[Ip-health] Firms fight move to obtain cheap anti-blindness drug Avastin
Riaz K Tayob
riaz.tayob at gmail.com
Mon Jan 3 01:46:47 PST 2011
[If this were a developing country... ]
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 <http://www.guardian.co.uk/profile/sarahboseley>,
* guardian.co.uk <http://www.guardian.co.uk>, Sunday 2 January 2011
* Article history
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. Photograph: Ben Birchall/PA Archive/PA Photos
The NHS <http://www.guardian.co.uk/society/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
<http://www.guardian.co.uk/science/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.
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