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

Severe Crohn disease

Initial treatment - Initial 1 (new patient)

Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND

Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; or

Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND

Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment and which is no more than 4 weeks old at the time of application; or

Patient must have extensive intestinal inflammation of the small intestine as evidenced by radiological imaging; AND

Patient must not receive more than 16 weeks of treatment under this restriction; AND

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)]; or

Must be treated by a paediatrician; or

Must be treated by a specialist paediatric gastroenterologist; AND

Patient must be aged 6 to 17 years inclusive.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); 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).

For patients assessed as having extensive intestinal inflammation of the small intestines, such evidence of intestinal inflammation includes:

(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or

(ii) faeces: higher than normal lactoferrin or calprotectin level; or

(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.

If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website (www.servicesaustralia.gov.au).

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

Severe Crohn disease

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

Patient must have a documented history of severe Crohn disease; 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, or ceased to respond to, PBS-subsidised treatment with this drug for this condition more than once in the current treatment cycle; AND

Patient must not receive more than 16 weeks of treatment under this restriction; AND

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)]; or

Must be treated by a paediatrician; or

Must be treated by a specialist paediatric gastroenterologist; AND

Patient must be aged 6 to 17 years inclusive.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); 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).

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.

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

Severe Crohn disease

Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)

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

Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; 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, consultant physician, paediatrician or specialist paediatric gastroenterologist; AND

Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40; or

Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease that is no more than 4 weeks old at the time of application; AND

Patient must not receive more than 16 weeks of treatment under this restriction; AND

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)]; or

Must be treated by a paediatrician; or

Must be treated by a specialist paediatric gastroenterologist; AND

Patient must be aged 6 to 17 years inclusive.

The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include:

(1) details of the proposed prescription(s); 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).

For patients assessed as having extensive intestinal inflammation of the small intestines, such evidence of intestinal inflammation includes:

(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or

(ii) faeces: higher than normal lactoferrin or calprotectin level; or

(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.

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

An assessment of a patient's response to this initial course of treatment must be made following a minimum of 12 weeks therapy so that there is adequate time for a response to be demonstrated.

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.