Faculty of Pharmaceutical Sciences (Zhang) and School of Population and Public Health (Anis), University of British Columbia; Centre for Advancing Health Outcomes (Zhang, Sun, Guh, Anis), Providence Research, Vancouver, BC; Leslie Dan Faculty of Pharmacy (Grootendorst), University of Toronto, Toronto, Ont.; Department of Economics (Hollis), University of Calgary, Calgary, Alta.
CMAJ. 2024 May 26;196(20):E691-E701. doi: 10.1503/cmaj.231485.
The Patented Medicine Prices Review Board (PMPRB), the agency that regulates the prices of patented medicines in Canada, published proposed amendments to the regulatory framework in December 2017. Because of a series of changes and delays, the revised policy has not yet been finalized. We sought to evaluate the potential early impact of the uncertainty about the PMPRB policy on patented-medicine launches.
We developed a retrospective cohort of patented medicines (molecules) sold in Canada and the 13 countries that the PMPRB currently uses or has proposed to use as price comparators, from sales data from the IQVIA MIDAS database for 2012-2021. The outcome was whether a molecule was launched (i.e., sold) in a specific country within 2 years of its global first launch (2-yr launch). We compared the change of 2-year launch before (2012-2017) and after the proposed amendments were published ("uncertain period," 2018-2021) in Canada with the change in the United States and the other 12 countries as a group ("other-countries group"), using interrupted time series and logistic regressions, respectively. We further conducted analyses for each individual country and subgroups by molecule characteristics, such as therapeutic benefit, separately.
We included 242 and 107 new molecules launched before publication of the proposed amendments and during the uncertain period, respectively. The corresponding 2-year launch proportions were 45.0% and 30.8% in Canada, 81.4% and 82.2% in the US, and 83.9% and 70.1% in the other-countries group. All analyses showed changes in 2-year launch during the uncertain period in the US and in the other-countries group that were similar to the changes in Canada. Greater decreases were observed in Norway and Sweden than in Canada. The 2-year launch proportion for molecules with major therapeutic benefit decreased from 45.8% to 31.3% in Canada during the uncertain period and from 87.5% to 62.5% in the other-countries group, but increased from 91.7% to 100% in the US.
No negative impact of the PMPRB-policy uncertainty on molecule launches was observed when comparing Canada with price-comparator countries, except for molecules with major therapeutic benefit. The reduction in launches of medicines with major therapeutic benefit in Canada requires continuing investigation.
加拿大专利药品价格审查委员会（PMPRB）是监管专利药品价格的机构，该机构于 2017 年 12 月发布了对监管框架的拟议修正案。由于一系列变化和延迟，修订后的政策尚未最终确定。我们试图评估 PMPRB 政策不确定性对专利药品推出的潜在早期影响。
我们从 IQVIA MIDAS 数据库的销售数据中，开发了一个在加拿大销售的专利药品（分子）的回顾性队列，以及 PMPRB 目前使用或提议用作价格比较的 13 个国家，时间范围为 2012-2021 年。结果是一个分子是否在全球首次推出后的 2 年内（2 年推出）在特定国家推出（即销售）。我们分别使用中断时间序列和逻辑回归比较了在拟议修正案发布之前（2012-2017 年）和发布之后（不确定期，2018-2021 年）加拿大与美国和其他 12 个国家（“其他国家组”）的 2 年推出变化。我们还根据分子特征（如治疗效益）对每个国家和亚组进行了进一步分析。
在发布拟议修正案之前和不确定期间，我们分别纳入了 242 种和 107 种新分子。加拿大的 2 年推出比例分别为 45.0%和 30.8%，美国为 81.4%和 82.2%，其他国家组为 83.9%和 70.1%。所有分析均显示，在美国和其他国家组的不确定期间，2 年推出的变化与加拿大的变化相似。挪威和瑞典的降幅大于加拿大。在不确定期间，加拿大具有主要治疗效益的分子的 2 年推出比例从 45.8%降至 31.3%，而其他国家组从 87.5%降至 62.5%，但在美国从 91.7%增至 100%。
在将加拿大与价格比较国家进行比较时，没有观察到 PMPRB 政策不确定性对分子推出的负面影响，除了具有主要治疗效益的分子。加拿大主要治疗效益药物推出减少的情况需要进一步调查。
