Mac-degeneration - epetition reply
23 January 2008
We received a petition asking:
"We the undersigned petition the Prime Minister to authorise use of all available drugs to combat age related macular degeneration."
Details of Petition:
"The current proposals by NICE to only authorise restricted treatment after the loss of sight in one eye is barbaric.People who may or may not be healthy in other respects could be condemned to life without their sight - surely this is unacceptable for a civilised society."
Read the Government's response
The National Institute for Health and Clinical Excellence (NICE) is currently appraising pegaptanib (brand name Macugen) and ranibizumab (Lucentis). Lucentis was approved by the European Medicines Agency in January 2007 and authorised for use in the treatment of AMD and Macugen was licensed in February 2006. In response to comments NICE received on its consultation document published in June 2007, NICE has published a second consultation document which recommends Lucentis in patients meeting a number of clinical criteria and subject to the manufacturer funding treatment in excess of 14 injections. Macugen is not recommended. Stakeholders have until 14 January to respond to this consultation and NICE expects to publish final guidance as soon as it has considered the responses.
NICE is an independent body that makes decisions on the clinical and cost effectiveness of products based on the latest evidence. It is important not to prejudge NICE's guidance, but we recognise that it can have serious implications for patients and their carers.
The consultation process is wide-ranging, and the Institute invites comments from patient groups and individual patients, carers and other members of the public. Further details, including a list of stakeholders, are available at: www.nice.org.uk (by searching for 'pegaptanib').
Decisions to fund treatments are made by Primary Care Trusts (PCTs) in consultation with the healthcare professionals who are best placed to decide on the most appropriate treatments for their patients. The Department of Health has made it clear to the NHS that it is not acceptable for funding for licensed treatments to be withheld from patients simply because NICE has not published guidance on them. In these circumstances, PCTs are expected to take full account of available evidence when reaching funding decisions. This is confirmed in a good practice guide issued to the NHS in December 2006.
With regard to another drug used to treat AMD, Avastin, this drug is licensed for use in colorectal cancer; it is not licensed for the treatment of AMD. Before a licence could be granted, a company would have to carry out the necessary research and development to demonstrate its safety, quality and efficacy for this use.
The companies that make Avastin have not applied for a licence for the treatment of AMD and no clinical trials have been conducted for that purpose. The Department of Health cannot compel the companies to apply for a licence, but has already urged both companies to start clinical trials for the use of Avastin for people with this condition and to apply for a licence.
The fact that Avastin is unlicensed as a treatment for AMD does not mean that it cannot be used by the NHS for this purpose. Some clinicians have been using Avastin 'off-licence' (other than for its licensed indications) to treat AMD. Clinicians can prescribe medicines off-licence if they feel it is right for an individual patient after discussing the potential risks and taking into account the patient's medical history. In those circumstances, the clinician would have to retain clinical responsibility for the patient while prescribing the drug.
The Health Technology Assessment (HTA) programme of the National Institute for Health Research has agreed to fund a head to head trial of Avastin and Lucentis over a period of 42 months. A similar trial in the United States is about to start, funded by US Government agencies, and the HTA has ensured that it will be possible to combine the results of these two trials.
Further Information
YouTube: Holocaust remembered
