Decision on access criteria for oral COVID-19 treatments

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.