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First COVID-19 antiviral receives PBS funding


Anastasia Tsirtsakis


1/03/2022 4:25:25 PM

GPs can now prescribe molnupiravir for COVID-positive adult patients at risk of developing severe disease.

A hand holding a box of Lagevrio.
Clinical trial data found participants treated with molnupiravir had a reduced risk of hospitalisation, down from 14.1% to 7.3%. (Image: AAP)

Thousands of vulnerable Australians, who are at risk of developing severe COVID-19, are now eligible to access an oral antiviral treatment through the Pharmaceutical Benefits Scheme (PBS).
 
Listed as of 1 March, GPs can now prescribe molnupiravir (sold as Lagevrio), which will be available to patients for $42.50 per script – or $6.80 for concession card holders.
 
Associate Professor Paul Griffin, an infectious disease physician and microbiologist at Mater Health in Brisbane, said the listing of the oral antiviral is ‘great news’, and likely to play an ‘important role’ in treating at-risk patients who contract the virus.
 
‘Access to an oral treatment through the PBS will allow many at-risk people to be treated at home, which is a win-win-win for these patients, the community and our hospital system,’ he said.
 
According to the National COVID-19 Clinical Evidence Taskforce (the taskforce) guidelines, molnupiravir is recommended for the treatment of patients with mild-to-moderate COVID-19 who are at risk of developing severe disease requiring hospitalisation.
 
To be eligible under the PBS, the Pharmaceutical Benefits Advisory Committee (PBAC) has stated patients must fall under one of the following criteria:

  • Be 65 or older with two additional high-risk factors for developing severe disease
  • Be 75 or older with one additional high-risk factor for developing severe disease
  • Be moderately to severely immunocompromised, irrespective of vaccination status
  • Identify as Aboriginal and/or Torres Strait Islander, and be aged 50 or older with two additional high-risk factors for developing severe disease
The taskforce guidelines also note that eligible patients must not be at the stage where they require oxygen or hospitalisation for COVID-19.
 
In addition to the age-based restrictions, the PBAC considers patients who have received just one dose of a COVID-19 vaccine or who are unvaccinated as being at the ‘greatest risk of severe infection’.

The listing follows the launch of NPS Medicinewise’s new antivirals hub, which features new clinical information, resources and links, and is designed to keep health professionals up to date with the latest approvals, evidence and guidance.
 
Patients must also provide evidence of a positive PCR test result or a verified rapid antigen test (RAT), and have at least one sign or symptom attributable to COVID-19, to obtain a script.
 
‘The reach of the PBS and its integration with general practice prescribing processes means all eligible Australians will be able to access treatment in a timely and equitable way,’ a statement from the PBAC reads.

RACGP NSW&ACT Chair Associate Professor Charlotte Hespe, who is also a member of the college’s COVID Working Group, agrees that the listing is a ‘fantastic move’ but admits she has her concerns.
 
She told newsGP that it would have made more sense for GPs to be given access to both molnupiravir and nirmatrelvir plus ritonavir (sold as Paxlovid) – another antiviral treatment approved for use in Australia – through the PBS simultaneously so as to give patients timely access to the most appropriate treatment, rather than the most convenient.
 
‘The PBS listing for me actually brings up a dilemma because it’s not the right medication for everybody and the other medication is definitely a preferred option most of the time … from my perspective,’ Associate Professor Hespe said.
 
‘So that brings up concerns about safety.
 
‘GPs should be able to do whatever is easiest and quickest for our patients, and if you provide a PBS script on your software, well that’s going to be a preference, isn’t it? Not to say that is what’s going to happen, but it’s a risk.’
 
According to the taskforce guidelines, molnupiravir is only recommended where other treatments – such as sotrovimab or nirmatrelvir plus ritonavir – ‘are not suitable or available’.
 
To avoid any access issues in New South Wales, Associate Professor Hespe worked alongside a team of GPs in collaboration with NSW Health to establish a system that has been in place since 14 February, whereby a patient’s GP is automatically notified when the patient registers a positive RAT or PCR test and whether they are eligible for an antiviral treatment, based on a risk matrix.
 
‘We’ve got this form that’s very easy to fill out that’s associated with the guidance for how to use it, and then the consent for it,’ Associate Professor Hespe said.
 
‘It’s a slightly interactive form; you can fill it out, but then you have to print it off, hand sign it and email it to the local hospital pharmacy that will supply it for that patient.
 
‘The GP can [also] say no [to being the prescriber] and it flicks back through into the hospital system and the hospital will organise it.’
 
The Sydney-based GP says that having a patient’s GP as the first portal for access to antivirals is vital, so that the decision on which treatment is suitable is made in the context of the patient’s history. 
 
‘In other states, the GPs can’t prescribe it to patients outside of nursing homes or Aboriginal Medical Services [AMS’s], it has to be done through the hospitals,’ Associate Professor Hespe said.
 
‘Whereas in NSW we said pragmatically GPs are in the best position to do this, so we set up the system so they could.
 
‘Now it’s just got murkier waters because you can do a PBS for one of them, but you can’t do the PBS for the other. But there are still plentiful supplies of both to be able to give them the most appropriate drug rather than just going through the PBS.’
 
As timely administration of the drug is vital – for example molnupiravir should be administered within five days of symptom onset twice daily for five days – she says the biggest concern has always been that patients would fall through the cracks if GPs didn’t have direct access.
 
‘And there still is concern,’ Associate Professor Hespe said.
 
‘Because there are still GPs around Australia not getting told when their patients have COVID. So they can’t easily highlight when patients would benefit from an antiviral.’
 
For GPs in this position, she advises having a list of the practice’s immunocompromised patients at the ready.
 
‘Because anybody who’s immunocompromised, whether they’re fully vaccinated or not, qualifies for an oral antiviral,’ she said.
 
‘So you can have a conversation with them about which is the appropriate medication as soon as they get COVID, and you can flick them a prescription.’
 
There are currently more than 200,000 courses of molnupiravir available in Australia.
 
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