Cost Impact of Rivaroxaban Plus Aspirin versus Aspirin

Cost Impact of Rivaroxaban Plus Aspirin versus Aspirin in the COMPASS Trial Andre Lamy on behalf of the COMPASS Investigators www. phri. ca

Disclosures • The COMPASS trial was funded by grant from Bayer AG • The authors had free access to the complete study data and performed all of the analyses independently • Other conflicts of interest were reported in the main manuscript (NEJM) www. phri. ca 2

COMPASS Key objectives To determine in stable CAD or PAD whether: • Rivaroxaban 2. 5 mg bid + aspirin 100 mg od, or • Rivaroxaban 5 mg bid reduces the risk of CV death, stroke or MI compared with aspirin 100 mg od www. phri. ca October 4, 2017

Design Stable CAD or PAD 2, 200 participants with a primary outcome event Rivaroxaban 2. 5 mg bid + Aspirin 100 mg od Run-in (Aspirin) R Rivaroxaban 5 mg bid Aspirin 100 mg od Expected mean follow up: 3 -4 years www. phri. ca October 4, 2017

Primary Outcome CV death, stroke, MI R+A N=9, 152 Riva N=9, 117 Aspirin N=9, 126 Riva + aspirin vs. aspirin Rivaroxaban vs. aspirin N (%) HR (95% CI) p 379 (4. 1) 448 (4. 9) 496 (5. 4) 0. 76 (0. 66 -0. 86) <0. 0001 0. 90 (0. 79 -1. 03) 0. 12 Outcome CV death, stroke, MI NEJM 2017; 377: 1319 -30. www. phri. ca October 4, 2017

Economic Analysis Design • Only Riva 2. 5 mg BID + ASA 100 mg OD (n=9152) vs. ASA 100 mg OD (n=9126) • • In-trial analysis of cost impact Cost-effectiveness model is in development (QALYs) All costs converted to US dollars ($USD) No discounting (mean follow-up of 23 months) www. phri. ca 6

Economic Analysis Design • All CV events included (non-CV excluded) • Costs are direct medical costs consumed in hospital – Events and procedures (DRG approach) – Stroke, dialysis and limb amputations incur costs beyond the event itself (1 year perspective) • Unit costs from the following countries: – US, Canada, France, Germany • Events and resources from all patients are applied to each country using their specific unit costs www. phri. ca 7

Events: Difference in costs (1) Riva 2. 5 mg BID + ASA 100 mg OD (n=9152) N Events ASA 100 mg OD Diff. Costs $ USD (n=9126) N Events Stroke (all) 97 172 -75 -3, 664, 425 Myocardial Infarction 229 269 -40 -337, 667 Severe Limb Ischemia 60 113 -53 -364, 163 Resuscitated Cardiac Arrest 56 73 -17 -15, 626 Venous Thromboembolism 23 45 -22 -153, 824 Angina 526 575 -49 -184, 725 www. phri. ca 8

Events: Difference in costs (2) Riva 2. 5 mg BID + ASA 100 mg OD N Events Aspirin 100 mg OD Diff. N Events Costs $ USD Heart Failure 280 265 15 115, 803 Cardiac Arrhythmia 292 264 28 146, 485 Syncope 101 86 15 72, 525 TIA 51 42 9 37, 907 Bleeding – ER Visit 108 72 36 9, 108 Bleeding – Hosp. 32 11 21 158, 277 Total event costs -4, 180, 325 www. phri. ca 9

Procedures: Difference in costs Riva 2. 5 mg BID + ASA 100 mg OD Aspirin 100 mg OD Diff. Costs $ USD Vascular Surgery 72 109 -37 -319, 203 Peripheral Angioplasty 143 186 -43 -804, 117 Limb Amputation 41 67 -26 -558, 179 PCI 446 491 -45 -703, 000 Coronary Angiography 397 400 -3 -14, 420 CABG 75 67 8 297, 914 Carotid Angioplasty 14 12 2 27, 565 Pacemaker/ICD 92 86 6 109, 456 Total procedures costs -1, 963, 984 TOTAL (events and procedures) -6, 144, 309 www. phri. ca 10

Results: Mean event and procedure cost Mean cost per participant Riva 2. 5 mg BID + ASA 100 mg OD (n=9152) ASA 100 mg OD Events 1528 (13, 982, 655) 1990 (18, 162, 890) -462 (4, 180, 325) Procedures 1936 (17, 715, 544) 2156 (19, 679, 529) -220 (1, 963, 984) TOTAL (overall) 3964 (31, 698, 199) 4646 (37, 842, 419) -682 (6, 144, 309) (n=9126) Difference $ USD www. phri. ca 11

Results: Mean costs per country Mean cost per participant (R+A vs. A) Events Procedures (R+A vs. A) Total Difference (R+A vs. A) $USD United States -462 -220 -682 Canada -516 -155 -671 France -379 -165 -543 Germany -396 -152 -548 www. phri. ca 12

Subgroup: CAD and PAD Mean cost per participant (R+A vs. A) N Events Procedures (R+A vs. A) Total Difference (R+A vs. A) $USD CAD only 13277 -382 22 -360 PAD only 1699 -205 -1065 -1270 CAD + PAD 3297 -922 -741 -1663 2 or more vascular beds 4158 -1069 -615 -1684 www. phri. ca 13

Limitations • Only direct health care costs – Indirect costs for R+A presumably lower • Only events, procedures costs • Rivaroxaban 2. 5 mg BID plus aspirin – Not yet approved for this indication – List price for Rivaroxaban 2. 5 mg BID is still unknown for this indication www. phri. ca 14

Conclusions Rivaroxaban 2. 5 mg BID + ASA 100 mg OD: • Clinically better than ASA 100 mg OD • Decreases direct costs of hospitalization, procedures, and major cardiovascular events • Similar results in US, Canada, France and Germany www. phri. ca 15