14 January 2023
Via email: [FYI request #21102 email]
Tēnā koe J Bruning Request for information: Rolling reviews of safety & efficacy of COVID-19 treatments
Thank you for your request dated 11 November 2022
under the Official Information Act 1982
(OIA) for information relating to rolling reviews of safety & efficacy of (non-mRNA gene
therapy) COVID-19 treatments.
In our letter of 9 December 2022, we extended the due date for making a decision on your
request to 15 January 2023. I am pleased to now provide you with our response to your
Additionally, you may be interested to know that we regularly publish responses to OIA
requests to our website. Search for “COVID-19 treatments” on our OIA responses webpage
to read our other OIA responses regarding COVID-19 treatments.
In your request, you wrote:
1. Ronapreve, Baricitinib, Remdesivir, Tocilizumab, Molnuprivar,
Please provide me with:
(a) The clinical trial data ID numbers used to claim efficacy and
safety; and the date that the particular safety and efficacy data for
these drugs were supplied.
(b) Any evaluations of reviews published in the scientific literature
that have analysed the (i) safety and (ii) efficacy of these drugs post
release onto the market. This includes for prevention of
hospitalisation and death as well as efficacy claims by the
(c) All reviews of the scientific literature to understand state of
knowledge on drug-drug interactions of these drugs in order to
triangulate the claims of the manufacturer.
(d) All current information regarding drug-drug interactions held
with Pharmac for these drugs.
(a) Please provide evidence of rolling reviews undertaken to
evaluate the evidence in the peer reviewed literature of any of the
treatments listed in [the COVID-19 Science Updates report (Ministry
of Health, 2021, Jul 9)].
(b) Please supply all emails, reports and memos discussing
vitamin D in relation to the scientific evidence relating to immune
health, pneumonia, lower respiratory tract infections and other
COVID-19 related pathophysiological symptoms considered by the
COVID-19 Treatments Advisory Group.
3. Please advise the Access Criteria Assessment process for off-
patent/repurposed drugs and nutrient formulations for treatment of
4. Does (a) Pharmac, Pharmacology and Therapeutics Advisory
Committee (PTAC) or the (b) COVID-19 Treatments Advisory Group:
(i) recognise that nutrients and drugs with a long history of safe
use, where the safety profile is well established; where off-patent use
is cheaper than new medicines; carry a different cost-benefit profile
than new medications?
(ii) Recognise the implications of the Cochrane review that RCTs
are an overly strict requirement and quite unnecessary to
demonstrate efficacy. Instead, observational studies are an equally
valid study design…
Ref: Anglemyer A et al (2014) Healthcare outcomes assessed with
observational study designs compared with those assessed in
randomized trials. Cochrane Database of Systematic Reviews 2014,
Issue 4. Art. No.: MR000034. DOI:
Evidence used to assess funding of COVID-19 antiviral treatments
Medsafe is the authority responsible for regulating therapeutic products in New Zealand.
Medsafe uses its evaluation and approval process
to assess the safety and efficacy of
medicines before they are approved for use in New Zealand. Some clinical trial information
can be found in Data Sheets using Medsafe’s Data Sheets and Consumer Medicine
Information search tool.
For more specific information related to question 1a of your request,
please contact Medsafe.
In our response, we have not included any “evaluations of reviews that have analysed the (i)
safety and (ii) efficacy of the above drugs, post-release onto the market” (question 1b) or;
“reviews of scientific literature to understand state of knowledge on drug-drug interactions”
(question 1c) – this is because we do not hold this information.
You may also find the meeting records of the COVID-19 Treatments Advisory Group
as they contain details of the advisory group’s discussions and recommendations about
COVID-19 treatments. Please see the meeting records published on our website1, 2, 3, 4, 5 for
details of the advisory group’s discussions and recommendations. We endeavour to publish
meeting records for all our advisory committee and advisory group meetings as soon as
possible following the conclusion of the meeting.
Drug interactions of funded COVID-19 treatments
The Consumer Medicine Information (CMI) documents, which contain information about drug
interactions, can be found using Medsafe’s Data Sheets and Consumer Medicine
Information search tool.
Pharmac does not hold information about specific drug interactions of funded treatments.
Therefore, we have not provided the drug interaction information requested in question 1d,
as allowed under section 18(d) of the OIA, as it is contained within the CMI documents which
are publicly available via the Medsafe website. Rolling reviews of COVID-19 treatments
COVID-19, and evidence of its burden and treatment, is constantly evolving and changing.
Many of the treatments that have been developed are also new. Available evidence and the
quality of evidence also continues to evolve.
The COVID-19 Treatments Advisory Group meets regularly to consider the latest
information. Since it was established in 2021, the COVID-19 Treatments Advisory Group has
considered a number of the treatments identified in Manatū Hauora’s (Ministry of Health) COVID-19 Science Updates report
dated 9 July 2021.
While Pharmac is responsible for determining which COVID-19 treatments are funded,
Pharmac does not determine which treatments are prescribed in community or Te Whatu
Ora hospital settings. Prescribers are responsible for determining which medicines are most
suitable/appropriate for their patients regardless of whether they are registered by Medsafe
or funded by Pharmac. See the Medsafe website for more information about the use of
unapproved medicines and unapproved use of medicines. Vitamin D for the treatment and/or prevention of COVID-19
Vitamin D has not been assessed by the COVID-19 Treatments Advisory Group for the
treatment and/or prevention of COVID-19. However, Pharmac has received the materials
listed below which were shared with us by a member of the Pharmacology and Therapeutics
Advisory Committee (PTAC).
• Can vitamin D protect against covid-19? Two new trials find no effect, but aren’t the
, BMJ 2022;378:e071230, http://dx.doi.org/10.1136/bmj-2022-071230
• Prevention of covid-19 and other acute respiratory infections with cod liver oil
supplementation, a low dose vitamin D supplement: quadruple blinded, randomised
placebo controlled trial
, BMJ 2022;378:e071245; http://dx.doi.org/10.1136/bmj-2022-
• Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause
acute respiratory tract infection and covid-19: phase 3 randomised controlled trial
, BMJ 2022;378:o1822; http://dx.doi.org/10.1136/bmj.o1822
I have not included a copy of the email sent to Pharmac staff by the member of PTAC, as
allowed under section 18(h) of the OIA, as the email itself did not contain any information
other than the attachments of the above materials. Furthermore, I have not included copies
of the attachments listed above as these are already publicly available (section 18(d) of the
Determining access criteria for off-label use of funded medicines
In appropriate circumstances, Pharmac is open to funding medicines for off-label use. The
process for considering funding, including access criteria, is fundamentally the same: we use
our Factors for Consideration (FFC)
for our assessment and get clinical advice. For the
treatment of COVID-19, this would include a review of available evidence by our COVID-19
Treatments Advisory Group. As an example, tocilizumab is funded as an off-label treatment,
as it is not currently approved by Medsafe for use in the treatment of COVID-19. Cost-benefit of generic (off-patent) medicines
Pharmac recognises that generic (“off-patent”) medicines are often cheaper (e.g., cost less
for the same dose/quantity) than the original patented medicine. Where appropriate, we fund
generic medicines to help us get the best health outcomes from our budget. Information
about generic medicines
is available on our website.
As stated earlier in this letter, COVID-19 and the treatment framework are constantly
evolving and changing. Many of the treatments that have been developed are new and often
come with a relatively high cost. In terms of their funding, COVID-19 treatments are funded
through a separate fund outside the Combined Pharmaceutical Budget (CPB). Clinical data sources used to assess efficacy
Pharmac recognises the value of observational studies when estimating relative treatment
effects. We keep an open mind to all evidence and information that can inform and support
our assessments. Please see our Prescription for Pharmacoeconomic Analysis,
which has a
section on evidence for relative clinical effect. Closing
Thank you again for writing to us. We trust that the above information answers your queries.
Please note, you have the right to make a complaint to the Ombudsman about our response
to your OIA, under section 28(3) of the OIA. Details of how to make a complaint
are on the
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.
Nāku noa, nā
Director, Engagement and Implementation