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Item |
Description |
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1 |
Where can I locate pouchitis applications in Processing and National Demand Allocation (PaNDA) system?
In PaNDA, work items for Pouchitis (POUCH) have been merged with Ulcerative Colitis (UC) in Health Professional Online Services (HPOS) and Written (WRIT) folders respectively as follows:
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HPOS UC/Pouch
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UC/Pouch WRIT
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2 |
Is there an age restriction for patients applying for PBS-subsidised vedolizumab to treat moderate to severe chronic pouchitis?
No. Patients of any age can apply for it.
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3 |
What are the baseline measurements for chronic pouchitis?
Modified Pouchitis Disease Activity Index (mPDAI) score and endoscopic mPDAI sub-score. The patient must have a baseline mPDAI score ≥ 5 and a minimum endoscopic mPDAI sub-score ≥ 2 when initiating treatment with vedolizumab for this condition.
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4 |
Is an adequate response to PBS-subsidised treatment with vedolizumab defined as a reduction from baseline mPDAI score and endoscopic mPDAI subscore?
No. The patient’s demonstration of a partial or complete response to PBS-subsidised vedolizumab for this condition is determined by the treating clinician.
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5 |
Can recommencement of treatment be approved for patients who have previously failed, or ceased to respond to, PBS-subsidised treatment with vedolizumab for this condition?
No.
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6 |
What is the timeframe for a break in therapy before a recommencement application can be submitted?
There is no minimum or maximum break. As long as patients have had prior PBS-subsidised treatment with this drug for this condition and have not failed, they can recommence treatment at any time.
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7 |
Are patients required to re-trial antibiotics prior to re-initiating PBS-subsidised vedolizumab?
No. However, vedolizumab must be recommenced in combination with standard of care antibiotic therapy.
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8 |
Are patients required to have a mPDAI total score ≥ 5 with a minimum endoscopic sub-score ≥ 2 when they recommence therapy following a treatment break?
No.
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9 |
Can increased quantity and/or repeats be authorised for vedolizumab?
No increase (NO INC) in the PBS-listed quantity of 1 vial and repeats of 2 are allowed for this item.
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10 |
What is ileal pouch–anal anastomosis (IPAA)?
IPAA is the most common surgery for patients with ulcerative colitis who undergo colectomy to remove their large intestine (colon and rectum) when medications don’t work to control symptoms. An ileal pouch is an internal pouch made from the end of the small intestine (ileum) to replace colon and rectum that connects to the anal canal. It allows the patient to control their bowel movements without wearing a bag outside the body (stoma bag).
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PBS chronic pouchitis restriction and item codes