The Pharmaceutical Benefits Advisory Committee (PBAC) is legally required, in evaluating applications for Pharmaceutical Benefits Scheme (PBS) subsidy, to take into account the clinical effectiveness, safety and cost-effectiveness (value for money) of the medication concerned compared to other available therapies.
Importantly, a medicine cannot be subsidised via the PBS unless the PBAC makes a positive recommendation. In other words, a decision by the Committee not to recommend a medicine be subsidised is binding on the Government.
The PBAC has considered the listing of lactulose for the treatment of patients in domiciliary or nursing home care in the past. However, the PBAC was of the opinion that lactulose is an expensive synthetic disaccharide which is no more effective than other cheaper osmotic laxative preparations, and it is associated with abdominal discomfort in a number of patients. The Committee felt that further widening the indication would encourage unnecessary and definitely non-cost-effective use.
The PBAC is reluctant to recommend laxative products for listing on the PBS and considers that other measures such as modification of diet can be used in the treatment of constipation in most patients.