Alitretinoin for the treatment of severe chronic hand eczema

• Published in: Health technology assessment (Winchester, England) England), 2010-05, Vol.14 Suppl 1 (Suppl 1), p.39-45
• Main Authors: Paulden, M, Rodgers, M, Griffin, S, Slack, R, Duffy, S, Ingram, J R, Woolacott, N, Sculpher, M
• Format: Article
• Language: English
• Subjects: Algorithms; Azathioprine - therapeutic use; Chronic Disease; Cyclosporine - therapeutic use; Dermatologic Agents - therapeutic use; Eczema - drug therapy; Eczema - economics; Eczema - therapy; Hand Dermatoses - drug therapy; Hand Dermatoses - economics; Humans; Immunosuppressive Agents - therapeutic use; Psychometrics; PUVA Therapy; Quality of Life; Quality-Adjusted Life Years; Tretinoin - adverse effects; Tretinoin - economics; Tretinoin - therapeutic use
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta14Suppl1/06

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of alitretinoin for the treatment of adults with severe chronic hand eczema refractory to topical steroid treatment in accordance with the licensed indication, based upon the evidence submission from Basilea Pharmaceuticals Ltd to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. The clinical evidence came from a single placebo-controlled randomised controlled trial of daily treatment with alitretinoin for 12-24 weeks, with follow-up for a further 24 weeks, in patients with severe chronic hand eczema (CHE) unresponsive to topical steroids. A statistically significantly greater proportion of patients using alitretinoin achieved the primary end point of clear or almost clear hands by week 24 than did those with placebo. Dose-dependent headache was the most commonly reported adverse event in patients treated with alitretinoin. Serious adverse events were rare, but alitretinoin was associated with increases in both total cholesterol and triglycerides, which has implications for risks of future cardiovascular events. The manufacturer submitted a de novo decision analytic model to estimate, over a time horizon of 3 years, the cost-effectiveness of alitretinoin versus the other relevant comparators identified by NICE. In response to the points of clarification put to it by the ERG regarding the initial submission, the manufacturer provided additional evidence and a revised decision analytic model with a 'placebo' arm. In the manufacturer's original submission to NICE, the base-case incremental cost-effectiveness ratios (ICERs) reported for alitretinoin were 8614 pounds per quality-adjusted life-year (QALY) versus ciclosporin, -469 pounds per QALY versus psoralen + UVA (with alitretinoin dominant) and 10,612 pounds per QALY versus azathioprine. These ICERs decreased as the time horizon was extended in sensitivity analyses. In patients with hyperkeratotic CHE and in women of child-bearing potential, the ICER remained below 20,000. pounds When the health-related quality of life (HRQoL) values used in the model were replaced with those derived from an alternative study, these ICERs increased significantly (to 22,312 pounds per QALY for alitretinoin versus azathioprine). In the revised model, alitretinoin was reported to have an ICER of 12,931 pounds per QALY gained versus supp