3 neurology medications get PBAC recommendations, 2 in limbo

By Michael Woodhead

26 Aug 2020

Therapies for multiple sclerosis, focal spasticity of the upper limb and spinal muscular atrophy (SMA) have received recommendations for PBS listing from the Pharmaceutical Benefits Advisory Committee (PBAC).

At its July 2020 meeting, the PBAC recommended the following listings:

  • Mayzent: listing of siponimod for patients with secondary progressive MS who are ambulant (with or without support). The PBAC recommended listing on a cost-minimisation basis compared with fingolimod but said additional financial measures would be required to facilitate a PBS listing. In a statement, MS Research Australia said this was the first time in Australia that a medication for secondary progressive MS had been recommended for subsidy. However, it noted that the PBAC did not recommend extending the listing of ocrelizumab to include people with early, MRI-active primary progressive MS.
  • Dysport: listing for the treatment of moderate to severe focal spasticity of the upper limb in patients with cerebral palsy. The PBAC said it was satisfied that Dysport was non-inferior to Botox in terms of comparative efficacy and safety.
  • Spinraza: the PBAC recommended the addition of pre-symptomatic initiation to the current listing of nusinersen to include the pre-symptomatic initiation of treatment of patients genetically diagnosed with spinal muscular atrophy, who have a Survival-of-Motor-Neuron 2 (SMN2) gene copy number of 1 or 2 (i.e. SMN2 copy number ≤2).

Meanwhile, Eli Lilly Australia has said it is hoping for a successful PBS listing outcome for its migraine prevention therapy galcanezumab (Emgality) with a revised submission to be reviewed by the PBAC at its November meeting.

A previous application for listing became bogged down over wrangling between the company and government over a financial risk sharing agreement.

“Following consultation with the Department of Health and leading neurologists after an initial, yet unviable, PBAC recommendation, the company has provided a minor resubmission for reimbursement of Emgality for the tens of thousands of patients with chronic migraine …” the company said in a statement.

“We are encouraged by the feedback and optimistic that the Committee can now provide a recommendation that is affordable for the Commonwealth and viable for the company,” it said.

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