National Institute for Health and Clinical Excellence (NICE)
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NICE consults on proposal for dose-capping scheme to make Lucentis available on the NHS

The National Institute for Health and Clinical Excellence (NICE) is currently appraising Lucentis (ranibizumab) and Macugen (pegaptanib) for the treatment of age-related macular degeneration (AMD). NICE is consulting on draft recommendations for a dose-capping proposal to make Lucentis available on the NHS for people with wet AMD. Consultation on the draft recommendations will begin today Friday 14 December 2007 and ends on 14 January 2008. NICE has not yet issued final guidance to the NHS on these drugs.

The draft guidance recommends that the NHS should pay for a maximum of 14 injections of Lucentis per eye, which should result in stable vision for most patients and improved vision for around a quarter of patients. It recommends that the manufacturer should pay if any further doses are needed. Any dose-capping scheme will need to be agreed by both the manufacturer and the Department of Health. Responses to earlier consultation made clear that many people felt it was unacceptable for NICE to recommend treating only the second affected eye. NICE has taken these concerns on board, and now recommends treating the first eye to come to clinical attention.

NICE Chief Executive Andrew Dillon stated: “The manufacturer of Lucentis has proposed a scheme in which the number of injections paid for by the NHS could be capped, with any remaining injections paid for by the manufacturer. NICE’s independent advisory committee thinks that such a scheme could work where a maximum of14 injections per eye of Lucentis is paid for by the NHS, with the cost of additional treatment reimbursed by the manufacturer. 14 injections should result in

stable vision for most patients and improved vision for around a quarter of patients. This proposal therefore represents a good use of NHS resources”.

He added: “I would like to thank those who responded to consultation on an earlier draft of this guidance. Two key issues in particular were highlighted by those who responded: first, that allowing the first eye to deteriorate would cause anxiety and depression; and two, that treating only the second eye could mean losing the chance to preserve vision if it was affected by untreatable vision loss or didn’t respond to treatment. NICE has taken these concerns on board, and now recommends treating the first eye to come to clinical attention.”

The draft guidance does not recommend Macugen for the treatment of wet AMD. NICE’s draft recommendations on the use of Lucentis and Macugen can be found at: http://www.nice.org.uk/guidance/index.jsp?action=byID&o=11700.

Notes to Editors

About NICE

1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

2. NICE produces guidance in three areas of health:

public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
health technologies – guidance on the use of new and existing medicines, treatments and procedures within the NHS
clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

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