Dear Ms Hodson

Thank you for your request for official information, received by the
Ministry of Health on 03 August 2015, requesting:

1. For each of the years 1960, 1970, 1980, 1990, 2000, 2010 and
2015, what of the following have met the criteria to be listed on Med
Safe’s safe medicines list; 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.

2. What are the current criteria thyroid medications and/or the NDT
equivalents such as Whole Thyroid Extract need to meet to qualify to be
included on the Medsafe safe medicines list?

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).

4. Have NDTs ever been up for consideration for inclusion on Med Safe’s
safe medicines list?
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?

5. Have thyroid medications containing T3 e.g. Cytomol, ever been up for
consideration for inclusion on Med safe’s safe medicines list?
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?

Your request has been received and logged.  As required under the Official
Information Act 1982, the Ministry will respond to your request within 20
working days.  You should receive a response on or before 31 August 2015.

If a large amount of information has been requested or if the Ministry
needs to consult in order to make a decision, we may need to extend this
date (this is provided for in section 15A of the Act).  We will advise you
if such an extension is necessary.

The Ministry's reference number for your request is: H201503268

Yours sincerely
 
Ashley Goodwin
OIA Co-ordinator l Government Relations l Office of the Director General

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Sarah Reader | Manager | Product Regulation | Medsafe | Ministry of Health
| (04) 819 6836 |

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