PBS restrictions on the use of levetiracetam and lamotrigine should be lifted to allow first line use in women of childbearing potential, the Pharmaceutical Benefits Advisory Committee has recommended.

And the PBAC has signalled it will also consider recommending lifting restrictions on the anti-epileptic drugs (AEDs) as first-line agents in all people with epilepsy.

At its September 2020 meeting the PBAC said it had accepted the advice of the Epilepsy Society of Australia (ESA), that first line use of levetiracetam and lamotrigine represents best practice clinical management of epilepsy.

Neurologists have been lobbying against the PBS restrictions, which limit access to levetiracetam and lamotrigine to women who have failed to have their epilepsy controlled with other AEDs.

Clinicians have condemned the restrictions as outdated and say they put patients at risk by encouraging the use of valproate during pregnancy when it has a risk of causing congenital malformations.

The ESA advice, endorsed by the Australian and New Zealand Association of Neurologists (ANZAN), is that guidelines now recommend levetiracetam and lamotrigine for first-line use in new-onset focal epilepsies. In addition, the TGA recommends that physicians avoid use of valproate in women of childbearing age for all non-seizure indications and to consider alternatives to valproate in seizure indications.

The PBAC noted that its utilisation data and estimates suggested that prescribing of levetiracetam and lamotrigine is already occurring in approximately 75% of women with epilepsy who are of childbearing potential.

It recommended expanding the indications for levetiracetam and lamotrigine, saying the financial impact to the PBS was estimated to be small and less than $10 million per year.

And in response to the information by the ESA, the PBAC requested that the Department of Health provide estimates of the cost to the PBS of allowing first-line use of levetiracetam and lamotrigine in the remaining population with epilepsy (i.e. males and females of all ages).

“In addition, the PBAC requested that the Department provide utilisation data and any further evidence on the broader use of other second-line AEDs to the DUSC in the same report,” it said.