The Committee reviewed the re-application, submitted through Family and Community Health, WHO, to include miconazole nitrate buccal tablets for the treatment of oropharyngeal and oesophageal candidiasis in the Model List¹. The application to add miconazole nitrate buccal tablets was first considered by the Committee at its previous meeting. At that time, the Committee had been concerned about the lack of comparative data on the efficacy and safety of miconazole nitrate buccal tablets and nystatin lozenges and, thus, on the grounds of insufficient evidence of any additional benefit, had decided not to add miconazole nitrate buccal tablets to the Model List (2).

¹ Details of the full application (including comments received) are available via the Internet from the WHO web site (http://www.who.int/medicines).

The Committee reviewed the new evidence provided with the reapplication and concluded that the efficacy of miconazole nitrate buccal tablets is no worse than that of ketoconazole given systemically and nystatin used locally. The Committee also noted that adverse effects were rarely reported on an estimated 552381 patient exposure worldwide. Assuming therapeutic equivalence, the appropriate economic evaluation would be a cost-minimization analysis, comparing treatment with miconazole nitrate buccal tablets, ketoconazole tablets and nystatin lozenges. On this basis, the total cost for 100 patients was similar for the miconazole nitrate- and ketoconazole-based medications, and lower that that for the nystatin-based preparation. In a secondary analysis, cumulative costs at week 3 were approximately one-third less for patients treated with miconazole nitrate buccal tablets when compared with ketoconazole- and nystatin-treated patients.

The Committee considered that the comparison of the effectiveness of miconazole nitrate formulations and nystatin formulations was inadequate; that comparative safety data for miconazole nitrate buc-cal tablets and nystatin lozenges were lacking; and that evidence for clinical benefits arising from a possibly improved adherence to treatment had not been provided. Furthermore, the application was not specifically supported by Family and Community Health. The Committee therefore recommended that the application to add miconazole nitrate buccal tablets to the Model List be rejected.