On 1 November 2023, changes introduced following the March 2023 PBAC meeting will take effect with a view to encouraging biosimilar uptake in Australia. This will simplify the procedure for prescribers for obtaining authority to prescribe (ie an authority script) for certain biosimilar medicines which are reimbursed under Australia’s Pharmaceutical Benefits Scheme (PBS). The affected medicines are:
- rheumatoid arthritis: adalimumab, abatacept, baricitinib, certolizumab, etanercept, golimumab, infliximab, tocilizumab and tofacitinib; and
- severe chronic plaque psoriasis: etanercept (children and adolescents).
The intention of these changes is to encourage greater use of biosimilars by easing the administrative burden for prescribers to obtain the necessary authority. For initial therapy with a biosimilar, authority from Services Australia may be obtained by telephone or online with immediate effect, rather than in writing. The requirement to obtain prior authority to prescribe the biosimilar for continuing therapy will be removed, with the requirement now ‘Authority Required (Streamlined)’.
For the rheumatoid arthritis medicines, in general brand substitution of a biosimilar with the reference brand will not be permitted where the approval was by telephone, online or by Streamlined prescription. An exception applies for subsequent continuing therapy where substitution is permitted by the prescriber.