(1) Why were the drugs Aricept and Exelon used to treat Alzheimer's disease rejected by the Pharmaceutical Benefits Advisory Committee for Pharmaceutical Benefits Scheme (PBS) listing in September 2000.

(2) Will he include these drugs on the PBS and relieve many Alzheimer's sufferers and their carers from the financial burden of these costly but effective drugs.

(1) The Pharmaceutical Benefits Advisory Committee rejected applications to list Aricept and Exelon on the PBS up until recently because it had not accepted that the cost effectiveness and health benefits measures for these medicines were adequate to support PBS listing for all patients with mild to moderate Alzheimer's disease, or that prescribing criteria could ensure that pharmaceutical benefits were directed only to those patients most likely to benefit from treatment.

The application considered at the September 2000 meeting was rejected because the Committee considered the prescribing criteria and guidelines proposed by expert clinicians attending an April 2000 stakeholder meeting were impractical and too complicated to administer. Although the criteria for initiation of treatment were appropriate, the Committee was concerned that the cessation of treatment rule would not target Aricept to those patients who experience an unambiguous clinical improvement on treatment.

In rejecting the application, the Committee also encouraged the manufacturer of Aricept to re-submit a listing application which proposed a simpler cessation of treatment rule and also included descriptions of the meaning of improvement resulting from treatment with Aricept in terms of the impact on a typical Alzheimer's patient and their carer.

(2) Subsequent applications to list Aricept and Exelon on the PBS were considered by the Committee at its meeting held on 30 November - 1 December and have recently been approved for PBS subsidy following a recommendation from the Pharmaceutical Benefits Advisory Committee.

The PBS listings aim to provide affordable access to these medicines while ensuring that subsidy is directed in ways that will achieve the best outcomes for those who will benefit most. This involves consideration by prescribing doctors of clinical factors such as diagnostic criteria, disease progression and treatment responses.

The terms and conditions of the PBS listings for these medicines were advised to all doctors and pharmacists in late January.