12:00 AM
Apr 15, 2013
 |  BioCentury  |  Regulation

Uniting Europe's Orphans

EC project recommends scheme to assess value of Orphan products across EU

A voluntary collaboration of EU member states, patients and industry plans to present recommendations this week for a framework to assess the value of Orphan drugs that could be used as the basis for pricing negotiations at the national level.

In principle, the plan seeks to reduce the health technology assessment burden on smaller EU member states and make the reimbursement process more predictable for companies, in turn increasing patient access to Orphan drugs.

While the concept of collaboration on health technology assessments (HTAs) may be attractive in theory, putting such a system into practice may prove difficult. The initiative's success depends on the continued participation of European member states, starting with a planned pilot trial to test the feasibility of the collaborative assessment process.

Regardless of the assessment framework's success, other recommendations from the EC working group would be worth implementing to improve access to Orphan drugs in Europe, according to industry representatives who spoke to BioCentury.

Orphan inequality

The collaboration, known as the Mechanism for Coordinated Access to Orphan Medicinal Products (MoCA-OMP), is part of the EC project Platform on Access to Medicines in Europe. The platform includes other projects examining managed entry agreements such as pay-for-performance plans, and market access for biosimilars.

The collaboration includes EU state representatives from Austria, Belgium, Estonia, Finland, France, Hungary, Italy, Malta, Portugal, Spain and the Netherlands. The rare disease patient group Eurordis is also involved. Physicians were represented by the Standing Committee of European Doctors (CPME); and payers included the European Social Insurance Platform (ESIP).

Industry representatives included the European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio and the European Generic medicines Association (EGA).

The project is voluntary and non-binding because drug pricing and reimbursement are the sole responsibility of national authorities.

According to Wills Hughes-Wilson, a member of the MoCA-OMP working group, the EC started the project in 2010 to attempt to remedy significant variations in Orphan drug availability...

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