Evidence Underlying Policy Proposals for Sustainable Anticancer Drug Prices

Abstract

he financial consequences of high-expenditure innovative drugs and the association of these consequences with access to treatment and the sustainability of health care systems have been extensively discussed. 1 Public interest has increased in the past 20 years, 2 and particularly in oncology, a trend of increasing drug prices has been observed since imatinib and bevacizumab entered the market. The launch prices of anticancer treatments have continued to increase substantially even when adjusted for inflation and value. 3 Moreover, decisions underlying pricing are not transparent, and prices vary among countries, 4 creating accessibility issues even in highand middle-income regions. Extremely expensive treatments for rare diseases and combination therapies in precision medicine further challenge the sustainability of the research and development (R&D) system and current pricing policies.The intellectual property (IP) system has received specific attention because it creates a market that allows monopolistic pricing. 1 Considering the 20-year period for patents, the lengthy R&D process, and additional extensions, the median postapproval market exclusivity is 14.5 years for highly innovative, first-in-class drugs. 5,6 The association of the IP regimen with drug prices is evident considering the substantial price erosion after generic entry 7 and the low production costs compared with prices. 8 High drug prices may be associated with a suboptimal pharmaceutical system that needs fundamental rethinking. Confronted with budgetary pressure, countries have introduced reimbursement regulations, such as reference pricing, value based pricing, price controls, and tendering. 1 Although these tools are valuable, we believe it is time to think beyond incremental changes and consider inno-IMPORTANCE The financial consequences of high-expenditure innovative drugs and the association of these consequences with access to cancer treatment are substantial. With oncology being one of the major spending blocks of care and research, innovative policies are needed to secure the sustainability and accessibility of health care systems. Despite this strong interest, structured approaches are missing to date, and proposals are often based on opinion rather than fact.OBJECTIVES To evaluate an inventory of policies to reduce drug prices at market launch and analyze the quantitative evidence on which these policies are based.

Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications

“…However, there are concerns that such approaches disincentivize R&D efficiency, do not factor in failures, may not sufficiently encourage innovation and may be highly disruptive [29,51,133,134]. In view of this, the AIM approach (Table 6) may be more applicable; however, this remains to be seen.…”

“…Other pricing approaches include amortization or leasing scheme approaches for new high priced medicines as well as seeking to de-link the costs of R&D from a medicine's price [134]. De-linkage models have been proposed for new cancer medicines to help lower their costs given increasing recognition that most basic research for new cancer medicines is now predominantly undertaken in universities or funded by public sources [52,110].…”

“…Two-part pricing approaches have also been proposed to help spread the costs of new premium-priced but valued medicines [134]. Under this system, manufacturers and payers agree an entry fee for a population or subpopulation and for every treatment, with the manufacturer receiving a 'user fee' for every patient treated.…”

“…Under this system, manufacturers and payers agree an entry fee for a population or subpopulation and for every treatment, with the manufacturer receiving a 'user fee' for every patient treated. However, for such schemes to work, there has to be a degree of certainty surrounding the outcome with new treatments such as schemes proposed for hepatitis C [134,142]. [43] as well as by Uyl-de Groot et al for new oncology medicines [44].…”

Ansätze zur Begegnung der Hochpreisigkeit

“…In unserem Forschungsprojekt widmen 10 wir uns aus vorgenannten Gründen innovativen Maßnahmen jenseits inkrementeller Anpassungen mit einem besonderen Fokus auf ein evidenzbasiertes Vorgehen. Dieses Kapitel basiert in weiten Zügen auf den Ergebnissen einer systematischen Literaturanalyse von 4.775 Artikeln, veröffentlicht in JAMA Oncology, in der wir eine Einordnung von Lösungsansätzen zur Reduktion von Arzneimittelpreisen beim Markteintritt vorgestellt haben (Franzen et al 2020) (Shepherd 1983). Die Krankenkassen auf der anderen Seite haben laut SGB V als Teil der Solidargemeinschaft den Auftrag, für den Gesundheitszustand der Versicherten zu sorgen.…”