Return to Special Authority drug list
Generic name |
upadacitinib |
|
Strength & form |
15 mg/30 mg/45 mg, extended-release tablet |
Special Authority criteria |
Approval period |
---|---|
InitialModerately to severely active Crohn's disease For the treatment of adult patients with moderately to severely active Crohn's disease when ALL of the following criteria are met: Special Authority request is submitted by a gastroenterologist AND Patient has a Harvey-Bradshaw Index of 8 or higher1 AND Patient has had an unsuccessful trial of steroids for their current Crohn’s disease activity. The trial must include a steroid dose equivalent to oral prednisone 40 mg or more daily taken for at least 14 consecutive days. Unsuccessful trial is defined as one of the following:
istulizing Crohn's disease For the treatment of adult patients with active fistulizing Crohn's disease when ALL of the following criteria are met: Special Authority request is submitted by a gastroenterologist AND Patient has had an inadequate response or intolerance to a course of ciprofloxacin for a minimum of 3 consecutive weeks at maximally tolerated doses, or
|
16 weeks |
RenewalModerately to severely active Crohn’s disease For the continued treatment of adult patients with moderately to severely active Crohn's disease when ALL of the following criteria are met: Special Authority request is submitted by a gastroenterologist AND Patient has a Harvey-Bradshaw Index decrease of at least 4 points, or
Fistulizing Crohn's disease For the continued treatment of adult patients with active fistulizing Crohn's disease when ALL of the following criteria are met: Special Authority request is submitted by a gastroenterologist AND Patient has demonstrated an improvement in the number of and/or severity of fistulae |