TABRECTA (capmatinib)

TABRECTA (capmatinib)

SELF ADMINISTRATION—ORAL

Indication for Prior Authorization:

Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test

Coverage Criteria:

• Patient is 18 years of age or older, AND
• Patient has a diagnosis of metastatic NSCLC as confirmed by chart note documentation, AND
• Prescribed by or in consultation with an oncologist, AND
• Patient has a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test

Reauthorization Criteria:

• Patient had a positive response to therapy as confirmed by specialist chart note documentation

Dosing:

• 400 mg orally twice daily
• Tabrecta™ should not be used in combination with moderate or strong CYP3A inducers

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 Committee.

Additional Information:

• Interstitial Lung Disease (ILD)/Pneumonitis: ILD/pneumonitis, which can be fatal, occurred in patients treated with Tabrecta™. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold Tabrecta™ in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified
• Hepatotoxicity: Hepatotoxicity occurred in patients treated with Tabrecta™. Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of Tabrecta™, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or bilirubin. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue Tabrecta™
• Embryo-Fetal Toxicity: Based on findings from animal studies and its mechanism of action, Tabrecta™ can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Tabrecta™ and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Tabrecta™ and for 1 week after the last dose

Review History:

10/20/20- Original review

References:

• Tabrecta [package insert]. East Hanover (NJ): Novartis Pharmaceuticals Corporation; 2020.