EARLY ACCESS PROGRAMMES (EAPS)- REVIEW OF THE EUROPEAN SYSTEM
Author(s)
Urbinati D1, Toumi M21Creativ-Ceutical, Luxembourg, Luxembourg, 2University Claude Bernard Lyon 1, Lyon, France
Presentation Documents
OBJECTIVES: Early Access Programmes (EAPs) provide the possibility of making medicines that address an unmet medical need available to patients before regulatory approval of the European Medicine Agency. Market Access includes market development activities and patient access strategy, EAPs can positively impact both areas. The aim of this review is to consider, compile and describe the main EAPs available in Europe. METHODS: We conducted a review and performed a mapping of EAPs systems that exists in Europe. We searched existing literature in Embase, National Health Systems Website, ISPOR conference websites and Internet. In the countries where information were more scattered we directly contacted regulatory agencies and clinicians familiar with the local EAP regulations and practices. RESULTS: We described the practical implications surrounding the regulatory framework for EAPs, the key stakeholders involved in EAP decision-making and administration, the timelines for EAPs approval, and the key factors for success. Many countries do not have an EAP in place and compassionate use is the only route to market for unregistered or investigational products. This is the case for Germany, Belgium, Poland, Austria and Switzerland. The markets where EAP are more developed and sales are possible are: France, Spain, United Kingdom, Italy, Sweden, Denmark, Portugal, and Norway. CONCLUSIONS: This project made specific recommendations on the most favourable countries, based on the ease of setting up such a programme and the potential revenue that could result. At the time, there were several countries where the legal framework was changing (e.g. Austria) and some markets where information was simply not available.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PHP147
Topic
Organizational Practices
Topic Subcategory
Academic & Educational
Disease
Multiple Diseases