RETEVMO (selpercatinib)

RETEVMO (selpercatinib) 

SELF-ADMINISTRATION

Indications for Prior Authorization:

• Indicated for the treatment of:
  • Adults patients with metastatic RET fusion-positive NSCLC
  • Adults and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant Medullary Thyroid Cancer (MTC) who require systemic therapy
  • Adults and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine (RAI)-refractory (if radioactive iodine is appropriate)

Patients must meet the following criteria for the indication(s) above:

• Non-Small Cell Lung Cancer
  • Diagnosis of advanced RET fusion-positive NSCLC, AND
  • Prescribed by or in collaboration with an oncologist, AND
  • Patient is 18 years of age or older
• Thyroid Cancer
  • Diagnosis of RET-mutant MTC OR RET fusion-positive thyroid cancer (thyroid cancer subtypes include MTC, differentiated [Hurthle cell, papillary, follicular] thyroid carcinoma, anaplastic thyroid carcinoma, AND
  • Prescribed by or in consultation with an oncologist, AND
  • Patient is 12 years of age or older, AND
  • One of the following:
    • Trial and failure of cabozantinib and/or vandetanib, OR
    •  Cabozantinib/vandetanib treatment naïve (for RET-mutant MTC), OR
    • Tumor is unresectable, not amenable to local therapies such as radioactive iodine ablation, and has progressed following systemic therapy (for RET Fusion-positive thyroid cancer)

Dosing:

• <50 kg: 120 mg twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity
• ≥50 kg: 160 mg twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity
• Reduce dose in patients with severe hepatic impairment
• Do not initiate in patients with uncontrolled hypertension
• Permanently discontinue in patients with severe or life-threatening hemorrhage
• Avoid concomitant use of strong and moderate CYP3A inhibitors

Coverage Duration:

• Initial: 1 year
• Continuation: 1 year, if responding positively to therapy

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.

Review History:

• 7/6/2020 – New policy.

References:

• American Cancer Society. Thyroid Cancer Survival Rates, by type and stage. American Cancer Society Web site. https://www.cancer.org/cancer/thyroid-cancer/detection-diagnosis-staging/survival-rates.html. Accessed June 29, 2020.
• American Society of Clinical Oncology. Guidelines in development. ASCO Web site. https://www.asco.org/research-guidelines/quality-guidelines/guidelines-tools-resources/guidelines-development. Accessed June 9, 2020.
• Blueprint Medicines Press Release. Blueprint Medicines announces data presentations at ASCO20 highlighting deep, durable clinical activity and well-tolerated safety profile of pralsetinib across broad range of RET fusion-positive tumors. Blueprint Medicines Web site. May 29, 2020. http://ir.blueprintmedicines.com/news-releases/news-release-details/blueprint-medicines-announces-data-presentations-asco20. Accessed June 5, 2020.
• Cabometyx [package insert], Alameda, CA: Exelixis Inc. January 2020.
• Caprelsa [package insert], Cambridge, MA: Sanofi Genzyme. June 2020.
• Clinicaltrials.gov. Trial registry. Web site. https://clinicaltrials.gov/. Accessed June 15, 2020.
• Cometriq [package insert], Alameda, CA: Exelixis Inc. January 2020.
• Drilon A, Rekhtman N, Arcila M, et al. A Phase 2 single arm trial of cabozantinib in patients with advanced RET-rearranged lung cancers. Lancet Oncol. 2016;17(12):1653-1660.
• 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 Jan;13(1):27-45. doi: https://doi.org/10.1016/j.jtho.2017.10.021
• Gainor JF, Curigliano G, Kim DW, et al. Registrational dataset from the phase I/II ARROW trial of pralsetinib (BLU-667) in patients with advanced RET fusion+ non-small cell lung cancer. Poster presented at: 2020 ASCO Virtual Scientific Program. J Clin Oncol. 2020;38 (suppl): abstract 9515. doi: 10.1200/JCO.2020.38.15_suppl.9515
• Goto K, Oxnard GR, Shao-Weng Tan D, Loong HHF, et al. Selpercatinib (LOXO-292) in patients with RET-fusion+ non-small cell lung cancer. J Clin Oncol. 2020;38(suppl): abstr 3584. doi: 10.1200/JCO.2020.38.15_suppl.3584
• Kalemkerian GP, Narula N, Kennedy EB, et al. Molecular testing guideline for the selection of patients with lung cancer for treatment with targeted tyrosine kinase inhibitors: American Society of Clinical Oncology endorsement of the College of American Pathologists/International Association for the study of Lung Cancer/Association for Molecular Pathology Clinical Practice Guideline Update. J Clin Oncol. 2018;36(9):911-919.
• Lenvima [package insert], Woodcliff Lake, NJ: Eisai Inc. February 2020.
• Midthun DE. Overview of the initial treatment and prognosis of lung cancer. UpToDate Web site. Updated February 7, 2020. www.uptodate.com. Accessed May 27, 2020.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Non-small cell lung cancer, v6.2020 – June 15, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed June 16, 2020.
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Thyroid carcinoma, v1.2020 – June 12, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf. Accessed June 15, 2020.
• Nexavar [package insert], Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc. April 2020.
• Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-55.
• Retevmo [package insert], Indianapolis, IN: Lilly USA, LLC. May 2020.
• Retevmo [formulary dossier]. Indianapolis, IN: Lilly USA, LLC. May 2020.
• Sequist LV, Neal JW. Personalized, genotype-directed therapy for advanced non-small cell lung cancer. UpToDate Web site. Updated May 27, 2020. www.uptodate.com. Accessed June 5, 2020.
• Shah MH, Sherman EJ, Robinson B, et al. Selpercatinib (LOXO-292) in patients with RET-mutant medullary thyroid cancer. J Clin Oncol. 2020;38(suppl): abstr 3594. doi: 10.1200/JCO.2020.38.15_suppl.3594
• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70(1):7-30.
• Subbiah V, Gainor JF, Oxnard GR, et al. Intracranial activity of selpercatinib (LOXO-292) in RET fusion-positive non-small cell lung cancer (NSCLC) patients on the LIBRETTO-001 trial. Poster presented at: 2020 ASCO Virtual Scientific Program. J Clin Oncol. 2020;38 (suppl): abstract 9516. doi: 10.1200/JCO.2020.38.15_suppl.9516
• Wells SA, Asa SL, Dralle H, et al. Revised American Thyroid Association guidelines for the management of medullary thyroid carcinoma. Thyroid. 2015;25(6):567-610.
• Yoh K, Seto T, Satouchi M, et al. Vandetanib in patients with previously treated RET-rearranged advanced non-small cell lung cancer (LURET): an open-label, multicenter, phase 2 trial. Lancet Respir Med. 2017;5(1):42-50.