Proposed addition to the schedule of the Medicines (Designated Pharmacist Prescribers) Regulations 2013
Overview
Overview
The Ministry of Health (the Ministry) invites submissions on proposed additions to the schedule of specified prescription medicines for designated pharmacist prescribers.
The Ministry, on behalf of the Director-General, must consult with those people or organisations that may be affected by a change to the schedules before making a legal change by Gazette notice. The Ministry is doing a joint consultation, in partnership with the Pharmacy Council.
This submission will allow you to provide feedback on the proposed medicines:
Active pharmaceutical ingredients |
Proposed for addition to Schedule [1] |
Approved Medsafe product (brand name) |
Nirmatrelvir Ritonavir |
Yes (Note: ritonavir is already scheduled) |
Yes (Paxlovid) |
Molnupiravir
|
Yes |
Yes (Lagevrio) |
Casirivimab |
Yes |
Yes (Ronapreve) |
Imdevimab |
Yes |
Yes (Ronapreve) |
Etesevimab |
Yes |
No |
Sotrovimab |
Yes |
No (Xevudy) |
Ensovibep |
Yes |
No |
Cilgavimab |
Yes |
No |
Tixagevimab |
Yes |
No |
[1] https://gazette.govt.nz/notice/id/2021-go4269
The oral antiviral medicines, Paxlovid and Lagevrio are used in the treatment of COVID-19 in adults, who do not require initiation of supplemental oxygen and are at increased risk of progression to hospitalisation or death.
The medicine should be taken as soon as possible after a diagnosis of COVID-19 has been made and within five days of symptoms onset. Pharmacist prescribers are well positioned to ensure equitable and early access to COVID-19 treatments for their local communities.
At the time of consultation, sotrovimab (Xevudy), etesevimab, ensovibep, cilgavimab, tixagevimab are section 29, or unapproved medicines. Current legislation does not authorise pharmacist prescribers to prescribe unapproved medicines and does allow the inclusion of unapproved medicines in these specified medicine schedules.
Therefore these proposals are forward-looking to avoid barriers to accessing important medicines which may become available in New Zealand. Approval status may change; please check the Medsafe website for up-to-date information on the approval status of this medicine. Please refer to the Pharmac website for the latest funding information and access criteria.
Please submit your feedback on the proposed additions by 22 May 2022.
Other information can be found at:
MEDSAFE: Approval status of COVID-19 treatment applications received by Medsafe
PHARMAC: New Zealand's COVID-19 treatments portfolio
Update for health professional: Therapeutics for the treatment of COVID-19
Audiences
- Members of the public
- Health sector
- Disability sector
- Pharmaceutical companies
- Service providers
Interests
- Therapeutic products
- Pharmacy
- COVID-19 response
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