Cost-effectiveness of gene-expression profiling for tumor-site origin.

Area of Science:

• Oncology
• Genomics
• Health Economics

Background:

• Gene-expression profiling (GEP) provides valuable tissue of origin (TOO) information for metastatic or poorly differentiated cancers.
• Traditional clinicopathological methods may be insufficient for accurate TOO determination in complex cases.

Purpose of the Study:

• To conduct a cost-effectiveness analysis of GEP TOO testing compared to usual care.
• To evaluate the impact of GEP TOO testing on clinical practice patterns and patient outcomes from a US third-party payer perspective.

Main Methods:

• Retrospective observational study analyzing changes in treatment recommendations (chemotherapy, surgery, radiation, etc.) post-GEP TOO testing.
• Survival impact assessed using data from National Comprehensive Cancer Network and UpToDate guidelines.
• Cost analysis incorporated drug costs, administration costs, and unit costs from CMS fee schedules.
• Quality-of-life weights from literature and sensitivity analyses (bootstrap, probabilistic) were used to estimate variability and uncertainty.

Main Results:

• Chemotherapy recommendations aligned with guidelines increased from 42% to 65% (P<0.001).
• Projected overall survival increased by 3.6 months (15.9 to 19.5 months).
• Average quality-adjusted life-months increased by 2.7 months, with a mean cost increase of $10,360 per patient.
• The cost per quality-adjusted life-year gained was $46,858.

Conclusions:

• GEP TOO testing significantly alters clinical practice for metastatic or poorly differentiated cancers.
• The test is projected to improve overall survival and quality-adjusted life-years.
• The cost-effectiveness is favorable, with an expected cost per quality-adjusted life-year below $50,000.