Cost-Effectiveness Analysis of Protocol Biopsy and Non-Invasive Biomarkers for Monitoring Transplant Rejection Within One-Year Post-Kidney Transplants
Author(s)
Nabin Poudel, PhD, Roberto S. Kalil, MD, Nikhil Reddy, B.S, Amanda Medoro, B.S/M.B.A, Julia F. Slejko, PhD;
University of Maryland Baltimore, Baltimore, MD, USA
University of Maryland Baltimore, Baltimore, MD, USA
OBJECTIVES: To assess the cost-effectiveness of protocol biopsies and non-invasive biomarkers for detecting kidney transplant (KT) rejection within the first year after transplantation.
METHODS: A Markov model compared surveillance strategies, including: 1) serum creatinine, 2) protocol biopsy assessment at 3 and 12 months, and 3) non-invasive biomarker assessments at 1, 3, 6, and 12 months, from the payers’ perspective. The model incorporated five health states: well, subclinical rejection, acute rejection, allograft failure, and death, with all states progressing to death. We modeled monthly cycles over one year time horizon. Current literature informed the model parameters. Quality-adjusted life years (QALYs) and costs were discounted at 3% annually. We calculated the incremental cost-effectiveness ratio (ICER) as the ratio of incremental cost to incremental QALY. One-way deterministic sensitivity analysis (DSA) examined the parameter uncertainty. All costs were converted to 2024 U.S. dollars using the consumer price index.
RESULTS: As compared to serum creatinine, monitoring of the KT rejection with protocol biopsies (at 3 and 12 months) and biomarkers (at 1, 3, 6, and 12 months) was the dominant strategy (lower cost and higher QALY). Compared to protocol biopsies, the incremental benefit of non-invasive biomarker was 0.003 QALY and the incremental cost was $1,057 resulting in the ICER of $323,705 per QALY. DSA showed that sensitivity of the non-invasive biomarker had the greatest impact on QALY, while the cost of non-invasive biomarker test had the greatest influence on overall cost.
CONCLUSIONS: Screening for kidney transplant rejection with protocol biopsies or non-invasive biomarkers potentially reduces costs within the first-year post-transplant if preventing graft loss from rejection. However, monitoring with non-invasive biomarkers is not cost-effective compared to protocol biopsies at the commonly accepted threshold of $150,000 per QALY. Future studies should consider longer time horizons to capture the potential long-term cost and health outcomes of these surveillance strategies.
METHODS: A Markov model compared surveillance strategies, including: 1) serum creatinine, 2) protocol biopsy assessment at 3 and 12 months, and 3) non-invasive biomarker assessments at 1, 3, 6, and 12 months, from the payers’ perspective. The model incorporated five health states: well, subclinical rejection, acute rejection, allograft failure, and death, with all states progressing to death. We modeled monthly cycles over one year time horizon. Current literature informed the model parameters. Quality-adjusted life years (QALYs) and costs were discounted at 3% annually. We calculated the incremental cost-effectiveness ratio (ICER) as the ratio of incremental cost to incremental QALY. One-way deterministic sensitivity analysis (DSA) examined the parameter uncertainty. All costs were converted to 2024 U.S. dollars using the consumer price index.
RESULTS: As compared to serum creatinine, monitoring of the KT rejection with protocol biopsies (at 3 and 12 months) and biomarkers (at 1, 3, 6, and 12 months) was the dominant strategy (lower cost and higher QALY). Compared to protocol biopsies, the incremental benefit of non-invasive biomarker was 0.003 QALY and the incremental cost was $1,057 resulting in the ICER of $323,705 per QALY. DSA showed that sensitivity of the non-invasive biomarker had the greatest impact on QALY, while the cost of non-invasive biomarker test had the greatest influence on overall cost.
CONCLUSIONS: Screening for kidney transplant rejection with protocol biopsies or non-invasive biomarkers potentially reduces costs within the first-year post-transplant if preventing graft loss from rejection. However, monitoring with non-invasive biomarkers is not cost-effective compared to protocol biopsies at the commonly accepted threshold of $150,000 per QALY. Future studies should consider longer time horizons to capture the potential long-term cost and health outcomes of these surveillance strategies.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
EE183
Topic
Economic Evaluation
Disease
SDC: Urinary/Kidney Disorders