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.

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Page created: 20/08/2013
Page last updated: 07/11/2014
 
 
Die Stimme der Menschen mit seltenen Krankheiten in EuropaEURORDIS Die internationale Stimme für Menschen mit seltenen KrankheitenRare Disease International Ein moderiertes mehrsprachiges Forum, das Patienten, Familien und Experten zum Erfahrungsaustausch zusammenführt. RareConnect Das Rare Barometer Programm ist eine EURORDIS-Initiative, die Umfragen durchführt und die Erfahrungen von Patienten mit seltenen Erkrankungen in Fakten und Zahlen umwandelt, die wiederum Entscheidungsträgern vermittelt werden können.Rare Barometer Eine internationale Aufklärungskampagne, die jedes Jahr am letzten Tag im Februar stattfindet. Der Tag der Seltenen Erkrankungen ist eine EURORDIS-InitiativeRare Disease Day Nehmen Sie am größten Zusammentreffen von Interessenvertretern für seltene Krankheiten in Europa teil und besuchen Sie die zweijährliche Europäische Konferenz für Seltene Krankheiten und Orphan-Produkte (ECRD). ECRD ist eine EURORDIS-InitiativeEuropean Conference on Rare Diseases