Truqap (capivasertib)

Truqap (capivasertib)

Self-Administration – Oral Tablets

Diagnosis considered for coverage:

Breast Cancer: Indicated, in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Coverage Criteria:

For diagnosis of breast cancer:

• Diagnosis of breast cancer AND
• Disease is one of the following:
  • Locally advanced
  • Metastatic AND
• Will be taken in combination with fulvestrant AND
• Disease is hormone receptor (HR)-positive AND
• Disease is human epidermal growth factor receptor 2 (HER2)-negative AND
• Patient has one or more PIK3CA/AKT1/PTEN-alterations as detected by a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) AND
• One of the following: 
  • Following progression on at least one endocrine-based regimen in the metastatic setting (e.g., anastrozole, letrozole, exemestane, tamoxifen, etc) OR
  • Recurrence on or within 12 months of completing adjuvant therapy (e.g., chemotherapy)

Reauthorization Criteria:

For diagnosis of breast cancer:

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

Dosing: 

For diagnosis of breast cancer:

• 400 mg (two 200 mg tablets) orally twice daily approximately 12 hours apart for 4 days on followed by 3 days off; give with fulvestrant 500 mg IM on days 1 and 15 of cycle 1 and then on day 1 of cycle 2 and beyond (28-day cycle); continue until disease progression or unacceptable toxicity
• For premenopausal and perimenopausal women, administer a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standard
• For men, consider administering a LHRH agonist according to current clinical practice standards 

Coverage Duration: 

Initial: 12 months

Reauthorization: 12 months

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: 

• Key AEs and warnings that include hyperglycemia, diarrhea, and cutaneous AEs

Policy Updates:

• 6/1/2024 (policy effective date)- New Truqap Criteria (P&T 5/20/2024) (P&T Meeting May)

References:

1.    Truqap Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. November 2023.