Update on Avastin and Lucentis in the Untited Kingdom

Irv Arons · medicine forum beginner Joined: 19 Mar 2006 Posts: 25

The following article appeared online today in The Guardian in the
United Kingdom, relating to the use of Avastin in the treatment of
age-related macular degeneration.

Drugs firm blocks cheap blindness cure
Company will only seek licence for medicine that costs 100 times more

Sarah Boseley, health editor
Saturday June 17, 2006

A major drug company is blocking access to a medicine that is cheaply
and effectively saving thousands of people from going blind because it
wants to launch a more expensive product on the market.

Ophthalmologists around the world, on their own initiative, are
injecting tiny quantities of a colon cancer drug called Avastin into
the eyes of patients with wet macular degeneration, a common condition
of older age that can lead to severely impaired eyesight and blindness.
They report remarkable success at very low cost because one phial can
be split and used for dozens of patients.

But Genentech, the company that invented Avastin, does not want it used
in this way. Instead it is applying to license a fragment of Avastin,
called Lucentis, which is packaged in the tiny quantities suitable for
eyes at a higher cost. Speculation in the US suggests it could cost
£1,000 per dose instead of less than £10. The company says Lucentis
is specifically designed for eyes, with modifications over Avastin, and
has been through 10 years of testing to prove it is safe.

Unless Avastin is approved in the UK by the National Institute for
Clinical Excellence (Nice) it will not be universally available within
the NHS. But because Genentech declines to apply for a licence for this
use of Avastin, Nice cannot consider it. In spite of the growing drugs
bill of the NHS, it will appraise, and probably approve, Lucentis next
year.

Although Nice's role is to look at cost-effectiveness, it says it
cannot appraise a drug and pass it for use in the NHS unless the drug
is referred to it by the Department of Health. The department says its
hands are tied.

"The drug company hasn't applied for it to be licensed for this use. It
wouldn't be referred to Nice until they have made the first move," said
a Department of Health spokeswoman. "They need to step up and get a
licence. If they are not getting it licensed, why aren't they?"

New drugs for the condition are badly needed: those we have now only
slow the progression to blindness. With Avastin, many patients get
their sight back with just one or two injections.

Avastin was first used on human eyes by Philip Rosenfeld, an
ophthalmologist in the US, who was aware of animal studies carried out
by Genentech that showed potential in eye conditions. This unlicensed
use of Avastin has spread across continents entirely by word of mouth
from one doctor to another. It has now been injected into 7,000 eyes,
with considerable success.

Professor Rosenfeld has published his results and a website has been
launched in the US to collate the experiences of doctors from around
the world. But although the evidence is good, regulators require
randomised controlled trials before they grant licences, which
generally only the drug companies can afford to carry out.

Prof Rosenfeld said the real issue was drug company profits. "This
truly is a wonder drug," he said. "This shows both how good they [the
drug companies] are and on the flip side, how greedy they are." He
would like to see governments fund clinical trials of drugs such as
Avastin in the public interest.

Rising drug bills are a big problem on both sides of the Atlantic. In
the UK, said David Wong, chairman of the scientific committee of the
Royal College of Ophthalmologists, doctors are fighting battles to
persuade primary care trusts to pay for drugs to stop their patients
going blind while they wait for Nice to decide on Lucentis and another
expensive drug called Macugen. That decision is not expected before the
end of next year.

About 20,000 people are diagnosed with age-related macular degeneration
in the UK each year. "From the patient's point of view, if they have an
eye condition that deteriorates very quickly, there is no question of
waiting," said Professor Wong. "We're talking about days and weeks,
rather than months. The question is should we do nothing and say there
is no randomised controlled trial to prove Avastin is of value?" He
called for primary care trusts to agree to pay for the planned
phasing-in of new drugs for the condition.

Last night Genentech said its main concern over the use of Avastin to
treat eye conditions was patient safety. "While there are some small,
single-centre, uncontrolled studies of Avastin being performed, safety
data on patients who are treated with Avastin off-label is not being
collected in a standard or organised fashion," said a spokeswoman for
the company.

Pharmaceutical firms say they need to launch drugs at high prices
because of the hundreds of millions of pounds spent on developing them.
Critics point out that the company's calculations also include the
marketing budget.

The Guardian Unlimited © Guardian Newspapers Limited 2006

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