Proposal to change the access criteria for COVID-19 antiviral treatments

Medicines COVID-19 Consultation Closed

A decision has been made

We have published our decision following this consultation.

What we’re proposing

We are seeking feedback on a proposal to make changes to the access criteria for COVID-19 antiviral treatments, to reflect recent recommendations from our COVID-19 Treatments Advisory Group.

The changes in this proposal would provide greater access for people who are vulnerable to severe illness following infection with the currently circulating variants of COVID-19. Changes would be implemented from 1 October 2023 or earlier and apply to the following COVID-19 antiviral treatments:

  • nirmatrelvir with ritonavir (Paxlovid)
  • remdesivir (Veklury)
  • molnupiravir (Lagevrio) – separate criteria

We are also seeking feedback on how discretion could be incorporated to allow access to COVID-19 antiviral treatments for people who meet the intent of the access criteria and are not explicitly identified in the criteria wording, so that they still could be treated.

Consultation closes at 5pm, Monday 21 August 2023 and feedback can be emailed to consult@pharmac.govt.nz

What would the effect be?

From 1 October 2023 or earlier the access criteria to COVID-19 antiviral treatments would be amended to:

  • include people receiving Disability Support Services (DSS Recipients)
  • include people with single conditions that mean they are at high risk of hospitalisation and death as a result of COVID-19 infection

To help interpret the access criteria, Pharmac would have a list of conditions to help determine if a person is ‘severely immunocompromised’ and to identify those at ‘high-risk of severe illness from COVID-19’.

We expect that as the global and local response to COVID-19 evolves, further changes would be made to the criteria.

It is our intention that any changes resulting from this proposal would be implemented as soon as possible after the close of the consultation and a decision is made to ensure any new groups of eligible people would have access to treatments sooner. This may be before 1 October 2023. The date of implementation for any changes as a result of this proposal would be confirmed once the consultation has closed and we have worked with our partners in the heath sector to understand what timeframes would be achievable for any system changes to be completed.

Who we think will be interested

  • People involved in the care and treatment of people with COVID-19
  • People and their whānau/carers, at higher risk of experiencing severe COVID-19, such as older people, non-vaccinated, having other health conditions/comorbidities, Māori, and Pacific people
  • People with severe or chronic neurological, cardiovascular, renal or respiratory conditions
  • People with a disability receiving Disability Support Services, and their whānau/carers
  • Prescribers of antiviral treatments for COVID-19
  • Pharmacists providing antiviral treatments for COVID-19
  • Suppliers of COVID-19 treatments
  • Clinicians and researchers evaluating the benefits of COVID-19 treatments available in New Zealand

Why we’re proposing this

Antiviral treatments have been available in New Zealand for the treatment of COVID-19 since late 2020. Since this time, changes have been made to the access criteria to ensure the people at the highest risk of hospitalisation or death as a result of COVID-19 infection are able to access them. The most recent changes to the access criteria were made in September 2022.

Pharmac has recently made the decision to change the access criteria for molnupiravir to ensure its use is limited to the small number of high-risk people who cannot receive the preferred antiviral treatments, nirmatrelvir with ritonavir and remdesivir.

We continue to receive requests from the public, Government organisations, and advocacy groups to widen access to antiviral treatments for specific groups of people who are considered to be high risk of severe illness. We will continue to review these requests as they are received.

Pharmac’s COVID-19 Treatments Advisory Group has considered the access criteria and made recommendations regarding COVID-19 treatments in New Zealand on a number of occasions. Records of the Advisory Group’s discussions are available on the Pharmac Website.

New data on people using Disability Support Services affected by COVID-19

In May 2023 Pharmac’s COVID-19 Treatments Advisory Group considered new data published by Whaikaha – Ministry of Disabled People(external link) (note: opens a Word document in your browser) regarding the impact of COVID-19 on people receiving Disability Support Services. The Advisory Group considered that the data illustrated a higher risk of hospitalisation and death from COVID-19 for DSS recipients compared to the general population. The Group recommended that COVID-19 antivirals should be funded for DSS recipients. The record of the Group’s most recent discussion will be published soon.

Considering people with single high-risk conditions or affected by disability

In February 2023 Pharmac’s COVID-19 Treatments Advisory Group reconsidered access criteria for COVID-19 antiviral treatments for people with conditions putting them at high risk of severe illness or death as a result of COVID-19. The record of this discussion [PDF, 335 KB] is available on the website. In May 2023 the Advisory Group considered access to COVID-19 antiviral treatments for people receiving Disability Support Services (DSS recipients). The record of this discussion has not been published yet.

In summary the Advisory Group recommended that Disability Support Services recipients be included in the access criteria for COVID-19 antiviral treatments, in addition to the groups that were recommended at its February 2023 meeting [PDF, 335 KB].

Age limits for access to COVID-19 antivirals

In February 2023 Pharmac’s COVID-19 Treatments Advisory Group recommended that the age limits in the criteria be changed to all people over 70 years old instead of 65 years old, and Māori and Pacific peoples 60 years and over instead of 50 years old to better reflect the groups of people at high risk of severe illness following COVID-19 infection.

Age remains the most significant predictor of risk of hospitalisation or death from COVID-19 infection. While we have not proposed changes to the ages of eligibility for access at this time, we will continue to monitor the risk levels and consider whether changes are needed in future.

We welcome any feedback or comments that people may wish to make regarding the recommendations to increase the age limits.

Identifying people with severe immunocompromise or high-risk conditions

We have heard from a number of stakeholders that using external hyperlinks within the criteria to the Manatū Hauora - Ministry of Health website to identify ‘severe immunocompromise’ and ‘high risk medical conditions’ can make the criteria difficult to interpret, as the hyperlinks can break/ and the specific high-risk conditions can change.

To address this, we have proposed that Pharmac establish its own lists for identifying immunocompromised people and those at high-risk for severe illness from COVID-19 infection, which would be hosted on the Pharmac website.

Detail of the proposed lists is provided below. These lists have been developed based on recommendations from our COVID-19 Treatments Advisory Group and previous lists hosted on the Ministry of Health website, including versions that have been superseded.

Considering antivirals for the prevention or treatment of long COVID

In February 2023 [PDF, 335 KB], Pharmac’s COVID-19 Treatments Advisory Group noted evidence for the efficacy of nirmatrelvir with ritonavir in reduction of long COVID (also referred to as post COVID-19 condition). The Group considered that the efficacy of nirmatrelvir with ritonavir in reducing illness associated with long COVID would be difficult to assess, due to difficulties diagnosing long COVID, different definitions of long COVID, and difficulties assessing a more subjective endpoint.

In May 2023 further advice was sought from Pharmac’s COVID-19 Treatments Advisory Group on the use of COVID-19 antivirals to either prevent or treat long COVID. Records of the Advisory Group’s discussion will be published soon. In summary the Advisory Group considered that the evidence to support the use of currently available COVID-19 treatments to treat long COVID, after symptoms of long COVID have developed is not yet available. The Group also considered that evidence for the use of COVID-19 antivirals during an initial COVID-19 infection preventing later long COVID is very early and confined to a few clinical studies. The Advisory Group deferred its recommendations regarding preventive and symptomatic treatments for long COVID until further evidence is available. We will continue to review evidence for the treatment of long COVID and consider changes to the criteria in future as appropriate. 

Details about our proposal

Nirmatrelvir with ritonavir (Paxlovid) and remdesivir (Veklury) access criteria

The following Access Criteria would apply to nirmatrelvir with ritonavir (Paxlovid) and remdesivir (Veklury) from 1 October 2023 or earlier.

Proposed changes are indicated in bold.

Prescriptions must be endorsed by the prescriber confirming that the person meets the Access Criteria. For Pharmacist-Only supply, pharmacists must confirm that access criteria are met.

Access criteria – from any relevant practitioner.

Approvals are valid for patients where the prescriber 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. Patient is aged 65 years or over; or
    2. Patient is Māori or Pacific ethnicity AND aged 50 years or over; or
    3. Patient is aged 50 years or over AND has not completed a primary course^ of COVID-19 vaccination; or 
    4. 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
    5. Patient has had a previous admission to Critical Care or High Dependency care directly as a result of COVID-19; or
    6. Patient has Down syndrome; or
    7. Patient has sickle cell disease; or
    8. Patient receives Disability Support Services funded by Whaikaha - Ministry of Disabled People (previously Ministry of Health); or
    9. Patient has pre-existing high risk due to a health condition and needs direct family, whānau or external disability care most days; or
    10. Patient has pre-existing severe frailty and/or vulnerability due to a single severe chronic condition, including but not limited to: neurological, cardiovascular, renal and respiratory conditions; or
    11. Patient has any combination of three or more high-risk factors for severe illness from COVID-19**;
      AND
  5. Not to be used with other COVID-19 antiviral treatments.

Notes:

* Identifying people who are severely immunocompromised [page to be hosted on the Pharmac website]

** High risk factors for severe illness from COVID-19 [page to be hosted on the Pharmac website]

^ ‘primary course’ defined as receiving at least two courses of vaccination against COVID-19

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

We acknowledge that our access criteria for COVID-19 antiviral treatments do not include everyone who may be at risk of severe illness or death from COVID-19 infection, and the timeframe for providing treatment to people who need it is very short.

We are interested in feedback to help us understand how we could incorporate discretion within the access criteria. This is to make sure that people who meet the intent of the access criteria (they are at a similarly high risk of severe illness and death from COVID-19 infection as the groups identified in the criteria) but are not identified explicitly could access COVID-19 antiviral treatments.

Pharmac’s Exceptional Circumstances Framework is currently used to provide access to appropriate treatment for people whose clinical situations are exceptional. We have heard feedback that this pathway may not be suitable for the short timeframes required to start COVID-19 antiviral treatment. We seek feedback on what alternative options could be.

Molnupiravir (Lagevrio) access criteria

Pharmac recently notified of a decision to retain funding of molnupiravir for a small group of people in New Zealand with COVID-19 subject to its own separate access criteria.

The same proposed changes to the access criteria for nirmatrelvir with ritonavir (Paxlovid) and remdesivir (Veklury) would also be made to the new separate molnupiravir access criteria.

Identifying immunocompromised people

The following list would be used to identify people who are severely immunocompromised for the purpose of interpreting the access criteria (criterion 4.4). This criterion has been informed by recommendations from our COVID-19 Treatments Advisory Group and the criteria used to define severe immunocompromise for access to tixagevimab with cilgavimab (Evusheld).

Person is severely immunocompromised due to ANY of the following clinical situations:

  • heart or lung transplant recipient (any time frame)
  • other solid-organ transplant recipient with any of the following:
    • transplant received within the last 12 months
    • receiving induction immunosuppressant treatment (any timeframe)
    • receiving maintenance immunosuppressant treatment that includes mycophenolate mofetil (any timeframe)
    • treated for graft rejection within the past 12 months
  • allogenic haematopoietic stem cell transplant recipient with any of the following:
    • transplant received within last 12 months
    • has chronic graft versus host disease
    • requires significant ongoing immunosuppression for another reason
  • autologous haematopoietic stem cell transplant received within the last 12 months
  • multiple myeloma on active and/or maintenance treatment
  • combined primary immunodeficiency syndromes (including Severe Combined Immunodeficiency (SCID))
  • common variable immunodeficiency (CVID) with additional T-cell defects, past opportunistic infection or requiring immunosuppressive therapy
  • diagnosed humoral immunodeficiency with baseline IgG < 3g/L
  • HIV with a CD4 T lymphocyte cell count <200 cells/mm3
  • person who is receiving:
    • potent B-cell or T-cell depleting therapy within the previous 12 months*
    • a B-cell inhibitor (e.g. venetoclax or a Bruton tyrosine kinase inhibitor)
    • ruxolitinib
    • regular 3-4-weekly intravenous or subcutaneous immunoglobulin
    • sphingosine 1- phosphate receptor modulator therapy (eg fingolimod) within previous 12 months
    • high dose cyclophosphamide (>1g/m2) within previous 6 months.
    • high-dose or long-term moderate dose corticosteroids
  • is considered otherwise severely immunocompromised and had been given a third dose in their primary course of COVID-19 vaccine^

Notes:

* potent B-cell or T-cell depleting therapy such as rituximab, obinutuzumab, ocrelizumab, bendamustine, fludarabine, cladribine, alemtuzumab, anti-thymocyte globulin, CamPath antibody treatment, anti-B-cell bispecific antibody, CAR T-cells or BiTE antibody treatment.

Identifying people at high risk for severe illness from COVID-19

The following list of factors (previously the ‘high risk medical conditions’ list) would be used to identify people who are at high risk for severe illness from COVID-19 infection based on three or more factors, for the purpose of interpreting the access criteria (criterion 4.11):

  • chronic lung or airways disease
  • serious heart conditions such as congestive heart failure, coronary artery disease, rheumatic heart disease and congenital heart disease
  • poorly controlled hypertension
  • chronic neurological or neuromuscular disease
  • significant developmental disability
  • diabetes
  • chronic kidney disease
  • severe liver disease such as cirrhosis
  • severe haematological disorders
  • severe mental illness such as schizophrenia, major depressive disorder, bipolar or schizoaffective disorder
  • active cancer
  • morbid obesity — a body mass index (BMI) greater than 35
  • people who are pregnant
  • people currently in contact with secondary and tertiary mental health and addiction services
  • people with mental health and addiction issues who are currently homeless or without permanent housing.

Information to help interpret the access criteria including the access criteria assessment tool, heat maps and examples would be updated to reflect any changes.

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 get in contact with your healthcare 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.

Learn what to do if you have COVID-19 on The Unite Against COVID-19 website(external link)

Accessing supply of antiviral treatments

Access to antiviral treatments will continue under the current arrangements that are in place for now. Over the next 12 months we do expect to review these arrangements as we integrate the management of COVID-19 treatments with our usual medicines processes.

The antiviral COVID-19 treatments are not accessed via a standard Special Authority. Instead, prescriptions must be endorsed by the prescriber confirming that the person meets the access criteria. For Pharmacist-Only supply, pharmacists must confirm that access criteria are met. The access criteria will continue to be available on Pharmac’s website and linked to Health Pathways.

Antiviral treatments are currently supplied to pharmacies and Te Whatu Ora hospitals at no cost, as they have been purchased directly by Pharmac.

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 by community pharmacies and Te Whatu Ora hospitals. This process is being managed by Te Whatu Ora. More information is available on the Te Whatu Ora 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. The XPharm rule applies to these treatments in the community which means community pharmacies are not able to claim subsidy through usual claiming systems as Pharmac has purchased these medicines directly.

Pharmacies will be reimbursed for their services by COVID-19 Care in the Community funding through Te Whatu Ora. Information regarding the claiming mechanism for this payment to pharmacies will be available from Te Whatu Ora.

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. 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.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5 pm, Monday 21 August 2023.

All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.

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Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

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