Drug Formulary Exclusion Lists Reduce Patient Access to Treatment

Drug formulary exclusion lists are getting longer, making it more difficult for patients to access the medications and treatments they may need to manage their illnesses, according to a recent study from the Doctor-Patient Rights Partnership (DPRP).

A drug formulary list is “a list of prescription drugs covered by a prescription drug plan or another insurance plan offering prescription drug benefits,” according to Healthcare.gov.

A formulary exclusion list includes the drugs that an insurer, health plan, or pharmacy benefits manager (PBM) does not cover.

Proponents of drug formulary exclusion lists say they quell costs by having patients use lower cost drugs. Ideally, patients should be using drugs that are the best value for their cost. CVS estimates that it will save over $4 billion from its exclusion list in 2018, and Express Scripts reports it will save about $2.5 billion.

However, drug formulary exclusion lists are growing too long, which keeps patients from accessing the medication they truly need. Drug formulary exclusion lists ranked as the top reason why a patient’s medication claim was denied in 2017, with 37 percent of patients reporting such, according to the DPRP report.

Drug formulary exclusion lists have increased by nearly 160 percent since 2014, the DPRP report found. In 2014, the combined number of treatments on CVS Pharmacy’s and Express Scripts’ drug formulary exclusion lists ran at 132 treatments. In 2018, that list has grown to 344.

These skyrocketing drug formulary exclusion lists will likely have a negative impact on patient access to effective treatment, DPRP founding member Stacey Worthy said in a statement.

“Formulary exclusion lists can undoubtedly serve as important tools to help manage the skyrocketing cost of patient care,” explained Worthy, Executive Director of the Alliance for the Adoption of Innovations in Medicine (Aimed Alliance). “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.”

Both CVS and Express Scripts, which have the largest pharmacy market share per DPRP’s report, both predict that patients will need to adjust their medication access as a result of the growing formulary exclusion lists. About 275,000 patients will need to switch medications because of the exclusions, the health companies have said.

To its credit, CVS has become the first PBM to allow cancer patients to remain on their treatments regardless of formulary exclusion list status, the report noted. Despite the benefits of this move, DPRP claims that the choice confirms that some medications on drug formulary lists are not equivalent alternatives.

Some patient demographics will suffer from the growing drug formulary exclusion lists more than others, the report showed. Treatments for diabetes, for example, are the most consistently included on exclusion lists. Low-income and minority patients will also likely be adversely impacted by these growing lists.

Patients might cope with limited treatment choices by becoming non-adherent to their treatment protocol. If a certain treatment is on a PBM’s exclusion list, the patient may not work to identify the best fit, the report suggested.

But limited medication adherence has its own costly healthcare impacts, the researchers acknowledged. When a patient does not take her medication, she runs the risk of her condition deteriorating. This in turn could call for more medical treatments that could be costly.

Healthcare professionals have recently begun to question certain PBM cost-cutting strategies. In addition to drug formulary lists, many PBMs and payers have step therapy and prior authorization requirements.

Step therapy asks patients to try the lowest-cost drugs first in an attempt to land on the most effective drug at the lowest possible cost.

Prior authorization asks patients to receive permission from stakeholders including payers and providers before using a certain drug.

Both of these processes can be lengthy and keep patients from accessing their medications in a timely manner.

In 2017, trade groups such as the AMA have offered strategies to reduce these barriers. While these treatment authorization strategies do have the power to reduce healthcare spending, they must be used efficiently and judiciously to also care for the patient.

“Utilization management programs, such as prior authorization and step therapy, can create significant barriers for patients by delaying the start or continuation of necessary treatment and negatively affecting patient health outcomes,” AMA wrote in a previous report.

“Due to its widespread usage and the significant administrative and clinical concerns it can present, the AMA believes that prior authorization is a challenge that needs to be addressed through a multifaceted approach to reduce burdens on physicians and patients,” the organization said.