Cost-Effectiveness Analysis of Cannabinoid Oromucosal Spray Use for the Management of Spasticity in Subjects with Multiple Sclerosis

Massimiliano Mirabella; Lorenzo G. Mantovani; Paolo Cozzolino; Paolo A. Cortesi; Francesco Patti; F. Patti; S. Messina; C. Solaro; M. P. Amato; R. Bergamaschi; S. Bonavita; R. Bruno Bossio; V. Brescia Morra; G. F. Costantino; P. Cavalla; D. Centonze; G. Comi; S. Cottone; M. Danni; A. Francia; A. Gajofatto; C. Gasperini; A. Ghezzi; A. Iudice; G. Lus; G. T. Maniscalco; M. G. Marrosu; M. Matta; E. Montanari; C. Pozzilli; M. Rovaris; E. Sessa; D. Spitaleri; M. Trojano; P. Valentino; M. Zappia; M. D. Benedetti; A. Bertolotto; E. Berra; A. Bianco; F. Buttari; R. Cerqua; C. Florio; A. Fuiani; A. Guareschi; D. Ippolito; A. Nuara; V. Palmieri; D. Paolicelli; L. Petrucci; S. Pontecorvo; F. Saccà; G. Salomone; E. Signoriello; G. Spinicci; M. Russo; E. Tavazzi; E. Trabucco; M. Trotta; M. Zaffaroni

doi:10.1007/s40261-020-00895-6

Cost-Effectiveness Analysis of Cannabinoid Oromucosal Spray Use for the Management of Spasticity in Subjects with Multiple Sclerosis

Massimiliano Mirabella, Lorenzo G. Mantovani, Paolo Cozzolino, Paolo A. Cortesi, Francesco Patti, F. Patti, S. Messina, C. Solaro, M. P. Amato, R. Bergamaschi, S. Bonavita, R. Bruno Bossio, V. Brescia Morra, G. F. Costantino, P. Cavalla, D. Centonze, G. Comi, S. Cottone, M. Danni, A. FranciaA. Gajofatto, C. Gasperini, A. Ghezzi, A. Iudice, G. Lus, G. T. Maniscalco, M. G. Marrosu, M. Matta, E. Montanari, C. Pozzilli, M. Rovaris, E. Sessa, D. Spitaleri, M. Trojano, P. Valentino, M. Zappia, M. D. Benedetti, A. Bertolotto, E. Berra, A. Bianco, F. Buttari, R. Cerqua, C. Florio, A. Fuiani, A. Guareschi, D. Ippolito, A. Nuara, V. Palmieri, D. Paolicelli, L. Petrucci, S. Pontecorvo, F. Saccà, G. Salomone, E. Signoriello, G. Spinicci, M. Russo, E. Tavazzi, E. Trabucco, M. Trotta, M. Zaffaroni

Risultato della ricerca: Contributo in rivista › Articolo in rivista › peer review

1 Citazioni (Scopus)

Abstract

INTRODUCTION: Multiple sclerosis (MS) is a highly symptomatic disease, with a wide range of disabilities affecting many bodily functions, even in younger persons with a short disease history. The availability of a cannabinoid oromucosal spray (Sativex) for the management of treatment-resistant MS spasticity has provided a new opportunity for many patients. OBJECTIVE: Our study aimed to assess the cost effectiveness of Sativex in Italian patients with treatment-resistant MS spasticity. The analysis was based on the real-world data of a large registry of Italian patients. METHODS: A cost-utility analysis was conducted using data collected prospectively from an electronic registry of all patients who began to use Sativex for MS-resistant spasticity between January 2014 and February 2015 in 30 specialized MS units across Italy and were followed up for ≤ 6 months. Data on drug consumption and spasticity/utility were used to estimate the incremental cost-effectiveness ratio (ICER) of Sativex, as compared with no intervention. No costs or spasticity/utility changes were assumed for no treatment intervention. The ICER was expressed as quality-adjusted life-years (QALYs) gained, using the Italian NHS perspective and a 6-month time horizon. RESULTS: Sativex effectiveness and consumption was estimated analyzing data of 1350 patients from the registry. These patients reported a mean (SD) utility increment of 0.087 (0.069) after 1 month of treatment, 0.118 (0.073) after 3 months' treatment and 0.127 (0.080) after 6 months' treatment. The 6-month cost of treating the entire population with Sativex was €1,361,266, with a €1008 cost and 0.0284 QALYs gained per patient. The estimated ICER was €35,516 per QALY gained, with little variability around the central estimate of cost-effectiveness, as shown by the cost-effectiveness acceptability curve. CONCLUSION: The use of Sativex could improve the quality of life of patients with a reasonable incremental cost resulting as a cost-effective option for patients with MS-resistant spasticity. These results could help clinicians and decision makers to develop improved management strategies for spasticity in patients with MS, optimizing the use of available resources.

Lingua originale	English
pagine (da-a)	N/A-N/A
Rivista	Clinical Drug Investigation
Volume	2020
DOI	https://doi.org/10.1007/s40261-020-00895-6
Stato di pubblicazione	Pubblicato - 2020

Keywords

spasticity, multiple sclerosis, cannabinoid

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10.1007/s40261-020-00895-6

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Mirabella, M., Mantovani, L. G., Cozzolino, P., Cortesi, P. A., Patti, F., Patti, F., Messina, S., Solaro, C., Amato, M. P., Bergamaschi, R., Bonavita, S., Bruno Bossio, R., Brescia Morra, V., Costantino, G. F., Cavalla, P., Centonze, D., Comi, G., Cottone, S., Danni, M., ... Zaffaroni, M. (2020). Cost-Effectiveness Analysis of Cannabinoid Oromucosal Spray Use for the Management of Spasticity in Subjects with Multiple Sclerosis. Clinical Drug Investigation, 2020, N/A-N/A. https://doi.org/10.1007/s40261-020-00895-6

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title = "Cost-Effectiveness Analysis of Cannabinoid Oromucosal Spray Use for the Management of Spasticity in Subjects with Multiple Sclerosis",

abstract = "INTRODUCTION: Multiple sclerosis (MS) is a highly symptomatic disease, with a wide range of disabilities affecting many bodily functions, even in younger persons with a short disease history. The availability of a cannabinoid oromucosal spray (Sativex) for the management of treatment-resistant MS spasticity has provided a new opportunity for many patients. OBJECTIVE: Our study aimed to assess the cost effectiveness of Sativex in Italian patients with treatment-resistant MS spasticity. The analysis was based on the real-world data of a large registry of Italian patients. METHODS: A cost-utility analysis was conducted using data collected prospectively from an electronic registry of all patients who began to use Sativex for MS-resistant spasticity between January 2014 and February 2015 in 30 specialized MS units across Italy and were followed up for ≤ 6 months. Data on drug consumption and spasticity/utility were used to estimate the incremental cost-effectiveness ratio (ICER) of Sativex, as compared with no intervention. No costs or spasticity/utility changes were assumed for no treatment intervention. The ICER was expressed as quality-adjusted life-years (QALYs) gained, using the Italian NHS perspective and a 6-month time horizon. RESULTS: Sativex effectiveness and consumption was estimated analyzing data of 1350 patients from the registry. These patients reported a mean (SD) utility increment of 0.087 (0.069) after 1 month of treatment, 0.118 (0.073) after 3 months' treatment and 0.127 (0.080) after 6 months' treatment. The 6-month cost of treating the entire population with Sativex was €1,361,266, with a €1008 cost and 0.0284 QALYs gained per patient. The estimated ICER was €35,516 per QALY gained, with little variability around the central estimate of cost-effectiveness, as shown by the cost-effectiveness acceptability curve. CONCLUSION: The use of Sativex could improve the quality of life of patients with a reasonable incremental cost resulting as a cost-effective option for patients with MS-resistant spasticity. These results could help clinicians and decision makers to develop improved management strategies for spasticity in patients with MS, optimizing the use of available resources.",

keywords = "spasticity, multiple sclerosis, cannabinoid, spasticity, multiple sclerosis, cannabinoid",

author = "Massimiliano Mirabella and Mantovani, {Lorenzo G.} and Paolo Cozzolino and Cortesi, {Paolo A.} and Francesco Patti and F. Patti and S. Messina and C. Solaro and Amato, {M. P.} and R. Bergamaschi and S. Bonavita and {Bruno Bossio}, R. and {Brescia Morra}, V. and Costantino, {G. F.} and P. Cavalla and D. Centonze and G. Comi and S. Cottone and M. Danni and A. Francia and A. Gajofatto and C. Gasperini and A. Ghezzi and A. Iudice and G. Lus and Maniscalco, {G. T.} and Marrosu, {M. G.} and M. Matta and E. Montanari and C. Pozzilli and M. Rovaris and E. Sessa and D. Spitaleri and M. Trojano and P. Valentino and M. Zappia and Benedetti, {M. D.} and A. Bertolotto and E. Berra and A. Bianco and F. Buttari and R. Cerqua and C. Florio and A. Fuiani and A. Guareschi and D. Ippolito and A. Nuara and V. Palmieri and D. Paolicelli and L. Petrucci and S. Pontecorvo and F. Sacc{\`a} and G. Salomone and E. Signoriello and G. Spinicci and M. Russo and E. Tavazzi and E. Trabucco and M. Trotta and M. Zaffaroni",

year = "2020",

doi = "10.1007/s40261-020-00895-6",

language = "English",

volume = "2020",

pages = "N/A--N/A",

journal = "Clinical Drug Investigation",

issn = "1173-2563",

publisher = "Adis International Limited:Private Bag 65901, Mairangi Bay, Auckland 1311 New Zealand:011 64 9 4770741, EMAIL: subs@adis.com, david.herrick@adis.co.nz, INTERNET: http://www.adis.com, Fax: 011 64 9 4770766",

}

Mirabella, M, Mantovani, LG, Cozzolino, P, Cortesi, PA, Patti, F, Patti, F, Messina, S, Solaro, C, Amato, MP, Bergamaschi, R, Bonavita, S, Bruno Bossio, R, Brescia Morra, V, Costantino, GF, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, GT, Marrosu, MG, Matta, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, Valentino, P, Zappia, M, Benedetti, MD, Bertolotto, A, Berra, E, Bianco, A, Buttari, F, Cerqua, R, Florio, C, Fuiani, A, Guareschi, A, Ippolito, D, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Saccà, F, Salomone, G, Signoriello, E, Spinicci, G, Russo, M, Tavazzi, E, Trabucco, E, Trotta, M & Zaffaroni, M 2020, 'Cost-Effectiveness Analysis of Cannabinoid Oromucosal Spray Use for the Management of Spasticity in Subjects with Multiple Sclerosis', Clinical Drug Investigation, vol. 2020, pagg. N/A-N/A. https://doi.org/10.1007/s40261-020-00895-6

TY - JOUR

T1 - Cost-Effectiveness Analysis of Cannabinoid Oromucosal Spray Use for the Management of Spasticity in Subjects with Multiple Sclerosis

AU - Mirabella, Massimiliano

AU - Mantovani, Lorenzo G.

AU - Cozzolino, Paolo

AU - Cortesi, Paolo A.

AU - Patti, Francesco

AU - Patti, F.

AU - Messina, S.

AU - Solaro, C.

AU - Amato, M. P.

AU - Bergamaschi, R.

AU - Bonavita, S.

AU - Bruno Bossio, R.

AU - Brescia Morra, V.

AU - Costantino, G. F.

AU - Cavalla, P.

AU - Centonze, D.

AU - Comi, G.

AU - Cottone, S.

AU - Danni, M.

AU - Francia, A.

AU - Gajofatto, A.

AU - Gasperini, C.

AU - Ghezzi, A.

AU - Iudice, A.

AU - Lus, G.

AU - Maniscalco, G. T.

AU - Marrosu, M. G.

AU - Matta, M.

AU - Montanari, E.

AU - Pozzilli, C.

AU - Rovaris, M.

AU - Sessa, E.

AU - Spitaleri, D.

AU - Trojano, M.

AU - Valentino, P.

AU - Zappia, M.

AU - Benedetti, M. D.

AU - Bertolotto, A.

AU - Berra, E.

AU - Bianco, A.

AU - Buttari, F.

AU - Cerqua, R.

AU - Florio, C.

AU - Fuiani, A.

AU - Guareschi, A.

AU - Ippolito, D.

AU - Nuara, A.

AU - Palmieri, V.

AU - Paolicelli, D.

AU - Petrucci, L.

AU - Pontecorvo, S.

AU - Saccà, F.

AU - Salomone, G.

AU - Signoriello, E.

AU - Spinicci, G.

AU - Russo, M.

AU - Tavazzi, E.

AU - Trabucco, E.

AU - Trotta, M.

AU - Zaffaroni, M.

PY - 2020

Y1 - 2020

N2 - INTRODUCTION: Multiple sclerosis (MS) is a highly symptomatic disease, with a wide range of disabilities affecting many bodily functions, even in younger persons with a short disease history. The availability of a cannabinoid oromucosal spray (Sativex) for the management of treatment-resistant MS spasticity has provided a new opportunity for many patients. OBJECTIVE: Our study aimed to assess the cost effectiveness of Sativex in Italian patients with treatment-resistant MS spasticity. The analysis was based on the real-world data of a large registry of Italian patients. METHODS: A cost-utility analysis was conducted using data collected prospectively from an electronic registry of all patients who began to use Sativex for MS-resistant spasticity between January 2014 and February 2015 in 30 specialized MS units across Italy and were followed up for ≤ 6 months. Data on drug consumption and spasticity/utility were used to estimate the incremental cost-effectiveness ratio (ICER) of Sativex, as compared with no intervention. No costs or spasticity/utility changes were assumed for no treatment intervention. The ICER was expressed as quality-adjusted life-years (QALYs) gained, using the Italian NHS perspective and a 6-month time horizon. RESULTS: Sativex effectiveness and consumption was estimated analyzing data of 1350 patients from the registry. These patients reported a mean (SD) utility increment of 0.087 (0.069) after 1 month of treatment, 0.118 (0.073) after 3 months' treatment and 0.127 (0.080) after 6 months' treatment. The 6-month cost of treating the entire population with Sativex was €1,361,266, with a €1008 cost and 0.0284 QALYs gained per patient. The estimated ICER was €35,516 per QALY gained, with little variability around the central estimate of cost-effectiveness, as shown by the cost-effectiveness acceptability curve. CONCLUSION: The use of Sativex could improve the quality of life of patients with a reasonable incremental cost resulting as a cost-effective option for patients with MS-resistant spasticity. These results could help clinicians and decision makers to develop improved management strategies for spasticity in patients with MS, optimizing the use of available resources.

AB - INTRODUCTION: Multiple sclerosis (MS) is a highly symptomatic disease, with a wide range of disabilities affecting many bodily functions, even in younger persons with a short disease history. The availability of a cannabinoid oromucosal spray (Sativex) for the management of treatment-resistant MS spasticity has provided a new opportunity for many patients. OBJECTIVE: Our study aimed to assess the cost effectiveness of Sativex in Italian patients with treatment-resistant MS spasticity. The analysis was based on the real-world data of a large registry of Italian patients. METHODS: A cost-utility analysis was conducted using data collected prospectively from an electronic registry of all patients who began to use Sativex for MS-resistant spasticity between January 2014 and February 2015 in 30 specialized MS units across Italy and were followed up for ≤ 6 months. Data on drug consumption and spasticity/utility were used to estimate the incremental cost-effectiveness ratio (ICER) of Sativex, as compared with no intervention. No costs or spasticity/utility changes were assumed for no treatment intervention. The ICER was expressed as quality-adjusted life-years (QALYs) gained, using the Italian NHS perspective and a 6-month time horizon. RESULTS: Sativex effectiveness and consumption was estimated analyzing data of 1350 patients from the registry. These patients reported a mean (SD) utility increment of 0.087 (0.069) after 1 month of treatment, 0.118 (0.073) after 3 months' treatment and 0.127 (0.080) after 6 months' treatment. The 6-month cost of treating the entire population with Sativex was €1,361,266, with a €1008 cost and 0.0284 QALYs gained per patient. The estimated ICER was €35,516 per QALY gained, with little variability around the central estimate of cost-effectiveness, as shown by the cost-effectiveness acceptability curve. CONCLUSION: The use of Sativex could improve the quality of life of patients with a reasonable incremental cost resulting as a cost-effective option for patients with MS-resistant spasticity. These results could help clinicians and decision makers to develop improved management strategies for spasticity in patients with MS, optimizing the use of available resources.

KW - spasticity, multiple sclerosis, cannabinoid

UR - http://hdl.handle.net/10807/165301

U2 - 10.1007/s40261-020-00895-6

DO - 10.1007/s40261-020-00895-6

M3 - Article

VL - 2020

SP - N/A-N/A

JO - Clinical Drug Investigation

JF - Clinical Drug Investigation

SN - 1173-2563

ER -

Cost-Effectiveness Analysis of Cannabinoid Oromucosal Spray Use for the Management of Spasticity in Subjects with Multiple Sclerosis

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