December 2, 2015
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Gilead Sciences, Inc. , the maker of blockbuster hepatitis C treatments Harvoni and Sovaldi, are under fire after a U.S. Senate investigation said the company was maximizing profits before providing needed care to patients, Reuters reported this morning.
According to the investigation, Medicaid programs spent $1.3 billion before rebates for the hepatitis C drugs to treat fewer than 2.4 percent of enrollees diagnosed with the liver disease. More than 700,000 hepatitis C patients on state Medicaid programs are still waiting to receive their medications, Reuters reported. Hepatitis C affects about 3.2 million Americans.
Sovaldi can treat about 90 percent of those cases. A 12-week treatment for Sovaldi has an approximate price tag of $84,000, about $1,000 per pill. Reports show Gilead sold $10.3 billion of Sovaldi in 2014. The probe said Gilead considered a number of factors in determining a price point for Sovaldi, including costs for the existing standard of care for Hepatitis C treatment and setting a high baseline for the next wave of drugs, such as Harvoni.
Sen. Ron Wyden, an Oregon Democrat and Sen. Chuck Grassley, an Iowa Republican, the two lead lawmakers conducting the probe, expressed concern over the high price of the treatments and how that negatively impacts healthcare budgets. The senators said Gilead refused to offer substantial discounts for the drugs, or when the company did offer discounts, they came with unrealistic strings attached. In a statement Wyden said Gilead cannot justify the high cost of the drugs by using research and development or the multi-billion acquisition of Pharmasset, Inc., the drug’s first developer, for the price point of Sovaldi.
“Gilead pursued a calculated scheme for pricing and marketing its Hepatitis C drug based on one primary goal, maximizing revenue, regardless of the human consequences,” Wyden said in a statement. “Gilead knew these prices would put treatment out of the reach of millions and cause extraordinary problems for Medicare and Medicaid, but still the company went ahead. If Gilead’s approach to pricing is the future of how blockbuster drugs are launched, it will cost billions and billions of dollars to treat just a fraction of patients.”
Gilead disagreed with the findings of the senate report, saying its prices are lower than previous treatments and touting the efficacy of Harvoni and Sovaldi, Reuters reported.
This is not the first time Gilead’s hepatitis C treatments have been criticized due to their high price points. In June Express Scripts Holding Company, a pharmacy benefit management service, dropped coverage of Sovaldi because of the costs. A normal 12-week regimen of the hepatitis C drug has a price tag of about $84,000. One Express Scripts Inc. executive actually bandied about the notion of loading up a cruise ship in India with the hepatitis C drug, where the drug can be acquired for about 1 percent of the cost in the U.S., and sailing it to America to provide the drug to those who needed it. Of course, the executive never attempted such a plan due to the laws about selling foreign drugs in the United States, but he told Bloomberg news the market for the treatment demands solutions that “borders on the ridiculous.” In December 2014, Express Scripts cut a deal with AbbVie Inc. to offer their hepatitis C drug Viekira Pak to Express Scripts’ customers at an affordable cost.
In December, the Southeastern Pennsylvania Transportation Authority filed a lawsuit against drugmaker Gilead charging the company is abusing its rights as a patent holder “by charging discriminatory prices that apparently have no other rational basis other than to inflate the company’s bottom line.” Because of that high price, the transit authority, which paid out $2.4 million for Sovaldi in 2014, said the drug has brought financial harm to the organization. The lawsuit additionally notes Sovaldi can be acquired overseas in countries like India and Egypt, for about $900 per 12-week regimen through generics programs Gilead works with the provide the drug in poorer countries.
High prescription prices are likely to take center stage during the 2016 presidential election, particularly after former Secretary of State Hilary Clinton, a candidate for the Democratic nomination, tweeted out her support for prescription drug price controls following Turing Pharmaceuticals 5,000 percent increase for Daraprim, a 65-year-old toxoplasmosis treatment.
