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Draft National Policy on Sight-saving Drugs unacceptable

Restricting use of drugs for macular degeneration to patients who have already gone blind in one eye is unacceptable concludes the July issue of Drug and Therapeutics Bulletin (DTB).

But that is what the National Institute for Health and Clinical Excellence (NICE), the body responsible for guiding the NHS on which treatments to use, is proposing.

Ranibizumab (Lucentis) and pegaptanib (Macugen) are licensed in the UK for the treatment of neovascular (wet) age-related macular degeneration. A third drug bevacizumab (Avastin) is also used, but not licensed for the condition.

In wet age-related macular degeneration, in which fine central vision is progressively lost, new blood vessels grow beneath the retina, a process stimulated by vascular endothelial growth factor (VEGF). All three drugs potentially block the effects of VEGF.

Wet age-related macular degeneration is the third most common cause of blindness worldwide. It affects around 2.3% of over-65s in Europe. In the UK around 26,000 people develop it each year and 245,000 are blind or visually impaired because of it.

After a thorough examination of published clinical trial data, DTB concludes that there is good evidence that both ranibizumab and pegaptanib prevent further deterioration in vision in most patients. Ranibizumab improved vision in a third.

The NICE draft guidance on use of ranibizumab and pegaptanib was published in June. It recommends ranibizumab for only about 20 per cent of patients with wet age-related macular degeneration, restricting its use to those in whom both eyes are affected and then to the better seeing eye.

Final guidance is due in September.

DTB says: We believe that policies that dictate that patients must go blind in one eye before being given treatment for the other are unacceptable.

It continues: Pegaptanib and ranibizumab need to be made available for use thr oughout the NHS, as is the case in Scotland. In the absence of such national arrangements elsewhere in the UK, NHS commissioners need to work with local clinicians to ensure that the benefits of these drugs are made available to as many patients as possible.

NICE has not issued draft guidance on bevacizumab, but many primary care trusts recommend its use because it is cheaper than pegaptanib and ranibizumab.

DTB says that bevacizumab might provide a lower cost alternative, but cautions that there is as yet no robust evidence of its safety and effectiveness in the treatment of macular degeneration. Therefore, we cannot recommend such use outside of clinical trials.


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