Verteporfin photodynamic therapy for neovascular age-related ...

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34 Key changes to the protocolsites. The questionnaires elicited the use of HSS relating to the patient’s eye condition in thepreceding 3 months. This included unscheduled low-vision appointments, use of antidepressants,visits to the general practitioner (GP), visits from social services (mainly home carers) and timein nursing homes, residential care or sheltered housing. The patient-reported HSS use at eachtime point was combined with national unit costs to give an estimate of the costs in the 3 monthspreceding the visit that were ‘attributable’ to the patients’ vision. 54 All costs (inflated to 2007prices) were summed across years 1 and 2 to give total costs per patient and were reported in UKpound sterling. 55Estimating incremental quality-adjusted life-years, and incremental costs forverteporfin photodynamic therapy versus best supportive careThe incremental costs of VPDT versus BSC comprised the mean differences in both interventionand HSS costs between the VPDT and BSC groups. The association of BCVA with HSS cost wasestimated using regression models, following the same strategy used to measure the associationbetween BCVA and HRQoL. Estimates for the CEA were taken from a model which included justBCVA (or CS) as an independent variable because other covariates did not improve model fit.Because a substantial proportion of the sample of patients incurred zero HSS costs, we used a‘two-part’ model. 56 The first part modelled all observations in a logistic regression, with use (ornot) of any service in the 3 months preceding the visit as the dependent variable and BCVA as theindependent variable. The second part of the model included only those observations for whichHSS was used and fitted a linear regression with the HSS cost per user as the dependent variableand BCVA as an independent variable. The resultant conditional probabilities of HSS use andHSS costs per user were combined to predict overall HSS costs with varying BCVA.The CEA then combined the 3-monthly BCVA data from the TAP trial with the associationbetween BCVA and HSS cost to report the incremental HSS costs for VPDT versus BSC. Thesecosts were added to the incremental intervention costs of VPDT and BSC to give the overallincremental costs of VPDT at 1 and 2 years.This association between BCVA and SF-6D was combined with the differential decline inBCVA from baseline for the VPDT and placebo groups in TAP to derive differences in HRQoLbetween VPDT and BSC at 3-monthly intervals. The incremental QALYs for VPDT versus BSCwere calculated as the average HRQoL difference for each 3-monthly time point multiplied by0.25 years and summed over 1 or 2 years. The CEA reported incremental (mean VPDT – meanBSC) costs, QALYs and costs per QALY.Sensitivity analysesA probabilistic sensitivity analysis was undertaken to recognise the sampling uncertaintysurrounding the key parameters (BCVA, association between BCVA and HRQoL, interventioncosts and association between BCVA and HSS costs), and to report the probability that VPDT iscost-effective compared with BSC at different levels of willingness to pay for a QALY gain (e.g.£20,000 per QALY). 28,57Further sensitivity analyses assessed the robustness of the results to the main methodologicalassumptions and data sources used in the base case. Five alternative scenarios were considered:1. The treatment frequency was taken from TAP trials rather than the VPDT cohort study.2. BCVA data for the VPDT group were taken from the cohort study (post- vs pre-VPDT)rather than TAP.
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 6353. The relationships of cost and HRQoL with CS rather than BCVA were used.4. To assess whether or not the results were sensitive to the costs of BSC, which may be higherwhen financed under private health insurance, the BSC costs were assumed to be 10-foldhigher than in the base case.5. Cost-effectiveness was estimated over 5 rather than 2 years, assuming that the difference inBCVA between the treatment groups observed at 2 years applied for years 2–5.As when quantifying the association between BCVA and HRQoL, the analysis to quantify therelationship between BCVA and resource use included all patient visits for which visual functiondata (BCVA or CS) and resource use data (NEIVFQ or SF-36) were reported. The treatmentfrequency data were restricted to the group of patients with predominantly classic lesions whohad completed treatment or who had follow-up data to 1 year.© 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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Page 12 and 13: xExecutive summaryretreat on criter
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Page 88 and 89: 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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120 Appendix 110.6 Sub-group analys
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122 Appendix 112. Data issues12.1 D
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124 Appendix 113. Organisation13.1
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126 Appendix 114. References[1] Ref
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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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142 Appendix 1something to do with
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144 Appendix 1College of Ophthalmol
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146 Appendix 1Appendix 5:Protocol f
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148 Appendix 16.2 Subjective Refrac
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150 Appendix 1• The patient shoul
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152 Appendix 1Appendix 6:Protocol f
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154 Appendix 18. It is customary to
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166 Appendix 1Appendix 9:Site imple
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170 Appendix 1Dos and Don’tsDosDo
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174 Appendix 1Appendix 11: Recommen
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176 Appendix 1ADVERSE REACTION AND
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178 Appendix 1acute Trust; note tha
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180 Appendix 1Ophthalmologistrespon
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FeedbackThe HTA programme and the a
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