23 June 2008
We received a petition asking:
“We the undersigned petition the Prime Minister to end the NHS postcode lottery of sight-saving drug Avastin.”
Details of Petition:
“Avastin - a sight-saving and anti-cancer drug - is currently not available on the NHS at all PCTs in the country. We believe that the drug should be readily available to all those who could benefit from it. Case Study - Brian Turner, of West Yorkshire, suffers wet age-related macular degeneration and will go blind within three months unless he has injections of avastin. But the drug costs £700 per injection, and he could need as many as nine - that’s £3,600! Fortunately Mr Turner has a big enough family willing to club together and pay for his treatment. But what happens to the sufferers who don’t have that safety net - do we let them go blind?.”
Read the Government’s response
The Government fully understands the importance of having access to new and potentially beneficial treatments.
The National Institute for Health and Clinical Excellence (NICE) is an independent Special Health Authority set up to tackle inequity of access to healthcare. NICE produces guidance for the NHS on the clinical and cost effectiveness of treatments.
NICE was established to look at issues such as new drug treatments and it has the expertise and independence to enable it to do so. It would not be appropriate for the Government to direct NICE or give it detailed instructions on its methodology. The Department of Health, as a stakeholder in NICE, is invited to comment on the guidance the Institute produces. The Government trusts NICE to take on board all the comments made about its guidance and give proper credence to all issues raised.
The methodologies that NICE uses to develop its guidance are based on the best available evidence and are a matter for the Institute. NICE has a world class reputation and the Institute’s appraisal process has been reviewed by the World Health Organization, which stated in its report that NICE has developed a well-deserved reputation for innovation and methodological developments that represent an important model for technology appraisals internationally.
NICE processes are open and transparent, inviting comments from a wide range of stakeholders in the development of its guidance. NICE’s Technology Appraisal process also allows stakeholders to appeal against the guidance if they feel that the Institute has failed to act fairly and in accordance with its published procedures as set out in the Institute’s Guide to the Technology Appraisal Process or has prepared a Final Appraisal Determination (FAD) that is perverse in the light of the evidence submitted or the Institute has exceeded its own powers. If a stakeholder in a NICE appraisal has issues with technical aspects of an appraisal, then the appropriate course of action is to raise these concerns with the Institute.
NICE received appeals against its FAD on bevacizumab (Avastin) and cetuximab (Erbitux). The appeal hearing was convened on 27 November last year and the independent Appeal Panel announced on 24 January that the appeals had not been upheld.
As a result, NICE’s final guidance was also published on 24 January. It is unchanged from the recommendations contained in the FAD and states that:
- bevacizumab in combination with 5-fluorouracil plus folinic acid, with or without irinotecan, is not recommended for the first-line treatment of metastatic colorectal cancer;
- cetuximab in combination with irinotecan is not recommended for the second-line or subsequent treatment of metastatic colorectal cancer; and
- people currently receiving bevacizumab or cetuximab should have the option to continue therapy until they and their consultants consider it appropriate to stop.
These are not easy recommendations to make and the Government recognises that all NICE’s decisions have implications for patients and their carers. However, sometimes NICE has to refuse to recommend a treatment because the evidence does not support it as being clinically and cost effective.
It should be explained that Avastin is licensed for use in colorectal cancer; it is not licensed for the treatment of age-related macular degeneration (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 Government cannot compel the companies to apply for a licence, but Ministers have 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 the NHS cannot use it 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.
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