Clinical Added Value of Orphan Medicinal Products Information Flow (CAVOMP-INF)

The CAVOMP-INF considers how to coordinate the respective procedures for marketing authorisation and for reimbursement decisions.

Disparities in access to market-authorised orphan medicines exist between as well as within the European Member State countries. This translates into varying delays from the marketing authorisation date to the pricing and reimbursement decision amongst Member States. One identified means of improving access to orphan medicines involves increasing cooperation between EU-level authorities (for market authorisation) and the Member States, health insurers and payers (MS), at the earliest possible stage of a medicinal product development. Based on an initial proposal made by Eurordis, the European Commission mandated the auditing firm Ernst & Young to identify and assess possible options for the creation of a mechanism for the exchange of knowledge between European authorities and MS on the scientific assessment of the relative effectiveness of orphan medicines. Ernst and Young in response issued a report in December 2011.

Consequently, the European Commission requested the European Union Committee of Experts of Rare Diseases (Eucerd) to make recommendations for facilitating the exchange of scientific information on orphan medicinal products that would support the clinical assessment processes undertaken by the MS. In September 2012 the Eucerd adopted the Recommendation Improving Informed Decisions Based on the Clinical Added Value of Orphan Medicinal Products (Cavomp) Information Flow, which advocates the creation of an “Information Flow” between individual MS as well as between the MS and the European Medicines Agency in order to bridge existing knowledge gaps, especially at the time of marketing authorisation. This flow fits into existing regulatory, clinical, Health Technology Assessment (HTA), pricing and reimbursement processes, capitalising on existing regulatory frameworks, mechanisms, and procedures and emphasising the continuum of evidence generation occurring during the life cycle of an individual OMP. The Information Flow will accelerate access to approved orphan medicinal products, encourage pricing and reimbursement decisions based on the value of the OMP, and promote good medical practices throughout the EU.