Updated changes to the access criteria for remdesivir for COVID-19
What we’re doing
We have heard from our expert advisors and clinicians treating people with COVID-19 that we need to make changes to the temporary access criteria for remdesivir announced earlier this week.
Updated access criteria is effective immediately. This is to better target treatment to people who are most at risk in the context of high COVID-19 case numbers and limited supply of remdesivir. The changes mean that people need to have more risk factors to access remdesivir. The number of risk factors will be different for people who are unvaccinated and vaccinated.
Completed treatment notification forms from DHB hospitals are no longer required to be sent to Pharmac. Pharmac has secured additional remdesivir stock to support the wider use.
Detail about this decision
The oral antivirals Pharmac has secured for treating COVID-19 are still some weeks away from availability in New Zealand. We therefore temporarily widened access to remdesivir from Monday 28 February 2021 (follow this link to the previous notification) to enable clinicians to use it earlier in the disease course for people with COVID-19 at risk of developing severe disease. This was based on the clinical advice we received at the time.
This change in access criteria is temporary. It will be reassessed in the future, for example when other COVID-19 treatments are available in New Zealand.
Since the initial criteria were set in 2020, further evidence has become available. Based on this evidence, the COVID-19 Treatments Advisory Group recommended to Pharmac that remdesivir be available for those with mild to moderate COVID-19, rather than moderate to severe disease, due to the known benefits of treatment in this setting. A record of this advice is being finalised and will be publicly available soon.
We have heard from our advisors and clinicians treating people with COVID-19 that the criteria confirmed on 28 February are very broad and in the context of limited stock and the escalating Omicron outbreak, that treatment should be targeted further to ensure that those who need it most can get it. We have worked with our expert advisors to update the criteria to better target use of remdesivir to people with mild to moderate COVID-19 considered at high risk of developing severe disease. People will need to have more risk factors to access remdesivir.
We will continue to regularly review these criteria over the coming weeks and consider further changes if needed.
The updated funding criteria from 4 March 2022 are as follows:
Initial application – from any relevant practitioner
All of the following:
- Patient has confirmed (or probable) symptomatic COVID-19; and
- Patient’s symptoms started within the last 7 days; and
- Any of the following:
- Immunocompromised individuals not expected to reliably mount an adequate immune response to COVID-19 vaccination or SARS-CoV-2 infection; or
- Patient is unvaccinated* and has at least three of the following: Aged 65 years or over, Māori or any Pacific ethnicity, or any of the comorbidities as listed below**; or
- Patient is vaccinated* and has at least five of the following: Aged 65 years or over, Māori or any Pacific ethnicity, or any of the comorbidities as listed below**; and
- Patient does not require supplemental oxygen (oxygen saturation >93%); or
- Patient does not require supplemental oxygen at saturations no lower than baseline for patients with chronic resting hypoxia; and
- Not to be used in conjunction with other COVID-19 antiviral treatments; and
- Treatment not to exceed five days.
Treatment may be given in an inpatient or outpatient setting
* ‘Vaccinated’ defined as having received at least two vaccine doses more than seven days earlier.
** Comorbidities associated with a higher risk of severe outcomes are: severely immunocompromised, significant cardiac disease, uncontrolled hypertension, uncontrolled diabetes, chronic lung disease, chronic kidney disease, chronic liver disease, cancer, BMI 40 or higher. More detail available on the Ministry of Health website(external link)
Summary of changes to 28 February 2022 remdesivir criteria
- Unvaccinated patients need to have three risk factors rather than one risk factor for severe disease.
- Vaccinated patients need to have five risk factors rather than two risk factors for severe disease.
- Wording is amended to clarify that individual comorbidities are considered as part of this risk factor count for a patients access to remdesivir.
- We have removed a history of smoking from the list of comorbidities as the advice we have received indicates that those people with chronic lung disease likely includes those with a history of smoking and most at risk of severe disease.
We have secured an additional 5,000 doses of remdesivir, enough to treat about 1000 people. This stock is now available and we are working to secure more.
Remdesivir is currently undergoing regulatory review by Medsafe. For more information refer to the Medsafe website for the approval status of COVID-19 treatments(external link). As remdesivir is not approved by Medsafe for use in New Zealand, it would continue to be prescribed and used in accordance with section 25 of the Medicines Act 1981.(external link)
Accessing supply of remdesivir
Access to remdesivir will continue as it is now. Remdesivir is currently not listed on the Pharmaceutical Schedule.
DHB hospitals can order stock direct from Onelink. Wholesale stock is held and distributed to DHB Hospitals by Onelink in Auckland. DHBs will not be invoiced for supply because this stock has been purchased directly by Pharmac.
DHB hospitals are no longer required to complete and provide a treatment notification form to Pharmac.
For more information, such as dosage and method of administration, please refer to the factsheet provided by Gilead Sciences (New Zealand) [PDF, 975 KB].
Distribution considerations in the community
The distribution mechanism for COVID-19 treatments in the community hasn’t been confirmed. We are working with the Ministry of Health to identify and consider available options, including the possible use of regional and local coordination hubs that are being established to support New Zealand’s response to COVID-19.
At this stage, remdesivir will not be readily available in the community. We are working to ensure the oral antiviral treatments are available as soon as feasible to meet this need.
Level 1 hospitals are able to order and administer remdesivir and DHB Hospitals are able to provide remdesivir to both inpatients and outpatients.