Introduction
Methods
Literature Search
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American College of Rheumatology Annual Meeting (ACR/ARHP)
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American College of Gastroenterology Annual Scientific Meeting (ACG)
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American Diabetes Association Scientific Sessions (ADA)
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American Society of Hematology Annual Meeting (ASH)
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American Thoracic Society International Conferences (ATS)
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Annual Meeting of the European Association for the Study of Diabetes (EASD)
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American Society of Clinical Oncology Annual Meeting (ASCO)
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European League Against Rheumatism Annual Congress (EULAR)
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European Congress of Endocrinology (ECE)
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European Society of Cardiology Annual Congress (ESC)
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European Crohn’s and Colitis Organization Annual Congress (ECCO gastro)
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International Society for Pharmacoeconomics and Outcomes Research Annual European Congress (ISPOR Europe)
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International Society for Pharmacoeconomics and Outcomes Research Annual International Meeting (ISPOR International)
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Scientific Sessions of American Heart Association (AHA)
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European Cancer Congress (ECCO cancer).
Literature Screening
Disease areas | Citations | Publication type | Study type | Biosimilar | Total population | Time horizon |
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Rheumatology, dermatology and gastroenterology diseases | Jha 2015 [46] | Abstract | Simulation study | Biosimilar infliximab | NR | 1 year |
Jha 2015 [47] | Journal article | Simulation study | Biosimilar infliximab | 3,750,611 | 1 year | |
Ala 2016 [48] | Abstract | Center-based cohort study | Biosimilar infliximab | 21 | 6 months | |
Becciolini 2016 [49] | Abstract | Simulation study | Biosimilar etanercept | NR | 3 years | |
Bhattacharyya 2016 [50] | Abstract | Simulation study | Biosimilar etanercept | 27,052 | 1 year | |
Bocquet 2016 [51] | Abstract | Simulation study | Biosimilar infliximab | 5483 | 1 year | |
Rahmany 2016 [52] | Abstract | Center-based cohort study | Biosimilar infliximab | 88 | 6 months | |
Shah 2016 [53] | Abstract | Simulation study | Biosimilar infliximab | 7343 | 1 year | |
Biosimilar adalimumab | ||||||
Sheppard 2016 [34] | Abstract | Center-based cohort study | Biosimilar infliximab | 25 | 1 year | |
Trancart 2016 [54] | Abstract | Simulation study | Biosimilar etanercept | 45,903 | 3 years | |
Alexandre 2017 [55] | Abstract | Simulation study | Biosimilar infliximab | 3142 | 5 years | |
Barnes 2017 [38] | Abstract | Simulation study | Biosimilar etanercept | NR | NR | |
Dyball 2017 [36] | Abstract | Center-based cohort study | Biosimilar etanercept | 38 | NR | |
Glintborg 2017 [16] | Abstract | Registry/National database | Biosimilar infliximab | 769 | 1 year | |
Gomez 2017 [56] | Abstract | Simulation study | Biosimilar adalimumab | 326 | 1 year | |
Gutermann 2017 [33] | Abstract | Center-based cohort study | Biosimilar infliximab | 333 | 10 months | |
Plevris 2017 [29] | Abstract | Center-based cohort study | Biosimilar infliximab | 161 | NR | |
Ratnakumaran 2017 [32] | Journal article | Center-based cohort study | Biosimilar infliximab | 210 | 1 year | |
Razanskaite 2017 [35] | Journal article | Center-based cohort study | Biosimilar infliximab | 143 | 1 year | |
Rodriguez 2017 [28] | Abstract | Center-based cohort study | Biosimilar infliximab | 72 | 1 year | |
St. Clair Jones 2017 [31] | Abstract | Center-based cohort study | Biosimilar infliximab | 71 | 6 months | |
Szlumper 2017 [57] | Abstract | Center-based cohort study | Biosimilar etanercept | 39 | 3 months | |
Szlumper 2017 [19] | Abstract | Center-based cohort study | Biosimilar etanercept | 109 | 7 months | |
Barnes 2018 [23] | Abstract | Interview | Biosimilar etanercept | 627–689 | NR | |
Garcia-Fernandez 2018 [58] | Abstract | Center-based cohort study | Biosimilar infliximab | 76 | 8 months | |
Gibofsky 2018 [39] | Abstract | Simulation study | NR | 5000 | < 1 year | |
Gibofsky 2018 [41] | Journal article | Simulation study | NR | 1000 | 3 months | |
Glintborg 2018 [17] | Journal article | Registry/National database | Biosimilar infliximab | 769 | 1 year | |
Healy 2018 [59] | Abstract | Center-based cohort study | Biosimilar infliximab | 60 | 1 year | |
Husereau 2018 [42] | Journal article | Simulation study | Biosimilar infliximab | NR | NR | |
Ma 2018 [60] | Abstract | Center-based cohort study | Biosimilar etanercept | 50 | 6 months | |
Mora 2018 [61] | Abstract | Center-based cohort study | Biosimilar infliximab | 18 | 1 year | |
Nisar 2018 [27] | Abstract | Center-based cohort study | Biosimilar rituximab | 39 | 1 year | |
O’Brien 2018 [62] | Abstract | Center-based cohort study | Biosimilar infliximab | 20 | 8 months | |
Peral 2018 [20] | Abstract | Simulation study | Biosimilar etanercept | NR | 1 year | |
Rodriguez 2018 [26] | Abstract | Center-based cohort study | Biosimilar infliximab | 48 | 11 months | |
Shah 2018 [21] | Abstract | Center-based cohort study | Biosimilar etanercept | 151 | 1 year | |
Shah 2018 [63] | Abstract | Center-based cohort study | Biosimilar etanercept | 151 | 6 months | |
Valido 2018 [37] | Abstract | Center-based cohort study | Biosimilar infliximab | 60 | 1 year | |
Zahorian 2018 [22] | Abstract | Center-based cohort study | Biosimilar infliximab | 110 | NR | |
NHL, multiple myeloma, colorectal and breast cancer | Abraham 2014 [64] | Journal article | Simulation study | Biosimilar epoetin alfa | 100,000 | 15 weeks |
Sun 2015 [65] | Journal article | Simulation study | Biosimilar filgrastim | 10,000 | 14 days | |
McBride 2017 [66] | Abstract | Simulation study | Biosimilar filgrastim | 20,000 | Chemotherapy of 1 or 6 cycles | |
McBride 2017 [67] | Abstract | Simulation study | Biosimilar filgrastim-sndz | 20,000 | 5, 7, 11, 14 days | |
McBride 2017 [68] | Journal article | Simulation study | Biosimilar filgrastim-sndz | 20,000 | 1–14 days | |
Peck 2017 [25] | Abstract | Center-based cohort study | Biosimilar filgrastim | 100 | 1 year | |
Hemodialysis | Minutolo 2016 [30] | Journal article | Center-based cohort study | Biosimilar epoetin alfa | 149 | 36 weeks |
Biosimilar epoetin zeta | ||||||
Pediatric growth disturbances | Flodmark 2013 [24] | Journal article | Center-based cohort study | Biosimilar somatropin | 98 | About 3 years |
Obstetrics/gynecology | Ravonimbola 2017 [69] | Abstract | Simulation study | Biosimilar follitropin alfa | 100 | NR |
Not reported | Brown 2016 [40] | Abstract | Simulation study | NR | 1 year | |
Claus 2016 [70] | Abstract | Simulation study | Biosimilars of infliximab, epoeitin alfa, filgrastim and follitropin alfa | NR | 5 years | |
Hakim 2017 [43] | Journal article | Policy review | NA | 1000 | NA | |
Phillips 2017 [18] | Abstract | Registry/National database | Biosimilar infliximab | 1524 | 1 year | |
Reichardt 2017 [71] | Abstract | Simulation study | Biosimilar infliximab | NR | NR |
Data Extraction and Analysis
Citations | Diseases | Study type | Biosimilar | Time horizon | Data source | Reported HRU |
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Flodmark 2013 [24] | Pediatric growth disturbances | Center-based cohort study | Biosimilar somatropin | About 3 years | Hospital data | Twelve patients experienced injection-site pain, three required an extra visit to the responsible physician or specialized nurse, 10 required extra phone contact with the physician/nurse |
Minutolo 2016 [30] | Hemodialysis | Center-based cohort study | Biosimilar epoetin alfa Biosimilar epoetin-zeta | 36 weeks | 11 nonprofit Italian dialysis centers | Thirty-five percent of patients switched experienced dose escalation |
Glintborg 2017 [16] | Rheumatology | Registry/National database | Biosimilar infliximab | 1 year | Danish quality registry, DANBIO | The mean rate of days with services provided was 5.4 before the switch and 5.7 after switch (p = 0.0003) |
Peck 2017 [25] | Multiple myeloma, non-Hodgkin lymphoma | Center-based cohort study | Biosimilar filgrastim | 1 year | Hospital data | Use of Plerixafor (bone marrow stimulant) was higher in the biosimilar G-CSF group compared with the originator product (18 vs. 5 patients) |
Phillips 2017 [18] | All authorized indications | Registry/National database | Biosimilar infliximab | 1 year | Turkish healthcare administrative database | Patients who switched to CT-P13 had higher outpatient (€86.6 vs. €58.3; p = 0.005), inpatient (€20.6 vs. €9.3; p = 0.313) and pharmacy costs (€474.2 vs. €427.9; p = 0.371), which resulted in significantly higher total health care costs (€646.8 vs. €528.0; p = 0.046) compared to patients who continued infliximab |
Plevris 2017 [29] | IBD | Center-based cohort study | Biosimilar infliximab | NR | Gastrointestinal units, center data | Nine percent of patients switched experienced dose escalation |
Ratnakumaran 2017 [32] | CD, UC | Center-based cohort study | Biosimilar infliximab | 1 year | Hospital data | Six percent of patients switched experienced dose escalation |
Rodriguez 2017 [28] | IBD (CD and UC) | Center-based cohort study | Biosimilar infliximab | 1 year | Hospital data | Eleven percent and 13 percent of patients switched had surgery and used steroid after the non-medical switch |
St. Clair Jones 2017 [31] | IBD (CD and UC) | Center-based cohort study | Biosimilar infliximab | 6 months | Hospital data | Of switch patients, 11.3 percent experienced dose escalation and a payment was negotiated to fund the switch |
Szlumper 2017 [19] | Rheumatology | Center-based cohort study | Biosimilar etanercept | 7 months | Biologic registry | Three switchers requested face-to-face consultations on use of delivery device; all potential switchers were invited to face-to-face switching clinic with specialist pharmacist and nurse |
Barnes 2018 [23] | RA, AS, PA | Interview | Biosimilar etanercept | NR | Interview | Staff spent 320–1076 additional hours on the non-medical switch across the four centers |
Glintborg 2018 [17] | RA, PA, AS | Registry/National database | Biosimilar infliximab | 1 year | DANBIO, Danish National Patient Registry | The included patients had 39 more outpatient visits within 6 months after the switch than before Total days with services were 4131 before (mean 5.4 days, SD 2.8) and 4400 after switch (mean 5.8 days, SD 2.8) (p < 0.01, paired t test). After the switch, 259 patients (34%) had fewer (mean − 2.4, SD 1.7), 169 patients (22%) had the same and 341 patients (45%) (mean 2.6, SD 2.0) had more days with services than before switch Patients on average had more phone consultation (1.17 vs. 1.03, p = 0.03), patient guidance (0.49 vs. 0.35, p < 0.01), intravenous medication (0.11 vs. 0.03, p < 0.01), clinical investigation (0.47 vs. 0.31, p < 0.01), clinical control (2.26 vs. 2.08, p < 0.01) and observation (0.22 vs. 0.17, p < 0.01) within 6 months after switch |
Nisar 2018 [27] | RA | Center-based cohort study | Biosimilar rituximab | 1 year | Hospital data | Two patients (8%) experienced emergency department visits after switching 5 (20%) had severe serum sickness reaction within the 1st week of the second dose and lost response Four (17%) requested to return to the originator |
Peral 2018 [20] | RA | Simulation study | Biosimilar etanercept | 1 year | DANBIO registry, survey of 30 rheumatologists in Spain | The non-medical switch is associated with treatment adjustment costs, including monitoring, hospitalization and other healthcare costs |
Rodriguez 2018 [26] | CD, UC, AS, RA | Center-based cohort study | Biosimilar infliximab | 11 months | Hospital data | One patient required treatment intensification; a total of four patients required an increased dose of immunomodulatory drugs |
Shah 2018 [21] | RA | Center-based cohort study | Biosimilar etanercept | 1 year | Hospital data | For RA patients treated with high intensity etanercept to switch to etanercept biosimilar, 2 days of pharmacists’ time were required per week for 6 months, costing about €22,294 |
Zahorian 2018 [22] | IBD (CD and UC) | Center-based cohort study | Biosimilar infliximab | NR | Pharmacists’ experience and hospital data | Pharmacists spent an average of 5–10 min on the phone per patient providing education and answering questions to assist the switching process |
Citations | Diseases | Study type | Time horizon | Switch populationa | Drug costs (total €) | Annualized drug costs (€/person/year) |
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Jha 2015 [47] | RA, AS, IBD (CD and UC), PsO, PA | Simulation study | 1 year | 3,750,611 | 3.0–34.5 million cost reduction | 7–21 cost reduction |
Bocquet 2016 [51] | Gastroenterology, rheumatology, dermatology and others | Simulation study | 1 year | 5483 | 20% discount: 7.8 million cost reduction 30% discount: 11.7 million cost reduction | 20% discount: 1427 cost reduction 30% discount: 2141 cost reduction |
Shah 2016 [53] | RA | Simulation study | 1 year | 7343 | Infliximab: 37,115,928 cost reduction Adalimumab: 28,599,516 cost reduction | Infliximab: 5055 cost reduction Adalimumab: 3895 cost reduction |
Dyball 2017 [36] | RA | Center-based cohort study | NR | 38 | 29,428 cost reduction | 774 cost reduction |
Gomez 2017 [56] | Rheumatology, dermatology, gastroenterology | Simulation study | 1 year | 326 | 784,270 cost reduction | 2406 cost reduction |
Ratnakumaran 2017 [32] | IBD (CD and UC) | Center-based cohort study | 1 year | 191 | > 1.11 million cost reduction | > 5812 cost reduction |
Razanskaite 2017 [35] | IBD (CD and UC) | Center-based cohort study | 1 year | 143 | 565,905-848,858 cost reduction | 3957–5936 cost reduction |
Rodriguez 201 7 [28] | IBD (CD and UC) | Center-based cohort study | 1 year | 72 | 248,716 cost reduction | 3454 cost reduction |
Garcia-Fernandez 2018 [58] | Gastroenterology, rheumatology, dermatology and other diseases | Center-based cohort study | 8 months | 76 | 62,692 cost reduction | 1237 cost reduction |
Husereau 2018 [42] | IBD (CD) | Simulation study | 10 years | NR | 31,042 cost reduction | 3104 cost reduction |
Mora 2018 [61] | Gastroenterology and dermatology | Center-based cohort study | 1 year | 10 | Total: 38,237 cost reduction Gastroenterology: 25,037 cost reduction Dermatology: 13,200 cost reduction | Overall average: 3824 cost reduction Gastroenterology: 6259 cost reduction Dermatology: 2200 cost reduction |
O’Brien 2018 [62] | IBD | Center-based cohort study | 8 months | 20 | 15–45% discount on biosimilar price: 77,953–183,189 cost reduction | 15% discount on biosimilar price: 5846 cost reduction 45% discount on biosimilar price: 13,739 cost reduction |
Rodriguez 2018 [26] | IBD (CD and UC), RA and AS | Center-based cohort study | 11 months | 48 | 73,476 cost reduction | 1670 cost reduction |
Shah 2018 [21] | RA | Center-based cohort study | 1 year | 151 | 557,350 cost reduction | 3691 cost reduction |
Valido 2018 [37] | RA, SA and PA | Center-based cohort study | 1 year | 60 | 26.4% cost reduction | 26.4% cost reduction |
Abraham 2014 [64] | DLBCL, colorectal cancer, breast cancer | Simulation study | 15 weeks | 100,000 | 120,968,327 cost reduction | NA |
IBD (CD and UC) | Simulation study | 1 year | NR | Switch population incurred cost reduction CD 0.7–16.4 million UC 0.3–5.4 million | NA | |
Sun 2015 [65] | Breast cancer, DLBCL | Simulation study | 14 days | 10,000 | 10%, 20%, 30%, 40%, 100% conversion rate, annual cost reductions 1.5, 3, 4.5, 6, 7.5, 15 million | NA |
Bhattacharyya 2016 [50] | RA and PsO | Simulation study | 1 year | 27,052 | 5.7–16.9 million cost reduction | NA |
Claus 2016 [70] | All authorized indications | Simulation study | 5 years | NR | 20% switch: Infliximab: 772,630 cost reduction Filgrastim: 106,895 cost reduction Follitropine alfa: 19,598 cost reduction Epoetin alfa: 7469 cost reduction 100% switch: Infliximab: 7,910,767 cost reduction Filgrastim: 534,474 cost reduction Follitropine alfa: 97,988 cost reduction Epoetin alfa: 37,343 cost reduction | NA |
Trancart 2016 [54] | RA | Simulation study | 3 years | 45,903 | 28.9 million cost reduction | NA |
Alexandre 2017 [55] | RA | Simulation study | 5 years | 943–1571 | 4.1–6.9 million cost reduction | NA |
McBride 2017 [67] | Chemotherapy-induced (febrile) neutropenia | Simulation study | 5, 7, 11, 14 days | 20,000 | Cost reduction per cycle of filgrastim-sndz over filgrastim 5 days: 6,263,133 7 days: 8,768,386 11 days: 879,435,766 14 days: 17,536,772 | NA |
McBride 2017 [68] | Chemotherapy induced neutropenia | Simulation study | 1–14 days | 20,000 | 6.2–17.6 million cost reduction | NA |
McBride 2017 [66] | Chemotherapy-induced (febrile) neutropenia prophylaxis | Simulation study | Chemotherapy of 1 or 6 cycles | 20,000 | Biosimilar vs. Neupogen: 164–2158 cost reduction Biosimilar vs. Neulasta: 541–11,971 cost reduction | NA |
Peck 2017 [25] | Multiple myeloma, NHL | Center-based cohort study | 1 year | 50 | 2676 cost increase | NA |
Ravonimbola 2017 [69] | Obstetrics/gynecology | Simulation study | NR | 100 | Follitropin Alfa biosimilar 1: 25,900 cost reduction Follitropin Alfa biosimilar 2: 27,900 cost reduction | NA |
Reichardt 2017 [71] | NR | Simulation study | NR | NR | 16,848 cost reduction | NA |
St. Clair Jones 2017 [31] | IBD (CD and UC) | Center-based cohort study | 6 months | 71 | 249,693 cost reduction | NA |
Szlumper 2017 [19] | Rheumatology | Center-based cohort study | 7 months | 80 | 155,947 cost reduction | NA |
Healy 2018 [59] | IBD (Pediatric) | Center-based cohort study | 1 year | 60 | 278,675–306,543 cost reduction | NA |
Ma 2018 [60] | Rheumatology | Center-based cohort study | 6 months | 50 | 732,671 cost reduction | NA |
Results
Study Selection
Study Characteristics
Post-NMS HRU and HRU-Related Costs
NMS-Related Drug, Healthcare and Management Costs
Citations | Diseases | Study type | Biosimilar | Time horizon | Switch populationa (N) | Cost difference after vs. before NMS |
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Observed annual cost difference per patient (€/person/year) | ||||||
Phillips 2017 [18] | All authorized indications | Registry/National database | Biosimilar infliximab | 1 year | 136 | 119 cost increase per patient |
Anticipated annual cost difference per patient (€/person/year) | ||||||
Peral 2018 [20] | RA | Simulation study | Biosimilar etanercept | 1 year | NR | 1215 cost increase per patient |
Anticipated total cost difference (€) | ||||||
Flodmark 2013 [24] | Pediatric growth disturbances | Center-based cohort study | Biosimilar somatropin | About 3 years | 98 | 730,000 cost reduction |
Ala 2016 [48] | IBD (CD) | Center-based cohort study | Biosimilar infliximab | 6 months | 21 | 305,326 cost reduction |
Rahmany 2016 [52] | IBD (CD and UC) | Center-based cohort study | Biosimilar infliximab | 6 months | 88 | 749,437 cost reduction |
Sheppard 2016 [34] | Rheumatology | Center-based cohort study | Biosimilar infliximab | 1 year | 25 | 82,528 cost reduction |
Plevris 2017 [29] | IBD (CD and UC) | Center-based cohort study | Biosimilar infliximab | NR | 160 | 791,437 cost reductions |
Szlumper 2017 [19] | Rheumatology | Center-based cohort study | Biosimilar etanercept | 7 months | 80 | 155,947 cost reductions |
Szlumper 2017 [57] | PsO | Center-based cohort study | Biosimilar etanercept | 3 months | 17 | 154,492 cost reductions |
Ma 2018 [60] | Rheumatology | Center-based cohort study | Biosimilar etanercept | 6 months | 50 | 174,628 cost reductions |
Healy 2018 [59] | IBD (Pediatric) | Center-based cohort study | Biosimilar infliximab | 1 year | 60 | 278,675–306,543 cost reductions |