AUGTYRO (repotrectinib)

AUGTYRO (repotrectinib)

Self-Administration – oral

Diagnosis considered for coverage:

• NSCLC: Indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) 

Coverage Criteria:

For diagnosis of NSCLC:

• Diagnosis of non-small cell lung cancer (NSCLC); AND
• Disease is one of the following:
  • Locally advanced 
  • Metastatic; AND
• Patient has ROS1 rearrangement positive tumor(s)

Reauthorization Criteria:

For diagnosis of NSCLC:

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

Dosing:

NSCLC:

• 160 mg taken orally once daily with or without food for 14 days, then increase to 160 mg twice daily and continue 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 locally advanced or metastatic NSCLC with Augtyro based on the presence of ROS1 rearrangement(s) in tumor specimens. An FDA-approved test to detect ROS1 rearrangements for selecting patients for treatment with Augtyro is not currently available 
• Prior to initiation of Augtyro, evaluate: liver function tests including bilirubin and uric acid level

Policy Updates:

• Effective 6/1/2024 – New policy approved by WHA P&T Committee. (P&T, 5/21/2024)

References:

• Augtyro Prescribing Information. Bristol-Myers Squibb Company. Princeton, NJ. November 2023.