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Changes to COVID-19 oral antiviral (Paxlovid) PBS eligibility criteria – April 2023

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  • 27 April 2023

 

What's changed?

Changes have been made to the eligibility criteria of nirmatrelvir and ritonavir (Paxlovid), an oral combination antiviral medicine. Paxlovid is listed on the General Schedule (Schedule 85) of the Pharmaceutical Benefits Scheme (PBS) as Authority Required (Streamlined) for specific patient groups with mild-to-moderate COVID-19 at high risk of progressing to severe disease.

From 1 April 2023, the patient eligibility criteria for Paxlovid on the PBS have been expanded to include people aged 60 to 69 years with mild to moderate COVID-19 and one risk factor for severe disease.1

Examples of risk factors include living in residential aged care, having certain medical conditions such as asthma, diabetes or obesity. Please see Table 2 below for a list of risk factors for developing severe disease.

All other eligibility criteria remain unchanged. 

Please see PBS website for more details.

 

Background

Paxlovid was added to the PBS from 1 May 2022 as a treatment for COVID-19. Paxlovid is an oral antiviral medicine which can be used by patients with mild to moderate COVID-19 who have a high risk for developing severe disease, reducing the need for admission to hospital.

Paxlovid is a prescription only medicine which must be started as soon as possible after symptom onset or a diagnosis of COVID-19. From the onset of COVID-19 symptoms, a course of Paxlovid must be started within the first 5 days.

The two active substances of the medicine, nirmatrelvir and ritonavir are given as separate tablets. The recommended dosage is nirmatrelvir 300 mg (two 150mg tablets) taken together with ritonavir 100 mg (one tablet) every 12 hours for 5 days.2

From 1 November 2022, medical practitioners and nurse practitioners can add Paxlovid to Prescriber’s Bag supplies.

 

Clinical criteria for all included patient populations

Eligible adults with mild to moderate COVID-19, confirmed by a positive polymerase chain reaction (PCR) test or a rapid antigen test (RAT), can be prescribed PBS‑subsidised Paxlovid by their doctor or authorised nurse practitioner.

Please see Table 1 for PBS eligibility criteria for Paxlovid from 1 April 2023.

Table 1: PBS eligibility criteria for Paxlovid from 1 April 2023

Patient population

PBS eligibility criteria for Paxlovid

Adults 70 years or older
  • Patients must
    • have COVID-19 confirmed by a PCR or RAT test, and
    • have treatment commenced within 5 days of onset of symptoms, or
    • have treatment initiated as soon as possible after diagnosis is confirmed when asymptomatic, and
    • not require hospitalisation for COVID-19 infection at the time of prescribing.
  • For adults 70 years of age or older, no further risk factors for progression to severe disease are required for PBS eligibility.

Adults 60 – 69 years of age
  • Patients must
    • have mild to moderate COVID-19 (with at least one sign or symptom attributable to COVID-19) confirmed by a PCR or RAT test,
    • have treatment commenced within 5 days of onset of symptoms, and
    • not require hospitalisation for COVID-19 infection at the time of prescribing.
  • Patients in this patient population are eligible for treatment if they have one risk factor for developing severe disease.
  • Please see Table 2 for a list of risk factors for developing severe disease.

Adults 50 – 59 years of age
  • Patients must
    • have mild to moderate COVID-19 (with at least one sign or symptom attributable to COVID-19) confirmed by a PCR or RAT test
    • have treatment commenced within 5 days of onset of symptoms, and
    • not require hospitalisation for COVID-19 infection at the time of prescribing.
  • Patients in this patient population are eligible for treatment if they have two risk factors for developing severe disease.
  • Please see Table 2 for a list of risk factors for developing severe disease.

Adults 30 years or older identifying as First Nations people
  • Patients must
    • have mild to moderate COVID-19 (with at least one sign or symptom attributable to COVID-19) confirmed by a PCR or RAT test,
    • have treatment commenced within 5 days of onset of symptoms, and
    • not require hospitalisation for COVID-19 infection at the time of prescribing.
  • Patients in this patient population are eligible for treatment if they have one risk factor for developing severe disease.
  • Please see Table 2 for a list of risk factors for developing severe disease.

Adults 18 years or older

  • Patients must
    • have mild to moderate COVID-19 (with at least one sign or symptom attributable to COVID-19) confirmed by a PCR or RAT test,
    • have treatment commenced within 5 days of onset of symptoms, and
    • not require hospitalisation for COVID-19 infection at the time of prescribing.
  • Patients in this patient population are eligible for treatment if
    • they are moderately to severely immunocompromised, or
    • have been previously hospitalised from COVID-19 disease, if subsequently re-infected.
  • Please see Table 3 for definition of moderately to severely immunocompromised patients for the purpose of PBS eligibility of Paxlovid.

Table 2: List of risk factors contributing to the PBS definition of high risk for development of severe disease

Risk factors
  1. The patient is in residential aged care,
  2. The patient has disability with multiple comorbidities and/or frailty,
  3. Neurological conditions, including stroke and dementia and demyelinating conditions,
  4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease,
  5. Heart failure, coronary artery disease, cardiomyopathies,
  6. Obesity (BMI greater than 30 kg/m2),
  7. Diabetes type I or II, requiring medication for glycaemic control,
  8. Renal impairment (eGFR less than 60mL/min),
  9. Cirrhosis,
  10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above,
  11. Past COVID-19 infection episode resulting in hospitalisation.

Table 3: Definition of moderately to severely immunocompromised adults at high risk of severe disease for the purpose of PBS eligibility of Paxlovid

Moderately to severely immunocompromised includes:

1. Any primary or acquired immunodeficiency including:
  • Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,
  • Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),
  • Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency.

2.  Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received any of these treatments:
  • Chemotherapy or whole body radiotherapy,
  • High-dose corticosteroids (≥20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,
  • Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1‑phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin),
  • Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6‑mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus).Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received anti-CD20 monoclonal antibody treatment, including rituximab, ocrelizumab, ofatumumab and obituzumab


3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received anti-CD20 monoclonal antibody treatment, including rituximab, ocrelizumab, ofatumumab and obituzumab

4. Patients with very high-risk conditions including: People with disability with multiple comorbidities and/or frailty.

  • Down Syndrome,
  • Cerebral palsy,
  • Congenital heart disease,
  • Thalassemia, sickle cell disease and other haemoglobinopathies.


5. People with disability with multiple comorbidities and/or frailty.
 

For prescribers and dispensers

  • The onus of diagnosis for PBS eligibility is on the prescriber to be satisfied that the COVID-19 test is valid and to record that in the patient records.
    • Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record,
    • Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.

For complete details on the PBS eligibility criteria for Paxlovid, please visit the PBS website at www.pbs.gov.au by using the search term “Paxlovid”.

  • PBS restrictions for COVID-19 antiviral treatments do not restrict the number of courses of treatment a person can have in a lifetime. Provided patients meet the eligibility criteria for the treatment, they may access second or subsequent courses of antiviral treatment for second or subsequent COVID-19 infections.
  • Prescribers and dispensers should carefully review a patient’s concomitant medications including over-the-counter medications, herbal supplements, and recreational drug before prescribing or dispensing Paxlovid. For complete details of drug interactions, including medicines for which concomitant use of Paxlovid is contraindicated, please refer to Paxlovid Product Information approved by the TGA.3
 

References

  1. Pharmaceutical Benefits Scheme. Paxlovid® (nirmatrelvir and ritonavir) PBS Factsheet. Canberra: Australian Government Department of Health and Aged Care, 2023 (accessed 17 April 2023).

  2. Australian Medicines Handbook. Nirmatrelvir and ritonavir. Adelaide: AMH Pty Ltd, 2023 (accessed 17 April 2023).

  3. Therapeutic Goods Administration. PAXLOVID nirmatrelvir 150 mg tablet and ritonavir 100 mg tablet blister composite pack (377572). Canberra: Australian Government Department of Health and Aged Care, 2023 (accessed 17 April 2023)