Centre for Health Evaluation and Outcome Sciences, Vancouver, BC, Canada.
School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.
Int J Health Policy Manag. 2022 Jun 1;11(6):768-776. doi: 10.34172/ijhpm.2020.215.
Generic drug prices have been capped at specified percentages of the interchangeable branded drug's price by the Canadian provincial public drug plans since 1993. The Pan-Canadian Pharmaceutical Alliance, formed as a coalition by the provinces/territories in Canada, implemented an alternative approach, a tiered-pricing framework (TPF) for new generic drugs on April 1, 2014, under which the percentage varies with the number of generic firms in each market. We evaluate the impact of the TPF on generic entry, ie, listing in public drug plans in Canada.
Our study compared the pre-TPF period (01/01/2012-03/31/2014) with the TPF period (04/01/2014- 06/30/2016). Prescription drugs from nine provincial public drug plans were grouped into a "market" if they had the same active ingredient and strength, route of administration, and dosage form. Each "market" was contestable by generics and met the eligibility criteria for TPF. At the "market" level, Cox proportional-hazards models with time-varying covariates were used to measure the impact of the TPF on the first generic listing in any provincial public drug plan in Canada relative to the first launch date worldwide.
A total of 189 markets in Canada were selected for the analyses. Generic drugs in small markets were more likely to be listed in Canada during the TPF period compared to the pre-TPF period (hazard ratio [HR], 95% CI: 3.81, 1.51-9.62). There was no significant difference in generic drug listings in large markets between the two policy periods.
TPF speeds up generic entry in small markets and generates the benefits of generic competition while avoiding the pitfalls of the previously employed price-cap regulations.
自 1993 年以来，加拿大省级公共药品计划将仿制药价格上限设定为可互换品牌药品价格的特定百分比。作为加拿大各省份/地区的联盟成立的泛加拿大药品联盟于 2014 年 4 月 1 日实施了一种新的仿制药分层定价框架（TPF），根据该框架，每个市场的仿制药公司数量不同，价格上限的百分比也不同。我们评估了 TPF 对仿制药进入市场的影响，即加拿大公共药品计划中的上市情况。
我们的研究比较了 TPF 实施前（2012 年 1 月 1 日至 2014 年 3 月 31 日）和 TPF 实施期间（2014 年 4 月 1 日至 2016 年 6 月 30 日）的情况。来自九个省级公共药品计划的处方药根据活性成分和强度、给药途径和剂型相同被分为一个“市场”。每个“市场”都可由仿制药竞争，并符合 TPF 的资格标准。在“市场”层面，使用带有时间变化协变量的 Cox 比例风险模型来衡量 TPF 对加拿大任何省级公共药品计划中第一个仿制药上市的影响，与全球首次推出的时间相比。
加拿大共有 189 个“市场”入选分析。与 TPF 实施前相比，小市场中的仿制药在 TPF 实施期间更有可能在加拿大上市（风险比 [HR]，95%置信区间：3.81，1.51-9.62）。在这两个政策时期，大市场中的仿制药上市情况没有显著差异。
TPF 加快了小市场中的仿制药进入市场的速度，产生了仿制药竞争的效益，同时避免了之前采用的价格上限法规的缺陷。
