Where We Stand:
AMCP supports the use of value frameworks as a resource for determining the value of pharmaceuticals and other health technologies when the Frameworks are based on sound methods using good scientific evidence and economic models. Value frameworks represent tools and approaches that use clinical, real-world, and unpublished evidence along with patient-reported outcomes and economic modeling where applicable to measure the value of medications, treatments, and other health technologies. For value frameworks to be meaningful, they must be used by professionals or health care decision-makers who are in the best position to review the totality of evidence and should be used in conjunction with other tools and resources.
Various organizations in the United States and globally have developed value frameworks specific to a certain purpose. For example, the Institute for Clinical and Economic Review (ICER) evaluates the cost and clinical effectiveness of medications and treatments from a health care 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 a relevant evidence base to identify 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 and comparing it to health benefit. Value frameworks represent tools which may be used to measure the value of medications and other health technologies to determine potential impacts on the healthcare system.
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 of value frameworks will be needed as real-world evidence becomes available.
AMCP’s Format for Formulary Submissions (Format) is one resource that provides a well-established, evidence-based framework approach to facilitate discussions on therapeutic appropriateness and value between manufacturers and health care decision-makers. The Format, first disseminated in 2000 and now in version 4.1 released in 2020, 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 producers and payers. AMCP supports its use by health care decision-makers.
AMCP believes that value frameworks should follow these principles:
- Developers should consider key stakeholder perspectives from across the healthcare continuum, including patients, providers, payers and other health care 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 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. 4.1.
- Value frameworks should provide interpretable outputs that allow health care decision-makers and health care 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 formats 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 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 health care 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.
AMCP Where We Stand series: https://www.amcp.org/policy-advocacy/policy-advocacy-focus-areas/where-we-stand-position-statements
Revised by the AMCP Board of Directors, February 2022
1 Chandra,A; Shafrin, J, Dhawan R. JAMA. 2016;315(19):2069-2070. doi:10.1001/jama.2016.4915.
2 AMCP’s Format for Formulary Submissions available at https://www.amcp.org/Resource-Center/format-formulary-submissions/AMCP-Format-for-Formulary-Submissions-4.1. Accessed April 20, 2022.