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

Support for the proposal

Support for the proposal as it would provide access to COVID-19 antivirals to additional groups of people in New Zealand at risk of severe illness from COVID-19 infection.

We are pleased that responses were supportive of the proposal and access being widened to include people with one or more severe health conditions and people with disabilities.

Supportive of proposal – Additional considerations

Support for the proposal as it would allow people with severe respiratory conditions, specifically for cystic fibrosis, to access COVID-19 antivirals, however raised concerns with the timeliness of Pharmac’s decision making.

We are pleased to provide access to COVID-19 antivirals for people with cystic fibrosis.

Access to COVID-19 antivirals for people with cystic fibrosis has been considered by Pharmac’s COVID-19 Treatments Advisory Group on two occasions.

• In October 2022(external link) the Group deferred making a recommendation because available evidence was considered to be of poor quality and strength. It was noted that other people with severe cardiovascular, renal and lung conditions would have similar risk of hospitalisation due to COVID-19 as people with cystic fibrosis and considered that these populations should also be considered for access.
• In February 2023(external link) the Group recommended that access to COVID-19 antivirals be widened to include people with high risk conditions. This included severe respiratory conditions such as people with complications from conditions such as cystic fibrosis.

Consultation and changes to the access criteria for COVID-19 treatments are carefully considered and prioritised alongside other activities managed by Pharmac. We are working with the sector to implement changes as quickly as possible.

Respondents supported the inclusion of both criteria 4.8 and 4.9 as this would encompass people with rare disorders who receive Disability Support Services and people with similar needs, who are not able to receive support services.

Concerns were raised that the wording ‘single severe chronic condition’ would exclude people with rare disorders who have not received a diagnosis.

We are pleased that criteria 4.8 and 4.9 would help meet the needs of the population with rare disorders.

The wording ‘one or more severe health conditions’ has been purposely included to be clear that people with severe frailty and/or vulnerability due to one or more severe conditions would be eligible to receive antiviral treatments, which could include people with rare disorders, including people without a defined diagnosis for the cause of their severe frailty and/or vulnerability.

It is not intended that this wording would disadvantage people without a defined diagnosis.

A respondent noted that due to income levels and other factors, disabled people may not be able to receive Disability Support Services even if they need it and may not be able to receive support from family or whānau. These people would not be eligible to receive COVID-19 antivirals.

The separate inclusions of people receiving Disability Support Services or people who require family, whānau or external disability care most days are intended to encompass disabled people at highest risk of severe COVID-19, who need regular care to meet their needs.

People who do not meet the specific wording in the criteria but meet its intent will be able to have their prescribers apply for access to antiviral treatments via Pharmac’s exceptional circumstances pathway(external link).

Changes to age limits within the criteria

Responses did not support any changes being made to the access criteria to increase the age limits for people to access antiviral treatments. Respondents noted that Māori and Pacific People are at risk of poor outcomes from COVID-19 at younger ages that people of other ethnicities

We appreciate the feedback received regarding changes to the age limits in the criteria. We acknowledge that advanced age remains the most significant predictor of poor outcomes including hospitalisation and death from COVID-19.

In February 2023(external link) Pharmac’s COVID-19 Treatments Advisory Group recommended that the age limits for access to COVID-19 antivirals be increased, to better reflect the groups of people at high risk of severe illness following infection with the Omicron variant of the SARS-CoV-2 virus that causes COVID-19.

We have not made changes to the ages for access to COVID-19 antivirals at this time. We will continue to monitor emerging evidence and changes to COVID-19 in New Zealand and would consider future changes to the ages in the access criteria if this was required in the future to better target the populations most at risk from COVID-19.

Some respondents requested that the age threshold for all people to access COVID-19 antivirals be amended to include all people 50 years and over.

Advanced age has been identified as the most significant single predictor for the risk of hospitalisation and death because of COVID-19, with a significant increase in risk for people 70 years and over.

The access criteria have been designed to target people at high risk of severe illness and death of COVID-19. It is expected that widening access to antivirals to include all people over 50 would include a significant number of people who do not have a high risk of severe illness and death from COVID-19 and would not be an appropriate use of the Paxlovid that has been secured.

Widened access

Responses supported wider access than proposed to COVID-19 antivirals to all people at risk of severe illness from COVID-19 following the Government’s decision to remove the remaining COVID-19 public health requirements.

Pharmac operates within a fixed budget for the funding of pharmaceuticals. Access to COVID-19 antiviral treatments has been targeted towards New Zealanders with a high risk of severe illness or death from COVID-19. We acknowledge there is uncertainty regarding the future trajectory of COVID-19 in New Zealand, and we will continue to monitor evidence as it emerges and regularly review the access criteria for COVID-19 treatments to ensure people at risk are able to access treatment.

A large number of respondents shared personal stories regarding long COVID-19. Access was requested to COVID-19 antivirals for the following uses:

• Preventing long COVID for all people who may be infected with COVID-19
• Preventing the worsening or re-emergence of long COVID symptoms in people with existing or recent long COVID if they are reinfected with COVID-19
• The treatment of long COVID once symptoms have developed.

We appreciate the time that people have taken to share their personal stories with us and acknowledge the significant impact that long COVID-19 can have on people’s lives.

The use of COVID-19 antiviral treatments and other medicines to prevent the development of long COVID was considered by our COVID-19 Treatments Advisory Group in February(external link) and May 2023(external link). In May 2023 the Advisory Group deferred making a recommendation because it considered that the evidence supporting the use of COVID-19 antivirals and other treatments in the prevention of long COVID is early and limited. Evidence for the use of COVID-19 antivirals in the treatment of long COVID is not available.

We are aware that evidence continues to emerge regarding the use of COVID-19 antiviral treatments and other medicines for the prevention or treatment of long-COVID.

We acknowledge the high health need of people with long COVID and the advocacy and strong support for the funding of COVID-19 antivirals for the prevention and treatment of long COVID. We will continue to review evidence as it becomes available and make changes to the access criteria as appropriate.

Respondents requested that the criteria should also include dysautonomia (including postural orthostatic tachycardia syndrome (POTS)) or myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

We would like to thank respondents for providing this feedback to us. We note that ME/CFS, Dysautonomia and long COVID-19 share many of the same symptoms, and we consider that these conditions should be considered together as evidence becomes available.

A respondent expected that the burden of long COVID would fall more heavily on Māori, Pacific peoples, and disabled people. However, they supported the proposal to wait until there is a greater body of supporting evidence and clarity about the diagnosis before funding antivirals to treat or prevent long COVID-19.

We note the support for the consideration of access to COVID-19 antivirals for people with long COVID. We will continue to review evidence as it becomes available and make changes to the access criteria to reflect this as appropriate.

A respondent requested previous hospitalisation due to COVID-19 be included in list of conditions that identify someone as being at ‘high risk of a severe outcome’.

Pharmac staff consider that the current criterion ‘Person has had a previous admission to Critical Care or High Dependency care directly as a result of COVID-19’ provides immediate access to COVID-19 antivirals for the people hospitalised with COVID-19 at the highest risk of progressing to severe illness and death. Including previous hospitalisation due to COVID-19 could result in people with a lower risk of severe illness and death accessing COVID-19 treatments (as considered by our COVID-19 Treatments Advisory Group in February 2023(external link)). We intend to seek updated advice from our COVID-19 Treatments Advisory Group regarding this point at a future meeting.

Respondents requested that the proposed criterion 4.9 be revised to remove the requirement that eligible people need direct care most days, indicating that high risk people who are not given COVID-19 antivirals may then require care as a result of a COVID-19 infection.

We expect that the combination of 4.9, 4.10 and 4.11 will ensure that people with a high risk with a severe illness are able to access COVID-19 antivirals regardless of whether they require regular direct care or not.

The intent of criterion 4.9 ‘Person has pre-existing high risk due to a health condition and needs direct family, whānau or external disability care most days’ is to encompass disabled people who require daily care but may not be receiving Disability Support Services.

The intent of Criteria 4.10 ‘has pre-existing severe frailty and/or vulnerability due to one or more severe health conditions’ Is to provide access to COVID-19 antivirals for people who are at high risk from COVID-19 due to one or two health conditions which put them at risk from COVID-19 infection due to severe frailty.

The intent of criterion 4.11’Person has any combination of three or more high-risk factors for severe illness from COVID-19***’ Is to provide access to antivirals for people at high risk from COVID-19 with three or more risk factors.

Based on the combination of these three criteria and the groups of people included we do not consider further changes to criterion 4.9 are needed.

A respondent requested access to COVID-19 antiviral treatments for people with type one diabetes mellitus

We appreciate this feedback being provided to us. Diabetes is currently included in the list of high risk conditions(external link) for access to COVID-19 Treatments. People are currently required to have three high risk conditions to access COVID-19 antivirals. People with pre-existing severe type one diabetes could meet criterion 4.10: eligibility from having a pre-existing severe frailty and/or vulnerability due to one or more severe health conditions.

We regularly review the access criteria for COVID-19 treatments and make changes to the criteria as new evidence becomes available. We would be happy to consider specific evidence for all people with type one diabetes.

A respondent queried whether people with autism would be eligible to access COVID-19 antiviral treatments

Autism has not been explicitly identified as a condition for access to COVID-19 treatments. People with autism would need to have a combination of three or more high-risk factors for severe illness from COVID-19. In some circumstances people with severe autism might meet criterion 4.10 due to pre-existing severe frailty and/or vulnerability from one or more severe health conditions.

Discretion within the access criteria

Respondents, including Te Aka Whai Ora did not support explicit discretion being included in the criteria, as previous experience has shown that discretion for access to medicines typically results in reduced access for Māori and other priority populations compared to other ethnicities in New Zealand.

A risk was noted that discretion, particularly when applied to molnupiravir, could result in inappropriate dispensing of antivirals.

We acknowledge the feedback and concerns raised by Te Aka Whai Ora. The intention of allowing discretion within the access criteria was to ensure that people at the same level of risk as currently eligible people are able to access COVID-19 antivirals. We note the concerns that explicit changes to the access criteria to allow discretion could increase inequities.

Considering the concerns raised, we have not included explicit discretion in the criteria.

We note that the current criteria already imply discretion, specifically the interpretation of the number of risk factors and the inclusion of multiple conditions within the same organ system.

Respondents considered that the current criteria included sufficient discretion and allowing further discretion at this time in the COVID-19 pandemic is unlikely to have a positive impact.

We appreciate that a number of respondents consider that the current access criteria provide sufficient discretion for people at risk of severe outcomes from COVID-19 infection.

Following the Government’s decision to remove the remaining COVID-19 requirements, respondents requested that discretion be allowed within the access criteria to allow prescribers to provide access to antivirals for all people that are considered high risk of severe illness resulting from COVID-19 infection.

We understand that the removal of the remaining COVID-19 requirements may create anxiety for some people, particularly for people at high risk of severe illness from COVID-19.

COVID-19 treatments are funded from within Pharmac’s fixed budget for pharmaceuticals. This means that difficult decisions need to be made about the groups of people who will have access to treatments. The access criteria has been designed to target the people most at risk of COVID-19 infection. We continue to consider the addition of new population groups to the access criteria as evidence becomes available.

Respondents requested that discretion be included in the criteria to allow dispensing to eligible people prior to overseas travel.

The purpose of funding COVID-19 antivirals is to allow eligible people at high risk of COVID-19 infection in New Zealand to access treatments when they are diagnosed with a COVID-19 infection, to prevent them from becoming severely unwell and thus reduce the number of people requiring hospital care in New Zealand. Providing antiviral treatments to people travelling overseas falls outside of this scope and intent.

Respondents requested access to COVID-19 antivirals for people that may experience hardship resulting from COVID-19 infection, including people with no sick leave, solo parents and people living on their own without support.

COVID-19 treatments in New Zealand are funded from within Pharmac’s fixed budget for pharmaceuticals. Access has been designed to reduce the rates of hospitalisation and death. We expect that expanding access to people expected to benefit from a reduced duration of symptoms would include a significant portion of the population and exceed the supply of antiviral treatments available and Pharmac’s fixed budget for pharmaceuticals.

Respondents suggested that outcomes other than hospitalisation and death should be considered in establishing access criteria for COVID-19 treatments.

Our COVID-19 Treatments Advisory Group has advised us that the reductions in hospitalisation and death from COVID-19 are the most important outcomes to be prioritised from New Zealand’s investment in COVID-19 antivirals. Expanding the criteria to include other outcomes would be expected to include a significant portion of the population and could exceed Pharmac’s budget for the funding of pharmaceuticals.

A respondent suggested changes to the wording in criteria 4.10 to allow access for people with single conditions who are at risk of these conditions becoming exacerbated by COVID-19 infection/reinfection.

Criterion 4.10 is intended to provide access to COVID-19 treatments for people at high risk of hospitalisation and death from COVID-19 due to pre-existing severe frailty and/or vulnerability from one or more severe health conditions.

This is based on advice from our COVID-19 Treatments Advisory Group in February 2023(external link) regarding the populations most expected to benefit from treatment.

We acknowledge that separating the effects of COVID-19 illness from underlying severe comorbid health conditions can be difficult clinically. However, we consider that such a change would change the intent of the criteria and could allow people who are not at high risk of severe COVID-19 outcomes to access to COVID-19 antiviral treatments that is less appropriate.

The Combined Pharmaceuticals Budget for funded pharmaceuticals, including COVID-19 treatments is fixed. As a result, we consider it is important for funding access to be directed towards people most likely to benefit.

Number of conditions required for access to COVID-19 antivirals

A respondent queried, for the purposes of criterion 4.11, whether multiple conditions within the same organ system, for example the lungs would be considered as single, or multiple conditions for calculating the three conditions required for access to COVID-19 treatments.

Criterion 4.11 is already in the current eligibility criteria, allowing access for people with three or more high risk conditions. As is the case currently, it is Pharmac’s intention that each condition is counted individually towards the total needed for access to COVID-19 antiviral treatments. This means that, for example, a person with two separate chronic lung diseases is considered to have two of the three required conditions for access to COVID-19 antivirals.

Support for healthcare professionals

Questioned how healthcare providers would gain access to medical information to assess eligibility including assessing eligibility for people with Disability Support Services

We have not made any changes to the way antiviral treatments are provided, or how eligible people are identified. We would expect that this would continue to be managed as it has been since funded antiviral treatments became available in New Zealand.

Whaikaha – Ministry of Disabled People has advised that that people receiving Disability Support Services are typically well known to their healthcare providers, including Pharmacists. Where it is unclear whether a person is a Disability Support Services recipient, this should be clarified in the same way as other aspects of the criteria such as identifying people who are 65 years and over and people with three or more high risk conditions.

Numbers of pharmacies prescribing antivirals

A respondent queried whether it would be possible to increase the number of pharmacies dispensing antivirals, particularly those that are open late.

Te Whatu Ora Pharmacy Portfolio Managers have overall responsibility for the pharmacies distributing COVID-19 antivirals within their region. We have shared this feedback with them.

Private supply of antiviral treatments

Respondents requested that nirmatrelvir with ritonavir (Paxlovid) be available privately in New Zealand.

The decision to make a medicine available for private purchase in New Zealand is the responsibility of the supplier and is not something that Pharmac is able to influence. We understand that Pfizer is considering making Paxlovid available privately in New Zealand.

Lists for identifying immunocompromised people

Respondents requested that biologic treatments for arthritis be included explicitly in the list of people identified as being immunocompromised.

Biologic treatments have not been explicitly included in the access criteria as people receiving biologic treatments will be receiving different doses based on their particular disease and severity. This means people will have different degrees of immunocompromise and not all will be severely immunocompromised.

To allow access to antiviral treatments for people using biologic treatments, the access criteria have been updated to clarify that access to antiviral treatments is available for people who received a third primary dose of vaccination against COVID-19 or would have been eligible to receive a third primary dose of vaccination against COVID-19. This could include people receiving immunosuppressive biologic therapy identified as being severely immunocompromised by their clinician.

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

Respondents did not support the inclusion of pregnancy being included in the list of conditions for identifying people at high risk for severe illness from COVID-19 due to a lack of evidence or guidance supporting this indication.

The list of conditions for identifying people at high risk for severe illness from COVID-19 were intended to identify a relatively broad group of people at high risk of severe illness. The proposed inclusion of pregnancy was based on previous lists of high-risk conditions managed by other health sector partners which identified groups or conditions at higher risk of severe COVID-19, including pregnancy. Noting the concerns raised, we have removed pregnancy from the list of conditions for identifying people at high risk for severe illness from COVID-19.

We also note that the data sheet for nirmatrelvir with ritonavir does not recommend Paxlovid during pregnancy and in women of childbearing potential not using contraception. On 14 September 2023 remdesivir was approved by Medsafe(external link) for the treatment of COVID-19. We have not been provided with a New Zealand data sheet for remdesivir yet.

We would consider including pregnancy in the criteria for COVID-19 antivirals if this was supported by evidence in the future.

COVID-19 vaccines

A respondent requested that access to COVID-19 vaccines should also be widened to include a larger group of people.

Since 1 July 2023 Pharmac has been responsible for managing the access criteria for COVID-19 vaccinations. We are planning to seek advice from our Immunisation Advisory Committee later in 2023 to help inform any future changes to the criteria. Any proposed changes to the access criteria for COVID-19 vaccines would be included in a separate consultation process.