Radar on Specialty Pharmacy

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.

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.

As fiduciaries, employers must act in the best interests of their employees and plan, but when it comes to biosimilars, some are not fully promoting them over higher-cost, rebatable reference drugs. During a recent webinar hosted by Midwest Business Group on Health (MBGH), employers including United Airlines and Caterpillar Inc. shared details of their successful efforts to move employees onto the cost-saving drugs.

MBGH also unveiled an Employer Action Brief on biosimilars with the same title as the webinar: Improved Adoption of Biosimilars by Employers Matters.

Even though uptake of the agents could be much better, they produced more than $12.4 billion in savings in 2024, according to the Association for Accessible Medicines. Overall, since the first biosimilar launched in the U.S. in 2015, they have produced more than $36 billion in savings and have had more than 344 million patient days of therapy.

With a new executive order on prescription drug prices, President Donald Trump directed HHS to extend the period in which new-to-market small molecule drugs are exempt from Medicare price negotiation, a policy change that pharmaceutical companies have long supported.

The Medicare Drug Price Negotiation Program, which is part of the Inflation Reduction Act, allows the federal government to negotiate the prices of select drugs if they are brand-name medications or biological products without generic or biosimilar equivalents. Drugs subject to negotiation also must have been on the market seven years (for small molecule drugs) or 11 years (for biologics) after FDA approval.

But under the new executive order, HHS is directed to work with Congress to modify the program to “align the treatment of small molecule prescription drugs with that of biological products,” giving small molecule drugs an extra four years before they’re eligible to be selected for the negotiation program.

April 7: The FDA granted interchangeable status to Celltrion, Inc.’s Yuflyma (adalimumab-aaty) for its 20 mg/0.2 mL prefilled syringe and 80 mg/0.8 mL PFS and PFS with safety guard for its nine indications: the treatment of (1) adults with moderately to severely active rheumatoid arthritis, (2) people at least 2 years old with moderately to severely active juvenile idiopathic arthritis, (3) adults with active psoriatic arthritis, (4) adults with active ankylosing spondylitis, (5) people at least 6 years old with moderately to severely active Crohn’s disease, (6) adults with moderately to severely active ulcerative colitis, (7) adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate, (8) adults with moderate to severe hidradenitis suppurativa and (9) adults with noninfectious intermediate and posterior uveitis and panuveitis. The agency first approved the biosimilar of AbbVie Inc.’s tumor necrosis factor (TNF) blocker Humira (adalimumab) on May 23, 2023. The company tells AIS Health that it “anticipate[s] that the 40 mg dosage will also receive interchangeability approval following the expiration of exclusivity in the coming months.” Dosing via subcutaneous injection varies depending on the indication. The unbranded version of the drug is priced at an 85% discount to Humira’s wholesale acquisition cost, which is around $7,000 for two autoinjectors, and the branded version is priced at a 5% discount to Humira’s WAC.