Patient Access: Early Access, Compassionate Use, Off-label Use
Online seminar on HTA, Pricing, Reimbursement & Market Access
- Patient access to orphan drugs and high-price therapies
- Early access schemes in Europe: Are they reimbursed?
- Pricing considerations
- Compassionate use programmes in Europe
- Compounding, off-label use and hospital exemption
Aims and objectivesThis online seminar addresses the various options for fast access to innovative medicines in Europe, the reimbursement options and the mechanisms of compounding and off-label use.
from 08:30 registration)
10:00 Coffee break
- What is the legal basis in the EU?
- How does the practice differ from one EU country to the other?
- Reimbursed early access or free of charge supply?
- Who takes legal responsibility: the company or the physician?
- What can we learn from case studies?
11:20 Discussion round
11:30 Coffee break
- Pay for performance revival?
- Payer contracting prior to HTA assessment?
- How to use the data generated
- The role of patient organisations and payers
- How to enable patient access between FDA and EU approval
- Some case studies on how to set up CUPs in the EU
15:45 Coffee break
- ATMPs made by hospitals and the hospital exemption
- Compounding pharmacies
- Off-label use
17:00 Seminar end
Vice President, Head of Legal and Compliance International/GM DACH
Chief Executive Officer Christian is a seasoned Market Access professional with over 20 years of experience in the International Biotech and Pharmaceutical industry. He has been involved in over 50 HTAs across Europe and has built up a strong network of key influencers including EU and national agencies. Prior to co-founding MAP in 2012, he led market access teams and submissions at InterMune, Gilead, Pfizer and Genzyme on a very broad range of products and disease areas from chronic disease to ultra-orphan indications. Christian is a member of the Board of EUCOPE (European Confederation of Pharmaceutical Entrepreneurs); he is also a member of the Steering Group of EMIG (Ethical Medicines Industry Group) in the UK and Ireland.
Since 2009, Alexander Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org) in Brussels and works as lawyer in his own law firm in Düsseldorf (www.natz-law.com). From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer with Sträter Law Firm in Germany with a special focus on discount agreements and licensing of pharmaceuticals. Dr. Natz also was working in the field of competition law with the European Commission and the pharmaceutical industry. As research assistant at Duke University (USA) he has dealt with international pharmaceutical law. His doctorate was supervised by former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling.
Head of Market Access Europe
- Detailed knowledge of the various patient access options in Europe
- The latest on compassionate use in Europe
- Patient access options and HTA reality check, all in one seminar
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