Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom

T. Spelman; W. L. Herring; C. Acosta; R. Hyde; V. G. Jokubaitis; E. Pucci; A. Lugaresi; G. Laureys; E. K. Havrdova; D. Horakova; G. Izquierdo; S. Eichau; S. Ozakbas; R. Alroughani; T. Kalincik; P. Duquette; M. Girard; T. Petersen; F. Patti; T. Csepany; F. Granella; F. Grand'Maison; D. Ferraro; R. Karabudak; M. Jose Sa; M. Trojano; V. van Pesch; B. Van Wijmeersch; E. Cartechini; P. McCombe; O. Gerlach; D. Spitaleri; C. Rozsa; S. Hodgkinson; R. Bergamaschi; R. Gouider; A. Soysal; null Castillo-Triviño; J. Prevost; J. Garber; K. de Gans; R. Ampapa; M. Simo; J. L. Sanchez-Menoyo; G. Iuliano; A. Sas; A. van der Walt; N. John; O. Gray; S. Hughes; G. De Luca; M. Onofrj; K. Buzzard; O. Skibina; M. Terzi; M. Slee; C. Solaro; null Oreja-Guevara; C. Ramo-Tello; Y. Fragoso; V. Shaygannejad; F. Moore; C. Rajda; E. Aguera Morales; H. Butzkueven

doi:10.1080/13696998.2023.2293379

Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom

T. Spelman, W. L. Herring, C. Acosta, R. Hyde, V. G. Jokubaitis, E. Pucci, A. Lugaresi, G. Laureys, E. K. Havrdova, D. Horakova, G. Izquierdo, S. Eichau, S. Ozakbas, R. Alroughani, T. Kalincik, P. Duquette, M. Girard, T. Petersen, F. Patti, T. CsepanyF. Granella, F. Grand'Maison, D. Ferraro, R. Karabudak, M. Jose Sa, M. Trojano, V. van Pesch, B. Van Wijmeersch, E. Cartechini, P. McCombe, O. Gerlach, D. Spitaleri, C. Rozsa, S. Hodgkinson, R. Bergamaschi, R. Gouider, A. Soysal, Castillo-Triviño, J. Prevost, J. Garber, K. de Gans, R. Ampapa, M. Simo, J. L. Sanchez-Menoyo, G. Iuliano, A. Sas, A. van der Walt, N. John, O. Gray, S. Hughes, G. De Luca, M. Onofrj, K. Buzzard, O. Skibina, M. Terzi, M. Slee, C. Solaro, Oreja-Guevara, C. Ramo-Tello, Y. Fragoso, V. Shaygannejad, F. Moore, C. Rajda, E. Aguera Morales, H. Butzkueven

College of Medicine and Public Health

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Abstract

Aim: To evaluate the real-world comparative effectiveness and the cost-effectiveness, from a UK National Health Service perspective, of natalizumab versus fingolimod in patients with rapidly evolving severe relapsing-remitting multiple sclerosis (RES-RRMS).

Methods: Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD). Matched cohorts were selected by 3-way multinomial propensity score matching, and the annualized relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M) were compared between treatment groups. Comparative effectiveness results were used in a cost-effectiveness model comparing natalizumab and fingolimod, using an established Markov structure over a lifetime horizon with health states based on the Expanded Disability Status Scale. Additional model data sources included the UK MS Survey 2015, published literature, and publicly available sources.

Results: In the comparative effectiveness analysis, we found a significantly lower ARR for patients starting natalizumab compared with fingolimod (rate ratio [RR] = 0.65; 95% confidence interval [CI], 0.57-0.73) or BRACETD (RR = 0.46; 95% CI, 0.42-0.53). Similarly, CDI6M was higher for patients starting natalizumab compared with fingolimod (hazard ratio [HR] = 1.25; 95% CI, 1.01-1.55) and BRACETD (HR = 1.46; 95% CI, 1.16-1.85). In patients starting fingolimod, we found a lower ARR (RR = 0.72; 95% CI, 0.65-0.80) compared with starting BRACETD, but no difference in CDI6M (HR = 1.17; 95% CI, 0.91-1.50). Differences in CDW6M were not found between the treatment groups. In the base-case cost-effectiveness analysis, natalizumab dominated fingolimod (0.302 higher quality-adjusted life-years [QALYs] and £17,141 lower predicted lifetime costs). Similar cost-effectiveness results were observed across sensitivity analyses.

Conclusions: This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.

Original language	English
Pages (from-to)	109-125
Number of pages	17
Journal	Journal of Medical Economics
Volume	27
Issue number	1
Early online date	26 Dec 2023
DOIs	https://doi.org/10.1080/13696998.2023.2293379
Publication status	Published - 2024

Keywords

comparative effectiveness
cost-effectiveness
fingolimod
I
I1
I10
I11
Multiple sclerosis
natalizumab
real-world data

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Spelman, T., Herring, W. L., Acosta, C., Hyde, R., Jokubaitis, V. G., Pucci, E., Lugaresi, A., Laureys, G., Havrdova, E. K., Horakova, D., Izquierdo, G., Eichau, S., Ozakbas, S., Alroughani, R., Kalincik, T., Duquette, P., Girard, M., Petersen, T., Patti, F., ... Butzkueven, H. (2024). Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom. Journal of Medical Economics, 27(1), 109-125. https://doi.org/10.1080/13696998.2023.2293379

@article{259e166ba29a42c4bd21e34f95d01cad,

title = "Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom",

abstract = "Aim: To evaluate the real-world comparative effectiveness and the cost-effectiveness, from a UK National Health Service perspective, of natalizumab versus fingolimod in patients with rapidly evolving severe relapsing-remitting multiple sclerosis (RES-RRMS). Methods: Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD). Matched cohorts were selected by 3-way multinomial propensity score matching, and the annualized relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M) were compared between treatment groups. Comparative effectiveness results were used in a cost-effectiveness model comparing natalizumab and fingolimod, using an established Markov structure over a lifetime horizon with health states based on the Expanded Disability Status Scale. Additional model data sources included the UK MS Survey 2015, published literature, and publicly available sources. Results: In the comparative effectiveness analysis, we found a significantly lower ARR for patients starting natalizumab compared with fingolimod (rate ratio [RR] = 0.65; 95% confidence interval [CI], 0.57-0.73) or BRACETD (RR = 0.46; 95% CI, 0.42-0.53). Similarly, CDI6M was higher for patients starting natalizumab compared with fingolimod (hazard ratio [HR] = 1.25; 95% CI, 1.01-1.55) and BRACETD (HR = 1.46; 95% CI, 1.16-1.85). In patients starting fingolimod, we found a lower ARR (RR = 0.72; 95% CI, 0.65-0.80) compared with starting BRACETD, but no difference in CDI6M (HR = 1.17; 95% CI, 0.91-1.50). Differences in CDW6M were not found between the treatment groups. In the base-case cost-effectiveness analysis, natalizumab dominated fingolimod (0.302 higher quality-adjusted life-years [QALYs] and £17,141 lower predicted lifetime costs). Similar cost-effectiveness results were observed across sensitivity analyses. Conclusions: This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.",

keywords = "comparative effectiveness, cost-effectiveness, fingolimod, I, I1, I10, I11, Multiple sclerosis, natalizumab, real-world data",

author = "T. Spelman and Herring, {W. L.} and C. Acosta and R. Hyde and Jokubaitis, {V. G.} and E. Pucci and A. Lugaresi and G. Laureys and Havrdova, {E. K.} and D. Horakova and G. Izquierdo and S. Eichau and S. Ozakbas and R. Alroughani and T. Kalincik and P. Duquette and M. Girard and T. Petersen and F. Patti and T. Csepany and F. Granella and F. Grand'Maison and D. Ferraro and R. Karabudak and {Jose Sa}, M. and M. Trojano and {van Pesch}, V. and {Van Wijmeersch}, B. and E. Cartechini and P. McCombe and O. Gerlach and D. Spitaleri and C. Rozsa and S. Hodgkinson and R. Bergamaschi and R. Gouider and A. Soysal and Castillo-Trivi{\~n}o and J. Prevost and J. Garber and {de Gans}, K. and R. Ampapa and M. Simo and Sanchez-Menoyo, {J. L.} and G. Iuliano and A. Sas and {van der Walt}, A. and N. John and O. Gray and S. Hughes and {De Luca}, G. and M. Onofrj and K. Buzzard and O. Skibina and M. Terzi and M. Slee and C. Solaro and Oreja-Guevara and C. Ramo-Tello and Y. Fragoso and V. Shaygannejad and F. Moore and C. Rajda and {Aguera Morales}, E. and H. Butzkueven",

year = "2024",

doi = "10.1080/13696998.2023.2293379",

language = "English",

volume = "27",

pages = "109--125",

journal = "Journal of Medical Economics",

issn = "1369-6998",

publisher = "Taylor & Francis",

number = "1",

}

Spelman, T, Herring, WL, Acosta, C, Hyde, R, Jokubaitis, VG, Pucci, E, Lugaresi, A, Laureys, G, Havrdova, EK, Horakova, D, Izquierdo, G, Eichau, S, Ozakbas, S, Alroughani, R, Kalincik, T, Duquette, P, Girard, M, Petersen, T, Patti, F, Csepany, T, Granella, F, Grand'Maison, F, Ferraro, D, Karabudak, R, Jose Sa, M, Trojano, M, van Pesch, V, Van Wijmeersch, B, Cartechini, E, McCombe, P, Gerlach, O, Spitaleri, D, Rozsa, C, Hodgkinson, S, Bergamaschi, R, Gouider, R, Soysal, A, Castillo-Triviño, Prevost, J, Garber, J, de Gans, K, Ampapa, R, Simo, M, Sanchez-Menoyo, JL, Iuliano, G, Sas, A, van der Walt, A, John, N, Gray, O, Hughes, S, De Luca, G, Onofrj, M, Buzzard, K, Skibina, O, Terzi, M, Slee, M, Solaro, C, Oreja-Guevara, Ramo-Tello, C, Fragoso, Y, Shaygannejad, V, Moore, F, Rajda, C, Aguera Morales, E & Butzkueven, H 2024, 'Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom', Journal of Medical Economics, vol. 27, no. 1, pp. 109-125. https://doi.org/10.1080/13696998.2023.2293379

TY - JOUR

T1 - Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom

AU - Spelman, T.

AU - Herring, W. L.

AU - Acosta, C.

AU - Hyde, R.

AU - Jokubaitis, V. G.

AU - Pucci, E.

AU - Lugaresi, A.

AU - Laureys, G.

AU - Havrdova, E. K.

AU - Horakova, D.

AU - Izquierdo, G.

AU - Eichau, S.

AU - Ozakbas, S.

AU - Alroughani, R.

AU - Kalincik, T.

AU - Duquette, P.

AU - Girard, M.

AU - Petersen, T.

AU - Patti, F.

AU - Csepany, T.

AU - Granella, F.

AU - Grand'Maison, F.

AU - Ferraro, D.

AU - Karabudak, R.

AU - Jose Sa, M.

AU - Trojano, M.

AU - van Pesch, V.

AU - Van Wijmeersch, B.

AU - Cartechini, E.

AU - McCombe, P.

AU - Gerlach, O.

AU - Spitaleri, D.

AU - Rozsa, C.

AU - Hodgkinson, S.

AU - Bergamaschi, R.

AU - Gouider, R.

AU - Soysal, A.

AU - Castillo-Triviño, null

AU - Prevost, J.

AU - Garber, J.

AU - de Gans, K.

AU - Ampapa, R.

AU - Simo, M.

AU - Sanchez-Menoyo, J. L.

AU - Iuliano, G.

AU - Sas, A.

AU - van der Walt, A.

AU - John, N.

AU - Gray, O.

AU - Hughes, S.

AU - De Luca, G.

AU - Onofrj, M.

AU - Buzzard, K.

AU - Skibina, O.

AU - Terzi, M.

AU - Slee, M.

AU - Solaro, C.

AU - Oreja-Guevara, null

AU - Ramo-Tello, C.

AU - Fragoso, Y.

AU - Shaygannejad, V.

AU - Moore, F.

AU - Rajda, C.

AU - Aguera Morales, E.

AU - Butzkueven, H.

PY - 2024

Y1 - 2024

N2 - Aim: To evaluate the real-world comparative effectiveness and the cost-effectiveness, from a UK National Health Service perspective, of natalizumab versus fingolimod in patients with rapidly evolving severe relapsing-remitting multiple sclerosis (RES-RRMS). Methods: Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD). Matched cohorts were selected by 3-way multinomial propensity score matching, and the annualized relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M) were compared between treatment groups. Comparative effectiveness results were used in a cost-effectiveness model comparing natalizumab and fingolimod, using an established Markov structure over a lifetime horizon with health states based on the Expanded Disability Status Scale. Additional model data sources included the UK MS Survey 2015, published literature, and publicly available sources. Results: In the comparative effectiveness analysis, we found a significantly lower ARR for patients starting natalizumab compared with fingolimod (rate ratio [RR] = 0.65; 95% confidence interval [CI], 0.57-0.73) or BRACETD (RR = 0.46; 95% CI, 0.42-0.53). Similarly, CDI6M was higher for patients starting natalizumab compared with fingolimod (hazard ratio [HR] = 1.25; 95% CI, 1.01-1.55) and BRACETD (HR = 1.46; 95% CI, 1.16-1.85). In patients starting fingolimod, we found a lower ARR (RR = 0.72; 95% CI, 0.65-0.80) compared with starting BRACETD, but no difference in CDI6M (HR = 1.17; 95% CI, 0.91-1.50). Differences in CDW6M were not found between the treatment groups. In the base-case cost-effectiveness analysis, natalizumab dominated fingolimod (0.302 higher quality-adjusted life-years [QALYs] and £17,141 lower predicted lifetime costs). Similar cost-effectiveness results were observed across sensitivity analyses. Conclusions: This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.

AB - Aim: To evaluate the real-world comparative effectiveness and the cost-effectiveness, from a UK National Health Service perspective, of natalizumab versus fingolimod in patients with rapidly evolving severe relapsing-remitting multiple sclerosis (RES-RRMS). Methods: Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD). Matched cohorts were selected by 3-way multinomial propensity score matching, and the annualized relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M) were compared between treatment groups. Comparative effectiveness results were used in a cost-effectiveness model comparing natalizumab and fingolimod, using an established Markov structure over a lifetime horizon with health states based on the Expanded Disability Status Scale. Additional model data sources included the UK MS Survey 2015, published literature, and publicly available sources. Results: In the comparative effectiveness analysis, we found a significantly lower ARR for patients starting natalizumab compared with fingolimod (rate ratio [RR] = 0.65; 95% confidence interval [CI], 0.57-0.73) or BRACETD (RR = 0.46; 95% CI, 0.42-0.53). Similarly, CDI6M was higher for patients starting natalizumab compared with fingolimod (hazard ratio [HR] = 1.25; 95% CI, 1.01-1.55) and BRACETD (HR = 1.46; 95% CI, 1.16-1.85). In patients starting fingolimod, we found a lower ARR (RR = 0.72; 95% CI, 0.65-0.80) compared with starting BRACETD, but no difference in CDI6M (HR = 1.17; 95% CI, 0.91-1.50). Differences in CDW6M were not found between the treatment groups. In the base-case cost-effectiveness analysis, natalizumab dominated fingolimod (0.302 higher quality-adjusted life-years [QALYs] and £17,141 lower predicted lifetime costs). Similar cost-effectiveness results were observed across sensitivity analyses. Conclusions: This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.

KW - comparative effectiveness

KW - cost-effectiveness

KW - fingolimod

KW - I

KW - I1

KW - I10

KW - I11

KW - Multiple sclerosis

KW - natalizumab

KW - real-world data

UR - http://www.scopus.com/inward/record.url?scp=85181176590&partnerID=8YFLogxK

U2 - 10.1080/13696998.2023.2293379

DO - 10.1080/13696998.2023.2293379

M3 - Article

C2 - 38085684

AN - SCOPUS:85181176590

SN - 1369-6998

VL - 27

SP - 109

EP - 125

JO - Journal of Medical Economics

JF - Journal of Medical Economics

IS - 1

ER -

Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom

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Keywords

UN SDGs

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