Potential lawsuits are being reviewed for people who were denied insurance coverage for Sovaldi, a new antiviral medication that has been reported to cure more than 90% of patients with the most common form of Hepatitis C.
Update: University of Minnesota Sues Gilead Over Patent Infringement for Marketing Hep C Drugs
September 12, 2016 – The University of Minnesota has filed a lawsuit against Gilead for allegedly infringing on a patent when it marketed Sovaldi, Harvoni and Epclusa, 3 sofosbuvir-containing Hepatitis C treatments that the complaint alleges were assigned to the university in 2014. The suit claims that the structural formula of sofosbuvir is protected under the patent, and that the protection extends to antiviral compounds and methods for using those compounds to treat viral infections, such as that caused by Hepatitis C virus.
What’s the Problem?
Sovaldi was approved by the U.S. Food & Drug Administration (FDA) on December 6, 2013. Since then, the medication has reached blockbuster status, generating $10 billion in sales in 2014 alone.
The problem is that because Sovaldi is so expensive ($1,000 per pill, or about $84,000 for a 12-week regimen), health insurance companies have restricted coverage to patients with the most severe liver damage. As a result, only a tiny fraction of the estimated 3.2 million Americans with Hep C have received the treatment they need.
Class Action Lawsuit Filed Over Cost of Sovaldi
In December 2014, a class action lawsuit was filed against Gilead Sciences Inc., the company that makes Sovaldi, on behalf of the Southeastern Pennsylvania Transportation Authority (SEPTA). The organization accused Gilead of “price gouging” by charging exorbitant fees for Sovaldi. SEPTA has spent nearly $2.5 million to provide Sovaldi for its employees, according to the Wall Street Journal.
Can Anyone Compete with Gilead?
There is no doubt that Gilead’s introduction of Sovaldi and Harvoni revolutionized hepatitis C treatment and cure rates. The drugs are easy to take, cause few side effects, and offer cure rates of greater than 90%. Even with a competing therapy on the market (Viekira Pak), Gilead is on track to generate more than $12 billion in HCV sales by the end of 2015.
On September 21, the biotech company took another step in cementing its Hep C dominance by reporting results from 4 late-stage studies which examined the combination of Sovaldi and velpatasvir, an NS5A inhibitor, as a once-daily therapy for the treatment of all 6 HCV genotypes.
For the studies, a cohort of 1,035 patients were treated with Sovaldi/velpatasvir, with 1,015 of them achieving SVR12, the primary endpoint of the study. This means that just 20 of 1,035 patients failed to be completely ridden of the Hep C virus after 12 weeks of treatment. Of the 20, 7 did not complete the SVR12 visit, so no data on them could be collected, and 12 of the remaining 13 patients relapsed. Amazingly, no patients in the lesser-common genotypes 2, 4, 5, or 6 relapsed.
What this means in no uncertain terms is that Gilead has once again upped the bar for Hepatitis C treatment. The company plans to file a new drug application for Sovaldi/velpatasvir in the U.S. and EU later this year, according to The Motley Fool.
FDA Approves Gilead’s New Combo Hepatitis C Drug
June 28, 2016 – Gilead Sciences has received approval from the FDA for its Epclusa hepatitis C combination drug, according to the Wall Street Journal. Epclusa, the first drug approved to treat all 6 major strains of the disease, combines Sovaldi with the new velpatasvir. Gilead priced Epclusa lower than both Sovaldi and Harvoni, at $74,760 per treatment course, according to a company spokesperson.
Gilead to Pay Merck $200M Over Hepatitis C Drug Patents
March 28, 2016 – A California federal jury has ordered Gilead to pay Merck & Co. and a partner $200 million for infringing on patents involving Sovaldi and Harvoni, according to The Wall Street Journal. While the verdict was technically a victory for Merck, the damages awarded fell significantly short of the 10% royalty on U.S. sales of the two drugs Merck was seeking. The award covers sales from 2013 to 2015, which amounted to over $20 billion.
Report Accuses Gilead of Putting Profits Ahead of Patients
December 1, 2015 – A Senate Finance Committee investigation into the cost of Gilead Sciences’ Hepatitis C treatments Sovaldi and Harvoni has determined that the drugmaker put maximizing revenue ahead of patient access, according to Reuters. The report found that state Medicaid programs spent $1.3 billion before rebates in 2014 to treat less than 2.4% of enrollees with the liver disease.