NICE 2002/033
Issued: 13 June 2002

PRESS RELEASE

One of the reasons NICE was established was to look at technologies where there is genuine uncertainty regarding their value and to end this uncertainty by providing clear authoritative guidance for the NHS in England and Wales. The Department of Health and the Welsh Assembly Government have asked the National Institute for Clinical Excellence (NICE or the Institute) to conduct an appraisal of photodynamic therapy for age-related macular degeneration and provide clear guidance to the NHS as to where the evidence suggests it should be used.


The process NICE follows to develop its guidance involves patients, health professionals, the manufacturers of the technology and an independent advisory committee. NICE wants its guidance to be robust and it therefore provides organisations representing patients, professionals and manufacturers with the opportunity for consultation and appeal. In line with the Institute's commitment to transparency, consultation and appeal documents are published on the NICE web site at www.nice.org.uk.

Anne-Toni Rodgers, NICE Executive Lead for the appraisal of photodynamic therapy said: "NICE have not made any recommendations on photodynamic therapy. As a part of the NHS we are committed to transparency, and we publish in full documents prepared during the process. We are genuinely seeking the views of consultees during the appeal process and will consider carefully any points they make to us. This document may change as a result of the appeal process. If it does not change it would result in thousands of NHS patients who are currently being denied this treatment being provided with access to photodynamic therapy through specialist centres, at a cost to the NHS of between 4 and 8 million pounds."

Ends


Notes for Editors

1. The final appraisal determination (FAD), which has been sent to consultees for appeal is published on the NICE web site (http://www.nice.org.uk/article.asp?a=32774). Note that this document does not constitute the Institute's formal guidance on this technology. Guidance is not issued until the results of any appeal are known. The earliest guidance could be available is the end of July / August 2002.
   
2. Patients, professionals and manufacturers were sent the FAD document on the 30 May 2002 and have until June 28th to determine if they wish to appeal.
   
3.

Point 1 of the he guidance section of the FAD actually states:

It is recommended that treatment of wet age-related macular degeneration using photodynamic therapy (PDT) should be carried out only in centres specialising in this treatment and as part of an ongoing nationally co-ordinated collection of robust and relevant data on clinical outcome and cost effectiveness, including quality of life as assessed by properly validated instruments, when the following criteria are met:

  • the individual has predominantly classic subfoveal CNV
  • the individual has relatively good residual visual acuity (6/36 or better) in the eye to be treated
  • the better-seeing eye, or only functioning eye is to be treated (that is, patients who develop the condition in the eye that they rely on for most of their visual function)
4. From section four of the document it is clear in preparing this determination that the Committee heard from experts in the field and carefully discussed the considerable uncertainty as to the most appropriate treatment regimen for verteporfin PDT. They were made aware of the need for further research to clarify whether the clinical effectiveness and/or cost effectiveness can be improved by adjusting the treatment regimen - in particular whether continuation of verteporfin PDT should be related to decline in visual acuity or to the presence of continuing leakage for CNV as defined by fluorescein angiography, or whether a regimen involving more frequent treatment in the early phase might be more effective.
   
5. It is also uncertain if it is necessary to continue treatment once vision has stabilised whether or not CNV leakage as defined by fluorescein angiography is still present. Neither is it known whether further treatment is indicated if visual acuity declines significantly despite treatment. The economic analysis submitted by the manufacturer assumed that patients who lost more than 3 lines of visual acuity by the 6-month assessment would be deemed to have not responded and would receive no further treatment.
   
6.

In developing its guidance NICE commissions an independent review of the published evidence and the manufacturers own data, this 'Assessment Report', together with evidence submitted by patient/carer organisations, health professionals and manufacturers, is considered by an independent appraisal committee. Patient/carer and professional representatives, nominated by their own organisations, attend and inform the committee meeting.

Following their first consideration of the evidence the independent appraisal committee consult on their initial thoughts with all of the stakeholders including the patient/carer and professional groups. This consultation document is called an ACD (Appraisal Consultation Document). The ACD is also published on the NICE web site and it is important to note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in it are preliminary and may change after consultation.

The feedback from the consultation process is considered by the appraisal committee at a further meeting and they then draft a further document which is sent to NICE. NICE considers the committee's recommendations, and sends their proposed guidance to the same stakeholder groups who have the opportunity to appeal. If there are no appeals this guidance is issued to the NHS. If appeals are made the Institute considers them carefully.