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20th Congress of the European Haematology Association, June 2015, Vienna, Austria Micro-costing study of rituximab subcutaneous injection versus intravenous infusion in Dutch setting Mihajlović J1,2, Bax P1, van Breugel E1, Blommestein HM3, Hoogendoorn M4, Hospes W5,6, Postma MJ1,7 1Unit of PharmacoEpidemiology & PharmacoEconomics, University of Groningen, Netherlands, 2Mihajlović Health Analytics, Novi Sad, Serbia, 3Erasmus University, Rotterdam, Netherlands 4Department of Haematology, Medical Center Leeuwarden, Netherlands, 5Department of Pharmacy, Isala Clinics, Zwolle, Netherlands, 6Department of Pharmacy, Ommelander Zorggroep, Winschoten/Delfzijl, Netherlands, 7Institute of Science in Healthy Aging & health caRE (SHARE), University Medical Center Groningen, Netherlands Material costs Background Diffuse large B-cell lymphoma (DLBCL) is the most common type of NonHodgkin Lymphoma (NHL) comprising 30-58% of NHL cases. Intravenously (IV) administered rituximab combined with cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP) is the standard initial treatment of DLBCL. Rituximab for subcutaneous (SC) administration has recently been approved for use in common forms of DLBCL. This form of rituximab is supplied in ready-to-use vials that do not require individual dose adjustment. It is expected that SC-injection will shorten the treatment time per administration of rituximab in comparison with currently available intravenous (IV) infusion The goal of this study is to identify and compare all direct costs of IV and SC rituximab administered to the DLBCL patients in the Dutch setting Methods The study was conducted alongside the MabEase phase IIIB international clinical trial of Hoffmann-La Roche from December 2012 until January 2014 in several hospitals in the Netherlands (an ongoing non-inferiority study that compares SC and IV rituximab in DLBCL patients). We measured time and calculated respective costs for 20 administrations of SC rituximab and 33 administrations of IV rituximab performed by nurse in the chemotherapy unit. We also followed preparation of 7 IV infusions and 6 SC injections perforemed by pharmacist’s assistant. Costs were divided into four classes: i) drug costs including spillage, ii) labor costs, iii) daycare treatment costs and iv) material costs. Drug costs including spillage The drug costs of IV and SC rituximab were retrieved from the official pricelist as of September 2014 (500mg of IV rituximab was priced at €1351.02 and 1400mg of SC rituximab at €1822.15) Rituximab IV was given in doses of 375 mg/m2, while rituximab SC was given in a unique dose of 1400mg for all patients regardless of their body surface area (BSA) according to the drugs official posology. Spillage of rituximab IV could not have been estimated from the original sample (N=33), thus we collected real world data on rituximab IV cost spillage (412 patients from Isala Clinics in Zwolle (ICZ) and 517 patients from Medical Center Leeuwarden (MCL)) Material costs related to the use of disposable materials for IV and SC administration that was not included in the daycare costs treatment (syringes, clamps, needles, etc.) Results Drug cost per patient of SC rituximab was €85.34 lower than that of IV rituximab, estimated from 33 IV and 20 SC administrations (p=0.0273, Table 1). Spillage of IV rituximab was estimated at €69.11 using secondary data from ICZ (412 patients) and MCL (517 patients). Labor costs of a nurse were less for IV than for SC administration and the difference was estimated at €1.43 per patient (p=0.05, Table 2). Labor cost of two pharmacist’s assistants differed insignificantly for IV and SC rituximab (p=0.41) when estimated on preparations of 7 IV and 6 SC. Daycare treatment costs (cost of CTU) correlated with significant difference in time needed for IV and SC administration (mean times of 139.30 and 57.80 min. per administration, respectively) and were lowered by €102.39 (p<0.0001, Table 2) when SC rituximab was used. Material costs differed for IV (€5.40) and SC administration (€1.38), however, this was based on one estimate of disposables’ costs taken per each type of administration. Table 2. Measurements of nurses’ and chemotherapy unit (CTU) time and costs Table 1. Measurements of BSA, doses and drug costs IV rituximab Measurement number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Mean Lower limit of 95% CI Upper limit of 95% CI Standard deviation IV rituximab SC rituximab BSA (m2) Dose (mg) Cost (€) 1.6520 2.1829 1.8821 1.4277 1.8004 1.9637 1.8661 2.1438 1.7032 1.9994 1.6203 1.8980 2.0186 1.7252 1.8338 2.3364 1.5812 2.0609 1.7455 2.0850 1.8173 1.9303 1.6791 1.7829 1.9468 2.1121 2.0389 1.5274 1.8501 1.9812 1.9140 1.7647 2.2367 1.8821 619.49 818.59 705.77 535.37 675.14 736.40 699.79 803.92 638.71 749.79 607.61 711.75 756.97 646.94 687.68 876.17 592.95 772.83 654.57 781.87 681.49 723.85 629.67 668.58 730.05 792.05 764.60 572.78 693.77 742.96 717.77 661.75 838.76 705.77 1674.18 2212.57 1907.49 1446.72 1824.65 1990.33 1891.32 2172.91 1726.15 2026.53 1642.07 1923.66 2045.93 1748.41 1858.59 2368.26 1602.41 2088.83 1769.04 2113.28 1841.83 1956.39 1701.70 1806.92 1973.15 2140.80 2066.57 1547.86 1875.05 2008.06 1939.93 1788.45 2267.12 1907.49 1.8108 679.03 1.9533 0.2090 Measurement number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 BSA (m2) Dose (mg) Cost (€) 1.6152 1.7455 1.7695 1.7177 1.8204 1.8473 1.6791 1.7501 1.7921 1.8821 1.8880 1.9740 1.9603 2.0518 2.0289 1.9312 1.9594 2.1735 2.0189 2.1109 1400 1400 1400 1400 1400 1400 1400 1400 1400 1400 1400 1400 1400 1400 1400 1400 1400 1400 1400 1400 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1822.15 1.8858 1400.00 1822.15 1835.19 1.8198 1400.00 1822.15 732.51 1979.79 1.9518 1400.00 1822.15 78.3649 211.9065 0.1505 0.0000 0.0000 SC rituximab Measurement Total nurse Nurse costs Total CTU Daycare number time (min) (€) time (min) costs (€) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 Mean Lower limit of 95% CI Upper limit of 95% CI Standard deviation 17.93 16.85 12.58 11.73 15.65 9.37 8.33 11.45 13.57 8.58 15.88 11.97 13.67 7.88 12.9 9.25 13.03 8.7 15.22 17.65 18.4 19.78 7.23 19.72 16.58 10.9 17.33 12.97 12.3 20.22 19.7 11.52 11.67 13.65 9.04 8.49 6.34 5.91 7.88 4.72 4.2 5.77 6.84 4.32 8 6.03 6.89 3.97 6.5 4.66 6.57 4.38 7.67 8.89 9.27 9.97 3.64 9.93 8.36 5.49 8.73 6.53 6.2 10.19 9.93 5.8 5.88 6.88 147 150 140 133 125 105 100 126 109 140 105 225 126 123 125 160 129 126 179 115 161 138 138 126 124 119 157 103 138 230 196 138 141 139.3 184.67 188.44 175.88 167.09 157.04 131.91 125.63 158.29 136.93 175.88 131.91 282.66 158.29 154.52 157.04 201.01 162.06 158.29 224.87 144.47 202.26 173.37 173.37 158.29 155.78 149.50 197.24 129.40 173.37 288.94 246.23 173.37 177.14 175.00 12.33 6.22 128.74 14.97 7.54 3.8622 1.9467 Measurement Total nurse Nurse costs Total CTU number time (min) (€) time (min) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Daycare costs(€) 15.97 17.55 12.85 15.92 19.85 19.98 17.22 15.62 11.82 16.25 16.22 21.57 16.15 17.77 19.12 17.67 16.92 11.8 9.75 19.95 8.04 8.84 6.47 8.02 10 10.07 8.67 7.87 5.95 8.19 8.17 10.87 8.14 8.95 9.63 8.9 8.52 5.84 4.91 10.05 60 85 17 55 80 85 95 24 27 60 29 92 30 48 21 112 73 67 16 80 75.38 106.78 21.36 69.10 100.50 106.78 119.35 30.15 33.92 75.38 36.43 115.58 37.69 60.30 26.38 140.70 91.71 84.17 20.10 100.50 16.50 8.31 57.80 72.61 161.73 15.16 7.63 44.75 56.22 149.86 188.27 17.84 8.99 70.85 89.01 30.9521 38.8845 3.0532 1.5478 29.7757 37.4066 Difference in total costs for administration of IV (€2166.77) and SC rituximab (€1907.15) was estimated at €259.62 per patient (95% CI: €226.55-292.69, Table 3). Table 3. Total costs difference between IV and SC rituximab administration Labor costs Labor costs related to the time needed for preparation of infusion/injection done by two pharmacist’s assistants and administration of the drug done by a nurse. Per hour wages of medical staff were taken from the official wage reports (€21.43/h for a pharamacist assistant and €30.23/h for a nurse) Daycare treatment costs Cost item Costs for IV rituximab administration Costs of SC rituximab administration Costs' difference p-value Drug costs 1907.49 1822.15 85.34 0.0273 Spillage cost 69.11 0.00 69.11 N/A Material costs 5.40 1.38 4.02 N/A Labor costs (nurse) 6.88 8.31 -1.43 0.0050 2.89 2.70 0.19 0.4119 Daycare costs 175.00 72.61 102.39 <0.0001 Total costs Lower limit of 95% CI 2166.77 1907.15 259.62 2125.36 1897.98 226.55 Upper limit of 95% CI 2208.18 1916.33 292.69 Standard deviation 107.7268 18.7208 77.3160 Labour costs (preparation) Conclusions Standard daycare treatment cost concerned costs of facilities and capital investment and was cited from a recent Dutch report on costs of hospital Rituximab administered in the form of SC injection is less costly than its IV form services amounting to €175. This was divided by the mean time [min.] of Costs difference is mainly based on savings related to the shorter time spent in IV administration to obtain daycare treament cost per minute for a CTU, reduced drug cost and lack of spillage when SC rituximab is used. chemotherapy unit (CTU). Taking into account their equal effectiveness, favorable economic profile of SC Multiplying mean time [min.] of a SC administration by the average cost rituximab can result in significant savings when transferred to the total DLBCL of CTU minute we calculated daycare treatment cost for SC rituximab. population in the Netherlands. Sponsored by: For further information contact: [email protected] For a copy of the poster: