[Ip-health] 'Off License' drug that cures blindness costs one percent of most commonly prescribed drug

[Ira Glazer]

http://news.independent.co.uk/uk/health_medical/article1799454.ece

By Jeremy Laurance, Health Editor
Published: 05 October 2006

A drug that could save thousands of people from going blind is being
hailed as a "miraculous" advance against a modern epidemic. But the
drug, Lucentis, has sparked a row over its cost after ophthalmologists
found that it worked in a similar way to an existing drug that was
equally safe and effective and sells at a fraction of the price.

An estimated 27,000 people in England and Wales develop wet macular
degeneration, the commonest cause of blindness, each year. The
progressive condition slowly destroys the retina, causing the loss of
central vision.

Until recently there has been no treatment for macular degeneration,
which affects one in three people by the age of 75 and is increasing as
the population ages. The first breakthrough came with the development of
photo dynamic therapy, which helps 7,000 of the 27,000 sufferers a year,
and a drug, Macugen, launched last year has been shown to halve the risk
of severe loss of vision.

Results from two trials of Lucentis, conducted in the United States,
show it is even more effective, actually improving vision in a third of
patients and halting the deterioration in most of the rest.

In an editorial headlined "A very effective treatment for neovascular
macular degeneration", The New England Journal of Medicine, which
publishes the findings today, says the drug is "miraculous" and the
results "exciting".

But it uses identical terms to describe the rival drug, Avastin,
normally used to treat cancer and not licensed for macular degeneration,
and says a "head to head comparison of the two drugs is now warranted".

Such a trial would cost tens of millions of dollars and Genentech, the
Californian biotech company that makes both drugs, is reluctant to fund
it because it could undermine its profits.

Lucentis costs around =A31,000 a dose and is given by injection directly
into the eye. Patients need injections monthly for up to two years and
possibly for life. It is licensed in the US and a licence is expected in
the UK by the end of the year.

Avastin, licensed as a treatment for colon cancer two years ago, costs
from =A310 to =A325 a dose when given by injection into the eye. Its use in
macular degeneration was discovered by a US consultant ophthalmologist,
Philip Rosenfield, chief author of the new study of Lucentis, who
noticed that the two drugs worked in a similar way. He experimented on
two patients and after he published his results last year,
ophthalmologists around the world rapidly took up the treatment, using
the drug "off licence", with the consent of patients.

Professor Rosenfield described Avastin as "truly a wonder drug" and said
it showed both how good drug companies were "and, on the flip side, how
greedy they are". He called for governments to fund clinical trials in
the public interest.

Steve Winyard, policy director of the Royal National Institute for the
Blind, said Lucentis was "very good news" for patients and a
"significant further step forward". Trials to test Lucentis against
Avastin were now necessary and should be funded by the Government.

"It could be a very good spend-to-save measure [to run a
government-funded trial]. If the drug companies don't want to do it
maybe the NHS should."

Winfried Amoaku, consultant ophthalmologist at Queen's Medical Centre in
Nottingham and deputy chairman of the scientific committee of the Royal
College of Ophthalmologists said: "[Lucentis] is expensive but you can't
put a price on vision. If you lose your sight you lose your independence
and the care you need ends up costing more."

Macular degeneration and its possible treatments

Macular degeneration affects an estimated 500,000 people in the UK.

The macula is at the centre of the retina, where the light is focused,
and is essential for reading, writing and seeing colour.

In affected individuals, the delicate cells at the centre of the macula
stop working for reasons that are not understood.

Most cases are of the slow progressing, dry kind for which there is no
treatment.

Wet macular degeneration, which progresses faster, affects 27,000 new
patients each year.

Most of these patients can now be helped by laser treatment,
photodynamic therapy or drugs.

Most patients have to pay privately for drug treatment because the
National Institute for Clinical Excellence is not due to issue guidance
on their NHS use until autumn 2007.

A drug that could save thousands of people from going blind is being
hailed as a "miraculous" advance against a modern epidemic. But the
drug, Lucentis, has sparked a row over its cost after ophthalmologists
found that it worked in a similar way to an existing drug that was
equally safe and effective and sells at a fraction of the price.

An estimated 27,000 people in England and Wales develop wet macular
degeneration, the commonest cause of blindness, each year. The
progressive condition slowly destroys the retina, causing the loss of
central vision.

Until recently there has been no treatment for macular degeneration,
which affects one in three people by the age of 75 and is increasing as
the population ages. The first breakthrough came with the development of
photo dynamic therapy, which helps 7,000 of the 27,000 sufferers a year,
and a drug, Macugen, launched last year has been shown to halve the risk
of severe loss of vision.

Results from two trials of Lucentis, conducted in the United States,
show it is even more effective, actually improving vision in a third of
patients and halting the deterioration in most of the rest.

In an editorial headlined "A very effective treatment for neovascular
macular degeneration", The New England Journal of Medicine, which
publishes the findings today, says the drug is "miraculous" and the
results "exciting".

But it uses identical terms to describe the rival drug, Avastin,
normally used to treat cancer and not licensed for macular degeneration,
and says a "head to head comparison of the two drugs is now warranted".

Such a trial would cost tens of millions of dollars and Genentech, the
Californian biotech company that makes both drugs, is reluctant to fund
it because it could undermine its profits.

Lucentis costs around =A31,000 a dose and is given by injection directly
into the eye. Patients need injections monthly for up to two years and
possibly for life. It is licensed in the US and a licence is expected in
the UK by the end of the year.

Avastin, licensed as a treatment for colon cancer two years ago, costs
from =A310 to =A325 a dose when given by injection into the eye. Its use in
macular degeneration was discovered by a US consultant ophthalmologist,
Philip Rosenfield, chief author of the new study of Lucentis, who
noticed that the two drugs worked in a similar way. He experimented on
two patients and after he published his results last year,
ophthalmologists around the world rapidly took up the treatment, using
the drug "off licence", with the consent of patients.

Professor Rosenfield described Avastin as "truly a wonder drug" and said
it showed both how good drug companies were "and, on the flip side, how
greedy they are". He called for governments to fund clinical trials in
the public interest.

Steve Winyard, policy director of the Royal National Institute for the
Blind, said Lucentis was "very good news" for patients and a
"significant further step forward". Trials to test Lucentis against
Avastin were now necessary and should be funded by the Government.

"It could be a very good spend-to-save measure [to run a
government-funded trial]. If the drug companies don't want to do it
maybe the NHS should."

Winfried Amoaku, consultant ophthalmologist at Queen's Medical Centre in
Nottingham and deputy chairman of the scientific committee of the Royal
College of Ophthalmologists said: "[Lucentis] is expensive but you can't
put a price on vision. If you lose your sight you lose your independence
and the care you need ends up costing more."


Macular degeneration and its possible treatments


Macular degeneration affects an estimated 500,000 people in the UK.

The macula is at the centre of the retina, where the light is focused,
and is essential for reading, writing and seeing colour.

In affected individuals, the delicate cells at the centre of the macula
stop working for reasons that are not understood.

Most cases are of the slow progressing, dry kind for which there is no
treatment.

Wet macular degeneration, which progresses faster, affects 27,000 new
patients each year.

Most of these patients can now be helped by laser treatment,
photodynamic therapy or drugs.

Most patients have to pay privately for drug treatment because the
National Institute for Clinical Excellence is not due to issue guidance
on their NHS use until autumn 2007.