The Economic Impact of Etanercept Biosimilar Remonopolization in Poland

Market remonopolization by a biosimilar drug led to a significant increase in the pricing of etanercept, resulting in higher treatment costs for patients and excess costs for the health care system, estimated at over €3.42 million, according to a study published in BioDrugs.¹

The study investigated the impact of market remonopolization by a biosimilar drug on pricing and access to biologic therapies in Poland. The results revealed that although biosimilars initially lower costs, remonopolization by a single biosimilar can lead to significant price increases, reducing the benefits of cost reductions and impacting patient access. The authors said the study highlights the need for effective market regulation to maintain competitive pricing and ensure broader access to treatments.

The study was conducted to analyze the evolution of etanercept pricing during 2 distinct market phases: competition and remonopolization. Covering November 2017 to December 2023, the research examined 473 tenders for etanercept purchases, including prefilled syringes and automatic injectors. The analysis compared pricing trends between the reference drug Enbrel and its biosimilars, Benepali and Erelzi.

Data were sourced from public procurement platforms, hospital websites, and the Public Information Bulletin, with prices adjusted for value-added tax and converted to euros. The researchers assessed mean and median prices, exploring the impact of market competition and monopoly on pricing and reimbursement costs. They also evaluated hospital financial incentives related to drug pricing, focusing on how these incentives influenced pricing during competitive vs monopolistic conditions.

Of the 473 tenders covered, 462 were included in the final assessment. The total volume analyzed was 212,214 etanercept packages (4 × 50 mg), equating to 6,063,257 defined daily doses (DDD). During the market competition period, 160,626 packages (4,589,314 DDD) were tendered compared with 51,588 packages (1,473,943 DDD) during the remonopoly period.

Erelzi emerged as the dominant player, winning 297 tenders with a total volume of 146,272 packages (n = 4,179,200 DDD), followed by Enbrel with 113 tenders (n = 49,652 packages; n = 1,418,629 DDD) and Benepali with 52 tenders (n = 16,290 packages; n = 465,429 DDD). The median tender volume for Erelzi during the competition period was 200 packages, with a median etanercept DDD price of €7.26, while Enbrel's median tender volume was 130 packages at a median price of €7.84 per DDD. Benepali, which only participated during the competition period, had a median tender volume of 105 packages and a median price of €8.58 per DDD.

In the remonopoly period, Erelzi's median tender volume increased to 366 packages, with a median price of €7.77 per DDD, highlighting a significant price increase compared with the competition period. The price disparity was stark, with Erelzi's highest price in the last months of remonopoly reaching €15.825, more than 3 times the lowest prices of €5.299 for Erelzi and €5.148 for Enbrel during the competition period.

The analysis also noted that the average monthly cost of etanercept reimbursement decreased from €17.22 in January 2018 to €5.58 in November 2022, followed by a significant increase to €7.46 in December 2023. This price fluctuation resulted in a calculated loss of €3,419,712 for the public payer in the rheumatology sector due to the lack of competition during the remonopoly period. Additionally, the potential financial losses for hospitals, if tender prices had remained competitive, were estimated to range between €1,892,717 and €2,523,623.

The report acknowledged concerns about the accuracy of public tender data but notes that current price data align with other public records, with no known risk-sharing agreements or regulatory changes affecting projections, and emphasized that recent tender prices likely understate the long-term health care burden.

The authors concluded, “This nationwide study provides an extensive analysis of the [etanercept] price evolution in an off-patent market, covering all [rheumatic and musculoskeletal disease] drug purchases by the public payer. This real-life scenario demonstrates how remonopolization, even by a biosimilar, rapidly increases health care expenditure, which has negative downstream effects on hospital funds and may lead to treatment restriction for patients, while also reversing the cost reduction previously derived through competition due to biosimilar market introduction.”

Biosimilar Accessibility in Poland

Earlier this year, during the Festival of Biologics USA conference, Magnus Bodin, senior director and head of international access and policy at Biogen, discussed the Polish experience with biosimilars, showcasing that although uptake for immunology biosimilars is high (72% by 2021), ineffective policies have created issues with biosimilar access.²

“You could argue this is a perfect example of a sustainable biosimilar market…. But the commonly used metric of biosimilar penetration doesn't speak very much to sustainability or a holistic view of the system. Actually, if you compare Poland…with Norway, which is best in class in this therapeutic example, the difference is 25 times higher treatment rates in Norway vs Poland,” Bodin explained.

During his presentation, Bodin highlighted 6 key policy factors to future-proof biosimilar markets and ensure accessibility for all patients:

• Allowing free, fair, and open competition
• Balanced decision-making models that take a broad set of stakeholders into account
• Selection criteria that consider factors other than price
• Tender systems that allow for multiple winners
• More transparency in development planning and contract implementation
• Measure and communicate value of procurement policies to ensure appropriate reinvestment of savings

Regarding tender systems, Bodin said, “We have seen multiple examples—with generics and biosimilars—of supply shortages. And one way of mitigating this is to break down contracts or tenders into multiple awardees. This could be done, for instance, in a framework or a ranking. Or it could be done by formalizing who is the backup solution if one player fails to supply.”

References

1. Stajszczyk M, Batko K, Żuber ZM, Kwiatkowska B, Krajewska-Włodarczyk M, Batko B. Charting the etanercept journey: tracing cost dynamics in Poland’s off-patent market from reference drug rivalry to biosimilar monopoly. BioDrugs. 2024;38(4):557-569. doi:10.1007/s40259-024-00663-4

2. Jeremias S. The 6 key policy factors to ensure biosimilar market sustainability. The Center for Biosimilars®. April 16, 2024. Accessed August 13, 2024. https://www.centerforbiosimilars.com/view/the-6-key-policy-factors-to-ensure-biosimilar-market-sustainability