The processes and evidence used in making pharmaceutical coverage decisions vary substantially among US health plan payers. These variations during the pharmaceutical technology assessment (PTA) process could affect reimbursement, patient access, and potentially heath care outcomes across health plans.
While there is prescriptive information about how evidence should be shared with P&T members and payers, how this evidence is assessed is highly variable.
- Although US payers prefer similar types of evidence, there is considerable variability in how they evaluate that evidence
- Level of knowledge and sophistication
- Level of scientific rigor
- Level of transparency in reporting/supporting coverage policies
- Heterogeneous approaches in evidence evaluation may be driving variable reimbursement and patient access outcomes
Although all payer respondents used a structured approach to gather and review evidence, only two organizations had a systematic manner to grade evidence based upon rigor, validity and quality.
- An increased emphasis on systematic approaches and greater transparency in decision-making could improve objectivity and consistency
- Payers remain challenged about how to make decisions when the available evidence is inconsistent or inadequate
Payers were less likely to use observational data than randomized controlled trials (RCTs) and systematic reviews, but did not express concerns about using their own observational data.
- Although most payers use internal utilization data at P&T, the role of this data varies among US plans
- Most are cost/volume data and do not include information about patient outcomes
- Payers placed the highest value on randomized controlled trials, followed by systematic reviews/meta analyses and peer-reviewed articles
For health plans, PBMs and Medicaid drug review committees, the result of PTA may include coverage, tier placement and utilization management recommendations.
- “Tier assignment decisions were largely based on expected clinical outcomes, and most payers placed a new pharmaceutical into the second or ‘preferred brand’ tier if it was expected to provide superior outcomes relative to its comparators in the same class.”
- There were substantial variations among respondents regarding whether and how P&T decisions affected contract and rebate negotiations with manufacturers.
As decision-maker requests for evidence expand (CER, etc.), it is unclear what information will be utilized given the highly subjective nature of what will be considered "must have" vs. "need to have" information
An increased emphasis on systematic approaches and greater transparency in decision-making could improve objectivity and consistency.
About the Methods/Results:
One-hour, structured interviews were conducted with 26 respondents from payer, payer-intermediate, and drug compendium organizations between November 2009 and April 2010.
Due to copyright issues, the article must be downloaded from the Journal of Managed Care Pharmacy website.