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    Biosimilars Come to Community Pharmacy

    The long-awaited wave of biosimilar biologic agents is finally moving into community pharmacy. PBMs and payers are encouraging patients to move from the familiar long-acting insulin Lantus (insulin glargine, Sanofi) to Basaglar (insulin glargine, Lilly), approved by the FDA in late 2016.

    The cost difference between the two is relatively small, about 15%, but the impact at the pharmacy counter could be huge.

    Sidebar“The PBM and payer push made Basaglar a kind of explosion at retail in January because no one knew anything Ken Sternfeld, PharmDKen Sternfeld, PharmDabout it,” said Ken Sternfeld, PharmD, founder of RxVIP Concierge. “When you think about a generic, you think about an identical product. When you think about a biosimilar, you think about something that is similar to—sort-of like—the Lantus that keeps me alive.”

    It’s a different story in managed care. Major integrated-care organizations adopted Basaglar for patients starting on long-acting insulin and actively promote switching for patients who were already taking Lantus.

    Managed care organizations prepared prescribers, patients, and pharmacists in 2016 for the coming switch. It wasn’t the first time payers had switched preferred insulins.

    “Over the years, a number of insurers have switched from a Lilly product to a Novo Nordisk product at various times,” said Susan A. Cantrell, RPh, CAE, CEO of the Academy of Managed Care Pharmacy (AMCP). “This kind of switching has Susan A. Cantrell, RPhSusan A. Cantrell, RPhoccurred numerous times and the results have been very good. It’s something pharmacists have a lot of experience with.”

    When a Biosimilar Is Not a Biosimilar

    Biosimilars are not generics and cannot be switched without the prescriber’s authorization. Nor can pharmacists switch patients from Lantus to Basaglar, even though, strictly speaking, Basaglar is not a biosimilar. Basaglar is a follow-on biologic. The difference is regulatory, not clinical.

    Nearly all biologics are licensed under the Public Health Service Act (PHSA). But a handful of biologics, including insulin glargine, are approved under Section 505 of the Food, Drug, and Cosmetic Act. That regulatory distinction makes Basaglar a follow-on biologic, not a biosimilar. The distinction is not meaningful in most settings.

    “For all intents and purposes, Basaglar is a biosimilar, just under a different regulatory pathway, said Mary Jo Carden, RPh, JD, AMCP Vice President for Government and Pharmacy Affairs. “We are treating follow-on insulins as biosimilars.” 

    Follow the Money

    Biosimilars, biologics, and generics do share one important attribute. All three promise cost savings.

    Biosimilars approved by the European Medicines Agency are priced about 30% less than the reference biologic according the Express Scripts. The PBM is projecting U.S. savings of about $250 billion by 2024 from biosimilars that are already approved by the FDA or under submission.

    Mary Jo Carden, RPh, JDMary Jo Carden, RPh, JDBut the actual savings may be less. Zarxio (filgrastim-sndz, Novartis), the first biosimilar to reach to U.S. market, is priced about 15% below Neupogen (filgrastim, Amgen). Basaglar offers similar savings compared to Lantus.

    Express Scripts has both Basaglar and Lantus as preferred agents. Pharmacists report the PBM is actively promoting Basaglar for both new starts and existing Lantus patients.

    The company declined to provide comparative utilization data, but spokesperson Jennifer Leone Luddy said the addition of Basaglar added much needed competition to the class that is helping to drive down the cost of these drugs for payers and patients.

    Up next: Making the switch

    Fred Gebhart, Contributing Editor
    Contributing Editor Fred Gebhart works all over the world as a freelance writer and editor, but his home base is in San Francisco.

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