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Shifting Health Plan Policies Impact Access to Specialty Drugs


The number of health plans that put in place restrictive policies that go beyond FDA-approved label is increasing, a new Tufts study finds.

Commercial health plans in the United States seem to be implementing more limitations and restrictions when it comes to coverage for specialty drugs, according to a recent analysis of health plan policies from 2017 to 2021 by researchers at Tufts Medical Center.

While no standard definition exists for specialty drugs, drugs in this category are typically very expensive and have complex handling and administration requirements. Specialty drugs include biologic and protein-based medications prescribed for treating complicated conditions such as autoimmune disorders, cancers, and rare diseases.

Previous research has found that for specialty drugs in particular, commercial health plans set more restrictive criteria for coverage than the FDA labeling about 33% of the time. The restrictions and medication-indication pairings, which exist primarily to control costs, often create complex challenges for patients, especially those in need of treatment with specialty drugs. For this reason, coverage often varies between different health plans and even within an individual health plan over time.

To better understand these changes and restrictions, a group of researchers at Tufts Medical Center conducted a study looking at trends in specialty drug coverage. The team collected data on specialty drug-indication pairings from 17 major health plans (representing about 70% of individuals with prescription drug coverage in the United States) from 2017 to 2021. Then the team looked at any addition or removal of coverage and changes in potential drug restrictions. The four types of restrictions included patient subgroup requirements, step-therapy protocols, specialist prescriber requirements, and other mandates, such as combination therapy protocols.

James D. Chambers, Ph.D.

James D. Chambers, Ph.D.

The investigation used the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) Database, which is a database maintained by a team of researchers led by James D. Chambers, Ph.D., associate professor of Medicine at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies.

The researchers collected data on 357 drug-indication pairings in all. Between 2017 and 2021, the percentage of pairings that had restrictions increased from 39.5% to 51.7%. Over the same period, the proportion of pairings with two or more restrictions rose from 10.2% to 18.4%. Of the 17 U.S. commercial health plans investigated, 13 increased their limitations on specialty drugs, while only four plans reduced their coverage restrictions.

Most of the restriction increases came in the form of step therapy-protocols and prescriber requirements. While restrictions increased, outright exclusion of drug-indication pairings from coverage remained stagnant at 3% throughout the four-year study window.

“The most important implication is for patients. It suggests that health plans are ‘tightening’ their drug coverage policies, which means that patients face additional utilization management criteria before they can access certain treatments,” Chambers told Formulary Watch.

Chambers explained the likely reason for these findings is that “health plans face increasing budgetary pressures, driven in part by high drug prices. The approval of more costly cell and gene therapies, among other expensive new orphan drugs, may have led plans to better control utilization of costly products.”

“Plans can use utilization management as part of their negotiations with product manufacturers, for example, by providing more favorable coverage for a lower price,” he said.

While these restrictions may help ensure more appropriate care for some, they can delay or impede access to care for others while placing a significant burden on the healthcare system. Further research is required to understand how these restrictions impact patient cost-sharing and access.

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