Medicaid Directors say studies of Sovaldi are generally of poor quality

Medicaid Directors Question Need for $1,000 HCV Pill
Published: May 22, 2014

By Michael Smith, North American Correspondent, MedPage Today

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 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 its manufacturer, Gilead Sciences of Foster City, Calif., 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.

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

The "unprecedented nexus of cost and widespread demand threaten to disrupt the healthcare landscape in the near term," according to Matt Salo, executive director of NAMD, in Washington.

"The potential for eliminating hepatitis C is an exciting one," Salo said in a statement. But the cost and possible demand for sofosbuvir "requires careful consideration of how to responsibly decide how to best use this new treatment option."

Spokesmen for the AASLD and Gilead were not immediately available for comment.

The current standard of care for genotype 1 HCV -- the most common variant in the U.S. -- is treatment with pegylated interferon-alfa, ribavirin, and a protease inhibitor, either boceprevir (Victrelis) or telaprevir (Incivek). Treatment of genotypes 2 and 3 involves just peginterferon and ribavirin.

The interferon-based regimens have cure rates of 40% to 80%, depending on patient and disease characteristics, but are difficult and dangerous to take owing to a range of adverse effects.

The so-called direct-acting agents, such as sofosbuvir, offer the promise of interferon-free regimens and improved success rates.

But the available published research, the report noted, consists of just 10 studies, reported in seven articles, most of which were noncomparative. No studies compared sofosbuvir in HCV genotype 1 patients with another regimen, the report said, and in particular, none compared the drug with the standard of care.

The studies "do not provide sufficient evidence for the routine use of sofosbuvir-containing regimens," the report said.

It added that response rates appear to be high in the trials -- all but one of which was sponsored by Gilead -- but are likely to be lower in "real world" clinical use.

In its approval process, the FDA also looked at data from three unfinished studies, according to the report, but data from those have yet to be published and could not be reviewed.

The guidelines, the report said, are "of poor methodologic quality and [do] not adhere to international or U.S. standards for guideline development. In particular, they do not give assessments of the quality of individual studies nor the strength of the evidence for recommendations."

In addition, the authors wrote, there is "substantial risk of conflict of interest" influencing the recommendations. Four of the five guideline panel chairs and 15 of the 21 panel members had financial relationships with Gilead.

The report is an important step that will help public and private payers make decisions about sofosbuvir, NAMD's Salo said. "Having the highest-quality evidence is critical to inform these decisions."

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." 

Posted Today: 
Investment Commentary @ Seeking Alpha
Gilead: Sovaldi Pricing Ethically And Economically Justified

Pharmaceutical Research and Manufacturers of America
Singling out patients who need specialty meds w/ high OOP costs goes against basic concept of health ins. coverage
New treatments for hepatitis C effectively cure patients, whereas an untreated patient could develop end-stage liver disease and ultimately need a transplant that can cost over $500,000 on average and require many years of costly follow-up care. For hepatitis C patients that progress to end- stage liver disease, annual treatment is estimated to cost nearly $60,000 annually and for those with that progress to liver cancer, costs are estimated to be more than $112,000 annually...

Related: Reducing the cost of new hepatitis C drugs 
An index of articles pointing the reader to current information and controversy over the high price of Solvadi.