News in brief: PBS cuts red tape for Authority script approvals; Silica dust exposure to cause 10,000 lung cancers; Mixed results for Evusheld against Covid-19

PBS cuts red tape for Authority script approvals

The PBS approval system is being simplified to allow prescribers to obtain immediate approval for Authority Required (Written) prescriptions online without having to submit paperwork by post to Services Australia for assessment.

Starting from 1 July, prescribers will be to apply digitally for authority approval to prescribe certain PBS listed medicines using Services Australia’s Online PBS Authorities (OPA) System.

Authority requests will be assessed via questions within the OPA system via HPOS in real time, allowing prescribers to obtain immediate authority approval (following confirmation of eligibility), without having to submit physical copies of forms, prescriptions and test results.

“This same channel is already in use for medicines that have Authority Required (telephone) PBS listings and these changes are intended to reduce the administrative burden for prescribers and allow patients to have faster access to their medicines,” the Department of Health said.

However it cautioned that the changes would be phased in gradually as not all PBS medicine listings could be updated at the same time. A list of cancer medicines for which PBS changes has been published by Services Australia.

Prescribers will still be able to submit applications for authority to prescribe via Australia Post or upload documents in HPOS if they choose to do so.

Silica dust exposure to cause 10,000 lung cancers

As many as 10,000 Australians are predicted to develop lung cancer and 103,000 workers will be diagnosed with silicosis as the result of their current exposure to silica dust at work, according to modelling by researchers at Curtin University, WA.

Their report notes that that more than half a million Australian workers are currently exposed to the harmful dust in construction, mining and quarrying and especially because of the popularity of engineered stone in kitchen benchtops.

Co-author Professor Lin Fritschi from the Curtin School of Population Health said banning engineered stone would save lives – with almost 100 lung cancers and a thousand silicosis cases could be prevented.

“While a complete ban of engineered stone would be the best option, it is possible to reduce the health impacts of working with engineered stone by various methods such as mandatory wet-cutting or on-tool dust extraction, as long as these methods are combined with the consistent use of high-quality respiratory protection,” she said.

The International Agency for Research on Cancer classified crystalline silica as a Group 1 (definite) carcinogen in 1997 and 2012.

Mixed results for Evusheld in patients hospitalised with COVID-19

The monoclonal antibody combination Evusheld (tixagevimab-cilgavimab) has failed to accelerate time to sustained recovery in patients hospitalised with COVID-19, but has shown a “clinically relevant” improvement in mortality in a multinational Phase III trial.

In the randomised, placebo-controlled study, patients hospitalised for COVID-19 at 81 sites in Europe, the US, Uganda, and Singapore were randomly assigned to receive either intravenous tixagevimab 300mg-cilgavimab 300mg (n=710) or placebo (n=707), in addition to remdesivir and standard care.

The data, published in The Lancet Respiratory Medicine, showed that Evusheld did not improve the primary endpoint of time to sustained recovery compared to standard care plus placebo (rate ratio 1·08; p=0·21).

The drug did lead to a relevant risk reduction in mortality compared to placebo (28-day: 6% vs 9% [p=0·02]; and 90-day: 9% vs 12% [p=0·03]), but the authors noted that this will need further validation given that it was a secondary endpoint.

The research also showed that the mortality signal “was numerically larger in patients requiring high-flow oxygen or non-invasive mechanical ventilation at study entry and in patients infected with the delta SARS-CoV-2 variant,” according to the research team.

Taken together, the findings suggest that a single IV dose of Evusheld “might provide additional clinical benefits to current standard care in patients hospitalised with COVID-19,” and that “benefits might actually be greatest in patients with more advanced respiratory failure”, they concluded.

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