Etanercept Biosimilar Launch Saves Aussie Govt $6M: Pricing Policy Win

US Awaits the Launch of Enbrel Biosimilars Amid Patent Litigation

Despite being approved, two etanercept (Enbrel) biosimilars remain unlaunched in the United States due to ongoing patent litigation, likely keeping them off the market until 2029. When eventually introduced, these biosimilars are anticipated to reduce the cost of the reference product, similar to previously launched biosimilars.

Enbrel’s Sales Forecast and Price Negotiation under Inflation Reduction Act

Enbrel, despite earning less than Humira, hit sales exceeding $4 billion in 2022. A considerable opportunity for cost savings may emerge when lower-priced alternatives enter the market. The drug has also been selected by CMS for Medicare price negotiation under the Inflation Reduction Act in America. Enbrel has been named among the top 10 drugs for this process.

Impact of First Etanercept Biosimilar, Brenzys, in Australia

In Australia, the launch of Brenzys, the first etanercept biosimilar, in 2016 resulted in similar treatment persistence between the original product and biosimilars. Cost savings were also achieved due to the government’s pricing policy, which ensures cost-minimization by linking the price of new medicines to their safety and efficacy, according to a real-world effectiveness study in the Internal Medicine Journal.

Role of Biosimilars in Reducing Healthcare Costs

Listing a biosimilar often results in statutory price reductions and price disclosure, leading to decreased prices for both the originator and biosimilar drugs. This competition contributes to cost-savings, making biosimilars crucial in managing rising healthcare costs in Australia, according to the authors of the study.

Analysis of Etanercept Biosimilar Effectiveness

The researchers analyzed data from the Optimising Patient Outcomes in Rheumatology Australian dataset to assess treatment persistence between the reference product and Brenzys. The study involved 53,526 patients with rheumatoid arthritis, of which 1153 eligible patients had received the originator or the biosimilar as their first recorded biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD). Only 386 individuals had three months of recorded follow-up.

Cost Savings from Biosimilars in Australia

The estimated cost of treatment before the biosimilar introduction was approximately AU$23,982,400 (US$16,063,411). However, the introduction of the biosimilar triggered a 40% reduction in price for etanercept, saving the Australian government AU$9.5 million (US$6.3 million).

Low Rate of Switching from Originator to Biosimilar

While more rheumatologists in Australia chose to prescribe the biosimilar during the study period, there was a low rate of switching from the originator to the biosimilar. The authors speculated that this might be due to the desire to maintain effective and stable treatment or try a different treatment approach if the initial one was not effective.

Study Limitations

The study’s observational nature made it prone to missing data and lacked randomization. It also did not evaluate patients who were taking the originator before the biosimilar was available or any switching that may have occurred.

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

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