Value Frameworks

Legislative and Regulatory Position: 

AMCP supports the use of value frameworks as a resource for determining the value of pharmaceuticals and other health technologies when based on sound methods using good scientific evidence and economic models. Value frameworks are tools and approaches that use clinical, real-world, and unpublished evidence along with patient-reported outcomes and economic modeling to measure the value of medications, treatments, and other health technologies. For value frameworks to be meaningful, they must be used in conjunction with other tools and resources by healthcare decision-makers to review the totality of evidence. 

Various organizations in the United States and globally have developed value frameworks for specific purposes. For example, the Institute for Clinical and Economic Review (ICER) evaluates the cost and clinical effectiveness of medications and treatments from a healthcare decision-maker perspective. The American Society of Clinical Oncology (ASCO) Value Framework aids in treatment decision-making in oncology. While the methodologies and measurement outputs vary among the existing frameworks, they all generally focus on four broad principles: selecting health outcomes of interest (e.g., efficacy or safety); identifying relevant evidence to quantify the impact of treatment on each outcome of interest; aggregating the outcomes into a single measure of health benefit; and calculating the cost of care relative to health benefits. 

Existing value frameworks have largely been designed to evaluate the value of medications and treatments used over a set duration or over a patient’s lifetime. For potentially curative therapies, including cell and gene therapies, value frameworks need to be adjusted to accurately assess both the clinical impact and cost-effectiveness over a patient’s expected lifetime to determine a reasonable value-based price. As the long-term effectiveness of these medications and treatments is yet to be determined in many cases, additional refinement will be needed as more real-world evidence becomes available.¹

AMCP’s Format for Formulary Submissions (Format)² is one resource that provides a well-established, evidence-based framework approach to facilitate discussions on therapeutic appropriateness and value between manufacturers and healthcare decision-makers. 

The Format, first disseminated in 2000 and now in version 5.0 released in 2024, provides useful guidance on relevant evidence to consider in Value Framework development and use. The Format is comprehensive and flexible, permitting an evidence-driven exchange of information between manufacturers and payers. 

AMCP supports its use by healthcare decision-makers. AMCP believes that value frameworks should follow these principles: 

• Developers should consider diverse perspectives from across the healthcare continuum, including patients (and their families and caregivers), providers, payers and other healthcare decision-makers, and pharmaceutical manufacturers. 
• Analytic methodology and economic models used in the development of a value framework should be validated and made publicly available. 
• Value frameworks should incorporate scientifically valid evidence from a variety of sources, including real-world evidence, breakthrough treatments needed, and patient-reported outcomes, as part of the evaluation of a medication or other health technology, a process fully described in the AMCP Format, v. 5.0.
• Value frameworks should provide interpretable outputs that allow healthcare decision-makers and healthcare providers to conduct assessments of medications and health technologies in order to make value-based policy and treatment decisions for patients. 
• Value frameworks intended for patient audiences should provide sufficient information in a format that can be understood by patients.
• The identities, credentials, qualifications and/or conflicts of interest of those involved in the development or approval of value frameworks should be disclosed and publicly available. 
• Value frameworks should be updated with the most current product evaluation techniques and should continue to provide accessible information to stakeholders. 
• Value frameworks should assist healthcare decision-makers in determining the cost-effectiveness of each medication or treatment for each of its indications.
• Value frameworks should incorporate adjustments and considerations for differences in subpopulations of individuals based on age, gender, ethnicity, or socioeconomic status. These frameworks should work towards recognizing any potential bias within their data and calculations and acknowledge and address those biases.

See also:

AMCP Legislative and Regulatory Positions

Revised by the AMCP Board of Directors, July 2024 

Revised by the AMCP Board of Directors, February 2022 

1 In 2022, AMCP held a Partnership Forum to identify opportunities to improve how value assessments are developed and applied to formulary decision-making and provide strategies and guidance on best practices to equip managed care pharmacists and other professionals when applying these tools to assess value and optimize patient care. For more information about the outcomes of this Partnership Forum, see https://amcp.org/Resource-Center/meeting-proceedings-findings/partnership-forum-health-technology-value-frameworks-coverage-reimbursement. 

2AMCP’s Format for Formulary Submissions available at https://amcp.org/Resource-Center/format-formulary-submissions/AMCP-Format-for-Formulary-Submissions-5.0.