Shortages of interleukin 6 (IL-6) blockers such as tocilizumab are likely as they become the next ‘must-have’ treatment for COVID-19 and Australia must move rapidly to secure supplies, the government has been warned.
The Australasian Society of Clinical Immunology and Allergy (ASCIA) has written to Federal minister for health Greg Hunt and the Chief Medical Officer Professor Brendan Murphy advising them that clinical trial results for IL-6 blockers in COVID-19 are about to be released that will create huge worldwide demand for the agents and likely shortages in supply.
In their letter they say there is growing scientific evidence for the benefits of IL-6 inhibitors in severe COVID-19 disease, and ASCIA is “cautiously optimistic” about the potential of tociluzumab (Actemra, Roche) and siltuximab (Sylvant , Janssen-Cilag).
The letter written by ASCIA’s COCID-19 working party chaired by Dr Theresa Cole notes that several preliminary studies in more than 120 patients have shown that IL-6 inhibitors significantly reduce the ventilation rate and mortality for patients presenting with COVID-19.
And they point to a phase 2 trial of tocilizumab – TOCIVID-19 – involving more than 400 patients that is about to report its results in COVID-19 patients. As yet, the positive findings for IL-6 inhibitors have not yet been picked up by the media in the same way as those for hydroxychloroquine or remdesivir, ASCIA notes.
“We believe that there is a rapidly closing window to secure supply of IL-6 blockers, before a large trial is reported out of Italy, which is likely to lead to increased demand and reduced drug access worldwide,” they say.
“Based on the information in this letter and the attached papers, we request that the government rapidly investigates securing a supply of IL-6 blockers. We believe this may reduce the curve of serious cases requiring ICU, which will provide a major positive benefit for Australia and countries that have an ongoing supply of these drugs. Securing supply for future use, should be a strategic goal of the Australian Government.”
The media hype around hydroxychloroquine has already resulted in shortages of the drug for Australians relying on it for rheumatoid arthritis and lupus, even though the latest clinical trial results have shown the drug to be ineffective for COVID-19 disease. And the additional 33 million doses of hydroxychloroquine reportedly secured by billionaire Clive Palmer for use against COVID-19 disease in Australia will not be made available to patients with arthritis because these imported products have not been registered for use in Australia, according to the TGA.
“In most cases, medicines used in clinical trials and included in the national medicines stockpile for the purposes of Covid trials or therapy are not Australian-registered medicines and the TGA has not evaluated their quality, safety and effectiveness,” a TGA spokesman told the Guardian.
“They are supplied under specific exemptions in the Therapeutic Goods Act 1989 and are not approved for general use in Australia and cannot be lawfully released for general use.”
To further restrict unauthorised use of hydroxychloroquine, on 1 May the PBS re-classified it as an authority (streamlined) listing for use in autoimmune disorders and malaria. This means that initial therapy must now be authorised by a specialist physician, dermatologist or specialist in emergency medicine/intensive care/paediatrics.