

(AP Photo/Courtesy of Gilead Sciences)

There has been a lot of outrage over the price of Sovaldi, the drug that costs $1,000 per day for treating hepatitis C. And now comes the first lawsuit.

The federal lawsuit from Philadelphia's public transit agency appears to be the first directly challenging the price of Sovaldi, which costs $84,000 overall during a normal 12-week course of treatment in the United States. Since Gilead Sciences launched Sovaldi last year, the drug has shattered sales records and set off a contentious debate about how to make treatments affordable and accessible while also encouraging drugmakers to invest in new drug development.

The lawsuit from the transit agency contends that Gilead 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." The lawsuit contends that some government programs and other countries have received steep discounts on the drug, while pricing out others from being able to access it. The transit agency says its health plan has paid out $2.4 million for Sovaldi in 2014 and has been injured by the drug's pricing.

Sovaldi is priced as low as $900 in a poor country like Egypt, while it costs $57,000 in the United Kingdom and $66,000 in Germany, where governments play a role in setting drug prices. Much of the debate around Sovaldi has centered on why the drug costs so much more in the United States.

Gilead officials on Thursday said they're still reviewing the lawsuit. The company has previously said it priced Sovaldi and its latest hepatitis C drug, Harvoni, based on previously available treatments. Harvoni, which can treat a broader set of hepatitis C patients, was launched in October and is priced slightly higher at $1,125 per pill, though some patients will be able to finish treatment in eight weeks instead of 12.

Knowledge Ecology International director Jamie Love, a vocal critic of drug industry pricing, said "excessive pricing is the right allegation to make," though the lawsuit faces an uphill battle.

"A challenge to prevail on this, but really the right issue," he said of the lawsuit over email. Love said other health-care payers may follow the transit agency's example to, in the very least, have better leverage in price negotiations with the drugmaker. And he said the legal process could help peel back the curtain on Gilead's pricing strategy and whether the company expressed concern that pricing it so high could limit access to the drug.

Meanwhile, health plans and state Medicaid programs over the past year have set up varying barriers to limit access to these high-cost hepatitis C drugs. Those, too, could soon come under legal scrutiny.

Patient advocates earlier this year sued the Arkansas Medicaid program for limiting access to Vertex, a $300,000 cystic fibrosis drug. And since this summer, Donna Cryer, chief executive of the Global Liver Institute, has been looking into bringing similar legal action over states' access limits on hepatitis C drugs.

"The group of 20 organizations I am working with is attempting to pursue a myriad of options, regulatory and legislative, before resorting to a lawsuit," she wrote in an e-mail Thursday morning.

"However, we are working with a group at Harvard Law to evaluate and maintain that option."