Transplant, cancer patients missing out on COVID prevention drug

Severely immunocompromised Australians including organ transplant and cancer patients cannot access or do not know about a COVID preventative drug more than five months after the treatment was added to the National Medical Stockpile.

The long-acting antibody therapy Evusheld (tixagevimab and cilgavimab) was granted provisional approval by the Therapeutic Goods Administration as a prophylaxis in February but patient advocates and infectious disease experts say patients at greatest risk amid the Omicron surge are missing out.

“In the last few months people kept referring to a ‘post-COVID world’, but there has never been a post-COVID world for us,” says country music singer and heart transplant recipient Victoria McGee.Credit:Janie Barrett

“We are most definitely under-utilising this drug,” said Dr Paul Griffin, director of infectious diseases at Mater Health Services and member of the AstraZeneca advisory board for the drug.

“We know that for immunocompromised people [vaccination] can’t generate a good enough response to enjoy the protection that most of us get from the vaccines,” he said.

“Evusheld was designed to be a way of addressing that and giving them protection without relying on their own immune response.”

The federal government bought 36,000 doses of the combination drug but declined to disclose how many doses have been used.

Griffin said an estimated 2 per cent of the Australian population could be eligible for the combination drug.

Heart transplant recipient Victoria McGee, 38, said she finally got her Evusheld dose less than two weeks ago, “but not without a fight”.

The country music singer has become a dogged advocate for her fellow transplant patients, many of whom didn’t know the drug existed.

Advocates blame a patchwork of confusing guidelines dictating patient eligibility, mistaken perceptions of a scarcity of supply, and a lack of awareness among doctors and patients.

“Almost every state has its own guidelines,” Griffin said. “Patients have different eligibility in different states and in some states they have had variable guidelines depending on perceived supply and demand.”

McGee said navigating the guidelines has been exhausting.

“I’ve had to do my own research, essentially give myself a degree in this to be able to talk to clinics and hospitals and say ‘this is available, this is why we are eligible, this is why we need this’,” she said.

“In the last few months people kept referring to a ‘post-COVID world’, but there has never been a post-COVID world for us. When restrictions eased we were forced further into isolation.”

McGee missed her sister’s 50th birthday and her seven-year-old son, Onyx, turns down invitations from friends because he is worried he will get COVID and infect his mother.

The combination therapy must be administered by a specialist and involves two intramuscular injections usually administered in the buttocks in a hospital, rather than a vaccination clinic or a GP, which Griffin said, “makes the process incredibly complicated”.

The National COVID-19 Clinical Evidence Taskforce only recommends the use of Evusheld in “exceptional circumstances” for people who are severely immunocompromised (including organ and bone marrow transplant patients and patients on immune-suppressing medications) who might expect for some reason that they are likely to be exposed to COVID.

In contrast to the taskforce recommendation, the Royal Australian College of General Practitioners advice to GPs says the therapy is recommended for “moderately to severely immunocompromised” or for people for whom vaccination is not recommended due to a history of adverse reactions.

Associate Professor Tari Turner, taskforce director, said the definition of “severely immunocompromised” was “a grey area”.

The TGA and Department of Health have published fact sheets for Evusheld on their websites, but do not define patient eligibility.

The taskforce’s recommendation was based on one study conducted before the Omicron subvariant and funded by AstraZeneca. The PROVENT trial involved more than 5000 unvaccinated adults who worked or lived in high-risk transmission environments, including healthcare workers, meat-packing plants and students in dormitories.

“There is only one trial of this medication for this purpose, it was conducted by the manufacturer, against earlier variants of the virus, and in an unvaccinated population, so it’s not clear how well this translates into the current Australian context,” Turner said.

She said that there is no better protection against COVID than vaccination.

Griffin called for clear, consistent guidelines and greater education for prescribers and patients.

General manager of people living with blood cancer at the Leukaemia Foundation, Kathryn Huntley, said for blood cancer patients, access to prophylaxis would be an important component of their COVID action plan, particularly if a family member were to be infected during the Omicron wave.

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