CurrentNeighborhood Health Plan of Rhode IslandPolicy 2498-A

Erleada (apalutamide) — Coverage Criteria for Prostate Cancer

This policy governs coverage and authorization criteria for apalutamide (Erleada) for FDA-approved and compendial uses in prostate cancer for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyErleada (apalutamide) — Coverage Criteria for Prostate Cancer

Policy CodePolicy 2498-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization for up to 12 months and document bilateral orchiectomy or concurrent LHRH therapy as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

FDA & compendialcovered indications

Presentexcluded combinations

Coverage and Medical Necessity Criteria

Covered indications with authorization

Covered when ALL of the following are met:

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Covered Indication: Patient has an FDA‑approved indication: non‑metastatic castration‑resistant prostate cancer (nmCRPC) OR metastatic castration‑sensitive prostate cancer (mCSPC)

supported by chunk 1

And: Prior orchiectomy or concurrent LHRH therapy: Member has had a bilateral orchiectomy OR will receive apalutamide in combination with a luteinizing hormone‑releasing hormone (LHRH) agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix)

supported by chunks 4 and 5

Authorization duration: Authorization may be granted for up to 12 months for initial therapy12 months

supported by chunks 4 and 5

Continuation / Reauthorization: Authorization of up to 12 months for continued treatment may be granted when there is no evidence of unacceptable toxicity or disease progression while on the current regimen12 months

supported by chunk 6

Compendial uses: Other compendial uses for prostate cancer may be considered when approval criteria are met

supported by chunk 2

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Authorization of up to 12 months may be granted for treatment of non‑metastatic castration‑resistant prostate cancer when the member has had a bilateral orchiectomy or will be using the requested medication in combination with a luteinizing hormone‑releasing hormone (LHRH) agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix). Authorization of up to 12 months may also be granted for treatment of metastatic castration‑sensitive prostate cancer under the same bilateral orchiectomy or concurrent LHRH agonist/antagonist conditions.

Duration: up to 12 months
Applicable indications: non‑metastatic castration‑resistant prostate cancer; metastatic castration‑sensitive prostate cancer

Note

Provider Action — Required Information

Providers must submit documentation supporting the request for authorization and ensure that the member meets the indication-specific requirements (e.g., surgical history of bilateral orchiectomy or plan for concurrent LHRH agonist/antagonist therapy).

Include indication being treated
Specify whether member has bilateral orchiectomy or will receive LHRH agonist/antagonist

Documentation Required

Continuation/Reauthorization Documentation

For continuation/reauthorization requests, documentation must demonstrate there is no evidence of unacceptable toxicity or disease progression while on the current regimen. Include clinical progress notes, relevant lab or imaging results, and any adverse event documentation.

Evidence of clinical benefit or stability
No unacceptable toxicity documented
No disease progression documented

Denial Risk

Excluded Combinations — Denial Risk

Coverage will be denied if the requested medication is used in combination with a second‑generation oral anti‑ (second‑generation oral agent).

Do not submit requests for combinations with second‑generation oral agents — these are excluded

Background and Drug Information

Apalutamide (Erleada) is indicated for treatment of prostate cancer, including non‑metastatic castration‑resistant prostate cancer (nmCRPC) and metastatic castration‑sensitive prostate cancer (mCSPC). Authorization may be granted for up to 12 months for these indications; continuation or reauthorization also may be approved for up to 12 months provided there is no evidence of unacceptable toxicity or disease progression. Use is governed by FDA approvals and compendial recommendations; uses outside those indications are considered investigational and not medically necessary.

Indications and Definitions

Indications covered — FDA‑approved and compendial summary

FDA‑approved indicationsNon‑metastatic castration‑resistant prostate cancer (nmCRPC) and metastatic castration‑sensitive prostate cancer (mCSPC)

Compendial usesCompendial uses for prostate cancer may be considered when approval criteria are met

Non‑covered indicationsAll other non‑FDA and non‑compendial indications are considered experimental/investigational and not medically necessary