National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 7) (Cth)

Case

PB 66 of 2022

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022
(No. 7)

National Health Act 1953

________________________________________________________________________

I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

Dated           8 July 2022

NIKOLAI TSYGANOV

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

________________________________________________________________________

Name of Instrument

(1)This instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2022 (No. 7).

(2)This instrument may also be cited as PB 66 of 2022.

  1. Commencement

(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1. The whole of this instrument 11 July 2022 11 July 2022

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

  1. Authority

This instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.

  1. Schedule

Schedule 1 to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1 - Amendments

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

  1. Schedule 1, Part 1, entry for Molnupiravir

omit from the column headed “Circumstances”: C12839 C12923 C12936   substitute: C13107 C13108 C13110 C13112

  1. Schedule 1, Part 1, entry for Nirmatrelvir and ritonavir

omit from the column headed “Circumstances”: C12839 C12923 C12936   substitute: C13107 C13108 C13110 C13112

  1. Schedule 4, Part 1, entry for Molnupiravir

substitute:

Molnupiravir C13107 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
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 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 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, the test must be verified by a medical practitioner or nurse practitioner. 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 13107
C13108 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
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 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 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, the test must be verified by a medical practitioner or nurse practitioner. 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 13108
C13110 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation at the time of prescribing; AND
Patient must be moderately to severely immunocompromised; AND
Patient must be at risk of progression to severe disease due to immunocompromised status; AND
The treatment must be initiated within 5 days of symptom onset.
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 rituximab; 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 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, the test must be verified by a medical practitioner or nurse practitioner. 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 13110
C13112 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must not require hospitalisation 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.
Patient must be at least 70 years of age.
Access to this drug through this restriction is permitted irrespective of vaccination status.
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, the test must be verified by a medical practitioner or nurse practitioner. 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 13112

  1. Schedule 4, Part 1, entry for Nirmatrelvir and ritonavir

substitute:

Nirmatrelvir and ritonavir C13107 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
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 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 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, the test must be verified by a medical practitioner or nurse practitioner. 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 13107
C13108 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation at the time of prescribing; AND
The treatment must be initiated within 5 days of symptom onset.
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 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 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, the test must be verified by a medical practitioner or nurse practitioner. 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 13108
C13110 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must have at least one sign or symptom attributable to COVID-19; AND
Patient must not require hospitalisation at the time of prescribing; AND
Patient must be moderately to severely immunocompromised; AND
Patient must be at risk of progression to severe disease due to immunocompromised status; AND
The treatment must be initiated within 5 days of symptom onset.
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 rituximab; 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 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, the test must be verified by a medical practitioner or nurse practitioner. 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 13110
C13112 SARS-CoV-2 infection
Patient must have received a positive polymerase chain reaction (PCR) test result; OR
Patient must have received a positive rapid antigen test (RAT) result verified by a medical practitioner or nurse practitioner; AND
Patient must not require hospitalisation 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.
Patient must be at least 70 years of age.
Access to this drug through this restriction is permitted irrespective of vaccination status.
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, the test must be verified by a medical practitioner or nurse practitioner. 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 13112
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