Evidence-based medicine relies on the availability and uptake of information to inform decisions, including coverage and reimbursement decisions. To deepen our understanding of how evidence impacts coverage decisions among insurers, the NPC/Tufts team sought to determine the answers to three key questions:
- How frequently health plans update their specialty drug coverage decisions,
- How frequently health plans update the evidence cited in these decisions, and
- To compare the proportion of published evidence cited by plans in their specialty drug decisions.
This study, published in the September issue of the Journal of Managed Care and Specialty Care Pharmacy, found that:
- Most health plan coverage policies are routinely updated. On average, 84% of plans are updated annually and 95% over a two-year period.
- 8 out of 10 coverage policies update the evidence in health policies
- Only 1% of all evidence is cited in coverage policies, suggesting that relevant, high-quality research is not being considered by plans.
It is still unclear what a “good,” or, comprehensive review of the evidence would be. But, assuming that 10% of the evidence is relevant and of high quality, researchers expected to see a higher proportion of evidence cited. Instead, for most drug-indication pairs, only 3% of the evidence was cited and no plan cited more than 24% of the available evidence across all 20 studied drug-indications pairs. These findings show a mismatch in the evidence developed, the evidence evaluated, and the evidence used in decision-making—which is not efficient for researchers, funders, clinical practice guideline groups, health plans, and the patients participating or contributing data.
The restriction or exclusion of specialty medications has key implications for patients. The path forward should focus on the evidence developed and processes to encourage the use of that evidence. This includes:
- Development of better and more impactful evidence.
- Greater availability of evidence that is fit-for-use-could increase the amount of evidence cited by plans. The FDA is working to define regulatory-grade evidence. Similarly, efforts to identify “reimbursement-grade” or “HTA-grade” evidence are needed. Understanding payer thresholds and requirements or engaging in early payer dialogues with plans can help ensure the evidence created is useful.
- Increased transparency and consistent evidence reporting.
- Processes for reporting different types of evidence vary. A more consistent reporting format (e.g., EuNehta or updated sections in the AMCP Format dossiers) could help enable more consistent evaluation.
- Voluntary processes to aid more consistent evaluation of evidence.
- Malone et al. found that a key barrier to health plan use of evidence is the organization’s capacity. Health plan representatives report the need for tools and continuing education on evaluating and using real-world evidence (RWE) and other types of evidence.
- Others could contribute to evidence synthesis capacity to reduce the time and effort required. With health plan consolidation, administrative costs to conduct reviews can be spread across the larger plan membership.
- Encouragement from regulatory and accreditation bodies to use “best available evidence.”
- Groups that provide accreditation or standards (e.g., CMS Part D, URAC PBM, and Health plan standards, etc.) could require expertise with diverse evidence types among plan staff or pharmacy and therapeutics (P&T) committee members.
Addressing these areas can help drive more consistent use of evidence, which will ultimately provide a better understanding for patients and physicians of the rationale underpinning their access to specialty products. Furthermore, product manufacturers will possess an important indicator of health plans’ evidence standard for coverage, helping them design clinical development programs that meet plans’ needs. Ultimately, working towards these solutions would ensure patients’ appropriate and evidence-based access to specialty medicines.
Over the past four years, NPC and their research partners have endeavored to explore this important subject. NPC and the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center’s first study, published in 2018, found that insurance coverage and reimbursement for specialty medications varied substantially, with only 15.9% of drug coverage policies consistent across the largest United States commercial health plans. Less than half of all coverage decisions were similar across the majority of the health plans reviewed.
In their next study, the NPC/Tufts team examined one potential factor: the use of evidence by payers to inform those same coverage decisions. They found only 15% of coverage policies cited the same study evaluating a specific drug for a specific indication. While it is expected that not all studies were cited by all plans, only 38% of all studies were cited by more than one plan. Underlying this inconsistency, the quantity of evidence used varied widely.
This prior research identified variation in the decisions, even among the amount and types of studies health plans cited for the same drug or condition-specific decisions. Yet, it was still unclear if these discrepancies could be explained by different review times, information, or other decision processes.