Comparing how Antiseizure Medications are Publicly Regulated by Australia and New Zealand
Daniel Ashley1, Christian Gericke2
1Faculty of Medicine, The University of Queensland; Ochsner Health, 2Faculty of Medicine, The University of Queensland
Objective:
In this study, we aim to address this issue by comparing antiseizure medications (ASMs) licensing and reimbursement in Australia and NZ, in particular, public-sector prescribing restrictions for recommended first-line ASMs.
Background:
Epilepsy affects approximately 50 million people worldwide. People with epilepsy have increased mortality and more physical and psychological comorbidities. New antiseizure medications (ASMs) with similar efficacy to older treatment options but with better side effect profiles and safety have reached the market in recent years. While the availability of these drugs hasn’t reduced the number of patients with epilepsy, the options available allow for more tailored treatment for individuals and the possibility of more target therapeutic drugs being discovered. Access to some recommended ASMs is limited in New Zealand (NZ) compared to Australia. A review of the literature revealed a paucity of studies looking specifically at the licensing and reimbursement of ASMs in Australia and NZ with none comparing the differences.
Design/Methods:
Information related to the licensing and reimbursement of 31 ASMs was collected from the Australian Therapeutic Goods Administration and Pharmaceutical Benefits Scheme (PBS), and the NZ Medsafe and Pharmac databases.
Results:
Australia funds and reimburses a significantly greater number of new ASMs than NZ, with public access to new medications both significantly limited and delayed in NZ.
Conclusions:
Understanding the licensing and reimbursement process is crucial to determining differences in ASM availability in different countries. Regulators in both countries base their decisions primarily on clinical trial efficacy outcomes which do not differ between older and newer ASMs. However, the main patient benefit of newer ASMs in terms of short- and long-term tolerability and epilepsy syndrome-tailored treatment is neglected in the current reimbursement decision-making process. Personalised treatment plans and tolerability are known key drivers for compliance and hence routine effectiveness in terms of seizure control and quality of life.