Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Oct;13(5):1415-1430.
doi: 10.1007/s40120-024-00644-3. Epub 2024 Aug 2.

Predicted Expenditure for Prescription Drugs for Multiple Sclerosis in the Italian Market Between 2023 and 2028: Results of the Oracle Project

Damiano Paolicelli  1 , Giovanna Borriello  2   3 , Raffaella Clerici  4 , Elena Colombo  5 , Davide Croce  6 , Emanuele D'Amico  7 , Nicola De Rossi  8 , Alessia Di Sapio  9 , Giuseppe Fenu  10 , Davide Maimone  11 , Girolama A Marfia  12 , Marcello Moccia  13   14 , Paola Perini  15 , Maria G Piscaglia  16 , Lorenzo Razzolini  17 , Massimo Riccaboni  18 , Elisabetta Signoriello  19 , Gianluca Agostoni  20 , Alberto Farina  20 , Margaret Mondino  20 , Francesco Berruto  21 , Alessia Tettamanti  21 , Francesca Donnaloja  22 , Carla Tortorella  23
Affiliations

Predicted Expenditure for Prescription Drugs for Multiple Sclerosis in the Italian Market Between 2023 and 2028: Results of the Oracle Project

Damiano Paolicelli et al. Neurol Ther. 2024 Oct.

Abstract

Introduction: Multiple sclerosis (MS) is a chronic neurodegenerative disease that leads to impaired cognitive function and accumulation of disability, with significant socioeconomic burden. Serious unmet need in the context of managing MS has given rise to ongoing research efforts, leading to the launch of new drugs planned for the near future, and subsequent concerns about the sustainability of healthcare systems. This study assessed the changes in the Italian MS market and their impact on the expenditures of the Italian National Healthcare Service between 2023 and 2028.

Methods: A horizon-scanning model was developed to estimate annual expenditure from 2023 to 2028. Annual expenditure for MS was calculated by combining the number of patients treated with each product (clinical inputs) and the yearly costs of therapy (economic inputs). Baseline inputs (2020-2022) were collected from IQVIA® real-world data, while input estimation for the 5-year forecast was integrated with analog analyses and the insights of clinicians and former payers.

Results: The number of equivalent patients treated in 2028 in Italy was estimated at around 67,000, with an increase of 10% versus 2022. In terms of treatment pattern evolution, first-line treatments are expected to reduce their shares from 47% in 2022 to 27% in 2028, and Bruton tyrosine kinase inhibitors are expected to reach 23% of patient shares. Overall, expenditure for MS is estimated to decrease from €721 million in 2022 to €551 million in 2028, mainly due to losses of exclusivity and renegotiation of drug prices.

Conclusion: Despite the increase in the number of patients treated for MS and the launch of new molecules that will reach high market penetration, the model confirmed sustainability for the Italian National Healthcare Service.

Keywords: BTKi; Costs; Forecast; Italian National Healthcare Service expenditure; Multiple sclerosis; Treatment pattern.

PubMed Disclaimer

Conflict of interest statement

Damiano Paolicelli, Giovanna Borriello, Raffaella Clerici, Elena Colombo, Davide Croce, Emanuele D’Amico, Nicola De Rossi, Alessia Di Sapio, Giuseppe Fenu, Davide Maimone, Girolama A. Marfia, Marcello Moccia, Paola Perini, Maria G. Piscaglia, Lorenzo Razzolini, Massimo Riccaboni, Elisabetta Signoriello, Carla Tortorella received honoraria from Sanofi S.r.l. to participate in the study. Giovanna Borriello received fees for participating to Advisory Boards and travel compensations from Almirall, Biogen, Bristol-Myers Squibb, Johnson and Johnson, Merck, Novartis, Roche, and Sanofi. Elena Colombo reports travel expenses, speaker honoraria, and advisory board work from Alexion, Biogen, Bristol-Myers Squibb, Janssen, Merck, Novartis, Roche, and Sanofi. Alessia Di Sapio received speaker and consulting personal compensation by Alexion, Alnylam, Amgen Biogen, Bristol-Myers Squibb, Janssen, Merck Serono, Novartis, Roche, and Sanofi and received reimbursement for attending conferences by Biogen, Merck Serono, Novartis, Roche, and Sanofi. Davide Maimone received honoraria for participating to Advisory Boards and lectures and received travel grants from Alexion, Biogen, Bristol-Myers Squibb, Merck, Novartis, Roche, and Sanofi. Giuseppe Fenu received honoraria for consultancy or speaking from Biogen, Bristol-Myers Squibb, Merck, Novartis, Roche, and Sanofi. Marcello Moccia has received financial support by the MUR PNRR Extended Partnership (MNESYS no. PE00000006, and DHEAL-COM no. PNC-E3-2022-23683267), research grants from the ECTRIMS-MAGNIMS, the UK MS Society, and Merck, and honoraria from Biogen, Bristol-Myers Squibb, Ipsen, Janssen, Merck, Novartis, Roche, and Sanofi. Elisabetta Signoriello received travel grants and performed consultancy for Almirall, Biogen, Bristol-Myers Squibb, Novartis, Merck, Roche, Sanofi, and Teva. Carla Tortorella received travel funding and/or speaker honoraria from Alexion, Almirall, Biogen, Bristol-Myers Squibb, Horizon, Merck, Novartis, Roche, and Sanofi.

Figures

Fig. 1
Fig. 1
Overview of the methodology and sources used to define and validate clinical (on the left) and economic (on the right) inputs of the model. All clinical and economic inputs were collected either via IQVIA®’s proprietary database or in qualitative/quantitative interviews with experienced neurologists and payers. All clinical inputs were validated by a panel of neurologists in a virtual expert board
Fig. 2
Fig. 2
Total population of treated patients, based on IQVIA® PET database (2020–2022) and estimates (2023–2028). Total growth was calculated according to CAGR and the increase in the number of patients following the availability of new treatments. Starting from 2026, the reimbursement of tolebrutinib for the treatment of NR-SPMS is expected to lead to a progressive increase the in total number of treated patients up to 4%
Fig. 3
Fig. 3
Patient shares of classes of products available for MS. Figure includes real-world data (2020–2022) as well as projections (2023–2028)
Fig. 4
Fig. 4
MS expenditure (on the left) and number of treated patients (on the right) between 2020 and 2028. The forecast includes the baseline period (in violet; 2020–2022) as well as projections (in orange; 2023–2028). All expenditure results are expressed as millions of euros (€)
See this image and copyright information in PMC

References

    1. Browne P, Chandraratna D, Angood C, Tremlett H, Baker C, Taylor BV, et al. Atlas of multiple sclerosis 2013: a growing global problem with widespread inequity. Neurology. 2014;83(11):1022–4. 10.1212/WNL.0000000000000768 - DOI - PMC - PubMed
    1. Thompson AJ, Baranzini SE, Geurts J, Hemmer B, Ciccarelli O. Multiple sclerosis. Lancet. 2018;391(10130):1622–36. 10.1016/S0140-6736(18)30481-1 - DOI - PubMed
    1. Niglio T, Mandolesi S, De Lucia O, d’Alessandro A. The incidence of the multiple sclerosis in Italy: 2011–2015. Clin Ter. 2022;173(5):453–7. - PubMed
    1. Puthenparampil M, Perini P, Bergamaschi R, Capobianco M, Filippi M, Gallo P. Multiple sclerosis epidemiological trends in Italy highlight the environmental risk factors. J Neurol. 2022;269(4):1817–24. 10.1007/s00415-021-10782-5 - DOI - PMC - PubMed
    1. Jakimovski D, Bittner S, Zivadinov R, Morrow SA, Benedict RH, Zipp F, et al. Multiple sclerosis. Lancet. 2024;403(10422):183–202. 10.1016/S0140-6736(23)01473-3 - DOI - PubMed

LinkOut - more resources