PBAC Recommendations for COVID-19 Oral Antivirals

The Pharmaceutical Benefits Advisory Committee (PBAC) has issued a statement regarding the COVID-19 oral antivirals, molnupiravir (Lagevrio®) and nirmatrelvir and ritonavir (Paxlovid®). This statement makes the following four recommendations for future updates to the Pharmaceutical Benefits Scheme (PBS) listings for each of these medicines.

1. Allow PBS access for patients with any significantly immunocompromising condition who have been treated with an anti-CD20 monoclonal antibody (e.g. rituximab, ocrelizumab, ofatumumab, obinutuzumab) within the previous 12 months;
2. For patients who have been previously hospitalised with COVID-19, allow PBS access if re-infection occurs, even if the patient does not meet the current criteria for high risk;
3. Amend the wording regarding the verification of RAT results to state, “Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) should be recorded on the patient record”; and
4. Consider using molnupiravir only when nirmatrelvir plus ritonavir is contraindicated or otherwise unsuitable.

This final recommendation has been made following the pre-print release of a preliminary analysis of the PANORAMIC trial. This open-label study included 25,783 participants who were randomised to receive molnupiravir plus usual care or usual care alone.

The primary outcome measure (hospitalisation or death within 28 days) did not differ between groups, coming in at 0.8%. This low figure may be at least partially explained by the fact that 99% of participants had received at least one dose of a COVID-19 vaccine.

While there may not have been any observed difference in the primary outcome, molnupiravir showed significant benefit in the secondary outcome of recovery time. Patients in the molnupiravir group had a 4.2 day improvement in time to first recovery, reduced time to sustained recovery, and less moderate or severe symptoms from day 7. In the smaller cohort of patients who participated in intensive sampling, molnupiravir showed a faster reduction in viral load. At day 7, 20% of the patients in the molnupiravir group had an undetectable viral load compared to 5% of the control group.

The PBAC notes some significant differences in the trial population compared to the patients receiving molnupiravir in Australia. Less than 15% of PANORAMIC participants were aged 70 years or older, whereas this age group accounts for two-thirds of PBS utilisations in Australia.