Where We Stand:
Various organizations, including the American College of Cardiology, the American Heart Association, the American Society of Clinical Oncology, the European Society for Medical Oncology, the Institute for Clinical and Economic Review, Memorial Sloan Kettering Cancer Center, and the National Comprehensive Cancer Network, have developed conceptual frameworks intended to help evaluate the value of pharmaceuticals and other health technologies in patient care. 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.1 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.
The Academy of Managed Care Pharmacy (AMCP) supports the use of 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. However, for value frameworks to be meaningful they must be used in conjunction with other tools and resources, such as formulary review by pharmacists, physicians, nurses, and other health care professionals who make population health decisions. These health care professionals are in the best position to review the totality of evidence, including information contained in frameworks, to ensure that patients receive appropriate medications.
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 4.0 released in 20162, provides useful guidance on relevant evidence to consider in supporting value framework development. 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. 4.0.
- Value frameworks should provide interpretable outputs that allow health care decisions 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.
AMCP Where We Stand series: https://www.amcp.org/policy-advocacy/policy-advocacy-focus-areas/where-we-stand-position-statements
Approved by the AMCP Board of Directors, February 2017
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/amcp-format-formulary-submissions. Accessed January 8, 2017.