Study: Health Plans Adjust Drug Coverage Criteria Based on New Evidence

Health plans use updated evidence when revising their specialty drug coverage policies, but those updates tend to focus on health technology assessments, randomized clinical trials, and systematic reviews/meta-analyses and not real-world evidence studies and economic evaluations, according to a recent review published in the Journal of Managed Care + Specialty Pharmacy.

James D. Chambers, Ph.D.

“The mismatch between the evidence developed by researchers and the evidence cited by health plans suggests that health plan officials may not find much of the available evidence to be of value when formulating coverage policies,” James D. Chambers, Ph.D., one of the authors of the paper told Formulary Watch. “Going forward, we should aim for greater alignment. This may require product manufacturers to engage earlier, and more often, with health plans when developing evidence generation programs for their products.” Chambers is associate professor of medicines, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center in Boston.

Researchers at the Institute for Clinical Research and Health Policy Studies reviewed the citations of clinical and economic evidence plans included in their drug coverage policies between August 2017 and August 2019. They identified drug-indication pairs (e.g., infliximab for rheumatoid arthritis) and examined the frequency with which plans reissued these policies between these two time points and the frequency with which plans altered coverage criteria or updated the cited evidence.

Researchers selected 20 drug-indication pairs and they performed a literature search of PubMed to identify the evidence available, including randomized controlled trials, real-world evidence studies, other clinical studies, economic studies, technology assessments and treatment guidelines. They then compared the literature search with evidence cited in coverage policies.

They identified 4,597 coverage policies that plans made available in both August 2017 and August 2019, of which plans reissued 4,468 (97%). Of the reissued policies, 17% revised coverage criteria and 84% revised the evidence cited, and 15% of reissued policies revised both their coverage criteria and the evidence cited, 2% revised only their coverage criteria, and 69% revised only the cited evidence. A total of 14% of policies revised neither the coverage criteria nor the evidence cited.

For drugs approved no earlier than August 2014, plans cited randomized controlled trials and other clinical studies most comprehensively (7% and 5%, respectively); for drugs approved from August 2009 to August 2014, plans cited clinical guidelines and evidence synthesis studies most comprehensively (8% and 5%, respectively); and for drugs approved before August 2009, plans cited health technology assessments most comprehensively (4%).

“Our study indicates that the evidence cited in coverage policies evolves over a product’s life cycle. Plans tended to cite RCTs and other clinical studies for recently approved products and cite clinical treatment guidelines and evidence syntheses for products on the market for longer,” researchers wrote.

Researchers cited several limitations, including a reliance on health plans’ publicly available coverage policies. They said that plans may not fully report the evidence that they review. Additionally, the suggested that the study may not be generalizable to other U.S. commercial health plans or to public healthcare payers (e.g., Medicaid and Medicare). They also did not investigate how newly cited studies affected plan decision making.

This study was funded by the National Pharmaceutical Council.