PBM Exclusions Increasing, Finds New Analysis

Xcenda’s review of the three largest PBMs—CVS Caremark, Express Scripts, and OptumRx—finds they are excluding medicines in classes where generics are not available or for serious conditions, such as oncology and autoimmune disorders.

In 2022, at least one of the three largest PBMs—CVS Caremark, Express Scripts, and OptumRx—placed a total of 1,156 medicines on their standard formulary-exclusion lists, an increase of 961% from 2014 when just 109 therapies were excluded, according to a recent analysis by Xcenda.

Xcenda’s analysis found that PBMS are increasingly excluding medicines in classes where generics are not available or for serious conditions, such as oncology and autoimmune disorders. In fact, the number of single-source medicines excluded from at least one PBM formulary increased from 50 in 2014 to 548 in 2022.

“Formulary exclusions can limit patient and provider choice and may prevent a patient from accessing a particular medicine unless they pay completely out of pocket or undertake a burdensome appeals or exceptions process,” Xcenda researchers wrote.

In 2020, Xcenda created a database of the 2014 to 2020 standard commercial formulary exclusion lists for Express Scripts, CVS Caremark, and OptumRx. Researchers classified medicines as excluded if they were placed on one or more of the three PBM formulary exclusion lists for at least one plan year between 2014 and 2022.

Formulary exclusions most often impacted are therapies in diabetes, autonomic and central nervous system disorders, cardiovascular disease, and dermatological conditions. Compared with 2014, almost six times more cardiovascular treatments were excluded from one or more PBM formulary in 2022, according to Xcenda research.

Oncology is one area where exclusions are increasing. The highest number of oncology exclusions occurred in 2022 for each of the three largest PBMs. “The trend in formulary exclusions for oncology medicines suggests some patients with cancer may face barriers to access for medications included in their treatment plan,” Xcenda said.

One example an excluded drug is Eliquis (apixaban), from Bristol Myers Squibb, which was removed from CVS Caremark’s drug list for 2022. It is an anticoagulant approved to treat and prevent blood clots and stroke.

Related: CVS Caremark Announces Formulary for 2022

The alternatives CVS recommended for Eliquis include warfarin or Xarelto (rivaroxaban), which has sparked concern among doctors and patients about “non-medical switching.” For example, patient and patient advocate Beth Waldron had been notified by mail in November 2021 that Eliquis, a therapy she had been taking eight years and was stable on, would no longer be covered.

“For me personally, for my type of blood clots, the clinical studies show that patients have lower risk of recurrent clot and lower risk of major bleeding—including intracranial and serious internal bleeding abdomen while taking Eliquis,” she said in a recent interview.

A study published in January 2022 in the Annals of Internal Medicine showed that patients with venous thromboembolism (VTE) who started on Eliquis had lower rates for recurrent VTE and bleeding than those who started on Xarelto.

For Waldron, her doctor was able to get a prior authorization approval from CVS for Waldron to remain on Eliquis. Her advocacy work continued, and Waldron is committed to helping other patients remain on therapy.

CVS Caremark, however, has not been willing to speaking specifically about Eliquis. A company spokesperson said by email in November 2021 that CVS Caremark uses formulary management and preferred placement to negotiate better pricing and greater discounts to reduce costs for payers when clinically equivalent alternatives are available.

But the Xcenda analysis indicated that exclusions may be driven in part by misaligned PBM incentives, especially if pharmaceutical manufacturers are willing to offer greater rebates on drugs that are given preferred status, even if that means the excluded product is less expensive.

Xcenda researchers are concerned that the increasing exclusions are burdensome to patients and that burden may be particularly challenging for underserved populations. “The alarming growth in the number of medicines excluded from PBMs’ formularies warrants additional research on the impacts such coverage restrictions have on patients, providers, and the healthcare system,” they wrote.