Capmatinib (Tabrecta) Form

Capmatinib (Tabrecta™) is a kinase inhibitor that targets mesenchymal-epithelial transition (MET). FDA Approved Indication(s) Tabrecta is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Tabrecta is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Non-Small Cell Lung Cancer (must meet all):

1. Diagnosis of recurrent, advanced or metastatic NSCLC;
   2. Prescribed by or in consultation with an oncologist;
   3. Age ≥ 18 years;
   4. Disease is positive for a mutation causing MET exon 14 skipping (see Appendix D);
   5. Disease is epidermal growth factor receptor (EGFR) wild-type and anaplastic lymphoma kinase (ALK) negative;
2. Member does not have symptomatic CNS metastases;
   7. For Tabrecta requests, member must use generic capmatinib, if available, unless contraindicated or clinically significant adverse effects are experienced;

3. Request meets one of the following (a or b): a. Dose does not exceed 800 mg (4 tablets) per day;
   b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN
   Approval duration:
   Medicaid/HIM – 6 months
   Commercial – 12 months or duration of request, whichever is less Page 1 of 5

   CLINICAL POLICY Capmatinib
   B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Non-Small Cell Lung Cancer (must meet all):
6. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Tabrecta for a covered indication and has received this medication for at least 30 days;
7. Member is responding positively to therapy;
   
   3. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 800 mg (4 tablets) per day; b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration:
      Medicaid/HIM – 12 months
      Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or Page 2 of 5

   CLINICAL POLICY Capmatinib

9. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents; B. Positive MET amplification WITHOUT an Exon 14 skipping mutation.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration MET: mesenchymal-epithelial transition NSCLC: non-small cell lung cancer
   EGFR: epidermal growth factor receptor ALK: anaplastic lymphoma kinase Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings None reported Appendix D: General Information • Mutation causing MET exon 14 skipping
   o The test is interpreted by the pathologist that signs the report. o The ONLY test that should be POSITIVE is the presence of an Exon 14 Skipping Mutation for the MET gene. o The following results should be considered NEGATIVE:  Presence of MET amplification WITHOUT the presence of an Exon 14 skipping mutation of the MET gene.  Presence of any other genomic aberration (mutation, deletion, rearrangement) of the MET gene.  There exists a potential for abuse/misuse of the drug would be if the patient’s tumor had a MET amplification ONLY. The drug was tested AND found to be ineffective in patients whose tumors were positive for the MET amplification WITHOUT an Exon 14 Skipping Mutation. Thus, the drug should NOT be approved for a positive MET amplification WITHOUT an Exon 14 skipping mutation. V. Dosage and Administration
   Indication NSCLC Dosing Regimen 400 mg PO BID Maximum Dose 800 mg/day Page 3 of 5

   CLINICAL POLICY Capmatinib
   VI. Product Availability
   Tablets: 150 mg, 200 mg VII.