New recommendation for a CAVOMP Information Flow

October 10, 2012 in News, Orphan medicinal products, Recommendation

EUCERD’s recommendation for improving the assessment of the Clinical Added Value of Orphan Medicinal Products encourages the creation of an Information Flow

Equitable and timely access to market-authorised orphan medicinal products is an ongoing issue for thousands of rare disease patients and their families across the European Union (EU). Large disparities in access exist between and even within the European Member State countries. Increasing cooperation between EU-level authorities and the Member States (MS) has been identified as a means of improving access to Orphan Medicinal Products (OMP) and reducing inequities. Global auditing firm Ernst & Young was mandated by the European Commission to identify and assess the possible options for the creation of a mechanism for the exchange of knowledge between the MS and European authorities on the scientific assessment of the relative effectiveness of orphan medicines and issued a reportin December 2011. The European Commission consequently asked the European Union Committee of Experts of Rare Diseases (EUCERD) to make recommendations in the area of facilitating the exchange of scientific information on orphan medicinal products that would support the clinical assessment processes undertaken by the MS.
No need to reinvent the wheel…
The EUCERD recommendation involves the creation of an Information Flow between individual MS and between MS and the EU that would bridge existing knowledge gaps, especially at the time of marketing authorisation. This flow would fit into existing regulatory, clinical, Health Technology Assessment (HTA), pricing and reimbursement processes. The recommendation thus capitalises on existing mechanisms, procedures, and regulatory frameworks, and does not bring new obstacles to the assessment process. The EUCERD Recommendation emphasises the continuum of evidence generation that takes place during the life cycle of an individual OMP and the Information Flow would be harboured by the corresponding institution responsible during each particular point in time (see the diagram).
The EUCERD Recommendation Improving Informed Decisions Based on the Clinical Added Value of Orphan Medicinal Products (CAVOMP) Information Flow will ultimately accelerate access to approved orphan medicinal products, while encouraging pricing and reimbursement decisions based on the value of the OMP and promoting good medical practices throughout the EU. The Recommendation has been submitted to the European Commission.