An Analysis of Excuses: Achieving Patient Access on Day One Following European Commission Authorization

OBJECTIVES: To identify barriers to patient access in Europe and ways in which access could be achieved on day one of European Commission authorization.

METHODS: Analysis of EFPIA Patient W.A.I.T. Survey and the European Access Hurdles Portal. Pricing simulation based on lower bound PICO models.

RESULTS: There are increasing access delays for new drugs in Europe due to a combination of reasons including health system infrastructure, economic viability, P&R process and value assessment. Delays in Western Europe are largely due to the value assessment process and evidence requirements, delays in Eastern and Southern Europe are mostly due to health system constraints. Pharmaceutical companies leverage delays to maximize European revenues. All parties appear to be covertly guilty of delaying patient access to new drugs whilst overtly claiming they seek faster access.

Although there are 10 interrelated factors that explain unavailability and delays these are rarely insurmountable and solutions that would allow access as soon as a drug received authorization by the European Commission are possible.

Best practice evolving in Canada, Italy, and Germany indicate this could involve an initial price determined according to algorithms based on “lower bound PICO model(s)” which assumes non-inferiority to standard(s) of care and factors in budget impact neutrality and includes other specific predetermined variables. At the end of the time limited negotiation process an adjustment would address the difference between the price applied and the negotiated price. Failure to achieve a negotiated price would be addressed through a pre-agreed industry arbitration process that trades off the benefits of early access with affordability considerations.

CONCLUSIONS: Reducing time to patient access for new medicines can be best achieved by focusing on national initiatives. Access on day one of regulatory approval would be an ambitious goal that would be achievable if there was willingness and increased collaboration between all parties.