PTAC’s record of consideration for hypothyroidism Nov 2018
Request for the information that supported PTAC's consideration of whole thyroid extract and normal and extended release T3 for the treatment of hypothyroidism.
7 April 2020
[name and contact details redacted]
Dear [name redacted]
REQUEST FOR INFORMATION
Thank you for your email of 18 February 2020, in which you asked for:
Supporting papers/supplementary papers and other documentation – including costings, cost benefit analysis, notes, written records of phone calls and emails between PHARMAC staff and other external parties – written and held by the PTAC endocrine subcommittee and PTAC committee members, which support PTAC’s Record of the Pharmacology and Therapeutics Advisory Committee Meeting Held On 1 & 2 November 2018 minutes at: https://www.pharmac.govt.nz/assets/ptac-minutes-2018-11.pdf [PDF, 364 KB], page 32-34 titled: 11 Whole thyroid extract and normal and extended release T3 for the treatment of hypothyroidism.
Your request for this information has been considered under the Official Information Act 1982 (OIA).
At its meeting on 1-2 November 2018, the Pharmacology and Therapeutics Advisory Committee (PTAC) considered the Thyroid Association of New Zealand’s application for funding of whole thyroid extract, and normal and extended release T3 for the treatment of hypothyroidism. The report of the meeting indicates that PTAC’s decision was formed by consideration of three documents, these being:
- The application and supporting documentation supplied by the Thyroid Association of New Zealand Incorporated
- PHARMAC’s Pharmaceutical Schedule Application (November 2018), titled Whole thyroid extract, normal and extended release T3 for hypothyroidism, prepared by PHARMAC’s Funding Application Advisor
- PHARMAC’s decision-making framework, as relevant.
Each of these documents is discussed below.
The application and supporting documentation supplied by the Thyroid Association of New Zealand Incorporated
The application from the Thyroid Association of New Zealand identifies you as the contact person for the Association. We therefore understand that you have access to the Association’s application and its supporting documents. Accordingly, we have interpreted your request as excluding this material.
PHARMAC’s Pharmaceutical Schedule Application (November 2018), titled Whole thyroid extract, normal and extended release T3 for hypothyroidism, prepared by PHARMAC’s Funding Application Advisor
PHARMAC’s Pharmaceutical Schedule Application of November 2018, excluding the Appendix, is attached with this response.
The contents of the Appendix to the Pharmaceutical Schedule Application report are provided in Table 1 below. Studies 1-6 were provided in full to PTAC. Study 7 was cited to PTAC, but our records are inconclusive about it being supplied in full to PTAC members. These cited studies are publicly available documents and are withheld in accordance with section 18(d) of the OIA. Copyright provisions also apply.
Table 1: Supplied publications
|
|
Study |
Citation |
|
1 |
Thyroxine-triiodothyronine combination therapy versus thyroxine monotherapy for clinical hypothyroidism: meta-analysis of randomised controlled trials |
Grozinsky-Glasberg, et al. J Clin Endocrinol Metab. 2006;91(7):2592 |
|
2 |
Systematic review of all the published controlled studies comparing treatment with levothyroxine alone with combinations of levothyroxine plus liothyronine in hypothyroid patients |
Escobar-Morreale et al. J Clin Endocrinol Metab. 2005;90(8):4946 |
|
3 |
Desiccated thyroid extract compared with levothyroxine in the treatment of hypothyroidism: a randomized, double-blind, crossover study |
Hoang, et al. J Clin Endocrinol Metab. 2013;98(5):1982-90 |
|
4 |
Current evidence for the treatment of hypothyroidism with levothyroxine/levotriiodothyronine combination therapy versus levothyroxine monotherapy. |
Hennessey, et al. Int J Clin Pract. 2018;72(2). doi: 10.1111/ijcp.13062 |
|
5 |
Common variation in the DIO2 gene predicts baseline psychological wellbeing and response to combination thyroxine plus triiodothyronine therapy in hypothyroid patients |
Panicker, et al., J Clin Endocrinol Metab. 2009;94(5):1623 |
|
6 |
Polymorphisms in type 2 deiodinase are not associated with well-being, neurocognitive functioning, and preference for combined thyroxine/3,5,3'-triiodothyronine therapy |
Appelhof, et al. J Clin Endocrinol Metab. 2005;90(11):6296 |
|
7 |
No Effect of the Thr92Ala Polymorphism of Deiodinase-2 on Thyroid Hormone Parameters, Health-Related Quality of Life, and Cognitive Functioning in a Large Population-Based Cohort Study |
Wouters, et al. Thyroid. 2017;27(2):147 |
PHARMAC’s decision-making framework, as relevant
PHARMAC’s decision-making framework is available publicly on its website, at: Factors for Consideration
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 under this OIA.
We trust that this information answers your queries. We are making our information more freely available, so we will now publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this.
Yours sincerely
Rachel Read
Policy Manager, Engagement and Implementation