COVID-19 antivirals: The role of molnupiravir in New Zealand’s funded treatments portfolio
What we’re proposing
Pharmac is considering options to clarify the role of molnupiravir in New Zealand’s portfolio of funded COVID-19 treatments.
There is evolving evidence that suggests that molnupiravir may no longer be as effective in the treatment of COVID-19 compared to what we knew when molnupiravir was first purchased in early 2022.
We have sought feedback from various groups about the ongoing role of molnupiravir in treating COVID-19. What we have heard to date suggests that there are two broad options for the future role of molnupiravir in New Zealand’s COVID-19 funded treatment portfolio. They are:
- Stop funding molnupiravir and delist it from the Pharmaceutical Schedule altogether, meaning that it would no longer be publicly funded for any person for the treatment of COVID-19 in New Zealand.
- Make changes to the eligibility criteria for molnupiravir to limit funded access to a smaller group of people who may still be expected to benefit from treatment.
We would like to consider all relevant information and perspectives before we make a decision, so we are now seeking wider feedback. This will help us understand the ongoing role of molnupiravir and the benefit, if any that treatment offers people with COVID-19 in New Zealand.
We have proposed some questions under the heading “Details about our proposal”.
Consultation closes at 5pm on Tuesaday 2 May 2023 and feedback can be emailed to firstname.lastname@example.org
What would the effect be?
Following consideration of feedback to this consultation, we will determine if changes are required to the current funding arrangements for molnupiravir in New Zealand. This process will also inform future funding decisions for COVID-19 antiviral treatments.
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, eg. older people, non-vaccinated, unwell from other health conditions/comorbidities, Māori, Pacific peoples, people with disabilities
- People taking many or particular medicines which may interact with other funded COVID-19 antivirals
- People with kidney failure
- Prescribers of antiviral treatments for COVID-19
- Suppliers of COVID-19 treatments, including antivirals
- Clinicians and researchers evaluating the benefits of COVID-19 treatments available in New Zealand.
Why we’re proposing this
It is important to make sure funded treatments provide meaningful benefits for eligible New Zealanders. This requires that we review the ongoing role of molnupiravir in New Zealand’s portfolio of funded COVID-19 treatments and make decisions based on expert advice and evidence.
Currently, Pharmac’s funding eligibility criteria indicate that molnupiravir (or remdesivir) should be considered when nirmatrelvir with ritonavir is unsuitable or unavailable; which means it is not the first preferred option for the treatment of COVID-19.
Summary of clinical advice and key evidence
Pharmac has received advice from various clinical groups about the role of molnupiravir in New Zealand’s portfolio of funded COVID-19 treatments. Evolving evidence suggests that molnupiravir does not reduce the risk of hospitalisation or death from COVID-19 infection in highly vaccinated populations where the Omicron variant of the SARS-CoV-2 virus COVID-19 is dominant, such as New Zealand now. This advice is based on the available evidence that was considered at the time, often before publication, and in the context of a New Zealand population with increasing immunity due to vaccination and infection but changing variants.
The recent publication of the PANORAMIC randomised controlled trial(external link) provides updated evidence on the effectiveness of molnupiravir. We note that the results from the PANORAMIC study arm relating to nirmatrelvir with ritonavir are not yet available.
Advice from the Pharmac COVID-19 Treatments Advisory Group
Pharmac has received advice from our COVID-19 Treatments Advisory Group regarding molnupiravir on a number of occasions. The three most recent meeting records (linked below) summarise its clinical considerations on molnupiravir and includes key points and links to evidence. Records of earlier meetings will be made available soon.
At its February 2023 meeting the Advisory Group recommended that, based on the evidence available, molnupiravir should not be funded for the treatment of COVID-19 in New Zealand. This recommendation was based on a lack of evidence that molnupiravir provides benefit to people with COVID-19.
The Advisory Group considered there was no subgroup of people with any health condition or particular heath need who would benefit from using molnupiravir. The Advisory Group considered that the continued funding of molnupiravir could prevent the use of other antivirals that it considered are probably more effective in treating COVID-19.
Advice from primary care clinicians
We also recently sought advice about molnupiravir from primary care clinicians who are members of Pharmac’s network of specialist advisory committees. The advice received was mixed, and is summarised below.
- Some clinicians supported removing or restricting access to funded molnupiravir in New Zealand based on evolving evidence suggesting reduced efficacy in the treatment of COVID-19. They acknowledged that prescribers were using molnupiravir less frequently and noted that, in some cases, some prescribers were using molnupiravir if they thought it may be better than no treatment at all.
- Other clinicians queried what options would be available for people who are not able to receive other funded antiviral treatments for COVID-19, such as people on multiple medicines with drug-drug interactions, people with poor kidney function, people having COVID-19 again who had earlier experienced side effects with nirmatrelvir with ritonavir (Paxlovid) that couldn’t be tolerated, or people who experience barriers to care. Concerns were raised that removing funded access to molnupiravir would unevenly and unfairly impact people who are already facing existing barriers to care such as Māori, Pacific peoples and those who live rurally.
- Clinicians considered that remdesivir is currently not a practical option for treatment of COVID-19 in non-hospitalised patients due to challenges providing three daily infusions in the community setting.
Other relevant information
The Manatū Hauora COVID-19 Therapeutic Technical Advisory Group (CT-TAG) published a position statement on 28 February 2023 with its rationale for a recommendation not to use molnupiravir as treatment in non-hospitalised patients with COVID-19.
Position Statement on the use of molnupiravir – Te Whatu Ora website(external link)
The CT-TAG was established by Manatū Hauora in August 2021 to provide expert advice on existing and emerging medicines for use in the management of COVID-19 (including clinical guidelines).
Te Whatu Ora has subsequently published updated clinical guidance for clinicians in primary care.
Guidance on community use of oral COVID-19 antivirals – Te Whatu Ora website(external link)
About molnupiravir and other antivirals
Molnupiravir is an oral antiviral treatment for COVID-19 which has been funded and available in New Zealand since early April 2022. Molnupiravir is approved by Medsafe under section 23 of the Medicines Act.
Datasheet for molnupiravir (Lagevrio) - Medsafe [PDF](external link)
Molnupiravir is one of three antiviral treatments currently funded in New Zealand for COVID-19. The other antivirals are nirmatrelvir with ritonavir (Paxlovid) another oral antiviral treatment, and remdesivir (Veklury) which is administered via intravenous infusion.
Current availability and access criteria for antiviral treatments
Community / primary care
- all three antivirals currently have the same funding eligibility criteria
- remdesivir may be used to treat patients in the community via Te Whatu Ora hospital outpatient services.
Te Whatu Ora hospitals
- molnupiravir and nirmatrelvir with ritonavir (Paxlovid) have the same eligibility criteria as in the community
- remdesivir has some additional criteria for inpatient use(external link)
The eligibility criteria for COVID-19 antiviral treatments have been reviewed by Pharmac and its COVID-19 Treatments Advisory Group on several occasions over the last 12 months and were most recently updated on 14 September 2022.
Supply and usage
To date Pharmac has secured 69,000 courses of molnupiravir. As of 20 March 2023, approximately 44,200 courses have been dispensed to people who meet the eligibility criteria.
We have also secured 120,000 courses of nirmatrelvir with ritonavir (Paxlovid) and 8,000 courses of remdesivir.
Current dispensing data indicates that, of the two available oral antiviral treatments for COVID-19 (molnupiravir and nirmatrelvir with ritonavir), molnupiravir has comprised approximately one-third of all dispensing’s for funded oral antiviral treatments in New Zealand.
About New Zealand’s COVID-19 Treatments Portfolio
Pharmac is making sure New Zealanders can access funded medicines to treat and prevent COVID-19. Supplies are limited and distributed through a specific COVID-19 national model.
Since the pandemic began, Pharmac has had to make purchasing decisions using limited amounts of evidence so, to make sure New Zealanders could access funded treatments to protect against severe illness, we took a risk-balanced portfolio approach and purchased a range of different medicines.
Due to the changing nature of COVID-19, some of the treatments that were developed for the virus in the past few years may no longer be as effective.
We assess the efficacy of treatments using the information that is available, so we are regularly reviewing new evidence and considering the current environment to inform any appropriate changes to our approach.
COVID-19 treatments are funded from a dedicated budget allocated by the Government, which means that COVID-19 treatment costs do not come from the annual budget for New Zealand’s medicines (the Combined Pharmaceutical Budget).
Learn more about Pharmac's role in New Zealand's COVID-19 response and our treatment portfolio (includes distribution and stock availability).
Details about our proposal
Pharmac is considering if molnupiravir should continue to remain funded for the treatment of COVID-19 treatments. There are two options we have identified:
- Stop funding molnupiravir and delist it from the Pharmaceutical Schedule, meaning that:
- Molnupiravir would no longer be publicly funded for any person for the treatment of COVID-19 in New Zealand from a certain date.
- Existing stock would no longer be available for dispensing or distribution.
- Pharmac would store current stock until it expires, then it would be destroyed.
- Make changes to the eligibility criteria for funded molnupiravir to limit access to a smaller group of people who may still be expected to benefit from treatment.
We are interested in evidence, feedback and information that will help us to further understand if there is an ongoing need for funded molnupiravir and who the population groups are that may be expected to benefit from treatment with molnupiravir. This may include:
- clinical opinion on the ongoing use of molnupiravir in New Zealand.
- evidence that supports the ongoing funding of molnupiravir for any specific population groups in New Zealand
- other information you would like Pharmac to consider in future decision-making on the ongoing funding of molnupiravir.
To help guide your feedback, we have proposed some questions:
- Are there any particular groups of people who are being treated with funded molnupiravir in New Zealand who may still benefit from it?
- Is there any way to clearly identify the groups of people who would be expected to benefit from treatment with molnupiravir?
- Are there any groups of people who would be negatively impacted if molnupiravir was not publicly funded in New Zealand?
- Would any of these groups not be able to receive other funded COVID-19 antivirals (i.e. nirmatrelvir with ritonavir or remdesivir)? If not, why not?
- How would these people’s acute COVID-19 disease be managed if molnupiravir was no longer funded in New Zealand?
- Is there any information or evidence Pharmac should be aware of to support our ongoing consideration of funding for molnupiravir?
Next steps after consultation
Following the consultation we will consider the feedback and use this to inform a proposal to remove or restrict the funding of molnupiravir. We expect a decision would be made in May for implementation in June 2023.
We will continue to seek updated clinical advice from our expert advisory network, which may include taking information or evidence that we receive through this consultation to them for additional advice.
To provide feedback
Send us an email: email@example.com by 5pm, Tuesday, 2 May 2023.
All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision.
Your feedback may be shared
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.
We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.