The two drugs are anti-VEGF2 agents and the working group concluded that
both are equally effective in the treatment of AMD and have a similar safety
profile.

 

The use of Avastin instead of Lucentis would save the NHS considerable
sums of money but when Avastin is used for the treatment of eye disease it is
used “off-label”. Current General Medical Council (GMC) guidance states that
doctors who prescribe off-label must be satisfied that doing so would better
serve the patient’s needs than using an appropriately licensed alternative.
There is no evidence that Avastin is more effective than Lucentis for the
treatment of AMD.

 

The College supports the continued use of Lucentis rather than Avastin for
patients with wet AMD who fall within the National Institute for Health and
Clinical Excellence (NICE) guidelines for treatment. Primary Care Trusts are
legally obliged to fund NHS treatment with Lucentis if an ophthalmologist
prescribes it.

 

The College believes that the NHS executive should urgently instruct NICE
and the Medicines and Healthcare Products Regulatory Agency (MHRA) to
evaluate the use of Avastin in the treatment of AMD and produce National
Guidelines for the use of anti-VEGF agents in AMD.

 

Ophthalmologists should have the discretion to use Avastin rather than
Lucentis for the treatment of AMD if it is in the patient’s best interest to do so
and provided the patient gives informed consent. This may occur, for
example, when an ophthalmologist wishes to use an anti-VEGF agent earlier than specified in the NICE guidelines or when the patient has failed to
respond to Lucentis.

The College supports the use of Avastin for medical retina conditions for
which no licensed or NICE approved alternative medicine is available.
The ophthalmologist must source the Avastin from a reputable pharmacy.
The key issue is that the patient must be provided with full information about
treatment alternatives and must give informed consent.

Notes for Editors

1. Age related macular degeneration (AMD) is one of the commonest causes
of visual impairment in the UK and it predominantly affects the elderly.
Estimates from the Royal National Institute for the Blind and National Institute
of Health and Clinical Excellence indicate there may be 26,000 people with
exudative AMD now eligible for treatment in the UK each year. (RCOphth
Age-Related Macular Degeneration Guidelines for Management February
2009).

2. There are two forms: geographic atrophy (‘dry’) AMD that causes very
gradual loss of vision and a neovascular (‘wet’) form of AMD that can cause
quite rapid loss of vision. The symptoms of wet AMD occur first in one eye
but loss of vision in the second eye may occur sooner or later. The wet form
of AMD may be treated by a drug that inhibits the function of a biological
growth factor called vascular endothelial growth factor (VEGF) that is a key
element in causing the wet form of AMD. Such drugs, termed anti-VEGF
agents, are given by injection into the eye and most patients need several
injections at regular intervals to get the desired treatment effect. Anti VEGF
agents can be very effective in treating wet AMD but not all patients respond
to treatment. They arrest progression of AMD and may restore some, but not
all, of the sight that has been lost.

3. Ranibizumab (Lucentis) is an anti-VEGF agent that has been specifically
developed for treatment of eye conditions and has been shown in clinical trials
to be effective in the treatment of ‘wet’ AMD. It also has a very good safety
record. It has been evaluated by the National Institute for Clinical Excellence
(NICE) and found to be cost effective. NICE has approved Lucentis for use
within the NHS and Primary Care Trusts (PCTs) are legally obliged to fund
Lucentis when an ophthalmologist prescribes it for the treatment of AMD.
The drug is expensive and costs the NHS £740 per injection. With an
average of 7 injections required per eye in the first year of treatment the total
cost of the drug per eye can mount to £5,180. For some patients who need
treatment over a longer period, the cost of the drug can be considerably more.

 

4. Bevacizumab (Avastin) is an anti-VEGF agent that was originally developed
for the treatment of cancer, where it is given intravenously. It has a similar
mode of action to Lucentis. Avastin is licensed for use in cancer treatment
and has been used widely around the world for treatment of wet AMD and
other eye disorders. It has not been licensed or approved by NICE for use
within the eye. It is not marketed by the manufacturers for treatment of eye
disorders or prepackaged in the very much smaller doses required for
injection into the eye (specialist pharmacies have been splitting phials of the
drug supplied by the manufacturer).

Avastin is much cheaper than Lucentis, costing the NHS about £60 per
injection, with a total equivalent cost of £420 in the first year of treatment.

 

The College has received financial support from Novartis (the manufacturer of
Lucentis) for it educational activities and has in the past received a donations
for its research fund. Some College officers and members of Council have
received individual support from Novartis and some are employed by
Moorfields Eye Hospital whose manufacturing pharmacy markets
bevacizumab (Avastin) for ophthalmic use.

The conflicts of interest policy of the College can be viewed at
http://www.rcophth.ac.uk/core/core_picker/download.asp?id=1174&filetitle=Conflict+of+Interest+Policy

 

More information and advice to the public is available at
http://www.rcophth.ac.uk

 

For more information, please contact Amanda Hayhurst, Schwartz MSL
Communications; 020-8 973 2632/07720 205581 or Holly Brace 0208 973
2630/07534 409680.

 

ends