title: The challenge of conducting pharmacoeconomic evaluations in oncology using crossover trials: the example of sunitinib for gastrointestinal stromal tumour.
abstract: This paper examines the challenge of conducting economic evaluations to support patient access to cancer therapies when the cost-effectiveness estimation is hampered by crossover trial design. To demonstrate these limitations, we present the submission to the Canadian Drug Review (CDR) of a cost-effectiveness evaluation of sunitinib versus best supportive care (BSC) for the treatment of gastrointestinal stromal tumour in patients intolerant or resistant to imatinib. The economic model generated an incremental cost-effectiveness ratio for sunitinib versus BSC of dollars 79,884/quality-adjusted life-year gained. Eight months after initial submission, CDR granted a final recommendation to fund sunitinib following the manufacturer's appeal against their first recommendation. Although cost-effectiveness is an important consideration in reimbursement decisions, there is a need for improved decision-making processes for cancer drugs, as well as a better understanding of the limitations of clinical trial design.
authors: Department of Outcomes Research, Medical Division, Pfizer Canada Inc., 17300 Trans-Canada Highway, Kirkland, QC, Canada H9J 2M5. isabelle.chabot@pfizer.com
authors: Isabelle
authors: I
authors: Chabot
authors: Jacques
authors: J
authors: LeLorier
authors: Martin E
authors: ME
authors: Blackstein
mesh_terms: D000970:Antineoplastic Agents / Q000191:economics* / Q000627:therapeutic use; D001549:Benzamides; D002170:Canada; D003362:Cost-Benefit Analysis; D018592:Cross-Over Studies; D018572:Disease-Free Survival; D016527:Drug Costs; D019008:Drug Resistance, Neoplasm; D046152:Gastrointestinal Stromal Tumors / Q000188:drug therapy / Q000191:economics*; D006801:Humans; D000068877:Imatinib Mesylate; D007211:Indoles / Q000191:economics* / Q000627:therapeutic use; D008390:Markov Chains; D010879:Piperazines / Q000191:economics / Q000627:therapeutic use; D011743:Pyrimidines / Q000191:economics / Q000627:therapeutic use; D011758:Pyrroles / Q000191:economics* / Q000627:therapeutic use; D019057:Quality-Adjusted Life Years; D000077210:Sunitinib
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D007211:Indoles; D010879:Piperazines; D011743:Pyrimidines; D011758:Pyrroles; D000068877:Imatinib Mesylate; D000077210:Sunitinib