Subcutaneous Versions Emerge as Alternatives to Intravenous Oncology Drugs

  • Apr 17, 2025

    Several oncology drugs that initially came to market as intravenous (IV) infusions are now available as subcutaneous (SC) injections. Both payers and oncologists expect the agents will have a positive impact in several aspects, according to a Zitter Insights survey.

    Roche Group member Genentech USA, Inc. has a handful of these agents: Rituxan Hycela (rituximab and hyaluronidase), which was approved June 22, 2017; Herceptin Hylecta (trastuzumab and hyaluronidase-oysk), which was approved Feb. 28, 2019; and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), which was approved Sept. 12, 2024.

    Other examples include Darzalex Faspro (daratumumab and hyaluronidase-fihj) from Johnson & Johnson Innovative Medicine, which was approved May 1, 2020, and Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) from Bristol Myers Squibb, which was approved Dec. 27, 2024.

    Among the pipeline candidates are Merck & Co., Inc.’s SC Keytruda (pembrolizumab), which is expected to have an FDA decision by Sept. 23, and J&J’s SC Rybrevant (amivantamab-vmjw), which received a complete response letter (CRL) in mid-December based on an inspection at a manufacturing facility and unrelated to the product’s formulation or its efficacy and safety. J&J said it is working with FDA toward the latter agent’s approval and that the agency has not requested any additional clinical studies.

    The new formulations offer much shorter administration time: about five to seven minutes vs. 30 minutes to a few hours, which is especially helpful if the drug is being given as a monotherapy. That shorter duration also will free up capacity in infusion centers. In addition, the SC versions need only administration by a health care professional, allowing them to be given in a provider’s office or even in the home setting by an infusion nurse.

    And studies have found that most patients prefer SC administration over IV.

    For the Managed Care Oncology Index: Q1 2025, from March 17, 2025, to March 28, 2025, Zitter Insights polled 35 commercial payers covering 119.2 million lives, 29 Medicare payers covering 45.6 million lives and 50 oncologists about their management and prescribing of SC versions of treatments for non-small cell lung cancer. 

    AIS Health and Zitter Insights are both divisions of MMIT.

    None of the payer respondents said they expect the new formulations would have a negative impact, while 56% said they expected a neutral impact compared with 44% who said positive. Among the latter group, respondents pointed to better member adherence and compliance, improved patient convenience and potential cost savings. Among payers overall, 58% said they expected to see cost savings with the SC version as opposed to IV.

    Payer responses were mixed over whether their organization would prefer new SC versions over the established IV versions (see infographic). Among payers who said their company was not likely to prefer the SC over the IV, many said they would defer to the oncologist’s preference, and some explained that if the costs were similar, the SC agents would be placed at parity with the IV ones. 

    All of the oncologists said SC administration would have a positive impact on patient care quality.

    © 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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