Updated Access Criteria for antiviral COVID-19 treatments

Medicines COVID-19 Decision

What we’re doing

We're pleased to announce that we have made the decision to widen access to three antiviral medicines used to treat COVID-19 from 18 July 2022. 

  • nirmatrelvir with ritonavir (supplied under the brand name Paxlovid)
  • molnupiravir (supplied under the brand name Lagevrio) and
  • remdesivir (supplied under the brand name Veklury) 

The changes mean that more New Zealanders who get COVID-19 will be able to access these treatments. 

These treatments are currently available in New Zealand and are being used in the treatment of early COVID-19 for people at risk of severe illness from COVID-19 infection. Criteria changes implemented from 18 July 2022 will make these treatments available to a larger priority population of people at risk of severe illness from COVID-19 in New Zealand. 

Access Criteria have been developed based on advice from our clinical expert advisors and other stakeholders and New Zealand rates of COVID-19 hospital admissions. The updated criteria widen access to antiviral treatments to additional groups of people who are at increased risk of severe COVID-19. This includes:

  • people aged 75 years and over
  • people who have been previously admitted to Intensive Care units as a result of COVID-19 infection
  • Māori and Pacific peoples 

Pharmac initially widened the access criteria in May 2022. This update expands on these changes to include population groups with an estimated 10% risk of hospitalisation as a result of COVID-19 infection. 

Māori people aged 50 years and over who have not received a primary course of vaccination are eligible for antiviral treatments 

The number of factors Māori are required to have to access these antiviral treatments will reduce, with greater emphasis placed on factors that are most predictive of poor outcomes from COVID-19 infection including age and vaccination status. Māori aged 50 years and over who have not received a primary course of vaccination against COVID-19 would be able to access these treatments without requiring other factors for severe illness from COVID-19.

People who are eligible for these treatments under the current criteria will continue to have access. 

No changes have been made to the distribution arrangements for these treatments at this time. More information about New Zealand’s COVID-19 treatments portfolio, availability of the treatments and how to access them is available here. 

Detail about this decision

The Access Criteria 

The following Access Criteria will apply to nirmatrelvir with ritonavir (Paxlovid), molnupiravir (Lagevrio) and remdesivir (Veklury) from 18 July 2022. Prescriptions must be endorsed by the prescriber confirming that the patient meets the Access Criteria.

Access criteria – from any relevant practitioner.

Approvals are valid for patients where the prescribing clinician confirms the patient meets the following criteria and has endorsed the prescription accordingly:

All of the following:

  1. Patient has confirmed (or probable) symptomatic COVID-19, or has symptoms consistent with COVID-19 and is a household contact of a positive case;
    AND
  2. Patient’s symptoms started within the last 5 days (if considering nirmatrelvir with ritonavir or molnupiravir) or within the last 7 days (if considering remdesivir);
    AND
  3. Patient does not require supplemental oxygen#;
    AND 
  4. ANY of the following:
    1. The patient meets ONE of the following:
      1. Patient is immunocompromised* and not expected to reliably mount an adequate immune response to COVID-19 vaccination or SARS-CoV-2 infection, regardless of vaccination status; or
      2. Patient has Down syndrome; or
      3. Patient has sickle cell disease; or
      4. Patient has had a previous admission to ICU directly as a result of COVID-19; or
      5. Patient is aged 75 years or over
        OR           
    2. Patient is of Māori or Pacific ethnicity and has at least FOUR of the following factors:
      1. Any combination of high-risk medical conditions for severe illness from COVID-19 identified by the Ministry of Health** (with each individual condition counting as one factor),
      2. Patient is under the age of 50 and has not completed their primary course^ of vaccination (counts as one factor)
      3. Patient is aged between 50 and 64 years (counts as one factor, or four if patient has not completed a primary course^ of vaccination)
      4. Patient is aged between 65 and 74 years (counts as two factors, or four if patient has not completed a primary course^ of vaccination)
        OR
    3. Patient is of another ethnicity and has at least FIVE of the following factors:
      1. Any combination of high-risk medical conditions for severe illness from COVID-19 identified by the Ministry of Health** (with each individual condition counting as one factor)
      2. Patient is under the age of 50 and has not completed their primary course^ of vaccination (counts as one factor)
      3. Patient is aged between 50 and 64 years (counts as one factor, or two if patient has not completed a primary course^ of vaccination)
      4. Patient is aged between 65 and 74 years (counts as two factors, or five if patient has not completed a primary course^ of vaccination)
        AND
  5. Not to be used in conjunction with other COVID-19 antiviral treatments. 

Notes:

Consider molnupiravir or remdesivir if nirmatrelvir with ritonavir is unsuitable or unavailable.

* As per Ministry of Health criteria(external link) of ‘severe immunocompromise’ for third primary dose of COVID-19 vaccine

** People with high risk medical conditions identified by the Ministry of Health(external link)

^ ‘Primary Course’ defined as receiving at least two doses of vaccination against COVID-19.

# Supplemental oxygen to maintain oxygen saturation >93% or at or above baseline for patients with chronic resting hypoxia

How to interpret the access criteria? 

We have updated the below heat maps to help healthcare professionals interpret the access criteria and identify eligible patients. These heat maps and other resources have been developed to help interpret the access criteria and will be available on our website alongside the access criteria from 18 July 2022. 

Some factors in the criteria now have greater emphasis and may be counted more than once. This reflects the factors that are most predictive of poor outcomes from COVID-19 infection, including age and people who have not completed a full course of vaccination against COVID-19. 

We will continue to monitor the evidence as it becomes available, as well as available supply and update the criteria as required. 

Heat maps to identify eligible patients 

Green boxes reflect the additional people who are now eligible under criteria 4.2 and 4.3 with widened access from 18 July 2022. Orange boxes reflect current criteria.

The following table is a non-visual version of the heatmap. But the online tool is hopefully easier to use. .
Heatmap for outlining high-risk condition requirements for access to antivirals

Table representation of the heat maps showing counts of high-risk conditions required to meet criterion 4.2 or criterion 4.3, depending on other factors 

Ethnicity Vaccination status Aged less than 50 Age between 50 and 64 Age between 65 and 74 Age 75 or over
Māori or Pacific Not completed primary course 3 0 0 0
Completed primary course 4 3 2 0
Other ethnicities Not completed primary course 4 3 0 0
Completed primary course 5 4 3 0

For clarity, no specific factors (under criterion 4.2 and criteria 4.3) are required to access these treatments. 

A person of Māori or Pacific ethnicity with any combination of at least four factors from 4.2.1. 4.2.2, 4.2.3 and 4.2.4 would meet criterion 4.2. This could include the factors named in the criteria (4.2.2, 4.2.3 or 4.2.4) or be any combination of the high-risk conditions listed on the Ministry of Health website (4.2.1).  

A person of another ethnicity with any combination of at least five factors from 4.3.1. 4.3.2, 4.3.3 and 4.3.4 would meet criterion 4.3. This could include the factors named in the criteria (4.3.2, 4.3.3 or 4.3.4) or be any combination of the high-risk conditions listed on the Ministry of Health website (4.3.1). 

Below are some examples of scenarios for eligibility: 

Please note these examples have been drafted as per the high-risk medical conditions listed on the Ministry of Health website as of 14 July 2022. These risk factors may change over time. Please refer to the Ministry of Health website(external link) for the most up to date risk factors. 

Example 1: Patient is 35 years old, has severe mental illness, diabetes that isn’t well controlled, has chronic lung disease, hypertension which isn’t well controlled and a BMI of 40.

This patient has five risk conditions (as on the Ministry of Health website) and therefore meets criterion 4.3. If the patient meets the other criteria the patient is eligible for treatment. 

Example 2: Patient is of Māori ethnicity aged 55 and has not completed a full course of vaccination.

This patient has four factors and therefore meets criterion 4.2. If the patient meets the other criteria the patient is eligible for treatment. 

Example 3: Patient is of Pacific ethnicity aged 68, has hypertension and diabetes and has completed a primary course of vaccination (at least two doses of vaccination against COVID-19).

This patient has four factors and therefore meets criterion 4.2. If the patient meets the other criteria the patient is eligible for treatment. 

Example 4: Patient is immunocompromised and is not expected to reliably mount an adequate immune response to COVID-19 vaccination or SARS-CoV-2 infection, regardless of vaccination status. This patient meets criterion 4.1.1. If the patient meets the other criteria the patient is eligible for treatment. 

Information for people with COVID-19

If you have, or suspect you have COVID-19 and are at high risk of developing severe illness from COVID-19, test early and please get in touch with your health care provider. They are best placed to let you know what your treatment options are. Treatments must be started within short timeframes from onset of symptoms. You can find more information on the Ministry of Health website here(external link). 

Accessing supply of antiviral treatments

Access to antiviral treatments will continue under the current arrangements that are in place. 

The antiviral COVID-19 treatments are not accessed via a standard Special Authority. Instead, prescriptions must be endorsed by the prescriber confirming that the patient meets the Access Criteria. The Access Criteria will continue to be available on Pharmac’s website and linked to Health Pathways. This approach allows us to easily make changes to the criteria if required in a timely manner. 

Antiviral treatments are supplied to pharmacies and Te Whatu Ora Hospitals at a cost of $0, as they have been purchased directly by Pharmac. COVID-19 treatments are funded from a dedicated budget allocated by the Government. That means COVID-19 treatment costs do not come from the annual budget for New Zealand’s medicines (the Combined Pharmaceutical Budget). 

Nirmatrelvir with ritonavir and molnupiravir 

Nirmatrelvir with ritonavir and molnupiravir will continue to be listed in Section B and Part II Section H of the Pharmaceutical Schedule. 

Supply of nirmatrelvir with ritonavir and molnupiravir is currently available to order only by selected community pharmacies and DHB Hospitals. This process is being managed by the Ministry of Health. More information is available on the Ministry of Health website(external link). 

Supply to community pharmacies is currently managed through one wholesaler, ProPharma and Te Whatu Ora Hospitals can order from OneLink as required. More deliveries will continue to arrive throughout 2022 and the access criteria have been designed to help to support prescribers to target treatment to those most in need and most likely to benefit. The XPharm rule applies to these treatments in the community as Pharmac has purchased these medicines directly. Community pharmacies are not able to claim subsidy through normal claiming systems as alternative funding arrangements have been established. 

Nirmatrelvir with ritonavir and molnupiravir have been purchased directly by Pharmac and there will be no standard dispensing fee or patient co-payment. Pharmacies will be reimbursed by COVID-19 Care in the Community funding through DHBs. Information regarding the claiming mechanism for this payment to Pharmacies will be available from DHBs. 

Remdesivir 

Remdesivir will continue to be listed in Part II Section H of the Pharmaceutical Schedule. 

Supply of remdesivir will continue as it is now and is available to order by Te Whatu Ora Hospitals through OneLink. Wholesale stock is held and distributed to Te Whatu Ora Hospitals by OneLink in Auckland. 

Level 1 hospitals can order and administer remdesivir, and Te Whatu Ora Hospitals are able to provide remdesivir to both inpatients and outpatients. 

Te Whatu Ora Hospitals will not be invoiced for supply because this stock has been purchased directly by Pharmac.  

For more information about distribution and stock availability, please visit our main COVID-19 web page (external link)

Where to get more information 

Up to date information regarding relevant COVID-19 treatments

People at risk of severe illness from COVID-19 identified by the Ministry of Health(external link)

The Ministry of Health’s advice for all health care professionals(external link) 

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.