- PAXLOVID® (nirmatrelvir tablets and ritonavir tablets) will be available on the Pharmaceutical Benefits Scheme (PBS) to people between 50–59 years with mild to moderate COVID-19, with one additional risk factor from 1 July 2023.
- Wider eligibility criteria mean more Australians most at risk of severe disease may be able to access PBS-subsidised PAXLOVID if they test positive for COVID-19.
- In the Phase 2/3 EPIC-HR trial PAXLOVID demonstrated 86% relative risk reduction in hospitalisation or death, compared with placebo for patients who received treatment within five days from symptom onset with demonstrated consistent efficacy across prespecified patient types and a range of comorbidities.
SYDNEY, AUSTRALIA, JULY 2023 – From 1 July 2023, the eligibility criteria for access to PAXLOVID® (nirmatrelvir tablets and ritonavir tablets) on the Pharmaceutical Benefits Scheme (PBS) will be expanded to include people between 50–59 years with mild to moderate COVID-19, with one additional risk factor for developing severe disease. Previously, people aged 50–59 years were required to have two additional risk factors.
This follows the expansion on 1 April 2023 to include people between 60–69 years with mild to moderate COVID-19 with one additional risk factor for developing severe disease, rather than two additional risk factors.
PAXLOVID is the one COVID-19 oral anti-viral medicine to receive these two expanded PBS eligibility criteria in the past three months.1
National COVID-19 Clinical Evidence Taskforce guidelines were updated in May 2023 to provide guidance about the treatment of COVID-19. In these guidelines, PAXLOVID is recommended as one of the first line treatment options for high-risk adult patients and the elderly as defined in the registration trial, with mild to moderate COVID-19 infections not requiring the initiation of oxygen therapy or hospitalisation at presentation and in whom therapy can be initiated within five days of symptom onset.2
Australia’s Therapeutic Goods Administration (TGA) granted provisional approval for PAXLOVID based on positive results from the Phase 2/3 EPIC-HR trial, demonstrating 86% relative risk reduction in hospitalisation or death compared with placebo for patients who received treatment within five days from symptom onset with demonstrated consistent efficacy across prespecified patient types and a range of comorbidities.3 PAXLOVID was well-tolerated in the EPIC-HR trial.3
Dr Krishan Thiru, Pfizer Australia and New Zealand Medical Director said: “Government data shows that Australians are still being hospitalised, are still being admitted to ICU and sadly in some cases not surviving from COVID-19, and most of those people have risk factors for serious illness.4
“This widening of PBS eligibility criteria means many more Australians most at risk of severe disease may be able to access PAXLOVID through the PBS if they test positive for COVID-19, and take treatment at home,” Dr Thiru said.
PAXLOVID is available on the PBS for those with mild to moderate COVID-19 confirmed by a PCR or a RAT test who meet the following criteria:5
- People 70 years of age or older;
- [From 1 July 2023] People between 50 to 69 years, with one additional risk factor for developing severe disease;
- People 30 years of age or older, identifying as Aboriginal and Torres Strait Islander, with one risk factor for developing severe disease;
- People 18 years of age or older, who are moderately to severely immunocompromised;
- People 18 years of age or older who have been previously hospitalised from COVID-19 disease, if subsequently reinfected.
There are a range of factors that increase an individual’s risk of serious illness, hospitalisation, and death from COVID-19. These include age, health conditions or whether someone is taking treatments for another condition. There are other factors such as living in a remote community or living in residential care that may make someone eligible for anti-viral medicines.5
Recent Pfizer research showed three in five people were unaware whether they would be eligible for anti-viral treatment should they test positive.6
“As we age, we tend to have more risk factors for developing severe disease, so it’s important to have an early discussion with your GP or nurse practitioner about whether oral anti-viral medicines suit your health needs, and to develop a plan if you test positive to COVID-19,” said Dr Thiru.
“It is also important we help protect ourselves and our loved ones. We need to practice COVID-safe behaviours where we can. Stay up to date with vaccinations according to government recommendations. If you do get symptoms that could be COVID-19, do a test and then if you are positive speak with a health professional to see what you can do to help protect yourself,” Dr Thiru said.
PAXLOVID is a prescription only oral medicine taken twice-daily for five days. It should be taken as soon as possible after a diagnosis of COVID-19, and within five days of symptoms appearing.7
PBS Information: Authority Required (STREAMLINED).
Category: GENERAL – General Schedule (Code GE).
For verified SARS-CoV-2 infection. Treatment must be initiated within 5 days of symptom onset. Refer to PBS Schedule for full authority information.
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Patients can help by reporting any side effects they may get. Patients can report side effects to their doctor, or directly at www.tga.gov.au/reporting-problems.
Minimum Product Information
PAXLOVID® (nirmatrelvir 150 mg/ritonavir 100 mg) film-coated tablets
Indications: PAXLOVID has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in adults 18 years of age and older, who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death.
Contraindications: hypersensitivity to active ingredients or excipients, severe renal and severe hepatic impairment, potent CYP3A inducers, highly dependent CYP3A inhibitors. See PI for details.
Precautions: CYP3A inhibitors or inducers may increase or decrease PAXLOVID concentrations; anaphylaxis and other hypersensitivity reactions, Toxic Epidermal Necrolysis and Stevens-Johnson syndrome have been reported with ritonavir; use with caution in patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis; low dose ritonavir may risk HIV-1 resistance to HIV protease inhibitors; contains lactose; pregnancy; lactation. See PI for details.
Interactions with other Medicines: the drug-drug interactions for this medicine are extremely complex. See PI for details.
Adverse Effects: Common: diarrhoea, vomiting, dysgeusia, headache. Uncommon: myalgia and hypertension. Post-marketing experience: anaphylaxis, hypersensitivity, nausea, abdominal pain and malaise. See PI for details.
Dosage and Administration: 300 mg nirmatrelvir and 100 mg ritonavir tablets taken together orally every 12 hours for 5 days. Mild renal impairment, mild and moderate hepatic impairment, elderly: no dose adjustments. Moderate renal impairment: 150 mg nirmatrelvir and 100 mg ritonavir taken together orally every 12 hours for 5 days. See PI for details.
Before prescribing, please review Product Information available at pfizer.com.au
Pfizer Australia Pty Ltd.
For more information on PAXLOVID, health care professionals can consult the Product Information leaflet available from: PI: PAXLOVID™ (tga.gov.au).
About PAXLOVID® (nirmatrelvir tablets and ritonavir tablets)
PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir, which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.
Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. PAXLOVID, however, works intracellularly by binding to the highly conserved Mpro (3CL protease) of the SARS-CoV-2 virus to inhibit viral replication. Nirmatrelvir has shown consistent in vitro antiviral activity against the variants Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, BA.2, BA.2.12.1, BA.4, BA.4.6, BA.5, BF.7, BQ.1.11, BQ.1 and XBB.1.5. Work is ongoing to evaluate activity against recently identified variants as they become available for testing.
PAXLOVID is generally administered at a standard dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, taken together twice-daily for five days. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. The dose for patients with moderate renal impairment (eGFR ≥30 to <60 mL/min) should be reduced to 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet), with both tablets taken together twice daily for five days (PAXLOVID is not recommended in patients with severe renal impairment [eGFR <30 mL/min]). PAXLOVID® is a registered trademark.
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The information contained in this release is as of 1 July 2023. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This statement contains forward-looking information about Pfizer’s efforts to combat COVID-19 and PAXLOVID (including a Phase 2/3 study in paediatric patients, a potential age-appropriate formulation for three additional planned cohorts of younger than 6 years old, qualitative assessments of available data, potential benefits, expectations for clinical trials, advance purchase agreements and an agreement with MPP, efforts toward equitable access, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorisations, potential to maintain antiviral activity against current variants of concern, planned investment and anticipated manufacturing, distribution and supply), involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the possibility of unfavourable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data, including the risk that final results from EPIC-SR could differ from the interim data; the ability to produce comparable clinical or other results including efficacy, safety and tolerability profile observed to date, in additional studies or in larger, more diverse populations following commercialisation; the ability of PAXLOVID to maintain efficacy against emerging virus variants; the risk that serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any drug applications or submissions to request emergency use or conditional marketing authorisation for any potential indications for PAXLOVID may be filed in particular jurisdictions and if obtained, whether or when such emergency use authorisation or licenses will expire or terminate; whether and when regulatory authorities in any jurisdictions may approve any applications or submissions for PAXLOVID that may be pending or filed (including a potential new drug application submission in the U.S. and submissions in other jurisdictions), which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labelling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of PAXLOVID, including development of products or therapies by other companies; risks related to the availability of raw materials for PAXLOVID; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand, which would negatively impact our ability to supply the estimated numbers of courses of PAXLOVID within the projected time periods; whether and when additional purchase agreements will be reached; the risk that demand for any products may be reduced or no longer exist; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
1For the full PBAC outcome, see: Pharmaceutical Benefits Scheme (PBS) | PBAC Outcome.
2 National Clinical Evidence Taskforce: COVID-19. Drug treatments for adults with COVID-19. Available at: FLOWCHART-DT-FOR-ADULTS.pdf (clinicalevidence.net.au) (accessed 30 June 2023).
3 Hammond J et al. N Engl J Med 2022;386:1397-1408.
4 Australian Government. Weekly COVID-19 reporting. Available at: https://www.health.gov.au/health-alerts/covid-19/weekly-reporting (accessed 30 June 2023).
5 Australian Government. Updated eligibility for oral COVID-19 treatments. Available at: https://www.health.gov.au/health-alerts/covid-19/treatments/eligibility#eligibility-for-oral-covid19-treatments (accessed 30 June 2023).
6Pfizer Australia and New Zealand. Data on file, May 2023.
7 Australian Government. Paxlovid. Available at: https://www.tga.gov.au/resources/auspmd/paxlovid#:~:text=Paxlovid%20should%20be%20taken%20as,chewed%2C%20broken%2C%20or%20crushed (accessed 30 June 2023).