Decision to secure supply of remdesivir for the treatment of moderate to severe COVID-19

Medicines Decision

What we’re doing

We have secured additional stock of remdesivir (Veklury) for the treatment of patients hospitalised with moderate to severe COVID-19 subject to inclusion and exclusion criteria.

Detail about this decision

In August 2020 Pharmac entered into an agreement with Gilead Sciences, Australia & New Zealand (Gilead) for the supply of a limited quantity of remdesivir (Veklury) for the treatment of patients hospitalised with moderate to severe COVID-19. This stock has now been exhausted. 

As a result of the current COVID-19 delta variant outbreak in New Zealand, and to prepare for future COVID-19 outbreaks, Pharmac has secured further supply of remdesivir for use in New Zealand. Remdesivir will not be listed on the Pharmaceutical Schedule; however, it will be available for DHB Hospitals to order via pharmaceutical wholesaler Onelink. 

Remdesivir is not approved by Medsafe for use in New Zealand, meaning it would continue to be prescribed and used in accordance with section 25 of the Medicines Act 1981(external link)

The prescribing clinician is required to review the following inclusion and exclusion criteria, which have been adopted and adapted from the current Australian Government’s criteria for access (as of 14 October 2020). 

Funded access to remdesivir is available for the treatment of moderate to severe COVID-19 in patients who satisfy all of the following inclusion and exclusion criteria, and special considerations:

Inclusion Criteria

  • Patient
    • age ≥ 18 years, or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg.
    • is hospitalised with confirmed SARS-CoV2 or known contact of confirmed case with syndrome consistent with coronavirus disease (COVID-19) awaiting confirmation by diagnostic testing.
    • has oxygen saturation (SpO2) ≤ 92% on room air and requiring supplemental oxygen
    • has alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN) by local laboratory measure; and/or ALT < 3 x ULN and bilirubin < 2 x ULN. 
  • The treating clinicians consider that such escalation of care is appropriate. 
  • Informed consent has been provided by the patient or the patient’s legal representative, according to local practices. 

Exclusion Criteria

  • Patient
    • has evidence of multiorgan failure including but not limited to coagulopathy (significant thrombocytopenia), hepatic failure (elevated bilirubin) or renal failure (low urine output or estimated glomerular filtration rate (eGFR) less than 30 mL/min), or significant cardiomyopathy (low cardiac output).
    • has renal failure (eGFR less than 30 mL/min or dialysis or continuous venovenous haemofiltration.
    • has been on mechanical ventilation for longer than 48 hours at time of application
    • is receiving ECMO.
    • has known hypersensitivity to remdesivir, the metabolites, or formulation excipient. 

Special Considerations 

The clinical benefit of remdesivir is uncertain in some scenarios. The prescribing clinician should give strong consideration to whether remdesivir is likely to benefit the patient in the following scenarios: 

  • Mechanical ventilation for less than 48 hours at time of commencing treatment with remdesivir
  • Presence of an intercurrent illness which is likely to lead to the patient’s death within one year
  • Advanced age with limitations on activities of daily living
  • Need for more than a 5 day treatment course.

Further context and review of evidence can be found in the record of the Pharmac ad hoc Remdesivir COVID-19 Advisory Group (September 2020) [PDF, 125 KB].

Accessing supply of remdesivir

DHB hospitals will order stock direct from Onelink. Wholesale stock will be held and distributed to DHB Hospitals by Onelink in Auckland and Dunedin. 

When patients are treated with remdesivir, DHB hospitals are required to complete and send a copy of the completed treatment notification form [DOCX, 37 KB] to waivers@pharmac.govt.nz

For more information, such as dosage and method of administration, please refer to the factsheet provided by Gilead Sciences (New Zealand) [PDF, 975 KB].