CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Erleada (apalutamide) — Coverage Criteria and Authorization

Defines coverage criteria, exclusions, and authorization periods for Erleada (apalutamide) for FDA-approved and compendial prostate cancer indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyErleada (apalutamide) — Coverage Criteria and Authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing FDA‑approved indication and evidence of bilateral orchiectomy or concurrent GnRH agonist/degarelix use when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 mostandard authorization period

2FDA-approved indications

1explicit exclusions

Coverage Criteria for Erleada (apalutamide)

Initial authorization criteria (12 months)

Covered when ALL of the following are met for the specified indication:

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Indication: Member has one of the FDA‑approved indications: non‑metastatic castration‑resistant prostate cancer OR metastatic castration‑sensitive prostate cancer

From FDA‑approved indications list

Androgen deprivation requirement: Member has had a bilateral orchiectomy OR will use Erleada in combination with a gonadotropin‑releasing hormone (GnRH) agonist or degarelix (as specified for the indication)

Required for authorization of 12 months

Reauthorization criteria (12 months)

Continuation of therapy — Covered when ALL of the following are met:

Continuation criteria: No evidence of unacceptable toxicity or disease progression while on the current regimen

Authorization of 12 months may be granted for continued treatment

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization and reauthorization (12 months)

Prior authorization may be granted for up to 12 months for FDA‑approved indications and for reauthorization when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Authorization period: up to 12 months for initial authorization and reauthorization

Documentation Required

Required documentation for authorization and reauthorization

Providers should confirm and document the member's castration status (bilateral orchiectomy) or concurrent use of a gonadotropin‑releasing hormone (GnRH) agonist or degarelix when requesting authorization.

Document indication (NM-CRPC or mCSPC)
Document evidence of bilateral orchiectomy OR intent to use with GnRH agonist/degarelix

Denial Risk

Combination therapy exclusion

Do not prescribe or request coverage if the medication will be used in combination with a second‑generation oral anti‑androgen (e.g., enzalutamide) or an oral androgen metabolism inhibitor (e.g., abiraterone). Requests for combination therapy are excluded from coverage and will be denied.

Combination therapies excluded: enzalutamide (Xtandi), abiraterone acetate (Zytiga), and other second‑generation oral anti‑androgens or oral androgen metabolism inhibitors

Note

Provider action and alerts

Action: verify exclusions and submit complete supporting documentation with the prior authorization request to avoid delays or denial.

Confirm member does not have a contraindicated combination therapy
Include prior therapy and toxicity/disease progression status for reauthorization

Key Definitions

Non‑metastatic castration‑resistant prostate cancer — key definition (FDA‑approved indication)

DefinitionNon‑metastatic castration‑resistant prostate cancer (nmCRPC) — FDA‑approved indication for Erleada (apalutamide).

Authorization periodInitial and reauthorization may be granted for up to 12 months when criteria are met.

Androgen‑deprivation requirementMember must have undergone bilateral orchiectomy OR receive concurrent GnRH agonist/degarelix when specified by indication.

Metastatic castration‑sensitive prostate cancer — key definition (FDA‑approved indication)

DefinitionMetastatic castration‑sensitive prostate cancer (mCSPC) — FDA‑approved indication for Erleada (apalutamide).