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

Complex refractory Fistulising Crohn disease

Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)

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:

(i) details of the proposed prescription; and

(ii) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

• a completed current Fistula Assessment Form including the date of assessment of the patient's condition.

The most recent fistula assessment must be no more than 1 month old at the time of application.

A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.

An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.

This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial 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

Change or Recommencement of treatment after a break in therapy of less than 5 years (Initial 2)

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.

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

(i) details of the proposed prescription; and

(ii) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:

1. a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
2. details of prior biological medicine treatment including details of date and duration of treatment.

The most recent fistula assessment must be no more than 1 month old at the time of application.

Where the most recent course of PBS-subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.

To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.

If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.

A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.

An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.

This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.

Where a response assessment is not provided within this 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

First continuing treatment

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 previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have demonstrated an adequate response to treatment with this drug.

An adequate response is defined as:

(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or

(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.

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

(a) details of the proposed prescription; and

(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.

The most recent fistula assessment must be no more than 1 month old at the time of application.

The application for first continuing treatment with this drug must include an assessment of the patient's response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.

Where a response assessment is not provided within this 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.

A maximum of 24 weeks of treatment with this drug will be authorised under this restriction.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.

Up to a maximum of 2 repeats will be authorised.

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

Complex refractory Fistulising Crohn disease

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 treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or

Patient must have received insufficient therapy with this drug for this condition under the Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); or

Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND

The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment) or 2 repeats (first Continuing or Subsequent Continuing treatment).