British Parliament Responds to Macular Degeneration Petition

The British Parliament was presented with a petition from Macular Degeneration Patients stating “We the undersigned petition the Prime Minister to authorise use of all available drugs to combat age-related macular degeneration.”  The British Prime Minister replied to this macular degeneration petition in early 2008 indicating there would be a 42 month trial to compare the drugs Avastin and Lucentis, both of which have shown considerable promise in treating wet macular degeneration.

The National Institute for Health and Clinical Excellence (NICE) is currently appraising the macular degeneration drug pegaptanib (Macugen) and ranibizumab (Lucentis).  Lucentis was approved by the European Medicines Agency in January 2007 and authorised for use in the treatment of macular degeneration.  Macugen was licensed in February 2006.

NICE has published consultations documents which recommends Lucentis be used in macular degeneration patients meeting a number of clinical criteria and subject to the manufacturer funding treatments in excess of 14 injections.  Macugen was not recommended as a treatment for macular degeneration.  Stakeholders were given until January 14 to respond to the consultation.

With NICE beign the independent body that will make the final decision on the clinical and cost effectiveness of Lucentis based on the latest evidence.  It is important not to prejudge NICE’s guidance but recognize that it can have serious implications on people with macular degeneration and their care givers.

The consultation process is wide-ranging and the Institute invites comments from patient groups and individual patients suffering from the eye disease, care givers and other members of the public concerned about macular degeneration.  Further details, including a list of stakeholder are available at http://www.nice.org.uk and then searching for “pegaptanib”.

While NICE makes recommendations as to which drugs to use, decisions to fund individual treatments are made by Primary Care Trusts (PCTs) in consultation with 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 regards to another drug used to treat macular degeneration, particularly the off-label use of Avastin, this drug is licensed for colorectal cancer;  it is not licensed for the treatment of wet macular degeneration.  Before a license could be granted, a company would have to carry out the necessary research and development to demonstrate the safety of Avastin, quality and efficacy for its use to treat the eye disease macular degeneration.

The companies that manufacture the drug Avastin have not applied for a license for the treatment of macular degeneration and no clincial trials have been conducted for that purpose.  The Department of Health cannot compel the companies to apply for a license but has already urged the companies to start clinical trials for the use of Avastin for people with macular degeneration and to apply for a license.

The fact that the drug Avastin is unlicensed as a treatment for macular degeneration does not mean that it cannot be used by the NHS for this purpose however.  Some clinicians have been using Avastin “off-license” (other than for its licensed indications) to treat wet macular degeneration.  Clinicians can prescribe medicines off-license if they feel it is right for an individual patient after discussing potential risk 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 to treat macular degeneration.

The Health Technolgy Assessment (HTA) program of the National Insitute for Health Research has agreed to fund a head to head trial of Avastin and Lucentis over a period of 42 months to determine if there is a difference in treating macular degeneration patients with these two drugs.  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.

Source: Prime Minister’s Response to Petition – UK Government

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