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CLINICAL RESEARCH: COST EFFECTIVENESS AND REGULATORY CONSIDERATIONS

Cost Effectiveness of Cardiac Resynchronization Therapy in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Trial

Arthur M. Feldman, MD, PhD, FACC^_*,_*, Gregory de Lissovoy, PhD^,, Michael R. Bristow, MD, PhD, FACC, Leslie A. Saxon, MD, FACC^||, Teresa De Marco, MD, FACC^¶, David A. Kass, MD, FACC, John Boehmer, MD, FACC^#,_**, Steven Singh, MD, FACC^,, David J. Whellan, MD^_*, Peter Carson, MD, FACC^,, Audra Boscoe, MPH, Timothy M. Baker, BS and Matthew R. Gunderman, MBA

^_* Department of Medicine, Jefferson Medical College, Philadelphia, Pennsylvania
MEDTAP Institute at UBC, Bethesda, Maryland
Department of Health Policy Management, Johns Hopkins School of Public Health, Baltimore, Maryland
Division of Cardiology, University of Colorado, Denver, Colorado
^|| Division of Cardiology, University of Southern California, Los Angeles, California
^¶ Division of Cardiology, University of California, San Francisco, California
^# Division of Cardiology, The Johns Hopkins University School of Medicine, Baltimore, Maryland
^_** Division of Cardiology, Hershey Medical Center, Hershey, Pennsylvania
Department of Medicine and Pharmacology at Georgetown University School of Medicine, Washington, DC
Veterans Affairs Medical Center, Washington, DC
Guidant Corporation, St. Paul, Minnesota

Manuscript received February 25, 2005; revised manuscript received July 7, 2005, accepted August 9, 2005.

^_* Reprint requests and correspondence: Dr. Arthur M. Feldman, Department of Medicine, Jefferson Medical College, 1025 Walnut Street, Philadelphia, Pennsylvania 19107 (Email: arthur.feldman{at}jefferson.edu).

A preliminary report of this work was presented at the 54th Annual Scientific Session of the American College of Cardiology, Orlando, Florida, 2005.

OBJECTIVES: The analysis goal was to estimate incremental cost-effectiveness ratios (ICERs) for the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial patients who received cardiac resynchronization therapy (CRT) via pacemaker (CRT-P) or pacemaker-defibrillator (CRT-D) in combination with optimal pharmacological therapy (OPT) relative to patients with OPT alone.

BACKGROUND: In the COMPANION trial, CRT-P and CRT-D reduced the combined risk of all-cause mortality or first hospitalization among patients with advanced heart failure and intraventricular conduction delays, but the cost effectiveness of the therapy remains unknown.

METHODS: In this analysis, intent-to-treat trial data were modeled to estimate the cost effectiveness of CRT-D and CRT-P relative to OPT over a base-case seven-year treatment episode. Exponential survival curves were derived from trial data and adjusted by quality-of-life trial results to yield quality-adjusted life-years (QALYs). For the first two years, follow-up hospitalizations were based on trial data. The model assumed equalized hospitalization rates beyond two years. Initial implantation and follow-up hospitalization costs were estimated using Medicare data.

RESULTS: Over two years, follow-up hospitalization costs were reduced by 29% for CRT-D and 37% for CRT-P. Extending the cost-effectiveness analysis to a seven-year base-case time period, the ICER for CRT-P was $19,600 per QALY and the ICER for CRT-D was $43,000 per QALY relative to OPT.

CONCLUSIONS: For the COMPANION trial patients, the use of CRT-P and CRT-D was associated with a cost-effectiveness ratio below generally accepted benchmarks for therapeutic interventions of $50,000 per QALY to $100,000 per QALY. This suggests that the clinical benefits of CRT-P and CRT-D can be achieved at a reasonable cost.

Abbreviations and Acronyms   COMPANION = Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure trial   CRT = cardiac resynchronization therapy   CRT-D = cardiac resynchronization therapy with pacemaker-defibrillator   CRT-P = cardiac resynchronization therapy with pacemaker   DRG = diagnostic-related group   ICER = incremental cost-effectiveness ratio   LV = left ventricular   MLHFQ = Minnesota Living With Heart Failure Questionnaire   NYHA = New York Heart Association   OPT = optimal pharmacological therapy   QALY = quality-adjusted life-year

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