Background: Advancements in biologics and personalized medicine and the implementation of national prescription drug policies have likely prompted payers to implement additional health technology assessment and cost-containment strategies. A payer's decision to provide coverage for a drug and its associated benefit design draws on information from many sources. However, there is an incomplete understanding of the process employed and the criteria applied in formulary assessments of pharmaceuticals by public and private health plans.
Objectives: To explore the pharmaceutical technology assessment (PTA) process to determine (a) who is involved in the decision making, (b) the timing and process of assessment and decision making, (c) the information and data that are considered, and (d) the outcomes of the assessment.
Methods: Using a convenience sample drawn for exploratory purposes, we targeted health plans, pharmacy benefit management (PBM) companies, stand-alone Medicare Part D prescription drug plans, Medicaid agencies, and drug compendia. We used multiple approaches to identify and recruit medical and pharmacy directors responsible for prescription drug benefit design and formulary management. We conducted 1-hour semistructured telephone interviews with pharmacy benefit decision makers between November 2009 and April 2010 to address the PTA process, and they rated the importance of different sources and types of evidence. Qualitative analysis and descriptive statistics were used to explore coverage, preferred choice, and utilization management.
Results: Thirty-two respondents representing 26 organizations participated in the interview. On a scale from 1 to 5 (not important to very important), interview respondents most valued published peer-reviewed studies, technology assessments, and internal data on drug utilization as sources of information (means = 4.68, 4.22, and 4.14, respectively). Randomized controlled trials (RCTs) and systematic reviews/meta-analyses were the most valued types of evidence (means = 4.40 and 3.66, respectively); economic and observational data studies received low ratings (means = 3.19 and 3.03, respectively). There was substantial variation in the process of evidence review, who and how individuals participated in the process, and outcomes related to formulary tier placement and utilization management.
Conclusions: U.S. health plan payers have established processes for PTA and prefer certain sources and types of evidence. Formulary decision makers value a broad range of information, and the specific factors influencing coverage and utilization management decisions vary across organizations and therapeutic areas.