Masucci Lisa, Beca Jaclyn, Sabharwal Mona, Hoch Jeffrey S
St. Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.
Cancer Care Ontario, 620 University Avenue, Toronto, ON, M5G 2L7, Canada.
Pharmacoecon Open. 2017 Dec;1(4):255-263. doi: 10.1007/s41669-017-0018-3.
Public drug plans are faced with increasingly difficult funding decisions. In Canada, the pan-Canadian Oncology Drug Review (pCODR) makes funding recommendations to the provincial and territorial drug plans responsible for cancer drugs. Assessments of the economic models submitted by pharmaceutical manufacturers are publicly reported.
The main objective of this research was to identify recurring methodological issues in economic models submitted to pCODR for funding reviews. The secondary objective was to explore whether there exists any observed relationships between reported methodological issues and funding recommendations made by pCODR's expert review committee.
Publicly available Economic Guidance Reports from July 2011 (inception) until June 2014 for drug reviews with a final funding recommendation (N = 34) were independently examined by two authors. Major methodological issues from each review were abstracted and grouped into nine main categories. Each issue was also categorized based on perception of the reviewer's actions to manage it.
The most commonly reported issues involved costing (59% of reviews), time horizon (56%), and model structure (36%). Several types of issues were identified that usually could not be resolved, such as quality of clinical data or uncertainty with indirect comparisons. Issues with costing or choice of utility estimates could usually be addressed or explored by reviewers. No statistically significant relationship was found between any methodological issue and funding recommendations from the expert review committee.
The findings provide insights that can be used by parties who submit or review economic evidence for continuous improvement and consistency in economic modeling, reporting, and decision making.
公共药品计划面临着日益艰难的资金决策。在加拿大，泛加拿大肿瘤药物审查（pCODR）向负责癌症药物的省级和地区药品计划提出资金建议。制药商提交的经济模型评估报告是公开的。
本研究的主要目的是确定提交给pCODR进行资金审查的经济模型中反复出现的方法学问题。次要目的是探讨报告的方法学问题与pCODR专家审查委员会做出的资金建议之间是否存在任何观察到的关系。
两位作者独立审查了2011年7月（成立）至2014年6月期间公开可用的经济指导报告，这些报告涉及有最终资金建议的药物审查（N = 34）。每次审查的主要方法学问题被提取并归为九个主要类别。每个问题还根据审查者对其管理行动的认知进行了分类。
最常报告的问题涉及成本核算（59%的审查）、时间范围（56%）和模型结构（36%）。确定了几种通常无法解决的问题类型，如临床数据质量或间接比较的不确定性。成本核算或效用估计选择方面的问题通常可以由审查者解决或探讨。在任何方法学问题与专家审查委员会的资金建议之间未发现统计学上的显著关系。
这些发现为提交或审查经济证据的各方提供了见解，可用于在经济建模、报告和决策方面持续改进并保持一致性。
