MEMORANDUM FOR CONSIDERATION BY DIRECTOR OF OPERATIONS
To:
Director of Operations
From:
Manager Pharmaceutical Funding
Date:
September 2020
__________________________________________________________________________
Procurement of emergency stock of remdesivir for use in New Zealand
Recommendations
It is recommended that having regard to the decision-making framework set out in PHARMAC's
Operating Policies and Procedures you exercise your delegated authority and:
resolve to approve the 31 August 2020 Stock Agreement with Gilead Sciences (NZ);
note that the Stock Agreement for this Pharmaceutical is required to secure supply as
the global supply of remdesivir is constrained;
note that the number of vials secured and the total impact to the CPB are confidential
and they cannot be disclosed to the public.
released under the
Official Information Act
A1422150 – T20-1160
Factors for Consideration
This paper sets out PHARMAC staff’s assessment of the proposal using the Factors for
Consideration in the Operating Policies and Procedures. Some Factors may be more or less
relevant (or may not be relevant at all) depending on the type and nature of the decision being
made and, therefore, judgement is always required. The Decision Maker is not bound to accept
PHARMAC staff’s assessment of the proposal under the Factors for Consideration and may
attribute different significance to each of the Factors from that attributed by PHARMAC staff.
released under the
Footnotes
1 The person receiving the medicine or medical device must be an eligible person, as set out in the
Health and Disability Services Eligibility Direction 2011 under Section 32 of the New Zealand Public
Health and Disability Services Act 2000.
2 The current Māori health areas of focus are set out in PHARMAC’s Te Whaioranga Strategy.
3 Government health priorities are currently communicated to PHARMAC by the Minister of Health’s
Letter of Expectations.
4 Pharmaceutical expenditure includes the impact on the Combined Pharmaceutical Budget (CPB) and
/ or DHB hospital budgets (as appropriate).
Official Information Act
5 Please note PHARMAC’s Factors for Consideration schematic currently does not explicitly refer to
the health needs of family, whānau and wider society, but this Factor should be considered alongside
those depicted in the schematic.
A1422150 – T20-1160
7
MEMORANDUM FOR CONSIDERATION BY DIRECTOR OF OPERATIONS
UNDER DELEGATED AUTHORITY
To:
Director of Operations
From:
Manager Pharmaceutical Funding
Date:
September 2021
__________________________________________________________________________
Procurement of additional stock of remdesivir for use in New Zealand
Recommendations
It is recommended that having regard to the decision-making framework set out in
PHARMAC's Operating Policies and Procedures you exercise your delegated authority and:
resolve to direct Pharmac staff to extend the current agreement dated 31 August 2020
between Pharmac and Gilead Sciences, Australia & New Zealand via exchange of
emails to include an additional Withh vials of remdesivir;
eld
resolve to approve the Purchase Order (15106) provided in Appendix One for the
supply of Withh vials of remdesivir;
eld
note that the price for remdesivir has increased to $586.78 NZD per vial from $578.72
paid previously;
note that remdesivir is used in the treatment of patients hospitalised with COVID-19, it
is anticipated that a portion of this stock would be used to treat patients from the
current outbreak and the remaining stock would be held to treat eligible patients who
may be hospitalised with COVID-19 in the future.;
note that the number of vials secured and the total impact to the CPB are confidential
and they cannot be disclosed to the public;
note that the costs would be recovered from COVID-19 funds.
released under the
Official Information Act
A1525003
EXECUTIVE SUMMARY
Remdesivir is a novel antiviral agent that is used in the treatment of patients
hospitalised with COVID-19
In August 2020 Pharmac entered into an agreement with Gilead Sciences, Australia &
New Zealand for the supply of With vials of remdesivir. The terms of this agreement
held
allow additional stock to be ordered by mutual agreement.
Based on the current August 2021 outbreak of COVID-19 in New Zealand and the
possibility of future outbreaks it is recommended that this agreement be extended to
include an additional Withh vials, sufficient to treat Withhpatients.
eld
eld
Withheld
It is estimated that this proposal would have a cost of
to the Combined
under section
Pharmaceuticals Budget. This expenditure would be recovered from COVID-19 funds.
Why proposal should be considered by the Director of Operations under
Delegated Authority
The proposal involves a Schedule change that has an estimated Financial Impact (NPV) of
less than $10,000,000 and:
will not result in the Pharmaceutical budget or its future funding path being exceeded;
is not inconsistent with previous Board decisions; and
is not considered contentious by Pharmac staff; and
approves a stock purchase order.
released under the
Official Information Act
A1525003T20-1160
3
The Proposal
It is proposed to extend the existing agreement dated 31 August 2020 between Gilead
Sciences, Australia & New Zealand (Gilead) and Pharmac for the supply of remdesivir to
include an additional Withh vials to be used for the treatment of patients hospitalised with
eld
COVID-19.
Remdesivir would continue to be supplied under the terms of the 31 August 2021 agreement,
which is based on Pharmac’s standard terms of listing and includes the following terms of
supply:
Stock is to be ordered by Onelink at the price specified in Annex One of the agreement
Gilead has agreed to submit an application for Ministry of Health market approval as
soon as reasonably practicable
Remdesivir will be available subject to access criteria set by Pharmac.
Stock is to be supplied to and held by Onelink for use by DHB Hospitals. Pharmac staff
intend to investigate positioning some stock in the South Island, likely held at either
CDHB or ProPharma.
Pharmac and Gilead may agree in writing to extend this agreement to include
additional orders as required.
The 31 August 2020 agreement includes a price for remdesivir of $578.72 per vial. Recent
communications from Gilead have noted that the price per vial of remdesivir is now $390
USD and that Gilead has a fixed NZD/USD 2021 budget rate of $0.665. This means that the
price per vial of remdesivir will now be $586.78 NZD. Acknowledgement and agreement of
this updated price would be included in the exchange of emails to extend the agreement.
Remdesivir would not be listed on the Pharmaceutical Schedule and would continue to be
held as emergency stock for use by DHB Hospitals as required.
Remdesivir is not Medsafe approved and would continue be supplied under Section 29 of the
Medicines Act 198; however, Gilead has noted that is continuing to progress regulatory
approval for remdesivir with Medsafe.
The Withhel vials of remdesivir stock would be dispatched from Ireland and supplied in English
d under
language packaging. Timeframes for delivery of the stock would be confirmed once a
purchase order has been submitted. Gilead expects the full volume of stock would be
available in New Zealand in less than three weeks.
released under the
Gilead is unable to confirm the expiry of the remdesivir stock until a purchase order is
submitted and accepted; however, Gilead anticipates the stock will have an expiry of
September 2023.
In accordance with clause 8 of the 31 August 2020 Agreement, Gilead has noted it is
amenable for the agreement extension for Withh additional vials of remdesivir stock to be
eld
completed via email.
Official Information Act
The Australian Government’s Criteria for access to remdesivir from the National Medical
Stockpile (31 July 2020) would continue to be used as inclusion and exclusion criteria for
access to remdesivir the New Zealand, in line with recommendations from the Ad Hoc
Remdesivir COVID-19 Advisory Group. Pharmac staff note that the evidence for the use of
A1525003T20-1160
4
remdesivir is still emerging and Pharmac staff intend to seek further clinical advice to
determine if the access criteria should be updated to reflect any recent changes in the
evidence. Remdesivir is currently included in the Middlemore Hospital guidelines for the
treatment of COVID-19, which are being adapted for national use.
It is estimated that this proposal would have a one-off cost of
Withheld
to the Combined
under
Pharmaceuticals Budget in the year ending 30 June 2022.
Background
Remdesivir is a novel antiviral agent that is used in the treatment of patients hospitalised with
COVID-19
On 31 August 2020, as a result of New Zealand’s 2020 outbreak of COVID-19 Pharmac
entered into an agreement with Gilead for the supply of With vials of remdesivir as it had
held
recently been identified as a possible treatment for patients hospitalised with COVID-19.
Remdesivir continues to be used for the treatment of COVID-19 and has recently received
provisional approval from the Therapeutic Goods Administration (TGA) in Australia for this
indication.
As a result of the current outbreak of COVID-19 in New Zealand and the possibility of future
outbreaks, Pharmac staff recommend that additional stock of remdesivir should be secured.
As a result of the considerable uncertainty regarding the length and spread of the current
COVID-19 outbreak and the possibility of future outbreaks, it is considered that Withh vials
eld
would be an appropriate volume of remdesivir to secure initially. It is important to have stock
on hand to initiate treatment promptly. The current agreement allows for further supplies to
be secured by mutual agreement.
In reaching this figure, Pharmac staff have considered the possibility the current outbreak
continues for longer than anticipated. In addition, the supplier has noted increasing global
demand for remdesivir as countries increasingly lessen COVID-19 restrictions and open their
international borders. Securing remdesivir stock in anticipation of demand will help to
mitigate the risk of future stock shortages or unavailability for the New Zealand market.
Withh vials of remdesivir would allow for the treatment of approximately With patients. It is
eld
held
anticipated that a portion of this stock would be used to treat patients as a result of the
current outbreak, with the remaining stock being retained for future COVID-19. The current
outbreak has demonstrated that the increased transmissibility of the delta variant can result
in a large number of active cases. A higher hospitalisation rate has also been observed,
released under the
although it is not known if this is due the delta variant causing more severe disease or that
the communities affected have high rates of comorbidities which can lead to more severe
COVID-19 cases.
Pharmac staff note that the 31 August 2020 agreement would remain in place and further
remdesivir stock could be secured in future if required.
Clinical Advice
Official Information Act
Following the signing of the 31 August 2020 agreement Pharmac staff sought clinical advice
from a number of groups:
A1525003T20-1160
5
In September 2020 advice was sought from PTAC members via email regarding the priority
of different groups for access to remdesivir. The members considered that the quality of the
available evidence for the use of remdesivir for the treatment of COVID-19 appeared to be
low and did not consider they were well placed to provide the required advice to Pharmac as
it appeared the decision to fund remdesivir had already been made.
In September 2020 advice was also sought from members of the Anti-Infectives
Subcommittee of PTAC via email regarding the priority of different groups for access to
remdesivir. The members were generally supportive of the process being followed in
Australia for the treatment of patients with remdesivir and considered that remdesivir is likely
to be most effective in patients requiring supplemental oxygen prior to ventilation being
required.
Advice was also sought from members of the Critical Care Advisory Group in September
2020 via email regarding the priority of different groups for access to remdesivir. The
members noted the concerns about the quality of the evidence available for the effectiveness
of remdesivir; However, they were generally supportive of the process being followed in
Australia for the treatment of patients with remdesivir and considered that remdesivir is likely
to be most effective in patients requiring supplemental oxygen prior to ventilation being
required.
To gain further advice on the priority of different groups for access to remdesivir an Ad Hoc
Remdesivir COVID-19 Advisory Group was established by Pharmac. On 24 September 2020
Advice was sought from the Ad Hoc Remdesivir COVID-19 Advisory Group. The Group
recommended the Australian Government’s Criteria for access to remdesivir from the
National Medical Stockpile (31 July 2020) be used as inclusion and exclusion criteria for the
New Zealand stock of remdesivir, with an added criterion that treating physicians consider
that such escalation of care is appropriate. The Group stressed that this recommendation
was made in the context of prioritising the supply of remdesivir that had already been
secured and reiterated the current evidence for benefits of remdesivir was limited.
The Group noted that Māori and Pacific populations are potentially more vulnerable to the
impacts of COVID-19, especially due to higher rates of comorbidities in these populations
compared with the non-Māori/non-Pacific population. Members considered that this would be
a case for case for assigning higher priority for availability for the Māori and Pacific
populations.
Implementation
We intend to communicate this directly to the following people within each DHB:
-
DHB Chief Pharmacists
released under the
-
Pharmac’s Expert Clinical advisors
-
MoH COVID-19 Therapeutics TAG
It is proposed to make the eligibility criteria visible on the Pharmac website, along with details
to advise DHBs how to obtain stock. Feedback from some DHBs has indicated this would be
helpful to guide staff. We intend to add these details to the website after a letter has been
sent to the key stakeholders listed above.
Official Information Act
A1525003T20-1160
6
Factors for Consideration
This paper sets out PHARMAC staff’s assessment of the proposal using the Factors for
Consideration in the Operating Policies and Procedures. Some Factors may be more or less
relevant (or may not be relevant at all) depending on the type and nature of the decision
being made and, therefore, judgement is always required. The decision maker is not bound
to accept PHARMAC staff’s assessment of the proposal under the Factors for Consideration
and may attribute different significance to each of the Factors from that attributed by
PHARMAC staff.
released under the
Footnotes
1 The person receiving the medicine or medical device must be an eligible person, as set out in the
Health and Disability Services Eligibility Direction 2011 under Section 32 of the New Zealand Public
Health and Disability Services Act 2000.
2 The current Māori health areas of focus are set out in PHARMAC’s Te Whaioranga Strategy.
3 Government health priorities are currently communicated to PHARMAC by the Minister of Health’s
Letter of Expectations.
4 Pharmaceutical expenditure includes the impact on the Combined Pharmaceutical Budget (CPB) and
Official Information Act
/ or DHB hospital budgets (as appropriate).
5. Please note PHARMAC’s Factors for Consideration schematic currently does not explicitly refer to
the health needs of family, whānau and wider society, but this factor should be considered alongside
those depicted in the schematic.
A1525003T20-1160
7
Factors for Consideration
Health need
Disease/illness
Coronavirus disease 2019 (COVID-19) is an infectious acute respiratory disease caused by a
novel coronavirus. The clinical presentation is generally that of a respiratory infection with a
symptom severity ranging from a mild common cold-like illness to a severe viral pneumonia
leading to acute respiratory distress syndrome that is potentially fatal. Severe viral
pneumonia patients are treated in intensive care setting and can be considered for
oxygenation and ventilation.
Availability and suitability of existing treatments
A number of other existing pharmaceuticals are used as treatments for severe COVID-19
patients; however, there is limited or no evidence to support their use. Remdesivir has
recently received provisional approval from the TGA for the treatment of COVID-19. In
addition tocilizumab, which can be used in the treatment of COVID-19 is currently
experiencing supply issues.
The availability of other treatments of COVID-19 would be unaffected by this proposal.
Impact on Māori health areas of focus and health outcomes
COVID-19 was not identified as a Māori health areas of focus as a result of the Hauora
Arotahi community consultation; however; Māori are more likely than other ethnic groups in
New Zealand to be hospitalised as a result of COVID-19
Any other populations experiencing health disparities
Of all the ethnic groups in New Zealand Pacific Peoples are the most likely to be hospitalised
as a result of COVID-19.
Is the disease/illness a Government health priority
COVID-19 is not one of the Government health priorities; however, the Government has
allocated significant funds and resources to manage the consequences and to respond to the
COVID-19 pandemic in New Zealand.
released under the
Health Benefit
Health benefit to others
Health benefit to others would be unchanged by this proposal as remdesivir would remain
available for patients who need it.
Official Information Act
Consequences for the health system
Consequences for the health system would remain unchanged by this proposal as remdesivir
would remain available for patients who need it.
A1525003T20-1160
8
Suitability
The Withh vials of remdesivir would be provided in the following form and strength:
eld
100 mg powder for injection. A vial contains 100 mg of remdesivir. After reconstitution,
each vial contains 5 mg/ml of remdesivir solution.
The recommended dosage of remdesivir in patients 12 years of age and older and weighing
at least 40 kg is:
Day 1 - a single loading dose of remdesivir 200 mg given by intravenous infusion
Day 2 onwards - 100 mg given once-daily by intravenous infusion
The total duration of treatment should be at least 5 days and not more than 10 days. This
would equate to between 6 and 12 vials per patient – such that Withh vials would be sufficient
eld
to treat approximately With patients in New Zealand.
held
Remdesivir does not have Medsafe approval in New Zealand. It has been approved under
emergency authorisations or provisional consent in other jurisdictions. Remdesivir has been
granted emergency authorisation in Australia.
Although granting provisional consent would be the preferred regulatory pathway for the
emergency supply of remdesivir, Gilead has advised that it is continuing to consider its
approach to regulatory approval in New Zealand internally and is working with Medsafe.
Medsafe has previously advised that supply under Section 29 would be acceptable in this
circumstance. The existing stock guarantee agreement with Gilead requires that Gilead
makes the necessary regulatory submission as soon as practicable, and Gilead has advised
that it is discussing this with Medsafe.
Costs and Savings
Cost and savings to Pharmaceutical expenditure
The 31 August 2020 agreement for the supply of remdesivir included a price of $586.78 per
vial this would result in a total cost of
Withheld
for the supply of Withh vials of remdesivir.
under
eld
released under the
These costs for remdesivir would be met from the COVID-19 funds.
Cost-Effectiveness
The cost-effectiveness of remdesivir has not been formally assessed.
Official Information Act
A1525003T20-1160
9
MINUTE OF THE DIRECTOR OF OPERATIONS DECISION UNDER
DELEGATED AUTHORITY
September 2021
The Director of Operations, exercising the authority delegated by the Chief Executive under
the Financial Delegations Policy has made the following decision to:
resolve to direct Pharmac staff to extend the current agreement dated 31 August 2020
between Pharmac and Gilead Sciences, Australia & New Zealand via exchange of
emails to include an additional Withh vials of remdesivir;
eld
resolve to approve the Purchase Order (15106) provided in Appendix One for the supply
of Withh vials of remdesivir;
eld
note that the price for remdesivir has increased to $586.78 NZD per vial from $578.72
paid previously;
note that remdesivir is used in the treatment of patients hospitalised with COVID-19, it
is anticipated that a portion of this stock would be used to treat patients from the current
outbreak and the remaining stock would be held to treat eligible patients who may be
hospitalised with COVID-19 in the future.;
note that the number of vials secured and the total impact to the CPB are confidential
and they cannot be disclosed to the public;
note that the costs would be recovered from COVID-19 funds.
released under the
Official Information Act
A1526227qA59075
