Health technology assessment : HTA
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Health Technol Assess · Nov 2010
Randomized Controlled TrialLIFELAX - diet and LIFEstyle versus LAXatives in the management of chronic constipation in older people: randomised controlled trial.
To investigate the clinical effectiveness and cost-effectiveness of laxatives versus dietary and lifestyle advice, and standardised versus personalised dietary and lifestyle advice. ⋯ Due to the low number of participants in the trial, no firm conclusions could be drawn about the effectiveness of the interventions. However, a number of factors that contributed to the conduct and progress of the trial are highlighted, which may be relevant to others conducting research on a similar topic or population.
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Health Technol Assess · Nov 2010
ReviewCost-effectiveness of screening high-risk HIV-positive men who have sex with men (MSM) and HIV-positive women for anal cancer.
Anal cancer is uncommon and predominantly a disease of the elderly. The human papillomavirus (HPV) has been implicated as a causal agent, and HPV infection is usually transmitted sexually. Individuals who are human immunodeficiency virus (HIV)-positive are particularly vulnerable to HPV infections, and increasing numbers from this population present with anal cancer. ⋯ Many of the criteria for assessing the need for a screening programme were not met and the cost-effectiveness analyses showed little likelihood that screening any of the identified high-risk groups would generate health improvements at a reasonable cost. Further studies could assess whether the screening model has underestimated the impact of anal cancer, the results of which may justify an evaluative study of the effects of treatment for HG-AIN.
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Health Technol Assess · Oct 2010
ReviewRelapse prevention in UK Stop Smoking Services: current practice, systematic reviews of effectiveness and cost-effectiveness analysis.
Reducing smoking is a chief priority for governments and health systems like the UK National Health Service (NHS). The UK has implemented a comprehensive tobacco control strategy involving a combination of population tobacco control interventions combined with treatment for dependent smokers through a national network of NHS Stop Smoking Services (NHS SSS). ⋯ Based on the totality of evidence, RPIs are expected to be effective and cost-effective if incorporated into routine treatment within the NHS SSS. While staff within the NHS SSS were largely favourably inclined towards providing RPIs, guidance would be needed to encourage the adoption of the most effective RPIs, as would incentives that focused on the importance of sustaining quit attempts beyond the currently monitored 4-week targets.
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Health Technol Assess · Oct 2010
ReviewGefitinib for the first-line treatment of locally advanced or metastatic non-small cell lung cancer.
This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of gefitinib for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in accordance with the licensed indication, based upon the manufacturer's submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. The submitted clinical evidence consisted of the IRESSA Pan-ASian Study (IPASS); a phase III open-label randomised controlled trial conducted in 87 centres in East Asia which compared the use of gefitinib with paclitaxel/carboplatin in 1217 chemotherapy (CTX)-naive patients with stage IIIB/IV pulmonary adenocarcinoma. The manufacturer's submission focused on a subgroup of patients in IPASS who were epidermal growth factor receptor (EGFR) gene mutation-positive (M+) (n = 261; 21% of the total IPASS population). ⋯ The manufacturer's submission provides clinical evidence to support the use of gefitinib in EGFR M+ patients with adenocarcinoma histology only. Before patients can be offered first-line treatment with gefitinib they must undergo EGFR mutation status testing which is currently not routinely available in the NHS. At the time of writing, the guidance document issued by NICE on 28 July 2010 states that 'Gefitinib is recommended as an option for the first-line treatment of people with locally advanced or metastatic non-small-cell lung cancer (NSCLC) if they test positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation and the manufacturer provides gefitinib at the fixed price agreed under the patient access scheme'.
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Health Technol Assess · Oct 2010
ReviewThe clinical effectiveness and cost-effectiveness of rituximab for the first-line treatment of chronic lymphocytic leukaemia: an evidence review of the submission from Roche.
This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of rituximab for the first-line treatment of chronic lymphocytic leukaemia (CLL) 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 searches for clinical effectiveness and cost-effectiveness data were appropriate and included all relevant studies. The submission's evidence came from a single, unpublished, well-conducted randomised controlled trial (RCT) comparing rituximab in combination with fludarabine and cyclophosphamide (R-FC) with fludarabine and cyclophosphamide (FC) alone for the first-line treatment of CLL. ⋯ However, the sensitivity analysis did not fully investigate the uncertainty associated with differential values across arms or with the structural assumptions of the model, and utility values were not drawn from an empirical study. The NICE guidance issued as a result of the STA states that: Rituximab in combination with fludarabine and cyclophosphamide (R-FC) is recommended as an option for the first-line treatment of chronic lymphocytic leukaemia in people for whom fludarabine in combination with cyclophosphamide (FC) is considered appropriate. Rituximab in combination with chemotherapy agents other than fludarabine and cyclophosphamide is not recommended for the first-line treatment of chronic lymphocytic leukaemia.