A majority of health care plans and programs with a drug exclusion policy have been successful, reducing costs and not negatively impacting patient care, concludes a new study published in The American Journal of Managed Care.
But the lead author of the study has cautioned that any drug restrictions must be transparent, with the evidence that informs the policy clearly communicated to doctors and patients.
While the majority of the plans studied were successful in reducing costs without negatively impacting patients, a “not insignificant number” had the opposite effect, James Chambers, associate professor at Tufts University in Boston, and the lead author of the study, “The Impact of Formulary Drug Exclusion Policies on Patients and Healthcare Costs," told American Pharmacy News.
“The study wanted to see if drug exclusions reduce costs or impact patient health or not,” Chambers, of the university’s Institute for Clinical Research and Health Policy Studies, said. “In the majority of cases, policies have been successful — they did reduce costs and did not impact negatively on patient health.”
Chambers also cautioned that the sample was not large.
“In 28.6 percent of cases the study found that it did negatively impact the health of patients and in one of five increased net costs," he said.
Chambers added, “These policies do offer opportunities for increased efficiency but that a not insignificant amount did not work. The result is that care has to be taken with these policies.”
The study, carried out by Chambers with the director of the institute’s Center for Evaluation of Value and Risk in Health, Professor Peter Neumann, was published as the debate continues over insurers and pharmacy benefit managers (PBMs) increasingly excluding drugs from their formularies.
In 2016, Express Scripts increased the number of drugs excluded from their preferred drugs list from 66 to 80, and CVS/Caremark increased the number of drugs excluded from their standard formulary from 95 to 124.
The authors reviewed 26 studies on 27 drug exclusion policies. Twenty studies reported the impact of 21 drug exclusion policies on patients.
Six, or 28.6 percent, policies were reported to have had a positive impact, six (28.6 percent) a negative impact, and nine, or 42.8 percent, no impact on patients.
Eighteen studies reported the impact of 19 drug exclusion policies on overall health care costs, with 14 policies reporting reduced costs, one having a neutral impact, and four increasing costs.
The report concluded that, although there were important exceptions, most studies found that drug exclusion policies reduced costs and did not negatively impact patients.
It further reported that the drug exclusion policies that were found to increase overall health care costs typically did so because the reduction in drug expenditures was exceeded by the costs associated with increases in health care services elsewhere in the system, including hospitalization.
“Decision makers should thus be mindful of the potential negative clinical and economic consequences of drug exclusion policies,” the study stated. “Decision makers can help mitigate this risk by using formal cost-effectiveness analyses and budget impact models to account for all potential costs and benefits in their decisions. Drug exclusion policies should be transparent, with the evidence that informed the policy clearly communicated to patients and physicians, and implemented with a goal of maximizing continuity of patient care.”
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