Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

SARS-CoV-2 infection

The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND

Patient must have received a positive nucleic acid test result; or

Patient must have received a positive rapid antigen test (RAT) result; AND

Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND

The treatment must be initiated within 5 days of symptom onset; or

The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic; AND

Patient must be at least 70 years of age.

Access to this drug through this restriction is permitted irrespective of vaccination status.

Where nucleic acid testing 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.

This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.

For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.

Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

SARS-CoV-2 infection

The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND

Patient must have received a positive nucleic acid test result; or

Patient must have received a positive rapid antigen test (RAT) result; AND

Patient must have at least one sign or symptom attributable to COVID-19; AND

Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND

Patient must satisfy at least one of the following criteria: (i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND

The treatment must be initiated within 5 days of symptom onset; AND

Patient must be at least 18 years of age.

For the purpose of administering this restriction, 'moderately to severely immunocompromised' patients are those with:

1. Any primary or acquired immunodeficiency including:

a. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders,

b. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),

c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR

2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received:

a. Chemotherapy or whole body radiotherapy,

b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,

c. 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),

d. 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); OR

3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR

4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR

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

Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records

For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.

Access to this drug through this restriction is permitted irrespective of vaccination status.

Where nucleic acid testing 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.

This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.

For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.

Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

SARS-CoV-2 infection

The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND

Patient must have received a positive nucleic acid test result; or

Patient must have received a positive rapid antigen test (RAT) result; AND

Patient must have at least one sign or symptom attributable to COVID-19; AND

Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND

The treatment must be initiated within 5 days of symptom onset; AND

Patient must be each of: (i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk.

For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions:

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.

Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.

For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.

Access to this drug through this restriction is permitted irrespective of vaccination status.

Where nucleic acid testing 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.

This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.

For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.

Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records.

Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

SARS-CoV-2 infection

The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND

Patient must have received a positive nucleic acid test result; or

Patient must have received a positive rapid antigen test (RAT) result; AND

Patient must have at least one sign or symptom attributable to COVID-19; AND

Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND

The treatment must be initiated within 5 days of symptom onset; AND

Patient must be both: (i) at least 50 years of age, (ii) at high risk.

For the purpose of administering this restriction, high risk is defined as either a past COVID-19 infection episode resulting in hospitalisation, or the presence of at least two of the following conditions:

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, or

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.

Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records.

For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are: fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell.

Access to this drug through this restriction is permitted irrespective of vaccination status.

Where nucleic acid testing 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.

This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.

For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.

Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records.