This year’s annual meeting of the Academy of Managed Care Pharmacy featured several biosimilar-themed posters and presentations. Discussion of interchangeability and the efforts to remove the designation were prevalent, especially through legislative means (e.g., Senate Bill 2305).
IPD Analytics gave their popular update on the specialty and biosimilar pipeline. Presenters Jeffrey Casberg, PharmD, and Leslie Fish, PharmD, both Senior Vice Presidents, noted that aflibercept biosimilars may launch anytime between 2024 and 2032, because the patent situation is still murky. Furthermore, biosimilars may well play into the GLP-1 game, perhaps as early as 2027, because dulaglutide (Trulicity®) is a biologic—the only one of the critical type 2 diabetes category/weight-loss class that is classified as such (the rest will be subject to generic competition).
Doug Long, PharmD, Vice President, Industry Relations, IQVIA indicated that the GLP-1s as a category grew 58% over the last 12 months. He indicated that 77% of the biologics currently do not have a biosimilar pipeline, representing mostly lower-value molecules. However, the potential savings through biosimilar competition is still great, with potentially $123 billion in savings between 2025 and 2027 alone.
How Did the Introduction of Interchangeable Insulin Affect State Medicaid Programs?
Arguably, the interchangeability designation has not been impactful for commercial or Medicare plans in automatically substituting biosimilars for reference products, and thus significantly increasing their utilization. However, this has not necessarily been the case for Medicaid programs and plans, which tend to be more aggressive in seeking drug savings. A poster presentation from Des Moines University described a study to determine how the interchangeable insulin glargine biosimilar Semglee® impacted spending and utilization within state Medicaid programs.
Utilization data from 2020 to 2022 were obtained (Semglee was designated as interchangeable in July 2021, and was followed by an unbranded version of the same biosimilar). The researchers found that interchangeable insulin glargine saved 5.0% over 5 fiscal quarters, with savings increasing steadily in each subsequent quarter (e.g., 7.8% savings in the fifth quarter) compared with 100% utilization of the reference product Lantus®. That translated to a savings of $60.6 million for the 5-quarter period after the interchangeability designation was given. Mean marketshare for interchangeable insulin glargine across state Medicaid programs was about 9% (range, 0% to 93%).
Changing Commercial Coverage Policies for Filgrastim and Pegfilgrastim, Over Time
Researchers from Cencora conducted a survey of 50 payers’ historical and July 2023 coverage policies for granulocyte colony-stimulating factors. As described by their poster, more than three quarters had pegfilgrastim or filgrastim coverage policies. For filgrastim, of the plans issuing coverage policies, an average of 4.7 months passed between launch and published coverage policy. For pegfilgrastim, this was slightly shorter, at 4.1 months.
They found that 84% of the payers with filgrastim coverage policies preferred Zarxio®, followed by Nivestym® (37%) in the filgrastim category. For pegfilgrastim, the picture was a bit more complex, with 62% preferring Ziextenzo® at the time of the research, 60% Neulasta®, 55% preferred Fulphila®, and 45% favored Udenyca®. The researchers found that two-thirds of the payers with pegfilgrastim coverage policies available had changed preferred products over time. With the pricing dynamics of these agents, this is not surprising. In addition, the approval of the on-body injector formulation of Udenyca has likely resulted in additional changes since the July 2023 review.
Rituximab Savings Increased Significantly After Plan Required New Therapy Starts With Biosimilars
Although the first rituximab biosimilar (Truxima®) was approved in 2018, it wasn’t until 2021 before the Capital District Physician’s Health Plan in Albany, New York, instituted a coverage policy mandating new patients receive a biosimilar. Pharmacists from the 400,000-member plan analyzed both utilization trends and plan savings for a 2-year period after implementation of the new policy.
According to this poster presentation, 477 members used rituximab during this period, resulting in 1,954 claims analyzed. They found that rituximab biosimilar marketshare increased from 50% before implementation, to 81% by the end of the study period. Plan savings (calculated based on average sales price) resulting from rituximab biosimilar use nearly doubled from $400,000 per quarter at the beginning of the study period to its conclusion; the plan saved $4.3 million over 2 years. Notably, reference product Rituxan®’s marketshare fell to 18% by the end of the study, but it still comprised 35% of total costs in the category.
Big Savings Predicted with Adalimumab Biosimilar Use for 1 Million Member Commercial Plans
One poster described a rather simplistic, adalimumab budget-impact model that found substantial savings when a biosimilar was switched for the reference product Humira® in a commercial health plan of 1 million members. This research, from Organon (the marketer partner for Samsung Bioepis’ Hadlima®), assumed that if Hadlima was switched for only 2% of the treatment-experienced patients taking the reference product across its multiple indications, the plan would save $25.3 million, solely based on year 1 drug acquisition costs. The major caveat to this analysis is that only wholesale acquisition costs are considered (not net costs). It is based on an 85% discount for the biosimilar, without accounting for Humira rebates.
