Verteporfin photodynamic therapy for neovascular agerelated macular degeneration: Cohort study for the UK

Health Technology Assessment

Volumn 16, Issue 6, 2012, Pages

  Reeves, B C ^a   Harding, S P ^b   Langham, J ^a   Grieve, R ^a   Tomlin, K ^a   Walker, J ^a   Guerriero, C ^a   Carpenter, J ^a   Patton, W P ^d   Muldrew, K A ^d   Peto, T ^d   Chakravarthy, U ^c  

^a LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^b ROYAL LIVERPOOL AND BROADGREEN UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

^c QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

^d MOORFIELDS EYE HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

VERTEPORFIN; PHOTOSENSITIZING AGENT; PORPHYRIN;

ARTICLE; CLINICAL PRACTICE; COHORT ANALYSIS; COMMUNITY CARE; CONFIDENCE INTERVAL; CONTRAST SENSITIVITY; COST EFFECTIVENESS ANALYSIS; DRUG EFFICACY; DRUG SAFETY; FOLLOW UP; HEALTH CARE COST; HEALTH CARE UTILIZATION; HUMAN; NATIONAL HEALTH SERVICE; PHOTODYNAMIC THERAPY; QUALITY ADJUSTED LIFE YEAR; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETINA MACULA AGE RELATED DEGENERATION; SOCIAL WORK; TREATMENT DURATION; TREATMENT OUTCOME; UNITED KINGDOM; UNSPECIFIED SIDE EFFECT; VISUAL ACUITY; AGED; COST BENEFIT ANALYSIS; ECONOMICS; FEMALE; MALE; MIDDLE AGED; OUTCOME ASSESSMENT; REGISTER; RETINA MACULA DEGENERATION; RETINA NEOVASCULARIZATION; ACUTE DISEASE; ADOLESCENT; ADULT; BACKACHE; CHILD; CONTROLLED STUDY; EYE DISEASE; INFRARED RADIATION; MAJOR CLINICAL STUDY; PUBLIC HEALTH SERVICE; RADIATION EXPOSURE; SCHOOL CHILD;

AGED; AGED, 80 AND OVER; COHORT STUDIES; COST-BENEFIT ANALYSIS; FEMALE; GREAT BRITAIN; HUMANS; MACULAR DEGENERATION; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PHOTOSENSITIZING AGENTS; PORPHYRINS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES; RETINAL NEOVASCULARIZATION; STATE MEDICINE;

EID: 84862650905     PISSN: 13665278     EISSN: 20464924     Source Type: Journal    
DOI: 10.3310/hta16060     Document Type: Article

References (84)

1. Klein R, Klein BE, Linton KL. Prevalence of age-related maculopathy: the Beaver Dam Eye Study. Ophthalmology 1992;99:933-43.
2. Vingerling JR, Dielemans I, Hofman A, Grobbee DE, Hijmering M, Kramer CF, et al. The prevalence of age-related maculopathy in the Rotterdam study. Ophthalmology 1995;102:205-10.
3. TAP Study Group. Photodynamic therapy of subfoveal choroidal neovascularisation in age-related macular degeneration with verteporfin: one-year results of 2 randomised clinical trials. TAP report 1. Arch Ophthalmol 1999;117:1239-45.
4. TAP Study Group. Photodynamic therapy of subfoveal choroidal neovascularisation in age-related macular degeneration with verteporfin: two-year results of 2 randomised clinical trials. TAP report 2. Arch Ophthalmol 2001;119:198-207.
5. Verteporfin in Photodynamic Therapy Study Group. Photodynamic therapy of subfoveal choroidal neovascularization in pathologic myopia with verteporfin. 1-year results of a randomized clinical trial - VIP report no. 1. Ophthalmology 2001;108:841-52.
6. National Institute for Clinical Excellence. The clinical effectiveness and cost effectiveness of photodynamic therapy for age-related macular degeneration; 2003. URL: www.nice.org.uk/ guidance/TA68 (accessed 30 November 2010).
7. Bren L. The importance of patient-reported outcomes ... It's all about patients. FDA Consumer Magazine 2006;40(6).
8. UK Department of Health. Guidance on the routine collection of Patient Reported Outcome Measures (PROMs); 2009. URL: www.dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsPolicyAndGuidance/DH_092647 (accessed 30 November 2010).
9. Brazier J, Ratcliffe J, Saloman JA, Tsuchiya A. Introduction to the measurement and valuation of health. In Measuring and valuing health benefits for economic evaluation. Oxford: Oxford University Press; 2007. pp. 7-36.
10. Bradley C. Importance of differentiating health status from quality of life. Lancet 2001;357:7-8.
11. Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD, et al. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol 2001;119:1050-8.
12. EuroQol Group. EuroQol - a new facility for the measurement of health-related quality of life. Health Pol 1990;16:119-208.
13. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002;21:271-92.
14. Gold M, Siegel J, Russel L, Weinstein M. Theoretical foundations of cost-effectiveness analysis. In Gold MR, Siegel JE, Russell LB, Weinstein MC, editors. Cost-effectiveness in health and medicine. New York, NY: Oxford University Press; 1996. pp. 82-134.
15. National Institute for Clinical Excellence. Updated guide to the methods of technology appraisal; 2008. URL: www.nice.org.uk/aboutnice/howwework/devnicetech/ technologyappraisalprocessguides/guidetothemethodsoftechnologyappraisal.jsp (accessed 4 October 2009).
16. Stelmack J. Quality of life of low-vision patients and outcomes of low-vision rehabilitation. Optom Vis Sci 2001;78:335-42.
17. Margolis MK, Coyne K, Kennedy-Martin T, Baker T, Schein O, Revicki DA. Vision-specific instruments for the assessment of health-related quality of life and visual functioning: a literature review. Pharmacoeconomics 2002;20:791-812.
18. Brown GC, Sharma S, Brown MM, Kistler J. Utility values and age-related macular degeneration. Arch Ophthalmol 2000;118:47-51.
19. Colquitt JL, Jones J, Tan SC, Takeda A, Clegg AJ, Price A. Ranibizumab and pegaptanib for the treatment of age-related macular degeneration: a systematic review and economic evaluation. Health Technol Assess 2008;12(16).
20. Harding SP, Tomlin K, Reeves BC, Langham J, Walker J, Carpenter J, et al. Verteporfin photodynamic therapy cohort study: report 1: effectiveness and factors influencing outcomes. Ophthalmology 2009;116:e1-8.
21. Grieve R, Guerriero C, Walker J, Tomlin K, Langham J, Harding S, et al. Verteporfin photodynamic therapy cohort study: report 3: cost effectiveness and lessons for future evaluations. Ophthalmology 2009;116:2471-7.
22. Reeves BC, Langham J, Walker J, Grieve R, Chakravarthy U, Tomlin K, et al. Verteporfin photodynamic therapy cohort study: report 2: clinical measures of vision and health-related quality of life. Ophthalmology 2009;116:2463-70.
23. Cruess AF, Zlateva G, Xu X, Soubrane G, Pauleikhoff D, Lotery A, et al. Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study. Pharmacoeconomics 2008;26:57-73.
24. Garattini L, Castelnuovo E, Lanzetta P, Viscarra C, Ricci E, Parazzini F, et al. Direct medical costs of age-related macular degeneration in italian hospital ophthalmology departments. A multicenter, prospective 1-year study. Eur J Health Econ 2004;5:22-7.
25. Greiner RA. Cost of care for patients with age-related macular degeneration in Switzerland and cost-effectiveness of treatment with verteporfin therapy. Semin Ophthalmol 2001;16:218-22.
26. Meads C, Salas C, Roberts T, Moore D, Fry-Smith A, Hyde C. Clinical effectiveness and cost-utility of photodynamic therapy for wet age-related macular degeneration: a systematic review and economic evaluation. Health Technol Assess 2003;7(9).
27. Stirling B, Shoshanna S, Taryn S, Gold M. Has the time come for cost-effectiveness analysis in US health care? Health Econ Pol Law 2009;4:425-43.
28. Brown GC, Brown MM, Campanella J, Beauchamp GR. The cost-utility of photodynamic therapy in eyes with neovascular macular degeneration - a value-based reappraisal with 5-year data. Am J Ophthalmol 2005;140:679-87.
29. Gold MR, Patrick DL, Torrance GW, Fryback DG, Hadorn DC, Kamlet MS, et al. Identifying and valuing outcomes. In Gold MR, Siegel JE, Russell LB, Weinstein MC, editors. Costeffectiveness in health and medicine. New York, NY; Oxford University Press; 1996. pp. 82-134.
30. Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) Study Group. Verteporfin therapy of subfoveal choroidal neovascularization in patients with age related macular degeneration: additional information regarding baseline lesion composition's impact on vision outcomes. TAP report no. 3. Arch Ophthalmol 2002;120:1443-54.
31. Brown GC. Vision and quality-of-life. Trans Am Ophthalmol Soc 1999;97:473-511.
32. Meads C, Hyde C. What is the cost of blindness? Br J Ophthalmol 2003;87:1201-4.
33. Wright SE, Keeffe JE, Thies LS. Direct costs of blindness in australia. Clin Exp Ophthalmol 2000;28:140-2.
34. Hart PM, Chakravarthy U, Mackenzie G, Chisholm IH, Bird AC, Stevenson MR, et al. Visual outcomes in the subfoveal radiotherapy study: a randomized controlled trial of teletherapy for age-related macular degeneration. Arch Ophthalmol 2002;120:1029-38.
35. Ali F, Chan WC, Stevenson MR, Muldrew KA, Chakravarthy U. Morphometric analysis of angiograms of exudative lesions in age-related macular degeneration. Arch Ophthalmol 2004;122:710-15.
36. Hogg R, Curry E, Muldrew A, Winder J, Stevenson M, McClure M, et al. Identification of lesion components that influence visual function in age-related macular degeneration. Br J Ophthalmol 2003;87:609-14.
37. Verteporfin Roundtable 2000 and 2001 Participants. Treatment of age-related macular degeneration with photodynamic therapy (TAP) study group principal investigators; Verteporfin in photodynamic therapy (VIP) study group principal investigators. Guidelines for using verteporfin (visudyne) in photodynamic therapy to treat choroidal neovascularization due to age-related macular degeneration and other causes. Retina 2002;22:6-18.
38. Early Treatment Diabetic Retinopathy Study Research Group. Early Treatment Diabetic Retinopathy Study design and baseline patient characteristics: ETDRS Report Number 7. Ophthalmology 1991;98:741-56.
39. Pelli DG, Robson JG, Wilkins AJ. The design of a new letter chart for measuring contrast sensitivity. Clin Vis Sci 1988;2:187-99.
40. Ware JE, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36):I. Conceptual framework and item selection. Med Care 1992;30:473-83.
41. Higgins JPT, Altman DG. Assessing risk of bias in included studies. In Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions. Chichester: John Wiley; 2008. pp. 187-242. URL: www.cochrane-handbook.org (accessed 31 August 2010).
42. Stevenson MR, Hart PM, Chakravarthy U, Mackenzie G, Bird AC, Owens SL, et al. Subfoveal radiotherapy study. Visual functioning and quality of life in a randomised controlled clinical trial SFRADS report 2. Br J Ophthalmol 2005;89:1045-51.
43. Desai P, Minassian DC, Reidy A. National cataract survey 1997-8: a report of the results of the clinical outcomes. Br J Ophthalmol 1999;83:1336-40.
44. Browne JP, Hopkins C, Slack R, Topham J, Reeves BC, Lund V, et al. Health-related quality of life after polypectomy with and without additional surgery. Laryngoscope 2006;116:297-302.
45. Langham J, Reeves BC, Lindsay KW, van der Meulen JH, Kirkpatrick PJ, Gholkar AR, et al. Variation in outcome after subarachnoid hemorrhage: a study of neurosurgical units in UK and Ireland. Stroke 2009;40:111-18.
46. Maguire MG, Klein ML, Chamberlin JA. Recurrent choroidal neovascularization after argon laser photocoagulation for neovascular maculopathy. Macular Photocoagulation Study Group. Arch Ophthalmol 1986;104:503-12.
47. Vingerling JR, Hofman A, Grobbee DE, de Jong PT. Age-related macular degeneration and smoking. The Rotterdam Study. Arch Ophthalmol 1996;114:1193-6.
48. Thornton J, Edwards R, Mitchell P, Harrison RA, Buchan I, Kelly SP. Smoking and age-related macular degeneration: a review of association. Eye 2005;19:935-44.
49. Guymer RH, Chiu AW, Lim L, Baird PN. HMG CoA reductase inhibitors (statins): do they have a role in age-related macular degeneration? Surv Ophthalmol 2005;50:194-206.
50. Smith W, Assink J, Klein R, Mitchell P, Klaver CC, Klein BE, et al. Risk factors for age-related macular degeneration: pooled findings from three continents. Ophthalmology 2001;108: 697-704.
51. Doris H, Hart PM, Chakravarthy U, McCleland J, Stevenson M, Hudson C, et al. Relation between macular morphology and visual function in patients with choroidal neovascularisation of age related macular degeneration. Br J Ophthalmol 2001;85:184-8.
52. Hendy J, Fulop N, Reeves BC, Hutchings A, Collin S. Implementing the National Programme for Information Technology: a qualitative study of progress in acute trusts. BMJ 2007;334:1360-4.
53. British Medical Association and Royal Pharmaceutical Society of Great Britain. British national formulary. No. 57, March 2009. London: BMA and RPS; 2009.
54. Department of Health. NHS Reference Costs 2002. Appendix 1E. National Schedule of Reference Costs: NHS Trust Outpatient HRG Data. Ophthalmology HRG Label. London: Department of Health; 2002. pp. 136.
55. Curtis L. Unit costs of health and social care. University of Kent, Canterbury: Personal Social Service Research Unit; 2008. pp. 35-178.
56. Mullahy J. Much ado about two: reconsidering retransformation and the two-part model in health econometrics. J Health Econ 1998;17:247-81.
57. Doubilet P, Begg CB, Weinstein MC, Braun P, McNeil BJ. Probabilistic sensitivity analysis using Monte Carlo simulation: a practical approach. Med Decis Making 1985;5:157-77.
58. Deeks JJ, Dinnes J, D'Amico R, Sowden AJ, Sakarovitch C, Song F, et al. Evaluating nonrandomised intervention studies. Health Technol Assess 2003;7(27).
59. Wormald R, Evans JR, Smeeth LL, Henshaw KS. Photodynamic therapy for neovascular agerelated macular degeneration. Cochrane Database Syst Rev 2007, Issue 3. Art. No. CD002030. DOI: 10.1002/14651858.CD002030.pub3.
60. El Mallah MK, Chakravarthy U, Hart PM. Amblyopia: is visual loss permanent? Br J Ophthalmol 2000;84:952-6.
61. Swets J, Tanner WP Jr, Birdsall TG. Decision processes in perception. Psychol Rev 1961;68:301-40.
62. Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol 2009;62:464-75.
63. Zwarenstein MJ, Treweek S. What kind of randomized trials do we need? CMAJ 2009;180:998-1000.
64. Espallargues M, Czoski-Murray CJ, Bansback NJ, Carlton J, Lewis GM, Hughes LA, et al. The impact of age-related macular degeneration on health status utility values. Invest Ophthalmol Vis Sci 2005;46:4016-23.
65. Submacular Surgery Trials Research Group. Evaluation of minimum clinically meaningful changes in scores on the National Eye Institute Visual Function Questionnaire (NEI-VFQ) SST Report Number 19. Ophthalmic Epidemiol 2007;14:205-15.
66. Bansback N, Czoski-Murray C, Carlton J, Lewis G, Hughes L, Espallargues M, et al. Determinants of health related quality of life and health state utility in patients with age related macular degeneration: the association of contrast sensitivity and visual acuity. Qual Life Res 2007;16:533-43.
67. Health Utilities Inc. Health Utilities Index Mark 3; 2008. URL: www.healthutilities.com/hui3. htm (accessed 30 November 2010).
68. Chakravarthy U, Stevenson M. Self-reported visual functioning and quality of life in agerelated macular degeneration. Curr Opin Ophthalmol 2005;16:179-83.
69. World Health Organization. Constitution of the World Health Organization. Basic Documents. 45th edn. Supplement, October 2006. URL: www.who.int/governance/eb/who_constitution_ en.pdf (accessed 30 November 2010).
70. Brazier J, Roberts J, Tsuchiya A, Busschbach J. A comparison of the EQ-5D and the SF-6D across seven patient groups. Health Econ 2004;13:873-84.
71. Feeny D, Furlong W, Torrance GW, Goldsmith CH, Zhu Z, DePauw S, et al. Multiattribute and single-attribute utility functions for the Health Utilities Index Mark 3 system. Med Care 2002;40:113-28.
72. Stevens KJ, McCabe CJ, Brazier JE. Mapping between Visual Analogue Scale and Standard Gamble data: results from the UK Health Utilities Index 2 valuation survey. Health Econ 2007;15:527-33.
73. Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 2006;355:1419-31.
74. Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, et al. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 2006;355:1432-44.
75. Browne J, Jamieson L, Lewsey J, Van der Meulen J, Black N, Cairns J, et al. Patient Reported Outcome Measures (PROMs) in elective surgery. Report to the Department of Health; 2007. URL: www.lshtm.ac.uk/hsru/research/PROMs-Report-12-Dec-07.pdf (accessed 4 October 2009).
76. Griffin SC, Barber JA, Manca A, Sculpher MJ, Thompson SG, Buxton MJ, et al. Cost effectiveness of clinically appropriate decisions on alternative treatments for angina pectoris: prospective observational study. BMJ 2007;334;624.
77. Smith DH, Fenn P, Drummond M. Cost effectiveness of photodynamic therapy with verteporfin for age related macular degeneration: the UK case. Br J Ophthalmol 2004;88:1107-12.
78. Fletcher EC, Lade RJ, Adewoyin T, Chong NV. Computerized model of cost-utility analysis for treatment of age-related macular degeneration. Ophthalmology 2008;115:2192-8.
79. Sharma S, Brown GC, Brown MM, Hollands H, Shah GK. The cost-effectiveness of photodynamic therapy for fellow eyes with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Ophthalmology 2001;108:2051-9.
80. Coleman AL, Yu F. Eye-related Medicare costs for patients with age-related macular degeneration from 1995 to 1999. Ophthalmology 2008;115:18-25.
81. Smiddy WE. Relative cost of a line of vision in age-related macular degeneration. Ophthalmology 2007;114:847-54.
82. Birchall W. Minimising the impact of visual impairment: training in use of low vision aids is important. BMJ 1999;319:707.
83. Margrain TH. Minimising the impact of visual impairment: low vision aids are a simple way of alleviating impairment. BMJ 1999;318:1504.
84. Kiss CG, Simader C, Michels S, Schmidt-Erfurth U. Combination of verteporfin photodynamic therapy and ranibizumab: effects on retinal anatomy, choroidal perfusion and visual function in the protect study. Br J Ophthalmol 2008;92:1620-7.