Readers are invited to write in with their questions about decisions of the Pharmaceutical Benefits Advisory Committee (PBAC). Australian Prescriber publishes selected questions from readers, together with answers from the PBAC. Questions may address issues such as regulatory decisions, pharmaceutical benefits listings and withdrawals.
This exclusive arrangement helps Australian Prescriber readers understand how the contents of the Pharmaceutical Benefits Scheme (PBS, see www.pbs.gov.au) are determined.
Letters and responses are reviewed by the Editorial Executive Committee and may be edited before publication. It may not be possible to reply to all individual questions.
Your question to the PBAC
Could you please review listing lamotrigine on the Pharmaceutical Benefits Scheme (PBS) as a treatment for bipolar disorder. Lamotrigine is a well established mood stabiliser and maintenance treatment for bipolar disorder. Patients with this severe mental illness have to pay $80 to $200 a month for this medication. These patients are very often unable to work due to their illness and this treatment is out of the reach of many.
Narre Warren, Vic.
Lamotrigine is currently listed on the PBS for treatment of epileptic seizures which are not adequately controlled by other antiepileptic drugs. Of the eleven brands of lamotrigine currently listed, none have marketing approval from the Therapeutic Goods Administration (TGA) for use in bipolar disorder.
The Pharmaceutical Benefits Advisory Committee (PBAC) has previously considered several submissions for a brand of lamotrigine that has TGA marketing approval for prevention of depressive episodes in patients with bipolar disorder, most recently in March 2005. However, it has not been provided with the necessary evidence to show cost-effectiveness in this patient group and therefore lamotrigine has not been recommended for PBS listing for this indication. The manufacturer is welcome to submit further information for consideration by the PBAC at any time.
The PBAC meets three times a year in March, July and November. Since July 2005, Public Summary Documents providing information of the PBAC's deliberations for major and selected minor submissions have been published on the website approximately four months after each meeting at: www.health.gov.au/internet/main/publishing.nsf/Content/public-summary-documents-by-meeting. You may wish to consult these pages for details of PBAC submissions.