IMPACT OF DYNAMIC CHANGES OF THE DEFINITION OF THE APPROPRIATE COMPARATIVE THERAPY (ACT) ON MARKET ACCESS PERFORMANCE OF NEW ACTIVE SUBSTANCES IN GERMANY

Author(s)

Schikowski M, Gibson L, Mrosowsky T, Schönermark M
SKC Beratungsgesellschaft mbH, Hannover, Germany

OBJECTIVES: The coming into effect of the Act on the restructuring of the pharmaceutical market (AMNOG) in 2011 has changed health-technology assessment (HTA) in Germany substantially. The current work aims on discovering strategic issues related to market access in specific fields of indication by extracting key learnings from previous HTA procedures, especially regarding the ACT. METHODS: All final resolutions released by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) between 2011 and 2017 were screened and assigned to their respective fields of indication. Fields of indication that underwent a large or small number of proceedings in the past were analyzed, respectively, by evaluating changes of the ACTs and main reasons for positive or negative benefit assessment outcomes for new active substances in each field of indication. RESULTS: We identified 276 proceedings concluded from 2011 until 2017. 105 proceedings on active substances in oncology, 39 proceedings in diabetology, and 21 proceedings in neurology. In these disease areas, we identified indications with high volatility, such as non-small cell lung cancer or melanoma, for which the G-BA had granted an additional benefit compared to the respective ACT in several cases. However, these HTA outcomes directly influenced some cases of ongoing HTA due to a sudden change of the ACT in a specific indication. In other disease areas, e.g. diabetology, most new medicines were not granted with an added benefit resulting in no change of ACT for several years. Similarly, ACTs in disease areas with a very small number of HTA proceedings, such as schizophrenia or epilepsy, were stable over many years. CONCLUSIONS: ACTs in specific fields of indication dynamically change. Continuous monitoring of ongoing HTA proceedings may help to predict the dynamics in HTA in Germany. Moreover, knowledge about previous and ongoing HTA may give rise to great advantage for market access strategies.

Conference/Value in Health Info

2018-11, ISPOR Europe 2018, Barcelona, Spain

Value in Health, Vol. 21, S3 (October 2018)

Code

PHP261

Topic

Health Service Delivery & Process of Care

Topic Subcategory

Health Care Research

Disease

Multiple Diseases

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