Pralsetinib (Gavreto): CADTH Reimbursement Recommendation [Internet]

What Is the CADTH Reimbursement Recommendation for Gavreto?: CADTH recommends that Gavreto be reimbursed by public drug plans for the treatment of adult patients with rearranged during transfection (RET) fusion–positive locally advanced unresectable or metastatic non–small cell lung cancer (NSCLC) if certain conditions are met.

Which Patients Are Eligible for Coverage?: Gavreto should only be covered to treat adult patients aged 18 years and older with locally advanced unresectable or metastatic RET fusion–positive NSCLC who have never received cancer treatment or who have received cancer treatment. Patients receiving Gavreto should be in relatively good health (i.e., have a good performance status as determined by a specialist) and not have cancer that has spread to the brain or if it has spread to the brain, is controlled.

What Are the Conditions for Reimbursement?: Gavreto should only be reimbursed if prescribed by a clinician with expertise in the management of NSCLC and if the cost of Gavreto is reduced. Gavreto should not be reimbursed in combination with other cancer treatment.

Why Did CADTH Make This Recommendation?: Evidence from a clinical trial demonstrated that people with locally advanced unresectable or metastatic RET fusion–positive NSCLC treated with Gavreto experienced tumour shrinkage or the tumour completely disappeared. As well, evidence from the clinical trial demonstrated brain tumour shrinkage in people whose cancer had spread to the brain.

Based on CADTH’s assessment of the health economic evidence, Gavreto does not represent good value to the health care system at the public list price. Therefore, a reduction in price is required. Over 3 years, Gavreto is expected to increase drug costs to the public drug plans by approximately $22 million.

What Is : Non–small cell lung cancer is a type of lung cancer that originates from specific lung cell tissues and may include squamous, adenocarcinomas, or large cell–type carcinomas. People with lung cancer whose cancer cells have spread to other parts of the body, such as the bones, adrenal glands, brain, and liver, likely have metastatic cancer.

NSCLC can be driven by a gene in the body such as the RET gene. The RET gene is present naturally in the body, but some cancers form due to changes in the RET gene.

Unmet Needs in : Patients with RET fusion–positive NSCLC are treated with chemotherapy and immunotherapy; however, not all patients respond to these available treatments.

How Much Does Gavreto Cost?: Treatment with Gavreto is estimated to cost approximately $12,426 per 30-day cycle.