The Clawbacks Paradox: When Abusing a Simple Approach Has the Most Complicated and Problematic Consequences for Patients and Healthcare Systems

Author(s)

Michele Pistollato, PhD.
Principal, Charles River Associates, Milano, Italy.
OBJECTIVES: Clawbacks are increasingly used to manage expenditure on innovative medicines. While these pricing mechanisms may appear attractive due to their simplicity and ability to deliver short-term savings, they have both immediate and longer-term unintended consequences. This research aims to reveal the ‘hidden’ costs of excessive clawback use, with a focus on the impact on oncology patients in smaller European countries.
METHODS: A targeted literature review was undertaken to document the most recent trends related to clawbacks in Europe and to identify studies on their implications in health, economic and social terms. The analysis used economic theory arguments to hypothesise the potential consequences and considered the extent to which the available evidence supports each hypothesis.
RESULTS: A trend of increasing clawback adoption is evident across European countries, particularly in high-budget-impact therapy areas, such as oncology. The growth rate of clawbacks currently exceeds that of annual sales by approximately 20% per year. Some of the smaller countries have the highest rates, e.g., Greece, currently at 27.3%, which is a result of both the need to manage internal fiscal pressure and to protect the internal market from external policies such as the increased use of international reference pricing. In these countries, availability and timely access to oncology medicines are lower compared to countries with less aggressive clawback mechanisms. The adoption of more systemic and value-based approaches to structure healthcare expenditure has the potential to address budgetary concerns while preserving faster access to innovative medicines, but requires a longer-term political commitment for implementation.
CONCLUSIONS: Our results indicate that clawbacks are overused, as they are often perceived as more politically acceptable solutions for securing funding than implementing broader health system reforms that involve reallocating resources or making significant structural changes. This situation underscores a fundamental tension between short-term political gains and long-term systemic health.

Conference/Value in Health Info

2025-11, ISPOR Europe 2025, Glasgow, Scotland

Value in Health, Volume 28, Issue S2

Code

HPR194

Topic

Health Policy & Regulatory

Topic Subcategory

Health Disparities & Equity, Pricing Policy & Schemes, Public Spending & National Health Expenditures, Reimbursement & Access Policy

Disease

Oncology

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