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

Severe Crohn disease

Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient

Patient must be receiving treatment with this drug for this condition where treatment was initiated as a paediatric patient via non-PBS pathways (e.g. compassionate access or public hospital individual patient use program); AND

Patient must have met the paediatric PBS eligibility criteria for initial treatment with a targeted therapy treatment for this condition; AND

Patient must have previously received this drug for this condition and demonstrated/maintained an adequate clinical response; AND

Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or

Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; 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.

The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:

(a) if applicable, current CDAI score and the date of assessment; and

(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and

(c) if applicable, the date of the most recent clinical assessment.

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.

A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested through the Balance of supply treatment phase PBS restriction. Under no circumstances will approvals be granted for treatment that would otherwise extend treatment beyond 24 weeks.

Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.

A patient may only qualify for PBS-subsidised treatment under this restriction once. For continuing PBS-subsidised treatment, patients must qualify under the Continuing treatment criteria.

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

Severe Crohn disease

Continuing (maintenance) treatment

Patient must have received this drug as their most recent course of PBS-subsidised targeted therapy treatment for this condition; AND

Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or

Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; or

The condition must have not met the improvements specified above due to the prescribed dose being too low - this authority application seeks higher dosing; 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.

The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:

(a) if applicable, current CDAI score and the date of assessment; and

(b) if applicable, details (date, unique identifying number/code or provider number) of the pathology or diagnostic imaging test(s) or details of intestinal inflammation marker/s used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy; and

(c) the date of the most recent clinical assessment.

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.

A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised targeted therapy was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.

Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.

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

Severe Crohn disease

Balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Continuing (maintenance) treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient restriction to complete 24 weeks of treatment; AND

The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment or Transitioning from non-PBS-subsidised therapy that was commenced as a paediatric patient treatment; 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].