28 August 2015
Ms Belinda Hodson
Via email:
[FYI request #3000 email]
Dear Ms Hodson
REQUEST FOR INFORMATION
Thank you for your request dated 31 July 2015 under the Official Information Act 1982
(OIA) for information relating to thyroid medications. You have asked for information
relating to the criteria for subsidisation by the government.
As you are aware, part of the information you have requested in part one of your
request, relating to the years 1960, 1970, 1980 and 1990, is believed to be more closely
associated to the functions and responsibilities of the Ministry of Health as these predate
the establishment of PHARMAC. Your request was transferred to the Ministry of Health
under Section 14(b)(ii) of the OIA on 14 August 2015.
For ease in responding to your requests for information, we have responded separately
to each section of your request.
1. For each of the years 1960, 1970, 1980, 1990, 2000, 2010 and 2015, what of the
following have met the criteria for subsidisation by the government; and under
what criteria. Please provide the breakdown by:
(a) all thyroid medications e.g. Synthroid, Cytomol, Eltroxin, and
(b) all Natural Desiccated Thyroid (NDT) equivalents to these medications (note
that NDTs are also called bio-identical hormones) e.g. Whole Thyroid Extract,
Extended Release T3 .
The thyroid and antithyroid agents that were subsidised by PHARMAC for the years you
have stipulated are:
• 2000: carbimazole, levothyroxine, liothyronine and propylthiouracil.
• 2010: carbimazole and levothyroxine.
• 2015: carbimazole, levothyroxine and propylthiouracil.
Natural Desiccated Thyroid (NDT) medications have never been funded by PHARMAC
and we have not received any funding applications for these medications. We note that
NDT medications are not registered by Medsafe for use in New Zealand. Medsafe is the
New Zealand Medicines and Medical Devices Safety Authority responsible for the
regulation of medicines, ensuring they are acceptably safe. Generally, a pharmaceutical
is unlikely to be funded by PHARMAC if it is not registered with Medsafe and registered
alternatives exist.
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2. What are the current criteria thyroid medications and/or the NDT equivalents
such as Whole Thyroid Extract need to meet to attract government funding so
that the cost of these are lower for patients?
In deciding which medicines to fund, and to ensure our decisions are as fair and robust
as possible, we use nine Decision Criteria along with expert clinical advice. We analyse
clinical, economic and commercial issues, and seek the views of users and the wider
community through consultation. The processes we generally use, as well as the nine
Decision Criteria, are outlined in our Operating Policies and Procedures. The Operating
Policies and Procedures can be found on our website here:
http://www.pharmac.health.nz/assets/opp-2006-01-3rd-ed.pdf
You may be interested to know that PHARMAC is changing the way it makes decisions
by introducing the Factors for Consideration which will replace the Decision Criteria.
PHARMAC will begin utilising the Factors for Consideration for decision making from 1
July 2016. We’re making this change to reflect feedback we’ve received about how we
make decisions, and also to ensure our process fits all our work, including medicines,
vaccines and medical devices. The long lead-in time is to help us and our stakeholders
adapt to the change, and we’ll be communicating with our stakeholders throughout the
implementation process. You may wish to read more about the Factors for Consideration
on our website here:
http://www.pharmac.health.nz/medicines/how-medicines-are-
funded/factors-for-consideration/
Anyone – a patient, a health professional or a pharmaceutical supplier – can make a
funding application to PHARMAC. Most applications are made by pharmaceutical
companies, who have access to the full range of information PHARMAC requires to
assess applications. You can find more information about new funding applications,
including application forms on the following link:
http://www.pharmac.health.nz/medicines/how-medicines-are-funded/new-funding-
applications/
3. What is the current process (as it applied to thyroid treatment) that is used to set
these criteria, specifically:
(a) What are the inputs to this process e.g. types of research and source(s); who
is consulted e.g. type of medical specialist or medical agency.
(b) Who ultimately decides whether a medication/NDT meets the criteria?
(c) How are patients’ actual experiences of being on these medications/NDTs
represented in this process?; and what New Zealand and/or overseas patient
data e.g. medical records of patients, are used to substantiate this? And, who
provides this information? And who funds this information (as funders and
providers may be different entities).
As noted in our response to part two of your request for information, PHARMAC
currently uses nine Decision Criteria. These assist us in deciding which medicines to
fund as we follow the processes outlined in our Operating Policies and Procedures.
PHARMAC requires good advice from clinicians to make decisions on medicines
funding. This advice is received in a number of ways, including through expert
committees. PHARMAC also keeps up-to-date with the latest clinical information through
ongoing professional development, monitoring of trials and medical journal articles. We
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also take other research and data into consideration that is provided to us in
new funding
application submissions. Our main clinical advice comes from an expert committee of medical practitioners, called
the Pharmacology and Therapeutics Advisory Committee (PTAC). PTAC considers
clinical evidence around funding applications, and takes into account PHARMAC’s nine
Decision Criteria before making recommendations to PHARMAC on medicines funding.
The Committee has 10 members who have expertise in examining clinical studies and
broad experience and knowledge of medicines and the conditions they treat. PTAC
operates under defined Terms of Reference which are available on our website, along
with minutes of their meetings, here:
http://www.pharmac.health.nz/about/committees/
PTAC also has a number of expert subcommittees which provide clinical evaluations in
specialist areas. The subcommittees and the minutes of their meetings can be viewed on
our website here:
http://www.pharmac.health.nz/about/committees/ptac/ptac-
subcommittees/
PHARMAC has a procedure for listing a pharmaceutical on the Pharmaceutical
Schedule. This diagram can be found in our
Operating Policies and Procedures
(Procedure 4.5). Ultimately the PHARMAC Board is responsible for all listing decisions
PHARMAC makes, and in the case of major decisions the Board makes the decision
itself. In other cases, the Board delegates decision making to the Chief Executive who
may further delegate to other PHARMAC staff.
Our work directly affects the lives of New Zealanders so we need to consider the views
of consumers and patients. We keep in touch with communities and consumers to hear
their views on pharmaceutical-related issues and involve them in our work.
PHARMAC consults with the public, when we consider it appropriate, about our activities
and the decisions we make. We carefully exercise this discretion to decide when we
seek public comment; both in relation to individual funding decisions and other activities.
When developing a new policy or considering a funding decision or a change to existing
funding, it will often be desirable to carry out a formal, time-bound, public, written
consultation exercise. More often than not we formally consult before making our funding
decisions.
Consultation can take many forms, and the approach we take may differ from proposal
to proposal, depending on the type of work underway. For example, some consultations
will be shorter than others, and involve a single round of written submissions to a
proposal. Consultation may be targeted to particular groups with a specific interest or
specialty.
In addition, the Consumer Advisory Committee (CAC) provides advice to PHARMAC
from a consumer and patient perspective on matters related to PHARMAC’s activities. Its
role is to provide advice to PHARMAC on appropriate processes and plans to better
understand consumer and patient perspectives. The Committee is made up of people
from a range of backgrounds and interests including the health of Māori people, Pacific
peoples, older people and patients with chronic disease, to name a few. The advice we
seek from the CAC covers many different areas including:
• How PHARMAC can obtain and consider consumers’ views on our funding and
policy decisions
• PHARMAC’s strategy, policy and operational activities related to funding
decisions, and access to and optimal use of medicines.
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• How PHARMAC can best communicate its decisions, policies and strategies.
• How the CAC can engage with consumers to ensure it can provide quality advice
to PHARMAC.
• Educational information to assist patients.
CAC members are not employed by PHARMAC, although they are reimbursed for the
time they give to serving on the Committee. CAC is guided by its Terms of Reference,
which you can view on our website here:
http://www.pharmac.health.nz/assets/cac-
terms-of-reference-april-2010.pdf
4. Have NDTs ever been up for consideration for government funding?
(a) If not, then why not? and
(b) If they have, then in what year did this happen? Which of the criteria did they
meet and which of the criteria did they not meet. What was the outcome of the
consideration and on what basis were they declined or accepted?
As noted in our response to part one of your request, PHARMAC has not received any
funding applications for NDT medications, therefore they have not been considered for
funding. While PHARMAC does have the ability to consider a product for funding in the
absence of an application from an external party, this has not occurred.
5. Have thyroid medications containing T3 e.g. Cytomol, ever been up for
consideration for government funding?
(a) If not, then why not? and
(b) If they have, then in what year did this happen? Which of the criteria did they
meet and which of the criteria did they not meet; what was the outcome of the
consideration and on what basis were they declined or accepted?
PHARMAC has not received any funding applications for thyroid medications containing
T3, therefore they have not been considered for funding. While PHARMAC does have
the ability to consider a product for funding in the absence of an application from an
external party, this has not occurred.
Please note you have the right, by way of complaint under Section 28(3) of the OIA to an
Ombudsman, to seek an investigation and review of our decision.
We trust that this information answers your queries, if you have any further questions
please feel free to contact us again.
Yours sincerely
Jude Urlich
Director of Engagement and Implementation
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Document Outline