Health technology assessment : HTA
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Health Technol Assess · Jun 2009
ReviewThe effect of different treatment durations of clopidogrel in patients with non-ST-segment elevation acute coronary syndromes: a systematic review and value of information analysis.
To update the previous systematic review of the use of clopidogrel in combination with aspirin for patients with non-ST-elevation acute coronary syndrome (NSTE-ACS), investigating the optimal duration of treatment and effects of withdrawal from treatment. ⋯ The review was limited by the lack of available data. There is considerable variation in the costs of uncertainty surrounding the different scenarios and populations considered. The validity of these may also be less reliable in the higher-risk groups owing to changes in clinical practice. An adequately powered, well-conducted RCT that directly compares different durations of clopidogrel treatment in patients with NSTE-ACS would ideally be required to provide more robust evidence in relation to the impact of clopidogrel withdrawal.
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Health Technol Assess · Jun 2009
ReviewSensitivity analysis in economic evaluation: an audit of NICE current practice and a review of its use and value in decision-making.
To determine how we define good practice in sensitivity analysis in general and probabilistic sensitivity analysis (PSA) in particular, and to what extent it has been adhered to in the independent economic evaluations undertaken for the National Institute for Health and Clinical Excellence (NICE) over recent years; to establish what policy impact sensitivity analysis has in the context of NICE, and policy-makers' views on sensitivity analysis and uncertainty, and what use is made of sensitivity analysis in policy decision-making. ⋯ The review and the policy impact assessment focused exclusively on documentary evidence, excluding other sources that might have revealed further insights on this issue. In seeking to address parameter uncertainty, both deterministic and probabilistic sensitivity analyses should be used. It is evident that some cost-effectiveness work, especially around the sensitivity analysis components, represents a challenge in making it accessible to those making decisions. This speaks to the training agenda for those sitting on such decision-making bodies, and to the importance of clear presentation of analyses by the academic community.
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Health Technol Assess · Jun 2009
Trastuzumab for the treatment of primary breast cancer in HER2-positive women: a single technology appraisal.
This paper presents a summary of the evidence review group (ERG) report into the the clinical and cost-effectiveness of trastuzumab for the treatment of primary breast cancer in human epidermal growth factor 2 (HER2)-positive women based upon a review of the manufacturer's submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The manufacturer's scope restricts the intervention to intravenous trastuzumab given for 1 year after surgery and after the completion of standard adjuvant chemotherapy, and the comparator to standard therapy without trastuzumab. The clinical rationale for the duration of treatment in the scope is open to question and leads to the exclsuion of one potentially relevant trial. ⋯ The addition of potential long-term cardiac events could push the ICER above 30,000 pounds, although there is no long-term evidence to date surrounding this issue. In addition, the small study excluded from the manufacturer's submission raises the possibility of an equally effective but shorter regimen, incurring lower cost and toxicity and with greater patient convenience. The guidance issued by NICE in June 2006 as a result of the STA states that trastuzumab, given at 3-week intervals for 1 year or until disease recurrence, is recommended as a treatment option for women with early-stage HER2-positive breast cancer following surgery, chemotherapy and radiotherapy.
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Health Technol Assess · Jun 2009
Rituximab for the first-line treatment of stage III/IV follicular non-Hodgkin's lymphoma.
This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of rituximab for the first-line treatment of stage III/IV follicular non-Hodgkin's lymphoma (FNHL) based upon the manufacturer's submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The manufacturer's scope restricts the intervention to rituximab in combination with CVP (cyclophosphamide, vincristine and prednisolone) (R-CVP); the only comparator used was CVP alone. The evidence from the one included randomised controlled trial (RCT) suggests that the addition of rituximab to a CVP chemotherapy regimen has a positive effect on the outcomes of time to treatment failure, disease progression, overall tumour response, duration of response and time to new lymphoma treatment in patients with stage III/IV FNHL compared with CVP alone. ⋯ For the most extreme scenario (no OS gain) the ICER appears to remain below 30,000 pounds per QALY gained. On balance the evidence indicates that R-CVP is more cost-effective than CVP. The guidance issued by NICE in July 2006 as a result of the STA states that rituximab within its licensed indication (in combination with cyclophosphamide, vincristine and prednisolone) is recommended as an option for the treatment of symptomatic stage III/IV follicular non-Hodgkin's lymphoma in previously untreated patients.
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This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of infliximab for the treatment of moderate to severe plaque psoriasis, in accordance with the licensed indication, based on the evidence submission from Schering-Plough to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The outcomes stated in the manufacturer's definition of the decision problem were severity [Psoriasis Area and Severity Index (PASI) score], remission rates, relapse rates and health-related quality of life. The main evidence in the submission comes from four randomised controlled trials (RCT) comparing infliximab with placebo and eight RCTs comparing either etanercept or efalizumab with placebo. ⋯ The guidance issued by NICE in August 2007 as a result of the STA states that infliximab within its licensed indication is recommended for the treatment of adults with very severe plaque psoriasis, or with psoriasis that has failed to respond to standard systematic therapies. Infliximab treatment should be continued beyond 10 weeks in people whose psoriasis has shown an adequate response to treatment within 10 weeks. In addition, when using the Dermatology Life Quality Index (DLQI), care should be taken to take into account the patient's disabilities, to ensure DLQI continues to be an accurate measure.