metastatic CRPC; PSADT ≤ 9 months for specified off‑label non‑metastatic castration‑sensitive recurrence).
• Confirm prescriber is an oncologist or urologist and patient age ≥ 18.
• Provide evidence of concurrent GnRH analog therapy or documentation of prior bilateral orchiectomy.
• For metastatic requests, document prior failure of generic abiraterone or an applicable bypass (contraindication, adverse effects, or state-level prohibition).
• State requested dose and ensure it does not exceed 240 mg/day (1 tablet/day) unless supported by guideline or literature with submitted evidence.

Clinical policy provides guidance; follow plan prior authorization processes

This clinical policy is intended as guidance to assist with coverage decisions and benefit administration; providers must follow the health plan's applicable prior authorization processes and administrative policies when submitting requests.

• Clinical policy guidance does not guarantee payment and is subject to plan administrative procedures.
• Follow the health plan's submission processes and any plan-level prior authorization requirements.

Step therapy: trial of generic abiraterone required for metastatic disease

For metastatic castration‑sensitive disease, apalutamide requests require prior failure of generic abiraterone before approval unless abiraterone is contraindicated, causes clinically significant adverse effects, or the request is for a State with regulations prohibiting oncology step therapy redirection (see Appendix E).

• Document prior trial and failure of generic abiraterone, or document contraindication/adverse effects.
• If the request falls under a state in which redirection is prohibited, include evidence of applicable state regulation or note the state per Appendix E.

Provider responsibility and scope of the clinical policy

Provider-impact note: coverage determinations are medical necessity determinations intended to guide benefits and do not dictate clinical care; providers retain independent professional judgment in treating members.

• This policy does not constitute medical advice or a contract and may be changed by the Health Plan.
• Providers are responsible for clinical decision-making for their patients.

Required clinical documentation to support that member meets criteria

Submit supporting clinical documentation with authorization requests, such as office chart notes, relevant laboratory results (including PSA and documentation to calculate PSADT), imaging or pathology reports as applicable, and any prior therapy records demonstrating abiraterone use and response.

• Provide PSA values and interval dates necessary to demonstrate PSADT where required.
• Include documentation of prior abiraterone therapy and reasons for failure or intolerance when applicable.

Providers must follow plan coverage documents and administrative policies when submitting requests

When submitting claims or authorization requests, providers must follow the member's coverage documents (evidence of coverage, certificate of coverage, policy/contract) and the health plan's administrative policies and procedures.

• Coverage determinations are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents.
• If plan documents or law conflict with this policy, applicable legal/regulatory requirements prevail.

Coverage not authorized for unspecified non‑FDA indications without supporting evidence

Requests for indications not listed in this policy or other non‑FDA approved uses lacking sufficient documentation per the Off‑Label Use Policy CP.PMN.53 or the member's evidence of coverage may be denied.

• Provide robust efficacy and safety evidence per the off‑label policy when requesting coverage for non‑FDA indications.
• If off‑label use is not supported per CP.PMN.53 or plan documents, coverage is not authorized.

Coverage decisions are subject to plan terms, exclusions, and state/federal requirements

Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions, and limitations of the coverage documents and to applicable state and federal requirements; failure to meet those requirements may result in denial.

• This policy does not guarantee payment and may be superseded by plan contracts or legal/regulatory requirements.
• Providers should verify member-specific coverage terms prior to treatment.