Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan
Abstract
:1. Introduction
2. Results
2.1. Drug Utilization
2.1.1. Insulin Therapies
2.1.2. Anticoagulants and Erythropoietins
2.1.3. Onco-Hematological Drugs and Medications for Autoimmune Diseases
2.1.4. Analysis of Prescriptions in Naïve Patients
2.2. Pharmacoeconomic Evaluation
Potential and Actual Savings
2.3. Therapeutic Switches
3. Discussion
- An in-depth analysis of the long-term clinical–economic impact: Prospective and retrospective real-world evidence studies should be planned to more precisely measure treatment duration, therapeutic adherence, the number of switches, and potential benefits in terms of clinical outcomes. This would provide more robust data to reinforce the confidence of clinicians and patients.
- A possible revision of procurement procedures: To foster the use of biosimilars, it is advisable to refine regional tenders and procurement contracts, in order to reward not only the lowest price but also supply continuity and long-term stability. This strategy would mitigate the risk of sudden shortages and reduce the occurrence of reverse switches.
- An evaluation of the effectiveness of training and awareness campaigns: Quantifying the impact of various educational initiatives (targeted at both specialist and general practitioners as well as hospital pharmacists) and informational campaigns (addressed to patients) on biosimilar adoption levels.
4. Materials and Methods
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
AIFA | Italian Medicines Agency |
ASST | Territorial Healthcare and Social Agencies |
ATS | Health Protection Agencies |
EMA | European Medicines Agency |
HMA | Heads of Medicines Agencies |
IRCCS | Scientific Institutes for Research, Hospitalization and Healthcare |
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Drug Name | 2022 | 2023 | 2024 | ||||||
---|---|---|---|---|---|---|---|---|---|
Total Units | Biosim. (N.) | Biosim. (%) | Total Units | Biosim. (N.) | Biosim. (%) | Total Units | Biosim. (N.) | Biosim. (%) | |
Adalimumab | 91,145 | 65,401 | 71.8% | 101,718 | 78,993 | 77.7% | 108,714 | 93,775 | 86.3% |
Bevacizumab | 14,686 | 13,478 | 91.8% | 11,976 | 11,786 | 98.4% | 11,300 | 11,258 | 99.6% |
Eculizumab * | 1943 | 0 | 0.0% | 2389 | 0 | 0.0% | 2756 | 204 | 7.4% |
Enoxaparin Sodium | 87,657 | 4302 | 4.9% | 89,643 | 17,747 | 19.8% | 85,007 | 48,766 | 57.4% |
Epoetin Alfa | 5834 | 2900 | 49.7% | 6039 | 3437 | 56.9% | 6435 | 3933 | 61.1% |
Epoetin Zeta | 5807 | 5807 | 100.0% | 5986 | 5986 | 100.0% | 4359 | 4359 | 100.0% |
Etanercept | 62,144 | 36,784 | 59.2% | 63,376 | 40,158 | 63.4% | 64,336 | 47,480 | 73.8% |
Filgrastim | 13,878 | 12,433 | 89.6% | 14,737 | 13,286 | 90.2% | 12,483 | 10,956 | 87.8% |
Infliximab | 34,458 | 31,892 | 92.6% | 40,915 | 38,924 | 95.1% | 43,743 | 42,420 | 97.0% |
Insulin Aspart | 22,749 | 0 | 0.0% | 23,543 | 0 | 0.0% | 20,599 | 0 | 0.0% |
Insulin Glargine | 757 | 276 | 36.5% | 824 | 220 | 26.7% | 1074 | 188 | 17.5% |
Insulin Lispro | 144 | 0 | 0.0% | 207 | 0 | 0.0% | 320 | 5 | 1.6% |
Natalizumab * | 5648 | 0 | 0.0% | 6059 | 0 | 0.0% | 9013 | 443 | 4.9% |
Drug name | 2022 | 2023 | 2024 | ||||||
Total units | Biosim. (N.) | Biosim. (%) | Total units | Biosim. (N.) | Biosim. (%) | Total units | Biosim. (N.) | Biosim. (%) | |
Pegfilgrastim | 1982 | 1981 | 99.9% | 2454 | 2445 | 99.6% | 2518 | 2518 | 100.0% |
Ranibizumab * | 13,983 | 0 | 0.0% | 12,683 | 0 | 0.0% | 8321 | 1161 | 14.0% |
Rituximab | 11,278 | 10,752 | 95.3% | 12,258 | 11,813 | 96.4% | 12,290 | 12,032 | 97.9% |
Teriparatide | 149 | 8 | 5.4% | 170 | 11 | 6.5% | 145 | 84 | 57.9% |
Tocilizumab * | 31,462 | 0 | 0.0% | 35,179 | 0 | 0.0% | 40,815 | 1772 | 4.3% |
Trastuzumab | 17,151 | 16,964 | 98.9% | 13,283 | 13,204 | 99.4% | 11,216 | 11,165 | 99.5% |
Ustekinumab * | 6336 | 0 | 0.0% | 8171 | 0 | 0.0% | 8929 | 269 | 3.0% |
Drug | Naïve Bios. 2023 | Naïve Orig. 2023 | Naïve Bios. 2024 | Naïve Orig. 2024 |
---|---|---|---|---|
Adalimumab | 1050 | 124 | 1127 | 46 |
Bevacizumab | 510 | 9 | 512 | 3 |
Eculizumab * | 0 | 18 | 1 | 18 |
Enoxaparin Sodium | 779 | 5066 | 2534 | 2356 |
Epoetin Alfa | 69 | 48 | 83 | 31 |
Epoetin Zeta | 115 | 0 | 95 | 0 |
Etanercept | 268 | 27 | 293 | 16 |
Filgrastim | 760 | 71 | 588 | 91 |
Infliximab | 445 | 5 | 407 | 6 |
Insulin Aspart | 0 | 40 | 0 | 14 |
Insulin Glargine | 32 | 2 | 27 | 5 |
Insulin Lispro | 0 | 2 | 0 | 2 |
Natalizumab * | 0 | 134 | 18 | 113 |
Pegfilgrastim | 541 | 5 | 580 | 0 |
Ranibizumab * | 0 | 1516 | 112 | 871 |
Rituximab | 1156 | 30 | 1136 | 14 |
Teriparatide | 0 | 3 | 2 | 2 |
Tocilizumab * | 0 | 282 | 27 | 322 |
Trastuzumab | 508 | 0 | 552 | 0 |
Ustekinumab * | 0 | 317 | 14 | 320 |
Drug | Biosimilar Expenditure 2022 (EUR) | Biosimilar Expenditure 2023 (EUR) | Biosimilar Expenditure 2024 (EUR) | Originator Expenditure 2022 (EUR) | Originator Expenditure 2023 (EUR) | Originator Expenditure 2024 (EUR) |
---|---|---|---|---|---|---|
Adalimumab | 2,900,790 | 3,423,767 | 3,698,916 | 4,026,478 | 3,745,818 | 2,446,345 |
Bevacizumab | 1,921,223 | 1,601,312 | 1,153,617 | 610,304 | 86,626 | 24,663 |
Eculizumab * | - | - | 364,113 | 7,934,768 | 8,246,430 | |
Enoxaparin Sodium | 5649 | 28,407 | 69,684 | 118,598 | 108,672 | 51,960 |
Epoetin Alfa | 189,984 | 249,149 | 342,561 | 351,836 | 323,053 | 309,517 |
Epoetin Zeta | 167,715 | 175,714 | 116,484 | - | - | - |
Etanercept | 1,753,022 | 1,945,104 | 2,464,618 | 3,813,805 | 3,514,185 | 2,482,370 |
Filgrastim | 59,137 | 69,327 | 58,143 | 93,781 | 101,731 | 108,681 |
Infliximab | 3,088,609 | 3,950,822 | 4,435,347 | 741,299 | 575,186 | 382,205 |
Insulin Aspart | - | - | - | 75,738 | 64,558 | 56,760 |
Insulin Glargine | 1939 | 1546 | 1320 | 12,705 | 16,388 | 19,040 |
Insulin Lispro | - | - | 26 | 458 | 631 | 1120 |
Natalizumab * | - | - | 425,574 | 8,247,294 | 7,304,026 | |
Pegfilgrastim | 162,197 | 182,865 | 157,532 | 685 | 6165 | |
Ranibizumab * | - | - | 268,813 | 6,913,999 | 5,039,293 | 2,729,022 |
Rituximab | 1,870,662 | 1,682,269 | 1,464,047 | 442,939 | 352,357 | 229,145 |
Teriparatide | 1628 | 2176 | 13,855 | 47,026 | 43,014 | 12,901 |
Tocilizumab * | - | - | 255,572 | 6,319,237 | 6,466,113 | 6,552,750 |
Trastuzumab | 2,109,615 | 1,200,323 | 934,065 | 63,323 | 26,556 | 17,278 |
Ustekinumab * | - | - | 197,201 | 14,315,206 | 18,407,717 | 19,304,575 |
Drug | Switch Biosim. → Orig. | Switch Orig. → Biosim. | Swap Biosim. → Biosim. | Multi-Switch | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
2022 | 2023 | 2024 | 2022 | 2023 | 2024 | 2022 | 2023 | 2024 | 2022 | 2023 | 2024 | |
Adalimumab | 11 | 10 | 7 | 68 | 95 | 312 | 28 | 487 | 301 | 69 | 45 | 53 |
Bevacizumab | 1 | 0 | 0 | 55 | 1 | 6 | 1 | 79 | 78 | 20 | 7 | 1 |
Eculizumab * | 0 | 0 | 0 | 0 | 0 | 9 | 0 | 0 | 0 | 0 | 0 | 0 |
Enoxaparin Sodium | 2 | 7 | 18 | 0 | 81 | 196 | 0 | 3 | 10 | 5 | 6 | 17 |
Epoetin Alfa | 8 | 23 | 8 | 2 | 1 | 3 | 0 | 0 | 0 | 23 | 28 | 22 |
Epoetin Zeta | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Etanercept | 3 | 27 | 6 | 12 | 35 | 98 | 5 | 85 | 118 | 121 | 135 | 37 |
Filgrastim | 3 | 11 | 30 | 5 | 7 | 27 | 70 | 262 | 82 | 20 | 33 | 47 |
Infliximab | 1 | 0 | 0 | 16 | 6 | 38 | 119 | 242 | 245 | 8 | 4 | 6 |
Insulin Aspart | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Insulin Glargine | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
Insulin Lispro | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Natalizumab * | 0 | 0 | 0 | 0 | 0 | 104 | 0 | 0 | 0 | 0 | 0 | 8 |
Pegfilgrastim | 0 | 0 | 0 | 0 | 2 | 1 | 13 | 5 | 8 | 0 | 0 | 0 |
Ranibizumab * | 0 | 0 | 0 | 0 | 0 | 375 | 0 | 0 | 0 | 0 | 0 | 3 |
Rituximab | 3 | 2 | 2 | 3 | 10 | 11 | 169 | 5 | 337 | 7 | 8 | 2 |
Teriparatide | 0 | 0 | 0 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 1 |
Tocilizumab * | 0 | 0 | 0 | 0 | 0 | 26 | 0 | 0 | 0 | 19 | 15 | 54 |
Trastuzumab | 1 | 0 | 0 | 4 | 0 | 0 | 397 | 168 | 72 | 19 | 7 | 10 |
Ustekinumab * | 0 | 0 | 0 | 0 | 0 | 213 | 0 | 0 | 0 | 0 | 0 | 0 |
ATC | Drugs | Analysis Period |
---|---|---|
A10AB04 | Insulin Lispro | 2022–2024 |
A10AB05 | Insulin Aspart | 2022–2024 |
A10AE04 | Insulin Glargine | 2022–2024 |
B01AB05 | Enoxaparin Sodium | 2022–2024 |
B03XA01 | Epoetin Alfa | 2022–2024 |
B03XA01 | Epoetin Zeta | 2022–2024 |
H05AA02 | Teriparatide | 2022–2024 |
L01XC02 | Rituximab | 2022–2024 |
L01XC03 | Trastuzumab | 2022–2024 |
L01XC07 | Bevacizumab | 2022–2024 |
L03AA02 | Filgrastim | 2022–2024 |
L03AA13 | Pegfilgrastim | 2022–2024 |
L04AA23 | Natalizumab | 2024 |
L04AA06 | Eculizumab | 2023–2024 |
L04AB01 | Etanercept | 2022–2024 |
L04AB02 | Infliximab | 2022–2024 |
L04AB04 | Adalimumab | 2022–2024 |
L04AC05 | Ustekinumab | 2024 |
L04AC07 | Tocilizumab | 2023–2024 |
S01LA04 | Ranibizumab | 2023–2024 |
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Langfelder, R.M.B.; Langella, R.; D’Angelo, C.; Panico, C.; Cattaneo, S. Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan. Pharmaceuticals 2025, 18, 482. https://doi.org/10.3390/ph18040482
Langfelder RMB, Langella R, D’Angelo C, Panico C, Cattaneo S. Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan. Pharmaceuticals. 2025; 18(4):482. https://doi.org/10.3390/ph18040482
Chicago/Turabian StyleLangfelder, Renata Maria Bianca, Roberto Langella, Cinzia D’Angelo, Claudia Panico, and Sarah Cattaneo. 2025. "Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan" Pharmaceuticals 18, no. 4: 482. https://doi.org/10.3390/ph18040482
APA StyleLangfelder, R. M. B., Langella, R., D’Angelo, C., Panico, C., & Cattaneo, S. (2025). Ensuring Sustainability in Pharmaceutical Care: A Retrospective Analysis of Administrative Databases on the Utilization, Costs, and Switching Patterns of Biological Therapies in the Agency for Health Protection of the Metropolitan Area of Milan. Pharmaceuticals, 18(4), 482. https://doi.org/10.3390/ph18040482