[Ip-health] UK's Nice moves to approve use of drug to prevent a cause of blindness, for which makers will not seek a licence

Jamie Love jamespackardlove at gmail.com
Sun Jan 2 20:17:56 PST 2011


http://www.guardian.co.uk/society/2011/jan/02/blindness-drug-avastin-nhs-nice/

Firms fight move to obtain cheap anti-blindness drug Avastin

Nice moves towards official appraisal of drug to prevent a cause of
blindness, for which makers will not seek a licence

Sarah Boseley, health editor

guardian.co.uk,	 Sunday 2 January 2011 19.07 GMT

A selection of drugs placed on a shelf. The National Institute for
Health and Clinical Excellence is moving towards an offical appraisal
of Avastin which has been used to prevent the leading cause of
blindness.

The NHS has moved a step closer to obtaining a cheap drug to prevent
the leading cause of blindness, in spite of attempts by drug companies
to block it.

The National Institute for Health and Clinical Excellence (Nice),
which decides which drugs may be prescribed on the NHS, has decided to
move towards an official appraisal of a drug, Avastin, that has been
widely and cheaply used to prevent wet age-related macular
degeneration – even though the drug companies that make and market it
refuse to seek a licence. They have a licensed version which is many
times more expensive.

Avastin is licensed for bowel cancer, but ophthalmologists in the US
discovered that – split into tiny doses suitable for injection into
the eye – it could halt and even reverse the progress of wet AMD,
which is the commonest cause of blindness. Eye specialists around the
world have been using Avastin in this way, because splitting a vial
into many tiny doses makes it relatively cheap.

But the manufacturer, Genentech, and the Swiss drugs company Roche,
which markets Avastin in Britain, have fought this use. Genentech has
produced and licensed a very similar but far more costly version,
which it calls Lucentis, and which has been approved by Nice for the
NHS.

The Royal Liverpool and Broadgreen University Hospitals pharmacy,
which has been producing Avastin for eyes, charges £50 a dose. Mass
production could bring the cost still lower. Lucentis costs around
£750 a dose.

The treatment involves one injection a month for three months, and
more if the patient's sight continues to deteriorate. Because of
Nice's concerns over the cost, Novartis, which markets Lucentis here,
agreed to pay for any patient who needed more than 14 injections of
that drug. But with 20,000 people diagnosed with wet AMD every year in
Britain, the bill is high.

Nice rarely appraises unlicensed drugs, but has decided that it will
do so with Avastin for eyes, subject to help from the licensing
authority with assessing safety and quality. It now needs the go-ahead
from the Department of Health.

The decision will not be welcomed by the drug companies. Roche, which
has bought Genentech, said it had decided not to apply for a licence
for eyes "due to corporate considerations" and had no plans to
reconsider that decision. The drug companies warned Nice that the
safety of Avastin in eyes could not be properly monitored without
their involvement – and they were not willing to help. "As a
consequence, these stakeholders suggested that an appraisal would not
be appropriate."

The Royal National Institute of Blind People, which receives funding
from the companies, also opposed the appraisal, arguing – as the
companies did – that there was not enough evidence of Avastin's safety
and there will not be unless the licence-granting bodies look at it.
Nice's role, it said in its submission, "is to assess the efficacy and
cost-effectiveness of new drugs in relation to existing treatments or
best supportive care. Any attempt to change this 'division of labour'
requires changes to the regulatory system and therefore political
decisions that go far beyond this exploratory work."

But in a cash-strapped NHS, there are already primary care trusts that
have voted with their feet. Stockport PCT offers Avastin to patients
at a private hospital, or Lucentis at an NHS hospital which has a
waiting list of four to five weeks. Patients are given very detailed
information about both drugs, but usually opt for Avastin. Stockport
PCT estimates it will have 200 new patients every year who could
benefit from the drugs. It would cost £1m more a year to treat them
with Lucentis rather than Avastin, it says.

Bury PCT was using Avastin before Lucentis got Nice approval but is
going back to Avastin, adopting the Stockport model. Peter Elton,
public health director at Bury, says there is potentially an even
bigger issue at stake. The licensing laws at the moment favour the
drug companies. But approval for an unlicensed use of Avastin could
open the door for other drugs to be appraised and used in the NHS,
especially for "orphan" conditions – where the small number of
sufferers does not make it commercially worthwhile for a drug company
to conduct the trials necessary to get a licence.

-- 
James Love.   US Mobile is +1.202.361.3040.  Geneva Mobile is +41.76.413.6584




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