Biologic prescribing restrictions eased for severe asthma

PBS restrictions have been eased on prescribing of the biologics in severe asthma from 1 December.

The PBS has adopted the following recommendation made by the Pharmaceutical Benefits Advisory Committee (PBAC) at its May meeting:

Initial treatment:

  • Amendment of the eosinophil cut-off from ≥ 300 cells per µL to 150 cells per µL for patients on oral corticosteroids
  • Removal of the forced expiratory volume (FEV1) ≤ 80% predicated normal. For omalizumab only, removal of the requirement for RAST testing and replacement with “Past or present evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE”
  • A 32 week initial treatment period across all three medicines.

Continuing treatment:

  • Continuation of therapy where Asthma Control Questionnaire (ACQ) is no greater than 0.5 higher than baseline where oral corticosteroid (OCS) dose has been reduced.


  • A new ‘initial 2’ restriction for patients switching therapy to remove the current requirement for a 6 month break between treatments.

Re-trialling and cycling:

  • Re-trial of the same biologic after previous failure following a 12 month break (increased from the current 6 month break)

In other regulatory changes, the TGA approval of two new self-administration options for mepolizumab (Nucala)  has been welcomed for offering patients with severe asthma more flexibility for at-home or community-based use.

Professor Peter Wark, a respiratory physician at Newcastle University NSW, says the approval for a pre-filled pen and pre-filled safety syringe for mepolizumab will be of particular benefit for rural residents who will now have greater choice as to where they can receive treatment, at home or via a nurse or GP.

“This is obviously a useful option for our regional patients,” he told the limbic.

“Access to medicines and ease of use are always important issues in reducing the burden of asthma, this is especially the case for people in regional and remote areas who can face significant barriers to accessing treatments.”

He said a recent study in 18-64 year old adults with severe asthma had shown that with training most patients were confident in being able to self administer the biologic treatment for severe eosinophilic asthma at home, and  this was preferred by most over receiving treatment at a clinic.

However he acknowledged that the at-home option would create challenges in terms of monitoring adherence to treatment, particularly given the cost of the biologics in asthma.

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