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

Type III Short bowel syndrome with intestinal failure

Initial treatment

Must be treated by a gastroenterologist; or

Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit; AND

Patient must have short bowel syndrome with intestinal failure following major surgery; AND

Patient must have a history of dependence on parenteral support for at least 12 months; AND

Patient must have received a stable parenteral support regimen for at least 3 days per week in the previous 4 weeks; AND

Patient must not have active gastrointestinal malignancy or history of gastrointestinal malignancy within the last 5 years; AND

The treatment must not exceed 12 months under this restriction; AND

Patient must not have previously received PBS-subsidised treatment with this drug for this condition.

Provide a baseline value in this authority application of the amount of parenteral support per week, expressed as either:

(i) for a patient of any age, the mean number of days of parenteral support per week

(ii) for a patient yet to turn 18 years of age, the mean volume of parenteral support per week in mL per kg.

Determine the mean over any given 4 week period prior to this authority application. For a patient yet to turn 18 years of age, both (i) and (ii) may be supplied, but provide at least (i).

Assessment of treatment response/non-response in the 'Continuing treatment' authority application will be compared against the baseline value(s) submitted in this application.

A stable parenteral support regimen is defined as a minimum of 3 days of parenteral support (parenteral nutrition with or without IV fluids) per week for 4 consecutive weeks to meet caloric, fluid or electrolyte needs.

The authority application must be made in writing and must include:

(a) details of the proposed prescription(s); and

(b) 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).