AKEEGA (niraparib and abiraterone)

AKEEGA (niraparib and abiraterone)

Self-Administration – oral

Diagnosis considered for coverage:

• Indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC) with prednisone. Select patients for therapy based on an FDA-approved test for Akeega

Coverage Criteria:

For diagnosis of mCRPC:

• Diagnosis of prostate cancer; AND
• Disease is all of the following:
  • Metastatic 
  • Castration-resistant 
  • Deleterious or suspected deleterious BRCA-mutated (BRCAm); AND
• Used in combination with prednisone; AND
• One of the following:
  • Used in combination with a gonadotropin-releasing hormone (GnRH) analog 
  • Patient has had a bilateral orchiectomy

Reauthorization Criteria:

For diagnosis of mCRPC:

• Patient does not show evidence of progressive disease while on therapy

Dosing:

mCRPC:

• 200 mg niraparib/1,000 mg abiraterone acetate orally once daily in combination with 10 mg prednisone daily until disease progression or unacceptable toxicity

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Select patients for the treatment of mCRPC with Akeega based on the presence of a BRCA gene alteration 
• Patients receiving Akeega should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy 

Policy Updates:

• 3/1/2024– New policy approved by WHA P&T Committee. (P&T, 2/20/2024)

References:

• Akeega prescribing information. Janssen Biotech, Inc. Horsham, PA. August 2023.