Brussels, 11 April 2022. The new pledge from EFPIA member companies should drastically increase the availability of innovative medicines in EU countries and decrease the time patients must wait for new medicines by several months.
From today EFPIA member companies commit to file for pricing and reimbursement in all EU countries as soon as possible and no later than 2 years from the central EU market authorisation, provided that local systems allow it. The commitment is designed to help deliver faster, more equitable access to medicines for patients across Europe.
Data published by EFPIA last week showed that disparities in the time it takes for patients to access new medicines in different EU Member States are increasing. Patients in Germany wait around 133 days to access new medicines compared to patients in Romania that endure a wait of 899 days. Significant disparities also occurred in terms of availability of innovative medicines since less than 30% of centrally approved products are available in smaller and Eastern European Member States compared with 92% in Germany and 46% in average in the European Union.
Modelling by IQVIA predicts that the commitment to file would increase the availability of medicines from 18% up to 64% in several countries depending on the country’s payer resource for assessment of the increased number of applications. Critically, the modelling also estimates that the commitment would reduce the time patients wait for new medicines by 4 to 5 months in several countries such as Bulgaria (-179 days), Poland (-129 days) and Romania (-155 days).
However, the time between getting marketing authorisation and companies filing for pricing and reimbursement in a country is just one part of the story. According to analysis by Charles River Associates, there are 10 inter-related factors that cause barriers and delays in patients getting access to new medicines. These causes are rooted in Member States’ access systems and processes and their corresponding impact on commercial decision-making.
This is why the commitment to file is supported by the launch of an online portal where marketing authorisation holders can provide timely information regarding the timing and processing of pricing and reimbursement applications in the EU-27 countries. Bringing greater transparency to the barriers and delays to access will facilitate finding solutions in partnership. Further details of both the commitment to file and the online portal are included in Addressing patient inequalities in Europe, a position paper published by EFPIA today.
In addition to a more equitable system for patients, EFPIA is opening discussions on a more equitable system for EU Members States where the price of innovative medicines can vary between countries depending on their economic level and ability to pay. Also published today, a discussion document entitled ‘A Shared Approach to Supporting Equity-based Tiered Pricing’ sets out the key features of an equity-based tiered pricing system, anchored in the principle of solidarity between Member States and enshrined in the EU treaties. To deliver an equity based, fairer system requires the Commission and Member States to amend external reference pricing systems and undertake mechanisms to prevent the unintended consequences from internal trade in medicines.
Speaking about the launch of the new commitments, EFPIA Director General Nathalie Moll said. “By reducing the time it takes to file for pricing and reimbursement in all 27 EU member States, by bringing greater transparency to the barriers and delays to access, by co-creating an equity-based pricing system, by adopting an efficient system of EU assessments of relative efficacy and by sharing information on the implementation of novel pricing mechanisms, we believe that together we can create a step-change in the access landscape for patients across Europe.”