Alitretinoin for the treatment of severe chronic hand eczema

Abstract

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 placebocontrolled 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 DOI: 10.3310/hta14suppl1/06Alitretinoin for the treatment of severe chronic hand eczema 40 submission to NICE, the base-case incremental cost-effectiveness ratios (ICERs) reported for alitretinoin were £8614 per quality-adjusted lifeyear (QALY) versus ciclosporin, -£469 per QALY versus psoralen + UVA (with alitretinoin dominant) and £10,612 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. 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 per QALY for alitretinoin versus azathioprine). In the revised model, alitretinoin was reported to have an ICER of £12,931 per QALY gained versus supportive care (placebo). However, the model underestimates the costs of treatment associated with alitretinoin.

Acitretin as a Therapeutic Option for Chronic Hand Eczema

“…In search of a safer therapy, oral alitretinoin (9- cis retinoic acid) was developed and approved for CHE, but its economic burden limits its broader use. Acitretin, a synthetic retinoid, is an alternative treatment for hand eczema that is more cost-effectiveness than alitretinoin12. This study describes the efficacy and safety of low-dose acitretin in patients with various subtypes of hand eczema.…”

Polarized Light: A Conservative Therapeutic Approach to Chronic Hand Eczema

“…Other forbidden factors include a history of childhood eczema and female sex [5]. Despite use of topical therapy is sufficient for various patients, some require supplementary systemic medications [6]. These medications have a potential for severe side effects, such as liver toxicity and renal toxicity (methotrexate, cyclosporine) teratogenicity (oral retinoids and skin melanoma) [7].…”

How to Appropriately Extrapolate Costs and Utilities in Cost-Effectiveness Analysis

“…Analysis of individual patient level data (IPD) has explored this relationship. An example is the Randomised Intervention Treatment of unstable Angina (RITA-3) trial [ 27] , which compared an early interventional strategy (coronary arteriography and myocardial revascularisation as clinically appropriate) or a conservative management strategy in patients admitted with an episode of cardiac chest pain associated with documented evidence of coronary heart disease. Resource use data, hospital visits, procedures and medications, were collected over a…”