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

Severe Crohn disease

Subsequent 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 received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or

Patient must have received this drug in the subcutaneous form as their most recent course of PBS-subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; 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

Patient must not receive more than 24 weeks of treatment under this restriction; AND

Patient must be aged 18 years or older.

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

(a) details of the proposed prescription; and

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

(i) the completed Crohn Disease Activity Index (CDAI) Score; or

(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and

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

All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.

Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course 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 within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine 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.

At the time of the authority application, medical practitioners should request the appropriate quantity 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.

If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period.