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

Severe Crohn disease

Initial treatment - Initial 1 (new patient)

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 severe 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 failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND

Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; or

Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; or

Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND

The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND

Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; or

Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; or

Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; AND

Patient must be at least 18 years of age.

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

(a) details of the two proposed prescriptions; and

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

(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and

(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and

(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and

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

Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:

(a) patient must have evidence of intestinal inflammation;

(b) patient must be assessed clinically as being in a high faecal output state;

(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.

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.

Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for a total dose of 90 mg and no repeats.

A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised

Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.

Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.

All assessments, pathology tests and diagnostic imaging studies must be made within 4 weeks of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.

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, details of this toxicity must be provided at the time of application.

Details of the accepted toxicities including severity can be found on the Services Australia website.

Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.

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.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Increase in the maximum quantity or number of units up to 4 may be authorised for the purpose of weight-based loading dose.

Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).

Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.au

Applications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hpos

Or mailed to:

Services Australia

Complex Drugs

Reply Paid 9826

HOBART TAS 7001

PBS GI Codes