GAVRETO (pralsetinib)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:
  • Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
  • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.
  • Adult 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-refractory (if radioactive iodine is appropriate).
Patients must meet the following criteria:

RET fusion-positive non-small cell lung cancer (NSCLC):

  • Diagnosis of metastatic NSCLC; AND
  • Prescribed by or in collaboration with an oncologist; AND
  • Presence of RET gene fusion-positive tumor(s) as detected by an FDA-approved test.

RET-mutant medullary thyroid cancer (MTC):

  • Diagnosis of advanced or metastatic MTC; AND
  • Prescribed by or in collaboration with an oncologist; AND
  • 12 years of age and older; AND
  • Documented RET-mutation positive tumor.

RET fusion-positive thyroid cancer:

  • Diagnosis of advanced or metastatic thyroid cancer; AND
  • Prescribed by or in collaboration with an oncologist; AND
  • 12 years of age and older; AND
  • Documented RET-fusion positive tumor; AND
  • Disease is not manageable using radioactive iodine (RAI) therapy.
This Medication Is Not Approvable for the Following Condition(s):

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.

Dosing:
  • RET fusion-positive NSCLC (adults): 400 mg taken by mouth once daily.
  • RET-mutant MTC (12 yr and older): 400 mg taken by mouth once daily.
  • RET fusion-positive thyroid cancer (12 yr and older): 400 mg taken by mouth once daily.
Approval:
  • Initial: 1 year.
  • Reauthorization: 1 year when documented that patient does not show evidence of progressive disease while on therapy.
Review History:
  • 02/16/2021- New policy.
References:
  • 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 October 12, 2020.
  • ClinicalTrials.gov Web site. https://clinicaltrials.gov/ct2/home. Identifiers: [NCT03037385] [NCT0303085] [NCT04280081] [NCT04320888] [NCT04211337] [NCT03157128] [NCT04194944] [NCT04268550] [NCT0394472] [NCT03155620] [NCT04222972]. Accessed October 12, 2020. 
  • 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
  • Food and Drug Administration press release: FDA approves pralsetinib for lung cancer with RET gene fusions. 2020. FDA Web site. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pralsetinib-lung-cancer-ret-gene-fusions. Accessed October 9, 2020.
  • Food and Drug Administration. Multidiscipline review: Gavreto. 2019. FDA Web site. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213721Orig1s000MultidisciplineR.pdf. Accessed October 12, 2020.
  • Gavreto [package insert], Cambridge, MA: Blueprint Medicines Corporation; December 2020.
  • 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 Guidelines Update J Clin Oncol. 2018;36(9):911-919.

Last review date: February 16, 2021

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