NICE 2002/ 0051
Issued: 14 October 2002

PRESS RELEASE

Photodynamic therapy

Despite reports to the contrary NICE has not yet issued its guidance, nor finalised any recommendations on the use of photodynamic therapy (PDT) for the treatment of age-related macular degeneration (AMRD).
The independent Appraisal Committee, which advises NICE, is currently consulting with stakeholders on its considerations of the evidence and professional and patient opinion.

Anne-Toni Rodgers, Corporate Affairs Director and executive lead for this appraisal said: "NICE is following a genuinely consultative process during which we want to be as transparent as possible, which is why we publish consultation documents on our web site. It is very disappointing that when the Independent Committee that advises us listens to, and acts on consultation feedback, it is accused of 'moving the goal posts', or 'developing a saga'. We expect those with whom we consult to respond to our consultation documents objectively and constructively. To do otherwise is not in the interests of the patients or the NHS on whose behalf we are working"

"We were asked to look at this treatment because genuine uncertainly as to it's long term value for patients, had resulted in 'post code prescribing'. The process NICE follows involves bringing all of the evidence together and engaging professionals and patients in the development of the guidance. When it is issued, early next year, it will make it clear to the NHS and patients, no matter where they live, if and where this treatment can add value. Thus promoting an end to the "post code prescribing".

"The independent group of experts that advise us have considered trial data from around the world and listened carefully to patients, ophthalmologists and other health professionals. Despite what is known about this treatment, the fact is that there is still a great deal of uncertainty about its long term effectiveness. As the consultation document makes clear, the Appraisals Committee heard from expert ophthalmologists, nominated by their own professional body and was made aware of the considerable uncertainly about this treatment and the need for further research to clarify when and how to use it. In order to help end these uncertainties the consultation document suggests that the most appropriate way for this treatment to be used, may be as part of a national data collection exercise.

"If, at the end of the consultation process, these initial views are firmed up into formal guidance, it could mean that around 1000 patients every year would be guaranteed access to PDT treatment at a potential cost to the NHS of £8 million per year and the data that would be collected would help the NHS be clear about the real benefit of these treatments"

" However I want to be clear NICE has not made any recommendations, nor issued any guidance to the NHS at this time".

Ends

Notes for Editors.

  1. During previous consultation on this appraisal the Royal College of Ophthalmologists issued a press release on June 13 last year in which they made clear that "sadly there are many patients with established age related macular degeneration in whom the treatment would not be effective"
  2. The Appraisal Consultation Document (ACD) referred to in today's NICE press release was published on the NICE web site on Monday 14 October, following three meetings of the Independent Appraisal Committee. Two of these meetings were attended by patients and expert ophthalmologists nominated by their own groups.
  3. This document is for consultation only, it would be wrong to represent this document as recommendations or guidance for the NHS.
  4. The consultation document makes it clear that, there are real uncertainties as to the long term effectiveness of this treatment and that the Committee considered and discussed them in detail with the professional and patient experts in attendance at the meetings. Following these discussions the committee's preliminary recommendations, which are subject to consultation and may change, are that:
    • the treatment should be carried out for individuals who have entirely classic CNV and visual acuity 6/60 or better, in centres specialising in this treatment and as part of an ongoing nationally coordinated collection of data on clinical outcome, including data on quality of life and costs.
    • PDT in predominately (but not entirely) classic CNV associated with wet age related macular degeneration is only used as part of an ongoing or new clinical trial that is designed to generate good quality data.
  5. The independent Appraisal Committee is consulting with manufacturers, patient groups and professionals on this ACD and will meet again to consider the original evidence and the ACD in the light if the consultation responses. They will then prepare a FAD which NICE will send to consultees who can consider if they wish to Appeal.
  6. NICE will not issue guidance on this topic until early 2003
  7. CNV = Choroidal neovascularisation
  8. AMD or AMRD = Age related Macular Degeneration

What is Age Related Macular Degeneration (AMD)?
AMD is characterised by irreversible damage to the central part of the retina (the macula) resulting in progressive loss of central vision. Peripheral vision is not affected and so individuals retain some useful vision.
The cause is not known, although it becomes much more common as people get older. Wet AMD is characterised by the development of new blood vessels beneath the retina which is known as choroidal neovascularisation (CNV). The new vessels are prone to leakage and bleeding leading to scarring and disruption causing complete or near complete loss of central vision. Around 70% of eyes will have severe loss of vision within 2 years of diagnosis. The majority of people with AMD are over 60 years of age.

How are patients currently treated?
PDT is not routinely available across the NHS. For most patients with AMD, management consists of 'best supportive care'. Visual rehabilitation, with teaching of skills and the provision of equipment to facilitate reading and other activities of daily living, may help people make the most of their remaining vision. However, the availability of these services is limited, and not everyone has access to high-quality visual rehabilitation.

What is photodynamic therapy (PDT)?
PDT is a combination of drug (verteporfin) and laser treatment that aims to destroy the damage without damaging the retina, thereby slowing the progression of vision loss.

Is PDT a cure for AMD?
No. PDT is not a cure for AMD and does not reverse any loss of vision but it may help slow down the progression of the condition, by closing the abnormal blood vessels. If leakage from the blood vessels beneath the retina persists, the treatment may have to be repeated every 3 months.

How effective is PDT?
At the end of a 2 year study on average, patients who had been treated with PDT could read one more line on an eye-test chart than patients who had received no treatment. It is uncertain how important this difference is in terms of a person's ability to carry out normal activities and have a good quality of life. There is a high degree of individual variation in the ability to cope with vision-loss. However, a difference such as this is only likely to be important if the treated eye is the one that the patient relies on, i.e. their better-seeing eye.

How many people get AMD?
It is estimated that each year about 5000 to 7,500 people England and Wales get the type of wet AMD we have been discussing. However, not all these would be eligible for PDT either because they present too late and the condition is too far advanced or it would be deemed unsuitable for other reasons.

Do people with AMD go blind?
Macular degeneration never leads to total blindness. Peripheral vision is not affected, so most people with AMD have enough vision at the outer edges of their visual field to enable them get around and maintain their independence to some extent. However, central vision may become severely affected and deterioration may be rapid with wet AMD. Central vision is particularly important for the perception of fine visual detail and colours. Thus activities such as reading, writing and recognising faces become very difficult1. The groups representing people with AMD and individuals with AMD have helped the committee fully understand the impact of AMD on an individual's quality of life


What process is NICE following to develop the guidance?
NICE follows the same open, structured and widely publicised process for all its technology appraisals. This process was developed following consultation and is the process we are following for this appraisal. The process involves the relevant manufacturers and organisations representing patients/carers, as well as health professionals treating patients. All these groups prepare and submit information on the technology and its use, comment on the emerging (provisional) views of the Appraisal Committee, and can lodge an appeal on the Committee's final conclusions. In addition professionals and patient/carer organisations provide experts to inform the process.

Who are the consultees involved in the PDT appraisal?
The appraisal process involves the relevant manufacturers and organisations representing patients/carers, as well as health professionals treating patients. Those involved in this appraisal are:

  • The Macular Disease Society
  • Royal National Institute for the Blind
  • Action for Blind People
  • Fight for Sight
  • Wales Council for the Blind
  • Age Concern England
  • Age Concern Cymru
  • Help the Aged
  • Sense
  • Novartis Ophthalmics
  • RCN - Ophthalmic Nursing Forum
  • Royal College of General Practitioners
  • RCN Institute
  • The College of Optometrists
  • The Royal College of Ophthalmologists
  • British Geriatrics Society
  • Department of Health
  • Welsh Assembly Government

What stage is the NICE process at?
Following a full consideration of the evidence, including that from consultees, NICE issued a Final Appraisal Determination (FAD) in June 2002. This FAD was for consultees to consider if they wished to appeal. The Department of Health and the Welsh Assembly Government responded to NICE indicating that there was little prospect of national sponsorship for the monitoring arrangements as proposed in the document, meaning that it was unlikely that the NHS would have been able to put the recommendations into practice if it had become guidance. Therefore NICE had no choice other than to ask the Independent Appraisal Committee that advises it to reconsider their recommendations and evidence in the light of this new information.

The Committee met again on 12th September 2002 with ophthalmologists and patient experts nominated by their own groups, they considered the original evidence, the consultation feedback and new information from all consultees. Following this meeting they prepared a consultation document (ACD), which has been sent to the consultees and which has also been published on the NICE web site. The results of this consultation will be considered by the Appraisal Committee who will then prepare another FAD that will again be sent to all consultees. Guidance will be issued to the NHS early next year.

1Royal College of Ophthalmologists patient information on AMD