Chabot Isabelle, LeLorier Jacques, Blackstein Martin E
Department of Outcomes Research, Medical Division, Pfizer Canada Inc., 17300 Trans-Canada Highway, Kirkland, QC, Canada H9J 2M5.
Eur J Cancer. 2008 May;44(7):972-7. doi: 10.1016/j.ejca.2008.02.041. Epub 2008 Mar 26.
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.
本文探讨了在交叉试验设计阻碍成本效益估计时,进行经济评估以支持患者获得癌症治疗药物所面临的挑战。为了说明这些局限性,我们展示了向加拿大药品审评局(CDR)提交的一份关于舒尼替尼与最佳支持治疗(BSC)用于治疗对伊马替尼不耐受或耐药的胃肠道间质瘤患者的成本效益评估报告。该经济模型得出舒尼替尼与BSC相比的增量成本效益比为每获得一个质量调整生命年79,884美元。在初次提交八个月后,CDR在制造商针对其首次建议提出上诉后,最终批准了资助舒尼替尼的建议。尽管成本效益是报销决策中的一个重要考虑因素,但仍需要改进癌症药物的决策流程,以及更好地理解临床试验设计的局限性。