Age-related macular degeneration (AMD) is the commonest cause of blindness. Macugen, the drug used for its treatment, has been approved yesterday by the Scottish Medicines Consortium (SMC). But the National Institute for Health and Clinical Excellence (NICE) which covers England and Wales, is expected to give its approval not before August 2007.
According to the campaigners, atleast 20,000 people will go blind unnecessarily due to this delay in approval.Though NICE has recently introduced a fast-track process to approve the essential drugs, Macugen has not been fast-tracked.
AMD usually occurs in people above 65 years in age. The wet form of AMD may cause a loss of central vision and altered color perception. This affects 10% of sufferers and accounts for 90% of blind registrations due to the disease. It can cause blindness within a matter of 3 months.
The causes of AMD are not known but the risk factors are age, smoking and family history. Vascular Endothelial Growth Factor (VEGF), is the protein that aids in new blood vessel formation. But excessive VEGF in the eye can cause a proliferation of blood vessels and leakage of fluids. These are the characteristics of wet AMD. Macugen targets this particular protein.
A course of three injections when given over 18-weeks, costs £1,542.According to Steve Winyard, head of research for the Royal National Institute for the Blind (RNIB) doctors are allowed to prescribe Macugen, but it is not being used due to its £4,000 annual cost. Mr Winyard said: "It would save the NHS money because the cost of supporting someone who is blind is greater than the cost of treatment."
Patients who wanted to get Macugen from their primary care trusts (PCTs) were refused, he said. "We are hearing of blanket bans on Macugen by PCTs even though Andy Burnham, the Health minister, told the Commons that each case should be treated on its merits," Mr Winyard said.
Macugen is also known as pegaptanib and is manufactured by Pfizer. A spokesman for NICE said: 'NICE has been asked to appraise both pegaptanib (Macugen) and ranibizumab (Lucentis) for the treatment of age-related macular degeneration.
'Pegaptanib (Macugen) was licensed for use across Europe in February 2006, but ranibizumab (Lucentis) is not yet licensed for use in the UK.
'NICE will be in a position to issue guidance to advise on the effectiveness of both drugs after ranibizumab receives its licence, and is currently expecting to issue guidance to the NHS in August 2007.
'Topics for appraisal under the Institute's faster single technology appraisal process are selected by the Department of Health.
'There is no restriction on the prescribing of any drug, within its licensed indications, whilst NICE is developing guidance. In the absence of NICE guidance, local NHS organisations should develop their own prescribing policies.'