A David and Goliath set-up: a qualitative study of the challenges of ensuring the introduction of cost-effective new cancer medicines in Finland

Abstract

Background 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. Methods 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. Results 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. Conclusions 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.

Drawing up the public national Rational Pharmacotherapy Action Plan as part of social and health services reform in Finland: a bottom-up approach involving stakeholders

“…According to the NMP published in 2011, rational pharmacotherapy and good medication safety enhance people's well-being, improve public health, and decrease healthcare expenditures [ 20 ]. However, achieving the NMP goals had become more challenging, especially due to rapidly increasing medicines costs [ 23 ], the unequal and uncontrolled introduction of new pharmaceutical products [ 49 ] and medication safety risks, especially in the vulnerable population groups such as older adults [ 22 , 24 ]. Thus, the government program for 2015–2019 mandated the MSAH to establish a Rational Pharmacotherapy Action Plan (RPAP) [ 25 ].…”