The Biosimilar Paradox : How AntieVascular Endothelial Growth Factor Biosimilars Could Increase Patient and Overall Health Care Costs

Ophthalmology Volume 130, Number 9, September 2023

生物類似物的矛盾：抗血管內皮生長因子生物類似物如何可能增加患者和整體醫療保健成本。

中文摘要

內容是一篇關於引入抗血管內皮生長因子（Anti-VEGF）生物類似物 (biosimilars)，特別是
bevacizumab，在眼科中可能帶來的潛在財務影響的詳細文章或研究。抗血管內皮生長因子藥物對於治療如新生血管性年齡相關性黃斑變性（nAMD）、糖尿病性黃斑水腫和視網膜靜脈阻塞（RVO）等眼部疾病至關重要。這些藥物成本高昂，並且它們的使用量正在增加，導致巨大的醫療保健支出。

該文章指出，雖然生物類似物通常是為了降低成本而引入的，但引入bevacizumab 的生物類似物可能出現費用的悖論。這主要是因為 bevacizumab 經常被off-label use使用於眼部，並且會被重新包裝(repackage)成較小的劑量，使其更具成本效益。然而，專門為眼科使用批准的生物類似物的引入可能會限制對off label bevacizumab 的重新包裝，從而推高成本。

以下是一些關鍵要點：

1. 對醫療保險和患者的成本影響：文章估計，如果一種眼內用 bevacizumab 生物類似物的價格為每劑500美元，醫療保險第B部分的成本將增加4.57億美元，增幅達到15.2%。

2. 切換至其他生物類似物：即使目前正在使用anibizumab or aflibercept 的患者轉換到相應的生物類似物，節省的費用也只能抵銷 bevacizumab 生物類似物所增加的28.8%的成本。

3. 監管問題：藥品質量和安全法案（Drug Quality and Security Act）可能會禁止在為眼科使用批准生物類似物的情況下repackage of off-label bevacizumab，進一步使成本情境變得更加複雜。

4. 患者取得：增加的成本還可能影響患者獲得這些關鍵治療方法的能力，因為成本更高可能導致保險政策變得更加嚴格，需要更多的先前授權要求。

5. 國際影響：該文章還暗示，bevacizumab 生物類似物的影響可能因當地法規和實踐而有所不同。

該文章對眼科中使用抗血管內皮生長因子藥物和生物類似物所涉及的複雜財務和監管環境提供了全面的探討。它提出了關於如何在醫療體系中平衡成本、取得和安全性的重要問題。

English Abstract

The text appears to be a detailed article or study discussing the potential financial implications of introducing biosimilars for anti-VEGF (Vascular Endothelial Growth Factor) drugs, particularly bevacizumab, in ophthalmic care. Anti-VEGF drugs are critical for treating various eye conditions like neovascular age-related macular degeneration (nAMD), diabetic macular edema, and retinal vein occlusion (RVO). These drugs are costly, and their use has been increasing, leading to significant healthcare expenditures.

The article suggests that while biosimilars are generally introduced to reduce costs, the introduction of a biosimilar for bevacizumab could paradoxically increase healthcare costs. This is primarily because bevacizumab is often used off-label for ophthalmic conditions and is repackaged into smaller doses, making it more cost-effective. However, the introduction of a biosimilar specifically approved for ophthalmic use could limit the repackaging of off-label bevacizumab, thus driving up costs.

Here are some key points:

1. Costs to Medicare and Patients: The article estimates that if an intraocular bevacizumab biosimilar were priced at $500 per dose, Medicare Part B costs would increase by $457 million, an increase of 15.2%.

2. Switching to Other Biosimilars: Even if patients currently on ranibizumab or aflibercept were switched to their respective biosimilars, the savings would only offset 28.8% of the increased cost due to the bevacizumab biosimilar.

3. Regulatory Concerns: The Drug Quality and Security Act (DQSA) may prohibit the repackaging of off-label bevacizumab if a biosimilar is approved for ophthalmic use, further complicating the cost scenario.

4. Patient Access: The increased costs could also affect patient access to these crucial treatments, as higher costs could lead to more restrictive insurance policies and prior authorization requirements.

5. International Implications: The article also hints that the impact of a bevacizumab biosimilar could vary internationally, depending on local regulations and practices.

6. Future Uncertainty: The article calls for a reevaluation of FDA policies, suggesting that an exemption for repackaged intraocular use of bevacizumab might be a prudent way to maintain patient access to this cost-effective treatment.

The article provides a comprehensive look at the complex financial and regulatory landscape surrounding the use of anti-VEGF drugs and biosimilars in ophthalmic care. It raises important questions about how best to balance cost, access, and safety in the healthcare system.