Months after launch, Hepatitis C drug pricing debate remains
According to the Centers for Disease Control and Prevention (CDC), each year, 15,000 people die of hepatitis C (HCV)-related causes, usually cirrhosis or liver failure. CDC also reports that the number of deaths attributable to HCV doubled between 1999 and 2007---despite the fact that antiviral treatments were available. The unfortunate reality is that many people are undiagnosed, and among those who are diagnosed and who initiate treatment, more than 20% are non-adherent.
Thus, when Gilead’s long-awaited hepatitis C drug, Sovaldi (sofosbuvir) was approved in December 2013, it was truly a game-changer. In contrast to other regimens, Solvadi, a once-daily oral medication designed to be taken daily for 12 weeks, is designed to be curative. It is also incredibly expensive. One tablet costs $1,000 and a 12-week regimen costs $84,000.
The conversation about cost
The outcry against Sovaldi’s price has been cacophonous. High-profile groups, such as America’s Health Insurance Plans and Doctors Without Borders, have openly accused Gilead of pricing the drug too high and putting entire economies at risk. Express Scripts, the largest pharmacy benefits manager in the US, has limited access, with the requirement that patients have to be sufficiently ill to get treatment. Many insurers and other payers are waiting for other treatments that are currently in development.
Industry representatives continually counter these attacks with their own statistics. Experts from Pharmaceutical Research and Manufacturers of America (PhRMA) assert that at 9% of the total healthcare budget, pharmaceuticals are not the leading cause of out-of-control healthcare costs. Gilead counters that paying upfront for a curative treatment offsets downstream consequences of unchecked HCV, including liver disease and liver failure.
Even before the introduction of Sovaldi, much of the conversation around HCV was related to costs. CDC focused on rapidly increasing treatment-related costs for patients who were starting to deteriorate and face the end-stage diseases caused by untreated HCV. Based on their estimates, treatment costs would more than double in little more than a decade, from $30 billion in 2012 to $85 billion in 2024.
Six months later…
As summer 2014 begins, 30,000 patients have been treated with Sovaldi. Two years ago, there patients would have had access to standard viral therapy combined with pegylated interferon---a drug that causes severe side effects, including extreme fatigue, nausea, diarrhea, visual changes, fever, anemia and depression. Whether they could stay on therapy for the entire 24- to 48-week regimen would be in question---and even then, they might not be cured. In 2011, FDA approved the addition of protease inhibitors to the antiviral regimen for HCV. Treatment options increased, along with prices.
Sovaldi is the next step in a long process of innovation. And while Gilead is taking steps to modify the price outside of the US, in response to pricing pressure and other strategic concerns, the issue of pricing is far from resolved in the domestic market. Analysts predict almost $7 billion in sales for 2014 for Sovaldi, as patients continue to seek authorization for a drug that can significantly change their future.