The decision will make it easier for patients with uncontrolled severe asthma to access biologic therapies.
The Pharmaceutical Benefits Advisory Committee has removed the need for patients with uncontrolled severe asthma to be required to have trialed oral corticosteroids before being eligible for a biologic prescription on the PBS.
The change, which came into effect at the start of the month, means the PBS authority requirements for benralizumab, dupilumab, mepolizumab and omalizumab now carry a new definition of “optimised asthma therapy”, which still requires adherence to maximal inhaled therapy (including high dose ICS plus LABA therapy) for at least a year, unless it is contraindicated, or the patient is unable to tolerate it.
“The PBAC did not consider that that the change to the OCS clinical criteria would increase the eligible population and therefore considered there to be nil financial impact to the Government,” the committee said in its public outcomes document.
The decision came on the back of a submission from GSK, who sponsor mepolizumab (Nucala). The pharmaceutical company’s request was supported by the Australasian Society of Clinical Immunology and Allergy.
GSK had also asked for a reduction in the PBS authority level required to prescribe the drug, which the committee declined.
“The PBAC considered that, while the available data suggested that the growth of mepolizumab is gradually stabilising, the overall uncontrolled severe asthma market continues to grow. The PBAC therefore considered that it would not be appropriate to amend the circumstances of mepolizumab in isolation, noting the growth of the overall anti-interleukin-5 market for uncontrolled severe asthma,” the committee said.
Related
The change for the four biologic agents has been restricted to the oral corticosteroids requirement, with other criteria – like the requirement for the patient to have a blood eosinophil count exceeding 300 cells/μl – remaining unchanged.
The updated PBS form is available via the Services Australia website.
