Gilead HCV Treatment News
It was reported by officials of Gilead Sciences, Inc. in a recent press release that they were going to create a new subsidiary, Asequa Therapeutics LLC. Officials stated they were planning to use Asequea Therapeutics to launch generic versions of Gilead’s leading treatments for chronic hepatitis C virus (HCV) in the United States: sofosbuvir 400mg/ velpatasvir 100mg (Epclusa) and ledipasvir 90mg/ sofosbuvir 400mg (Harvoni). These two drugs are on a list of current FDA-approved drugs for HCV treatment.
Hepatitis C. What is it?
Hepatitis is an inflammation of the liver, and this subsequent inflammation or damage can affect its functions. The three most common types of hepatitis in the US are A, B, and C, which are caused by three different viruses. Hepatitis A is a short-lived infection, whereas B and C can be chronic and even lifelong. While there are vaccines for A and B, there is no current vaccine available for hepatitis C.
Chronic HCV can be a dangerous condition, as many people can have it without knowing, due to its symptomatology. It doesn’t necessarily make one feel sick or have common symptoms, such as generalized fatigue. However, it can have negative long-term health consequences. It can result in liver damage, liver failure, liver cancer, or even death. Fortunately, there are multiple FDA-approved drugs that are used as treatment, including Epclusa and Harvoni, which cure over 90% of patients with few side effects.
Gilead Epclusa/ Harvoni Price Reduction & Future Plans
It is reported that these authorized generics would be made available, beginning in January 2019. It is reported they will be listed for a starting list price of $24,000, for the most common therapy. This is substantially lower than the current prices.
Since the initial release of Gilead’s HCV medication in 2013, there has been much debate regarding the cost of the treatment. Despite the fact that the average price paid for each bottle of medicine has decreased by more than 60% since then, the statement reports that “these discounts provided by Gilead may not always translate into lower costs for patients” due to the multifactorial structure of the US health care system. There are multiple larger agencies and government policies involved that serve as obstacles to lowering a product’s price.
However, Gilead reports that the new coming authorized generics’ prices are more reflective of the discounts that health insurers and government payers receive. It is reported that insurers will have the choice when offering the authorized generic or branded versions of both medications. For a patient who has the Medicare Part D Plan, this could translate into savings of up to $2500 in out-of-pocket courses. These savings may furthermore represent access to a larger pool of patients who are in need of treatment, and who were previously denied treatment and coverage, as the newly authorized generics will also offer these savings to state-managed Medicaid plans.
Gilead is not only focusing on reducing the costs of treatment in the short term but is launching a multipronged plan with the aim of eliminating HCV in the US and globally. This plan includes the implementation of various long-term financial models and collaborations with multiple institutions and corporations.
Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C [news release]. Foster City, Calif. Gilead Sciences; Sept. 24, 2018. Accessed at: https://www.gilead.com/news-and-press/press-room/press-releases/2018/9/gilead-subsidiary-to-launch-authorized-generics-of-epclusa-sofosbuvirvelpatasvir-and-harvoni-ledipasvirsofosbuvir-for-the-treatment-of-chronic