Unequal Access to Newly Registered Cancer Drugs Leads to Potential Loss of Life-Years in Europe

Abstract

Background. Many new cancer medicines have been developed that can improve patients’ outcomes. However, access to these agents comes later in Europe than in the United States (US). The aim of this study is to assess the access in Europe to newly registered cancer drugs and to get more insight in the implications of these variations for patients. Methods. A retrospective database study was conducted. Analyses involved 12 cancer drugs and 28 European countries in the period 2011–2018. Time to patient access, speed of drug uptake, and the potential loss of life years due to a delay in access have been studied. Results. Marketing approval for the cancer drugs came on average 242 days later in Europe than in the US, and actual patient access varied extensively across Europe. The average time to market in Europe was 403 days (range 17–1187 days). The delay in patient access of ipilimumab and abiraterone may have led to a potential loss of more than 30,000 life years. Conclusion. It takes a long time for patients to get access to newly registered cancer drugs and there is great variation in access. The health outcomes can be substantially improved by faster processes.

Unintended Regulatory Caused Early Death—A Difficult Endpoint in Cancer Patient Care and Treatment

“…In this journal, Uyl-de-Groot et al have recently published a detailed study shedding light on “unequal access to newly registered cancer drugs” and how it “leads to potential loss of life-years in Europe” [ 11 ]. This investigation sheds light on the delay in approval and, also, on the delay of access in different European countries.…”

COVID-19 and systemic anticancer therapy: exploiting uncertainty

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“… 6 Late introduction of new and active medication might lead to loss of life-years in general. 7 Use of new expensive medications outside the registered indication (eg, for an earlier line of therapy), has the potential to cause harm. Nevertheless, the COVID-19 pandemic has lead to more thoughtful provision of toxic adjuvant and palliative regimens with only small benefits, and thus could provide a unique window of opportunity for assessing the effects of de-escalating systemic anticancer therapy, which might stimulate the development of more refined and less toxic treatments.…”

Role of the EMA specific marketing authorization procedures for early access on the time to patient access in Bulgaria

“…Studies also show that the average delay in time to market and patient access for innovative medicines in Europe is approximately 400 days but for many Eastern European countries is above the average for the European Union (EU) (Uyl-de Groot et al 2020). Despite the centralized procedure for marketing authorization valid throughout the EU for oncology medicines, still the time to patient access varies among the Member states mainly due to the local legal requirements for pricing and reimbursement decisions.…”