Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Severe Crohn disease

Initial 4 (additional dose at week 10)

Patient must have received prior PBS-subsidised treatment with this drug for this condition in this treatment cycle; AND

Patient must have received 3 doses of initial treatment under either: (i) Initial 1, (ii) Initial 2, (iii) Initial 3; AND

Patient must not have achieved an adequate response to this drug after a total of 3 doses of initial treatment under either: (i) Initial 1, (ii) Initial 2, (iii) Initial 3; AND

Must be treated by a gastroenterologist; or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology]; AND

Patient must be at least 18 years of age.

A maximum quantity and number of repeats to provide for an additional dose of this drug consisting of one vial of 300 mg, with one dose to be administered at week 10, will be authorised.

A patient who does not demonstrate a response to treatment will not be eligible for further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. The patient will be considered not to have responded to treatment if a response assessment is not completed. A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as treatment failure.

Patient must be assessed as having an inadequate response to the drug after completing an initial infusion regimen at 0, 2, and 6 weeks and prior to 10 weeks.