TEPMETKO (tepotinib)

TEPMETKO (tepotinib)

Self Administration – Oral

Indications for Prior Authorization

• Indicated for the treatment of adult patient with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations

Coverage Criteria:

For diagnosis of metastatic non-small cell lung cancer (NSCLC):

• Dose does not exceed 450 mg once daily, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with an oncologist, AND
• Disease is metastatic, AND
• Presence of mesenchymal-epithelial transition (MET) exon 14 skipping

Reauthorization Criteria:

For diagnosis of metastatic non-small cell lung cancer (NSCLC):

• Dose does not exceed 450 mg once daily, AND
• Patient does not show evidence of progressive disease while on therapy

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:

• Tepmetko is the only approved once-daily oral MET inhibitor
• Warnings and Precautions
  • Interstitial Lung Disease (ILD)/Pneumonitis – withhold Tepmetko in patients with suspected ILD/pneumonitis and permanently discontinue in patients diagnosed with ILD/pneumonitis of any severity
  • Hepatotoxicity – monitor liver function test.  Withhold, dose reduce, or permanently discontinue Tepmetko based on severity
  • Embryo-fetal toxicity – Tepmetko can cause fetal harm
• Drug interactions
  • Dual strong CYP3A inhibitors and P-gp inhibitors: avoid concomitant use
  • Strong CYP3A inducers: avoid concomitant use
• Certain P-gp substrates: avoid coadministration of Tepmetko with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities

Policy Updates:

• 6/15/2021 – New policy approved by P&T

References:

• ClinicalTrials.gov Web site. http://clinicaltrials.gov/. Accessed March 30, 2021.
• Drilon A, Cark JW, Weiss J, et al. Antitumor activity of crizotinib in lung cancers harboring a MET exon 14 alteration. Nat Med. 2020;26:47-51.
• Ferrara R, Auger N, Auclin E, Besse B. Clinical and translational implications of RET rearrangements in non-small cell lung cancer. J Thorac Oncol. 2018;13(1):27-45. doi: 10.1016/j.jtho.2017.10.021.
• Food and Drug Administration (FDA). Drug development and drug interactions: table of substrates, inhibitors and inducers. FDA Web site. March 10, 2020. https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Accessed March 30, 2021.
• Food and Drug Administration (FDA). FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer [news release]. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-tepotinib-metastatic-non-small-cell-lung-cancer. February 3, 2021. Accessed March 30, 2021.
• Food and Drug Administration. Tepmetko multi-discipline review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214096Orig1s000MultidisciplineR.pdf. February 1, 2021. Accessed March 24, 2021.
• National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Non-small cell lung cancer. V4.2021. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/nscl_blocks.pdf. Accessed March 23, 2021.
• Paik PK, Felip E, Veillon R, et al. Tepotinib in non-small cell lung cancer with MET exon 14 skipping alterations. N Engl J Med. 2020;383:931-943. doi: 10.1056/NEJMoa2004407.
• Safi D, Abu Hejleh T, Furqan M. Narrative review: mesenchymal-epithelial transition inhibitors – meeting their target. Transl Lung Cancer Res. 2021;10(1):462-474. doi: 10.21037/tlcr-20-588.
• Sequist LV, Neal JW. Personalized, genotype-directed therapy for advanced non-small cell lung cancer. UpToDate Web site. Updated March 23, 2021. www.uptodate.com. Accessed March 24, 2021.
• Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71(1):7-33. doi: 10.3322/caac.21654.
• Tabrecta [package insert], East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2020.
• Tepmetko [package insert], Rockland, MA: EMD Serono, Inc.; February 2021.
• Wolf J, Set T, Han JY, et al. Capmatinib in MET exon 14-mutated or MET-Amplified non-small-cell lung cancer. N Engl J Med. 2020;383:944-957. doi: 10.1056/NEJMoa2002787.
• Wu YL, Chen Y, Zhou J, et al for the INSIGHT Investigators. Tepotinib plus gefitinib in patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study): an open-label, phase 1b/2, multicenter, randomized trial. Lancet Respir Med. 2020;8(11):1132-1143. doi: 10.1016/S2213-2600(20)30154-5.