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

Complex refractory Fistulising Crohn disease

Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND

Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND

Patient must have an externally draining enterocutaneous or rectovaginal fistula.

Applications for authorisation must be made in writing and must include:

(1) two completed authority prescription forms; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 4 weeks old at the time of application.

A maximum of 16 weeks of treatment with this drug will be approved under this criterion.

An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

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

Complex refractory Fistulising Crohn disease

Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND

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

Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

Applications for authorisation must be made in writing and must include:

(1) two completed authority prescription forms; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:

(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and

(ii) details of prior biological medicine treatment including details of date and duration of treatment.

The most recent fistula assessment must be no more than 4 weeks old at the time of application.

A maximum of 16 weeks of treatment with this drug will be approved under this criterion.

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

Complex refractory Fistulising Crohn disease

Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND

Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND

The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.