Urgent need to lift ‘outdated and unsafe’ PBS restrictions on anti-epileptic drugs

Epilepsy

By Michael Woodhead

4 Jul 2019

Prof Christian Gericke

PBS prescribing restrictions on anti-epileptic drugs need to be urgently revised because they promote the use of outdated and unsafe drugs for first line use, neurologists say.

Patients with epilepsy are being put at risk because drugs such as valproate and carbamazepine are favoured in PBS criteria over safer alternatives such as levetiracetam and lamotrigine, according to Professor Christian Gericke of the University of Queensland.

In an MJA commentary co-authored by Epilepsy Society of Australia president Professor Terence O’Brien from Monash University, Professor Gericke says Australian prescribing criteria lag so far behind US and European professional guidelines that clinicians may face medicolegal consequences if they prescribe a drug such as valproate, which has been banned for first line use by the European Medicines Agency (EMA).

Valproate’s risks of fetal malformations and its adverse effect on cognitive function on children exposed to it in utero mean that it should only be used as a last resort in low doses, they say.

Professional organisations in countries such as the UK, EU and the US now recommend lamotrigine and levetiracetam for first line therapy in new-onset focal epilepsies and for generalised epilepsies, they note.

But in Australia, PBS criteria maintain tight restrictions on the use of drugs such as levetiracetam, despite a recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) in 2008 to extend their use.

“In practice, most epileptologists ignore the PBS restrictions and follow the internationally recommended prescribing guidelines,” they write.

“This puts the practitioner at risk of legal and financial sanctions. Australian doctors treating patients with epilepsy are therefore stuck between the proverbial rock and hard place.”

Cost concerns should not be a barrier to lifting restrictions because generic preparations are now available for levetiracetam and lamotrigine, they add.

PBS restrictions may be justified for newly listed drugs to avoid cost blow outs, but there needs to be an effective mechanism to review the restrictions over the long term, to avoid outdated prescribing practice and suboptimal care, said Professor Gericke.

A second priority is to review PBS restrictions on other well tolerated and effective second and third line anti-epileptic drugs such as zonisamide, oxcarbazepine, lacosamide and perampanel.

“Doctors should not be forced to choose between safe patient care and complying with outdated government regulation. It’s not fair on doctors, and it’s not fair on our patients.

“This long-awaited PBS update would finally allow Australian doctors to prescribe anti-epileptic drugs in line with international best practice without imposing a financial burden on patients or contravening PBS regulations,” the authors concluded.

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