CurrentCignaPolicy CNF509

Oncology – Erleada Prior Authorization Policy - (CNF509)

Defines prior authorization requirements and medical necessity criteria for coverage of Erleada (apalutamide tablets) for FDA‑approved indications (non‑metastatic castration‑resistant prostate cancer and castration‑sensitive prostate cancer) when used with androgen deprivation therapy or after bilateral orchiectomy. Also states non‑coverage for other uses.

Policy Summary

PayerCigna

PolicyOncology – Erleada Prior Authorization Policy - (CNF509)

Policy CodePolicy CNF509

Change TypeRevised criteria and added approval option

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; document concurrent use of a GnRH analog or prior bilateral orchiectomy and, for high‑risk castration‑sensitive cases, document PSADT, PSA value, and prior radiation therapy or ineligibility.

SourceLink

POLICY UPDATE CHANGES

Changed wording from 'GnRH agonist' to 'GnRH analog' allowing both agonists and antagonists and added Firmagon and Orgovyx as examples.

Added approval option for patients with high‑risk second biochemical recurrence in castration‑sensitive prostate cancer with definition of high‑risk attributes.

Policy name updated to 'Oncology (Oral - Androgen Receptor Inhibitor) - Erleada PA Policy'.

2Covered Indications

1Approval Duration (years)

1Not Covered: Other Uses

Coverage Summary

Defines prior authorization requirements and medical necessity criteria for coverage of Erleada (apalutamide) tablets for FDA‑approved indications (non‑metastatic castration‑resistant prostate cancer (nmCRPC) and castration‑sensitive prostate cancer) when used with androgen deprivation therapy (GnRH analog) or after bilateral orchiectomy. Prior authorization approvals are provided for 1 year. Erleada is considered not medically necessary for any other uses not described in the FDA‑approved indications above or supported by evidence in this policy.

Thresholds and Approval Parameters

Age≥ 18 years

PSA doubling time (nmCRPC guidance)≤ 10 months (per NCCN preferred recommendation)

PSADT (high‑risk second biochemical recurrence)≤ 9 months

PSA level (high‑risk second biochemical recurrence)≥ 0.5 ng/mL

Approval Duration1 year

Covered Indications2 (nmCRPC and castration‑sensitive prostate cancer)

Medical‑Necessity Criteria

FDA‑Approved Indication: Prostate Cancer - Non‑Metastatic, Castration‑Resistant

Approve for 1 year if the patient meets the following (A and B):

ALL of the following

Patient is ≥ 18 years of age
ONE of
- The medication is used in combination with a gonadotropin-releasing hormone (GnRH) analog
  Examples include leuprolide acetate (Lupron Depot), triptorelin pamoate (Trelstar), goserelin acetate (Zoladex), histrelin acetate (Vantas), degarelix (Firmagon), relugolix (Orgovyx).
- Patient has had a bilateral orchiectomy

Coding

DrugNDCCovered

No codes listed

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Erleada; approvals are provided for 1 year when criteria are met.

Documentation Required

Document ADT use or orchiectomy

Provider must document concurrent use of a GnRH analog (examples provided) OR documentation of prior bilateral orchiectomy to meet coverage criteria.

Examples: leuprolide acetate (Lupron Depot), triptorelin pamoate (Trelstar), goserelin acetate (Zoladex), histrelin acetate (Vantas), degarelix (Firmagon), relugolix (Orgovyx)

Background & Evidence

Erleada (apalutamide) is an androgen receptor inhibitor indicated for treatment of patients with non‑metastatic castration‑resistant prostate cancer (nmCRPC) and metastatic castration‑sensitive prostate cancer (mCSPC). Therapy should be given with concurrent gonadotropin‑releasing hormone (GnRH) analog therapy or after bilateral orchiectomy. Examples of GnRH agents include leuprolide acetate (Lupron Depot), triptorelin pamoate (Trelstar), goserelin acetate (Zoladex), histrelin acetate (Vantas), and examples of GnRH antagonist/analog agents added as examples include Firmagon (degarelix) and Orgovyx (relugolix).

Source	Citation
Prescribing information (Janssen Erleada tablets, March 2026)	Erleada tablets prescribing information, Janssen; March 2026 (source citation).
NCCN Prostate Cancer Clinical Practice Guidelines (v5.2026 - Jan 23, 2026)	NCCN Prostate Cancer Guidelines v5.2026; lists Erleada recommendations for nmCRPC, high-risk second biochemical recurrence in CSPC, and mCSPC (Jan 23, 2026).

Definitions

Thresholds

Revision History

2024-04-10non-material

Policy name updated from 'Oncology - Erleada PA Policy' to 'Oncology (Oral - Androgen Receptor Inhibitor) - Erleada PA Policy'.

2024-04-10material_revision

Changed wording from 'GnRH agonist' to 'GnRH analog' allowing both agonists and antagonists; added Firmagon (degarelix) and Orgovyx (relugolix) as examples; deleted the separate criterion that previously asked for concurrent use specifically with Firmagon.

2026-03-25material_revisionLatest

FDA‑Approved Indication: Prostate Cancer - Castration‑Sensitive

Approve for 1 year if the patient meets the following (A, B, and C):

ALL of the following

Patient is ≥ 18 years of age
ONE of
- The medication is used in combination with a gonadotropin-releasing hormone (GnRH) analog
  Examples include leuprolide acetate (Lupron Depot), triptorelin pamoate (Trelstar), goserelin acetate (Zoladex), histrelin acetate (Vantas), degarelix (Firmagon), relugolix (Orgovyx).
- Patient has had a bilateral orchiectomy
ONE of
- Patient has high-risk second biochemical recurrence
  High-risk defined as PSA doubling time (PSADT) ≤ 9 months; PSA ≥ 0.5 ng/mL; and prior adjuvant or secondary radiation therapy OR patient not a candidate for radiation therapy.
- Patient has metastatic castration-sensitive disease