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July 20, 2022
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Nearly half of formulary exclusions offer ’questionable‘ clinical, economic benefit

Fact checked byShenaz Bagha
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Some formulary exclusions force patients to pay more for preferred drugs and use medications with dubious benefits for their needs, according to data published in the Health Science Journal.

“Other researchers have computed the number of annual exclusions and the types of medicines excluded,” Robert Popovian, PharmD, MS, the chief science policy officer at the Global Healthy Living Foundation, and senior health policy fellow at the Progressive Policy Institute, told Healio. “However, there is no research evaluating whether the exclusions are clinically sound or financially beneficial from a patient's perspective. This is why we were motivated to conduct the study and take a closer look at formulary exclusions.”

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Some formulary exclusions force patients to pay more for preferred drugs and use medications with dubious benefits for their needs, according to data.

To investigate whether formulary exclusions benefit patients, Popovian and colleagues analyzed data from the Express Scripts 2022 national formulary. Researchers categorized every exclusion as being an equivalent change, a therapeutic change or an exclusion with no viable alternative. Equivalent substitutions were defined as brand-name, generic or biosimilar drugs containing the same active ingredient as the excluded therapy. Therapeutic swaps were considered such if they did not contain the same active ingredient as the excluded drug.

In addition to these substitution classifications, the authors grouped the exclusions based on potential clinical and economic outcomes. A clinical outcome was determined if the substitution included drugs with the same active ingredient or formulation as the excluded drug. An economic substitution was considered a swap where the alternative drug contained similar ingredients, but was presumed cheaper than the preferred drug.

In all, the analysis included 563 exclusions. Of those, 258 exclusions had “questionable” clinical or financial benefits for patients, according to the researchers. About two-thirds of the exclusions were equivalent. Therapeutic substitutions made up 29.8% of the exclusions, and 1.6% had no preferred alternative.

“Although the medicines prescribed by rheumatologists may not be impacted through an exclusion, rest assured that at least a biopharmaceutical their patient is on will be affected,” Popovian said. “Hence, what rheumatologists and all [health care practitioners] need to do is to become an advocate for their patients accessing therapies that are in their best interest and aligned to current standards of care. They must continue fighting against policies that blur the line between insurance coverage and medical practice.”