Lamotrigine for bipolar disorder
Page last updated: 8 April 2026
At its November 2025 meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended a new Restricted Benefit listing on the Pharmaceutical Benefits Scheme (PBS) for lamotrigine to treat bipolar disorder. The new listing will be implemented as part of upcoming monthly changes to the PBS schedule.
Background
The Review of clinical guidelines and cost estimates for the use of anti-epileptic drugs (AEDs) for the treatment of epilepsy report (“the Report”) was considered by the Drug Utilisation Sub-Committee (DUSC) at its April 2025 meeting and by the PBAC at its May 2025 Intracycle meeting.
The PBAC recommended amending the PBS restrictions for levetiracetam (LEV) and lamotrigine (LTG) to Restricted Benefit listings for the treatment of epileptic seizures. This restriction change took effect on 1 November 2025 and allows the subsidised first‑line use of these medicines in the general Australian population with epilepsy.
The PBAC considered there may be an unmet need to subsidise LTG for mental illnesses such as bipolar disorder. The PBAC recommended in principle extending subsidy of LTG to this indication and requested that the Department undertake further work to estimate the cost to the R/PBS of a separate Restricted Benefit listing for LTG for bipolar disorder for its consideration at a future meeting.
Refer to the Review of clinical guidelines and cost estimates for the use of AEDs for the treatment of epilepsy webpage for further information.
PBAC consideration – November 2025
At its November 2025 meeting, the PBAC considered cost estimates to the R/PBS for a new Restricted Benefit listing for LTG for bipolar disorder.
The PBAC recommended a new Restricted Benefit listing for all existing PBS-listed strengths of LTG tablets for the treatment of bipolar disorder, to be priced equivalently to the existing LTG listings for epileptic seizures.
The PBAC noted pre-PBAC responses from the Royal Australian and New Zealand College of Psychiatrists (RANZCP), the Royal Australian College of General Practitioners (RACGP), the National Aboriginal Community Controlled Health Organisation (NACCHO) and one sponsor, which supported the proposed listing of LTG for this indication. The PBAC also noted that Australian clinical guidelines recommend LTG as a first-line monotherapy for bipolar depression and as a second-line monotherapy for the prevention of bipolar disorder in both adults and young people.
The PBAC noted that, although both the RANZCP and NACCHO supported an Unrestricted Benefit listing, only three of the eight brands of LTG available on the PBS (Lamictal, Lamotrigine GH, and Sandoz Lamotrigine) are approved by the Therapeutic Goods Administration (TGA) for the treatment of bipolar disorder. Consequently, the PBAC recommended that the new Restricted Benefit listing should be limited to these three brands only.
The PBAC accepted the financial estimates and considered the estimated net cost to the R/PBS of the proposed listing reasonable. The PBAC considered it is likely that LTG represents reasonable value for money for this indication for the following reasons:
- LTG is recommended as a first-line treatment for bipolar disorder in Australian clinical guidelines, suggesting its clinical effectiveness is comparable (non-inferior) to other PBS-listed alternatives.
- LTG is likely to offer improved safety and tolerability compared to other PBS-listed medicines for bipolar disorder, with a lower risk of teratogenic effects than alternatives such as valproate.
- Cost comparisons per defined daily dose indicate that LTG is similar in price to other PBS-listed treatments for bipolar disorder, such as quetiapine.
- As an F2 medicine, LTG is subject to statutory price reductions, price disclosure, and supply guarantees under the National Health Act 1953. Consequently, its cost-effectiveness for bipolar disorder is expected to improve further as prices decrease over time.
The PBAC recommended that the department monitor the use of LTG following implementation of the new listing and advised that it would be prepared to reconsider the appropriateness of an Unrestricted Benefit listing for this medicine at a future meeting.
A Public Summary Document (PSD) for this item is available below. In-confidence information in the PSD has been redacted.
