CONVERGENT TENDENCIES IN BUDGET IMPACT ANALYSIS ACROSS EUROPE AND BEYOND. GERMANY - DON'T LOSE OUT ON THE "ZEITGEIST"!

Author(s)

Bechtel B, Welte RGlaxoSmithKline, Munich, Germany

OBJECTIVES: On January 1, 2011, the rapid benefit assessment (RPA) as basis for central price regulations was introduced for new drugs in Germany. It requires the pharmaceutical manufacturer to submit a value dossier. The objective was to investigate converging trends in budget impact analysis (BIA) requirements in selected countries and to compare them to the German RPA. METHODS: We conducted a systematic review of national guidelines on BIA requirements for the pricing and reimbursement process of pharmaceuticals in 14 countries across the western world (Europe, North America, Israel). Where needed informal stakeholder interviews were used to supplement lacking information. The information was extracted and evaluated based on 10 characteristics obtained from the “ISPOR Principles of Good Research Practice for Budget Impact Analysis” (Mauskopf et al. 2007). RESULTS: All of the investigated countries except for Germany, Scotland and Norway consider the direct medical budget impact of new pharmaceuticals in their reimbursement decision making. In Germany, only the maximum annual direct intervention costs have to be stated. Although Norway and Scotland request no BIA from a payer’s perspective the drug’s impact on the change in medical resource consumption is analyzed as part of the pharmacoeconomic and comparative effectiveness analyses. 8 countries demand a self-contained BIA complementary to the broader health economic evaluation, while 3 countries deal with financial consequences as part of the economic evaluation. In all countries except for Germany economic consequences for the healthcare budget have to be presented for at least 2-5 years on an annual basis to capture medium to long term savings and expenditures associated with changes in the medical resource utilization following a drug’s availability in the market. CONCLUSIONS: All investigated countries except Germany consider changes in the resource consumption and their financial consequences (even for a medium term period) for decision making.

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

Value in Health, Vol. 14, No. 7 (November 2011)

Code

PHP78

Topic

Economic Evaluation

Topic Subcategory

Cost/Cost of Illness/Resource Use Studies

Disease

Multiple Diseases

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