Eyesight of thousands to be saved after Nice approves drug
Friday, 29 August 2008

Patients at risk of going blind will have their sight saved under a unique deal

The Telegraph

For the first time a drugs company will pay to top up patients' treatment where the level of care paid for by the Health Service is not enough.

In a decision that marks a climbdown for the National Institute for health and Clinical Excellence (NICE), the first 14 injections of the sight-saving drug Lucentis will be paid for by the NHS.
If the patient still needs further treatment then Novartis, the manufacturer, will pay for any additional doses.
The ruling overturns previous draft guidance that patients would have to go blind in one eye before receiving treatment with Lucentis, which costs more than £10,000 per eye, on the second.
It also paves the way for other new drugs for which top-up doses may be required to be funded in the same way in future.
Richard Barker, director general of the Association of British Pharmaceutical Industry suggested other medicines the NHS cannot afford to pay for in full could be provided through cost sharing schemes between the NHS and the drugs industry.
A similar approach has been suggested for kidney cancer drug Sutent, which costs £24,000 a year, and three other drugs after Nice issued draft guidance saying that they were not "cost effective" despite extending life by two months.
NICE has been severely criticised in recent months by health campaigners, who have accused them of condemning patients to "an early grave" by denying them the drugs.
It has also been at the centre of a previous controversy over its decision to deny the £2.50-a-day drug Aricept to victims of Alzheimer's in the early stages of the disease.
Lucentis can stop the deterioration in sight caused by the condition wet age related macular degeneration (AMD), which affects about 250,000 people in the UK including 26,000 new cases each year. It can cause blindness within three months.
Up until now around 40 per cent of primary care trusts have refused to fund the drug while others have approved its use only in 'exceptional cases' although the drug was approved in Scotland last year.
Nice has taken over two and a half years to issue its final guidance on the drug in which time many thousands of people have already gone blind as a result of the condition. The drug has no effect on the condition once the patient has gone blind.
Andrew Dillon, NICE Chief Executive, said the decision would be justified by both the improved quality of life for patients and cost savings in the long run.
"Lucentis is an expensive drug, costing more than £10,000 for each eye treated," he said. "But that cost needs to be balanced against the likely cost savings. AMD results in reduced quality of life and increased risks of illness, particularly in relation to accidents – especially falls – and psychological ill-health.
"Studies have also demonstrated that patients with visual impairment tend to have longer hospitalisations, make greater use of health and community care services and are more likely to be admitted to nursing homes.
"It has been estimated that the costs related to sight impairment for patients treated with Lucentis are around £8,000 cheaper than for patients who receive best supportive care over a 10 year period. Our guidance means that patients who are suitable for this treatment will have the same access to it, irrespective of where they live."
Steve Winyard, Head of Campaigns at Royal National Institute for the Blind, said: "We've been waiting for this for over two years. It is a victory for thousands, bringing overwhelming relief to desperate people across the country. Finally the torment faced by elderly people forced to either spend their life savings on private treatment or go blind, is over.
"NICE's guidance will finally bring an end to a cruel postcode lottery."
Primary care trusts in England and Wales now have three months to fund the treatment for all eligible patients.
Lucentis is being provided through the country's first dose capping scheme, which sees the NHS funding treatment only up to a given stage, in this case 14 injections.
Other similar schemes for the NHS to share costs with manufacturers include money back guarantees if the patient does not respond or sliding scale prices which sees the NHS paying less where the response is limited and more where it shows significant improvement.
Velcade for myeloma and beta interferon for MS are provided by so called risk sharing schemes of this type.
The ABPI's Mr Barker said drug companies were being flexible and suggesting cost sharing schemes but Nice had to be flexible also.
He said: "We believe these kinds of flexible options on the part of industry are part of the answer where Nice has said no or where there is an issue about cost effectiveness. "There is a range of different ways of dealing with the problem but there is no silver bullet."
The decision comes after Health Secretary Alan Johnson ordered an investigation into the policy of denying NHS services to patients in England who top up their care with private treatment.
Currently, anyone who pays for any private care can be barred from receiving the normal package of NHS care but the review will look at whether such co-payments should be allowed in future.
In July, RNIB also backed three pensioners in landmark High Court action against Warwickshire PCT for denying them treatment.
Tom Bremridge, chief executive of The Macular Disease Society said: "Those responsible for NICE should be aware that during the cumbersome two year review process 152 PCTs have individually had the power to decide whether to let patients go blind or to save their sight. The resulting stress and suffering has been cruel and unnecessary.
"Many hundreds of vulnerable patients have been subjected to an appalling emotional rollercoaster ride for the past two years – during which many of them have lost their remaining sight."
He called for Nice to speed up drug appraisals in order to avoid primary care trusts around the country making different decisions on funding drugs that have not yet been through Nice.
While Lucentis will be available to patients on the NHS, NICE has not recommended another similar drug, Macugen made by Pfizer.
Age related macular degeneration comes in two forms; dry which causes a slow wasting of the cells in the eye; and wet, which causes rapid deterioration.
Lucentis and Macugen work by blocking a substance that causes new blood vessels to grow in the eye thereby stopping the bleeding at the back of the eye which causes the wet form of AMD.
Dr Rafiq Hasan, Director of Market Access and Ophthalmics at Novartis said the new agreement was "an innovative approach which shows how pharmaceutical companies can work together with Nice and the Department of Health to ensure patients do get access to treatments on the NHS."
He said: "Wet AMD is a debilitating eye condition that can result in a rapid loss of sight if left untreated. Lucentis is a treatment for a key unmet medical need and it has the potential to save many peoples' sight.
"Rapid implementation of the guidance is now needed to ensure that patients receive the treatment they need as soon as possible."

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