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A ‘dominant’ treatment strategy: Xeloda. Jim Cassidy Beatson Oncology Centre Glasgow, UK. Replacing 5-FU/LV with Xeloda: prospective evaluation of costs and cost effectiveness. X-ACT trial showed that adjuvant Xeloda is at least as effective as 5-FU/LV, with 1,2
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A ‘dominant’ treatment strategy: Xeloda Jim Cassidy Beatson Oncology CentreGlasgow, UK
Replacing 5-FU/LV with Xeloda: prospective evaluation of costs and cost effectiveness • X-ACT trial showed that adjuvant Xeloda is at least as effective as 5-FU/LV, with1,2 • strong trend toward superior disease-free survival (DFS) • fewer serious grade 3/4 toxicities • Additional benefits in terms of medical resource savings and reduced burden on patients expected • X-ACT trial included prospective evaluation of costs and cost-effectiveness of Xeloda versus 5-FU/LV3 1Cassidy J et al. J Clin Oncol Proc ASCO Late-breaking Abstract Book 2004;23:14 (Abst 3509)2Scheithauer W et al. Ann Oncol 2003;14:1735–43 3Douillard J-Y et al. Ann Oncol 2004;15(Suppl. 3):iii73 (Abst 274PD)
Patients’ perspective: Xeloda reduces time spent travelling and receiving treatment
Base-case assumptions: cost of patients’ time and travel for treatment F. Hoffmann-La Roche, data on file
Xeloda reduces cost of patients’ travel and time associated with treatment Mean cost per patient (£) 1600 1200 800 400 0 Travel Travel and clinic time for treatment F. Hoffmann-La Roche, data on file
Replacement of 5-FU/LV with Xeloda is net cost saving: travel costs Net costs per patient versus 5-FU/LV (£) 4000 2000 0 –2000 –4000 TotalTravel Travel time F. Hoffmann-La Roche, data on file
Xeloda is cost-saving for the UK National Health Service (NHS) versus 5-FU/LV US and Italian data have been collected but have not been published yet
Cost model • Direct medical costs during the trial period assessed • Data on medical resource use and safety were collected prospectively during the X-ACT trial • The model took the perspective of the UK NHS
Base-case assumptions (direct costs) Costs were taken from: Monthly Index of Medical Specialties (September 2004); Unit Costs of Health and Social Care (UK-based Personal Social Services Research Unit); Health Service Database Douillard J-Y et al. Ann Oncol 2004;15 (Suppl. 3):iii73 (Abst 274PD)
Fewer outpatient visits for chemotherapy administration with Xeloda versus 5-FU/LV Mean number per 100 patients 3000 2500 2000 1500 1000 500 0 2804 738 Xeloda (n=995) 5-FU/LV (n=974) Douillard J-Y et al. Ann Oncol 2004;15(Suppl. 3):iii73 (Abst 274PD)
Fewer hospitalizations for adverse events (AEs) with Xeloda versus 5-FU/LV Mean number per 100 patients Xeloda (n=995) 5-FU/LV (n=974) 150 125 100 75 50 25 0 Admissions Total days Douillard J-Y et al. Ann Oncol 2004;15(Suppl. 3):iii73 (Abst 274PD)
Xeloda requires fewer costly medications for management of AEs Douillard J-Y et al. Ann Oncol 2004;15(Suppl. 3):iii73 (Abst 274PD)
Replacement of 5-FU/LV with Xeloda is net cost saving: direct payer costs Net costs per patient versus 5-FU/LV (£) 4000 2000 0 –2000 –4000 TotalDrugs Administration Hospital Medications Consultations use Updated from Douillard J-Y et al. Ann Oncol 2004;15(Suppl. 3):iii73 (Abst 274PD)
Xeloda increases quality-adjusted life expectancy* versus 5-FU/LV *Quality-adjusted life expectancy is a patient’s life expectancy adjusted to take into account their quality of life
Cost-utility model • Considers time spent in three health states: stable (relapse-free), post-relapse, dead • Time in each health state extrapolated to the long-term by fitting relapse-free and overall survival data to a Weibull distribution1 • Incremental cost per quality-adjusted life month (QALM) • difference in total costs in each arm divided by the difference in expected survival • adjusted for time and utility of each health state 1Collett D. Modelling Survival Data in Medical Research. Chapman and Hall CRC, 1994. pp 107–49
QoLadjustedfactors Total costs X Cost-utility model Expected survival = Cost per quality-adjusted life year/month gained
Xeloda versus 5-FU/LV: consistent benefit in all efficacy parameters Betterthan5-FU/LV Same as5-FU/LV Worsethan5-FU/LV Primary endpoint DFS p=0.0528 Secondary endpoints Relapse-free survival Overall survival p=0.0407 p=0.0706 Hazard ratio 0.6 0.8 1.0 1.2 1.4 1.6 Upper margin forsuperiority Upper margin for equivalence in DFS • Cassidy J et al. J Clin Oncol Proc ASCO Late-breaking Abstract Book 2004;23:14 (Abst 3509)
Xeloda versus 5-FU/LV: long-term extrapolation of overall survival Estimated probability Trial data Predicted Trial data Predicted Xeloda1 1.0 8.0 6.0 4.0 2.0 0.0 5-FU/LV1 Weibull projection2 0 20 40 60 80 100 120 Months 1Douillard J-Y et al. Ann Oncol 2004;15(Suppl. 3):iii73 (Abst 274PD) 2Collett D. Modelling Survival Data in Medical Research. Chapman and Hall CRC, 1994. pp 107–49
Xeloda provides a net gain in QALM compared with 5-FU/LV over extended time horizon Gain in QALMs 3 2 1 0 36 48 60 Model horizon (months) ‘Lifetime’ gain projected to be 8.7 Douillard J-Y et al. Ann Oncol 2004;15(Suppl. 3):iii73 (Abst 274PD)
Xeloda is a uniquely ‘dominant’ treatment in cancer chemotherapy 1Aballéa S et al. Proc 2005 GI Cancers Symposium 2005;181 (Abst 194)2UK National Institute of Clinical Excellence website: http://www.nice.org.uk 3Messori A et al. Eur J Clin Pharmacol 1996;51:111–16 4Hillner BE, Smith TJ. N Engl J Med 1991;324:160–8 *Quality-adjusted values†Cost saving and more effective in terms of quality-adjusted life months
Xeloda is a ‘dominant’ strategy: cost savings and superior outcomes • Xeloda reduces time travelling to and receiving treatment, and associated costs • Replacement of 5-FU/LV with Xeloda results in average savings of £1864 (€2721)* per patient as calculated by NHS costs • Efficacy and safety benefits of Xeloda provide a net gain in QALMs *Exchange rate: 1.46