Oral treatments for COVID-19 – Prescribing information for GPs

Introduction

Two antiviral medicines, Lagevrio (molnupiravir) and Paxlovid (nirmatrelvir plus ritonavir) were provisionally approved for use in Australia for the treatment of COVID-19 in January 2022, with supply of the medicines commencing in February 2022.

Initially, supply was limited to state and territory health departments, residential aged care facilities (RACFs), and Aboriginal and Torres Strait Islander communities via Aboriginal Controlled Community Health  Organisations(ACCHOs). The Federal Government allocated Lagevrio for pre-placement in all RACFs across Australia. States and territories and ACCHOs have also been allocated both Paxlovid and Lagevrio.

Both Lagevrio and Paxlovid are now listed on the Pharmaceutical Benefits Scheme (PBS) as Authority Required (Streamlined) items, enabling eligible patients to access these medicines from their local pharmacy where available. 

Regardless of how they are accessed, both medicines require a prescription from a GP, physician or nurse practitioner who meets the prescribing requirements before they can be issued.

The National COVID-19 Clinical Evidence Taskforce (the Taskforce) has released treatment recommendations for the use of both medicines for people aged 18 years or older with confirmed COVID-19 who do not require oxygen and who have one or more risk factors for disease progression. These treatment recommendations are supported by  the Taskforce’s decision tool for drug treatments and risk classification tool (both available on the Taskforce website). Please note that the PBS eligibility for both medicines is broader than the Taskforce recommendations.

Both medicines can decrease the risk of hospitalisation if taken within five days of symptom onset.

Not everyone who tests positive for COVID-19 will require these medicines, and they will both be of most benefit to people at risk of severe disease. GPs are well placed to make decisions with their patients on the appropriateness of these medicines to treat COVID-19 based on the person’s individual risk for disease progression, medical history, current medicines, age and COVID-19 vaccination status − including time since vaccination. 

Eligibility criteria*

Adults who have mild to moderate COVID-19 (confirmed by a PCR or medically verified RAT) and who can start treatment within five days of symptom onset, are eligible to be prescribed  if:

  • they are 70 years of age or older**
  • they are 50 years of age or older with two other risk factors for severe disease
  • they identify as Aboriginal or Torres Strait Islander origin, and are 30 years of age or older with two other risk factors for severe disease; or
  • they are 18 years of age or older and moderately to severely immunocompromised.

**see individual listing for each medicine for further information on prescribing.
*in people aged 70 years of age and above treatment can be initiated as soon as possible after diagnosis is confirmed even if the patient is asymptomatic. 

A COVID-positive person will not be able to attend in person to collect these medicines. Alternate collection or delivery will need to be arranged. You can now check which pharmacies stock each of these medicines.

Prescribing oral treatments in Residential Aged Care Facilities
A statement from the Commonwealth Chief Medical Officer on the standard of care required in the administration and use of these treatments in Residential Aged Care Facilities (RACF) has been published.
 

COVID-positive status can be confirmed via a rapid antigen test (RAT) or polymerase chain reaction (PCR) test. When a positive home RAT result is reported and antiviral treatment is being considered, the RAT must be "medically verified" before commencement of treatment.

The Department of Health has confirmed that where GPs have a ongoing trusted relationship with their patient, verbal confirmation or a photo of the RAT result are both appropriate methods of confirmation. If the GP is not familiar with the patient and/or is in doubt, evidence such as a photo of a RAT or evidence of a PCR result (which may be accessible via My Health Record) should be requested. Referal via state/territory based triage services (for example, healthdirect) is also adequate. In any scenario, the mode of proof should be documented in the patient's medical record.

Telehealth consultations will be sufficient in many cases to determine if treatment is appropriate, including via normal after-hours medical deputising services (see information on MBS phone items below). It is recommended medical deputising GPs and nurse practitioners work in partnership with the usual treating GP or physician to determine if treatment is appropriate.

A prescription needs to be issued for the medicine to be administered. When medicines have been pre-placed in RACFs and ACCHOs, the recommendation for recording and dispensing prescriptions is to follow the same process for other orders when medicines that are held in stock are issued (for example, antibiotics). Some RACFs and ACCHOs will do this differently, and how prescriptions are handled, and the medicines allocated, will depend on the local processes in place, and local state or territory requirements.

While clinical information systems (CIS) are being updated to include these medicines and expanded eligibility, they may not initially appear for prescribing purposes. In the interim you can still prescribe the medicines in your CIS by creating a custom medicine entry. It is important to note that the in-built medicine interaction and medical condition checker will not work, and you will need to be aware of the risks and contraindications as outlined in the product information for each medicine, and as per the University of Liverpool’s COVID-19 drug interactions checker.

The two treatments should not be prescribed for the same person at the same time.

Please refer to the prescribing requirements in your state or territory.
 

Two new temporary MBS items have been introduced to support medical practitioners with treating COVID-19 positive patients. Items 93716 (for GPs) and 93717 (for other medical practitioners) are available to assess a patient’s suitability to receive a prescription for a COVID-19 oral antiviral treatment via a telehealth phone consultation lasting at least 20 minutes for GPs and 25 minutes for OMPs. The items are temporary and will be available from 19 July 2022 until 31 October 2022. The new items are for eligible Medicare patients nationally who have confirmed their COVID-19 infection via a laboratory test (PCR) or by a rapid antigen test (RAT).

Visit MBS Online for more information.

As with all medicines, patients or carers will need to provide informed consent for these medicines to be prescribed. GPs working with patients in RACFs may find it helpful to pre-emptively discuss these medicines with their patients, even if they do not have COVID-19, to determine eligibility criteria and obtain pre-consent for these medicines to be prescribed in the event they test positive for COVID-19.

A subsequent discussion is advised at the point at which the patient requires the medicine to confirm the pre-consent is still applicable.

If a patient experiences an adverse event that you think may be related to the prescribed medicine, you can report this directly to the Therapeutic Goods Administration or via your normal state or territory reporting channels.
This event attracts CPD points and can be self recorded

Did you know you can now log your CPD with a click of a button?

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