Payers, Immunologists Expect Yimmugo to Impact Coverage, Prescribing

  • Jul 18, 2024

    The FDA recently approved a new agent for the treatment of primary immunodeficiency. Payers expect it will have a moderate impact on their coverage of other agents in the class, while immunologists also anticipate its availability will affect their prescribing of competing drugs, according to a survey conducted late last year.

    On June 13, the FDA approved Grifols Group company Biotest AG’s Yimmugo (immune globulin intravenous, human-dira) for the treatment of primary humoral immunodeficiency in people at least 2 years old. Dosing via intravenous infusion is every three to four weeks, with the first infusion started at 0.5 mg/kg per minute and increasing up to 3.0 mg/kg per minute; afterwards, the maintenance infusion rate is 13 mg/kg per minute. The dosage can be adjusted over time to achieve the desired trough levels and clinical response.

    Kedrion Biopharma Inc. will commercialize and distribute the polyvalent immunoglobulin G preparation in the U.S. That company revealed on July 1 that it expects Biotest to start supplying it with Yimmugo in fourth-quarter 2024 in preparation for a first-quarter 2025 launch.

    Yimmugo is the first FDA-approved therapy for Biotest, which has also gained approval for production and marketing of the therapy in Europe, where it has been commercialized since 2022.

    Primary immunodeficiencies consist of more than 450 rare and chronic conditions that impact the immune system.

    For the Managed Care Biologics & Injectables Index: Q4 2023, from Nov. 20, 2023, to Dec. 13, 2023, Zitter Insights polled 36 commercial payers covering 116.1 million lives, 27 Medicare payers covering 43.4 million lives, 51 immunologists and 51 practice managers about the immunodeficiency landscape. Sixty-one percent of both payers and immunologists rated their level of satisfaction with current treatments for immunodeficiency diseases as moderate. However, 61% of payers and 84% of immunologists said there is moderate or high unmet need in treating the condition, mainly due to a lack of effective drugs.

    AIS Health and Zitter Insights are both divisions of MMIT.

    Forty-two percent of payers said they are slightly aggressive in managing branded immunodeficiency agents, meaning that they are covered at parity or managed with step therapy or prior authorization based on a drug’s label without preferring one branded product over others.

    Both payers and immunologists expressed varying levels of awareness of Yimmugo, with 44% of payers and 33% of immunologists saying they were not aware of the agent at all, while 17% of payers and 20% of immunologists rated their level of awareness as moderate.

    Payers said that a price between $145,000 and $180,000 would be appropriate for Yimmugo and lead to their recommending that it be covered at parity to most of the currently available products. The agent’s price has not yet been revealed.

    Variation also existed in payers’ perception of the impact that Yimmugo would have on other available products, although respondents with 69% of commercial lives and 61% of Medicare lives said they expect it to have a moderate impact, meaning its availability is likely to lead to a change in formulary tiering and/or utilization management criteria for other products within the class (see infographic).

    In addition, 47% of immunologists said they expect the agent to have some impact on their treatment approach, leading them to potentially change it with certain patients, while 29% said they anticipate that it will have a moderate impact, resulting in changing their approach for a considerable portion of patients.

    © 2024 MMIT
  • Angela Maas

    Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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