PBS cuts bDMARD authority red tape for tocilizumab shortages
The PBS has eased prescribing red tape for some biological DMARDs in rheumatological conditions to help patients access appropriate treatments during the global shortages of tocilizumab.
Patients with severe active rheumatoid arthritis or severe active juvenile idiopathic arthritis will be able to switch from tocilizumab to an alternative bDMARD without the PBS requirement of demonstrating response if it’s not possible due to the shortage.
And under the new arrangement, prescribers switching patients from subcutaneous to intravenous tociluzumab will be able to obtain the balance of treatment through the relevant Balance of Supply (BOS) restriction in real time using the Online PBS Authorities System.
More details are available on the PBS site
Hydroxychloroquine CV risk re-assessed in non-COVID-19 patients
Cardiologists can reasonably continue supporting hydroxychloroquine (HCQ) use in rheumatoid arthritis (RA), with a new study suggesting there is minimal cardiovascular risk in non-COVID-19-affected patients.
American researchers reviewed cardiovascular outcomes in 8,852 US veterans who were newly diagnosed with RA and started on HCQ or nonbiologic disease-modifying antirheumatic drugs (DMARDs) between 2001 and 2017, after observational studies linked an increased risk of cardiovascular events and mortality with HCQ use in hospitalised COVID-19 patients.
The new study identified three long QT syndrome events, 56 arrhythmia-related hospitalisations and 280 all-cause deaths — two, 30 (hazard ratio associated with HCQ: 1.16, 95% CI: 0.68–1.95]) and 144 (HR associated with HCQ: 1.06, 95% CI: 0.84–1.34]) of which were in HCQ patients, respectively — at one year follow-up, the authors wrote in Arthritis & Rheumatology.
“Our findings indicate that the incidence of long QT syndrome and arrhythmia-related hospitalisation is low in patients with RA during the first year after the initiation of HCQ or another non-biologic DMARD,” they wrote.
“We found no evidence that HCQ therapy is associated with a higher risk of adverse cardiovascular events or death.”
Yet, study limitations, including lack of echocardiogram use, a mostly-male population inconsistent with the demographic distribution of RA, and relatively short follow-up time, “should give clinicians pause in their desire to be entirely reassured by the findings,” Associate Professor Candace Feldman and Professor Mark Link wrote in an accompanying commentary.
“Overall, the results of this methodologically rigorous study suggest that HCQ administration among patients with RA is unlikely to be associated with a significant enough risk to dissuade clinicians from continuing to safely prescribe the medication.”
“However, additional studies are essential to guide strategies for monitoring of QTc intervals, and to identify individuals at significantly higher risk of adverse outcomes for whom clinicians may consider avoiding HCQ.”
Doctor wins $450k damages for malicious reviews
A Sydney surgeon has been awarded $450,000 in defamation damages from a woman who mounted a campaign of online abuse and false claims against him after he refused to operate on her.
Dr Warwick Nettle, a Bondi-based plastic and reconstructive surgeon, became the target of virulent abuse, falsehoods and negative reviews from Catherine Cruse in 2018 when he declined to perform surgery on her, based on warnings from another surgeon who had previously treated her.
Dr Nettle took his case to the Federal Court of Australia, which found that his behaviour was professionally appropriate and justifiable, and that the online comments and maliciously false reviews reviews had seriously damaged both his professional reputation and his thriving practice.
As a results of Ms Cruse posting negative reviews, Dr Nettle’s “Google rating” fell from 5 to 3.5 stars and his workload declined significantly.
The court awarded damages of $450,000 to Dr Nettle and granted permanent injunctions barring Ms Cruse from posting further false and defamatory material about him. However Ms Cruse did not take part in the proceedings and could not be traced, having apparently deliberately concealed her whereabouts, the court was told.