Bridgepoint Collaboratory for Research and Innovation, Lunenfeld-Tanenbaum Research Institute, Sinai Health, 1 Bridgepoint Dr, Toronto, ON, M4M 2B5, Canada.
Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Appl Health Econ Health Policy. 2023 May;21(3):501-510. doi: 10.1007/s40258-022-00787-0. Epub 2023 Jan 18.
Buprenorphine-naloxone is an essential part of the response to opioid poisoning rates in North America. Manipulating market exclusivity is a strategy manufacturers use to increase profitability, as evidenced by Suboxone in the USA.
To investigate excess costs of buprenorphine-naloxone due to unmerited market exclusivity (no legal patent or data protection) in Canada.
Using controlled interrupted time-series, this study examined changes in the cost of buprenorphine-naloxone before and after the first generics were listed on public formularies. Methadone cost was the control. Public data from the Canadian Institute of Health Information in British Columbia, Manitoba, and Saskatchewan were used. All buprenorphine-naloxone and methadone claims (2010-2019) accepted for payment by the provincial drug plan/programme were collected. Primary outcome was mean cost per mg of buprenorphine-naloxone after the first listing of generics.
Mean cost per mg of buprenorphine-naloxone before the first listing of generics was $1.21 CAD in British Columbia, $1.27 CAD in Manitoba, and $0.85 CAD in Saskatchewan. Following the introduction of generics, the cost per mg decreased by $0.22 CAD (95% CI - 0.33 to - 0.10; p = 0.0014) in British Columbia, $0.36 CAD (95% CI - 0.58 to - 0.13; p = 0.004) in Manitoba, and $0.27 CAD (95% CI - 0.50 to - 0.05; p = 0.03) in Saskatchewan. Mean cost per mg decreased by $0.26 CAD (95% CI - 0.38 to - 0.13; p = 0.0004) after a third generic was introduced in British Columbia. Excess costs to public formularies during the 4- to 5-year period prior to the listing of generics were $1,992,558 CAD in British Columbia, $80,876 CAD in Manitoba, and $4130 CAD in Saskatchewan. If buprenorphine-naloxone cost $0.61 CAD (mean cost after the third generic entered) instead of $1.21 CAD per mg during the pre-generics period, public payers in British Columbia could have saved $5,016,220 CAD between 2011 and 2015.
Unmerited 6 years of market exclusivity for brand-name buprenorphine-naloxone in Canada resulted in substantial excess costs. There is an urgent need to implement policies that can help reduce costs for high-priority drugs in Canada.
丁丙诺啡纳洛酮是北美应对阿片类药物中毒率的重要手段。操纵市场独占权是制造商提高盈利能力的策略，美国的丁丙诺啡纳洛酮就是一个例证。
研究加拿大因非正当市场独占权（无合法专利或数据保护）而导致丁丙诺啡纳洛酮的额外费用。
本研究采用控制中断时间序列，在第一批仿制药上市前后，考察丁丙诺啡纳洛酮成本的变化。美沙酮成本作为对照。使用不列颠哥伦比亚省、马尼托巴省和萨斯喀彻温省加拿大卫生信息研究所的公共数据。收集了 2010 年至 2019 年期间经省级药物计划/方案接受付款的所有丁丙诺啡纳洛酮和美沙酮的索赔。主要结局是第一批仿制药上市后每毫克丁丙诺啡纳洛酮的平均成本。
在第一批仿制药上市前，不列颠哥伦比亚省、马尼托巴省和萨斯喀彻温省每毫克丁丙诺啡纳洛酮的平均成本分别为 1.21 加元、1.27 加元和 0.85 加元。引入仿制药后，不列颠哥伦比亚省每毫克的成本下降了 0.22 加元（95%置信区间 -0.33 至 -0.10；p=0.0014），马尼托巴省下降了 0.36 加元（95%置信区间 -0.58 至 -0.13；p=0.004），萨斯喀彻温省下降了 0.27 加元（95%置信区间 -0.50 至 -0.05；p=0.03）。在不列颠哥伦比亚省引入第三种仿制药后，每毫克的平均成本下降了 0.26 加元（95%置信区间 -0.38 至 -0.13；p=0.0004）。在仿制药上市前的 4 至 5 年期间，公共配方的超额成本分别为不列颠哥伦比亚省 1992558 加元、马尼托巴省 80876 加元和萨斯喀彻温省 4130 加元。如果丁丙诺啡纳洛酮的成本为 0.61 加元（第三批仿制药上市后的平均成本），而不是每毫克 1.21 加元，那么不列颠哥伦比亚省的公共支付者在 2011 年至 2015 年间可能节省 5016220 加元。
加拿大丁丙诺啡纳洛酮品牌 6 年非正当市场独占权导致了大量的额外费用。迫切需要实施政策，帮助降低加拿大高优先级药物的成本。
