Table A: Average Costs Per Patient (12 Months, 10 Years, Sensitivity Analysis 1)

Table A: Average Costs Per Patient (12 Months, 10 Years, Sensitivity Analysis 1)

<p> Cost-effectiveness of modern mTOR inhibitor based immunosuppression compared to the standard of care after renal transplantation in Germany</p><p>Supplementary material</p><p>Sensitivity Analyses</p><p>Table A: Average costs per patient (12 months, 10 years, sensitivity analysis 1). Average costs per patient Average costs per patient</p><p>(EUR, 12 months) (EUR, 10 years)</p><p>TR 1: Sirolimus+early withdrawal of Cyclosporine 26,310 146,078 +steroids</p><p>TR 2: Sirolimus-early-transition 19,424 116,153</p><p>TR 3: Everolimus-early-transition 24,925 155,524</p><p>TR 4: Tacrolimus low dose+MMF+steroids 18,538 126,779</p><p>EUR: Euro, TR: Therapy Regimen</p><p>Table B: Results of the MTC analysis (annual event probabilities for year 1, sensitivity analysis 2) Event Therapy regimen</p><p>1 2 3 4</p><p>15.70 1.90 0.09 3.30 Death (all causes) (0.1-82.8) (0-11.3) (0-0.1) (0.1-20.9)</p><p>8.00 5.40 32.30 3.20 Graft failure (0.2-46.0) (0.3-25.5 (0.0-100) (0.1-16.2)</p><p>6.37 4.58 8.59 12.81 Malignancies (total) (0.0-55.9) (0.1-25.7) (0.1-51.6) (0.2-66.9)</p><p>24.72 18.77 30.10 27.48 Post-transplant hypertension treatment (probability per year) (0.4-89.4) (0.9-66.1) (1.3-87.3) (1.2-84.7)</p><p>Probabilities (%) for 1 year with initial immunosuppressive regimen; credibility intervals presented in parentheses Table C: Outcomes for 12 months simulation (average costs, LYs, and years with FG per patient, sensitivity analysis 2). Average years Average cost per Average LY per with FG per patient (EUR) patient patient</p><p>TR 1: Sirolimus+early withdrawal of 25,607 0.925 0.892 Cyclosporine +steroids</p><p>TR 2: Sirolimus-early-transition 17,488 0.990 0.967</p><p>TR 3: Everolimus-early-transition 31,226 0.958 0.814</p><p>TR 4: Tacrolimus low dose+MMF+steroids 16,264 0.984 0.971 TR: Therapy Regimen; LY: Life Years; FG: Functioning Graft</p><p>Table D: ICER in Euro per LY gained for 12 months (sensitivity analysis 2). TR 1: TR 4: Tacrolimus Sirolimus+early TR 2: Sirolimus- TR 3: Everolimus- low withdrawal of early-transition vs. early-transition vs. dose+MMF+steroid Cyclosporine s vs. +steroids vs.</p><p>TR 1: Sirolimus+early Dominates Dominates withdrawal of N.A. N.E. Cyclosporine +steroids (+) (+)</p><p>Dominated Dominated TR 2: Sirolimus-early- N.A. N.E. transition (−) (−)</p><p>Dominates Dominates TR 3: Everolimus-early- 170,273 N.A. transition (+) (+)</p><p>Dominated Dominated TR 4: Tacrolimus low 204,000 N.A. dose+MMF+steroids (−) (−) Note: ICERs/dominance for therapy regimen in the top row versus therapy regimen in the left column. (+) indicates a domination of the therapy regimen in the top row versus therapy regimen in the left column. (−) indicates a domination of the therapy regimen in the left column versus therapy regimen top row. N.A.: ICER calculation not possible; N.E.: lower effects at lower costs, no ICER derived TR: Therapy Regimen; LY: Life Years</p><p>Table E: ICER in Euro per year with FG gained for 12 months (sensitivity analysis 2). TR 1: TR 4: Tacrolimus Sirolimus+early TR 2: Sirolimus- TR 3: Everolimus- low withdrawal of early-transition vs. early-transition vs. dose+MMF+steroid Cyclosporine s vs. +steroids vs.</p><p>TR 1: Sirolimus+early Dominates Dominated Dominates withdrawal of N.A. Cyclosporine +steroids (+) (−) (+)</p><p>Dominated Dominated Dominates TR 2: Sirolimus-early- N.A. transition (−) (−) (+)</p><p>Dominates Dominates Dominates TR 3: Everolimus-early- N.A. transition (+) (+) (+)</p><p>Dominated Dominated Dominated TR 4: Tacrolimus low N.A. dose+MMF+steroids (−) (−) (−) Note: ICERs/dominance for therapy regimen in the top row versus therapy regimen in the left column. (+) indicates a domination of the therapy regimen in the top row versus therapy regimen in the left column. (−) indicates a domination of the therapy regimen in the left column versus therapy regimen top row. N.A.: ICER calculation not possible; N.E.: lower effects at lower costs, no ICER derived TR: Therapy Regimen; LY: Life Years</p><p>Table F: Outcomes for 10 years simulation (average costs, LYs, and years with FG per patient, sensitivity analysis 2). Average years Average cost per Average LY per with FG per patient (EUR) patient patient</p><p>TR 1: Sirolimus+early withdrawal of 144,763 5.626 5.003 Cyclosporine +steroids</p><p>TR 2: Sirolimus-early-transition 108,048 6.509 5.857</p><p>TR 3: Everolimus-early-transition 160,569 5.464 4.185</p><p>TR 4: Tacrolimus low dose+MMF+steroids 114,457 6.495 5.915 TR: Therapy Regimen; LY: Life Years; FG: Functioning Graft</p><p>Table G: ICER in Euro per LY gained for 10 years (sensitivity analysis 2). TR 1: TR 4: Tacrolimus Sirolimus+early TR 2: Sirolimus- TR 3: Everolimus- low withdrawal of early-transition vs. early-transition vs. dose+MMF+steroid Cyclosporine s vs. +steroids vs.</p><p>TR 1: Sirolimus+early Dominates Dominated Dominates withdrawal of N.A. Cyclosporine +steroids (+) (−) (+)</p><p>Dominated Dominated Dominated TR 2: Sirolimus-early- N.A. transition (−) (−) (-)</p><p>Dominates Dominates Dominates TR 3: Everolimus-early- N.A. transition (+) (+) (+)</p><p>Dominated Dominates Dominated TR 4: Tacrolimus low N.A. dose+MMF+steroids (−) (+) (−)</p><p>Note: ICERs/dominance for therapy regimen in the top row versus therapy regimen in the left column. (+) indicates a domination of the therapy regimen in the top row versus therapy regimen in the left column. (−) indicates a domination of the therapy regimen in the left column versus therapy regimen top row. N.A.: ICER calculation not possible; N.E.: lower effects at lower costs, no ICER derived TR: Therapy Regimen; LY: Life Years</p><p>Table H: ICER in Euro per year with FG gained for 10 years (sensitivity analysis 2). TR 1: TR 4: Tacrolimus Sirolimus+early TR 2: Sirolimus- TR 3: Everolimus- low withdrawal of early-transition vs. early-transition vs. dose+MMF+steroid Cyclosporine s vs. +steroids vs.</p><p>TR 1: Sirolimus+early Dominates Dominated Dominates withdrawal of N.A. Cyclosporine +steroids (+) (−) (+)</p><p>Dominated Dominated TR 2: Sirolimus-early- N.A. 110,500 transition (−) (−)</p><p>Dominates Dominates Dominates TR 3: Everolimus-early- N.A. transition (+) (+) (+)</p><p>Dominated Dominated TR 4: Tacrolimus low N.E. N.A. dose+MMF+steroids (−) (−)</p><p>Note: ICERs/dominance for therapy regimen in the top row versus therapy regimen in the left column. (+) indicates a domination of the therapy regimen in the top row versus therapy regimen in the left column. (−) indicates a domination of the therapy regimen in the left column versus therapy regimen top row. N.A.: ICER calculation not possible; N.E.: lower effects at lower costs, no ICER derived TR: Therapy Regimen; LY: Life Years Table I : Average costs per patient (12 months, 10 years). Average costs per patient Average costs per patient</p><p>(12 months) (10 years)</p><p> lower value base case upper value lower value base case upper value</p><p>± 50% change in drug costs </p><p>(incl. co-med.) </p><p>TR 1: Sirolimus+early withdrawal of Cyclosporine 16,003 26,011 36,020 96,276 145,788 196,256 +steroids</p><p>TR 2: Sirolimus-early- 11,016 17,500 23,915 75,948 107,246 139,302 transition</p><p>TR 3: Everolimus-early- 16,238 24,225 32,212 105,181 154,822 206,403 transition</p><p>TR 4: Tacrolimus low 9,970 16,404 22,838 80,437 114,612 150,517 dose+MMF+steroids</p><p>± 50% change in costs of </p><p> dialysis</p><p>TR 1: Sirolimus+early withdrawal of Cyclosporine 24,256 26,011 27,862 128,431 145,788 164,361 +steroids</p><p>TR 2: Sirolimus-early- 16,316 17,500 18,620 89,170 107,246 125,642 transition</p><p>TR 3: Everolimus-early- 21,630 24,225 26,676 133,219 154,822 177,842 transition</p><p>TR 4: Tacrolimus low 15,631 16,404 17,088 97,974 114,612 132,363 dose+MMF+steroids</p><p>± 50% change in costs of acute rejection and graft failure</p><p>TR 1: Sirolimus+early withdrawal of Cyclosporine 25,579 26,011 26,462 144,949 145,788 147,177 +steroids</p><p>TR 2: Sirolimus-early- 16,835 17,500 18,098 105,991 107,246 107,703 transition</p><p>TR 3: Everolimus-early- 23,488 24,225 24,866 153,370 154,822 156,651 transition</p><p>TR 4: Tacrolimus low 16,147 16,404 16,635 113,842 114,612 115,684 dose+MMF+steroids</p><p>TR: Therapy Regimen Table J: ICERs affected by a ±20% of the probability for acute rejection (sensitivity analysis 4) lower value base case upper value</p><p>TR 2: Sirolimus-early-transition vs. TR 4: Tacrolimus low dose+MMF+steroids (12 months)</p><p>ICER in Euro per LY gained 466,000 548,000 620,500</p><p>TR 3: Everolimus-early-transition vs. TR 1: Sirolimus+early withdrawal of Cyclosporine +steroids (10 years)</p><p>ICER in Euro per LY gained 24,456 26,571 27,266</p><p>ICER in Euro per year with FG gained 40,929 45,626 N.A.</p><p>TR 4: Tacrolimus low dose+MMF+steroids vs. TR 2: Sirolimus-early-transition (10 years)</p><p>ICER in Euro per LY gained N.A. 387,684 453,706</p><p>ICER in Euro per year with FG gained 84,154 102,306 N.A.</p><p>TR: Therapy Regimen; N.A.: Use of lower/upper values from sensitivity analysis does not affect the lower/upper value of the simulation results</p><p>Table K: ICERs affected by a ±20% of the probability for graft failure (sensitivity analysis 5) lower value base case upper value</p><p>TR 2: Sirolimus-early-transition vs. TR 4: Tacrolimus low dose+MMF+steroids (12 months)</p><p>ICER in Euro per LY gained 474,000 548,000 620,500</p><p>TR 3: Everolimus-early-transition vs. TR 1: Sirolimus+early withdrawal of Cyclosporine +steroids (10 years)</p><p>ICER in Euro per LY gained N.A. 26,571 26,841</p><p>ICER in Euro per year with FG gained 43,875 45,626 N.A.</p><p>TR 4: Tacrolimus low dose+MMF+steroids vs. TR 2: Sirolimus-early-transition (10 years)</p><p>ICER in Euro per LY gained 379,947 387,684 616,077</p><p>ICER in Euro per year with FG gained 88,011 102,306 124,466</p><p>TR: Therapy Regimen; N.A.: Use of lower/upper values from sensitivity analysis does not affect the lower/upper value of the simulation results</p><p>Table L: SHI costs (generic) on mg basis (Lauer-Fischer (2012). WEBAPO® LAUER-Taxe (Stand 29.03.2012)) SHI- SHI- Pharmacies SHI- Mandatory Patients' Co- relevant Units per mg per relevant Active agent Brand considered Marketed by ' Retail Pack size relevant discount Payment price per package unit cost per Price (AVP) cost per mg pack unit Pfizer RAPAMUNE Sirolimus Pharma 1,868.40 € 236.48 € 10.00 € 1,621.92 € N3 100 2 16.22 € 8.11 € 2 mg Tabletten GmbH Novartis CERTICAN Everolimus Pharma 1,611.84 € 355.80 € 10.00 € 1,246.04 € N3 100 1 12.46 € 12.46 € 1 mg Tabletten GmbH</p><p>TACROLIMUS Hexal Tacrolimus Hexal Pharma 1,724.86 € 81.65 € 10.00 € 1,633.21 € N3 100 5 16.33 € 3.27 € 5 mg Kapseln</p><p>CICLOSPORIN 100 1A Pharma Cyclosporine 355.18 € 0.00 € 0.00 € 355.18 € N3 100 100 3.55 € 0.0355 € 1A Pharma Kapseln Pharma</p><p>MYCOPHENOLAT 1A Pharma MMF 1A Pharma 500 mg 527.99 € 65.49 € 10.00 € 452.50 € N3 250 500 1.81 € 0.0036 € Pharma Filmtabletten</p><p>MYFORTIC 180 mg Novartis EC-MPS magensaftresis- Pharma 198.06 € 33.70 € 10.00 € 154.36 € N2 100 180 1.54 € 0.0086 € tente Tabletten GmbH PREDNISOLON acis Prednisolon ACIS 20 mg Arzneimittel 20.11 € 0.00 € 5.00 € 15.11 € N3 100 20 0.15 € 0.0076 € Tabletten GmbH</p>

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