The National Institute for Health Research Health Technology Assessment programme.

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The paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of trabectedin for the treatment of relapsed platinumsensitive ovarian cancer, 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 process. The submission addressed only part of the decision problem and did not provide evidence to compare trabectedin (Yondelis  , PharmaMar) and pegylated liposomal doxorubicin hydrochloride (PLDH) (Caelyx  , Schering-Plough) with key comparators. The submission's 70Trabectedin for the treatment of relapsed ovarian cancer direct comparison evidence came from one reasonable-quality randomised controlled trial (RCT) of trabectedin and PLDH versus PLDH alone (ET743-OVA-301). The results of the RCT were subdivided into the entire platinum-sensitive population (> 6-month relapse after initial platinum-based chemotherapy) and partially platinum-sensitive (≥ 6-to 12-month relapse) and fully platinum-sensitive (> 12-month relapse) populations. The outcomes included were overall survival, progression-free survival measured by three types of assessor, response rates, adverse effects of treatment, health-related quality of life and cost per quality-adjusted-life-year (QALY) gained. A mixed treatment comparison (MTC) meta-analysis comparing trabectedin and PLDH with single-agent PLDH within the entire platinum-sensitive population, with paclitaxel or with topotecan also formed part of the submission. The RCT data showed that trabectedin plus PLDH compared with PLDH monotherapy had a significant effect on overall survival only within the partially platinum-sensitive subgroup. PFS results reported by the independent radiologists showed significant effects in favour of the trabectedin and PLDH arm for the entire and partially platinum-sensitive populations only. Rates of grade 3 and 4 adverse events were mostly higher in the trabectedin and PLDH arm than in the PLDH alone arm. There were several issues regarding the undertaking of the MTC, and thus the data were not considered robust. Furthermore, the ERG did not believe the MTC to be necessary to answer the decision problem. The manufacturer submitted a de novo cost-effectiveness model. The main analysis compared trabectedin in combination with PLDH versus paclitaxel, topotecan and PLDH (each as monotherapy) in the entire platinum-sensitive population, using results estimated from the MTC. Additional analyses were presented comparing trabectedin in combination with PLDH versus PLDH monotherapy using direct evidence from the OVA-301 trial for the fully, partially and entire platinum-sensitive populations. The cost per QALY gained for trabectedin in combination with PLDH versus PLDH monotherapy was estimated to be £70,076 in the main analysis. In the additional analyses, the cost per QALY gained for trabectedin in combination with PLDH versus PLDH monotherapy was £94,832, £43,996 and £31,092 for the ent...

Objective: To evaluate health-related quality of life (HRQoL) in a prospective randomized trial of patients suffering from venous ulceration comparing a generic four-layer elastic bandage (4LB) with a new cohesive short stretch bandage system (CSSB). Methods: Randomized prospective open parallel groups trial in community leg ulcer clinics within twelve trusts in England and Northern Ireland. Patients newly presenting for treatment suffering from chronic venous ulceration, with ankle brachial pressure index (ABPI) >0.8 were entered into the trial. Patients were asked to complete the Nottingham Health Profile (NHP) at entry, at end of trial period (withdrawal or healing), and at 24 weeks. Principal analysis was the comparison of final NHP scores using linear regression with baseline scores entered as a covariate. Results: In all, 154 of the 156 patients who entered the trial completed the initial questionnaire, with 139/154 (90.2%) patients completing at least one follow-up questionnaire. Improvements were noted for all scores after 24 weeks. The improvements were significantly greater in the 114 patients whose ulcers had healed compared with the 40 whose ulcers remained open in the domains of bodily pain (mean difference [d]=13.2, 95% CI 3.6-22.9, P =0.008), emotional reactions (d=10.5, 95% CI 2.8-18.1, P =0.007) and social isolation (d=8.5, 95% CI 1.2-15.9, P =0.024). There were similar mean scores between the 72 patients treated with the 4LB and the 82 patients treated with CSSB for all domains of the NHP, the largest adjusted difference favoured CSSB for energy (d=3.6, 95% CI-4.3-11.4, P =0.37). Conclusions: Patients suffering from leg ulceration show improvements in perceived health following effective ulcer management. The two bandage systems achieved similar improvements in perceived health over 24 weeks.