This CRA Insights is the third report in a series of reports on analysis of German and US data from CRA’s RAre Disease Assessment Review (RADAR) database.
In Part 3 of this series, RADAR data on orphan-drug pricing in Germany revealed a significant increase in manufacturer-set list prices for new orphan drugs (ODs) over time.
While GKV rebates seemed to have increased as well, their increase was less pronounced than the increases in list prices, resulting in rising reimbursed annual treatment costs. However, the analyses in Part 1 and Part 2 of this series did not provide a rationale for increasing list-price levels.
To understand the evolution of list prices for ODs in Germany, as previously reported on, we must first understand how manufacturers anchor their list prices and enter into GKV negotiations. This report sets out to explore the question of whether or not manufacturer-set prices in Germany are based on value perceptions in the US and not in Germany.
To fully understand how much value perception matters for orphan drugs, the third report seeks to answer the following questions:
- How close are the €-denominated US WACs and manufacturer-set list prices in Germany’s Lauer Taxe for the same OD, indication, formulation and pack size?
- Do manufacturer-set list prices for ODs in Germany follow the same trajectory as the US WACs over time, both overall and for different drug indication groups?
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