Time to access to novel anticancer drugs in Europe, a case study in seven European countries.

1586 Background: After European Medicines Agency Marketing Authorization (EMA-MA) different national reimbursement processes may contribute to unequal access throughout the EU. The aim of this study is to investigate the access time to new anticancer medicines in seven high-income Northern European countries and factors influencing the reimbursement process. Methods: We performed a retrospective database study. New anticancer medicines were included with a positive CHMP advice between January 2016 and January 2020, leading to EMA-MA followed by an application for national reimbursement approval in Germany, UK, France, The Netherlands, Belgium, Norway and Switzerland. The relevant Health Technology Assessment (HTA) - and reimbursement websites for each country were used to identify reimbursement dates. Time to access was defined as the time between EMA-MA and date of inclusion in the relevant reimbursement list. In addition we investigated the differences in national approval process and study-, medication- and patient- related factors which might influence the time to reimbursement. Results: We found that for the thirty-six new anticancer medicines, national reimbursement came on average 289 days after EMA-MA, with a variety of -125 in Switzerland (i.e. non EU-member) to 1415 days. Of these EMA-MA new anticancer medicines 42% were reimbursed in all countries. The average number of cancer medicines reimbursed in the examined countries was 27 (75%), with a range of 24 (67%) in Belgium to 36 (100%) in Germany. The shortest average time from EMA-MA to reimbursement were in Germany, 2.33 days, France and Switzerland following with 207 days and 279 days respectively. The median time to reimbursement was 227 days with a range of 3 days in Germany to 553 days in Belgium. In Germany, where there is no pricing and reimbursement approval required when launching a pharmaceutical, 100% of the cancer medicines are reimbursed within five days. After one year, In the UK 56% of the medicines are reimbursed, followed by 53% in the Netherlands, France and Switzerland. Belgium and Norway have a one year reimbursement rate of 14% and 11% respectively. Access to anticancer medicines is dependent on regulatory procedures, HTA and price regulations. Germany has a fast market access for anticancer medicines with a price regulation one year after launching the medicines. In the other countries, price regulation is part of the launching process. Other factors which might accelerate the time to reimbursement we are examining are high clinical benefit score (ESMO-MCBS), (non-)orphan status of the medicines and submission by big pharmaceuticals. Conclusions: This study shows that after EMA-MA, except for Germany, on average it takes a long time for anticancer medicines to be reimbursed in Northern European countries. There is a considerably variety both within and among countries.