PHOENIX — The Department of Veterans Affairs is moving to outsource care nationwide for up to 180,000 veterans who have hepatitis C, a serious blood and liver condition treated with expensive new drugs that are costing the government billions of dollars.
The VA has spent weeks developing a dramatic and controversial transition as patient loads have surged and funding has run out. Those efforts were not disclosed until records were released this week to The Arizona Republic.
Instructions on how to carry out the program show that the sickest veterans generally will get top priority for treatment. However, patients who have less than a year to live or who suffer “severe irreversible cognitive impairment” will not be eligible for treatment.
PHOENIX — The Department of Veterans Affairs is moving to outsource care
nationwide for up to 180,000 veterans who have hepatitis C, a serious
blood and liver condition treated with expensive new drugs that are
costing the government billions of dollars.
The VA has spent weeks
developing a dramatic and controversial transition as patient loads
have surged and funding has run out. Those efforts were not disclosed
until records were released this week to The Arizona Republic.
on how to carry out the program show that the sickest veterans
generally will get top priority for treatment. However, patients who
have less than a year to live or who suffer “severe irreversible
cognitive impairment” will not be eligible for treatment.
PHILADELPHIA — Researchers at Penn Medicine,
in collaboration with a multi-center international team, have shown
that a protease inhibitor, simeprevir, a once a day pill, along with
interferon and ribavirin has proven as effective in treating chronic
Hepatitis C virus infection (HCV) as telaprevir with interferon and
ribavirin, the standard of care in developing countries. Further,
simeprevir proved to be simpler for patients and had fewer adverse
events. The complete study is now available online and is scheduled to
publish in January 2015 in The Lancet Infectious Diseases.
“The observations from the study present simeprevir,
peginterferon and ribavirin as a good therapeutic option for regions of
the world where all-oral therapies are unavailable or cost prohibitive,”
says Rajender Reddy, MD, professor of Medicine and director of
Hepatology the Perelman School of Medicine at the University of
Pennsylvania. “This is the only study we are aware of that directly
compares telaprevir to simeprevir.” Telaprevir, another protease
inhibitor, is an oral HCV medication taken up to three times daily, has
multiple side effects and is less accessible than simeprevir. Simeprevir
is manufactured by Janssen Pharmaceuticals.
In the U.S. and other countries where access to the latest research
and treatment for HCV is available, physicians have moved towards
all-oral therapy and away from interferon-based therapies such as these,
as they are known to come with a significant number of side effects and
are not as effective.
A Senate hearing on Wednesday into the staggering cost of specialty drugs
to treat the deadly Hepatitis C virus has once again raised the
question of how far the government should go to try to beat down
pharmaceutical costs without discouraging research and development or
creating drug shortages.
Although the Department of Veterans Affairs – the largest provider of care for those with chronic Hepatitis C infections – receive a 40-percent bulk rate discount, the drugs are still blowing a hole in the agency’s budget and threaten to add $1.3 billion to VA hospitals’ operating costs over the next two years. Sen. Bernie Sanders (I-VT), chair of the Veterans Affairs Committee, is pushing to bring down the cost, but Gilead for now is fending off pressure – and company officials said they were too busy to testify yesterday.
“We cannot leave VA providers in the position where they are forced to choose which veterans get treated for their HCV [Hepatitis C virus] and which do not because of cost,” Sanders said in his statement. “Companies like Gilead are gouging the American consumer and the American taxpayer and ignoring any sort of moral obligation to help very sick people access life-saving medications.”
More than a decade after the first victories in the battle for
affordable HIV drugs, the gulf between the priorities of large
pharmaceutical companies and those of governments, affected communities
and the general public is again highlighted.
The new treatments for hepatitis C should herald a revolution; a
deadly disease can now be cured quickly and painlessly for a few hundred
dollars. But unless affordable treatments are made universally
available, millions of people in urgent need will be left behind.
Nobody who recognises the human cost of hepatitis C could question
the value of these new drugs. But even in wealthy countries such as
Australia, we are being forced to question their price tags.
THE long-awaited new Hepatitis C drug will be available on Spain’s
national health system shortly, but only for certain patients.
to Dr María Londoño from the Hospital Clínic in Barcelona, a member of
the Spanish Agency for Medication and Healthcare Products, the drug
Sovaldi will be administered to sufferers awaiting a liver transplant or
who have undergone one, those with liver cirrhosis, or who have found
more traditional treatment to have been ineffective.
Those with minor fibrosis – which accounts for the majority of Hepatitis C sufferers – will not be given the new drug.
Dara Gantly on the pressure to provide full access to powerful new treatments.
It is not often we hear the word ‘cure’ mentioned in the development
of a new class of drug, but the direct-acting antiviral (DAAs) agents
for people with the hepatitis C virus (HCV) have that exact potential.
Indeed, this revolution in treatment could mean the ‘eradication’ for
the condition. The only barrier to achieving this will be the ability to
access and afford these new therapies. The ‘US$1,000 pill’ tagline has,
as you might expect, caused quite a stir among healthcare funders and
media alike, with some experts describing the costs of the drugs “as
breathtaking as their effectiveness”.
From the standard treatment for chronic HCV genotype 1 with
ribavirin, pegylated interferon and a protease inhibitor — which could
involve 18 tablets a day, last a year, have a limited response rate and
cause severe side-effects — patients with HCV are now being presented
with three months or less of oral medications that are offering a 90 to
95 per cent ‘cure’ rate, with experts talking about the eradication of
hepatitis C over the next decade.
It is a drug that cures hepatitis C in 90 per cent of cases and was considered ground-breaking when it came on to the market.
Manufactured by Gilead, Sofosbuvir was licenced for use late last
year. And in April this year, NHS England took the unusual step of
setting up a special access scheme so patients with less than a year to
live were able to be treated without waiting for the National Insitute
for Health and Care Excellence (Nice) to evaluate whether it should
become routinely available on the NHS.
But it is expensive – £35,000 for a 12
week course. So now NHS England is balking at the potential cost. In
fact so much so, this programme has learned that they have asked Nice to