Verteporfin photodynamic therapy for neovascular age-related ...

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192 Appendix 3manufacturer’s perspective, the findings of the cohort study could at best only confirm thestatus quo; at worst, the findings could seriously damage their commercial interest.9. The size of the task was underestimated by all.10. The designation processes undertaken locally were very confused and varied greatly.Recommendations1. The NHS needs to better anticipate the requirements needed to manage the introduction ofnew treatments particularly where establishing a new treatment is likely to be complex.(Note that a recommendation has already been made through the SpecialisedCommissioning Group. This recommendation proposes that NICE, for example, involves‘on the ground’ NHS staff from both commissioning and provider organisations in discussionof the practical issues that may arise from specific pieces of guidance.)2. Establishing postlicensing studies to evaluate the introduction and use of new treatmentsshould not be considered without the explicit support of the Department of Health. Thissupport needs to be transparent and public.3. A clear set of aims and objectives must be published and made widely available beforecommencement of any cohort study to ensure that all stakeholders are fully informed andtake ownership.4. There needs to be better understanding of the role of cohort studies together with that ofregistries and databases.5. Clinicians should be better informed of the need for robust, continuing postmarketingevaluation of clinical therapies after marketing authorisation in order to ensure that resultsfrom RCTs carried out for the purposes of licensing are generalizable in everyday clinicalpractice after the RCTs have ended. The importance of continuing to acquire data on the useof treatments in everyday practice must be stressed and clinicians strongly encouraged tocollect these data particularly when introducing high cost medicines into the NHS.6. The NHS could benefit from the development of good practice guidance in relation todesignation and accreditation processes. (Some work on this has already begun in theWest Midlands.)7. The NHS could benefit from the development of good practice guidance on postlicensingcollection of data on new treatments.Overall, despite very serious obstacles, the cohort study has been established and has achieved themajority of its objectives with a large number of trusts providing good data. Wide geographicalaccess is being provided to a high standard.The review group strongly supports the development of on-going assessment of new treatmentsand for the health community and policy-makers to gain as much experience from the cohortstudy as possible. In spite of a complex set of problems that have been overcome to lesser orgreater extent, the model that has been developed by the cohort study team provides a usefulmodel for the future.Current status of the cohort studyThe study is running effectively with good rates of recruitment and data being submitted by mostdesignated providers.There has been slippage estimated at around 1 year at present. It was expected to reach a fullrecruitment rate by June 2004 but in reality only a handful of patients had been recruited by
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6193then. A year later, 1200–1500 patients had been recruited. Since the project review, a year’sextension to data collection has been provisionally funded. The study is expected to recruit untilNovember 2007.The study team continue to deal with issues around NHS implementation requiring a major timeinvestment to sort out on-going problems.Funding for treatment was not considered a major issue at the time of the review other than forthe establishment of some dedicated clinics to promote rapid referral. However, since then it hasbecome apparent that the current financial situation has resulted in clinical and nursing postsbeing frozen, waiting lists being allowed to develop and planned service developments being puton hold. In addition, the effects of national tariffs under Payment By Results are causing concernand generating uncertainties in the minds of managers in designated provider trusts. Indeed thewhole issue of funding flows is confused. It is likely that there are problems at all levels: failure ofsome commissioners to fully fund the cohort study, failure of some trusts not to forward fundsgiven for the cohort study and treatment to clinical teams and also some trusts receiving moneyfor the cohort study but not entering patients into the study.Compliance among clinicians with respect to the collection and submission of high-qualitydata continues to be an important problem. Some providers are receiving funding to providephotodynamic therapy but are not participating in the study. The Steering Group constantlymonitor this situation.Data collection is still being established at some sites.A number of centres are reporting considerable delays in getting patients to treating centres –such that a significant percentage of referrals are deemed ineligible for treatment owing to thepoor level of visual acuity in the eye being assessed, suggesting that earlier referral would haveresulted in the patient receiving treatment.Alternative treatments with antiangiogenic drugs with equivalent efficacy to VPDT and,potentially, wider application are due to be licensed for use in this condition during 2006–7. Itcan be anticipated that the implementation of these new treatments will present a major problemfor the NHS as well as a threat to the cohort study.© Queen’s Printer and Controller of HMSO 2012. This work was produced by Reeves et al. under the terms of a commissioning contract issued by theSecretary of State for Health.
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xExecutive summaryretreat on criter
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38 Results (1) - study cohortTABLE
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66 Discussion of resultsStrengths a
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68 Discussion of resultsThe VPDT st
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70 Discussion of resultsOur analyse
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74 Discussion of resultsVPDT. It is
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84 References16. Stelmack J. Qualit
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86 References49. Guymer RH, Chiu AW
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88 References83. Margrain TH. Minim
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90 Appendix 1THE VERTEPORFIN PHOTOD
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92 Appendix 11. Overview of Manual
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94 Appendix 1And, if also collectin
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96 Appendix 1more patients in the v
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98 Appendix 12.4 Limitations of the
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100 Appendix 1Box 2 Key advantages
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102 Appendix 14. Study population4.
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104 Appendix 15. Recruitment to the
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106 Appendix 16. Background data co
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108 Appendix 1Table 1: Schedule of
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110 Appendix 1The Verteporfin Photo
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112 Appendix 1• Additional clinic
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114 Appendix 18. Recording adverse
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116 Appendix 1level of benefit from
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122 Appendix 112. Data issues12.1 D
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128 Appendix 1Barnes RM, Gee L, Tay
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130 Appendix 1Appendix 1: Classifyi
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132 Appendix 1Liverpool re-treatmen
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134 Appendix 1Service StructurePlea
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136 Appendix 1Has your photographer
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138 Appendix 1There are many differ
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140 Appendix 1testing on vision tes
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