CurrentCentenePolicy CP PCH.45

Apalutamide (Erleada) coverage for prostate cancer

Defines medical necessity criteria, prior authorization requirements, and coverage limits for apalutamide (Erleada) for members with specified prostate cancer diagnoses across Centene lines of business.

Policy Summary

PayerCentene

PolicyApalutamide (Erleada) coverage for prostate cancer

Policy CodePolicy CP PCH.45

Change TypeAdded off-label indicationrevised continuation dosing

Effective DateMar 1, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, PSADT, castration status, concurrent GnRH use or orchiectomy, prescriber specialty, and dose limits.

SourceLink

POLICY UPDATE CHANGES

Added off-label coverage for non-metastatic castration-sensitive prostate cancer per NCCN Compendium.

Modified continuation of therapy quantity limit to allow up to 3 tablets per day for dose adjustments.

Added 240 mg tablet strength to product availability.

240 mg/dayMax dose

12 monthsApproval duration

60 mg, 240 mgTablet strengths

PSADT <10 moPSADT requirement

NCCN allowed

Policy Summary

PayerCentene

PolicyApalutamide (Erleada) coverage for prostate cancer

Policy CodePolicy CP PCH.45

Change TypeAdded off-label indicationrevised continuation dosing

Effective DateMar 1, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, PSADT, castration status, concurrent GnRH use or orchiectomy, prescriber specialty, and dose limits.

SourceLink

On This Page

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Coverage Criteria for Apalutamide (Erleada)

This policy applies only to the FDA‑approved and specified indications described in the coverage criteria. Non‑FDA approved indications not addressed in this policy are not authorized unless the request is supported by documentation of efficacy and safety consistent with Centene off‑label use policies (see CP.CPA.09 for Commercial and HIM.PA.154 for Health Insurance Marketplace) or by applicable evidence‑of‑coverage documents.

Requests for apalutamide for indications that are not listed in this policy will be reviewed against Centene’s off‑label use requirements. If the provider does not supply sufficient clinical documentation demonstrating efficacy and safety per the off‑label policies referenced above, the request will be considered not medically necessary and will be denied. Providers should include relevant clinical evidence and rationale when seeking coverage for off‑label uses.

Drug Codes, Dosing, and Identifiers

Drug codes / identifiersmixed

NDC	Not specified in document

Maximum daily dose

Maximum daily dose240 mg per day

Tablet frequency1 tablet per day (per dosing guidance)

Applies toNon‑metastatic CRPC and metastatic CSPC dosing limits

Prior Authorization, Documentation, and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, imaging, pathology, PSA values and trends, and other clinical information) supporting that the member meets all initial or continuation criteria (including diagnosis, castration status, PSA doubling time, prior therapies, and concurrence with an oncologist or urologist as applicable). Requests for brand Erleada will require use of generic apalutamide when available unless contraindicated or the member has experienced clinically significant adverse effects to the generic.

Affected product: Erleada (apalutamide)
Documentation to include: office notes, labs (PSA values and dates to document PSADT), imaging/pathology reports, prior treatment history, and prescriber specialty

Denial Risk

Non‑Covered / Off‑Label Indications

Requests for indications that are not FDA-approved and are not specifically addressed in this policy will be denied unless the provider submits sufficient documentation showing efficacy and safety per the plan's off‑label use policies (CP.CPA.09 for commercial and HIM.PA.154 for Health Insurance Marketplace) or other applicable evidence of coverage documents. Off-label requests must include supporting peer‑reviewed literature or guideline references when requested.

Key Definitions and Acronyms

CRPC definition

Definition (CRPC)Prostate cancer that progresses clinically, radiographically, or biochemically despite castrate levels of serum testosterone (< 50 ng/dL).

Required concurrent therapyAndrogen deprivation therapy should be continued (e.g., GnRH analog or bilateral orchiectomy) when treating CRPC.

Evidence of castration resistanceProgression despite bilateral orchiectomy or other androgen deprivation therapy.

Acronyms

GnRHGonadotropin‑releasing hormone (used in reference to GnRH analogs for androgen deprivation).

PSADTProstate‑specific antigen doubling time.

Background on Apalutamide

Apalutamide is an androgen receptor inhibitor used in specified prostate cancer populations covered by this policy. Coverage and clinical use must follow the indications and limits specified in the policy; any use outside those indications must meet the off‑label documentation requirements described above. Note that dosing and formulation details (including maximum daily dose and available tablet strengths) are addressed in the policy’s dosing and coding sections.