A Cost Impact Analysis of clonoSEQ as a Valid and CE-Certified Minimal Residual Disease (MRD) Diagnostic Compared to No MRD Testing in Multiple Myeloma in Germany.

Introduction: The measurement of minimal residual disease (MRD) with clonoSEQ can be used in the assessment of B-cell lymphoid tumor burden throughout treatment with accuracy, sensitivity and standardization when compared to traditional cytomorphology. With the approval of novel treatments, standardized MRD assessment with improved performance is increasingly important. The aim of this analysis is to estimate the cost-effectiveness of MRD testing with clonoSEQ compared to no MRD testing for patients with multiple myeloma (MM) on maintenance therapy in Germany.

Methods: The cost impact of clonoSEQ was analyzed from the German statutory insurance perspective. Clinical data were derived from the literature and expert opinions. Cost input was utilized based on publicly available data and literature. Patients in the MRD arm were tested every 6 months. The deterministic Markov model consists of six health states, and every patient begins at the start of maintenance. Included therapies are lenalidomide for maintenance and carfilzomib, lenalidomide and dexamethasone for relapse.

Results: For a time horizon of 10 years, the deterministic cost impact analysis shows total cost of €279,483 for patients using clonoSEQ in comparison to €356,623 for simulated patients without MRD testing. The main drivers of the cost differences are saved cost of drug holiday. The savings per patient in 1 year are €18,396. Savings after 3 years are €69,991 per patient. Savings after 10 years are €77,140 per patient.

Conclusions: Based on the underlying model, clonoSEQ can support German health insurance funds to use high-cost drugs more efficiently in the treatment of myeloma.