Eligibility criteria

Patients who have fulfilled each of the following criteria will be eligible for the XELJANZ UC Access Program.

Patients must:

  • Be an Australian resident who is eligible to receive Medicare Benefits
  • Not be eligible for a PBS prescription for XELJANZ
  • Not have previously experienced treatment failure or an inadequate response with XELJANZ
  • Meet either the initial treatment or switch treatment criteria below:

Initial treatment

Adult patient with moderate to severe ulcerative colitis who has failed to achieve an adequate response to:

  • a 5-aminosalicylate (5-ASA) oral preparation in one standard dose for induction of remission for 3 or more months; OR
    1. treatment with a 5-ASA is contraindicated according to the relevant TGA approved Product Information; OR
    2. intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal.

AND

  • azathioprine at a dose of at least 2 mg/kg daily for 3 or more months; OR
    1. treatment with azathioprine is contraindicated according to the relevant TGA approved Product Information; OR
    2. intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal.

OR

  • 6-mercaptopurine at a dose of at least 1 mg/kg daily for 3 or more months; OR
    1. treatment with 6-mercaptopurine is contraindicated according to the relevant TGA approved Product Information; OR
    2. intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal.

OR

  • a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period followed by 3 or more months of an appropriately dosed thiopurine agent; OR
    1. treatment with oral steroids or a thiopurine agent is contraindicated according to the relevant TGA approved Product Information; OR
    2. intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal.

AND

  • Has a Mayo clinic score ≥ 6; OR
  • Has a partial Mayo clinic score ≥ 6, provided the rectal bleeding and stool frequency subscores are both ≥ 2 (endoscopy subscore is not required for a partial Mayo clinic score)

Switch treatment

A patient, aged 18 years or older, with moderate to severe ulcerative colitis who has:

  • previously received PBS-subsidised treatment with a biological agent for this condition in this treatment cycle

Patient exclusion criteria

A patient, aged 18 years or older, with moderate to severe ulcerative colitis who has:

  • Patients who do not fulfil the inclusion criteria as outline above
  • Any patient with contraindications to XELJANZ, as listed in the Product Information and as determined by their treating physician
  • Patients who do not consent to the terms of the XELJANZ UC Access Program