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Canadian Drug Review Reimbursement Decision

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Generic Alitretinoin
Company Actelion
Indication eczema
Condition Skin and subcutaneous tissue
Submission Type
Patient Population Alitretinoin has a Health Canada indication for the treatment of severe chronic hand eczema refractory to high-potency topical corticosteroids in adults. The product monograph states it should only be prescribed by physicians knowledgeable in the use of retinoids systematically, who understand the risk of teratogenicity in females of child-bearing potential. Alitretinoin is an immunomodulator and antiinflammatory agent. It is available as 10 mg and 30 mg oral capsules. The Health Canada-approved dosage range is 10 mg to 30 mg once daily, with a recommended starting dose of 30 mg once daily; dose reduction to 10 mg once daily may be considered in patients with unacceptable adverse effects. The product monograph states that a treatment course of alitretinoin may be given for 12 to 24 weeks depending on response, with consieration to discontinue therapy for patients who still have severe disease after the initial 12 weeks of treatment.
Status Complete
Date of Recommendation 2011-10-24
Recommendation Summary List with criteria/condition
Recommendation Details The Canadian Drug Expert Committee (CDEC) recommends that Toctino 30 mg, which is also called alitretinoin, be listed for the treatment of severe chronic hand eczema refractory to (has not improved enough with) high-potency topical (used on the skin) corticosteroids, if all of the following criteria are met: - a reduced price - inadequate response to a minimum eight-week trial of high-potency topical corticosteroids - prescribed by a dermatologist
Reason for Recommendation 1. In one double-blind, randomized controlled trial (RCT) in patients with severe hand eczema refractory to topical corticosteroids, the percentage of patients achieving a physician global assessment (PGA) of 'clear' or 'almost clear' was statistically significantly higher for alitretinoin 30 mg compared with placebo. 2. Alitretinoin costs (confidential price removed at manufacturer's request) daily for both the 10 mg and 30 mg capsules. Topical corticosteroid preparations range from $0.04 to $2.30 per gram. There was no evidence that alitretinoin improved quality of life in the aforementioned trial. As a consequence, there was a considerable uncertainty around quality-adjusted life-year (QALY) estimation in the manufacturer's cost-effectiveness analysis. 3. The Committee considered that the lack of a gold standard for the relevant diagnosis, the potential teratogenic harms of alitretinoin, and the potential for off-label use warranted that alitretinoin be prescribed by a dermatologist.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.

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