Australian Government Pricing Policy Saved Over $6 Million After Etanercept Biosimilar Launched

In the United States, there are 2 etanercept (Enbrel) biosimilars approved, but neither have launched yet due to patent litigation keeping them off the market until 2029. However, there are expectations that once they do hit the market, they, like other biosimilars that have launched, will bring down the cost of the reference product.

Worldwide, Enbrel's sales topped $4 billion 2022. In the United States, 2 biosimilars have been approved but neither will launch until 2029 due to patent litigation.

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While Enbrel hasn’t brought in quite as much revenue as Humira, which gained competition from 8 biosimilars in 2023, its 2022 sales topped $4 billion, providing much opportunity for cost savings when lower-cost alternatives enter the market. In addition, in the United States, Enbrel has been named as 1 of the 10 drugs chosen by CMS for Medicare price negotiation under the Inflation Reduction Act.

In Australia, the first etanercept biosimilar, Brenzys, has been available since 2016, and there has been similar treatment persistence between the originator and biosimilars, as well as cost savings due to a government pricing policy that links the price of new medications with similar safety and efficacy to ensure cost-minimization, according to a real-world effectiveness study published in Internal Medicine Journal.

“When a biosimilar is listed, the government implements measures such as statutory price reductions and price disclosure to benefit from the competition the biosimilar creates, resulting in decreased prices for both the originator and biosimilar drugs,” the authors explained. “This increased competition between comparable products leads to cost-savings, making biosimilars an important tool in managing the rising cost of health care in Australia.”

The researchers used data from the Optimising Patient Outcomes in Rheumatology Australian real-world data set to assess the comparative treatment persistence—used as a surrogate of treatment effectiveness—of the reference product and the etanercept biosimilar Brenzys.

The data base identified 53,526 patients with rheumatoid arthritis, of them 1153 eligible patients had received the originator or the biosimilar as their first recorded biologic or targeted synthetic disease modifying antirheumatic drug (b/tsDMARD) between April 1, 2017, and December 31, 2020. Only 386 individuals had 3 months of recorded follow-up. Overall, 350 patients were matched: 209 treated with the originator and 141 treated with the biosimilar.

The median time from baseline to when half of the patients had stopped treatment was slightly longer for the biosimilar in the matched population (19.4 months vs 22.4 months). Within the full eligible population, 10.1% of patients taking the originator and 14.5% of patients taking the biosimilar stopped treatment due to an adverse reaction.

The estimated cost of treatment for the full eligible population, assuming a standard dose, prior to the introduction of the biosimilar would have been approximately AU$23,982,400 (approximately US$16,063,411). Due to Australia’s pricing policy, the listing of the biosimilar triggered a 40% reduction in price for etanercept. The price to treat the full eligible population for 1 year after the introduction of the biosimilar was an estimated AU$14,389,440 (approximately US$9,638,046). The cost savings to the Australian government as a result of the government’s policy and the introduction of the biosimilar was AU$9.5 million (US$6.3 million).

In addition, the researchers noted that rheumatologists in Australia increasingly chose to prescribe the biosimilar during the study window, although there was a low rate of switching from the originator to the biosimilar, which the authors speculated “may reflect rheumatologists' and patients' desire to maintain existing treatment if there is a good response and stable disease, or, for patients who are not responding, a desire to try an alternative [tumor necrosis factor inhibitor] or target a different mechanism.”

However, they added that since the study only included patients who initiated etanercept in the first line, it did not evaluate patients who were taking the originator before the biosimilar was available and any switching that might have occurred.

One of the limitations of the study was its observational nature, which makes it vulnerable to missing data and the lack of randomization.

Reference

Deakin CT, Littlejohn GO, Griffiths H, et al; OPAL consortium. Comparative effectiveness of etanercept originator and biosimilar for treating rheumatoid arthritis: implications for cost-savings. Intern Med J. Published online November 27, 2023. doi:10.1111/imj.16296