First COVID-19 pill funded through the PBS

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March 1, 2022 9:16 am Australia/Sydney

Thousands of Australians at risk of progressing to severe COVID-19 disease1 will now be eligible to access an oral antiviral treatment taken over five days through the Pharmaceutical Benefits Scheme (PBS).2

MSD in Australia welcomes the Australian Government’s announcement that LAGEVRIO (molnupiravir) will be listed on the PBS from 1 March 2022 for eligible adults who test positive for COVID-19 and are at risk of developing severe disease requiring hospitalisation.2

The subsidy will be available to certain people who due to one or a combination of factors such as an existing medical condition, advancing age and other factors, and are deemed at-risk of severe disease, have not been hospitalised and do not require oxygen supplementation for confirmed
COVID-19.2

“Today’s announcement is a landmark moment in Australia’s response to the ongoing COVID-19 pandemic,” said Mr Prashant Nikam, Vice President & Managing Director, MSD Australia & New Zealand.

“The PBS listing of LAGEVRIO will help ensure eligible Australians receive access to this oral treatment option in a timely and equitable manner,” he said.

“Sadly, COVID-19 has taken the lives of too many Australians. MSD is proud to have worked closely with the Australian Government to accelerate access to LAGEVRIO and provide an additional line of defence in the fight against COVID-19,” he said.

With more than 200,000 courses of LAGEVRIO already in Australia,3 doctors will be able to prescribe the oral treatment to eligible patients who can then have their prescription dispensed and pay $6.80 (Concession) or $42.50 (General Patients) from a community pharmacy.

Dr Paul Griffin, Infectious Disease Physician and Microbiologist at Mater Health, Brisbane described the PBS listing of LAGEVRIO as “great news”.

“Access to an oral treatment through the PBS will allow many at risk people to be treated at home, which is a win-win-win for these patients, the community and our hospital system,” he said.

“Taken twice daily for five days, LAGEVRIO is likely to play an important role in treating eligible, at risk patients diagnosed with COVID-19,” he said.

LAGEVRIO is taken twice daily for five days. It should be administered as soon as possible after a diagnosis of COVID-19 has been made and within five days of symptom onset in eligible adults.3

A positive COVID-19 polymerase chain reaction (PCR) test result or a verified rapid antigen test (RAT) result is required. Additionally, eligible adults will need to have at least one sign or symptom attributable to COVID-19, and not requiring oxygen or hospitalisation at the time of prescribing.4

Patients eligible to access LAGEVRIO through the PBS include:2

  • Patients 65 years or older with two additional high-risk factors* for developing severe disease
  • Patients 75 years or older with one additional high-risk factor* for developing severe disease
  • Moderately to severely immunocompromised people irrespective of vaccination status, and
  • Aboriginal and Torres Strait Islander people aged 50 years or older with two additional high-risk factors* for developing severe disease.

LAGEVRIO was provisionally registered by the Therapeutic Goods Administration on 18 January 2022.4 Since February, the treatment has been distributed through the National Medical Stockpile, with priority access provided to Aboriginal Community Controlled Health Organisations, the Royal Flying Doctor Service and residential aged care facilities.

All medicines carry the risk of side-effects. In clinical trials, the most common adverse events associated with LAGEVRIO treatment were diarrhoea, nausea, and dizziness.4

About LAGEVRIO (molnupiravir)4 LAGEVRIO (molnupiravir) has provisional approval for the treatment of adults with COVID- 19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death [see Section 5.1 PHARMACODYNAMIC PROPERTIES – Clinical Trials]. The decision to approve this indication has been made on the basis of the analysis of efficacy and safety data from a Phase 3 trial. Continued approval of this indication depends on additional data.

LAGEVRIO Selected Safety Information4 PRECAUTIONS: Pregnancy Category D: The use of LAGEVRIO is not recommended during pregnancy. In women of childbearing potential, health care providers should discuss the chance that they may be pregnant and consider the need for a pregnancy test. Advise women of childbearing potential to use effective contraception for the duration of treatment and for 4 days after the last dose of LAGEVRIO. Sexually active men with a partner of childbearing potential should use contraception during and for 3 months after treatment. Based on animal data, LAGEVRIO may cause fetal harm when administered to pregnant women. Breastfeeding: Based on the potential for adverse reactions on the infant from LAGEVRIO, breastfeeding is not recommended during treatment and for 4 days after the last dose of LAGEVRIO. Paediatric patients: Use in children is not recommended. Use in elderly: No dose adjustment of LAGEVRIO is recommended based on age. In the MOVe-OUT study there was no difference in the safety and tolerability between patients >65 years of age and younger who were treated with LAGEVRIO. INTERACTIONS: No drug interactions have been identified based on the limited available data. CONTRAINDICATIONS: Hypersensitivity to the active substance or any of the excipients.

*Definitions of high-risk factors will be accessible at www.pbs.gov.au from 1 March 2022

From 1 March 2022: PBS Information: STREAMLINED authority required. Refer to the PBS Schedule for full authority information.

For more information on LAGEVRIO, consult a healthcare professional.

The Consumer Medicines Information leaflet is available from www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-CMI-01048-1

  1. Australian Government. Department of Health. Advice for groups at greater risk. https://www.health.gov.au/health-alerts/covid-19/advice-for-groups-at-risk Accessed February 2022
  2. Pharmaceutical Benefits Scheme. https://www.pbs.gov.au/info/news/2022/02/pbac-recommendation-for-molnupiravir-lagevrio-february Accessed February 2022
  3. LAGEVRIO Product Information. www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-PI-01047-1&d=20220221172310101 Accessed February 2022
  4. Australian Government Department of Health, Therapeutic Goods Administration. TGA provisionally approves two oral COVID-19 treatments, molnupiravir (LAGEVRIO) and nirmatrelvir + ritonavir (PAXLOVID). https://www.tga.gov.au/media-release/tga-provisionally-approves-two-oral-covid-19-treatments-molnupiravir-lagevrio-and-nirmatrelvir-ritonavir-paxlovid Accessed February 2022