Thyrotropin AlfaThyrogen
Recommended EndocrinologyAuthority Required
preparation for radioiodine ablation of thyroid remnant tissue in adult post thyroidectomy patients without known metastatic disease who are/will be maintained on hormone suppression therapy
2
Submissions
2 resub
2006–07
On the record
$15k–45k
ICER range
2 sourced ICERs · 2006–2007
ICER stated
Cost basis
Decisions on record
- Meeting Jul 2009 Recommended Ablation of thyroid remnant tissue no PSD
- Meeting Jul 2008 Recommended Anterior pituitary hormone (used in post thyroidectomy) no PSD
- Meeting Jul 2008 Recommended Anterior pituitary hormone (used in post thyroidectomy) no PSD
Access path
- TGA registered · Thyrogen
TGA label narrower than the PBS population
- Jul 2006Recommended
vs withholding or withdrawing thyroid hormone therapy for 4–6…
- Mar 2007Recommended · restricted
Comparator changed: withholding or withdrawing thyroid hormone therapy for 4–6 weeks…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
The PBAC rejected the application on the basis of an uncertain quality of life improvement and uncertain cost-effectiveness. PBAC · 2006
ICER uncertain ×2ICER / price too highCost-effectiveness accepted
Decision context
Populationadult post thyroidectomy patients without known metastatic disease who are/will be maintained on hormone suppression therapy, in the ablation of thyroid remnant tissue
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2007 | Recommended · restricted | withholding/withdrawing thyroid hormone therapy for 4–6 weeks prior to ablation (induced hypothyroidism) | $15k–45k | RCT · Ablation success |
| Jul 2006 | Recommended | withholding or withdrawing thyroid hormone therapy for 4–6 weeks prior to ablation | $15k–45k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| THYR-008-00 | Ph 3 | 61 | To confirm the status of thyroid remnant ablation by using Thyrogen stimulated radioiodine… | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients without known metastatic disease; TGA label includes all post-thyroidectomy patients without this exclusion.