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COVID antiviral order doubled ahead of PBS listing


Jolyon Attwooll


11/04/2022 4:41:05 PM

Paxlovid will be available on the Pharmaceutical Benefits Scheme from May, with ‘really positive responses’ reported so far.

Paxlovid oral antiviral treatment
More than 40,000 courses of the oral antiviral have been dispensed in Australia so far. (Image: AAP Photos)

The Federal Government has reinforced its backing of the nirmatrelvir plus ritonavir oral antiviral (sold as Paxlovid) by placing another half a million treatment courses on order ahead of its listing on the Pharmaceutical Benefits Scheme (PBS).
 
It will mean a million courses of the treatment are available, more than three times the amount of molnupiravir (sold as Lagevrio), the other oral antiviral to be approved and listed on the PBS this year.
 
Dr Michael Bonning, the medical director at the Inner West GP-led respiratory clinic in Balmain, Sydney, said the PBS listing came after considerable use of nirmatrelvir plus ritonavir in the COVID response so far, despite it only being available for a short time.
 
‘It has become the most used oral antiviral medication for this wave of COVID, at least through hospitals and the community-controlled health sector and respiratory services,’ Dr Bonning told newsGP.
 
‘The recommendation to add it to the PBS I think was a very strong one.’
 
By the time of the announcement on Saturday (9 April), the DoH reported 42,867 courses of the oral antiviral had already been dispensed via the National Medical Stockpile.
 
Clinical trials for the use of the antiviral drugs took place predominantly among unvaccinated patients during a previous wave of the virus when Delta was the dominant SARS-CoV-2 variant of concern. According to the trial results, it reduced the risk of hospitalisation or death by 88% among those who took part.
 
Writing in the Australian Prescriber journal last month, senior pharmacists and clinicians involved in the pandemic response said more understanding is needed on how the oral antiviral drugs are performing given the difference between clinical trials and current prescription activity.
 
The treatment is being used among the fully vaccinated in Australia, while the BA.2 variant is also now dominant and has already potentially impacted the efficacy of another antiviral, sotrovimab, which last week prompted a change in National COVID-19 Clinical Evidence Taskforce recommendations.
 
Dr Khayyam Altaf, Chair of RACGP Specific Interests Aged Care, told newsGP evidence is still emerging about the real-world efficacy of the new COVID treatments.
 
‘We’ve started to prescribe [molnupiravir] more often now that we’re starting to get more cases of COVID in aged care facilities,’ he said.
 
‘The rollout of the new antivirals is relatively new so at this stage it is difficult to be sure [of the impact].’
 
However, while also acknowledging the difference between the clinical trials and contemporary use, Dr Bonning believes nirmatrelvir plus ritonavir is having a significant impact.
 
‘We have seen really positive responses from patients that we have personally prescribed these medications to through hospitals stockpiles, and partnership with our local virtual care service,’ he said.
 
‘We are finding that, for the right people who meet the criteria, these can be very useful.
 
‘The Pharmaceutical Benefits Advisory Committee has assessed them for their cost effectiveness and for their utility to be prescribed by general practice and has come to the conclusion that they are a useful medication that is cost effective because they help to significantly reduce the likelihood of going to hospital.’
 
The treatment is designed for those in the early stages of infection with an elevated risk of progressing to more serious illness. According to the DoH, these include patients diagnosed with COVID-19 within five days of symptom onset who:
 

  • are aged 65 or older, with two other risk factors for severe disease
  • are aged 75 or older with one other risk factor
  • are aged 50 and older and are of Aboriginal or Torres Strait Islander origin with two further risk factors for severe disease
  • are moderately to severely immunocompromised.
 
Dr Bonning said the PBS listing is likely to expand the treatment’s impact even further. He also said the move emphasises how much of the COVID response now rests with primary care, with the prescribing of oral antivirals added to the vaccination rollout and telehealth for symptom identification.
 
The treatment, which has a large number of contraindications, particularly with other drug treatments, will be available to those eligible for $42.50 per script at the most. For those with a concession card, it is available for $6.80.
 
The cost of nirmatrelvir plus ritonavir in the US has been reported as US$530 per course. While no figure has been confirmed for Australia, it would put the overall cost at more than $700 million if the expense is roughly parallel here.
 
The initial order of 500,000 courses of nirmatrelvir plus ritonavir, a treatment developed by Pfizer, was announced by the Federal Government last October.
 
In the same month, the DoH also confirmed an order for 300,000 courses of the Merck-developed molnupiravir oral antiviral, which was listed on the PBS at the beginning of last month.
 
According to the DoH, the latter treatment has been prescribed around 5000 times on the PBS so far.
 
Regardless of the antivirals’ potential effectiveness, for Dr Altaf the priority remains vaccination, with a fourth booster dose now open for the most clinically vulnerable cohorts including all over-65s.
 
‘We’ve had outbreaks at facilities before [the oral antiviral] was available and patients who had had their vaccinations did quite well,’ he said.
 
‘Elderly patients in aged care facilities compared to my experience last year are faring much better with the illness, and most of them are having some mild symptoms and recovering within a few days.’
 
The Therapeutic Goods Administration (TGA) provisionally approved the two oral antivirals in January.
 
A risk classification tool was released by the COVID-19 Evidence Taskforce last month to help guide clinicians when assessing treatment options for those with COVID.
 
A guide featuring information GPs need to know about the oral antivirals has also been published by newsGP. The RACGP has produced a list of COVID-19 resources with information relevant for every state and territory.
 
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