The Evolving Value Assessment Landscape in the US

Article

How current frameworks influence coverage decisions and pricing negotiations.

Left: Kimberly Westrich 

Right: Lisabeth Buelt

Left: Kimberly Westrich

Right: Lisabeth Buelt

Pharmaceutical innovation is driving advancements in healthcare delivery and patient outcomes, including extending life expectancy and improving quality of life. But as costs rise across all healthcare sectors, healthcare decision-makers including public and private payers face difficult decisions regarding how to allocate finite resources. Increasingly, payers are exploring opportunities to assess the relative value of prescription drugs to inform coverage decisions and pricing negotiations.

Numerous value assessment frameworks or tools have emerged in the last decade in the US to help stakeholders appraise the value of treatments and healthcare services. While the new frameworks offer payers additional resources, the extent to which payers value and use the tools and how—if at all—they influence treatment and coverage decisions has remained largely unknown. That’s critical to understand, particularly for biopharma companies seeking to develop a comprehensive value assessment strategy for their product.

Determining perceptions of value assessment tools

Members of AmerisourceBergen’s consulting team, in collaboration with experts at the Academy of Managed Care Pharmacy (AMCP), surveyed healthcare payers on their perceptions and use of the five predominant US value assessment tools cited in the literature: American Society of Clinical Oncology’s Value Framework, Drug Pricing Lab’s Drug Abacus, the Institute for Economic and Clinical Review (ICER’s) value assessment framework and evidence reports, the Innovation and Value Initiative (IVI’s) Open-Source Value Project models, and the National Comprehensive Cancer Network (NCCN’s) Evidence Blocks.

The results of the survey, which were published this month in the Journal of Managed Care & Specialty Pharmacy, revealed:

  1. Payers are familiar with value assessment tools. Surveyed payers were very familiar with US value assessment tools, with 86% reporting they were familiar with at least four of the five tools.
  2. Some payers are using value assessment tools to inform coverage decisions and pricing negotiations. A large portion of payers perceived ICER evidence reports and NCCN Evidence Blocks to be very or extremely useful in informing coverage decisions (57% and 49%, respectively). For example, payers reported using ICER evidence reports to both expand and restrict coverage decisions. Payers reported that ICER evidence reports were by far the most helpful tool in informing pricing negotiations, with 53% saying they were very or extremely useful. All other tools were perceived to be less useful in informing pricing negotiations.
  3. Payers recommended changes to make value assessment tools more useful and relevant. To advance more useful and relevant tools, payers recommended that value assessors incorporate more transparent and payer-centric data (i.e., generalizability to payer costs and/or plan demographics) into their assessments, increase the number of assessments conducted, and expand awareness of their assessment tools.
  4. Further examination of value assessment tools and methods is needed. As policy momentum behind value assessment grows, additional research on value assessment tools is needed to ensure application of value assessment in the US is appropriate, patient-focused, and advances the delivery of high-value care.

Navigating an evolving value assessment landscape

The findings from our study, combined with previous research, point to a shift in payer perspectives on value assessment tools over the years—evolving from awareness but limited use to referenced and more widespread use today. This shift in the value assessment landscape, whereby assessment tools are increasingly informing decisions that affect patient access to care, places greater emphasis on the need for appropriate and evidence-based approaches.

Value assessors in the US are updating their methods and processes for conducting value assessments. For example, ICER’s president Steve Pearson recently announced that the organization is planning to evolve its methods and will open its value assessment framework to public comments this summer. The decision enables all stakeholders—including biopharma companies, payers, and patients—to identify and recommend meaningful methodological and process changes.

The Inflation Reduction Act (IRA), which was signed into law in 2022 in the US, has intensified the spotlight on pharmaceutical pricing and sparked new conversations about how to define and measure treatment value. The Medicare Drug Price Negotiation Program, in particular, may consider comparative effectiveness research tied to clinical benefit, a common staple of health technology assessments (HTA). It may also consider manufacturer-specific data inputs (i.e., a product’s research and development costs, costs of production, etc.). This approach, which differs from more traditional HTAs, would require manufacturers to refocus their evidence-generation strategies to meet the needs of the program’s unique definition of value.

As biopharma companies look to launch new products in the US, companies and their partners must understand and consider the evolving value assessment landscape. Companies that are prepared for and can anticipate changes—including shifting payer trends, ICER’s updated value assessment methods and the implementation of the IRA’s drug pricing provisions—and develop a comprehensive value assessment strategy will be better positioned to execute successful product launches.

About the Authors

Kimberly Westrich is Director of Value and Access Strategy and Lisabeth Buelt is Manager of Value and Access Strategy, both on AmerisourceBergen’s consulting team.

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