A new report highlights the potential pitfalls of formulary exclusion lists used by pharmacy benefit managers.
Formulary lists are used by pharmacy benefit managers (PBMs) to control costs and prevent unnecessary drug spending by incentivizing the use of lower cost and generic medications over costlier branded products.
PBMs say this practice reduces overall spending on prescription drugs and helps patients lower their out-of-pocket costs; however, advocates argue that formulary lists could actually harm patients by limiting access to therapies.
A report published by the Doctor-Patient Rights Project suggests that the number of drugs included on formulary exclusion lists has significantly increased over the last few years and may leave hundreds of thousands of Americans without access to proper treatment.
The new study found that the number of drugs included on both Express Scripts’ and CVS Caremark’s formulary exclusion lists increased from 132 in 2014 to 244 for 2018, an increase of more than 160%.
The authors suggest that patients with cancer may be required to switch to generic treatments and low-income minority patients with diabetes are hit especially hard by formulary exclusion lists.
“Formulary exclusion lists can undoubtedly serve as important tools to help manage the skyrocketing cost of patient care,” said Stacey Worthy, executive director of the Alliance for the Adoption of Innovations in Medicine. “But, in some instances, these lists can also cause stable patients to lose access to their medications in the middle of their treatment regimens, resulting in adverse events. Therefore, formulary exclusion lists must be implemented carefully so as not to disrupt care.”
The authors said that CVS was the first PBM to begin including cancer drugs on its formulary exclusion lists. Although CVS said cancer treatments were only excluded when an effective generic was available, the authors examined several studies that questioned the efficacy of the generic treatments, according to the study.
A significant number of diabetes drugs are also excluded from the formulary lists of large PBMs, the authors found. The analysis revealed that diabetes drugs account for one-fifth of all exclusions, an 80% increase over the last 4 years, according to the study.
Notably, diabetes drugs were the most excluded category, with the number of exclusions increasing each year.
The authors also found that low-income and minority patients may face the greatest impact by formulary exclusion lists. Low-income African American and Hispanic patients with diabetes may be more likely to skip doses of excluded drugs to make the prescription last longer or they may stop treatment altogether, according to the study.
The authors concluded that if even a small number of patients stop adhering to or discontinue therapy as a result of formulary exclusion lists, the resulting medical costs would significantly outweigh what was saved.
In contrast to the study, PBMs say that they have developed special pathways to ensure that patients can access necessary treatments and remain adherent to established regimens, meaning that just because a drug is excluded does not mean that all patients are unable to gain access.