CurrentCentenePolicy CP.PCH.45

Apalutamide (Erleada)

Defines medical necessity criteria, authorization durations, dosing limits, and continuation criteria for apalutamide (Erleada) for commercial and HIM/ICHRA lines of business within Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyApalutamide (Erleada)

Policy CodePolicy CP.PCH.45

Change TypeRevised (annual review)

Effective Date03.01.22

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, etc.) supporting that member has met all approval criteria; include evidence for off-label dosing or indications when applicable.

SourceLink

POLICY UPDATE CHANGES

2Q 2025 annual review: added off-label use in non-metastatic castration-sensitive disease and modified continuation quantity limit to allow up to 3 tablets per day for dose adjustments.

2Q 2024 annual review: added clarification for daily quantity of 1 tablet per day.

2Q 2023 annual review: added new 240 mg tablet strength to Section VI.

2Q 2022 annual review: modified commercial approval duration to '12 months or duration of request, whichever is less'.

Added ICHRA line of business (HIM/ICHRA).

2FDA-approved indications listed

1Off-label indication added

240 mg/dayStandard daily dose

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Allowed tablets/day (continuation)

Coverage Summary

This policy defines medical necessity criteria for apalutamide (Erleada) and is covered with criteria for Centene-affiliated Commercial and HIM/ICHRA lines of business. It incorporates NCCN recommendations and FDA indications for non‑metastatic castration‑resistant prostate cancer and metastatic castration‑sensitive prostate cancer, and requires concurrent androgen deprivation therapy (e.g., continuous GnRH analog or bilateral orchiectomy) as a condition of coverage.

I. Initial Therapy Criteria — Prostate Cancer

I. Initial Approval Criteria - Prostate Cancer

Covered when ALL of the following are met:

ALL of the following

ONE of
- a
  - i: Castration-resistant, as evidenced by disease progression despite bilateral orchiectomy or other androgen deprivation therapy (see Appendix D)
  - ii: Prostate-specific antigen doubling time (PSADT) ≤ 10 monthsPSADT ≤ 10 months
- b
  - i: PSADT ≤ 9 monthsPSADT ≤ 9 months
  - ii: PSA ≥ 0.5 ng/mLPSA ≥ 0.5 ng/mL
  - iii: Prior adjuvant or secondary radiotherapy or not considered a candidate for radiotherapy
- c: Metastatic and castration-sensitive
Prescribed by or in consultation with an oncologist or urologist
Age ≥ 18 yearsAge ≥ 18 years
Member will use a gonadotropin-releasing hormone (GnRH) analog concurrently or has had a bilateral orchiectomy
For brand Erleada requests, member must use generic apalutamide, if available, unless contraindicated or clinically significant adverse effects are experienced
Request meets one of the following (a or b)
- a: Dose does not exceed 240 mg per day (1 tablet per day)≤ 240 mg/day
- b: Dose is supported by practice guideline or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Prescribed regimen must be FDA-approved or recommended by NCCN

Approval Duration - Initial

ALL of the following

HIM/ICHRA approval duration = 12 months12 months
Commercial approval duration = 12 months or duration of request, whichever is less12 months or duration of request, whichever is less

II. Continuation (Renewal) Criteria — Prostate Cancer

II. Continuation (Renewal) Criteria - Prostate Cancer

Covered when ALL of the following are met for members currently receiving Erleada:

ALL of the following

Member 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≥ 30 days
Member is responding positively to therapy
If CRPC, there is no evidence of metastases
Member continues to use a GnRH analog concurrently or has had a bilateral orchiectomy

III. Other Diagnoses / Off-Label & Policy Routing

III. Other Diagnoses/Off-Label & Policy Routing

ANY of the following

If drug label changed within last 6 months and not reflected in policy, refer to no coverage criteria or non-formulary policy as specified
Policies: CP.CPA.190, HIM.PA.33, HIM.PA.103
If requested use not specifically listed under section III AND label-change criterion above does not apply, refer to off-label use policy
Policies: CP.CPA.09 (commercial), HIM.PA.154 (HIM/ICHRA)

IV. Diagnoses/Indications Not Authorized

ALL of the following

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents is provided

Provider Actions & Prior Authorization

Prior Authorization

Prescriber specialty requirement

Prescription must be written by an oncologist or urologist, or provided in consultation with an oncologist or urologist.

Documentation Required

Submit supporting documentation

Provide supporting documentation such as office chart notes, laboratory results, and any clinical information that demonstrates the member meets all approval criteria. Include evidence when requesting off-label dosing or indications (e.g., practice guidelines or peer‑reviewed literature).

Applicable Codes & Product Availability

Drug strengths available (Product Availability)NDC

60 mg	Tablet strength 60 mg
240 mg	Tablet strength 240 mg

Clinical Evidence & References

Primary sources referenced: Erleada Prescribing Information August 2024; NCCN Prostate Cancer Guidelines v5.2026; and the NCCN Drugs & Biologics Compendium.

Background & Definitions

Apalutamide (Erleada) is an androgen receptor inhibitor indicated for non‑metastatic castration‑resistant prostate cancer and metastatic castration‑sensitive prostate cancer; the policy requires concurrent androgen deprivation therapy (continuous GnRH analog or prior bilateral orchiectomy) when used in these settings.

Term	Definition
CRPC	Castration-resistant prostate cancer: prostate cancer progressing clinically, radiographically, or biochemically despite castrate serum testosterone (< 50 ng/dL)
CSPC	Castration-sensitive prostate cancer
GnRH	Gonadotropin-releasing hormone
PSADT	Prostate-specific antigen doubling time

Revision History

2Q 2025materialLatest

2Q 2025 annual review: added off-label use in non-metastatic castration-sensitive disease and modified continuation quantity limit to allow up to 3 tablets per day for dose adjustments. P&T Approval Date = 05.25.

2Q 2024revised

2Q 2024 annual review: added clarification for daily quantity of 1 tablet per day. P&T Approval Date = 05.24.

2Q 2023revised

Policy Summary

PayerCentene

PolicyApalutamide (Erleada)

Policy CodePolicy CP.PCH.45

Change TypeRevised (annual review)

Effective Date03.01.22

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, etc.) supporting that member has met all approval criteria; include evidence for off-label dosing or indications when applicable.

SourceLink

On This Page

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

If request is for a dose increase, request meets one of the following (a or b)

a
- i: 240 mg per day≤ 240 mg/day
- ii: 3 tablets per day≤ 3 tablets/day
b: New dose is supported by practice guideline or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Prescribed regimen must be FDA-approved or recommended by NCCN

References: CP.CPA.09 (commercial), HIM.PA.154 (HIM/ICHRA)

Billing Rule

Brand vs generic requirement

For requests for brand Erleada, member must use generic apalutamide if available unless a contraindication or clinically significant adverse effects are documented.

Prior Authorization

Dose limit enforcement

Requests with doses exceeding 240 mg per day require supporting evidence from practice guidelines or peer‑reviewed literature. Continuation requests that increase the dose above the standard must be supported; continuation increases that result in more than 3 tablets per day also require supporting guideline or peer‑reviewed literature evidence.

Documentation Required

Continuation evidence

For renewal, submit documentation showing the member has been receiving Erleada for at least 30 days and is responding positively to therapy. If the indication is castration‑resistant prostate cancer (CRPC), provide documentation that there is no evidence of metastases.

2Q 2023 annual review: added new 240 mg tablet strength to Section VI. P&T Approval Date = 05.23.

2Q 2022revised

2Q 2022 annual review: modified commercial approval duration to '12 months or duration of request, whichever is less'. P&T Approval Date = 05.22.

added

Added ICHRA line of business (HIM/ICHRA).