GAVRETO (pralsetinib)

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.