Panzer AD, Enright DE, Graff J, Chambers JD
Journal of Managed Care & Specialty Pharmacy, 2022 Sep; 28(9): 1053-1058
Health plans universally state that the published scientific evidence is an important component in their drug-coverage decision-making process. Previous research identified variation in the decisions, as well as discrepancies in the number and types of studies health plans cite even when looking at the same drug and condition-specific decisions. However, it was unclear if these differences could be explained by different review times, information, or other decision processes.
Research published in the Journal of Managed Care & Specialty Pharmacy addresses this gap and examines the frequency with which health plans update their specialty drug coverage documents, the evidence cited in these policies, and the comprehensiveness of the evidence cited in their decisions.
Why it matters:
Understanding the evidence that health plans report when formulating drug coverage decisions is important for two reasons:
- First, for physicians and patients, it provides a better understanding of the rationale underpinning their access to specialty products.
- Second, for product manufacturers, it provides an important indicator of health plans’ evidence standard for coverage, which can aid in designing clinical development programs that meet plans’ needs.
The results of this work can serve as a foundation for future research examining the characteristics of studies that health plans cite in support of their coverage decisions. Working towards greater transparency for health plan evidence requirements would incentivize the generation of evidence relevant to decision-makers and increase the likelihood that it influences coverage decisions.
The researchers aimed to:
- Assess how frequently health plans update their specialty drug coverage decisions.
- Determine how frequently health plans update the evidence cited in these decisions.
- Compare the proportion of published evidence cited by plans in their specialty drug decisions.
To achieve these three goals, coverage policies from 17 large U.S. commercial health plans were retrieved from Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) Database for August 2017 and August 2019. Researchers identified drug-indication pairs (e.g., infliximab for rheumatoid arthritis) for which plans had issued coverage policies in August 2017 and August 2019 and examined the frequency that plans reissued these policies as well as the frequency that plans altered coverage criteria or updated the cited evidence.
A random sample of 20 drug-indication pairs was chosen to determine the comprehensiveness of cited evidence from SPEC. For each pair, a systematic literature search was conducted to identify relevant clinical and economic studies. The results of the systematic literature search were compared with the evidence cited in each drug-indication pair’s coverage policy to determine the comprehensive nature of each policy’s evidence.
Evidence-based medicine relies on the availability of evidence and the uptake of that information to inform decisions. Pharmacy and therapeutics (P&T) committee standards and best practices recommend that the best available evidence is used, and coverage decisions incorporate new evidence as it becomes available. But are health plans updating coverage policies? Are changes in coverage associated with changes in the evidence base? How comprehensive is the evidence cited? Researchers found:
- Most health plan coverage policies are routinely updated
- On average across the 17 health plans, at least 84% of all coverage policy documents are updated annually (range 19% to 100% across plans); Over a two-year period, nearly 95% of coverage policy documents were updated (range 66%-100%).
- On average, coverage decisions changed the restrictiveness 16% of the time (ranging from 9%-52% across health plans). If changes were made, coverage was most likely to become more restrictive rather than less restrictive.
- Further restrictions for step-edits or limiting the types or eligible prescribers were the most common restrictions for nearly 1 in 5 coverage decisions (range 7% to 58% across plans).
- 8 out of 10 health plan coverage policies update the evidence cited in coverage decisions
- 81% of the coverage decisions updated the evidence over the two-year period (ranging from 47% to 99%).
- Citations were more likely to be added rather than removed. On average 6.17 citations were added for each decision.
- Updates in the evidence were likely to result in a 60% greater likelihood of coverage.
- Only 1% of all evidence is cited in coverage policies
- Range (0.06%-2.6%) across all plans.
- Newer, rather than older, drugs are more likely to have more comprehensive evidence cited in coverage policies. Exondys for Duchenne’s was the highest with 24% of the evidence cited.
- One wouldn’t expect plans to cite all the available evidence. Still, assuming that 10% of the evidence is relevant and of high quality, the evidence cited by health plans is not comprehensive.
These findings suggest that there may be a mismatch between the evidence developed by researchers and the evidence cited in coverage policies. For example, researchers found that plans cited only a very small percentage of the available real-world studies and economic evaluations in their coverage policies. Greater transparency for health plan evidence requirements would help ensure that generated evidence is relevant to decision-makers.