Key takeaways

  • The current approach to attributing value to therapies used in combination is the incremental value (IV) approach. However, this method faces challenges in assessing cost-effectiveness and may not fairly attribute value under some likely scenarios.
  • Recent alternative value attribution frameworks (VAFs), such as the monotherapy ratio (MR) and generalized approach (GA), have been proposed to address these issues.
  • We developed an excel tool to compare the value attribution shares resulting from each VAF, which was piloted with by the Association of British Pharmaceutical Industry’s (ABPI’s) combination project team. A qualitative survey was given to the project team to understand the industry perspective on the differing VAFs.
  • The survey results showed that no single VAF represented the ideal solution. The GA was the preferred VAF in terms fairness and technical correctness. However, the IV approach was seen as the most feasible due to its lower information requirements.
  • Based on the results of this study, we recommend the GA as the starting point for thinking about value attribution in the arbitration process. The discussion between manufacturers and payers could also be supplemented by the shares generated using the IV and MR approaches.

However, when these therapies involve two or more on-patent drugs from different manufacturers, assessing and pricing them can be challenging, potentially delaying or preventing patient access. One significant issue is fairly apportioning the value of a CT among its components based on their contribution to the overall effectiveness. The balance of market power among the manufacturers can also influence value attribution.

The current approach to value attribution is the incremental value (IV) method. However, this method faces challenges in assessing cost-effectiveness and may not fairly attribute value except in cases of constant scale of additivity. Recent alternatives, such as the monotherapy ratio (MR) and generalized approach (GA), have been proposed to address these issues.

The Office of Health Economics (OHE) developed an Excel tool to compare the value attribution shares under each value attribution framework (VAF). This tool was piloted by the Association of the British Pharmaceutical Industry’s (ABPI’s) combination treatment project team, a group of ABPI member companies that have a specific focus on the issues and solutions surrounding access to combination therapies. Feedback was gathered from the project team through a qualitative survey. This paper presents the industry’s perspective on the VAFs, highlighting their strengths and weaknesses, ease of implementation, and considerations for further engagement.

Although no single solution was deemed ideal, the GA received the most support as a preferred VAF. It was considered a sensible, risk-mitigating approach for portfolios that include both backbone and add-on therapies. Key themes in evaluating the VAFs included fairness in value attribution shares, feasibility, uncertainty of inputs and outputs, and accuracy in cases of sub- or super-additivity. IV was seen as the simplest and most feasible but insufficient for overcoming access challenges for CTs. Each VAF had weaknesses: the MR and GA frameworks require extensive information, the GA approach is complex, and the IV method fails to address certain cost-effectiveness issues.

Factors influencing industry and HTA engagement included 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. While each approach has its strengths and weaknesses, with varying complexity and evidence requirements, the GA was generally considered the most appropriate for a range of products including backbones and add-ons. However, the MR or IV frameworks could also be considered in specific HTA and pricing negotiations.

Based on the results of this study, we recommend the GA as the starting point for thinking about value attribution in the arbitration process, especially under scenarios of sub- and super-additivity. However, the selection of the GA depends on the availability of evidence and the ability to generate relevant evidence. The discussion between manufacturers and payers could also be supplemented by the shares generated using the IV and MR approaches.

Download Full Publication