Ollila Eeva, Kataja Vesa, Sailas Liisa
Cancer Society of Finland, P.O. Box 238, 00131, Helsinki, Finland.
Faculty of Social Sciences, University of Tampere, Tampere, Finland.
J Pharm Policy Pract. 2022 Aug 29;15(1):52. doi: 10.1186/s40545-022-00449-5.
To combat the global challenge of cancer, priority has been placed on the research and development of new cancer medicines (NCMs). NCMs are often approved for marketing in accelerated processes. Despite significant advances in treating cancer, the overall added value and high prices of NCMs has been questioned. While market authorisations for NCMs are granted at the EU level, the assessment of added value, price negotiations and purchase or reimbursement decisions are made by member states. This article explores the practices in Finland for assessing and deciding on purchasing or reimbursing NCMs.
Semi-structured interviews were conducted with 26 civil servants, hospital employees, scientists, and representatives of cancer NGOs and of the pharmaceutical industry in 2019 and 2020. The transcribed interviews were coded inductively using Atlas.ti software and analysed thematically under 3 major themes and 11 sub-themes.
The clinical value of NCMs is considered to be high, especially regarding NCMs for certain types of cancer. Proper patient selection is important but difficult and not all NCMs can be considered as adding value. The prices are considered to often be very high, leading to concerns about the sustainability and equity of health systems. Equity concerns among cancer patients are raised concerning differences in the availability of NCMs between hospital districts and cost differences for patients between those receiving outpatient and inpatient treatment. The systems and processes in Finland for deciding on the introduction of NCMs are fragmentary, involving separate approaches for outpatient care and hospital medicines by under-resourced evaluation bodies. The scientific evidence available is often limited for evidence-based decisions on introduction. Individual hospital districts sometimes introduce NCMs without assessment by national bodies. This can hamper the proper assessment of some NCMs before their uptake and lead to unequal access to NCMs by hospitals. There is an increasing lack of transparency about pricing, due to the rapid increase of market entry agreements. Lack of transparency on information on prices poses a challenge for authorities responsible for equitable access to cost-effective care within the available resources.
Robust reform of the national introductory systems is needed. Internationally, efforts are needed to increase price transparency, to revise incentives within the system of market approval and to accumulate and assess evidence of comparable value and cost-effectiveness after the market approval of NCMs.
为应对癌症这一全球挑战，新型抗癌药物（NCMs）的研发成为重点。NCMs通常通过加速程序获批上市。尽管在癌症治疗方面取得了重大进展，但NCMs的总体附加值和高昂价格一直受到质疑。虽然NCMs在欧盟层面获得市场授权，但附加值评估、价格谈判以及购买或报销决定由成员国做出。本文探讨了芬兰在评估和决定购买或报销NCMs方面的做法。
2019年和2020年，对26名公务员、医院工作人员、科学家、癌症非政府组织代表和制药行业代表进行了半结构化访谈。对转录的访谈内容使用Atlas.ti软件进行归纳编码，并在3个主要主题和11个子主题下进行主题分析。
NCMs的临床价值被认为很高，特别是对于某些类型癌症的NCMs。正确选择患者很重要，但也很困难，并非所有NCMs都能被视为具有附加值。人们认为价格往往非常高，这引发了对卫生系统可持续性和公平性的担忧。癌症患者之间的公平性问题涉及医院地区之间NCMs可及性的差异以及门诊和住院治疗患者之间的费用差异。芬兰决定引入NCMs的系统和流程支离破碎，资源不足的评估机构对门诊护理和医院药品采用不同的方法。可获得的科学证据通常有限，难以基于证据做出引入决定。个别医院地区有时在未经国家机构评估的情况下引入NCMs。这可能会妨碍在采用前对某些NCMs进行适当评估，并导致医院获取NCMs的机会不平等。由于市场准入协议迅速增加，价格透明度越来越低。价格信息缺乏透明度给负责在现有资源范围内公平获得具有成本效益护理的当局带来了挑战。
需要对国家引入系统进行有力改革。在国际上，需要努力提高价格透明度，修改市场批准系统内的激励措施，并在NCMs市场批准后积累和评估可比价值和成本效益的证据。
