THE IMPACT STUDY: 100-DAY VS 200-DAY PROPHYLAXIS WITH VALGANCICLOVIR (VALCYTE®) TO REDUCE CMV DISEASE POST-TRANSPLANT IS COST-EFFECTIVE WITHIN US HEALTH CARE SETTING

CMV INFECTION

A.G. Jardine¹, I.A. Hauser², C. Gahlemann³, K. Berenson⁴, E. Blumberg⁵, A. Humar^6
1Bhf Cardiovascular Research Centre, University of Glasgow, Glasgow/UNITED KINGDOM, ²Nephrology, University Hospital Frankfurt/M, Frankfurt/M/GERMANY, ³, F.Hoffmann La Roche, Basel/SWITZERLAND, ⁴Global Health Outcomes, Analytica International, New York/NY/UNITED STATES OF AMERICA, ⁵, Uni of Pennsylvania Medical Center, Philadelphia/UNITED STATES OF AMERICA, ⁶Department Of Transplant Infectious Diseases, University of Alberta, Edmonton/AB/CANADA

Body: Introduction: Late onset cytomegalovirus (CMV) disease is a major problem in high-risk transplant recipients. Recent results from the IMPACT study report that an increase from 100 to 200 daysvalganciclovir prophylaxis reduces the incidence of CMV disease significantly. The aim of this study was to assess the long-term cost-effectiveness of extended post-transplant CMV prophylaxis for theUS health care setting.
Methods: In IMPACT, a global phase III, randomized, double blind, placebo-controlled study of 200 vs.100 days valganciclovir prophylaxis, the incidence of CMV disease was reduced significantly in high risk (D+/R-) renal transplant recipients, as assessed 12 months post transplant (16.1% vs 36.8%,p<0.0001). Based on that, a cohort Markov model was developed to evaluate CMV disease development as well as related costs, health outcomes and quality of life associated with 200 days vs. 100days valganciclovir prophylaxis over a 10 year time horizon. The incidence of CMV disease and acute rejection from the IMPACT study is used to model the first year post transplantation. The extensionto a 10 year period applying yearly cycles is based on the best available evidence retrieved through a systematic literature search. Disease states include development of CMV/no CMV disease, acuterejection, graft failure, dialysis and death. Cost data referring to the US setting were derived from previous published literature and inflated to 2009 US dollars. A 3% discount rate for costs andeffects was applied. Incremental costs, Quality Adjusted Life Years (QALY) gained and the incremental cost effectiveness ratio (ICER) are presented for a cohort of 10.000 patients.
Results: The 200 day treatment group experiences less CMV disease cases which translates into reduced incidence of graft failure, acute rejection and dialysis in the long term. Along with thata QALY gain of 2,380.5 over the 100 day treatment group could be observed over 10 years for the US setting. Within the US setting the 10-year analysis revealed lower cost for the 200 day treatmentarm thus being a cost saving alternative.

10 yrs	US
	Cost (US$)	QALY
Incremental	-1,745,063	2,380.5
ICER	dominant (cost saving)

Conclusion: The analyses demonstrate that extended CMV prophylaxis with valganciclovir can be regarded as a cost-effective treatment option in the US. Most likely, this favourable finding willbe applicable to other health care systems.

Disclosure: All authors have declared no conflicts of interest.