The therapeutic value of treatment for multiple sclerosis: analysis of health technology assessments of three European countries.
access
added therapeutic benefit
drug value
health technology assessment
multiple sclerosis
Journal
Frontiers in pharmacology
ISSN: 1663-9812
Titre abrégé: Front Pharmacol
Pays: Switzerland
ID NLM: 101548923
Informations de publication
Date de publication:
2023
2023
Historique:
received:
19
02
2023
accepted:
07
04
2023
medline:
16
5
2023
pubmed:
16
5
2023
entrez:
15
5
2023
Statut:
epublish
Résumé
In accordance with European regulation, medicines containing a new active substance to treat neurodegenerative diseases as well as autoimmune and other immune dysfunctions must be approved by the European Medicines Agency (EMA) through the centralized procedure before they can be marketed. However, after EMA approval, each country is responsible for national market access, following the assessment performed by health technology assessment (HTA) bodies with regard to the therapeutic value. This study aims to provide a comparative analysis of HTA recommendations issued by three EU countries (France, Germany, and Italy) for new drugs for multiple sclerosis (MS) following EMA approval. In the reference period, we identified 11 medicines authorized in Europe for MS, including relapsing forms of MS (RMS;
Identifiants
pubmed: 37188269
doi: 10.3389/fphar.2023.1169400
pii: 1169400
pmc: PMC10175632
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1169400Informations de copyright
Copyright © 2023 Gozzo, Romano, Brancati, Longo, Vitale and Drago.
Déclaration de conflit d'intérêts
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Références
Clin Drug Investig. 2016 Jul;36(7):579-89
pubmed: 27153824
N Engl J Med. 2012 Sep 20;367(12):1098-107
pubmed: 22992073
Front Immunol. 2021 Jul 06;12:661882
pubmed: 34295328
Neurology. 2022 Aug 23;99(8):e762-e774
pubmed: 35667837
Neurology. 2018 Apr 24;90(17):777-788
pubmed: 29686116
Biology (Basel). 2019 May 11;8(2):
pubmed: 31083577
Brain. 2020 Jun 1;143(6):1714-1730
pubmed: 32400866
Front Pharmacol. 2022 Feb 04;12:823199
pubmed: 35185551
J Neurol Neurosurg Psychiatry. 2014 Dec;85(12):1386-95
pubmed: 24899728
Front Pharmacol. 2017 Jun 30;8:384
pubmed: 28713265
Front Neurol. 2021 May 17;12:676095
pubmed: 34079516
Lancet. 2018 Mar 31;391(10127):1239-1240
pubmed: 29576503
Nat Rev Dis Primers. 2018 Nov 8;4(1):43
pubmed: 30410033
Brain Plast. 2020 Oct 01;5(2):123-133
pubmed: 33282676
Drug Discov Today. 2012 Jun;17(11-12):615-22
pubmed: 22366662
Neurol Neuroimmunol Neuroinflamm. 2020 Aug 14;7(6):
pubmed: 32801167
Lancet. 2018 Mar 31;391(10127):1263-1273
pubmed: 29576505
Expert Opin Emerg Drugs. 2020 Dec;25(4):377-381
pubmed: 32910702
Curr Opin Neurobiol. 2022 Aug;75:102588
pubmed: 35732103
Mult Scler. 2019 Mar;25(3):399-407
pubmed: 29363396
Front Pharmacol. 2020 Dec 17;11:604579
pubmed: 33390994
Lancet Neurol. 2023 Jan;22(1):66-77
pubmed: 36216015
Health Econ Rev. 2022 Jun 2;12(1):30
pubmed: 35652987
JAMA Neurol. 2018 Nov 1;75(11):1407-1415
pubmed: 30083762
Drug Des Devel Ther. 2014 Nov 10;8:2273-81
pubmed: 25419117
Curr Neuropharmacol. 2022;20(2):412-431
pubmed: 34191699
Healthcare (Basel). 2022 Jul 26;10(8):
pubmed: 35893214
J Neurol Neurosurg Psychiatry. 2020 May;91(5):483-492
pubmed: 32132224
JAMA Neurol. 2021 May 1;78(5):558-567
pubmed: 33779698
Eur J Health Econ. 2018 Jan;19(1):123-152
pubmed: 28303438
Front Pharmacol. 2020 Nov 30;11:621934
pubmed: 33329008
N Engl J Med. 2010 Feb 4;362(5):416-26
pubmed: 20089960
Front Pharmacol. 2021 Nov 11;12:748766
pubmed: 34899303
Nature. 2021 Sep;597(7878):709-714
pubmed: 34497421
Neurology. 2016 Aug 30;87(9 Suppl 2):S97-S102
pubmed: 27572869
Mult Scler. 2018 Oct;24(12):1594-1604
pubmed: 28870107
Neurol Ther. 2018 Dec;7(2):189-194
pubmed: 30315481
Front Pharmacol. 2021 Oct 08;12:755052
pubmed: 34690785
Front Pharmacol. 2020 Sep 16;11:579886
pubmed: 33041824
Biochim Biophys Acta. 2016 Mar;1862(3):506-10
pubmed: 26432481
Mult Scler. 2022 Apr;28(5):801-816
pubmed: 34465252
Curr Neurol Neurosci Rep. 2022 Nov;22(11):721-734
pubmed: 36301434
Pharmacoeconomics. 2020 Jun;38(6):527-536
pubmed: 32048205
Front Pharmacol. 2020 Aug 21;11:1307
pubmed: 32973526
Value Health. 2017 Jan;20(1):67-76
pubmed: 28212972
N Engl J Med. 2018 Jan 11;378(2):169-180
pubmed: 29320652
Arch Med Res. 2014 Nov;45(8):687-97
pubmed: 25431839
Biomedicines. 2021 Sep 24;9(10):
pubmed: 34680428
Drugs. 2022 Feb;82(3):323-334
pubmed: 35192158
N Engl J Med. 2017 Jan 19;376(3):209-220
pubmed: 28002688
Nat Rev Drug Discov. 2019 Dec;18(12):905-922
pubmed: 31399729
N Engl J Med. 2012 Sep 20;367(12):1087-97
pubmed: 22992072
Lancet Neurol. 2021 Sep;20(9):729-738
pubmed: 34418400
Front Pharmacol. 2020 Sep 25;11:588132
pubmed: 33101042
Int J Mol Sci. 2021 Mar 27;22(7):
pubmed: 33801644
Neurol Ther. 2022 Sep;11(3):981-1042
pubmed: 35610531
Mult Scler. 2018 Feb;24(2):175-185
pubmed: 28273780
J Neurol Neurosurg Psychiatry. 2013 Feb;84(2):141-7
pubmed: 23154123