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Canadian Drug Review Reimbursement Decision


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  Uloric
Generic febuxostat
Company Takeda Canada Inc.
Indication gout
Condition Endocrine, nutritional and metabolic diseases
Submission Type
Patient Population Febuxostat has a Health Canada indication to lower SUA levels in patients with gout. Febuxostat is a xanthine oxidase inhibitor. It is available as 80 mg tablets and the Health Canada-approved dose is 80 mg once daily.
Status Complete
Date of Recommendation 2011-04-25
Recommendation Summary List with criteria/condition
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that febuxostat be listed for patients with symptomatic gout who have documented hypersensitivity to allopurinol.
Reason for Recommendation 1. In three double-blind randomized controlled trials (RCTs), included in the systematic review considered by CEDAC, febuxostat achieved a statistically significantly greater proportion of patients with a serum uric acid (SUA) level of less than 6 mg/dL compared with allopurinol. However, the proportion of patients requiring treatment of gout flares was not statistically significantly different between febuxostat and allopurinol in two of the trials, and was statistically significantly greater for febuxostat compared with allopurinol in one trial. 2. The cost of febuxostat, 80 mg once daily ($1.59), is greater than allopurinol, 100 mg to 800 mg daily ($0.08 to $0.52). 3. Febuxostat and allopurinol have a similar mechanism of action; thus, febuxostat was not considered to be a useful alternative for patients inadequately treated with allopurinol. However, febuxostat and allopurinol have different chemical structures, and there is limited evidence to suggest that febuxostat may be an option for patients who have a hypersensitivity to allopurinol. Of Note: 1. Despite the statistically significant between-treatment differences in SUA levels, favouring febuxostat, the Committee was concerned that the fixed doses of allopurinol used in the trials (no titration or doses greater than 300 mg per day) may have overestimated the comparative efficacy of febuxostat. 2. Drug-induced Hypersensitivity Syndrome (DIHS) is characterized by a major skin manifestation, fever, multi-organ involvement, lymphadenopathy, and hematological abnormalities (eosinophilia, atypical lymphocytes). The onset of symptoms usually occurs two to eight weeks after therapy initiation of the causative drug (most commonly associated drugs: aromatic anticonvulsants, sulphonamides, allopurinol, antibiotics, and antiretroviral drugs). A large variability in the clinical presentation is seen among different patients, and not all of the characteristics listed above are seen in all patients. At least three of the characteristics listed above should be present, including involvement of at least one extracutaneous organ system, for the diagnosis of DIHS. Fever is seen in a majority of patients. The extracutaneous organ most frequently involved in DIHS is the liver (abnormal liver function tests, hepatitis), but a multitude of other organs can be involved as well (kidney, lung, blood system, lymphoid system, heart, gastrointestinal tract). A skin manifestation is seen in a majority of patients with DIHS. The most common skin manifestation is an exanthematous eruption, but other manifestations (e.g., urticarial plaques, exfoliative and pustular eruptions) are also seen.
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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