DOES CONDITIONAL MARKETING AUTHORISATION INFLUENCE MARKET ACCESS IN FRANCE, ENGLAND, AND GERMANY?

Author(s)

Kaaniche A1, Troubat A1, Sherwood A2
1IMS, PARIS, France, 2IMS Health, La Défense, France

OBJECTIVES: In 2006, Conditional Marketing Authorisation (MA) was implemented by the European Medicines Agency (EMA) to ensure early access to innovative medications for patients in Europe. The objective of this study is to compare the health technology assessment (HTA) process in France, England, and Germany for medicines having received a conditional approval over the past 9 years METHODS: The present study concerned all medicines having been approved with a conditional MA. The HTA assessments performed by three national bodies, IQWiG, NICE and HAS, were compared  for these products. RESULTS: Of the 19 medicines for which a conditional MA was requested, 17 have received an approval of this type. Three of these approved medicines have not yet been assessed by any of the three HTA bodies, or are currently undergoing assessment. Four medicines have undergone HTA assessment by all three agencies. An additional 9 medicines have been assessed in two of the three countries (4 by both HAS and NICE and 5 by both HAS and IQWiG). Whereas all products assessed by HAS received a favourable opinion for reimbursement, NICE and IQWiG are more restrictive in their recommendations. Indeed, only 1/8 medicines assessed by NICE received a favourable recommendation and 5/ 9 by IQWiG. Of note, a specific regulatory framework has been implemented in Germany by which IQWiG considers all orphan products approved by EMA to provide an added medical benefit. This disposition concerned 4 of the 5 products having received a favourable opinion in Germany. CONCLUSIONS: The HTA assessments by HAS, IQWiG and NICE of medicines having received a conditional approval are heterogeneous and lead to differing reimbursement statuses. Different criteria are taken into consideration, including the relevance of the comparator, the clinical trial design and endpoints as well as the relevant target population and health economic assessment.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PHP260

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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