How do cost-effectiveness analyses inform reimbursement decisions for oncology medicines in Canada? The example of sunitinib for first-line treatment of metastatic renal cell carcinoma.

Background: Canadian oncology decision-makers have reimbursed cancer drugs at incremental cost-effectiveness ratios (ICER) higher than those considered acceptable in other therapeutic areas. Sunitinib is a multitargeted receptor tyrosine kinase inhibitor, indicated for metastatic renal-cell carcinoma (MRCC) of clear cell histology. Canadian decision-makers evaluated sunitinib funding in the presence of important data limitations (including interim analysis of a surrogate outcome) and in the context of a high ICER.

Methods: First, a description was presented of the cost-effectiveness analysis submitted for sunitinib reimbursement decision-making in Canada before conclusive survival evidence had been available. Second, sunitinib access decisions and the oncology drug reimbursement literature were reviewed to explore the interpretation of sunitinib perceived value in the context of the decision-making framework in Canada.

Results: The economic evaluation yielded an ICER of $144K/quality-adjusted life-year gained for sunitinib compared with interferon-alfa. This high ratio was not an insurmountable barrier to access in Canada because all provinces now reimburse sunitinib for first-line treatment of MRCC. In this particular instance, payers were receptive to immature survival data but substantial progression-free gains, for patients with a relatively rare cancer and few treatment options.

Conclusion:   This demonstrates that the cost-effectiveness ratio is only one of many factors that affect an access decision in oncology.