Verteporfin photodynamic therapy for neovascular age-related ...
Verteporfin photodynamic therapy for neovascular age-related ... Verteporfin photodynamic therapy for neovascular age-related ...
96 Appendix 1more patients in the verteporfin treatment arm than the placebo arm had lost fewerthan 15 letters on the letter chart 24 months after treatment (53% vs 38%; p < 0.001).In a pre-specified subgroup analysis, the TAP trial demonstrated that eyes withcertain subtypes of CNV experienced a greater benefit. Specifically, lesions withclassic and no occult CNV (all of the lesion is classic CNV) or predominantly classicCNV (>50% of the lesion is classic CNV) had a better outcome relative to placebo(59% vs 31% losing fewer than 15 letters; p0.05). However, the differenceincreased by 24 months and was just statistically significant (55% vs 68%respectively ; p=0.03). NICE reviewed the sub-group comparisons andrecommended (a) that patients with lesions with classic and no occult CNV should beoffered PDT treatment in the NHS and (b) that patients with predominantly classiclesions should be treated as part of new clinical studies, such as the VPDT study.After consideration of the evidence, the NICE appraisal team also decided thatalthough the existing trials were supportive of clinical effectiveness in subgroups ofpatients with CNV, benefit in terms of patient-centred outcomes or cost-effectivenesswas lacking. Therefore guidance from NICE has limited the use of PDT to beundertaken within the NHS under specific and defined conditions while additionalevidence on its role and value in the treatment of CNV are acquired [2].The guidance from the 2 nd Final Appraisal Determination (FAD) dated September2003 has been posted on the NICE website and is reproduced in Box 1 below.2.3 Impact of NICE guidance on clinical practiceThe guidance from NICE proposes selection of patients for PDT treatment usingacuity criteria, thus demanding that the clinical assessments are undertaken tospecified standards. It is accepted that routine NHS clinics do not operate to thesestandards and visual function tests that are routinely performed may be unreliable.
DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 697Box 1: NICE Guidance on Verteporfin Photodynamic Therapy, 2 nd Final AppraisalDetermination (FAD), September 2003 [2]1.1 Photodynamic therapy (PDT) is recommended for the treatment of wet agerelatedmacular degeneration for individuals who have a confirmed diagnosis ofclassic with no occult subfoveal choroidal neovascularisation (CNV), and bestcorrectedvisual acuity of 6/60 or better. Only retinal specialists should carry outPDT with expertise in the use of this technology.1.2 PDT is not recommended for the treatment of people with predominantly classicsubfoveal CNV (that is, 50% or more of the entire area of the lesion is classicCNV but some occult CNV is present) associated with wet age-related maculardegeneration, except as part of ongoing or new clinical studies that are designedto generate robust and relevant outcome data, including data on optimumtreatment regimens, long-term outcomes, quality of life and costs.1.3 The use of PDT in occult CNV associated with wet age-related maculardegeneration was not considered because the photosensitising agent(verteporfin) was not licensed for this indication when this appraisal began. Norecommendation is made with regard to the use of this technology in people withthis form of the condition.1.4 Patients currently receiving treatment with PDT could experience loss of wellbeingif their treatment is discontinued at a time they did not anticipate. Becauseof this, all NHS patients who have begun a course of treatment with PDT at thedate of publication of this guidance should have the option of continuing toreceive treatment until their clinical condition indicates that it is appropriate tostop.NICE guidance also specifically requires angiographic classification of the CNV forthe purposes of ascertaining eligibility for PDT treatment and for assessing outcomesby CNV subtype. The classification and grading of CNV requires a systematicapproach and it is not always possible for treating clinicians to make subtledistinctions on CNV subtypes with certainty. Post treatment patient review and criteriafor re-treatment are also likely to vary. In the absence of standardised assessmentand data collection, these variations would interfere with the systematic analysis ofoutcomes which NICE wish to see at their planned review.© 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 104 and 105: 90 Appendix 1THE VERTEPORFIN PHOTOD
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DOI: 10.3310/hta16060Health Technology Assessment 2012; Vol. 16: No. 697Box 1: NICE Guidance on <strong>Verteporfin</strong> Photodynamic Therapy, 2 nd Final AppraisalDetermination (FAD), September 2003 [2]1.1 Photodynamic <strong>therapy</strong> (PDT) is recommended <strong>for</strong> the treatment of wet <strong>age</strong><strong>related</strong>macular degeneration <strong>for</strong> individuals who have a confirmed diagnosis ofclassic with no occult subfoveal choroidal <strong>neovascular</strong>isation (CNV), and bestcorrectedvisual acuity of 6/60 or better. Only retinal specialists should carry outPDT with expertise in the use of this technology.1.2 PDT is not recommended <strong>for</strong> the treatment of people with predominantly classicsubfoveal CNV (that is, 50% or more of the entire area of the lesion is classicCNV but some occult CNV is present) associated with wet <strong>age</strong>-<strong>related</strong> maculardegeneration, except as part of ongoing or new clinical studies that are designedto generate robust and relevant outcome data, including data on optimumtreatment regimens, long-term outcomes, quality of life and costs.1.3 The use of PDT in occult CNV associated with wet <strong>age</strong>-<strong>related</strong> maculardegeneration was not considered because the photosensitising <strong>age</strong>nt(verteporfin) was not licensed <strong>for</strong> this indication when this appraisal began. Norecommendation is made with regard to the use of this technology in people withthis <strong>for</strong>m of the condition.1.4 Patients currently receiving treatment with PDT could experience loss of wellbeingif their treatment is discontinued at a time they did not anticipate. Becauseof this, all NHS patients who have begun a course of treatment with PDT at thedate of publication of this guidance should have the option of continuing toreceive treatment until their clinical condition indicates that it is appropriate tostop.NICE guidance also specifically requires angiographic classification of the CNV <strong>for</strong>the purposes of ascertaining eligibility <strong>for</strong> PDT treatment and <strong>for</strong> assessing outcomesby CNV subtype. The classification and grading of CNV requires a systematicapproach and it is not always possible <strong>for</strong> treating clinicians to make subtledistinctions on CNV subtypes with certainty. Post treatment patient review and criteria<strong>for</strong> re-treatment are also likely to vary. In the absence of standardised assessmentand data collection, these variations would interfere with the systematic analysis ofoutcomes which NICE wish to see at their planned review.© 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 <strong>for</strong> Health.
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