ACHIEVING FASTER PRODUCT LAUNCH- HOW DO YOU OBTAIN NON-REIMBURSED PHARMACEUTICAL PRICES ACROSS EUROPE?
Author(s)
Craddy P1, Wolfram V2, Bailey S2, Foxon G2
1Remap Consulting, Zug, Switzerland, 2Remap Consulting, Cheshire, UK
Presentation Documents
OBJECTIVES: To determine the European price submission procedures required for launch of non-reimbursed medicinal products. METHODS: An analysis of OECD data was conducted to identify the countries which account for 90% of pharmaceutical spend and which are covered by the European Medicines Agency’s centralized marketing authorization procedure. Eleven countries were identified (Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Poland, Spain, Sweden, and UK) for which governmental price resources were analyzed to determine the launch price submission process for non-reimbursed medicinal products. If no governmental price resources were identified, pricing authorities or country pricing experts were contacted directly to obtain the relevant information. RESULTS: Of the 11 countries reviewed, nine countries require submission of pricing documents to secure and publish a launch price in the official price lists. For Belgium, Italy, and the UK a full pricing dossier is required, which is comparable to that needed to secure the price for a reimbursed product. For the remaining six countries (Austria, France, Germany, Greece, Netherlands, and Sweden), an abridged pricing submission is required. No pricing submission is required for Poland or Sweden. Furthermore, four countries require international reference prices from other European countries in their price submissions. CONCLUSIONS: The benefits of launching a non-reimbursed product include the ability of manufacturer to set the price and an opportunity for a faster product launch. Additionally, price publication in nine countries can help raise awareness of the non-reimbursed product to prescribers, pharmacists, and patients. Whilst the non-reimbursed price submission process is often less onerous than seeking reimbursement, local country knowledge is still essential due to significant variation in the pricing process by country. Whilst seeking a non-reimbursed launch price in Europe can be an optimal strategy for certain therapy areas, manufacturers should ensure that this approach optimizes revenues when compared to a reimbursed approach.
Conference/Value in Health Info
2016-05, ISPOR 2016, Washington DC, USA
Value in Health, Vol. 19, No. 3 (May 2016)
Code
PHP55
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Real World Data & Information Systems
Topic Subcategory
Health & Insurance Records Systems, Health Care Research, Health Disparities & Equity, Reimbursement & Access Policy
Disease
Multiple Diseases