Thyroxine Sodium
Management of demonstrated thyroid hormone deficiency and suppression of thyrotropin (TSH) for the management of TSH-responsive tumours of the thyroid, in the 25 microgram dose strength.
Decisions on record
- Meeting Mar 2016 Not recommended Thyroid hormone deficiency thyroid stimulating hormone-responsive tumours of the thyroid
- Meeting Nov 2015 Recommended Thyroid hormone deficiency thyroid stimulating hormone-responsive tumours of the thyroid
- Meeting Jul 2008 Recommended Thyroid hormone (replacement therapy for hypothyroid patients) no PSD
Access path
- Nov 2015Recommended
- Mar 2016Not recommended
no unmet clinical need, not cost-effective at proposed price, range of other thyroxine strengths already listed on PBS
From the public summary
5.1 The PBAC decided not to recommend thyroxine (as sodium) 25 microgram for PBS- listing. In making its recommendation, the PBAC considered that thyroxine 25 microgram tablets would not be cost-effective at the price proposed by the submission, noting that there were several strengths of thyroxine already listed or recommended for listing on the PBS (including 50, 75, 100, 125 and 200 2PSD · Mar 2016
5.2 The PBAC considered that given the range of different strengths of thyroxine that the PBAC has previously recommended for PBS listing, the availability of a new presentation would not address any unmet clinical need.PSD · Mar 2016
4.2 The PBAC noted and welcomed the input from the Sydney Children’s Hospital Network via the Consumer Comments facility on the PBS website. Their comment described the perceived benefits of the 25 microgram tablet, including particularly neonates, post-discharge. The comment stated that paediatric patients often need small doses of thyroxine (i.e.PSD · Mar 2016
4.3 The resubmission claimed that “a dose of 25 microgram or 12.5 microgram is recommended as an initiation dose for elderly patients, for those patients with ischaemic heart disease, and for children, as it is recognized that an accurate dose is important to reduce the risk of unacceptable adverse effects.” The resubmission claimed that thyroxine 25 microgram tablets will likely be used in a small population.PSD · Mar 2016
Cost-effectiveness
Cost-minimisation/BIA context only; no formal ICER calculated. PBAC considered cost-effectiveness but did not model an ICER.
Decision context
PopulationElderly patients, patients with ischaemic heart disease, and children requiring thyroxine initiation doses of 25 micrograms.
Why it was knocked back
- no unmet clinical need, not cost-effective at proposed price, range of other thyroxine strengths already listed on PBS
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2016 | Not recommended | — | — | Other |
| Nov 2015 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
Consumer voice
Sydney Children's Hospital Network highlighted perceived benefits of the 25 microgram tablet for neonates and paediatric patients post-discharge, noting that paediatric patients often require small doses of thyroxine and that splitting a 50 microgram tablet outside healthcare settings is inaccurate and burdensome for families.
paediatric patients often need small doses of thyroxine (i.e. less than 50 micrograms) Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to 25 microgram dose strength and specifies three patient populations: elderly, ischaemic heart disease, and children requiring low initiation doses.