MolnupiravirLagevrio
Treatment of patients with mild to moderate COVID-19 who are at high risk of severe disease requiring hospitalisation, including those aged ≥70 years, those aged ≥50 years with two or more risk factors or prior hospitalisation, immunocompromised patients, and Aboriginal or Torres Strait Islander people aged ≥30 years with one or more risk factors.
Decisions on record
- Meeting Nov 2023 Noted Mild to moderate COVID-19 (high-risk patients) no PSD
- Meeting Jul 2023 Noted Mild to moderate Coronavirus disease (COVID-19)
- Meeting Sep 2022 Recommended Treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection no PSD
Access path
- TGA registered · Lagevrio
TGA label narrower than the PBS population
- Nov 2023Recommended · restricted
vs usual care excluding use of antiviral treatments
- PBS listing · Authority Required
From the public summary
The PBAC provided advice regarding molnupiravir for the treatment of patients with mild to moderate Coronavirus disease (COVID-19) who are at high risk of developing severe disease requiring hospitalisation. The PBAC advised that the sponsor’s submission did not adequately support continuation of the current PBS listing of molnupiravir, and that additional information is required to inform further consideration of this matter.PSD · Jul 2023
The PBAC noted that observational trials showed results consistent with modest benefits, noting that the observational trials were subject to a range of biases. The PBAC considered that the cost-effectiveness of molnupiravir was highly uncertain due to the uncertainty of effectiveness.PSD · Jul 2023
The submission presented a cost-utility analysis, consistent with the claim of therapeutic superiority over usual care. Table 9 summarises the key features and key inputs to the modelled economic analysis. 28PSD · Jul 2023
Outpatient Inpatient, general ward Inpatient, ICU without mechanical ventilation Inpatient, ICU with mechanical ventilation Health states Hospital readmission Survive without long COVID Survive with long COVID Markov model:PSD · Jul 2023
The submission described molnupiravir as superior in terms of effectiveness compared to usual care. The commentary considered this claim was adequately supported but the magnitude of the effect was uncertain. The key issue with the evidence presented was the applicability of the evidence to the Australian setting. In 27PSD · Jul 2023
The submission described molnupiravir as inferior in terms of safety compared to usual care but with a manageable safety profile. The PBAC considered this claim was adequately supported.PSD · Jul 2023
Molnupiravir was described as well-tolerated with fewer drug interactions and contraindications for existing comorbidities, particularly amongst the elderly and those who are immunocompromised. Several inputs mentioned the ease of oral administration as an advantage over IV antivirals, enabling people to avoid hospitalPSD · Jul 2023
Concerns were mentioned in relation to adjusting concomitant therapies, especially for immunocompromised patients and that molnupiravir would be used when a prescriber considered other medications could not be adjusted, even for a period of 5 days. Feedback mentioned some GPs may be reluctant to recommend changes to medicines prescribed in tertiary settings.PSD · Jul 2023
Cost-effectiveness
This is a Category 2 (minor) submission for maintenance of existing listing with price reduction only; no new economic evaluation was conducted or reported in this PSD.
Decision context
PopulationAdults with mild to moderate COVID-19 at high risk of progression to severe disease: (i) people aged ≥70 years; (ii) people aged ≥50 years with two or more risk factors or past COVID-19 infection resulting in hospitalisation; (iii) people aged ≥18 years who are moderately to severely immunocompromised or previously hospitalised; and (iv) Aboriginal or Torres Strait Islander people aged ≥30 years with one or more risk factors.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended · restricted | usual care excluding use of antiviral treatments | — | RCT · Other |
Consumer voice
Healthcare professionals and organisations noted that while molnupiravir may be less effective than nirmatrelvir and ritonavir, it provides an important alternative for those unable to take these drugs, with advantages including better tolerability, fewer drug interactions, and ease of oral administration.
Molnupiravir was described as well-tolerated with fewer drug interactions and contraindications for existing comorbidities, particularly amongst the elderly and those who are immunocompromised. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to mild-to-moderate disease with specific risk stratification criteria; TGA label applies to broader 'increased risk' population without severity limits.