Payors need health care economic information (HCEI) that enables them to quantify the anticipated economic outcomes and overall value of therapies. This information ultimately informs coverage and reimbursement decisions. Accounting for coverage of new and existing therapies within a payor’s budget requires robust economic data that is communicated well and to tight deadlines.
HCEI encompasses more than simple cost comparisons. It can dive deeper and provide insights to the broader economic effects of therapy, which are often based on the clinical consequences of disease and treatment. As defined in Section 502(a) of the Food, Drug, and Cosmetic Act1, HCEI identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcome, of the use of the drug. HCEI may include an analysis comparing the economic consequences to alternative options (including the use of another drug) or to no intervention.
HCEI can be generated for multiple evidence areas such as efficacy that lowers total cost of care or a safety profile that avoids the cost of treating adverse events. Generating robust and compelling HCEI for a product can help to differentiate it from its competitors.
Multiple tools can be used to communicate and deliver HCEI to payors; examples include budget impact models, slide decks, flash cards, Academy of Managed Care Pharmacy (AMCP) dossiers and poster presentations. In the process of developing these tools manufacturers should consider the following points.
- What HCEI evidence is relevant to your product and important for payors?
- What is the optimal timing of HCEI communications?
- Who within the payor organization should receive HCEI?
- Who within the pharmaceutical manufacturer organization should communicate HCEI?
For manufacturers, having a strategic plan for producing and communicating HCEI to payors is key to illustrating the full value of new and existing therapies.
The Food and Drug Administration’s guidance on communicating HCEI?
The Food and Drug Administration (FDA) has provided ongoing guidance on how manufacturers can communicate with US payors.2 However, within the pharmaceutical industry there is still significant variability in how this guidance is interpreted.
What is Health Care Economic Information (HCEI) and how should it be communicated?1
What is HCEI?
HCEI is an analysis that identifies, measures, or describes the economic consequences of the use of a drug. HCEI may be based on the separate or aggregated clinical consequences of the health outcomes being represented.
What is the data standard?
HCEI must be based on competent and reliable scientific evidence (CARSE). HCEI is based on CARSE if it has been developed using generally accepted scientific standards, appropriate for the information being conveyed, that yield accurate and reliable results. This standard includes clinical data and inputs underlying the drug’s economic consequences, including indirect treatment comparisons.
Who is the appropriate audience?
HCEI can be provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement. Food and Drug Administration (FDA) guidance does not apply to dissemination of HCEI to other audiences, such as healthcare providers making individual patient prescribing decisions.
Who can deliver HCEI?
FDA guidance does not limit who can deliver HCEI to payors.
What are the barriers to communicating Health Care Economic Information to payors?
While the FDA has issued ongoing guidance, some of it may be unclear to pharmaceutical companies and this creates potential barriers to appropriate communication of HCEI. Guidance on specific considerations may be limited or missing, with the result that the HCEI messaging from manufacturers to payors is limited in scope. There may be internal challenges in identifying an appropriate process for creating and managing HCEI communications, and disagreement between internal teams as to what the guidance will allow can interfere with fully generating and communicating HCEI.
A key success factor for a well planned and executed strategy to produce and communicate HCEI is a robust internal data review process. Internal alignment between health economics and outcomes research (HEOR), Market Access, Medical Affairs, Legal and Regulatory teams can unite everyone involved in the process. This can ensure that a manufacturer fully leverages HCEI for their product. Timely, effective and compliant HCEI communication is vital for both manufacturers and payors.
- Federal Food, Drug, and Cosmetic Act (FD&C Act). 2018. Available at: https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act Accessed: 16 December 2022.
- Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-and-device-manufacturer-communications-payors-formulary-committees-and-similar-entities Accessed: 9 December 2022.