Macular Disease Society calls for government action over unlicensed drug for macular degeneration

10 October 2011

A leading national eye charity is calling on the government to act over the use of an unlicensed drug for macular degeneration.

The Macular Disease Society wants the Government to initiate a NICE appraisal of the cancer drug Avastin. It's a move which may set a controversial precedent, but one which the charity says is essential to protect patients, doctors and the NHS.

Age-related macular degeneration (AMD) is the biggest cause of sight loss in the western world. More than half a million people in the UK have AMD and it is becoming more common as the population ages. The licensed treatment for one form of the condition, 'wet' AMD, is an expensive drug called Lucentis. It is injected into the eye to stop the development of abnormal blood vessels which leak, scarring the macula (the centre of the retina) and causing loss of central vision.

Lucentis is a breakthrough drug which has saved the sight of tens of thousands of people. However, there is also a very similar cancer drug, Avastin, which is much cheaper when used in tiny eye-size doses. Lucentis costs around £900 per dose, Avastin about £100. Although not licensed for use in eyes, Avastin is widely used to treat AMD in other parts of the world including the US.

Last year, Lucentis accounted for more than 1% of the entire NHS drugs budget. Many hard-pressed PCTs now want to use Avastin here even though some clinicians say there is insufficient safety evidence to support this.

The Macular Disease Society wants NICE to appraise Avastin before it comes into widespread use in the NHS. However, NICE can only appraise licensed drugs and so cannot examine Avastin unless asked to do so by a Minister. The last Government asked NICE to conduct a scoping exercise to decide if an appraisal would be feasible and NICE concluded it was, if a safety regulator such as the Medicines and Healthcare Products Regulatory Agency (MHRA) also took part.

Last month health minister, Simon Burns said that the Government had no plans to ask NICE to appraise Avastin although the decision would be kept under review.

Helen Jackman, CEO of the Society, said: “This is a very controversial issue with strong views both for and against Avastin use. Individual clinicians are being put in an impossible position. They are legally responsible for the off-label or unlicensed drugs they prescribe and they have conflicting messages from the bodies they look to for guidance.

“The Royal College of Ophthalmologists does not recommend the use of Avastin in eyes (although a newly formed committee is looking at this issue now). The GMC says that doctors should only use unlicensed drugs if licensed treatments are not available or if it is in the patient's interests to use an unlicensed drug. They should not make prescribing decisions on the basis of cost. However PCTs are beginning to commission Avastin services specifically to save money sometimes asking patients to make the decision about which drug to have.”

There is concern that an appraisal would set a precedent and establish a “back-door” route to drug regulation which would bypass the usual safety regimes.

However, the Society believes this to be an exceptional case and that settling the issues of safety versus the cost of Avastin is necessary. Without such a decision, patients and doctors will be put under pressure to accept a drug which no regulatory body has approved.

Ms Jackman said: “Without a NICE appraisal we expect there to be dozens of 'mini-appraisals' in individual PCTs or PCT clusters. Some clinicians will be asked to prescribe against their clinical judgement and against the advice of their own Royal College. There will be a postcode lottery of treatment with some areas sticking to Lucentis, others using Avastin, and some using both. The argument about which is best will continue for years. If the pro-Avastin campaigners are right then the NHS will spend a lot of money on Lucentis unnecessarily. If the anti-Avastin campaigners are right then an inferior drug which is not as safe will be in use around the NHS.

“A credible and authoritative organisation needs to appraise this drug and make a decision. NICE is in the best position to do this and we call on the Secretary of State to provide the leadership needed now and ask NICE to appraise Avastin.”

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