Authors' objectives: In December 2010, the Department of Health and Ageing received an application from Genzyme Australasia, the Australian distributor of the Thyrogen® brand of thyrotropin alfa-rch, requesting an extension of the current Medicare Benefits Schedule (MBS) listing for thyrotropin alfa-rch (recombinant human thyroid stimulating hormone). Recombinant human thyroid-stimulating hormone (thyrotropin alfa-rch) is used as a component of a diagnostic test for recurrence of thyroid cancer. Patients who have had well-differentiated thyroid cancer and who have been successfully treated by surgical removal of the thyroid gland (thyroidectomy), followed by treatment with radioactive iodine, require monitoring for the recurrence of thyroid cancer. Patients who have had a thyroidectomy are typically treated with synthetic thyroid hormone therapy (THT) to replace the thyroid hormone that would otherwise have been produced by the patient's own thyroid gland. The recurrence of thyroid cancer is assessed by the measurement of serum thyroglobulin, a protein that is only produced by thyroid gland tissue. Thyroglobulin testing can be performed in conjunction with a radioactive iodine diagnostic whole body scan (dxWBS). To increase the sensitivity of these tests for the recurrence of thyroid cancer, the release of thyroglobulin and the uptake of radioactive iodine by the thyroid tissues can be promoted by increasing the patient's thyroid stimulating hormone (TSH) levels. This can be achieved by having the patient discontinue their THT to stimulate the production of their own TSH, or by the administration of another form of TSH, such as recombinant human thyroid-stimulating hormone. Thyrotropin alfa-rch is currently available on the MBS; however it is only available to patients in whom an increase in endogenous TSH by the method of withdrawal of THT is either contraindicated on not tolerated. The applicant proposes that Thyrogen® be made available to all patients with well-differentiated thyroid cancer as part of a diagnostic test for recurrence of thyroid cancer. Thyroid cancer, although relatively rare, is the most common endocrine malignancy. Thyroid cancer affects women more commonly than men and the majority of cases occur between ages 25 and 65. Well differentiated thyroid cancer accounts for approximately 80-90% of all thyroid cancers and is generally regarded as slow-growing with the potential for prolonged remission, with relatively good long-term survival rates for most patients who have definitive primary (initial) treatment and comply with ongoing monitoring.

Authors' recommendations: After considering the strength of the available evidence in relation to the safety, clinical effectiveness and cost-effectiveness of thyrotropin alfa-rch in the diagnosis of recurrence of patients with well differentiated thyroid cancer, MSAC advised the Minister that it did not support the application to broaden the current MBS item descriptor to include additional population groups.

Project Status: Completed

URL for project: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/app1156-1

Year Published: 2011

URL for published report: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1156-public

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: <p>Medical Services Advisory Committee (MSAC)</p>