EARLY ACCESS PROGRAMMES (EAPS)- REVIEW OF NON- 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 from the competent authorities. 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 Non-European Countries. 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 Russia, Turkey, South Korea, Israel, India, and Brazil. The markets where EAP are more developed and sales are possible are: South Africa, Canada and Australia. 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.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PHP108
Topic
Health Service Delivery & Process of Care
Topic Subcategory
Hospital and Clinical Practices
Disease
Multiple Diseases