Inavolisib (Itovebi)

Key Messages

• Canada’s Drug Agency recommends that Itovebi in combination with palbociclib (PAL) and fulvestrant (FUL) be reimbursed by public drug plans for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine treatment, only if certain conditions are met.
• Itovebi in combination with PAL and FUL should only be covered to treat adults with hormone receptor–positive, HER2-negative breast cancer that has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic); has come back after hormone (endocrine) therapy; and has an abnormal PIK3CA Patients should also have good performance status. Itovebi in combination with PAL and FUL should not be covered if the patient has been previously treated for hormone receptor–positive, HER2-negative metastatic breast cancer with mutations in the PIK3CA gene, or if they have uncontrolled diabetes.
• Itovebi in combination with PAL and FUL should be prescribed by, then managed under the care of, health care professionals with expertise in managing advanced or metastatic breast cancer. Reimbursement of Itovebi should be discontinued if the cancer becomes worse or there are unacceptable side effects. Price reductions exceeding 90% in the cost of Itovebi as part of the combination regimen with CDK4/6 inhibitor and FUL would be required to achieve an incremental cost-effectiveness ratio below $50,000 per quality-adjusted life-year gained, relative to therapies currently in use.