Cost Savings Utilizing Molecular Studies for Indetermined Thyroid Nodules

👉Cost savings from incorporating ThyroSeq testing into the management of patients with thyroid nodules with indeterminate cytology is based on:

  • The avoidance of unnecessary surgeries
  • Selection of the optimal extent for the initial surgery thereby minimizing the two-step surgeries, i.e. lobectomy followed by completion of thyroidectomy. 

👉The results of a prospective, double-blind, multicenter study of ThyroSeq v3 (Steward DL et al. JAMA Oncol. 2018.) allow to estimate the impact of ThyroSeq on avoiding unneeded diagnostic thyroid surgeries, as show on the figure below.

👉In a series of 100 patients with Bethesda III and Bethesda IV thyroid nodules and with the expected cancer/NIFTP prevalence of 28%:

  • 61 tests will be reported as Negative and 39 as Positive.

👉Among test-negative nodules only two cancers will be missed (those are expected to be low-risk, intrathyroidal cancers).

👉Among the test-positive nodules:

  • 23 (67%) will be diagnosed as cancer or NIFTP on surgery
  • The majority of remaining nodules are expected to be neoplasms, likely with some malignant potential.

👉Overall, 61% of thyroid surgeries will be avoided, with their costs and complications.

Negative and Positive Call Rate for ThyroSeq v3 and Expected Impact on Patient Management 

👉Nicholson KJ, et al. Molecular Testing of Bethesda III/IV Thyroid Nodules: A Cost-Effectiveness Analysis. Thyroid. 2019.

👉This study modeled a decision tree from the payor perspective, comparing the cost-effectiveness of diagnostic lobectomy, ThyroSeq v3, and Afirma GSC for indeterminate (Bethesda III/IV) thyroid nodules.

👉Based on the model, the cost per correct diagnosis was $14,277 for ThyroSeq v3, $17,873 for Afirma GSC, and $38,408 for diagnostic lobectomy.

👉One-way sensitivity analysis found that ThyroSeq v3 had robustly lower cost per correct diagnosis than Afirma GSC.

👉Two-way sensitivity analysis varying costs of ThyroSeq v3 and Afirma GSC demonstrated that ThyroSeq was still the preferred strategy.

👉The study stated that in no range of tested cost variations was diagnostic lobectomy the preferred strategy over molecular testing.

👉The study concluded that either Afirma GSC or ThyroSeq v3 was considerably more cost-effective than diagnostic lobectomy and that ThyroSeq v3 was more likely to be cost-effective than Afirma GSC.

👉Rivas AM, et al. ThyroSeq V2.0 Molecular Testing: A Cost-Effective Approach for the Evaluation of Indeterminate Thyroid Nodules. Endocr Pract. 2018 Sept; 24(9):780-788

👉This study evaluated cost effectiveness of ThyroSeq utilized for managing patients with Bethesda III-IV cytology nodules at Mayo Clinic Florida, where the test is used in routine clinical practice since January 2015.

👉The study showed that the cost of treatment per patient with Bethesda III category nodules was $54,000 when no molecular testing was used and $44,570 after ThyroSeq introduction.

👉Three patients with negative ThyroSeq results were able to avoid surgery resulting in cost saving of $67,500 per patient.

👉For patients with Bethesda IV category nodules, the cost of treatment was $29,000 and $43,200 using and not using ThyroSeq, respectively.

👉Twelve patients with Bethesda IV nodules were negative by ThyroSeq, of which 11 did not have surgery, resulting in cost saving of $84,000 per patient.

👉The authors of this independent study performed at a high volume thyroid medical center concluded that ThyroSeq is a cost effective tool to diagnose thyroid cancer compared to thyroidectomy without molecular testing in patients with nodules categorized as Bethesda III and IV. 

👉Yip L, et al. Comprehensive cost analysis of available molecular tests for thyroid nodules with follicular neoplasm cytology 2015 15th International Thyroid Congress, A-381

👉This study evaluated the costs associates with management of patients with Bethesda IV cytology nodule using ThyroSeq as compared to standard of care (SC) patient management without molecular testing, using Afirma®GEC, and using 7-gene mutational panel.

👉The study demonstrated that the ThyroSeq-guided care was associated with a substantially lower cost (average per patient $7,683, range $7,174-$8,333) as compared to the average per patient cost of standard of care ($11,505, range $10,676-$12,347) and of care utilizing Afirma®GEC ($13,027, range $12,373-$13,666) or 7-gene mutational panel ($12,029, range $11,254-$12,823).

👉The study estimated that due to high test sensitivity (90%) and specificity (93%), ThyroSeq GC-guided algorithm for Bethesda IV nodules should result in 30% reduction in the cost of management of patients with these nodules.