COMPARISON OF POST-AUTHORISATION MEASURES FROM REGULATORY AUTHORITIES WITH ADDITIONAL EVIDENCE REQUIREMENTS FROM HTA BODIES IN GERMANY

Author(s)

Ruof J1, Staab TR1, Slawik L2, Orben T3, Bosch S4
1Roche Pharma, Grenzach-Wyhlen, Germany, 2Bristol-Myers Squibb GmbH und Co. KGaA, Munich, Germany, 3vfa, Berlin, Germany, 4Bayer Business Service GmbH, Leverkusen, Germany

OBJECTIVES: Regulatory authorities such as the European Medicines Agency (EMA) can make marketing authorisation contingent upon post-authorisation measures (PAMs) so as to fill in information gaps in efficacy and safety. PAMs are generally formulated in agreement with manufacturers, and evaluate clinical hypotheses in an ethical and practical way. In Germany, novel medicines must also undergo an early benefit assessment (EBA) by the Federal Joint Committee (G-BA) following marketing authorisation. G-BA may demand additional evidence in order to formulate an opinion on added therapeutic value, which then leads to determination of reimbursement. We compared selected PAMs with the corresponding G-BA demands to see if they were similar.  METHODS: Medicines that received a restricted EBA from G-BA before 15 June 2014 were evaluated and compared with their marketing authorisations by EMA. PAMs from EMA, and EBA restrictions from G‑BA, were assessed in terms of their required additional evidence. RESULTS: Twenty-eight percent of all 79 medicines assessed by G-BA received a restricted EBA. Only nine of those had obligations for PAMs. Four of these were conditional approvals or approval under exceptional circumstances, while five received unconditional marketing authorisation. G-BA justified restricted EBAs for the four conditional approvals based upon agreement with the EMA opinion. For the five unconditional approvals, G-BA required considerably more information than EMA. The additional evidence requested by the two bodies rarely corresponded to one another. EBA restrictions were more influenced by transferability to the German healthcare context, choice of subgroups and appropriate comparator, than were the corresponding EMA PAMs. CONCLUSIONS: G-BA often demands more evidence than specified in EMA PAMs from medicines granted unconditional approval. Although PAMs are discussed and agreed between EMA and manufacturers, G-BA demands and restrictions are not. The possibility for such discussions with G-BA would be an improvement for the future.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PHP139

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

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