Time to tweak asthma biologics process


By Mardi Chapman

11 Jun 2019

Respiratory physicians are hopeful there might be some relaxation of the current requirement to wait six months before transferring patients with severe asthma from one biologic to another.

The PBAC, which met with key stakeholders including industry representatives in December 2018, have recently made public the meeting outcome statement.

It says the six-month treatment break was originally based on the omalizumab restriction and then subsequently applied to switching between other biologics.

“The treatment interval applies regardless of the reason for switching, including if the switch is due to adverse events, partial or non-responsiveness or patient/clinician choice,” the statement said.

The TSANZ and the Centre of Excellence in Severe Asthma have both proposed a shorter interval would be more appropriate.

Professor Peter Wark, from the Centre and the University of Newcastle, told the limbic he felt the six months was relatively arbitrary.

“We’re very much hoping that the PBAC will consider, based on the submissions that are currently in place, a relaxation of that six month rule to allow transfers of patients from one biologic to another particularly in the setting of adverse events but also just in terms of changing from one class to another.”

He said the six-month interval exposed patients to a period of uncontrolled asthma and likely increased their use of oral corticosteroids.

The requirement was also inconsistent with the use of monoclonal antibodies in other settings such as rheumatoid arthritis.

“From a practical point of view, by the time someone has ceased an agent and you’ve seen them in follow-up and gone through the process of applying again, under the fastest of circumstances you would be talking about a month to six weeks before someone would start another agent anyway. It’s not like it would be an immediate transfer from one agent to the next.”

Professor Wark said concerns were also raised at the meeting about the complexity of the application process for biologics, and prednisone and lung function thresholds for initiating biologics.

“We thought the meeting went well. It was very much a fact-finding effort on the PBAC’s part to see how things were progressing since the introduction of monoclonals.”

He said with the significant increase in the number of biologic agents being used in the setting of severe asthma, streamlining the process would lead to efficiencies for both government and clinicians.

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