MARKET ACCESS DELAYS FOR CNS DRUGS IN EUROPE
Author(s)
Flostrand SJA1, Anderson L2, Esposito G31IMS Consulting Group, Puteaux, France, 2IMS Consulting Group, London, United Kingdom, 3H. Lundbeck A/S, Copenhagen, Denmark
Presentation Documents
OBJECTIVES: A recent study[1] by the Tufts Center for the Study of Drug Development indicated that Central Nervous System (CNS) drugs take 35% longer to develop and are less likely to gain approval compared to other new prescription medicines. Once approved in Europe, Transparency Directive 89/105/EEC requires countries to determine pricing and reimbursement (P&R) within 180 days but this target is not always met. This study evaluated the time required to achieve P&R and to launch CNS products in Europe to quantify how such delays impact patients and companies. METHODS: We identified branded antidepressant and antipsychotic launches between 2003 and 2010. Market authorisation dates and P&R dates were sourced from national databases and launch dates were determined using IMS MIDAS data. The average time between market authorisation, P&R and launch was then calculated for fifteen European countries. RESULTS: In most countries the identified products were not launched until P&R was secured, making it a significant barrier to patient access. The average time taken to achieve P&R was approximately 310 days, with significant variation between countries. This delay was frequently longer than the average P&R delay seen across all therapy areas. On average only the United Kingdom, Germany and Denmark achieved P&R within Transparency Directive guidelines. Significant delays were seen in Portugal and France, taking on average 550 and 610 days respectively to gain P&R. CONCLUSIONS: In addition to known development challenges for CNS products, manufacturers experience greater delays in securing P&R in Europe, denying patients timely access to these drugs. Few countries comply with the current Transparency Directive[2], and if proposed changes are implemented to reduce the delay to 120 days, even fewer will be compliant. P&R is an additional hurdle to access that particularly impacts CNS drugs, and stronger efforts to reduce these delays are needed.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
DU3
Topic
Health Service Delivery & Process of Care
Topic Subcategory
Prescribing Behavior
Disease
Mental Health, Neurological Disorders