MAFVedolizumab (Entyvio) Infusion 300 mg
Treatment of adults with moderately to severely active Crohn’s disease who have failed both conventional therapy and anti-TNFα biologics.
Additional Clinical Criteria
Crohn's disease (Initial)
The patient on initial application:
• has moderately to severely active Crohn’s Disease (CD) confirmed by a gastroenterologist; AND
• has failed to achieve an adequate response*, or is intolerant to prior systemic therapy including:
Non-biologics:
• a tapered course of steroids over 6 weeks, and one of the following: azathioprine, 6-mercaptopurine, methotrexate for >= 3 months; OR
• a course of 100 mg hydrocortisone (IV) every 6 hours for 5 days
AND
Biologics:
• adequate induction and/or maintenance doses of one or more of the following: anti-TNFα (infliximab, adalimumab)
Reassessment should be conducted 14 weeks after initiation of treatment.
*Failure to achieve adequate response defined as:
Failure to achieve:
• Clinical remission defined as patient-reported outcome (PRO2) (resolution of abdominal pain (abdominal pain =<1) and diarrhoea/altered bowel habit (stool frequency =<3)), assessed at a minimum of 3 months during active disease; AND
• Endoscopic remission - defined as resolution of ulceration or SES-CD <3 at endoscopy (or resolution of findings of inflammation on cross-sectional imaging/bowel ultrasound in patients who cannot be adequately assessed with endoscopy) which should be assessed at 6- to 9-month interval during active disease.
Crohn's disease (Renewal)
The patient on subsequent reapplication:
• Is in clinical remission as defined by PRO2 (abdominal pain =<1 and stool frequency =<3) or Harvey Bradshaw Index <5
OR
• has improvement in intestinal inflammation documented by:
• improvement/normalisation of CRP or faecal calprotectin; and/or
• evidence of endoscopic improvement in disease activity and/or mucosal healing (SES-CD <3 or absence of ulceration) as demonstrated by endoscopy; and/or
• improvement/resolution of inflammation on cross-sectional imaging/bowel ultrasound
Reassessment should be conducted every 6 months and treatment continued only if there is clear evidence of ongoing clinical benefit.