Thompson Melissa, Henshall Chris, Garrison Louis P, Griffin Adrian D, Coyle Doug, Long Stephen, Khayat Zayna A, Anger Dana L, Yu Rebecca
Cornerstone Research Group Inc., Burlington, ON, Canada.
Health Economics Research Group, Brunel University London, London UK.
Clinicoecon Outcomes Res. 2016 Aug 26;8:427-33. doi: 10.2147/CEOR.S96616. eCollection 2016.
To address the uncertainty associated with procuring pharmaceutical products, product listing agreements (PLAs) are increasingly being used to support responsible funding decisions in Canada and elsewhere. These agreements typically involve financial-based rebating initiatives or, less frequently, outcome-based contracts. A qualitative survey was conducted to improve the understanding of outcome-based and more innovative PLAs (IPLAs) based on input from Canadian and international key opinion leaders in the areas of drug manufacturing and reimbursement.
Results from a structured literature review were used to inform survey development. Potential participants were invited via email to partake in the survey, which was conducted over phone or in person. Responses were compiled anonymously for review and reporting.
Twenty-one individuals participated in the survey, including health technology assessment (HTA) key opinion leaders (38%), pharmaceutical industry chief executive officers/vice presidents (29%), ex-payers (19%), and current payers/drug plan managers/HTA (14%). The participants suggested that ~80%-95% of Canadian PLAs are financial-based rather than outcomes-based. They indicated that IPLAs offer important benefits to patients, payers, and manufacturers; however, several challenges limit their use (eg, administrative burden, lack of agreed-upon endpoint). They noted that IPLAs are useful in rapidly evolving therapeutic areas and those associated with high unmet need, a quantifiable endpoint, and/or robust data systems. The Canadian Agency for Drugs and Technologies in Health, the pan-Canadian Pharmaceutical Alliance, and other arms-length organizations could play important roles in identifying uncertainty and endpoints and brokering pan-Canadian PLAs. Industry should work collaboratively with payers to identify uncertainty and develop innovative mechanisms to address it.
The survey results indicated that while challenging, use of IPLAs may be associated with various benefits. Collaboration among stakeholders remains key: Canadian agencies could play an important role in the success of these agreements, while industry should be proactive in offering solutions that will help improve outcomes across the entire health care system.
为解决与采购药品相关的不确定性问题，产品上市协议（PLA）在加拿大及其他地区越来越多地被用于支持合理的资金决策。这些协议通常涉及基于财务的回扣举措，或者较少情况下基于结果的合同。基于药品制造和报销领域的加拿大及国际关键意见领袖的意见，开展了一项定性调查，以增进对基于结果及更具创新性的产品上市协议（IPLA）的理解。
结构化文献综述的结果为调查的开展提供了参考。通过电子邮件邀请潜在参与者参与调查，调查通过电话或面对面进行。对回复进行匿名汇总以供审查和报告。
21人参与了调查，包括卫生技术评估（HTA）关键意见领袖（38%）、制药行业首席执行官/副总裁（29%）、前支付方（19%）以及现任支付方/药品计划经理/HTA（14%）。参与者表示，加拿大约80%-95%的PLA是基于财务而非基于结果的。他们指出，IPLA为患者、支付方和制造商带来了重要益处；然而，一些挑战限制了其使用（例如行政负担、缺乏商定的终点）。他们提到，IPLA在快速发展的治疗领域以及与高未满足需求、可量化终点和/或强大数据系统相关的领域中很有用。加拿大卫生药品和技术局、泛加拿大制药联盟以及其他独立组织在识别不确定性和终点以及促成泛加拿大PLA方面可以发挥重要作用。行业应与支付方合作，识别不确定性并开发创新机制来解决它。
调查结果表明，虽然存在挑战，但IPLA的使用可能带来各种益处。利益相关者之间的合作仍然至关重要：加拿大机构在这些协议的成功中可以发挥重要作用，而行业应积极提供有助于改善整个医疗保健系统结果的解决方案。
