Forms
Treatment
Initial treatment
Applications for initial treatment should be made where patients have received no prior PBS subsidised treatment with a bDMD.
All applications for initial treatment will be limited to a maximum of:
- 16 weeks of adalimumab
- 14 weeks of infliximab
- 14 weeks of vedolizumab
Patients must be assessed for a response to any course of PBS subsidised bDMD treatment:
- after 12 weeks of adalimumab treatment
- up to 12 weeks after the first dose for infliximab treatment
- up to 12 weeks after the first dose of vedolizumab treatment
Schedule item details
Adalimumab (Humira®) is presented as:
- a prefilled syringe containing 40 mg of adalimumab in 0.8 mL
- a prefilled pen containing 40 mg adalimumab in 0.8 mL
The dose for adult patients is 4 injections at week zero, 2 injections at week 2 and 1 injection thereafter.
You will be required to make 2 authority prescriptions. The first authority prescription will be for the induction pack of 6 doses of 40 mg and no repeats. The second prescription should be written for 2 doses of 40 mg and 2 repeats.
The form of adalimumab required must be specified on the prescription as either a prefilled syringe or a prefilled pen.
Infliximab (Remicade® or Inflectra) is presented as a vial containing 100 mg of lyophilised powder.
The dose for patients is 5 mg/kg given intravenously.
Initially, patients are to be treated at week zero, week 2 and week 6. Subsequent infusions are at 8 weekly intervals.
Authority prescriptions should be written as the actual number of vials to provide a dose of 5 mg/kg and 2 repeats.
Vedolizumab, Entyvio®, is presented as a vial containing 300 mg.
The dose is 300 mg per infusion.
Initially patients are to be treated at week zero, week 2 and then at week 6. Subsequent infusions are at 8 weekly intervals.
Authority prescriptions should be written as Vedolizumab – one vial of 300 mg and 2 repeats.
Crohn disease: Initial PBS authority application
Crohn disease: toxicity criteria and severity descriptors
Continuing treatment
After an initial treatment course with a bDMD agent, patients may qualify to receive up to 24 weeks of continuing treatment providing they have demonstrated an adequate response to treatment.
Patients are eligible to receive further continuing treatment in courses of up to 24 weeks providing they continue to sustain a response.
Patients must be assessed for a response to each course of continued treatment. The assessment must be submitted to us no later than 4 weeks from the date that the course is completed. Where a response assessment is not submitted to us within this timeframe, patients will be found to have failed to respond to treatment.
Treatment
Initial treatment using infliximab
All patients starting treatment with infliximab must meet all aspects of the initial criteria. They must be 6 years of age or older, and have:
- a Mayo clinic score greater than or equal to 6, or
- a partial Mayo score greater than or equal to 6, provided the rectal bleeding and stool frequency sub scores are both greater than or equal to 2, or
- for patients aged 6 to 17 years a Paediatric Ulcerative Colitis Activity Index (PUCAI) score greater than or equal to 30, or
- previously received induction therapy with infliximab in the last 4 months for an acute severe episode of ulcerative colitis and demonstrated that prior initial criteria was met at the time of induction and has a current response to treatment
Patients will be approved for a maximum of 3 infusions only.
Patients may qualify for this restriction once only.
Initial treatment using vedolizumab
Adult patients starting treatment with vedolizumab must meet all aspects of the initial criteria and:
- have a Mayo clinic score greater than or equal to 6, or
- have a partial Mayo score greater than or equal to 6, provided the rectal bleeding and stool frequency sub scores are both greater than or equal to 2, and
- must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy
Patients will be approved for a maximum of 3 infusions only.
Crohn’s Disease: Initial PBS authority application
Crohn’s Disease: Toxicity criteria and severity descriptions