New COVID-19 Oral Treatments Arriving in Australia

The Therapeutic Goods Administration (TGA) provisionally approved these treatments on 18 January 2022.  

Lagevrio® and Paxlovid®, both approved by Therapeutic Goods Administration (TGA), have been found to be effective in treating mild to moderate COVID-19 in adults aged 18 years of age and older, who do not require supplemental oxygen, and who are at increased risk of progression to hospitalisation or death. The advantage of these oral medications is that many people will be able to receive treatment for COVID-19 in their own homes without the need to travel to hospital for treatment as an inpatient.  

GPs are advised that due to limited supply, initial distribution will need to be prioritised to those who are at the highest clinical need. These medicines will be made available initially in Australia from the National Medical Stockpile to residents of residential aged care facilities, to rural and remote communities particularly in regions with high Aboriginal and Torres Strait Islander populations, and to state and territory governments for distribution to those at highest risk in the community, including people with disability.  

Working in partnership with the aged care sector, the Government will preplace Lagevrio®, a S4 medicine requiring a GP prescription, in residential aged care facilities as soon as possible, with the view to transition to PBS arrangements as supply continues to grow. This will support timely administration to eligible patients, once prescribed by their usual doctor, until listing on the PBS can commence.  

The National COVID-19 Clinical Evidence Taskforce recommends Lagevrio® be considered for use as follows:  

• within 5 days of symptom onset in adults with COVID-19 who do not require oxygen; and 

• who are unvaccinated and have one or more risk factors for disease progression; or 

• who are immunosuppressed or not immunocompetent regardless of vaccination status; or  

• who have received one or two doses of vaccine and are at high risk of severe disease on the basis of age and multiple risk factors; and 

• where other treatments (such as sotrovimab or nirmatrelvir plus ritonavir) are not suitable or available.  

Paxlovid® is being distributed to the states and territories via the National Medical Stockpile and, as with other COVID-19 treatments, those living in residential aged care facilities may be able to access this medication if suitable via application to state or territory health authorities from their GP.  GPs should note that there are significant contraindications to the use of Paxlovid® with many commonly prescribed medications.  

For more comprehensive information on these new oral treatments, please read the TGA media release and Ministerial statement.  

Supporting regulatory documents including the Product Information and Consumer Medicine Information, which provide details on dosage, side effects, contraindications and other essential prescribing information, can be found at www.tga.gov.au/covid-19-treatments-provisional-registrations.  

The National COVID-19 Clinical Evidence Taskforce – Caring for people with COVID-19 guidelines on the use of these treatments can be found at https://covid19evidence.net.au/.