Tepotinib (Tepmetko) Form

Tepotinib (Tepmetko®) is a kinase inhibitor that targets mesenchymal-epithelial transition (MET). FDA Approved Indication(s) Tepmetko is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
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 Tepmetko 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 or high-level MET amplification;
2. For NSCLC that is MET exon 14 skipping-positive: Member has not had progression with a MET exon 14 skipping mutation-targeting regimen (e.g., Tepmetko, Tabrecta®, Xalkori®);
   6. Prescribed as a single agent;
   7. For Tepmetko requests, member must use generic tepotinib, 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 450 mg (2 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
   Page 1 of 6

   CLINICAL POLICY Tepotinib Approval duration:
   Medicaid/HIM – 6 months
   Commercial – 12 months or duration of request, whichever is less
   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 Tepmetko for a covered indication and has received this medication for at least 30 days;
7. Member is responding positively to therapy;
   
   3. For Tepmetko requests, member must use generic tepotinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
   4. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed 450 mg (2 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: Page 2 of 6

   CLINICAL POLICY Tepotinib 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

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.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ALK: anaplastic lymphoma kinase
   EGFR: epidermal growth factor receptor FDA: Food and Drug Administration MET: mesenchymal-epithelial transition Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings None reported NCCN: National Comprehensive Cancer Network NSCLC: non-small cell lung cancer
   Appendix D: General Information • MET amplification is an oncogenic driver occurring in 1% to 5% of NSCLCs that confers a poor prognosis. High-level MET amplification is an emerging biomarker to identify novel therapies for patients with metastatic NSCL per NCCN. The definition of high- level MET amplification is evolving and may differ according to the assay used for testing. For NGS-based results, a copy number greater than 10 is consistent with high- level MET amplification. (NCCN NSCLC Guideline Version 1.2023) V. Dosage and Administration
   Indication NSCLC Dosing Regimen 450 mg PO QD Maximum Dose 450 mg/day VI. Product Availability
   Tablet: 225 mg Page 3 of 6

   CLINICAL POLICY Tepotinib VII.