Major PBM’s formulary exclusions cause concerns

Schafer

Pharmaceutical industry observers are concerned about some of the drugs that were slashed from Express Scripts’ 2019 National Preferred Formulary.

The PBM’s annual list of excluded medications encompasses 48 new medications, including the anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim), the hepatitis C medication sofosbuvir (Sovaldi, Gilead Sciences), and the HIV antiviral drug efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla, Gilead).

“They are excluded in exchange for bigger rebates from those drugs with preferred status. I expect other PBMs to exclude others to get the same deal,” Robert Goldberg, co-founder and vice president of the Center for Medicine in the Public Interest, told FormularyWatch.

"High drug prices are one reason that the U.S. spends more per capita on healthcare than any other developed nation. For far too long, drugmakers have been charging whatever the market will bear for their medications, including drugs that do not provide any additional clinical value for patients," said Steve Miller, MD, chief medical officer of Express Scripts, in a statement from the PBM. "Formularies such as our National Preferred Formulary, which drives out waste and gives preference to medications with lower prices and high value, can help Americans save significantly on their healthcare costs without sacrificing quality or care.”

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Preference on Express Scripts’ NPF is given to high-value therapies with the lowest net cost for clients, achieved through low list price, rebate or both, according to Express Scripts.

For example, efavirenz, lamivudine and tenofovir disoproxil fumarate (Symfi, and Symfi Lo, Mylan) are preferred for hepatitis C. The medications boast 40% lower list prices than Atripla.

However, the exclusions should be of concern to many pharma makers, including those specializing in medications to treat rare diseases - which typically have not been excluded on Express Scripts’ formulary, Jeremy Schafer, senior vice president at Precision for Value, told FormularyWatch. Examples include anti hemophilic factor Xyntha (Pfizer) and C1 esterase inhibitor (human) Berinert (CSL Behring) for hereditary angiodema.

“The surprise overall was the inclusion of some rare disease categories, and the inclusion of anticoagulants was also a surprise,” Jeremy Schafer, senior vice president at Precision for Value, told FormularyWatch. “Patients may be started on these products in the hospital and then discharged home. Will the patient be stopped by an exclusion and have a delay in therapy as the doctor files for a prior authorization or considers an alternative?”

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Several new therapy categories were included in the exclusions on Express Scripts’ 2019 NPF, including hemophilia, HIV, and hereditary angioedema, Schafer said. “The reasons for the exclusions are likely multifactorial. One reason could be changes in cost, but it may also be due to the increased competition within the class.”

Express Scripts’ move to cut some drugs for rare diseases is “problematic, because the belief that certain diseases may be too rare or too sensitive to be managed is now being challenged,” Schafer said. “If the PBM is successful, other PBMs will follow, leading to potential market commoditization and increased discounting.”

“Manufacturers of rare disease products need to be able to educate payers on the total value their products bring to the market. How a product improves patients clinically is important but how does it impact cost, how is healthcare resource utilization impacted, and what is the expected long-term benefit are important as well? Healthcare is shifting to a focus on value and rare disease manufacturers need to tell a story that resonates with the evolving marketplace,” Schafer added.

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