Molnupiravir (Covid 19 treatment)

The treatment — which is taken as 4 capsules every 12 hours over five days — must be started within five days of COVID-19 symptom onset

Before prescribing, GPs must ensure a COVID-19 test result is valid and make a note of the result, testing date, location and test provider in the patient’s record.

Older Australians and Aboriginal and Torres Strait Islander people, who test positive for COVID-19.

• 70 years or older regardless of risk factors, and with or without symptoms
• 50 years or older with 2 risk factors
• Aboriginal or Torres Strait Islander, 30 years or older and with 2 risk factors.

Risk factors include:

• living in residential aged care
• living with disability with multiple conditions and/or frailty (but not limited to living in supported accommodation)
• neurological conditions like stroke or dementia and demyelinating conditions e.g. multiple sclerosis, Guillain-Barre Syndrome
• chronic respiratory conditions including COPD, moderate or severe asthma
• obesity or diabetes (type I or II requiring medication)
• congestive heart failure, coronary artery disease, cardiomyopathies
• kidney failure or cirrhosis
• living remotely with reduced access to higher level healthcare.

Molnupiravir reduced hospitalisation or death by 30% in relative terms and 3% in absolute terms. 

Molnupiravir is not recommended during breastfeeding or pregnancy (category D)

Women of childbearing age should use contraception during and four days after treatment, and men who have a partner of childbearing age should use contraception during and three months after treatment.

Contraindication in known allergy to molnupiravir or any of the excipients of this medicine (croscarmellose sodium,
hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, red
iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol,
purified water, shellac, strong ammonia solution)

PBS Eligibility Criteria (Streamlined Authority):

• 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.
  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.

POPULATION 1 (PBS Code: 12582)

Adults aged 65 years or over and at high risk
High risk is defined as the presence of at least two of the following conditions:

1. The patient has received less than 2 doses of SARS-CoV-2 vaccine,
2. The patient is aged 75 years or over,
3. The patient is in residential aged care or residential disability care,
4. Neurological conditions, including stroke and dementia,
5. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis,
6. Congestive heart failure (NYHA Class II or greater),
7. Obesity (BMI greater than 30 kg/m2),
8. Diabetes Types I and II, requiring medication for glycaemic control,
9. Renal failure (eGFR less than 60mL/min),
10. Cirrhosis, or
11. 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 patients’ medical condition necessitating use of this drug must be recorded in the patients’ medical records.

POPULATION 2 (PBS Code: 12583)

Adults >18 years old AND Moderately to Severely Immunocompromised

“Moderately to severely immunocompromised” patients are those with:

1. any primary or acquired immunodeficiency including:
   1. Haematologic neoplasms: leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders
   2. Post-transplant: solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months),
   3. 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:
   1. Chemotherapy or whole body radiotherapy,
   2. High-dose corticosteroids (≥20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy,
   3. Biological agents and other treatments that deplete or inhibit B cell or T cell function (anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin),
   4. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate (more than 0.4 mg/kg/week), leflunomide, azathioprine (at least 3mg/kg day), 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
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 severe intellectual or physical disabilities requiring residential care

Details of the patients’ medical condition necessitating use of this drug must be recorded in the patients’ medical records.

POPULATION 3 (PBS Code: 12584)

Adults aged 50 or over, who identify as Aboriginal or Torres Strait Islander and at high risk

High risk is defined as the presence of at least two of the following conditions:

1. The patient has received less than 2 doses of SARS-CoV-2 vaccine,
2. The patient is in residential aged care or residential disability care,
3. Neurological conditions, including stroke and dementia,
4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis,
5. Congestive heart failure (NYHA Class II or greater),
6. Obesity (BMI greater than 30 kg/m2),
7. Diabetes Types I and II, requiring medication for glycaemic control,
8. Renal failure (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 patients’ medical condition necessitating use of this drug must be recorded in the patients’ medical records.