CurrentmhnPolicy CP.PCH.45

Apalutamide (Erleada) Coverage Criteria

Defines medical necessity and prior authorization criteria for apalutamide (Erleada) for treatment of prostate cancer (non-metastatic CRPC, metastatic CSPC, and specified off-label non‑metastatic castration-sensitive use) for members covered under the payer's commercial and HIM lines of business.

Policy Summary

Payermhn

PolicyApalutamide (Erleada) Coverage Criteria

Policy CodePolicy CP.PCH.45

Change TypeMaterial updates — off-label addeddosing limits revised

Effective DateMar 1, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating castration status, PSADT, prior therapies, and response to meet initiation or continuation criteria.

SourceLink

POLICY UPDATE CHANGES

Off-label use in non-metastatic castration-sensitive disease was added per NCCN Compendium.

Continuation therapy quantity limit modified to allow up to 3 tablets per day for dose adjustments.

Daily quantity clarified as 1 tablet per day for standard dosing (240 mg/day).

240 mg/dayFDA-approved dosing

60 mg, 240 mgTablet strengths

12 monthsApproval duration

≤10 moPSADT (non-met CRPC)

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≤9 moPSADT (off-label nm castrate-sensitive)

Coverage Criteria for Apalutamide (Erleada)

Initial Therapy

Covered when ALL of the following are met for Prostate Cancer initial therapy:

Initial therapy for Prostate Cancer

Disease characterization
- Non-metastatic CRPC
  - Castration-resistant evidence: Disease progression despite bilateral orchiectomy or other androgen deprivation therapy
  - PSADT threshold: Prostate-specific antigen doubling time (PSADT) ≤ 10 months
- Non-metastatic castration-sensitive (off-label)
  - PSADT and PSA: PSADT ≤ 9 months AND PSA ≥ 0.5 ng/mL
  - Radiotherapy history: Prior adjuvant or secondary radiotherapy OR not a candidate for radiotherapy
- Metastatic CSPC: Metastatic and castration-sensitive
Prescriber: Prescribed by or in consultation with an oncologist or urologist
Age ≥ 18 years
Castration concurrent therapy: Member will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy
Generic first: For brand Erleada requests, member must use generic apalutamide if available unless contraindicated or clinically significant adverse effects are experienced
Dose limits: Dose does not exceed 240 mg per day (1 tablet per day) OR dose is supported by practice guideline or peer-reviewed literature for the relevant off-label use with prescriber-submitted supporting evidence

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy:

Continuation therapy for Prostate Cancer

Current therapy: Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Erleada for a covered indication and has received this medication for at least 30 days
Response: Member is responding positively to therapy
CRPC metastases: If CRPC, there is no evidence of metastases
Castration concurrent therapy continued: Member continues to use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy

Uses of apalutamide (Erleada) for indications that are not FDA‑approved and are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the payer's off‑label use policies (see CP.CPA.09 for Commercial and HIM.PA.154 for HIM) or applicable evidence of coverage documents.

Requests for apalutamide to treat off‑label conditions or indications not covered by this policy will be denied unless the request is supported by adequate clinical documentation demonstrating efficacy and safety as required by the payer's off‑label use policies. Providers should follow CP.CPA.09 (Commercial) or HIM.PA.154 (HIM) and submit pertinent evidence per those policies to support coverage consideration.

Product Availability, Dosing, and Key Clinical Thresholds

Product Availability and Dosing

Non-metastatic CRPC / Metastatic CSPC dosing240 mg PO once daily; maximum 240 mg/day

Tablet strengths60 mg; 240 mg

Brand/formulary guidanceFor brand Erleada requests, member must use generic apalutamide if available unless contraindicated or clinically significant adverse effects occur

Prescriber and age requirementPrescribed by or in consultation with an oncologist or urologist; patient age ≥ 18 years

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Erleada (apalutamide). Providers must demonstrate the member meets the initiation or continuation criteria in this policy.

Applies to all requests for Erleada (brand or generic).
Prescriber should be an oncologist or urologist for prostate cancer indications.

Prior Authorization

Concurrent Androgen Deprivation Requirement

Concurrent Androgen Deprivation Required: Member must be receiving a gonadotropin-releasing hormone (GnRH) analog concurrently or have had a bilateral orchiectomy for both initiation and continuation of therapy.

Initiation: Member will use a GnRH analog concurrently or has had bilateral orchiectomy.
Continuation: Member continues to use a GnRH analog concurrently or has had bilateral orchiectomy.

Definitions

Castration‑resistant prostate cancer (CRPC)

Definition of CRPCDisease that progresses clinically, radiographically, or biochemically despite castrate serum testosterone (<50 ng/dL)

Clinical guidancePer NCCN, continue androgen deprivation therapy in CRPC while applying additional therapies

Evidence of castrationProgression despite bilateral orchiectomy or other androgen deprivation therapy supports CRPC designation

Gonadotropin‑releasing hormone (GnRH) — examples

Definition of GnRHGonadotropin‑releasing hormone analogs used for androgen deprivation (e.g., LHRH agonists and antagonists) or bilateral orchiectomy

LHRH agonist examplesZoladex (goserelin), Leuprolide (Lupron Depot or Eligard), Trelstar (triptorelin)

Background

Apalutamide is an androgen‑receptor inhibitor used in prostate cancer management. This policy defines coverage for its FDA‑approved and certain specified uses and clarifies that non‑FDA indications not addressed here require submission of supporting evidence per the off‑label use policies referenced above before coverage can be authorized.

Revision History

2025-05-?? or 2025-05annual_review (2Q 2025)Latest

Per NCCN Compendium, off-label use for non‑metastatic castration‑sensitive disease was added; continuation therapy quantity limit modified to allow up to 3 tablets per day for dose adjustments; references reviewed and updated.

2024-05-?? or 2024-05annual_review (2Q 2024)

Added clarification that the standard daily quantity is 1 tablet per day (240 mg/day) and references were reviewed and updated.

2023-05-23

Policy Summary

Payermhn

PolicyApalutamide (Erleada) Coverage Criteria

Policy CodePolicy CP.PCH.45

Change TypeMaterial updates — off-label addeddosing limits revised

Effective DateMar 1, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating castration status, PSADT, prior therapies, and response to meet initiation or continuation criteria.

SourceLink

On This Page

Generic first: For brand Erleada requests, member must use generic apalutamide if available unless contraindicated or clinically significant adverse effects are experienced

Dose increase: If request is for a dose increase, new dose must either not exceed both 240 mg per day and 3 tablets per day, OR be supported by practice guideline or peer-reviewed literature for the relevant off-label use with prescriber-submitted supporting evidence

Documentation Required

Documentation Requirements: The provider must submit documentation to support that the member meets all approval criteria. Acceptable documentation includes office chart notes, laboratory results (e.g., PSA and PSADT), imaging reports, and any supporting peer‑reviewed literature when required for off‑label dosing or indications.

Include office notes showing diagnosis and treatment history.
Include labs such as PSA and documentation of PSA doubling time (PSADT).
Include imaging reports when relevant and any prior radiotherapy documentation.
For off‑label requests, submit supporting practice guideline or peer‑reviewed literature.

Denial Risk

Non‑FDA Indication Request Handling

Requests for Non‑FDA Approved Indications: Requests for indications not addressed in this policy will be denied unless the provider submits sufficient documentation of efficacy and safety per the applicable off‑label use policies (CP.CPA.09 for commercial and HIM.PA.154 for Health Insurance Marketplace) or other evidence of coverage documents.

Non‑FDA indications addressed in this policy (see initiation/continuation criteria a–c) may be considered if criteria are met.
All other non‑FDA indications require documentation per off‑label use policies or will be denied.

LHRH antagonist examplesFirmagon (degarelix), Orgovyx (relugolix)

Added new 240 mg tablet strength to product availability (Section VI).