ResearchMoz.us include new market research report" Orphan Drugs in Europe: Pricing, Reimbursement, Funding and Market Access Issues, 2013 Edition" to its huge collection of research reports.
The cost of treating rare disease in an age when austerity measures are hitting total healthcare funding across Europe is a highly controversial, even emotive subject. There is a clear and pressing clinical need, a strong patient voice and the treatments themselves sometimes offer the only hope. But is this enough to assure premium prices and special status in an era of budget limitations, and growing demands for evidence of clinical and cost effectiveness?
Read Full Report With TOC @ http://www.researchmoz.us/orphan-drugs-in-europe-pricing-reimbursement-funding-and-market-access-issues-2013-edition-report.html
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.
Orphan Drugs in Europe: Pricing, Reimbursement, Funding & Market Access, 2013 Edition is a fully revised and greatly enlarged version of Justpharmareports best-selling 2008 and 2011 reports, and the author’s sixth major title on the subject.
Updated to autumn 2013, it includes:
Availability, price and reimbursement status for all 64 EU-designated orphan drugs as of June 2013 with centralised marketing authorisations granted prior to end-2012.
How orphan drug policies differ across Europe. Expanded sections on each EU-5 country, Belgium, Netherlands and Sweden. 25 countries covered in total.
Both hospital and out-of-hospital market segments.
How reimbursement systems treat orphan drugs. ‘High cost’ funding systems explained.
Impact of health technology assessment.
How managed entry agreements and patient registries can help bridge the data gap.
Key role of patient advocacy groups.
15 case studies.
The potential for European collaboration to accelerate market access.
Browse all latest market research report here @ http://www.researchmoz.us/latest-report.html
1. Introduction
1.1 Orphan Drugs
1.2 Rare Diseases
1.3 Business Opportunities with Orphan Drugs
2. EU Orphan Drug Regulation.
2.1 Objectives
2.2 Qualifying Criteria
2.3 Procedure/Timetable
2.4 Incentives
2.4.1 Protocol Assistance
2.4.2 Marketing Approval Assistance
2.4.2.1 Priority review/fast track assessment
2.4.2.2 Lower regulatory fees
2.4.3 Marketing Exclusivity
2.4.3.1 Issues Relating to similarity
2.5 Orphan Designation Withdrawn
2.6 Reduced Exclusivity for ‘Sufficiently Profitable’ Orphan Drugs
2.7 Comparison with US and Other Orphan Drug Policies
2.8. Results of EU Regulation
2.8.1 Designation
2.8.2 Marketing Approval
2.9 Paediatric Regulation
2.9.1 Paediatric Orphan Drugs
2.10 Advanced Therapies Regulation
Read All Pharmaceutical Market Research Reports @ http://www.researchmoz.us/pharmaceutical-market-reports-38.html
List of Tables
1.1 World’s top revenue generating orphan drugs
2.1 Recent history of EMA fee reductions for designated orphan drugs
2.2 Examples of criteria for orphan designation
2.3 Overview of EU orphan drug designation procedure, 2000-2012
2.4 Distribution of EU orphan drug designation by disease prevalence
2.5 Breakdown of approved orphan drugs by therapeutic category
2.6 Breakdown of approved orphan drugs by MA holder
2.7 US orphan drug designations and approvals, 2000-2012
2.8 Orphan drugs with EU marketing authorisation by INN
2.9 Orphan drugs with EU marketing authorisation by brand name
3.1 Examples of repositioned orphan drugs
3.2 Common disease/rare disease price comparison for Belgium
3.3 Previously available therapeutic alternatives for orphan drugs
3.4 Multiple treatment choices for some rare diseases
3.5 Examples of new orphan indications for previous orphan drugs
3.6 Cost comparison of using commercial and compounded forms
3.7 Proposed criteria for evaluation of orphan drugs
####
Related Report
1) Orphan Drugs in Europe
The cost(http://www.researchmoz.us/orphan-drugs-in-europe-pricing-reimbursement-funding-and-market-access-issues-2013-edition-report.html) of treating rare disease in an age when austerity measures are hitting total healthcare funding across Europe is a highly controversial, even emotive subject. There is a clear and pressing clinical need, a strong patient voice and the treatments themselves sometimes offer the only hope. But is this enough to assure premium prices and special status in an era of budget limitations, and growing demands for evidence of clinical and cost effectiveness?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.
2) Advances in the Obesity Market
This report reviews(http://www.researchmoz.us/advances-in-the-obesity-market-report.html) the current state of the obesity market for both pharmaceuticals and medical devices, examining why the obesity market is of such importance across established and emerging economies and how current interventions measure up.In July 2011, the American Association of Clinical Endocrinologists (AACE) reclassified obesity as a diseased state, not a condition, in order to move it up the US healthcare agenda. In 2012, the FDA reviewed its stance on anti-obesity products and approved two new products that were previously declined.
About Us
ResearchMoz is the one stop online destination to find and buy market research reports & Industry Analysis. We fulfill all your research needs spanning across industry verticals with our huge collection of market research reports. We provide our services to all sizes of organizations and across all industry verticals and markets. Our Research Coordinators have in-depth knowledge of reports as well as publishers and will assist you in making an informed decision by giving you unbiased and deep insights on which reports will satisfy your needs at the best price.
Contact
M/s Sheela
90 Sate Street, Suite 700
Albany, NY 12207
Tel: +1-518-618-1030
USA – Canada Toll Free: 866-997-4948
Email: sales@researchmoz.us
0 comments:
Post a Comment