Amgen, Coherus Pegfilgrastims Lose Formulary Placement

In what a company spokesman described as a minor setback, Coherus BioSciences has seen its Udenyca pegfilgrastim biosimilar dropped from the 2021 national preferred formulary list for the pharmacy benefit manager (PBM) Express Scripts, whose revenues in 2017, prior to its takeover by Cigna, amounted to over $100 billion.

Amgen’s Neulasta originator pegfilgrastim product was also switched to nonpreferred status on the 2021 formulary.

“Less than 5% of the pegfilgrastim market by unit volume is reimbursed through the nonmedical/pharmacy benefit,” the Coherus BioSciences spokesman said. “Express Scripts represents only a fraction of the pharmacy benefit, so a fraction of the ~5% volume.” The spokesman said the company is mainly focused on moving Udenyca through the medical benefit side, which applies to hospital and clinic administration of the drug.

Negotiations Determine Placement

Formulary placements with PBMs typically involve negotiations with manufacturers over rebates and discounts with manufacturers. Two other pegfilgrastim biosmilars, Sandoz’ Ziextenzo, and Biocon’s Fulphila, remain on the Express Scripts preferred list for 2021. All 4 pegfilgrastims, including the reference product, were included on the 2020 preferred list.

There was no inclusion on the list or reference to Pfizer’s Nyvepria pegfilgrastim biosimilar, which got an FDA approval in June and is expected to be launched in 2020.

Pegfilgrastim is used for the treatment of infection associated with febrile neutropenia in patients undergoing treatment with myelosuppressive anticancer agents. The drug is a granulocyte colony stimulating factor.

Despite the formulary placement outcome, Coherus BioSciences has glowing expectations for Udenyca, which was launched on the US market in January 2019.

In a 2020 second quarter earnings call on June 30, Denny M. Lanfear, president and CEO, said the market for Udenyca was expected to grow throughout the remainder of 2020, supported by a rebound in treatment of patients with cancer following the coronavirus disease 2019 (COVID-19)—induced slump. Further, updated National Comprehensive Cancer Network and American Society of Clinical Oncology guidelines have contributed to a rise in use of pegfilgrastim.

Express Scripts is aggressive about price negotiations in order to offer attractive health care options for the employers, managed care providers, health insurers, and others it represents. The company has extended that focus to lobbying Congress to tamp down specialty drug costs. Although the proportion of patients who use them is relatively small, biologics alone represent 42% of the total medicines market.

Express Scripts has urged Congress to eliminate manufacturers’ ability to set prices for certain critical drugs under Medicare Part D (prescription drugs) and has urged that Part D-style negotiation be introduced for Part B drugs (infused drugs). Further, the PBM has urged that coverage of some Part B drugs be shifted to Part D.

As of press time, Amgen had not responded to a request for comment. Second quarter 2020 sales for Neulasta dropped 40% to $609 million vs $1 billion in the comparable year-ago quarter, largely due to growing biosimilar competition.