DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/4fbrcg/orphan_drugs_in) has announced the addition of a new report "Orphan Drugs in Europe: Pricing, Reimbursement, Funding & Market Access Issues" to their offering.
Payers are becoming increasingly strict. Four of the first seven orphan drugs to enter Germany's AMNOG procedure were considered to bring only minor additional benefit and for two others the benefit was deemed non-quantifiable. Discounts were required for all. Re-evaluation by the Transparency Commission in France has seen both SMR and ASMR scores downgraded with resultant price cuts. Half of all orphan drugs evaluated have been rejected by one or more HTA bodies in the UK.
Manufacturers of treatments for Fabry and Pompe diseases are currently negotiating discounts in the Netherlands to prevent delisting after results from a four-year conditional reimbursement PMS period disappointed. On a more positive note, September 2013 saw the start of the first pilot pan-EU assessment under the Mechanism of Co-ordinated Access to Orphan Medicinal Products (MoCA-OMP) initiative.
Updated to autumn 2013, it includes:
Key Topics Covered:
2. EU Orphan Drug Regulation
3. Issues for Debate
4. Assisting the Market Access Process
5. Availability and Prices of Orphan Drugs
6. Situation in EU-5
7. Situation in Other European Countries
8. Opportunities and Challenges from Personalised Medicine
9. EU Initiatives
10. Future Prospects
For more information visit http://www.researchandmarkets.com/research/4fbrcg/orphan_drugs_in
Source: Research and Markets