Biosimilars Expand Access and Reduce Costs in Oncology, Immunology

Biosimilars offer significant cost-saving potential while expanding patient access, particularly in oncology and immunology. | Image Credit: Scott Hales - stock.adobe.com

The impact of biosimilars on health care costs and patient access is growing, with biosimilars demonstrating significant cost savings and expanded treatment options, according to new research presented at the Academy of Managed Care Pharmacy (AMCP) Nexus 2024 conference.

As of October 2024, more than 60 biosimilars have been approved by the FDA, although a small proportion of them were approved with the interchangeability designation.¹ The US has various biosimilars on the market that range in classes such as immunomodulators, oncology, ophthalmology, and rapid-and-long-acting insulin.

Posters released as part of AMCP Nexus 2024 evaluated the real-world market uptake of biosimilars and their cost-effectiveness in providing further access to all patients. AMCP Nexus took place in Las Vegas, Nevada, October 14-17, 2024.

One poster focused on increase in biosimilar use over reference products,² another poster found potential cost savings with biosimilar denosumab,³ and the final poster analyzed cost savings with the adalimumab biosimilar, suggesting more patients will be provided with treatment on a budget-neutral basis that improves overall patients access and equity.⁴

Real-World Biosimilar Use in Specialty Settings

Biologics are expected to cost Medicare $32 billion annually in medical costs and $12 billion a year for pharmacy costs, according to the HHS Office of Inspector General (OIG).² The OIG predicts Medicare members would save $179 million for medical benefit and $84 million for pharmacy benefit.

The first poster was a retrospective study that assessed the cost savings impact of biosimilars in comparison with reference products. Data was sourced from the California Specialty Pharmacy medical and pharmacy protected health information electronic system CPR+.

Results found an increased use of biosimilars progressed from 2022 to 2023, with more biosimilars used after Q2 2022. Biosimilars saved all independent physician associations (IPAs) around $22,003,938.17 over the 2-year period. Study results may be underestimated because every quarter price was unable to be included.

Biosimilar use in IPAs in specialty pharmacy practice reveals the financial impact biosimilars have for IPAs, that can benefit patients and IPAs through an increased use of biosimilars. Future studies are necessary to determine accurate financial savings impacts of biosimilar products.

Budget Impact of Biosimilar Denosumab

Denosumab, a bone-modifying agent, is one of the many biosimilars approved in the oncology therapeutic area used to prevent skeletal-related events across multiple tumor types.³ The second poster highlighted the significant cost-saving potential of denosumab in oncology through a Medicare lens.

The study utilized a budget impact model to estimated cost implications for oncology treatments of Xgeva and Prolia from a US provider point of view. The model incorporated pharmacy costs based on CMS limits and Medicare Part B, along with medical costs from public fee schedules and studies.

There were 46,556 patients out of 1 million who were estimated to be treated with denosumab over a 5 year period. A 25% uptake of biosimilar denosumab by year 5 was projected to result in net savings of $59.1 million, equivalent to $1.66 per member per year (PMPY) and $0.14 per member per month (PMPM).

A 50% biosimilar uptake could generate significant savings of $18.2 million, translating to $3.32 PMPY, and $0.28 PMPM. Increasing uptake to 70% could further amplify savings to $31.1 million, with $5.68 and $0.47 PMPY and PMPM, respectively. A significant 90% price reduction for biosimilar denosumab, combined with a 50% market uptake, could potentially generate $117.5 million in savings over 5 years.

Study findings are subject to limitations, including reliance on estimated savings, a simplified model, and assumptions regarding dosing, treatment discontinuation, and pricing.

Biosimilar denosumab has the potential to substantially reduce health care costs, the actual savings will depend on factors such as the final pricing of the biosimilar and the rate of adoption by patients and providers. 

Cost-Effectiveness of Adalimumab Biosimilars

There were 10 FDA approved adalimumab biosimilars launched since January 2023.⁴ Adalimumab is a tumor necrosis factor inhibitor used to treat patients with Crohn disease, plaque psoriasis, rheumatoid arthritis, and various other conditions.

The final poster aimed to estimate cost-effectiveness and budget-neutral expanded access to additional treatment from converting from reference to biosimilar adalimumab. The study analyzed 2 scenarios using a treatment regimen of 1 adalimumab dose administered every 2 weeks for 52 weeks.

The poster compared the wholesale acquisition costs of 40 mg doses for reference adalimumab (Humira Pen) and various biosimilars. Adalimumab-aqvh (Yusimry Pen) was the cheapest biosimilar priced at $292.13, althoughadalimumab-ryvk (Simlandi Autoinjector), the most expensive biosimilar at $1875, was still significantly cheaper than Humira ($3461.31).

The researchers compared the cumulative costs of biosimilar and Humira treatment for 1 and 100,000 patients. Adalimumab-aqvh (Yusimry) had the highest cost difference at week 0 ($3169), while adalimumab-ryvk (Simlandi) had the lowest ($1586).

Switching from Humira to any adalimumab biosimilar resulted in significant cost savings, allowing more patients to access treatment for 52 weeks. “This suggests the utility of biosimilar conversion and its potential to reallocate resources, providing more patients with treatment on a budget-neutral basis,” the authors concluded. “Conversion improves patient access and equity.”

References

1. Biosimilars approvals. The Center for Biosimilars^®. Updated October 16, 2024. Accessed October 25, 2024. https://www.centerforbiosimilars.com/biosimilar-approvals

2. Pham A, Kiener T, Tran T, Jeong A. Real-world uptake of biosimilars in patients in specialty pharmacy. Presented at: AMCP Nexus 2024; October 14-17, 2024; Las Vegas, Nevada. Poster U39.

3. Flanigan J, Chaplin S, van Stiphout J, et al. Budget impact model for biosimilar denosumab in the US oncology population. Presented at: AMCP Nexus 2024; October 14-17, 2024; Las Vegas, Nevada. Poster C44.

4. Jang J, Abraham I. Cost-efficiency and expanded access modeling of conversion to adalimumab biosimilars from a US payer perspective. Presented at: AMCP Nexus 2024; October 14-17, 2024; Las Vegas, Nevada. Poster U42.