Issued 11 April 2002
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 National Assembly for Wales 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.
NICE has not yet issued guidance on the use of photodynamic therapy for age related macular degeneration to the NHS. The guidance is in an early stage of development and has not been finalised.
The process NICE follows to develop its guidance involves patients, health professionals, the manufacturers of the technology and an independent advisory committee. It provides organisations representing patients, professionals and manufacturers with the opportunity for consultation and appeal. In line with the Institute's commitment to transparency, consultation documents are published on the NICE web site.
In developing its guidance NICE commissions an independent review of published evidence and 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 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 then 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.
Anne-Toni Rodgers, NICE Executive Lead for the appraisal of photodynamic therapy said: “NICE have not made any recommendations on photodynamic therapy. In fact we are weeks away from even receiving the independent appraisal committee's final thoughts. As a part of the NHS we are committed to transparency, and we publish in full the committee's initial evaluation of the evidence so that people can send us their views. We also send the same document to groups such as the RNIB as a part of the formal process of consultation.
“We are quite clear that the document contains preliminary views that may change after consultation. In this case it is not true to say that the preliminary views mean that the committee are seeking to ban this treatment from the NHS. It reflects the fact that the committee have noted that there are considerable uncertainties surrounding this treatment, and given this uncertainty are minded to suggest that people who are treated with it on the NHS should be a part of a clinical trial. This would mean that patients would be fully informed of the current evidence supporting the technology, and that patients and the NHS together would be collecting data to help end these uncertainties.”
Ends
Notes for Editors
1.The appraisal committee's consultation document is published on the NICE web site (link to consultation document. ). Note that this document does not constitute the Institute's formal guidance on this technology. The recommendations made in Section 1 are preliminary and may change after consultation.
2.Patients and professionals can send the appraisal committee their views on the document through the web site.
3.Closing date for comments is Tuesday 30 April 2002 and the Appraisal Committee will meet again on Wednesday 8 May 2002 after which the final draft guidance will be sent to consultees to consider whether they wish to appeal. The final draft guidance will also be published on the NICE web site.
4.The considerations section of the consultation document states:
There is considerable uncertainty as to the most appropriate treatment regimen for verteporfin photodynamic therapy and in particular, whether continued treatment is necessary once vision has stabilised irrespective of the continuing presence of wet ARMD as defined by fluorescein angiography.
This is a key issue in determining whether this treatment will be cost effective in clinical practice. The Committee considered that it is possible that the regimen investigated in the clinical studies does not represent optimal use of this therapy.
Further research is needed to clarify whether the clinical effectiveness and/or cost effectiveness can be improved by adjusting the treatment regimen - and 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 by better identification of patients who are most likely to achieve a substantial response.
