Application 1156 - Diagnostic use of thyrotropin alfa-rch for Patients with Well-Differentiated Thyroid Cancer
|Application Name||Diagnostic use of thyrotropin alfa-rch for Patients with Well-Differentiated Thyroid Cancer|
|Assessment Type||Submission Based|
|Description of Intervention||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 recurrence of thyroid cancer by the detection of thyroid tissue following treatment. Patients who have had 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 thyroid gland.
Recurrence of thyroid cancer is assessed by 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 whole body scan. In order to increase the sensitivity of these tests for the recurrence of thyroid cancer, the release of thyroglobulin and the uptake of radioactive iodine by thyroid tissue can be promoted by increasing the patient’s thyroid stimulating hormone (TSH) levels. This can be achieved by having the patient discontinue their THT, in order to stimulate the production of their own TSH, or by the administration of another form of TSH, such as recombinant human thyroid-stimulating hormone.
|Description of Disease||Thyroid cancer, although relatively rare, is the most common endocrine neoplasm (cancer of hormone-producing tissue). Thyroid cancer affects women more commonly than men and the majority of cases occur between ages 25 and 65. |
There are three main forms of thyroid cancer: well differentiated, medullary, and anaplastic (or poorly differentiated). The well-differentiated form accounts for approximately 80-90% of all thyroid cancers. Well-differentiated thyroid cancer is generally regarded as slow-growing with the potential for prolonged remission, with relatively good long-term survival rates for most patients with definitive primary (initial) treatment who comply with ongoing monitoring.
|Disease Sub Group||Thyroid/ Endocrine|
|Intervention Sub Type|
|Received||16 December 2010|
|Stage 2 - Eligibility||21 December 2010|
|Stage 3 - 1st PASC||17 February 2011|
|Stage 3 - Public Comment||Date released for comment 24 February 2011|
Date of closed for comments 31 March 2011
|Stage 3 - 2nd PASC||13-14 April 2011|
Final DAP 1156 - Diagnostic use of Thyrotropin alfa-rch for Patients with Well-Differentiated Thyroid Cancer (PDF 411 KB)
|Stage 4 - Submission of Evidence||15 October 2011|
Assessment Report - PDF Printable Version (PDF 12,479 KB)
|Stage 5 - ESC evaluation||9-10 February 2012|
|Stage 6 - MSAC Appraisal||MSAC appraised this assessment on 29 March 2012.|
Public Summary Document - PDF Printable Version (PDF 64 KB)
|Stage 6 - MSAC advice||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.|
|Stage 7 - Noting by Minister
||The Minister noted MSAC's advice 12 June 2012.|
|Stage 8 - Implementation|
Page currency, Latest update: 22 October, 2012
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