Medicaid Directors Question Need for $1,000 HCV Pill
Written by Editor   
Wednesday, May 28, 2014 08:26 AM

Under the "wow" category of news add this report:

The evidence base for one of the star hepatitis C drugs is poor and the guidelines for its use are flawed, according to a report prepared for the National Association of Medicaid Directors.  According to the report, studies of sofosbuvir (Sovaldi) are generally of poor quality, mostly directed by the drug's maker, and don't answer key questions, including whether the drug is better and safer than the current standard of care.  The only available guidelines for its use -- guidelines created by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America -- are "methodologically flawed," according to the report, which was prepared by the Center for Evidence-Based Policy at Oregon Health and Science University in Portland.  In addition, their authors and sponsors had "multiple and significant conflicts of interest," the report argued.

Sofosbuvir is widely regarded as the leading edge of a new wave of hepatitis C virus (HCV) drugs which promise routine cures for what is now a difficult-to-treat and costly illness.  But the drug has been controversial because Gilead has set the price high — $1,000 a pill. The drug is taken once daily and a course of treatment can last 12 or 24 weeks — $84,000 or $168,000, respectively.  The total cost would be higher, since other drugs must be used and treatment monitored carefully.

The manufacturer, Gilead Sciences of Foster City, Calif., said the drug "represents a significant therapeutic advance over existing therapies."  It is also safe and well-tolerated, the company said, with most adverse events in clinical trials attributable to other drugs used in conjunction with sofosbuvir.

A spokesman for the AASLD said the report’s authors had mistaken the nature of the joint publication with IDSA.  The two societies, he said, "felt that given the importance of this emerging data on hepatitis C, the fact that these drugs would out there for physicians, some advice, some consolidation of the information, would be very useful to practitioners [and] to insurance companies."  But the document was not meant to be a formal set of guidelines, he said.

The CDC estimates that some 3 million Americans have chronic HCV, and might be candidates for treatment. 

The Medicaid directors are not the first to flag the cost issue.  UnitedHealth Group, the nation's biggest insurer, said last month it spent $100 million on HCV drugs in the first quarter of 2014, contributing to the $2.27 billion the drug earned Gilead worldwide.

And this week a spokeswoman for America's Health Insurance Plans said drug makers are pricing new medications -- specifically sofosbuvir -- at "unsustainable levels."