Proposal on access criteria for two oral COVID-19 treatments
What we’re proposing
We are seeking feedback on the proposed access criteria for:
- Nirmatrelvir with ritonavir (Pfizer’s oral antiviral) for the treatment of acute COVID-19 disease, and
- Molnupiravir (Merck’s oral antiviral) for the treatment of acute COVID-19 disease.
Both medicines are taken orally and can be taken at home by eligible people shortly after COVID-19 symptoms start. In addition, we are interested in feedback on how community distribution of nirmatrelvir with ritonavir and molnupiravir could be achieved in an equitable way.
We have previously announced that we have secured stock for both nirmatrelvir with ritonavir and molnupiravir through advanced purchase agreements.
Changes are proposed to be made to the Pharmaceutical Schedule following any Medsafe approval and once supply is available in New Zealand.
Consultation closes at 5 pm on Wednesday 2 March 2022 and feedback can be emailed to consult@pharmac.govt.nz
We consider it is important to seek feedback on this proposal as soon as possible, given the rapidly evolving nature of the COVID-19 pandemic and the need to confirm access to treatments in a timely manner.
What would the effect be?
Nirmatrelvir with ritonavir (also known as Pfizer’s oral antiviral)
Nirmatrelvir with ritonavir would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule for the treatment of patients with acute COVID-19 disease who meet the following access criteria:
Special Authority for Subsidy
Initial application – from any relevant practitioner. Approvals valid for 2 weeks for applications meeting the following criteria:
All of the following:
- Patient has confirmed (or probable) symptomatic COVID-19; and
- Patient’s symptoms started within the last 5 days; and
- Any of the following:
- Immunocompromised individuals not expected to reliably mount an adequate immune response to COVID-19 vaccination or SARS-CoV-2 infection; or
- Patient is unvaccinated* and has at least one of the following: Aged 65 years or over, Māori or any Pacific ethnicity, any comorbidity as listed below**; or
- Patient is vaccinated* and has at least two of the following: Aged 65 years or over, Māori or any Pacific ethnicity, any comorbidity as listed below**; and
- Either:
- Patient does not require supplemental oxygen (oxygen saturation >93%); or
- Patient does not require supplemental oxygen at saturations no lower than baseline for patients with chronic resting hypoxia; and
- Not to be used in conjunction with other COVID-19 antiviral treatments.
Notes:
* ‘Vaccinated’ defined as having received at least two vaccine doses more than seven days earlier.
** Comorbidities associated with a higher risk of severe outcomes are: severely immunocompromised, significant cardiac disease, uncontrolled hypertension, uncontrolled diabetes, chronic lung disease, chronic kidney disease, chronic liver disease, cancer, history of smoking, BMI 40 or higher. More detail available on the Ministry of Health website(external link)
Nirmatrelvir with ritonavir tablets is currently undergoing regulatory review by Medsafe. For more information refer to the Medsafe website for the approval status of COVID-19 treatments(external link). It is anticipated that nirmatrelvir with ritonavir would be available in New Zealand between April and June 2022, subject to approval by Medsafe.
Nirmatrelvir with ritonavir is an oral antiviral medicine that could be used to treat patients with COVID-19 in the community. Our COVID-19 Treatments Advisory Group has told us that the proposed access criteria would target treatment to those who would benefit most. Full details of the advice we have received is available here: December 2021 record [PDF, 152 KB] and February 2022 record [PDF, 71 KB]. We continue to seek updated advice as evidence emerges.
Nirmatrelvir with ritonavir would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule, subject to the restrictions listed above, if approved by Medsafe, as follows.
| Chemical | Formulation | Brand | Pack size | Price and subsidy |
|---|---|---|---|---|
| Nirmatrelvir with ritonavir | Tab nirmatrelvir 150 mg (20) and tab ritonavir 100 mg (10) | Paxlovid | 30 | $0.00 |
The Xpharm restriction would apply, meaning that community pharmacies cannot claim subsidy because Pharmac has made alternative funding arrangements.
The price and subsidy would be listed as $0 as stock has 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). DHBs would need to order stock from a pharmaceutical wholesaler as required, but would not be invoiced for supply.
Nirmatrelvir with ritonavir would be supplied in packs of 30 tablets (ie. one treatment course). The recommended dose is 300 mg of nirmatrelvir (two 150 mg tablets) with 100 mg of ritonavir (one 100 mg tablet) every 12 hours (a total of 3 tablets, twice daily) for five days. This medicine is to be started within 5 days of symptom onset.
Ritonavir may impact how some other medicines work and the patient’s current medicines will require assessment by a prescriber before a patient is prescribed nirmatrelvir with ritonavir. More information regarding ritonavir interactions can be found in the ritonavir data sheet on the Medsafe website.(external link)
Pharmac has secured supply of a limited volume of nirmatrelvir with ritonavir, which would be sufficient to treat up to a maximum of 60,000 patients with acute COVID-19 throughout 2022.
Molnupiravir
Molnupiravir (Merck’s oral antiviral) would be listed in Section B and Part II of Section H of the of the Pharmaceutical Schedule for the treatment of patients with acute COVID-19 disease for patients who meet the following criteria:
Special Authority for Subsidy
Initial application – from any relevant practitioner. Approvals valid for 2 weeks for applications meeting the following criteria:
All of the following:
- Patient has confirmed (or probable) symptomatic COVID-19; and
- Patient’s symptoms started within the last 5 days; and
- Any of the following:
- Immunocompromised individuals not expected to reliably mount an adequate immune response to COVID-19 vaccination or SARS-CoV-2 infection; or
- Patient is unvaccinated* and has at least one of the following: Aged 65 years or over, Māori or any Pacific ethnicity, any comorbidity as listed below**; or
- Patient is vaccinated* and has at least two of the following: Aged 65 years or over, Māori or any Pacific ethnicity, any comorbidity as listed below**; and
- Either:
- Patient does not require supplemental oxygen (oxygen saturation >93%); or
- Patient does not require supplemental oxygen at saturations no lower than baseline for patients with chronic resting hypoxia; and
- Not to be used in conjunction with other COVID-19 antiviral treatments.
Notes:
* ‘Vaccinated’ defined as having received at least two vaccine doses more than seven days earlier.
** Comorbidities associated with a higher risk of severe outcomes are: severely immunocompromised, significant cardiac disease, uncontrolled hypertension, uncontrolled diabetes, chronic lung disease, chronic kidney disease, chronic liver disease, cancer, history of smoking, BMI 40 or higher. More detail available on the Ministry of Health website(external link)
Molnupiravir is not approved by Medsafe and was submitted for regulatory review by Medsafe this week. For more information refer to the Medsafe website for the approval status of COVID-19 treatments(external link). It is anticipated that molnupiravir would be available in New Zealand between April and June 2022, subject to approval by Medsafe.
Molnupiravir is an oral antiviral medicine that could be used to treat patients with COVID-19 in the community. After review in October 2021 and February 2022 our COVID-19 Treatments Advisory Group has told us that this access criteria would target treatment to those who would benefit most. Full details of the advice we have received is available here: October 2021 record [PDF, 291 KB] and February 2022 record [PDF, 71 KB]. We continue to seek updated advice as evidence emerges.
Molnupiravir would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule, subject to the restrictions listed above, if approved by Medsafe as follows:
|
Chemical |
Formulation |
Brand |
Pack size |
Price and subsidy |
|---|---|---|---|---|
|
Molnupiravir |
Cap 200 mg |
Lagevrio |
40 OP |
$0.00 |
The Xpharm restriction would apply, meaning that community pharmacies cannot claim subsidy because Pharmac has made alternative funding arrangements.
The price and subsidy for molnupiravir would be $0 as stock has been purchased directly by Pharmac. These medicines 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). It is anticipated that DHBs would need to order stock from a pharmaceutical wholesaler as required but would not be invoiced for supply.
We have secured supply of a limited volume of molnupiravir, which would be sufficient to treat up to a maximum of 60,000 patients with acute COVID-19 throughout 2022.
Molnupiravir would be supplied in packs of 40 capsules. The recommended dose is four 200 mg capsules (800 mg) taken twice-a-day for 5 days. Molnupiravir should be given as soon as possible after a diagnosis of COVID-19 has been made, and within 5 days of symptom onset.
Why we’re proposing this
Pharmac and the suppliers of nirmatrelvir with ritonavir (Pfizer) and molnupiravir (Merck Sharp & Dohme) have negotiated agreements for supply of a limited volume of the medicines for the treatment of COVID-19. The proposed criteria reflect the limited volume that would initially be available.
COVID-19 is an area of rapidly evolving evidence and knowledge. We understand that there may be additional groups in the community that could benefit from treatment with nirmatrelvir with ritonavir or molnupiravir who may fall outside the currently proposed criteria. Any future proposals for wider access criteria would be subject to a separate consultation process.
The exact process of how nirmatrelvir with ritonavir and molnupiravir would be distributed to patients in the community is yet to be confirmed. We are working with the Ministry of Health to identify and consider available options, including the possible use of regional and local coordination hubs that are being established to support New Zealand’s response to COVID-19. We are particularly interested in receiving feedback on how equitable distribution in the community could be achieved.
Given the emergence of novel Variants of Concern, Pharmac is continuing to work as quickly as possible to assess the latest information as it becomes available.
To provide feedback
Please send us an email: consult@pharmac.govt.nz by 5pm on Wednesday 2 March 2022.
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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