Addressing Challenges in the Changing European Market Access Environment

March 2013

Important health technology assessment and pricing & reimbursement reforms have been, or are about to be, implemented in France, Germany and the UK.

A US-based SME was about to enter the European market with two key products in Phase III clinical trials.  OHE Consulting was asked to assess the challenges the company was likely to face in light of the current reforms which are:

In France, changing HTA policy aims to improve pharmaceutical regulation in response to the “Mediator scandal”, enhance pharmacovigilance and introduce new requirements for the use of comparator treatments in reimbursement decisions.

In Germany, a new law, AMNOG (Arzneimittelmarkt-Neuordnungsgesetz), implemented on 1 January 2011, fundamentally changes the assessment and pricing of newly launched medicines. Instead of free pricing, new medicines will be reimbursed according to additional clinical benefit compared with the nearest comparator treatment.

In the UK, the new “value-based pricing” scheme will be introduced in 2014. “Value-based pricing” has not been formally implemented and so the practical application of its principles has not yet been stated.

OHE Consulting was able to advise the company on the pricing and reimbursement challenges it would face for each product in each market. Our analysis was based on in-depth knowledge and insight about the reforms, additional research and detailed information about the company’s two products.  We offered recommendations on how best to address the challenges identified, and also suggested where and how the company might influence policymaking. The client now has a process to address the market access issues it may face and is implementing the recommendations.

The content and posting of this case study have been explicitly approved by the client.


“OHE's counsel was extremely beneficial on how to participate in the European policy debate and help create a better environment for the development, licensing and market access of our product line. Our company is using this advice to become more actively involved in European discussions.”
-- Vice President, Government Affairs


To learn more about OHE Consulting’s services, please contact Dr Jorge Mestre-Ferrandiz  • • +44 (0)20 7747 8860