Thyrogen® recombinant human TSH is manufactured by Genzyme Corporation (USA) which has an Australian subsidiary based in Sydney.

The drug is not registered in Australia, and until registration by the Therapeutic Goods Administration (TGA), cannot be considered for subsidisation by the Pharmaceutical Benefits Advisory Committee (PBAC). Registration in Australia is dependent upon the company submitting the required material on efficacy and safety for detailed evaluation by the TGA and the approval of the drug by the Australian Drug Evaluation Committee. Any eventual listing on the Pharmaceutical Benefits Scheme (PBS) is dependent upon assessment of cost-effectiveness, therapeutic benefit etc and satisfactory negotiations on pricing.

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My small personal experience to date is consistent with the overseas experience. Clearly patients do not experience any period of hypothyroidism in preparation for scanning and the actual Thyrogen injection period is no problem.

The procedure is simple in that only daily attendance for 5 days without prior preparation is needed:

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The quality of the scans as shown by the trials is very similar for Thyrogen vs T₄-withdrawal. Some scans in the trials were rated better after T₄-withdrawal and some better after Thyrogen, perhaps slightly favouring T₄-withdrawal scanning.

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Associate Professor Duncan Toplilss is
Director , Department of Endocrinology & Diabetes, The Alfred
and is also a member of Thyroid Australia's Medical Advisory Committee

Post Script 1 March 2004:

We are pleased to advise that Thyrogen has been approved and is available on the Medicare Benefits Schedule. Full details are HERE

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