Appraisal Consultation Document: Photodynamic therapy for age-related macular degeneration
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
Appraisal Consultation Document
Photodynamic therapy for age-related macular degeneration
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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 guidance on its use in the NHS in England and Wales.The Appraisal Committee has had its first meeting to consider both the evidence submitted and the views put forward by the representatives nominated for this appraisal by professional organisations and patient/carer and service user organisations. The Committee has developed preliminary recommendations on the use of photodynamic therapy. This document has been prepared for consultation with the formal consultees. It summarises the evidence and views that have been considered and sets out the preliminary recommendations developed by the Committee. The Institute is now inviting comments from the formal consultees in the appraisal process (the consultees for this appraisal are listed on the NICE website). 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. The process the Institute will follow after the consultation period is summarised below. (For further details, see the Guide to the Technology Appraisal Process on the Institute's website).
The key dates for this appraisal are: Closing date for comments: Monday 4 November 2002 Details of membership of the Appraisal Committee are given in Appendix A and a list of the sources of evidence used in the preparation of this document is given in Appendix B. |
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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. |
| 1 | Appraisal Committee's preliminary recommendations |
| 1.1 | It is recommended that treatment of wet age-related macular degeneration using photodynamic therapy (PDT) should be carried out only for individuals who have entirely classic subfoveal choroidal neovascularisation (CNV), and visual acuity 6/60 or better. The treatment 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, including data on quality of life and costs. |
| 1.2 | It is recommended that PDT is used in predominantly (but not entirely) classic CNV associated with wet age-related macular degeneration only as part of ongoing or new clinical trials that are designed to generate robust and relevant outcome data, including data on quality of life and costs. |
| 1.3 | The use of PDT in occult CNV associated with wet age-related macular degeneration is outside the scope of this appraisal. The clinical and cost effectiveness of PDT in patients with this type of lesion have not been considered, and no recommendation is made with regard to the use of this technology in people with this condition. |
| 2 | Clinical need and practice |
| 2.1 | Age-related macular degeneration (ARMD) 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 condition has two forms, dry (non-exudative or non-neovascular) and wet (exudative or neovascular). The wet form is characterised by the development of new blood vessels beneath the retina known as choroidal neovascularisation (CNV). CNV can be subdivided into classic and occult forms according to its appearance on investigation by fluorescein angiography. The classic form is associated with more rapid progression than the occult form. Classic and occult CNV can occur within the same lesion. |
| 2.2 | CNV lesions are also classified according to their location relative to the fovea (the area at the centre of the macula that is associated with colour vision and perception of fine detail and where there are no blood vessels to interfere with vision). CNV lesions that extend under the fovea are described as subfoveal. |
| 2.3 | ARMD occurs in people over 50 years of age. On the basis of limited epidemiological data, it is estimated that each year in England and Wales there may be 5000 to 7500 new cases of predominantly classic subfoveal CNV associated with wet ARMD. However, there is a high degree of uncertainty about this estimate. |
| 2.4 | In people with the wet form of ARMD, the newly formed blood vessels may leak fluid and blood leading to scar formation and permanent damage to the macula. Individuals lose visual acuity (that is, the ability to detect fine details or small distances) and contrast sensitivity (that is, the ability to see less well-defined objects, such as faces, clearly). They may also experience distortion of vision, where the edges of objects and straight lines appear wavy. Wet ARMD usually progresses from a localised lesion to an end stage involving the entire macula, with complete or near complete loss of central vision. It has been estimated that 70% of eyes with CNV will have severe loss of vision within 2 years of diagnosis. |
| 2.5 | Central vision loss particularly impairs the perception of fine visual detail and colours. Thus activities such as reading, recognising faces and driving are affected. Significant loss of independence may occur. Rapidly deteriorating vision has an impact on emotional well-being, and individuals are likely to suffer depression and anxiety due to their loss of vision and reduction in independence. However, there is a great deal of individual variation in the ability to cope with visual loss. |
| 2.6 | For most patients with ARMD, 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. |
| 3 | The technology |
| 3.1 | The aim of photodynamic therapy (PDT) is to destroy CNV lesions without damaging the overlying retina, thereby slowing the progression of vision loss. The treatment involves infusion of a light-sensitive agent followed by light activation of the drug. At present, only verteporfin (Visudyne), a benzoporphyrin derivative, is available for this indication, but other agents are in development. |
| 3.2 | Verteporfin is given by intravenous infusion over 10 minutes at a dose of 6 mg per square metre of body surface area. Fifteen minutes after the start of the infusion, a low-powered laser calibrated to a specific wavelength is applied over a circular area slightly larger than the lesion. The laser is not powerful enough to cause any damage on its own, but the light is absorbed by the drug, which is 'activated', resulting in the formation of cytotoxic free radicals. These free radicals damage the new blood vessels, which may result in their closure. |
| 3.3 | In ARMD, verteporfin PDT is licensed for patients with subfoveal CNV that is predominantly (50% or more) composed of the 'classic' form. The marketing authorisation has recently been extended to include patients with CNV that is entirely composed of the occult form. However, review of the clinical and cost effectiveness of PDT in this indication is outside the scope of this appraisal. The use of PDT in conditions other than ARMD is also outside the scope of this appraisal. |
| 3.4 | A 15-mg vial of verteporfin (sufficient for one PDT treatment) costs £850 (British National Formulary 43, March 2002). Patients are re-evaluated every 3 months using fluorescein angiography. If CNV leakage is present, they are re-treated. |
| 4 | Evidence and interpretation |
| The Appraisal Committee considered evidence from a number of sources, including the Assessment Report, submissions by consultees, and views put forward at the meeting by clinical experts and representatives of patient/carer organisations (see Appendix B). | |
| 4.1 | Clinical effectiveness |
| 4.1.1 | Two randomised, double-blind, placebo-controlled trials of verteporfin PDT were identified: treatment of age-related macular degeneration with photodynamic therapy, the 'TAP' study; and verteporfin in photodynamic therapy, the 'VIP' study. |
| 4.1.2 | The TAP study included patients with ARMD and subfoveal CNV with some evidence of classic CNV, and visual acuity between 6/12 and 6/60. Visual acuity of 6/12 means that the patient can see at 6 metres the same line of letters that a person with 'normal' (6/6) vision could see at 12 metres. This is relatively mild visual impairment. Similarly a patient with visual acuity of 6/60 can see at 6 metres what someone with normal vision could see at 60 metres. This corresponds to severely impaired vision. The VIP study was in two parts. One part included patients with CNV related to pathological myopia and was therefore outside the scope of this appraisal. The other part included patients with ARMD, though most had the occult form of CNV (only 6% had predominantly classic CNV). |
| 4.1.3 | Both studies found less deterioration in visual acuity in the PDT-treated group compared with the placebo-treated group. In the TAP trial at 24 months 47% (95% confidence interval, 42% to 52%) of eyes treated with verteporfin PDT had lost 15 or more letters of visual acuity compared with 62% (95% confidence interval, 56% to 69%) of placebo-treated eyes. For the VIP study in ARMD, the corresponding figures were 54% (95% confidence interval, 47% to 60%) and 67% (95% confidence interval, 58% to 75%). The loss of 15 letters of visual acuity corresponds to being able to read three fewer lines on a standard eye-test chart. |
| 4.1.4 | A subgroup analysis of the TAP data found that the treatment effect was larger in the 40% of patients (242 of 609) whose lesions were composed of at least 50% classic type CNV. In this subgroup at 2 years 41% (95% confidence interval, 33% to 49%) of eyes treated with verteporfin PDT had lost 15 or more letters of visual acuity compared with 69% (95% confidence interval, 59% to 79%) of placebo-treated eyes. This is the basis of the licensed indication. In patients with between 0 and 50% classic lesion composition, verteporfin PDT appeared to have no benefit. |
| 4.1.5 | The treatment effect was also larger in the group of patients whose lesions were entirely composed of the classic type of CNV. In these patients at 2 years 30% (95% confidence interval, 21% to 39%) of eyes treated with verteporfin PDT had lost 15 or more letters of visual acuity compared with 71% (95% confidence interval, 59% to 84%) of placebo-treated eyes. This subgroup included 93 patients in the verteporfin group and 49 in the placebo group (25% of the trial population). The effect in the entirely classic subgroup was statistically significant relative to the effect in patients with any occult CNV (p < 0.001). |
| 4.1.6 | A further finding from the TAP trial was that PDT with verteporfin reduced the loss of contrast sensitivity - the extent to which this reduction contributes to the effect of verteporfin PDT on quality of life has not been quantified. In addition, improvement in distortion of vision has been reported anecdotally, but this aspect of the condition was not assessed in the clinical trials. |
| 4.17 | Some patients treated with verteporfin PDT have reported visual disturbances (abnormal vision, decreased vision, visual field defect) after treatment. Some of these disturbances involved severe loss of vision. In most patients who experienced severe loss of vision after verteporfin PDT there was partial or complete recovery of vision to baseline values. Other adverse effects reported in clinical trials of verteporfin PDT included infusion-related pain primarily presenting as back pain, and photosensitivity reactions in the form of sunburn following exposure to sunlight, usually within 24 hours of treatment. For full details of side effects and contraindications, see the Summary of Product Characteristics. |
| 4.1.8 | Overall, verteporfin was found to improve the chance of avoiding appreciable loss of vision (loss of 15 or more letters of visual acuity) over a period of 2 years. |
| 4.2 | Cost effectiveness |
| 4.2.1 | The Appraisal Committee considered three estimates of the cost effectiveness of verteporfin PDT: one was performed by the Assessment Group, another was commissioned by the manufacturer and submitted for this appraisal, and a third was found in the published literature. All three evaluations expressed the benefits of treatment in terms of quality-adjusted life years (QALYs). The values of the QALYs were derived from a study that related utility (quality of life) to visual acuity in the better seeing eye. Thus, the assumption that patients were receiving treatment in their better-seeing eye was inherent in all the analyses. The analyses by the Assessment Group and in the manufacturer's submission included costs to the public sector (NHS and social services). The published study was from North America, and so the costs included in that assessment reflect the organisation of healthcare in the USA. This limited its applicability to the evaluation of cost effectiveness in the NHS. |
| 4.2.2 | All three economic evaluations were based on data from the TAP study. The Assessment Group used the whole trial data to estimate effectiveness, whereas the manufacturer's submission and the published evaluation based estimates on data from the subgroup of patients with predominantly classic subfoveal CNV. |
| 4.2.3 | The Assessment Group's economic evaluation estimated that it would cost between £151,000 and £182,000 to gain one additional QALY over 2 years (the duration of the TAP study). The Assessment Group did not extrapolate the estimate of cost effectiveness beyond 2 years. |
| 4.2.4 | The manufacturer's submission estimated the cost effectiveness to be approximately £70,500 per additional QALY at 2 years for people with predominantly classic CNV. The model also made an estimate of cost effectiveness beyond 2 years. This required some assumptions about long-term outcomes to be incorporated as the clinical trials were only 2 years in duration, although the model was supported by unpublished follow-up data from a third year for some of the patients in the TAP study. The model was based on effectiveness data in the subgroup with predominantly classic CNV, and assumed that: a proportion of patients would fail to respond and would receive no more than two treatments; all patients would receive no further treatment after 42 months; and visual acuity would remain relatively stable after treatment. Using the assumptions regarding long-term outcome and continuation of treatment in this model resulted in continually improving cost effectiveness over time. For example, the manufacturer's model suggested that by 5 years, the cost per additional QALY could have fallen to about £33,000, and by 7 years to about £25,000. |
| 4.2.5 | The published estimate of cost effectiveness was between £61,000 and £122,000 (US $86,700-US $173,900, converted to pounds sterling at 2000 rates) per additional QALY at 2 years. The estimate was dependent on visual acuity at the start of therapy. The lower cost per QALY was obtained if the patient was assumed to have reasonably good vision in the better-seeing eye at the start of treatment (visual acuity 6/12), while the higher estimate related to a patient with relatively poor vision (visual acuity 6/60 in the better-seeing eye). This analysis also estimated cost effectiveness beyond 2 years. This model assumed that the effectiveness of the treatment would decline with time by 10% per year. At 11 years (the estimated average life-expectancy of patients in the TAP trial), the cost per additional QALY had fallen to £30,600 ($43,500) for a patient with good initial visual acuity, and to £61,300 ($87,200) for a patient with poor initial visual acuity. |
| 4.2.6 | None of the above models considered the cost effectiveness of PDT in the subgroup of patients with entirely classic lesions. Notwithstanding the general concerns about the validity of basing estimates of effectiveness on subgroup analyses (see Section 4.3.1), given the biological plausibility of a different effect in classic versus occult CNV, an adjustment to the Assessment Group's model was made using results from the TAP study for this subgroup. On the basis of the estimate of effectiveness in this subgroup, the cost per additional QALY of treating patients with entirely classic CNV was in the region of £10,000 to £57,000 at 2 years depending on the assumptions regarding progression of the disease with and without treatment over the trial period. More specifically, the estimate of £10,000 was based on the assumption that change in visual acuity occurred immediately, at the beginning of the study, whereas the estimate of £57,000 was based on the assumption that change occurred gradually over the 2-year period. A third scenario, in which visual acuity was assumed to change most rapidly during the first year and remain relatively stable during the second year, produced a cost per additional QALY of £26,000. This was viewed by the Appraisal Committee as being the most reasonable estimate of cost effectiveness for this subgroup. Of the three scenarios, this one reflected the progress of the patients in the TAP study most closely. |
| 4.2.7 | The cost effectiveness of PDT for ARMD depends on whether the benefits seen at 2 years in the clinical studies persist over time, and whether further treatment is required. As there is no direct evidence on which to base estimates of continued benefit, estimation of long-term cost effectiveness depends on assumptions about the future progress of treated patients. However, there is some support for a relatively stable outcome after treatment from studies of patients treated with 'hot' laser photocoagulation. There are also follow-up data for up to 4 years for 58% (93) of the verteporfin-treated patients from the TAP study, which support a relatively stable outcome, after the first 2 years, in patients with predominantly classic CNV. Loss of at least 15 letters of visual acuity occurred in 36% of patients at 24 months, 41% at 36 months and 43% at 48 months. However, these data must be interpreted with caution because only patients in whom it was judged that continued PDT might reduce the risk of further loss of vision were enrolled in the extension phase of the study, so various biases could be operating. |
| 4.3 | Consideration of the evidence |
| 4.3.1 | The Committee noted that two of the three cost-effectiveness analyses were based on data from the subgroup of the TAP trial (that is, those with predominantly classic subfoveal CNV). The Committee considered that, in general, subgroup analyses should be interpreted with caution. These analyses may exaggerate the potential treatment benefit and may provide a much less sound basis for an estimate of effectiveness than the results of a whole trial. The Committee accepted, however, that a difference in response according to specific types of lesion was a biologically plausible assumption on which to base the predetermined subgroup analyses. |
| 4.3.2 | The Committee considered the subgroup analyses in detail. It was considered plausible that classic and occult CNV may respond differently to the treatment. The subgroup analysis of the TAP study comparing the effectiveness of PDT in entirely classic lesions with its effectiveness in lesions with any occult CNV was highly significant. An adjustment was made to the Assessment Group model to investigate the potential impact of this finding on the cost effectiveness of PDT. If the apparently greater effect in entirely classic lesions is real, then the cost effectiveness of PDT is considerably improved relative to the whole trial population. The subgroup analysis comparing predominantly (> 50%) classic CNV with minimally (< 50%) classic CNV was less convincing, particularly in the light of evidence that interobserver agreement for classifying complex lesions with mixed membrane types was poor, whereas there was almost perfect interobserver concordance for small classic lesions. The Committee decided that PDT was likely to be most effective in patients with entirely classic lesions, and that these patients could be reliably identified. |
| 4.3.3 | The Committee reviewed the different estimates of cost effectiveness of PDT. These estimates were dependent on a number of different assumptions. In the case of the Assessment Group's economic model, decline in visual acuity was assumed to be linear with time, in both control and treated groups. This does not take into account the facts that the change in visual acuity was greatest in the early part of the TAP study and that the difference between treated and placebo groups was established during the first year of treatment. A recalculation correcting for this assumption of linearity produced a cost-effectiveness estimate of approximately half that in the original submission, in the region of £80,000 per additional QALY at 2 years. |
| 4.3.4 | The Committee believed that there was likely to be benefit of treatment beyond the 2 years of the clinical trial even though the evidence base for this assumption was limited. Therefore limiting estimates of the cost effectiveness of this technology to the first 2 years led to an unduly pessimistic analysis. The Committee therefore gave particular consideration to the economic evaluations that attempted to evaluate cost effectiveness beyond 2 years. |
| 4.3.5 | In the manufacturer's economic evaluation, the trial results were extrapolated using various assumptions about the long-term course of treated ARMD in comparison with the natural history of the condition. The model presented by the manufacturer assumed that vision remained relatively stable after treatment. This is the most optimistic outcome possible, as treatment is not expected to improve baseline visual acuity, but to reduce further loss of vision. There is little direct evidence on the long-term outcome after verteporfin PDT has been completed, so this approach might overestimate the benefits of treatment. Uncertainties were such that the Committee considered that the cost effectiveness of this technology beyond 2 years had not been fully substantiated and that the collection of further data on long-term progression after treatment was required. |
| 4.3.6 | The Committee noted that all the estimates of cost effectiveness contained an inherent assumption that it was the patient's better-seeing eye that was being treated. Wet ARMD is a condition which often affects both eyes. Once wet ARMD has developed in one eye, it is estimated that the risk of developing it in the other is about 42% by 5 years. When a patient presents with one affected eye, it is not known whether or not that eye will ultimately turn out to be the better of the two. Given that there is a limited 'window of opportunity' in which PDT treatment will be useful, and that the second eye may develop a lesion of a type that is not amenable to treatment, the Committee considered that it was appropriate to treat entirely classic lesions regardless of whether they occurred in the first or second eye. However, it was noted that those patients who received treatment in their poorer-seeing eye and did not go on to develop severe vision loss in their better-seeing eye would derive little benefit from PDT in terms of retaining visual function and quality of life. This means that the overall incremental cost effectiveness is likely to be less favourable than that suggested by the cost-effectiveness analyses considered for this appraisal. |
| 4.3.7 | In view of the high cost of each PDT treatment, a key issue in determining cost effectiveness is the number of treatments received by patients. In the TAP study, patients received further treatment if there was evidence of CNV leakage on fluorescein angiography, regardless of whether their visual acuity had deteriorated further. It is uncertain whether 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 15 letters of visual acuity by the 6-month assessment would be deemed to have not responded and would receive no further treatment. Preliminary data from follow-up for 12 months of 134 patients treated with PDT in the UK have shown that, on average, patients have received 2.7 treatments in the first year. In the first year of the TAP trial, patients received an average of 3.4 treatments. Further data are required on the number of treatments required for effective use of this technology in clinical practice. |
| 4.3.8 | 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. |
| 4.3.9 | The Committee considered in detail uncertainties surrounding the use of PDT. These uncertainties were such that the Committee was unable to recommend that this technology should be generally available for the treatment of classic and predominantly classic wet ARMD. The Committee considered that the treatment was likely to be cost effective in patients with entirely classic CNV if the assumptions about the long-term course of PDT-treated wet ARMD are correct. In view of the paucity of evidence on long-term outcome after PDT, the Committee considered that the introduction of this treatment into clinical practice should be accompanied by continued collection of a standard national dataset. |
| 5 |
Recommendations for further research |
| 5.1 |
Several randomised controlled trials of PDT are ongoing. One uses a different photosensitising agent. There are another two placebo-controlled trials of verteporfin PDT, one in patients with minimally classic CNV using standard or reduced laser settings, and one in patients with occult CNV. |
| 5.2 |
The Committee recommended that individuals with entirely classic CNV related to ARMD and who retain visual acuity of 6/60 or better, should be entered into a national surveillance programme of PDT. This should have the primary objective of determining the long-term benefit of PDT. Other objectives should include estimating the number of treatments required for effective use in clinical practice, and the identification of those individuals who are most likely to achieve a substantial response. |
| 5.3 |
If available, further data from the existing studies (particularly TAP) regarding long-term outcome of treated and untreated patients would provide further evidence on which to base the time horizon for the cost-effectiveness model. |
| 5.4 |
The Committee considered that the regimen investigated in the clinical studies might 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. |
| 6 |
Preliminary views on the resource impact for the NHS |
| 6.1 | The current best estimate suggests that in England and Wales as many as 5000-7500 new cases of predominantly classic CNV associated with wet ARMD occur each year. It is not known how many of these would fulfil the criteria outlined in section 1.1. As a guide, treatment of 1000 patients per year with the current PDT regimen would cost in the region of £4,000,000 in the first year, rising to £8,300,000 by the third year, and remaining constant thereafter (at current costs, excluding VAT). There may be additional costs associated with a surveillance programme. |
| 6.2 |
Wet ARMD can progress rapidly. For a PDT service to be as effective as possible, individuals with early wet ARMD and without serious visual loss will need to be fast-tracked through the referral and waiting list processes in order to receive treatment before further loss of vision occurs. |
| 7 | Proposals for implementation and audit |
| 7.1 | Clinicians who provide care for people with wet ARMD should take note of the guidance set out in Section 1. |
| 8 | Related guidance |
| 8.1 | There is no related guidance for this technology. |
| 9 | Proposed date for review of guidance |
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The review date for a technology appraisal refers to the month and year in which the Guidance Executive will consider any new evidence on the technology, in the form of an updated Assessment Report, and decide whether the technology should be referred to the Appraisal Committee for review. | |
| 9.1 |
The guidance on this technology will be reviewed in December 2003. |
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Professor David Barnett |
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Chairman, Appraisal Committee |
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September 2002 |
| Appendix A. Appraisal Committee members |
| NOTE The Appraisal Committee is a standing advisory committee of the Institute. Its members are appointed for a 3-year term. A list of the Committee members appears below. The Appraisal Committee meets twice a month other than in December, when there are no meetings. The Committee membership is split into two branches, with the chair, vice-chair and a number of other members attending meetings of both branches. Each branch considers its own list of technologies and topics are not moved between the branches. |
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Committee members are asked to declare any interests in the technology to be appraised. If there is a conflict of interest, the member is excluded from participating further in that appraisal. |
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The minutes of each Appraisal Committee meeting, which include the names of the members who attended and their declaration of interests, are posted on the NICE website. |
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Dr Jane Adam |
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Radiologist, St. George's Hospital, London |
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Professor R L Akehurst |
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Dean, School of Health Related Research, Sheffield University |
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Dr Sunil Angris |
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General Practitioner, Waterhouses Medical Practice |
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Professor David Barnett (Chairman) |
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Professor of Clinical Pharmacology, University of Leicester |
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Professor Sir Colin Berry |
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Professor of Morbid Anatomy, St Bartholomew's and Royal London School of Medicine |
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Dr Sheila Bird |
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MRC Biostatistics Unit, Cambridge |
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Professor Carol Black (resigned June 2002) |
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Consultant Physician, Royal Free Hospital & UCL, London |
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Professor John Brazier |
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Health Economist, University of Sheffield |
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Professor Rosamund Bryar |
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Professor of Community and Primary Care Nursing, St Bartholomew School of Nursing and Midwifery |
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Professor Martin Buxton |
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Director of Health Economics Research Group, Brunel University |
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Professor Mike Campbell |
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Statistician, Institute of General Practice & Primary Care, Sheffield |
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Dr Karl Claxton |
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Health Economist, University of York |
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Professor Sarah Cowley |
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Professor of Community Practice Development, Kings College, London |
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Dr Mike Davies |
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Consultant Physician, University Department of Medicine and Metabolism, The Manchester Royal Infirmary |
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Professor Jack Dowie |
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Health Economist, London School of Hygiene & Tropical Medicine, London |
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Mr Chris Evennett (resigned June 2002) |
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Chief Executive, Mid-Hampshire Primary Care Group |
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Dr Paul Ewings |
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Statistician, Taunton & Somerset NHS Trust |
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Professor Terry Feest |
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Clinical Director and Consultant Nephrologist, Richard Bright Renal Unit, and Chairman of the UK Renal Registry |
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Professor Gary A Ford |
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Professor of Pharmacology of Old Age/Consultant Physician, Newcastle upon Tyne Hospitals NHS Trust |
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Mrs Sue Gallagher |
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Former Chief Executive, Merton, Sutton and Wandsworth Health Authority |
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Dr Trevor Gibbs |
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Head, Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline |
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Sally Gooch |
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Director of Nursing, Mid-Essex Hospital Services Trust |
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Mr John Goulston |
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Director of Finance, Barts and the London NHS Trust |
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Professor Trisha Greenhalgh |
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Professor of Primary Health Care, University College London |
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Miss Linda Hands |
| Clinical Reader in Surgery, University of Oxford |
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Professor Philip Home |
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Professor of Diabetes Medicine, University of Newcastle |
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Dr Terry John |
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General Practitioner, The Firs, London |
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Dr Diane Ketley (term of office ended August 2002) |
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Research into Practice Programme Leader, NHS Modernisation Agency |
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Dr Mayur Lakhani (term of office ended in August 2002) |
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General Practitioner, Highgate Surgery, Leicester, and Lecturer, University of Leicester |
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Ruth Lesirge |
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Lay Representative, previously Director, Mental Health Foundation |
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Dr George Levvy |
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Lay Representative; Chief Executive, Motor Neurone Disease Association |
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Dr Gill Morgan |
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Chief Executive, NHS Confederation |
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Professor Miranda Mugford |
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Health Economist, University of East Anglia |
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Mr M Mughal |
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Consultant Surgeon, Lancashire Teaching Hospitals NHS Trust |
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Mr James Partridge |
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Lay Representative, Chief Executive, Changing Faces |
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Siān Richards |
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Chief Executive, Cardiff Local Health Group |
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Professor Philip Routledge |
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Professor of Clinical Pharmacology, University of Wales |
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Dr Rhiannon Rowsell |
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Medical and Regulatory Affairs Director, AstraZeneca UK Ltd |
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Dr Stephen Saltissi |
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Consultant Cardiologist, Royal Liverpool University Hospital |
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Professor Andrew Stevens (Vice-Chairman) |
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Professor of Public Health, University of Birmingham |
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Professor Ray Tallis |
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Consultant Physician, Hope Hospital, Salford |
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Dr Cathryn Thomas |
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General Practitioner, and Senior Lecturer, Department of Primary Care and General Practice, University of Birmingham |
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Professor Mary Watkins |
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Professor of Nursing, University of Plymouth |
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Dr Norman Waugh |
| Senior Lecturer and Public Health Consultant, University of Southampton |
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Dr David Winfield |
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Consultant Haematologist, Royal Hallamshire Hospital |
| Appendix B. Sources of evidence considered by the Committee | |
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The following documentation and opinion was made available to the Committee: | |
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A. |
Assessment Report prepared by West Midlands Health Technology Assessment Group, Department of Public Health and Epidemiology, The University of Birmingham: |
| B. |
Manufacturer/sponsor submissions from:
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| C. |
Professional/specialist group submissions from:
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| D. |
Patient/carer group submissions from:
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| E. |
Expert perspectives from:
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