PBS eligibility criteria changed for COVID-19 oral antiviral LAGEVRIO (molnupiravir)

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July 10, 2022 2:00 pm Australia/Sydney

MSD Australia welcomes the Australian Government’s decision to broaden the Pharmaceutical Benefits Scheme (PBS) eligibility criteria for oral antiviral medicine LAGEVRIO (molnupiravir) which is used to treat COVID-19 in adult patients who are at high risk of hospitalisation or death from their condition.1,2,3

Dr Gary Jankelowitz, Medical Director, MSD Australia & New Zealand says, “MSD welcomes the decision made by the PBAC to change the PBS restrictions for LAGEVRIO. This will ensure more Australians have timely and affordable access to this treatment option following a COVID-19 diagnosis.”

“The changes could allow further ‘at-risk’ people to be treated at home, help ease pressure on our hospital system, as well as provide an additional treatment option to help manage COVID-19 cases in the community,” he added.

Updated PBS Eligibility criteria

Patients eligible for COVID-19 medications under the updated restrictions include:

  • Adults 70 years of age or older, with no further risk factors for progression to severe disease
  • Adults with mild to moderate COVID-19 who are:
    • People 50 years of age or older, with two additional risk factors for developing severe disease;
    • People aged 30 years of age or older, identifying as Aboriginal or Torres Strait Islander, with two additional risk factors for developing severe disease; and
    • People 18 years of age or over, with moderate to severe immunocompromise.

Access to LAGEVRIO through the PBS for the above patients is permitted irrespective of vaccination status.

LAGEVRIO was first made available through the PBS on 1 March 2022 for eligible adults who test positive for COVID-19 and are at risk of progressing to severe disease.1

About LAGEVRIO (molnupiravir)2

LAGEVRIO contains the active ingredient molnupiravir. LAGEVRIO has provisional approval to treat COVID-19 in adults who are at increased risk for hospitalisation or death. The decision to approve this medicine has been made on the basis of results of data available at the time of provisional approval.

LAGEVRIO treatment should be commenced as soon as possible after a diagnosis of COVID-19 and within 5 days of symptom onset.

Before using LAGEVRIO check with your doctor if you have any other medical conditions; take any medicines for any other condition; have any allergies. Do not take LAGEVRIO if you are allergic to molnupiravir or any of the other ingredients. Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect LAGEVRIO. LAGEVRIO is not recommended in pregnancy. Discuss the need for a pregnancy test with your doctor if you are of childbearing potential and sexually active. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control while you are taking LAGEVRIO and for 4 days after the last dose of LAGEVRIO if there is a possibility of you getting pregnant. It is not known if LAGEVRIO gets into breast milk and will be passed to the baby. Tell your doctor if you are breastfeeding or plan to breastfeed before taking LAGEVRIO. Breastfeeding is not recommended during treatment and for 4 days after the last dose of LAGEVRIO. If you are a male who is sexually active with a partner who has the potential to become pregnant, use a reliable method of contraception during treatment and for 3 months after the last dose of LAGEVRIO.

All medicines can have side effects. Common side effects associated with LAGEVRIO are diarrhoea, nausea, dizziness.

For more information on LAGEVRIO (molnupiravir) refer to the Consumer Medicine Information or speak with your doctor.

PBS Information: STREAMLINED authority required. Refer to the PBS Schedule for full authority information.

  1. Pharmaceutical Benefits Scheme. https://www.pbs.gov.au/info/news/2022/03/lagevrio-molnupiravir-pbs-listing Accessed July 2022
  2. LAGEVRIO (molnupiravir) Consumer Medicine Information www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-CMI-01048-1 Accessed July 2022
  3. LAGEVRIO Australian Approved Product Information, https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2022-PI-01047-1 22nd April 2022.