Impact of updated trial data on the cost-effectiveness of percutaneous mitral repair.
Martin ConnockPeter AugusteJean-François ObadiaLazaros AndronisXavier ArmoiryPublished in: PloS one (2023)
When updated clinical trial data becomes available reassessing the cost-effectiveness of technologies may modify estimates and influence decision-making. We investigated the impact of updated trial outcomes on the cost-effectiveness of percutaneous mitral repair (PR) for secondary mitral regurgitation. We updated our previous three-state time-varying Markov model to assess the cost-effectiveness of PR + guideline directed medical treatment (GDMT) versus GDMT alone. Key clinical inputs (overall survival (OS) and heart failure hospitalisations (HFH)) were obtained using the 3-year trial findings from the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy) RCT. We calculated incremental cost-effectiveness ratios (ICER) and report how these differ between analyses based on early (2-year) and updated (3-year) evidence. Updated trial data showed an increase in mortality in the intervention arm between two and three years follow-up that was not seen in the control arm. Deterministic and multivariate cost-effectiveness modelling yielded incremental cost effectiveness ratios ICERs of €38,123 and €31,227 /QALY. Compared to our 2-year based estimate (€21,918 / QALY) these results imply an approximate 1.5-fold increase in ICER. The availability of updated survival analyses from the COAPT pivotal trial suggests previous estimates based on 2-year trial findings were over optimistic for the intervention.
Keyphrases
- clinical trial
- phase iii
- study protocol
- phase ii
- heart failure
- randomized controlled trial
- mitral valve
- open label
- left ventricular
- electronic health record
- decision making
- healthcare
- type diabetes
- machine learning
- double blind
- mass spectrometry
- ultrasound guided
- cardiovascular events
- data analysis
- radiofrequency ablation
- metabolic syndrome
- transcatheter aortic valve replacement
- weight loss
- cell therapy
- artificial intelligence