[Ip-health] The Observer: Hepatitis C patients in England denied lifesaving liver drug

Thiru Balasubramaniam thiru at keionline.org
Sun Aug 16 00:21:52 PDT 2015


http://www.theguardian.com/society/2015/aug/16/hepatitis-c-patients-england-denied-liver-drug-regulator

Hepatitis C
The Observer

Hepatitis C patients in England denied lifesaving liver drug

Health experts concerned about decision not to extend Daklinza treatment to
patients with genotype 3 strain of virus

Jamie Doward

Sunday 16 August 2015 00.03 BST


Hepatitis C patients in England denied lifesaving liver drug

Health experts concerned about decision not to extend Daklinza treatment to
patients with genotype 3 strain of virus

Thousands of people in England with a chronic form of liver disease are
being denied access to life-saving drugs that are available to patients in
Wales, Scotland and Northern Ireland.

Despite being recommended by European regulators and available in countries
such as France and Germany, draft guidance recently issued by the National
Institute for Health and Care Excellence (Nice), the body that advises NHS
England on whether to fund certain drugs, recommends restricting the use of
Daklinza in England. The stance will affect the treatment of adult patients
with a particular strain of hepatitis C.

The move has dismayed health experts and liver disease charities who say it
will mean a large subset of the sickest and most at risk patients in
England will not receive the treatment they need to prevent them from
potentially fatal liver failure or cancer.

They have urged Nice to rethink and take into account the results of trials
as well as clinical practice that, they say, have proved the drug’s
efficacy against a disease that is estimated to affect more than 200,000
people in the UK but remains undiagnosed in tens of thousands.

Hospital admissions and deaths due to hepatitis C, a virus spread by
contact with infected blood that infects the liver, are predicted to
continue rising in England until around 2030, according to health officials.

About a third of people infected with the virus eventually develop
cirrhosis, where normal liver tissue is replaced by scar tissue. A few
people with chronic hepatitis C and cirrhosis also go on to develop liver
cancer.

Last year the European regulator approved Daklinza for use, in conjunction
with other drugs, as a treatment for four main strains of hepatitis C
genotypes. But Nice has not recommended it for the treatment of patients
with the genotype 3 of the disease, which accounts for around 45% of all
cases in England. People from south Asia are particularly affected by the
genotype 3, which causes an aggressive form of the disease.

Current alternative treatments for genotype 3 cannot be given to people
with the most advanced forms of the disease because of their toxicity. They
can also result in hair loss and flu-like symptoms that discourage people
from completing the full course, or even seeking treatment in the first
place.

Nice, which is consulting on the use of Daklinza, says that prescribing the
drug for genotype 3 patients is not cost-effective. A full course of
Daklinza can cost up to £48,700.

But Dr Anna Maria Geretti, professor of virology and infectious diseases at
the University of Liverpool, said studies had shown that, when used in
combination with other drugs, almost 100% of patients taking Daklinza were
cured. She said studies in 2014 of nearly 500 patients in the UK at 17
centres had also shown that it worked better than alternative treatments.

She said: “Nice has left us with a situation where we are not able to
follow the European guidelines, despite them making a strong
recommendation. We are not able to offer treatment to a substantial
proportion of our patients with genotype 3 who need it and cannot take the
more toxic therapy.”

She suggested that up to 1,000 people in England could benefit from the
drug, although Nice is understood to put the figure at nearly 3,000.

“My message to Nice is that I would like the evidence coming from our
experience of treating nearly 500 people with very advanced hepatitis C
infections – including over 100 with genotype 3 – to be taken into account,
so some new treatment options may be allowed for people that have genotype
3 and are not able to receive the alternative, more toxic drugs,” Geretti
said.

Bristol-Myers Squibb, which makes the drug, said: “Nearly 100,000 patients
in the UK are thought to have hepatitis C genotype 3. This group could
suffer severe treatment inequality from this decision. BMS will be working
closely with Nice to see if a solution can be found, and hope that this
decision can be urgently reassessed so that patients do not suffer.”



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