Tuesday, July 16, 2024

Cost-Effectiveness of Plasma Microbial Cell-Free DNA Sequencing in Diagnosing Immunocompromised Host Pneumonia

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A breakthrough study underscores the potential of plasma microbial cell-free DNA (mcfDNA) sequencing to revolutionize the diagnostic landscape for immunocompromised host pneumonia (ICHP). Conducted across multiple US centers, the research highlights the limitations of conventional diagnostic tests, which often fail to pinpoint infectious etiologies in ICHP patients, particularly those with hematological malignancies or undergoing hematological cell transplants. By integrating mcfDNA sequencing, the study aims to enhance diagnostic precision and improve patient outcomes significantly.

Study Objectives and Methods

The primary goal of the study was to evaluate the cost-effectiveness of incorporating mcfDNA sequencing into the usual care (UC) diagnostic process for hospitalized ICHP patients. Utilizing a semi-Markov model from the perspective of US third-party payers, the analysis considered only direct costs over a lifetime horizon, applying a 3% discount rate for both costs and benefits. The study compared three diagnostic approaches: All UC (non-invasive and invasive testing, early bronchoscopy), All UC with mcfDNA, and a hybrid model involving non-invasive UC, mcfDNA, and conditional bronchoscopy.

Results and Market Access Implications

At a cost of $2000 for mcfDNA sequencing, the All UC & mcfDNA approach resulted in higher total costs ($165,247 vs. $153,642) but also achieved better health outcomes (13.39 vs. 12.47 life-years gained; 10.20 vs. 9.42 equal value life-years gained; 10.11 vs. 9.42 quality-adjusted life-years gained) compared to UC alone. This translates to a cost-effectiveness ratio of $16,761 per QALY. Similarly, the hybrid model also showed higher costs ($162,655) but improved effectiveness (13.19 life-years gained, 9.96 QALYs), yielding a cost/QALY of $16,729.

The probabilistic sensitivity analysis indicated that the All UC & mcfDNA scenario remains the most cost-effective option above a willingness-to-pay threshold of $50,000 per QALY. This suggests that integrating mcfDNA sequencing could provide substantial benefits in terms of market access by justifying the higher costs through improved patient outcomes.

Valuable Inferences

  • The addition of mcfDNA significantly enhances diagnostic accuracy, leading to more targeted and effective treatments.
  • Higher initial costs are offset by long-term health benefits, making it a favorable option for healthcare payers.
  • Increased willingness-to-pay thresholds indicate strong market potential and acceptance for advanced diagnostic technologies.
  • Scenario analyses confirm that mcfDNA is beneficial across various diagnostic pathways, ensuring flexibility in clinical application.

The study concludes that mcfDNA sequencing is a cost-effective addition to conventional diagnostic tests for ICHP, particularly when non-invasive tests fail to identify infectious etiologies. By enabling earlier and more accurate diagnoses, mcfDNA can lead to timely and appropriate treatments, ultimately improving patient outcomes and enhancing market access for advanced diagnostic methods.

Original Article:

Pharmacoeconomics. 2024 Jul 2. doi: 10.1007/s40273-024-01409-4. Online ahead of print.


INTRODUCTION: Immunocompromised host pneumonia (ICHP) is an important cause of morbidity and mortality, yet usual care (UC) diagnostic tests often fail to identify an infectious etiology. A US-based, multicenter study (PICKUP) among ICHP patients with hematological malignancies, including hematological cell transplant recipients, showed that plasma microbial cell-free DNA (mcfDNA) sequencing provided significant additive diagnostic value.

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AIM: The objective of this study was to perform a cost-effectiveness analysis (CEA) of adding mcfDNA sequencing to UC diagnostic testing for hospitalized ICHP patients.

METHODS: A semi-Markov model was utilized from the US third-party payer’s perspective such that only direct costs were included, using a lifetime time horizon with discount rates of 3% for costs and benefits. Three comparators were considered: (1) All UC, which included non-invasive (NI) and invasive testing and early bronchoscopy; (2) All UC & mcfDNA; and (3) NI UC & mcfDNA & conditional UC Bronch (later bronchoscopy if the initial tests are negative). The model considered whether a probable causative infectious etiology was identified and if the patient received appropriate antimicrobial treatment through expert adjudication, and if the patient died in-hospital. The primary endpoints were total costs, life-years (LYs), equal value life-years (evLYs), quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio per QALY. Extensive scenario and probabilistic sensitivity analyses (PSA) were conducted.

RESULTS: At a price of $2000 (2023 USD) for the plasma mcfDNA, All UC & mcfDNA was more costly ($165,247 vs $153,642) but more effective (13.39 vs 12.47 LYs gained; 10.20 vs 9.42 evLYs gained; 10.11 vs 9.42 QALYs gained) compared to All UC alone, giving a cost/QALY of $16,761. NI UC & mcfDNA & conditional UC Bronch was also more costly ($162,655 vs $153,642) and more effective (13.19 vs 12.47 LYs gained; 9.96 vs 9.42 evLYs gained; 9.96 vs 9.42 QALYs gained) compared to All UC alone, with a cost/QALY of $16,729. The PSA showed that above a willingness-to-pay threshold of $50,000/QALY, All UC & mcfDNA was the preferred scenario on cost-effectiveness grounds (as it provides the most QALYs gained). Further scenario analyses found that All UC & mcfDNA always improved patient outcomes but was not cost saving, even when the price of mcfDNA was set to $0.

CONCLUSIONS: Based on the evidence available at the time of this analysis, this CEA suggests that mcfDNA may be cost-effective when added to All UC, as well as in a scenario using conditional bronchoscopy when NI testing fails to identify a probable infectious etiology for ICHP. Adding mcfDNA testing to UC diagnostic testing should allow more patients to receive appropriate therapy earlier and improve patient outcomes.

PMID:38955978 | DOI:10.1007/s40273-024-01409-4

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