Tuesday, July 16, 2024

Evaluating Combination Therapies: New Frameworks for Fair Value Attribution in Oncology

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Combination therapies (CTs), which merge treatments with different mechanisms of action, offer greater clinical benefits than individual components alone, particularly in oncology. These therapies pose challenges in assessing cost-effectiveness and attributing value, especially when involving on-patent drugs from different manufacturers. The current approach, the incremental value (IV) method, often falls short in fairly distributing value among components except in constant additivity scenarios.

Recent alternatives, such as the monotherapy ratio (MR) and generalized approach (GA), aim to address these issues. The Office of Health Economics (OHE) developed an Excel tool to compare value attribution shares under each framework, piloted by the Association of the British Pharmaceutical Industry’s (ABPI’s) combination treatment project team. Feedback from the team highlighted that no single VAF is ideal. The GA approach received the most support for its fairness and technical correctness, despite being complex and requiring extensive information. The IV method was seen as the most feasible due to lower information requirements.

Challenges in Fair Value Attribution for Combination Therapies

Fairly apportioning the value of combination therapies among its components, based on their contribution to overall effectiveness, is complex. Market power among manufacturers also influences value attribution. The GA approach was considered sensible for portfolios with both backbone and add-on therapies. However, IV and MR frameworks, while simpler, fail to address certain cost-effectiveness issues and require extensive data. The survey showed the industry’s preference for GA, emphasizing its risk-mitigating potential despite its complexity.

Factors influencing engagement include the “not cost-effective at zero price” problem, the need for inter-company dialogue, payer and decision-maker acceptance of VAFs, and commercial strategy implications. The GA was generally considered the most appropriate for a range of products, including backbones and add-ons. IV and MR frameworks could also be considered in specific HTA and pricing negotiations, depending on the availability of evidence and the ability to generate relevant data.

Combination Therapies

GA Approach Recommended for Fair Value Attribution in Oncology Combination Therapies

Based on this study, the GA approach is recommended as a starting point for value attribution in the arbitration process, especially in scenarios of sub- and super-additivity. However, the selection of the GA depends on evidence availability. Discussions between manufacturers and payers should be supplemented by shares generated using the IV and MR approaches to ensure a comprehensive evaluation.

This study underscores the need for improved value attribution frameworks to fairly assess combination therapies in oncology. While the GA framework holds promise, it requires robust evidence and inter-company cooperation. By leveraging multiple frameworks, stakeholders can navigate the complexities of combination therapies value attribution, ensuring fair and effective pricing and access strategies.


Resource: The Office of Health Economics, July 09, 2024

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