Report questions safety, efficacy of pricey hepatitis C drug Sovaldi

Recent studies of the hepatitis C drug Sovaldi are of poor quality and don't answer pertinent questions about the drug's safety, according to a new report.

The new drug--which can cure a majority of hepatitis C patients, often within 12 weeks--does not have nearly enough data to back up its efficacy, finds a report from The Center for Evidence-Based Policy at Oregon Health and Science University. The Center found that Sovaldi studies do not offer comparisons to the current standard of hep C treatment and none of the studies confirmed whether the drug works better than current treatments, according to an announcement from the National Association of Medicaid Directors.

The Center noted that the only available guidelines for the drug's use--created by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America--are "methodologically flawed."

While the drug is somewhat controversial, given its high price tag--$1,000 per pill--it's considered a breakthrough for treating hep C.

But, noted the Center: "However exciting these new treatments are, the unprecedented nexus of cost and widespread demand threaten to disrupt the healthcare landscape in the near term."

The report mentions that available research on the drug includes only 10 studies--none of which are long-term--and most were non-comparative. As a result, "Medicaid programs must be deliberate in their decisions and may need to adapt their strategies over time as more detailed clinical research becomes available," notes the announcement.

What's more, payers need more outcomes data--clinical, economic and humanistic--from drug manufacturers for more informed decision-making, FierceHealthPayer previously reported.

To learn more:
- here's the MedPage Today piece
- check out the announcement (.pdf)
- check out the IDSA guidelines