澳大利亚曲坦类药物重新分类的成本效益：经济评估方法在监管决策中的应用。

Cost-Effectiveness of Reclassifying Triptans in Australia: Application of an Economic Evaluation Approach to Regulatory Decisions.

机构信息

Centre for the Health Economy, Macquarie University, Sydney, NSW, Australia.

出版信息

Value Health. 2019 Mar;22(3):293-302. doi: 10.1016/j.jval.2018.09.2840. Epub 2018 Dec 24.

DOI:10.1016/j.jval.2018.09.2840

PMID:30832967

Abstract

BACKGROUND

Migraine is a common, chronic, disabling headache disorder. Triptans, used as an acute treatment for migraine, are available via prescription in Australia. An Australian Therapeutic Goods Administration (TGA) committee rejected reclassifying sumatriptan and zolmitriptan from prescription medicine to pharmacist-only between 2005 and 2009, largely on the basis of concerns about patient risk. Nevertheless, pharmacist-only triptans may reduce migraine duration and free up healthcare resources.

OBJECTIVES

To estimate the cost-effectiveness of reclassifying triptans from prescription-only to pharmacist-only in Australia.

METHODS

The study design included decision-analytic modeling combining data from various sources. Behavior before and after reclassification was estimated using medical practitioner and patient surveys and also administrative data. Health outcomes included migraine frequency and duration as well as adverse events (AEs) discussed by the TGA committee. Efficacy and AEs were estimated using randomized controlled trials and observational studies.

RESULTS

Reclassifying triptans will reduce migraine duration but increase AEs. This will result in 337 quality-adjusted life-years gained at an increased cost of A$5.9 million over 10 years for all Australian adults older than 15 years (19.6 million). The incremental cost-effectiveness ratio was estimated to be A$17 412/quality-adjusted life-year gained.

CONCLUSIONS

The incremental cost-effectiveness ratio is likely to be considered cost-effective by Australian decision makers. Serotonin syndrome, a key concern of the TGA committee, had little impact on the results. Further research is needed regarding pharmacist-only triptan use by migraineurs currently using over-the-counter medicines and by nonmigraineurs, the efficacy of triptans, and the risk of cardiovascular and cerebrovascular AEs and chronic headaches with triptans.

摘要

背景

偏头痛是一种常见的、慢性的、使人丧失能力的头痛疾病。曲坦类药物可用作偏头痛的急性治疗药物，在澳大利亚凭处方供应。澳大利亚治疗商品管理局（TGA）委员会在 2005 年至 2009 年期间，主要基于对患者风险的担忧，否决了将舒马曲坦和佐米曲坦从处方药重新分类为仅限药剂师供应的药物。然而，仅限药剂师供应的曲坦类药物可能会缩短偏头痛持续时间并释放医疗保健资源。