Decision on access criteria for oral COVID-19 treatments

Medicines COVID-19 Decision

What we’re doing

We're pleased to announce the Access Criteria for the oral antiviral COVID-19 treatments, nirmatrelvir with ritonavir (Paxlovid) and molnupiravir (Lagevrio). 

These Access Criteria have been developed with the advice of our clinical expert advisors. Supply of the oral treatments will be arriving throughout 2022 and the criteria have been designed to help support prescribers to target available supply to those most in need and most likely to benefit. The evidence continues to change quickly in the COVID-19 treatment space and we will continue to review the criteria and consider any changes as required. 

The first delivery of nirmatrelvir with ritonavir (Paxlovid) supply has now arrived in New Zealand and we expect will be available for use in the community from next week. Molnupiravir is undergoing Medsafe evaluation currently and the Access Criteria would become effective if molnupiravir is approved by Medsafe and stock is available in the country. 

The medicines will be listed on the Pharmaceutical Schedule from 1 April 2022 in preparation of availability. 

Prescriptions must be endorsed by the prescriber confirming that the patient meets the Access Criteria. There will be a different distribution process for these medicines to ensure the available supply is equitably available. Further information is provided below. 

You can read about the New Zealand COVID-19 treatments portfolio and availability of the treatments here. 

Any changes to the original proposed access criteria?

This decision was subject to a consultation letter dated 16 February 2022. 

We received a large amount of thoughtful feedback and we would like to thank all those who took the time to provide this. A summary of the feedback received can be found at the end of this notification. We have made a number of changes to the Access Criteria following this feedback. 

The main changes include:

  • An increase in the number risk factors required
  • Age access has been adjusted based on new clinical data, hospitalisation risk and vaccination status
  • Reference to the Ministry of Health’s list of risk factors for severe COVID-19 disease. This ensures that there is one source of guidance and means that as evidence evolves the Access Criteria evolve in line with the Ministry’s advice
  • Community Pharmacies can claim for dispensing of these two treatments via the COVID-19 Community Care payment

Detail about this decision

The access criteria 

The following access criteria will apply to both nirmatrelvir with ritonavir (Paxlovid) and molnupiravir (Lagevrio), once available. 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:

Notes:

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

** Risk factors for severe COVID-19 disease identified by the Ministry of Health(external link)

*** ‘Fully Vaccinated’ defined as per the Ministry of Health definition [PDF].(external link)

Pharmac will continue to monitor the evidence as it becomes available, as well as available supply  and update the criteria as required. We will also review the access criteria for another COVID-19 treatment, remdesivir, in the next few weeks in light of the availability of oral treatment. 

For clarity, no specific factors (under criterion 3.2) are required to access these treatments. A person must have at least five of any of the factors, whether they be the factors named specifically in the criteria, the risk factors listed on the Ministry of Health website, or a combination of both. A person with any combination of five factors would meet criteria 3.2. 

Below are some examples of scenarios for eligibility: 

Please note these examples have been drafted as per the risk factors listed on the Ministry of Health website as of 30 March 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 has severe mental illness, has diabetes that isn’t well controlled, has chronic lung disease, has hypertension which isn’t well controlled and has a BMI of 40.

This patient has five risk factors (as on the Ministry of Health website) and therefore meets criterion 3. If the patient meets the other criteria the patient is eligible for treatment. 

Example 2: Patient is aged 55 and has not completed a full course of vaccination, has a history of smoking, has an addiction issue, has chronic lung disease and a serious heart condition.

This patient has five factors and therefore meets criterion 3. If the patient meets the other criteria the patient is eligible for treatment. 

Example 3: 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 3. If the patient meets the other criteria the patient is eligible for treatment. 

Information for patients

If you have, or suspect you have COVID-19 and are at high risk of developing severe COVID-19 disease, 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. You can find more information on the Ministry of Health website here: https://www.health.govt.nz/covid-19-novel-coronavirus(external link)

Information for health care professionals

The oral antiviral COVID-19 treatments will not be 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 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.

Supply of nirmatrelvir with ritonavir and molnupiravir will be available to order only by selected community pharmacies and DHB Hospitals. This process will be managed by the Ministry of Health and more information will be provided soon.   

The first delivery of nirmatrelvir with ritonavir stock has arrived in New Zealand and supply will be managed through one wholesaler, ProPharma. Supply will be arriving throughout 2022 and the criteria have been designed to help to support prescribers to target available supply to those most in need and most likely to benefit. The XPharm rule is applied to these agents 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 will be listed in Section B and Part II Section H of the Pharmaceutical Schedule from 1 April, at a price 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). There will be no standard dispensing fee or patient co-payment. Pharmacies will be reimbursed by COVID-19 Care in the Community funding. Information regarding the claiming mechanism for this payment to Pharmacies will be available from DHBs. 

For more information about distribution and stock availability please visit our main COVID-19 web page pharmac.govt.nz/treatcovid. Molnupiravir is not yet available, we will post updates to our website as information becomes available. 

Where to get more information

For the most up to date information regarding all COVID-19 treatments – please check our website pharmac.govt.nz/treatcovid

Risk factors for severe COVID-19 disease identified by the Ministry of Health(external link) 

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

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made are set out below. 

Theme

Pharmac staff comment

Support

Support for this proposal. In particular there was support for aligned criteria for the two agents, use in the community, ethnicity-based criteria and use in immunocompromised people. 

We are pleased to secure these treatments and to confirm Access Criteria that direct treatment to people with the highest health need and who will benefit most.

Restrict access criteria

Concerns were raised about the low threshold for access to these medicines and the potential for those at the highest risk (and who would benefit most) missing out on treatment because of this. Some responders considered that the number of required risk factors should be increased, particularly for the vaccinated cohort.

We have amended the criteria to require more risk factors to be required to access these treatments. The aim of this is to target these medicines to people who would benefit most from treatments.

We will continue to monitor the appropriateness of the criteria alongside available supply and make changes if required. 

Widen access criteria

Significant concerns were raised about the availability of these treatments for people with a range of rare disorders and disabilities as many people with these conditions would not fit into the proposed list of co-morbidities but could have significant negative impacts from COVID-19. 

Request for the inclusion of a criterion which would include people with such conditions and allow the treating clinician to make an access decision in these settings.

We appreciate that there are significant concerns around lack of access to these treatments for people with a range of conditions.

We have amended the criteria to directly reference the Ministry of Health’s list of people who are at high risk of severe illness from COVID-19(external link). This means that as evidence evolves and the Ministry updates this list, the criteria would evolve to match. We will be sharing this feedback with the Ministry of Health for its consideration. We note that since we consulted on these criteria, the Ministry of Health has included disability as a risk factor for severe illness from COVID-19.

We acknowledge that the number of risk factors have increased as part of decision and that this may present further barriers to some people accessing treatments. Following careful consideration of the consultation feedback and seeking further clinical advice, the criteria has been set to best direct treatment to those at highest risk and who the evidence demonstrates would benefit most. We understand the criteria may not capture every person who might be at risk of severe COVID-19 disease. We will continue to monitor the evidence as it becomes available, as well as available supply and update the criteria as required.

Our Exceptions pathway remains an option should any individual cases need consideration outside of the criteria. 

Align criteria with Ministry of Health risk factors for severe disease– eg. add mental health, addiction. 

Given the fluid nature of these risk factors, consider replacing the word ‘are’ with ‘include’ to indicate that this list is not exhaustive. 

We have amended the criteria to directly reference the Ministry of Health’s list of people who are at high risk of severe illness from COVID-19(external link). This means that as evidence evolves and the Ministry updates this list, the criteria would evolve to match.

We appreciate the fluid nature of evolving evidence, however in order to best target available stock the list will be limited to the Ministry’s list and those described in the criteria. We will continue to monitor the appropriateness of the criteria and make changes if required.

There is published evidence of substantial differences in the age gap of Māori and Pacific peoples compared with Euro/Other (Steyn et al. NZ Medical Journal 2021(external link)). 

Consider lowering the age requirement to 45 years for Māori and Pacific, or if left at 65 years that it should be counted as two risk factors.

The separate criterion of Māori or of any Pacific ethnicity encompasses lower age requirements, and in effect extends beyond this request to have ethnic-specific lower ages. Rather than lowering the age requirement for Māori and Pacific, the Access Criteria remove age for these groups, and they are counted having an extra unique factor.

We acknowledge that the Ministry of Health factors also include references to age and also Māori and Pacific ethnicity related risk factors (such as difficulties with access to health care, crowded housing), and consider these could be counted as a separate risk in addition to the Pharmac ethnicity criteria.

A number of small changes/ clarifications were requested to the list of risk factors.

We have amended the criteria to directly reference the Ministry of Health’s list of people who are at high risk of severe illness from COVID-19(external link). This means that as evidence evolves and the Ministry updates this list, the criteria would evolve to match.

Consider access extension to post-exposure prophylaxis for nirmatrelvir with ritonavir for high-risk groups. 

At this point in time our COVID-19 Treatments Advisory Group has not recommended nirmatrelvir with ritonavir for post-exposure prophylaxis use. We note the clinical trial investigating this use is still recruiting and no results have been published.

We will continue to monitor the appropriateness of the access criteria and seek clinical advice as required.

Consideration for longer treatment window (from five to seven days) for rural access.

We appreciate that a five-day window for treatment initiation may create an issue for accessing these medicines. However, this time period is where the evidence demonstrates efficacy of these treatments, our Advisory Group recommended that this time frame be implemented based on the available evidence.

Pharmac and the Ministry of Health COVID-19 Care in the Community team are working closely together to support a system that would ensure treatments are accessible quickly in rural settings.

Implementation

Clear prescriber guidance needs to be available, including contraindication information. 

Prescriber guidance regarding medicine selection should be available

Pharmac as a medicine funder does not directly provide clinical guidelines.

The Ministry of Health provides clinical advice for health professionals on COVID-19 treatments(external link). Pharmac will include relevant links on its website when guidance is available for the oral treatments.

Resources will also be available on He Ako Hiringa(external link) regarding guidance on nirmatrelvir with ritonavir for health care professionals.

Communications should be clear that some treatments for cancer and some cancers themselves would allow eligibility under the immunocompromised definition.

We have amended the criteria to directly reference the Ministry of Health’s list of people who are at high risk of severe illness from COVID-19(external link).

We acknowledge that some people with cancer would meet criterion 3.1 for those who are immunocompromised and not expected to mount an immune response to vaccination, and others may be eligible through 3.2 if they have five factors. 

Education to the public and primary care about getting tested when symptoms start and seeking medical treatment needed to ensure that those who will benefit from treatment get it within a timely manner. 

Access to rapid antigen tests will be important in identifying patients who are eligible for oral antivirals in a timely manner. Consideration should be given on how access to tests can occur in lower socio-economic groups

We agree that these are important aspects of successful implementation of these medicines. We will share this feedback with the Ministry of Health.

Pharmac could assist the implementation process by ensuring access criteria will not pose undue difficulties in implementation, by providing timely information on supply and distribution, and by supporting prescriber information and information to other relevant health professionals as appropriate.

We will keep our website updated with relevant supply and distribution information.

Pharmac and the Ministry of Health COVID-19 Care in the Community team are working closely together to support a system that would ensure treatments are accessible and information is shared between us.

Concerns surrounding the Xpharm distribution model for the supply of the two COVID-19 treatments. It does not utilise pharmacists as medicines experts. 

Pharmacies should be reimbursed for their time and service. 

Most community pharmacies already offer medicine deliveries and have a “Covid Care in the Community” system in place to be able to provide medicine to people isolating or sick at home.

We value the significant contributions that Community Pharmacies play in the healthcare sector, including during the COVID-19 response.

Through collaboration with the Ministry of Health, we can confirm that a mechanism will be in place to use selected pharmacies to support the provision of COVID-19 treatments. It would also allow reimbursement to Community Pharmacies for work in dispensing these XPharm pharmaceuticals through the COVID-19 Care in the Community funding payment pathway.

Concerns raised regarding short approval time and short window of treatment initiation. Suggest that preapproval be given to all high-risk people so they can have treatment on hand. 

Highlighted difficulties in accessing timely medical care in rural areas.

To ensure supply is available and accessible for those who would benefit most, we are not able to consider funding for preapproval for eligible patients.

We appreciate that it may be more difficult for those in rural areas to access timely medical care. The Ministry of Health is working on a range of initiatives to assist people in rural areas access treatment if they need it.

General

Preference for nirmatrelvir with ritonavir availability over molnupiravir, particularly for the highest risk groups. 

Molnupiravir is associated with an excess rate of SARS-CoV-2 mutations (and a risk of resistant variant emergence), particularly if given to severely immunocompromised people, who might not clear the SARS-CoV-2 virus for months.

We appreciate that there may be preferences for different medicines in different scenarios. Pharmac has taken a ‘portfolio’ approach to procuring COVID-19 medicines to ensure that there is a range of options available for this very reason. 

At this point in time, we do not have confirmation if or when molnupiravir would be granted Medsafe approval and be available in New Zealand. We will closely monitor available supply of the medicines and work with the relevant suppliers if more stock is required to meet the needs of New Zealanders.

Concern regarding inclusion of ethnicity-based criteria and the fairness of this.

The recommendations to include ethnicity-based criteria are based on what the evidence tells us about the impact of COVID-19 in New Zealand and are in line with the clinical advice from our Advisory Group. It is also in line with the Ministry of Health’s advice about who is at high risk of severe disease from COVID-19.

Concern that advantaging access to unvaccinated individuals sends the wrong message.

We appreciate the concerns raised about access to these medicines for those who are not fully vaccinated against COVID-19.

The criteria around vaccination status have been recommended by our Advisory Group based on the available evidence. You can read more about their considerations here under the ‘read more’ section under the relevant medicine headings.

Given the rapidly evolving knowledge about COVID-19 and its treatments, we wish to see regular reviews and updates of these criteria if indicated (and any changes widely communicated to prescribers).

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

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.