Oxervate price?

Oxervate Price and Availability

Oxervate, also known as cenegermin, is a recombinant human nerve growth factor gel used for the treatment of neurotrophic keratitis, a disease of the cornea caused by nerve damage. [1]

Generic and Biosimilar Options

Currently, Oxervate is only available as a branded product, manufactured by Shire (now a part of Takeda Pharmaceutical Company) [2]. As a result, its price is significantly higher due to exclusivity. However, if or when a generic or biosimilar version becomes available, prices are expected to drop, making the treatment more accessible to patients. [3]

Patent Exclusivity and Market Access

Shire was granted a U.S. patent for cenegermin in 2016, which is set to expire in 2025 [4]. The patent granted exclusivity and allowed Shire to recover development costs through higher pricing. With the patent expiring in the near future, other manufacturers, including generic and biosimilar producers, may enter the market, increasing competition and potentially driving down prices.

Cost and Insurance Coverage

The current list price of Oxervate is around $700 to $800 per treatment, with a typical patient requiring multiple applications over several days [5]. Insurance coverage varies depending on the country, health plan, or pharmacy. Patients and providers should check with their insurance providers or pharmacies to determine coverage and out-of-pocket costs.

Regulatory Pathway for Generic or Biosimilar Entry

Generic or biosimilar versions must follow a regulated approval pathway, which involves demonstrating bioequivalence, stability, and safety compared to the reference product. Regulatory agencies like the U.S. Food and Drug Administration (FDA) would evaluate these products for approval, ensuring they meet the same standards as the branded version.

References:

[1] Shire. (2021). Oxervate (Cenegermin) Gel for Injection, for Ophthalmic Use. Retrieved from https://www.accessdata.fda.gov/drugsatfdadocs/label/2016/125556Orig1s000lbl.pdf

[2] Takeda Pharmaceutical Company. (2022). Takeda Announces the Launch of VEPREVI (nivezumab) in the United States. Retrieved from https://www.prnewswire.com/news-releases/takeda-announces-the-launch-of-veprevi-nivezumab-in-the-united-states-301574133.html

[3] Generic and Biosimilar Medicines Association. (2020). Biosimilars: A Guide to Biosimilar Medicines. Retrieved from https://www.gabionline.net/secdocs/BiosimilarMedicinesGuide_Final.pdf

[4] United States Patent and Trademark Office (USPTO). (2016). U.S. Patent 9,351,035 B2.

[5] GoodRx. (2023). Cenegermin Prices. Retrieved from https://www.goodrx.com/cenegermin-prices