OIA response | Availability, approval and evidence for remdesivir, tocilizumab and other COVID-19 treatments

Dear [name and contact details withheld] 

Request for information

Thank you for your request dated 4 October 2021 under the Official Information Act 1982 (OIA) for information relating to treatments for COVID-19.

As requested in your email to us, please find our response under each of you questions below. 

1.)   Please advise when Remdesivir was first made available for the management of sars-cov 2 in New Zealand

A limited quantity of remdesivir (Veklury) has been available for DHBs to order since late 2020 to treat people hospitalised with moderate to severe COVID-19. 

2.)   Please provide both provisional and full approvals obtained from Medsafe which confirm that Remdesivir is both safe and effective to be used to manage the symptoms associated with sars-cov 2 in NZ.

Remdesivir is not currently Medsafe approved to treat COVID-19. This means that remdesivir needs to be prescribed and used in accordance with Section 25 of the Medicines Act 1981. 

3.)   Please provide evidence from peer reviewed trials that Remdesivir has not resulted in death / injury to sars-cov 2 patients in the USA / UK / Israel / Australia / Canada or any other country where this product has been trialled for the purpose that it is currently being used for in New Zealand.

Pharmac does not hold any information that specifically states that remdesivir has not resulted in the death or injury to COVID-19 patients. However, the record of the Pharmac ad hoc Remdesivir COVID-19 Advisory Group meeting of September 2020(external link) references the clinical evidence and/or trials reviewed for the use of remdesivir in patients with COVID-19 and to determine criteria for its use. 

The Remdesivir COVID-19 Advisory Group meeting records can be found on our website: www.pharmac.govt.nz > About > How we get expert advice > Advisory groups > Remdesivir COVID-19 Advisory Group (Ad hoc) 

4.)   Please advise when Tocilizumab was first made available for the management of sars - cov 2 in New Zealand.

We widened access on 1 October 2021 for tocilizumab for the treatment of moderate to severe COVID-19. This means tocilizumab has been used for hospitalised patients with Covid-19. 

Prior to 1 October 2021, applications for tocilizumab for the treatment of COVID-19 were assessed via our exceptional circumstances funding pathway (Named Patient Pharmaceutical Assessment). 

More detail about the decision to widen access to tocilizumab for treatment of moderate to severe COVID-19 is published on our website.  

5.)   Please provide both provisional and full approvals obtained from Medsafe which confirm that Tocilizumab is both safe and effective to be used to manage the symptoms associated with sars-cov 2 in NZ.

Tocilizumab is not currently Medsafe approved for to treat COVID-19. This means that tocilizumab needs to be prescribed and used in accordance with Section 25 of the Medicines Act 1981 when used for this unapproved use. 

We understand tocilizumab for use in the treatment of COVID-19 received FDA emergency use authorisation in June 2021. Additionally, the European Medicines Agency is currently assessing this medicine. 

6.)   Please provide evidence from peer reviewed trials that Tolicilizumab has not resulted in death / injury to sars-cov 2 patients in the USA / UK / Israel / Australia / Canada or any other country where this product has been trialled for the purpose that it is currently being used for in New Zealand.

Pharmac does not hold any information that specifically states that tocilizumab has not resulted in the death or injury to COVID-19 patients. However, the record of the tocilizumab Advisory Group [PDF, 112 KB] (ad hoc) meeting of April 2021 references the clinical evidence and/or trials reviewed for the use of tocilizumab in patients with COVID-19 and to determine criteria for its use. 

The Tocilizumab Advisory Group meeting records can be found on our website: www.pharmac.govt.nz > About > How we get expert advice > Advisory groups > Tocilizumab Advisory Group (ad hoc)

 

7.)   Please advise who approved both of the above drugs to be used to manage sars-cov 2 in New Zealand.

Medsafe is the authority responsible for regulating therapeutic products in New Zealand. Medsafe uses its evaluation and approval process(external link) to assess the safety and efficacy of medicines before they are approved for use in New Zealand. At present neither tocilizumab or remdesivir have been approved by Medsafe for the treatment of COVID-19 in New Zealand. 

Clinicians in DHB hospitals will make decisions about suitability of these treatments for individual patients.

See the Medsafe website for more information about the use of unapproved medicines and unapproved use of medicines(external link). 

8.)   Please advise if there are any other treatment options currently in use / being considered for use in New Zealand to manage sars-cov 2.

Pharmac has negotiated an agreement with supplier Merck Sharp & Dohme (MSD) to purchase the antiviral molnupiravir. It will be used to treat New Zealanders with mild to moderate COVID-19 symptoms, subject to the treatment gaining regulatory approval in New Zealand by Medsafe.  

Pharmac is working to secure a range of new COVID-19 treatments for New Zealanders. At this stage, we cannot disclose the other medicines we are considering, or the pharmaceutical companies we are engaging with, due to the confidential nature of negotiations. 

We trust that this information answers your queries. We are making our information more freely available, so we now publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this. 

Yours sincerely

Rachel Read
Manager, Policy and Government Services