The EUCERD issues a Recommendation to improve informed decisions based on the Clinical Added Value of Orphan Medicinal Products (CAVOMP)
Another important step has been made this month for People Living with Rare Diseases in Europe!
After years of front line advocacy by EURORDIS, the European Committee of Experts on Rare Diseases (EUCERD) has adopted its Recommendation to the European Commission and Member States on "improving informed decisions based on the Clinical Added Value of Orphan Medicinal Products (CAVOMP)”.
This technical recommendation is intended (i) to speed up access to approved Orphan Medicinal Products (OMP) throughout the European Union, (ii) to improve good medical practices and (iii) to promote pricing and reimbursement decisions based on the value of the OMP.
The Recommendation highlights the fact that the life cycle of an OMP is a continuum of evidence generation. This data generation is necessary to assessors and decision-makers in order to demonstrate the value of the OMP and to help improve the use of available resources by better targeting responsive patient populations.
The CAVOMP process will strengthen European collaboration in order to secure access for patients to an increased number of designated OMP. So far, out of 1000 products designated in the EU only 75 have received marketing authorisations.
The CAVOMP’s main innovation is to bring together all players involved in the assessment of the value of an OMP. Through early dialogue amongst the European Medicines Agency, the Health Technology Assessment bodies, the sponsors and the patients, real access for rare disease patients will be accelerated thereby reducing existing inequalities.