Study shows wide variation in specialty drug coverage among commercial payers, but rationale is murky

Pills in pill container
Different commercial payers use different rationales to determine patient access to specialty drug therapies. (Getty/Viperfzk)

Specialty drug coverage varies widely among commercial health insurers, but exactly why those variations occur remains murky, according to a new study.

Using data from Tufts Medical Center’s Specialty Drug Evidence and Coverage Database, a new study published in Health Affairs tracked payer coverage decisions for specialty drugs and how consistently they align with FDA indications. Across the 3,417 decisions evaluated by researchers, only 16% received equivalent coverage from all plans. Those coverage decisions that diverged from label indications were typically more restrictive.

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While researchers expected some variation, the level of variation came as a surprise, according to the study’s lead author, James Chambers, Ph.D., a researcher in the Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center.

The study found restrictions on coverage more likely when alternative drugs existed for a given indication, and in most cases, the restrictions involved step edits, where a patient needs to prove the ineffectiveness of an alternative drug before the insurer would alter its decision.

Findings also showed less restriction in cases where alternatives did not exist or where indications covered especially vulnerable populations, such as orphan diseases, pediatric patient populations or well-established drugs with few safety warnings.

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Different health plans cover different beneficiary populations and negotiate with product manufacturers for volume discounts, so payers have a range of possible rationales for restricting access to specialty drugs. In many cases, however, the rationale used to arrive at a restrictive coverage decision remains opaque to consumers, physicians and even drug manufacturers, raising questions about what exactly drives those decisions.

For example, the use of step edits might imply a learning process where insurers build evidence to support decisions about which drug works for a given subpopulation. However, Chambers points to differences between step edits applied by various payers as a reason to question whether such decisions arise form a base of solid evidence.

“One would assume that if these decisions were truly evidence-based, you maybe would be less likely to see the extent of the variation that we documented,” he told FierceHealthcare.

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Ultimately, the questions raised by the study point to a lack of transparency around the decision-making process commercial payers use for specialty drug coverage. Chambers pointed out that some payers do cite evidence in support of their decisions, but he worries that the lack of information in many cases could hurt patients.

“If we can get a better handle on the types of evidence the payers are using to make these decisions, then we can generate evidence and develop evidence that best meets these payers’ requirements, and potentially would expedite patients’ access to these important therapies,” he said.