Ulcerative Colitis Guide

Belinda Headon (IBD Nurse, Alfred Hospital Melbourne) outlined the processes for PBS prescribing of infliximab in moderate-to-severe UC. She emphasised the following points:

  • Information, forms and supporting materials are available on the Medicare website, here
  • The Mayo score or partial Mayo score at initial assessment must be included in the application. Recording the score should become a routine part of assessment, facilitating later infliximab treatment if needed. Janssen have provided forms to assist. Click here to help determine your patient’s MAYO score.
  • The application for initial use of infliximab must be signed by the patient, but does not need to be witnessed.
  • Patients must have failed to achieve an adequate response to a 5-ASA oral preparation in a standard dose for induction of remission, for example mesalazine 3–4.5 mg/day.
  • If intolerance of previous therapies is a factor, then intolerance must be graded. A list of toxicity criteria and severity descriptors is available on the Medicare website.
  • ‘Grandfather’ provisions allow PBS prescribing of infliximab in patients who have the appropriate severity of disease and have previously been treated with non-PBS-subsidised infliximab. The Mayo score must have been recorded before commencing the non-funded treatment course.
  • S100 arrangements apply to patients on discharge from hospital, as well as to day-admitted and non-admitted patients.
  • Patients who respond to the standard induction course of infliximab at 0, 2 and 6 weeks can qualify for a further maintenance course of three doses at 8-week intervals. PBS approvals can be obtained by phone: the current Mayo score and patient’s weight will be required for the application.
PBS supply: Acute severe ulcerative colitis

A single infusion at a dose of 5 mg/kg is available through the PBS in the following circumstances:

Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application,

AND

  • Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h;

OR

  • Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below,

AND

For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where: (i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C-reactive protein (CRP) greater than 45 mg/L; (ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood.

For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours.

Check the full PBS criteria before prescribing.

PBS supply: Moderate-to-severe ulcerative colitis: (Initial treatment)

Initial treatment (new patient)

An initial course of infliximab consisting of 3 doses at 5 mg/kg body weight per dose, to be administered at weeks 0, 2 and 6, is available through the PBS in the following circumstances. Patients may qualify once only.

Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more months or have intolerance necessitating permanent treatment withdrawal,

AND

  • Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg/kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal

OR

  • Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal

OR

Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal,

AND

Patient must have a Mayo clinic score ≥6 if an adult patient; or 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); or Paediatric Ulcerative Colitis Activity Index (PUCAI) Score ≥30 if aged 6 to 17 years.

All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment. The most recent Mayo clinic, partial Mayo clinic or PUCAI score must be no more than 1 month old at the time of application.

Check the full PBS criteria before prescribing.

PBS supply: Moderate-to-severe ulcerative colitis: (Continuing treatment)

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition,

AND

  • Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score ≤2, with no subscore>1 while receiving treatment with this drug;

OR

  • Patient must have demonstrated or sustained an adequate response to treatment by having a PUCAI score <10 while receiving treatment with this drug if aged 6 to 17 years.

Three infusions at 8-weekly intervals can be supplied.

Check the full PBS criteria before prescribing.

MAX: A CASE STUDY FOR STEROID-DEPENDENT ULCERATIVE COLITIS

 

BRENDA: A CASE STUDY FOR ACUTE SEVERE ULCERATIVE COLITIS

 

PBS PRESCRIBING INFORMATION FOR REMICADE IN ULCERATIVE COLITIS

 

PBS information: This product is listed as a Section 100 item for Crohn’s disease and ulcerative colitis. Refer to PBS Schedule for full authority information.

Please refer to Product Information before prescribing. Full product Information is available here. Further information is available on request from Janssen.

AU-REM0418. Date prepared: April 2015.