Study of U.S. Commercial Health Plans Shows Widespread Variation in Coverage and Reimbursement for Specialty Medicines

July 9, 2018

WASHINGTON - A new study published in the July issue of Health Affairs shows that insurance coverage and reimbursement for specialty medications varies substantially, finding that only 15.9 percent of drug coverage policies are consistent across the largest U.S. commercial health plans. Less than half (48 percent) of all drug coverage decisions are consistent across the majority of health plans, according to the study by the National Pharmaceutical Council and the Center for the Evaluation of Value and Risk in Health, Tufts Medical Center.

"Beyond approval from the FDA, health plans determine whether or not new treatments will be covered. Health plans make different decisions on which treatments to cover and what restrictions to implement. We expected to see some differences in drug coverage across plans due to differences in budgets and covered beneficiary populations. What was not known was the extent to which these coverage restrictions occurred," says James Chambers, PhD, MPharm, MSc, lead author of the study and Associate Professor of Medicine, the Center for the Evaluation of Value and Risk in Health, Tufts Medical Center. "We found that even if a drug was covered, many treatments had multiple restrictions prior to patients being able to access these medications."

The study has implications for both patients and providers. "Variation in coverage may substantially influence patient access to specialty medicines," explains Jennifer Graff, PharmD, Vice President of Comparative Effectiveness Research at the National Pharmaceutical Council and one of the study authors. "For patients switching between insurers or employers, differences in plans' coverage decisions may result in care disruptions. It also requires that physicians tailor care not only to diverse patients, but also to the multiple insurance plans that provide health care coverage."

The study also found that although 52 percent of coverage decisions were consistent with the Food and Drug Administration (FDA)-labeled indication, restrictions were common. The most common restriction types were step edits, when a prior treatment must be proven ineffective before the plan will cover the treatment (73 percent); limitations on the types of physicians who could prescribe the medication (31 percent); and restrictions to certain patient subgroups (16 percent). There were multiple coverage restrictions in 22.5 percent of decisions.

Plans were less likely to restrict coverage for treatments indicated for pediatric populations, rare diseases or cancer. There were also fewer restrictions for medicines administered by a physician, without therapeutic alternatives, approved under an FDA expedited review program, without safety warnings, or approved less recently. The findings point to the need for greater transparency in the evidence used to determine plan coverage decisions, given the wide variations in plan coverage and restrictions.

Study results were generated through a systematic review of coverage decisions contained within the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) Database, which includes the most common policies for specialty medications issued by 17 of the largest U.S. 20 commercial health plans.

About the National Pharmaceutical Council

The National Pharmaceutical Council is a health policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. Founded in 1953 and supported by the nation's major research-based pharmaceutical companies, NPC focuses on research development, information dissemination and education on the critical issues of evidence, innovation and the value of medicines for patients. For more information, visit and follow NPC on Twitter @npcnow.