Tighten Paxlovid eligibility: PBAC advice

Access to nirmatrelvir and ritonavir COVID-19 oral antiviral treatment (sold as Paxlovid) should revert to a more stringent setting, according to the Pharmaceutical Benefits Advisory Committee (PBAC).
 
The oral antiviral for those with mild to moderate COVID-19 most at risk of progressing to serious illness is currently accessible on the PBS for anyone aged over 70, and for those aged 50–69 with one or more risk factors.
 
The PBAC recommendation, which has not yet been put in place, would mean the first-line treatment would be limited for those aged 50–69 years with at least two risk factors if it is taken up.
 
‘The PBAC recommended that, at its current price, there should be a change to the restriction for patients aged 50–69 years, which currently allows access for patients with one or more additional risk factors, to revert to the requirement for two or more risk factors, due to reduced cost-effectiveness in this lower risk population,’ the advice states.
 
‘The PBAC advised that a price reduction is required from the current price because cost-effectiveness has almost certainly declined since the initial decision to recommend listing on the PBS was made.’
 
This is a reversal of previous recommendations, with the criteria first loosened in April last year to allow patients aged 60–69 years with one extra risk factor to access the oral antiviral on the PBS – reportedly extending access to more than 160,000 extra people.
 
The same step was subsequently taken for the younger cohort aged 50–59 years last July.
 
Dr Ken McCroary, a GP in the south-west of Sydney who sits on the RACGP Expert Committee – Quality Care (REC–QC), is unhappy with the latest advice.
 
‘That’s very disappointing, especially with the current strain and increase in cases,’ he told newsGP.
 
He said he was currently seeing an influx of patients with breathlessness and chest symptoms.
 
‘We never had evidence of cost efficiency, that was never part of the use of antivirals,’ he said.
 
‘It was to try and keep people out of hospital, keep people from dying and minimise the long-term sequelae of long COVID.
 
‘We never had cost efficiency, it was always a public health decision.’
 
He said many of his patients within the age category with one risk factor often face significant long-term health and economic costs.
 
‘It is cutting back for a group of people that are already doing it really tough anyway – a lot of these guys are the ones that don’t have healthcare cards and are still trying to work, even if it’s part time, with one significant chronic illness,’ he said.
 
‘They are often the group unable to access bulk-billing incentives.’

When the latest change was made in July, the PBAC said it was satisfied with the clinical benefit and safety for the proposed new patient group, although it did place a caveat on its advice at the time.
 
‘The listing will be cost-effective in the expanded population for so long as pharmaceutical benefits dispensed are sourced from the stock already purchased by the Commonwealth, and which might otherwise expire unused,’ its recommendation stated at the time.
 
‘As such, the PBAC recommended that this expansion of patient eligibility only apply until the Commonwealth purchased stock is exhausted or has expired.’
 
The first batches of nirmatrelvir and ritonavir were due to expire in July last year.

In its latest recommendations, the PBAC reiterated its previous stance that nirmatrelvir and ritonavir should be preferred over the other oral antiviral available on the PBS, molnupiravir (sold as Lagevrio), if clinically appropriate.
 
The report of the November 2023 meeting also noted that the higher number of molnupiravir prescriptions compared to nirmatrelvir and ritonavir ‘did not reflect clinical guidelines’.
 
‘The sponsor and Department of Health and Aged Care [should] explore initiatives to support the safe and effective use of oral antiviral medicines for COVID-19, consistent with quality use of medicines principles,’ the PBAC said.
 
While recommended as the first-line treatment, nirmatrelvir and ritonavir has a number of contraindications, including in patients with severe renal or hepatic impairment, as well as having significant drug/drug interactions.
 
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COVID-19 COVID-19 oral antivirals Paxlovid