Current and Future Use of HEOR Data in Healthcare Decision-Making in the United States and in Emerging Markets

Background

Health economics and outcomes research (HEOR) is a growing field that provides important information for making healthcare coverage and access decisions. However, there is no standard process for incorporating HEOR into the decision-making process, and the current use of HEOR by healthcare payers remains unknown.

Objectives

To examine how HEOR data are being used by healthcare payers, including managed care organizations today, and how the use of such data is expected to change in the future in relation to access and reimbursement decision-making.

Methods

The Managed Care Survey (MCS) and the Pharmacy & Therapeutics (P&T) Committee Survey (PTS) were distributed to decision makers in the United States. A total of 72 managed care decision makers responded to the MCS and 30 P&T Committee members responded to the PTS from US healthcare organizations that cover from tens of thousands to millions of lives. The goal of these surveys was to understand the current use of HEOR data, perceived barriers and limitations in the use of HEOR, and the expectations for future use, and how these and other factors affect formulary decisions. An international perspective was gained by modifying the MCS based on feedback received at a European conference, and a pilot version was given to individuals in emerging markets across Asia, Latin America, and the Middle East and Africa.

Results

The majority of US respondents to the MCS (74%; N = 53) and to the PTS (77%; N = 23) indicate that HEOR is currently being used in their decision-making process; but the majority of respondents to the MCS (66%; N = 48) also state that quality assessment is limited (quality assessment was not addressed in the PTS). In addition, the majority of respondents to the MCS (82%; N = 59) expect the use of HEOR to increase in the future. Safety and efficacy were reported in the PTS to be the most important factors in the P&T Committee decision-making process, followed by head-to-head comparisons, and cost. The current use of HEOR in Asia, Latin America, and the Middle East and Africa varied widely across respondents.

Conclusion

This study provides an important benchmark of HEOR use in the United States before the implementation of healthcare reform. Between the years 2010 and 2011, HEOR data were used to varying extents across global regions, but their use in the future is likely to increase in relation to access and reimbursement decisions.With increasing access and utilization of healthcare, resources become more restricted, and prioritization in healthcare becomes unavoidable. Health economics and outcomes research (HEOR) is a discipline that is used to complement traditional clinical development information (ie, efficacy, safety, quality) to guide decision makers regarding patient access to specific drugs and services. HEOR has advanced considerably in methodology and in quantity over the past several decades. HEOR can provide data to help healthcare payers determine if treatments work in the populations they serve, and how much of the drug or treatment cost should be reimbursed by the healthcare system.As a key part of the request for comparative effectiveness evidence, the increased use of HEOR data can be expected in future decision-making processes.1,2 In addition, a greater emphasis has recently been placed on positioning the patient at the center of healthcare decisions. Outcomes research plays an increasingly important role in this, because it can provide data on specific populations and treatment combinations that are used. Understanding how these data are used in decision-making in the United States and globally can direct future efforts in this area.Currently, several global reimbursement agencies formally ask for HEOR information for their standard assessment process, including the National Institute for Health and Clinical Excellence in the United Kingdom, some of the Spanish health technology assessment (HTA) agencies, the Korean Health Insurance Review Agency, and the Health Intervention and Technology Assessment Program in Thailand.3–5 However, health-care payers in the United States do not currently have a standardized process for requesting or for using HEOR data. In the United States, HEOR data may come primarily from pharmaceutical companies via the Academy of Managed Care Pharmacy (AMCP) dossier format. Consequently, the pharmaceutical industry invests heavily in HEOR studies alongside clinical trials and continues to collect clinical, humanistic, and economic real-world data throughout the life cycle of a therapy.3 Discussions between healthcare payers and academic health economists suggest a need for this information by decision makers, but there is a lack of standardization regarding how such information is integrated into the current processes for drug (and other technology) evaluations.6,7Therefore, it remains unclear how healthcare payers in the United States currently use HEOR, and whether the use of such evidence will change in the future. The objective of this article is to describe the current and expected future use of HEOR data by healthcare payers, and to examine how pharmaceutical drug and manufacturer attributes are used in the decision-making process. This article summarizes the results of 2 surveys administered to individuals in formulary and reimbursement decision-making positions in the United States, as well as an adaptation of one of these surveys and workshops performed in other parts of the world.