The battle between medicaid/insurance companies and Gilead rages on. This article was recently published in MedPage Today. Not only are Gilead's prices being questioned, but efficacy and safety concerns about Sovaldi are beginning to surface:
Medicaid Directors Question Need for $1,000 HCV Pill
Published: May 22, 2014 | Updated: May 23, 2014
By Michael Smith, North American Correspondent, MedPage Today
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 obtained by theNational Association of Medicaid Directors.
According to the report, studies ofsofosbuvir (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.
In addition, their authors and sponsors had "multiple and significant conflicts of interest," the report argued.
The report was originally prepared for the Medicaid Evidence-Based Decisions Project at OHSU and shared with the Medicaid directors.
In an emailed response to a MedPage Today request for comment, 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 reports authors had mistaken the nature of the joint publication with IDSA.
In fact, Adrian Di Bisceglie, MD, of the St. Louis University School of Medicine, toldMedPageToday, "we have been careful to label what we issued as a guidance, not a practice guideline."
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.
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 "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.
The indication for sofosbuvir, through, suggests it be used without interferon only in a limited number of situations; for most patients it should still be used with peginterferon and ribavirin.
Even in those cases, the company said, the drug "can reduce the time needed to cure the disease to just 12 weeks for most patients, while reducing the duration of interferon injections."
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."
The AASLD agrees that those assessments are important, Di Bisceglie said, and form part of the societys formal practice guidelines.
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.
In its formal practice guidelines, Di Bisceglie said, the society "strives" to keep the proportion of participants with relevant links to industry below 50%.
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.
And this week a spokeswoman for America's Health Insurance Plans said drug makers are pricing new medications -- specifically sofosbuvir -- at "unsustainable levels."
-- Edited by Isiscat2011 on Saturday 31st of May 2014 06:38:29 PM
The battle between medicaid/insurance companies and Gilead rages on. This article was recently published in MedPage Today. Not only are Gilead's prices being questioned, but efficacy and safety concerns about Sovaldi are beginning to surface:
Medicaid Directors Question Need for $1,000 HCV Pill
Published: May 22, 2014 | Updated: May 23, 2014
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 obtained by theNational Association of Medicaid Directors.
According to the report, studies ofsofosbuvir (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 theInfectious 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 (OHSU).
In addition, their authors and sponsors had "multiple and significant conflicts of interest," the report argued.
The report was originally prepared for the Medicaid Evidence-Based Decisions Project at OHSU and shared with the Medicaid directors.
In an emailed response to a MedPage Today request for comment, 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 reports authors had mistaken the nature of the joint publication with IDSA.
In fact, Adrian Di Bisceglie, MD, of the St. Louis University School of Medicine, toldMedPageToday, "we have been careful to label what we issued as a guidance, not a practice guideline."
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.
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.
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.
The indication for sofosbuvir, through, suggests it be used without interferon only in a limited number of situations; for most patients it should still be used with peginterferon and ribavirin.
Even in those cases, the company said, the drug "can reduce the time needed to cure the disease to just 12 weeks for most patients, while reducing the duration of interferon injections."
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."
The AASLD agrees that those assessments are important, Di Bisceglie said, and form part of the societys formal practice guidelines.
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.
In its formal practice guidelines, Di Bisceglie said, the society "strives" to keep the proportion of participants with relevant links to industry below 50%.
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."
-- Edited by Isiscat2011 on Saturday 31st of May 2014 06:38:29 PM