In addition to the overall 3.81% drug price inflation predicted in 2025, several originator biologics set to face biosimilar competition in the next few years are projected to increase their list prices, according to Vizient’s Pharmacy Market Outlook Report for Summer 2024.1
Of the top 10 drugs expected to have price increases, 4 (denosumab, pembrolizumab, secukinumab, and etanercept) have biosimilars in the pipeline, and 2 of these already have biosimilars approved by the FDA (denosumab, n = 2; etanercept, n = 2).2 Additionally, increases of over 3% are predicted for several disease states (autoimmune and inflammatory diseases, cardiopulmonary conditions, endocrine and metabolic diseases, infectious diseases, neurology, oncology, and plasma).
By 2026, it is anticipated that 35 novel therapies will enter the market, with an estimated spend of $25 billion, particularly for treating rare genetic disorders like Duchenne muscular dystrophy, sickle cell disease, hemophilia, spinal muscular atrophy, and various oncology conditions.
Authors of the report predicted that reference denosumab will experience the highest percentage price increase for any medication in 2025. This comes after the first 2 denosumab biosimilars were approved by the FDA in March 2024.3
“[Reference] ustekinumab (Stelara) has led the list for top drugs by size of projected price increase for several previous editions. However, with biosimilar ustekinumab approval and anticipated launch in January 2025, there’s no estimated inflation for this agent in 2025. Denosumab (Prolia, Xgeva) now tops the list for size of projected price increase due to its high spend and anticipated 10.75% price increase for 2025, followed by pembrolizumab (Keytruda) with an estimated 4% price increase,” the authors explained.
Biosimilars in Detail
As of the latest update, 61 biosimilar agents have been approved across 19 molecules, with new additions in late stages of development. Biosimilars currently account for 23% of the therapy volume in competitive markets. The most biosimilars are available for adalimumab (n = 10), pegfilgrastim (n = 7), and trastuzumab (n = 5). A recent milestone includes the approval of the first interchangeable biosimilar for eculizumab (Soliris) in May 2024.4
Projected inflation for this therapeutic area in 2025 is minimal at 0.53%, with originator products seeing 0.64% inflation and biosimilars remaining stable. Market uptake of biosimilars varies due to formulation differences and payer formularies, with bevacizumab and trastuzumab leading in market share. Biosimilar adalimumab has captured only 2% of the market due to factors like payer restrictions and continued product development by originators.
Recent changes in spend include:
- A 60% increase in spending for pegfilgrastim-jmdb (Fulphila) due to higher utilization, although originator products still dominate the market
- A 27% increase in spend for infliximab-axxq (Avsola) due to increased use and a decrease in average price
Conversely, spending on epoetin alfa-epbx (Retacrit) decreased by 25% due to lower utilization, while originator products saw a 20% decrease in spending despite increased usage.
Autoimmune and Inflammatory Diseases
With an estimated 50 million Americans affected by autoimmune and chronic inflammatory diseases, the prevalence increased annually by 3% to 12%, reaching epidemic levels. Treatment for these diseases often overlaps across dermatology, gastroenterology, and rheumatology. Despite the availability of multiple biosimilars, brand name adalimumab (Humira) remained the top medication in terms of spend for Vizient providers. Although the use of Humira is expected to drop about 0.5%, spending on the drug is expected to rise 7%.
Endocrinology and Metabolic Diseases
The report projected a 28% growth rate in outpatient endocrinology for adults over the next 5 years, significantly higher than the 8% population-based forecast, driven by the increasing prevalence of obesity and related conditions. Data showed a rise in diabetes prevalence from 3.0% to 4.1% and obesity from 32.7% to 40.9% between 2009 and 2020.
Medications for weight loss, such as semaglutide (Ozempic, Wegovy) and the newly approved tirzepatide (Zepbound), are becoming major pharmacy spend items, as they are used for both diabetes and obesity treatment and have been recently approved to reduce major cardiovascular event risks.
Recent trends include:
- A 77% increase in spending on semaglutide, now a significant portion of endocrine and metabolic medication spend
- A 25% increase in spending on sodium-glucose cotransporter-2 agents like empagliflozin (Jardiance) and dapagliflozin (Farxiga), driven by their expanded use in heart failure and kidney disease guidelines
Hematology and Oncology
In hematology, pegfilgrastim-jmdb (Fulphila) saw a 61% increase in utilization compared with the summer 2023 report. Ravulizumab-cwyz (Ultomiris) spend increased by 55%, with market share changes anticipated following the 2025 launch of biosimilar eculizumab-aeeb (Bkemv).
Epoetin alfa (Epogen) experienced a 28% drop in average price paid, leading to a 20% overall decrease in spend, despite increased utilization and the availability of biosimilar Retacrit.
Spending on oncology in the US was expected to reach $187 billion by 2028, according to the Use in Medicines 2024 IQVIA report, with biosimilars savings slowing growth by 8%. Previous IQVIA publications indicated that the number of new cancer drugs exceeding $200,000 per year had been increasing. These higher-cost medications accounted for approximately 44% of new drug launches in the past 5 years, up from 7% in the prior 5 years.
Most oncology medications launched in 2023 exceeded $299,000 each per year. Innovation in oncology continued to drive advancements in patient treatment and improved outcomes, including cancer vaccines, cellular therapy, immune therapy, and gene therapy.
Interestingly, reference rituximab (Rituxan), which has 3 biosimilar competitors on the US market,2 saw a decrease in spend, dropping from number 7 in the winter 2024 outlook to number 13, reflecting a decline in market share for the reference rituximab product and increased biosimilar uptake.
Neurology
Neurological disorders, affecting approximately 1 in 3 people worldwide, are the leading cause of illness and disability globally. The highest medication spends for Vizient pharmacy program participants are associated with multiple sclerosis (MS), migraines, myasthenia gravis, and seizures.
For MS, ocrelizumab (Ocrevus), ofatumumab (Kesimpta), and natalizumab (Tysabri) account for 80% of MS therapy spending, while ublituximab (Briumvi) has had limited uptake. Currently, there is 1 FDA-approved biosimilar for MS (Tyruko; natalizumab-sztn), with more nataliuzumab biosimilar candidates in the pipeline.5
References
1. Pharmacy market outlook report—Summer 2024. Vizient. July 30, 2024. Accessed August 2, 2024. https://info.vizientinc.com/pharmacy-market-outlook-summer-2024
2. Biosimilar approvals. The Center for Biosimilars®. Updated March 22, 2024. Accessed August 2, 2024. https://www.centerforbiosimilars.com/biosimilar-approvals
3. Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimilars. March 5, 2024. Accessed August 2, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar
4. Jeremias S. FDA approves first eculizumab biosimilar. The Center for Biosimilars. May 29, 2024. Accessed August 2, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-eculizumab-biosimilar
5. Jeremias S. FDA approves first MS biosimilar. The Center for Biosimilars. August 25, 2023. Accessed August 2, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-ms-biosimilar
