Radar on Specialty Pharmacy

  • New FDA Approvals: FDA Grants Interchangeability to Otulfi 45 mg/0.5 mL Vial

    April 30: The FDA granted interchangeability status to the Fresenius Group’s unit Fresenius Kabi USA, LLC and Formycon AG’s Otulfi (ustekinumab-aauz) for the 45 mg/0.5 mL single-dose vial for all of its indications: the treatment of adults and pediatric patients at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adults and pediatric patients at least 6 years old with active psoriatic arthritis, adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis. The agency first approved the biosimilar of Johnson & Johnson Innovative Medicine’s Stelara (ustekinumab) on Sept. 27, 2024, and gave it provisional interchangeability due to the unexpired period of exclusivity for Amgen Inc.’s Wezlana (ustekinumab-auub). Dosing for the interleukin-12/IL-23 antagonist varies based on indication. Fresenius Kabi did not respond to a request by AIS Health, a division of MMIT, for Otulfi pricing information.

  • News Briefs: FDA Revises Keytruda, Opdivo GI Indications

    The FDA has revised prescribing labels for two programmed death receptor-1 (PD-1) inhibitors to narrow their gastrointestinal indications to programmed death ligand-1 (PD-L1)-positive disease. In May 22 letters, the agency confirmed the changes to Merck & Co., Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab). The moves follows a Sept. 26, 2024, Oncology Drug Advisory Committee (ODAC) meeting on the use of immune checkpoint inhibitors in people with unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Committee members voted 10-2, with one abstention, that the risk benefit assessment for using PD-1 inhibitors in first-line advanced HER2-negative microsatellite stable gastric/GEJ adenocarcinoma in people with PD-L1 expression <1 was not favorable. They also voted 11-1 that the risk benefit assessment for using PD-1 inhibitors in first-line unresectable or metastatic esophageal squamous cell carcinoma with PD-L1 expression <1 was not favorable.

  • Subcutaneous Versions of IV Oncology Drugs Can Offer Various Benefits

    Multiple oncology drugs that first launched as intravenous (IV) infusions are now available as subcutaneous (SC) injections. The new formulations can provide advantages such as shorter infusion times, which can benefit both patients and crowded infusion suites. But an array of considerations should be taken into account, and not every patient may be a suitable candidate for the therapies.

    Among the agents are Roche Group member Genentech USA, Inc.’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), Johnson & Johnson Innovative Medicine’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) and Bristol Myers Squibb’s Opdivo Qvantig (nivolumab and hyaluronidase-nvhy). Merck & Co., Inc.’s SC Keytruda (pembrolizumab) is awaiting an FDA decision on its approval, which is expected by Sept. 23.

  • Payers Anticipate Advantages of Subcutaneous Versions of IV Oncology Drugs

    Over the last several years, multiple oncology drugs that first launched as intravenous (IV) infusions are now available as subcutaneous (SC) injections. Payers responding to a recent survey by Zitter Insights said they expect a variety of benefits from these newer formulations.

    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.

  • Report: Gaps May Exist in Some Specialty Drug Management Strategies

    Although people who utilize specialty drugs represent only about 6% of commercially insured member populations, they contribute to more than half of the overall pharmaceutical spend. Payers are struggling to get this spend in control and may employ a variety of strategies in their efforts, including utilization management (UM) strategies, as well as newer tactics such as copay accumulators and maximizers. In a new report, Pharmaceutical Strategies Group (PSG), an EPIC company, pulls back the curtain on specialty drug management strategies.

    For the 2025 Trends in Specialty Drug Benefits Report, which was published on April 28, a PSG survey collected responses from Sept. 16, 2024, through Oct. 15, 2024, from benefits leaders from employers (71% of total respondents), health plans (24%) and unions/Taft-Hartley plans (5%) with a median of 10,000 covered lives. The report was co-sponsored by Genentech USA, Inc., a member of the Roche Group.

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