CurrentHealth NetPolicy CP.PCH.45

Clinical Policy: Apalutamide (Erleada)

Clinical coverage policy for apalutamide (Erleada) for commercial and HIM/ICHRA lines of business, defining initial and continuation medical necessity criteria, dosing limits, required concurrent androgen deprivation, formulary/generic preference, approval durations, and exclusions/off-label handling.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Apalutamide (Erleada)

Policy CodePolicy CP.PCH.45

Change TypeAnnual reviews; revisions and additions

Effective DateMar 1, 2022

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

2Q 2025 annual review: per NCCN Compendium, added off-label use in non-metastatic and 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; references reviewed and updated.

2Q 2023 annual review: added new 240 mg tablet strength to Section VI and updated Appendix D examples.

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

Added ICHRA line of business (effective in latest revisions).

2FDA approved indications

1Off-label indication added

240 mg/dayStandard daily dose

12 months

Typical approval duration

Coverage Summary

Coverage stance: covered_with_criteria for apalutamide (Erleada). Indications covered align with FDA-approved uses: non-metastatic castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (CSPC). The policy requires concurrent androgen-deprivation therapy (use of a GnRH analog or prior bilateral orchiectomy) as a condition of coverage. For brand Erleada requests, use of generic apalutamide is required if available unless contraindicated. Typical approval duration is 12 months (HIM/ICHRA: 12 months; Commercial: 12 months or duration of request, whichever is less). Scope: applies to Commercial and HIM/ICHRA lines of business.

Key Policy Facts

Policy numberCP.PCH.45

Effective date03.01.22

Last review05.26 (2026-05-26)

Typical approval duration12 months (HIM/ICHRA) — Commercial: 12 months or duration of request, whichever is less

Standard daily dose240 mg per day (240 mg PO QD); maximum 240 mg/day

Off-label indication addedNon-metastatic castration-sensitive biochemical recurrence after radical prostatectomy (added per 2Q 2025) — requires PSADT ≤ 9 months and PSA ≥ 0.5 ng/mL

PSADT / PSA thresholdsPSADT ≤ 10 months for non‑metastatic CRPC; PSADT ≤ 9 months and PSA ≥ 0.5 ng/mL for non‑metastatic castration‑sensitive biochemical recurrence

Initial Therapy Criteria

I. Initial Approval Criteria - A. Prostate Cancer

Provider must submit documentation supporting that member has met all approval criteria. Erleada is medically necessary when the following criteria are met:

ALL of the following

Diagnosis (one of)
- Non-metastatic and both of the following
  - Castration-resistant, as evidenced by disease progression despite bilateral orchiectomy or other androgen deprivation therapy (see Appendix D)
  - Prostate-specific antigen doubling time (PSADT) ≤ 10 months≤ 10 months
- Non-metastatic and castration-sensitive with biochemical recurrence after radical prostatectomy (off-label)

Continuation Therapy Criteria

II. Continuation (Renewal) Criteria - A. Prostate Cancer

Member must meet all:

ALL of the following

Currently receiving medication via Centene benefit, or documentation supports that member has received Erleada for a covered indication 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

Diagnoses / Indications Not Authorized

III. Diagnoses/Indications NOT authorized

Non-FDA approved indications which are not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09 or HIM.PA.154) or evidence of coverage documents

Provider Actions & Requirements

Documentation Required

Submit supporting documentation

Provider must submit office chart notes, laboratory results, and other clinical information that support the member has met all approval criteria (diagnosis, PSA/PSADT data, prior therapies, concurrent androgen-deprivation therapy, dosing rationale, and any supporting literature for off‑label uses or dose increases).

Office chart notes
Lab results (e.g., PSA, PSADT)
Other clinical information (radiology reports, operative notes, prior therapy documentation, practice guidelines or peer‑reviewed literature when applicable)

Prior Authorization

Prescriber specialty requirement

Prescriptions must be written by or in consultation with an oncologist or urologist; include documentation of the prescriber specialty or consult note when submitting the request.

Applicable Codes

Product strengthsNDC

60 mg tablet	Apalutamide tablet strength
240 mg tablet	Apalutamide tablet strength

Clinical Evidence & References

Evidence and references: Erleada Prescribing Information (August 2024); NCCN Drugs & Biologics Compendium; NCCN Prostate Cancer Guidelines v5.2026. Policy coverage is aligned with FDA labeling and NCCN recommendations. Per the 2Q2025 review, an off-label non-metastatic castration-sensitive biochemical recurrence indication was added to the policy per the NCCN Compendium, and continuation quantity limits were modified to allow up to 3 tablets per day for dose adjustments. Thresholds applied in the policy: PSADT ≤ 10 months for non-metastatic CRPC and PSADT ≤ 9 months and PSA ≥ 0.5 ng/mL for non-metastatic castration-sensitive biochemical recurrence.

Background

Background: Apalutamide (Erleada) is an androgen receptor inhibitor indicated for non-metastatic CRPC and metastatic CSPC. This policy aligns coverage with FDA labeling and NCCN guidance and requires concurrent androgen-deprivation therapy (GnRH analog or bilateral orchiectomy). Scope summary: clinical coverage policy for apalutamide for Commercial and HIM/ICHRA lines of business defining initial and continuation medical necessity criteria, dosing limits (standard 240 mg/day), generic preference, approval durations, and handling of off-label uses.

Definitions

CRPCCastration‑resistant prostate cancer: prostate cancer that progresses clinically, radiographically, or biochemically despite castrate levels of serum testosterone (< 50 ng/dL).

CSPCCastration‑sensitive prostate cancer.

GnRHGonadotropin‑releasing hormone (GnRH).

PSADTProstate‑specific antigen doubling time (PSADT).

Revision History

2Q 2025revisedLatest

2Q 2025 annual review: per NCCN Compendium, 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; references reviewed and updated.

2Q 2024revised

2Q 2024 annual review: added clarification for daily quantity of 1 tablet per day; references reviewed and updated.

2Q 2023revised

Policy Summary

PayerHealth Net

PolicyClinical Policy: Apalutamide (Erleada)

Policy CodePolicy CP.PCH.45

Change TypeAnnual reviews; revisions and additions

Effective DateMar 1, 2022

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria.

SourceLink

On This Page

PSADT ≤ 9 months≤ 9 months
PSA ≥ 0.5 ng/mL>= 0.5 ng/mL
Prior adjuvant or secondary radiotherapy or not considered a candidate for radiotherapy

Metastatic and castration-sensitive

Prescribed by or in consultation with an oncologist or urologist

Age ≥ 18 years≥ 18

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

Dose limits (one of)

Dose does not exceed 240 mg per day (1 tablet per day)≤ 240 mg/day; 1 tablet/day
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

I. Initial Approval Criteria - B. Other diagnoses/indications

If indication not listed or recent label change, follow formulary/non-formulary or off-label use policies as noted:

ANY of the following

If drug had label change in last 6 months not reflected here, follow no coverage or non-formulary policy per line of business: CP.CPA.190 (commercial) and HIM.PA.33 (ICHRA) for formulary; CP.CPA.190 (commercial) and HIM.PA.103 (ICHRA) for non-formulary
If requested use is NOT listed in section III and criterion above does not apply, refer to off-label use policy CP.CPA.09 (commercial) and HIM.PA.154 (ICHRA)

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

Dose increase requests (one of)

New dose does not exceed both of the following:
- 240 mg per day≤ 240 mg/day
- 3 tablets per day≤ 3 tablets/day
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

II. Continuation (Renewal) Criteria - B. Other diagnoses/indications

Same referral to formulary/off-label policies as in Initial Approval B

ANY of the following

Refer to CP.CPA.190 or HIM.PA.33 for formulary no coverage guidance if recent label change
Refer to off-label use policy CP.CPA.09 or HIM.PA.154 if request not listed and no recent label change applies

Prior Authorization

Concomitant GnRH or orchiectomy requirement

Document concurrent use of a gonadotropin‑releasing hormone (GnRH) analog or evidence of bilateral orchiectomy. Include medication records or operative notes to verify ongoing GnRH therapy or surgical castration.

Medication record showing active GnRH analog (e.g., leuprolide, goserelin, degarelix, relugolix)
Bilateral orchiectomy operative report or notation

Billing Rule

Generic substitution preference

For brand Erleada requests, the member must use generic apalutamide if available unless there is a documented contraindication or clinically significant adverse effect to the generic product. Include rationale or documentation if requesting brand instead of generic.

Prior Authorization

Dose limit enforcement

Standard maximum dose is 240 mg per day (approved dosing regimen 240 mg PO QD). Continuation dose increase requests may allow up to 3 tablets per day for dose adjustments if the new dose does not exceed 240 mg/day and 3 tablets/day, or if the increase is supported by practice guidelines or peer‑reviewed literature — prescriber must submit supporting documentation.

Standard dose: 240 mg/day (240 mg PO QD)
Continuation dose increase: may allow up to 3 tablets/day with required supporting documentation
If dose exceeds standard limits, submit practice guideline or peer‑reviewed literature

Prior Authorization

Off-label use evidence requirement

If approval relies on an off‑label indication or a non‑standard dose, the prescriber must submit supporting practice guideline recommendations or peer‑reviewed literature that justify the requested use or dosing.

2Q 2023 annual review: added new 240 mg tablet strength to Section VI and updated Appendix D examples of androgen deprivation therapy; references reviewed and updated.

2Q 2022revised

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

2026added

Added ICHRA line of business.