Australia widens access to COVID-19 antiviral as expiry looms

Pharma News: In a significant development in the fight against COVID-19, the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended expanding patient eligibility criteria for Pfizer’s oral antiviral treatment, Paxlovid (nirmatrelvir and ritonavir).

The PBAC has now suggested broadening the patient eligibility criteria for Paxlovid to include individuals aged 50-59 years with mild to moderate COVID-19 and at least one additional risk factor. This decision comes just months after the committee expanded access to include people between the ages of 60 and 69.

While the PBAC was assured of the clinical benefit and safety of Paxlovid in this new patient group, they emphasised that the recommendation should only apply to “the stock already purchased by the Commonwealth, and which might otherwise expire unused.”

The national data on COVID-19 antiviral prescriptions in 2022 showed that Merck Sharp & Dohme’s (MSD) oral COVID-19 treatment, Lagevrio (molnupiravir), was dispensed more than threefold compared to Paxlovid. This may be attributed to its earlier introduction on the Pharmaceutical Benefits Scheme (PBS) and the higher number of drug interactions associated with Paxlovid. However, a study conducted at the end of last year reshaped the use of Lagevrio in clinical practice.

Notably, the Platform Adaptive trial of Novel antiviRals for eArly treatment of COVID-19 in the Community (PANORAMIC) study of Lagevrio in non-hospitalised, vaccinated individuals in the United Kingdom demonstrated a reduction in symptomatic days and viral load. However, there was no significant difference in the rate of hospitalisation or death. Following the publication of the PANORAMIC study, Australia’s National Clinical Evidence Taskforce advised against routine use of Lagevrio. They acknowledged that the treatment might still be suitable for the highest-risk patients when other options are not viable.

In response to the PANORAMIC study, the November 2022 PBAC meeting contrasted the results with observational data showing the benefits of Lagevrio in older patients. As a result, an Administrative Note was added to the PBS listing of Lagevrio, stipulating that it should only be considered when Paxlovid is unsuitable. It’s worth noting that the Paxlovid arm of the PANORAMIC trial is still ongoing and its results are yet to be reported.

Provisional approval for Paxlovid was granted by the Therapeutic Goods Administration (TGA) based on positive results from the Phase 2/3 EPIC-HR trial. The trial demonstrated 88% relative risk reduction in hospitalisation or death compared to a placebo when patients received treatment within five days of symptom onset. Paxlovid showcased consistent efficacy across different patient types and various comorbidities.

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