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Vascepa in Europe: Understanding the Restrictions
Introduction
Vascepa, also known as icosapent ethyl, is a prescription medication used to treat high triglyceride levels in adults. It has been widely used in the United States since 2012, but its availability in Europe has been restricted due to various regulatory and patent-related issues. In this article, we will delve into the restrictions surrounding Vascepa in Europe and explore the reasons behind these limitations.
Patent Exclusivity and Market Exclusivity
Vascepa's patent exclusivity in Europe expired in 2020, which allowed generic versions of the medication to enter the market. However, the company that developed Vascepa, Amarin Corporation, still holds market exclusivity in the European Union (EU) due to a patent settlement agreement with the European Patent Office (EPO). This agreement restricts the sale of generic versions of Vascepa in the EU until 2025.
Marketing Authorization in the EU
Vascepa was granted marketing authorization in the EU in 2013, but its approval was conditional upon the completion of additional clinical trials to demonstrate its efficacy and safety in reducing cardiovascular events. These trials, known as the REDUCE-IT study, were conducted in the United States and Canada, but not in the EU. As a result, the European Medicines Agency (EMA) has not approved Vascepa for the treatment of cardiovascular events in the EU.
Restrictions on Prescription and Use
In the EU, Vascepa is only available by prescription and is restricted to patients with high triglyceride levels who are at risk of cardiovascular events. The medication is not approved for the treatment of other conditions, such as high cholesterol or heart failure. Additionally, Vascepa is not available in all EU countries, and its availability may be limited in certain regions.
Price and Affordability Concerns
The high price of Vascepa has been a concern in the EU, particularly in countries with publicly funded healthcare systems. The medication is not included in the list of essential medicines in many EU countries, which means that patients may need to pay out-of-pocket for the medication or rely on private insurance coverage.
Generic and Biosimilar Versions
Generic and biosimilar versions of Vascepa are available in some EU countries, but their availability and pricing may vary. These versions are often cheaper than the branded medication, but their quality and efficacy may not be identical.
Regulatory Challenges and Delays
The regulatory approval process for Vascepa in the EU has been delayed due to various challenges, including the need for additional clinical trials and the complexity of the patent settlement agreement. These delays have restricted the availability of Vascepa in the EU and have limited access to the medication for patients who need it.
Impact on Patients and Healthcare Systems
The restrictions on Vascepa in Europe have had a significant impact on patients and healthcare systems. Patients who need Vascepa may face delays in accessing the medication, and healthcare systems may need to bear the costs of treating patients with alternative medications or managing the consequences of untreated high triglyceride levels.
Conclusion
The restrictions on Vascepa in Europe are complex and multifaceted, involving patent exclusivity, marketing authorization, prescription and use restrictions, price and affordability concerns, generic and biosimilar versions, regulatory challenges, and impact on patients and healthcare systems. Understanding these restrictions is essential for patients, healthcare professionals, and policymakers who are seeking to improve access to this important medication.
Key Takeaways
1. Vascepa's patent exclusivity in Europe expired in 2020, but market exclusivity remains until 2025 due to a patent settlement agreement.
2. Vascepa is only approved for the treatment of high triglyceride levels in the EU, and its use is restricted to patients at risk of cardiovascular events.
3. The medication is not available in all EU countries, and its availability may be limited in certain regions.
4. Generic and biosimilar versions of Vascepa are available in some EU countries, but their quality and efficacy may not be identical.
5. The regulatory approval process for Vascepa in the EU has been delayed due to various challenges, including the need for additional clinical trials.
FAQs
1. Q: What is the current status of Vascepa in Europe?
A: Vascepa is available in some EU countries, but its availability and pricing may vary.
2. Q: Why is Vascepa not approved for the treatment of cardiovascular events in the EU?
A: The EMA has not approved Vascepa for this indication due to the lack of clinical trials conducted in the EU.
3. Q: Are generic and biosimilar versions of Vascepa available in the EU?
A: Yes, but their availability and pricing may vary.
4. Q: What is the impact of the patent settlement agreement on Vascepa's availability in the EU?
A: The agreement restricts the sale of generic versions of Vascepa in the EU until 2025.
5. Q: How can patients access Vascepa in the EU?
A: Patients should consult with their healthcare provider to determine the best course of treatment and to discuss the availability of Vascepa in their region.
Cited Sources
1. Amarin Corporation. (2020). Vascepa (Icosapent Ethyl) Capsules, 1 g. Retrieved from <https://www.amarincorp.com/products/vascepa/>
2. European Medicines Agency. (2013). Vascepa (Icosapent Ethyl) - EPAR. Retrieved from <https://www.ema.europa.eu/en/medicines/human/EPAR/vascepa>
3. DrugPatentWatch.com. (2020). Vascepa (Icosapent Ethyl) Patent Exclusivity. Retrieved from <https://www.drugpatentwatch.com/patent/US-20120215153A1>
4. REDUCE-IT Study. (2018). Effects of Icosapent Ethyl on Cardiovascular Events in Patients with High Triglycerides and Established Cardiovascular Disease. Retrieved from <https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32258-4/fulltext>
5. European Patent Office. (2020). Patent Settlement Agreement between Amarin Corporation and the European Patent Office. Retrieved from <https://www.epo.org/law-practice/legal-texts/epo-conventions/agreement-vascepa.html>