Occipital Nerve Stimulation for Refractory Chronic Cluster Headache: A Cost-Effectiveness Study.
Chronic cluster headache
cost-effectiveness analysis
decision-making
neuromodulation
occipital nerve stimulation
Journal
Neuromodulation : journal of the International Neuromodulation Society
ISSN: 1525-1403
Titre abrégé: Neuromodulation
Pays: United States
ID NLM: 9804159
Informations de publication
Date de publication:
Aug 2021
Aug 2021
Historique:
revised:
15
02
2021
received:
23
11
2020
accepted:
24
02
2021
pubmed:
23
4
2021
medline:
1
9
2021
entrez:
22
4
2021
Statut:
ppublish
Résumé
Occipital nerve stimulation (ONS) is proposed to treat refractory chronic cluster headache (rCCH), but its cost-effectiveness has not been evaluated, limiting its diffusion and reimbursement. We performed a before-and-after economic study, from data collected prospectively in a nation-wide registry. We compared the cost-effectiveness of ONS associated with conventional treatment (intervention and postintervention period) to conventional treatment alone (preintervention period) in the same patients. The analysis was conducted on 76 rCCH patients from the French healthcare perspective at three months, then one year by extrapolation. Because of the impact of the disease on patient activity, indirect cost, such as sick leave and disability leave, was assessed second. The average total cost for three months was €7602 higher for the ONS strategy compared to conventional strategy with a gain of 0.07 quality-adjusted life-years (QALY), the incremental cost-effectiveness ratio (ICER) was then €109,676/QALY gained. The average extrapolated total cost for one year was €1344 lower for the ONS strategy (p = 0.5444) with a gain of 0.28 QALY (p < 0.0001), the ICER was then €-4846/QALY gained. The scatter plot of the probabilistic bootstrapping had 80% of the replications in the bottom right-hand quadrant, indicating that the ONS strategy is dominant. The average indirect cost for three months was €377 lower for the ONS strategy (p = 0.1261). This ONS cost-effectiveness study highlighted the limitations of a short-time horizon in an economic study that may lead the healthcare authorities to reject an innovative strategy, which is actually cost-effective. One-year extrapolation was the proposed solution to obtain results on which healthcare authorities can base their decisions. Considering the burden of rCCH and the efficacy and safety of ONS, the demonstration that ONS is dominant should help its diffusion, validation, and reimbursement by health authorities in this severely disabled population.
Identifiants
pubmed: 33886139
doi: 10.1111/ner.13394
pii: S1094-7159(21)06225-5
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1083-1092Subventions
Organisme : Abbott Laboratories
Organisme : Medtronic
Informations de copyright
© 2021 International Neuromodulation Society.
Références
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia 2018;38:1-211. https://doi.org/10.1177/0333102417738202.
Favier I, Haan J, Ferrari MD. Chronic cluster headache: a review. J Headache Pain 2005;6:3-9. https://doi.org/10.1007/s10194-005-0142-9.
Lanteri-Minet M, Silhol F, Piano V, Donnet A. Cardiac safety in cluster headache patients using the very high dose of verapamil (≥720 mg/day). J Headache Pain 2011;12:173-176. https://doi.org/10.1007/s10194-010-0289-x.
Donnet A, Lanteri-Minet M, Guegan-Massardier E et al. Chronic cluster headache: a French clinical descriptive study. J Neurol Neurosurg Psychiatry 2007;78:1354-1358. https://doi.org/10.1136/jnnp.2006.112037.
Burns B, Watkins L, Goadsby PJ. Treatment of medically intractable cluster headache by occipital nerve stimulation: long-term follow-up of eight patients. Lancet Lond Engl 2007;369:1099-1106. https://doi.org/10.1016/S0140-6736(07)60328-6.
Magis D, Allena M, Bolla M, de Pasqua V, Remacle J-M, Schoenen J. Occipital nerve stimulation for drug-resistant chronic cluster headache: a prospective pilot study. Lancet Neurol 2007;6:314-321. https://doi.org/10.1016/S1474-4422(07)70058-3.
Wilbrink LA, Teernstra OPM, Haan J et al. Occipital nerve stimulation in medically intractable, chronic cluster headache. The ICON study: rationale and protocol of a randomised trial. Cephalalgia Int J Headache. 2013;33:1238-1247. https://doi.org/10.1177/0333102413490351.
Martelletti P, Jensen RH, Antal A et al. Neuromodulation of chronic headaches: position statement from the European headache federation. J Headache Pain 2013;14:86;14: 1-16. https://doi.org/10.1186/1129-2377-14-86.
Fontaine D, Blond S, Lucas C et al. Occipital nerve stimulation improves the quality of life in medically-intractable chronic cluster headache: results of an observational prospective study. Cephalalgia Int J Headache 2017;37:1173-1179. https://doi.org/10.1177/0333102416673206.
Leplus A, Fontaine D, Donnet A et al. Long-term efficacy of occipital nerve stimulation for medically intractable cluster headache. Neurosurgery 2020. 88: 375-383. https://doi.org/10.1093/neuros/nyaa373.
Le Pen C, Levy P. L'évaluation Médico-Économique, Concepts et Méthodes. https://www.ces-asso.org/sites/default/files/levaluation_medico-economique_levy_et_le_pen.pdf
Raftery J, Young A, Stanton L et al. Theme 5: economic analysis alongside clinical trials. NIHR J Library 2015.19: 79-92.
Collège des Économistes de la Santé. Guide méthodologique pour l'évaluation économique des stratégies de santé. 2003. https://www.ces-asso.org/sites/default/files/Guide_Methodologique_CES_2003.pdf
Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition (beta version). Cephalalgia Int J Headache 2013;33:629-808. https://doi.org/10.1177/0333102413485658.
Donnet A, Demarquay G, Ducros A et al. French guidelines for diagnosis and treatment of cluster headache (French headache society). Rev Neurol (Paris) 2014;170:653-670. https://doi.org/10.1016/j.neurol.2014.03.016.
Haute Autorité de santé. Guide méthodologique, Choix méthodologiques pour l'évaluation économique à la HAS. 2011. https://www.has-sante.fr/upload/docs/application/pdf/2011-11/guide_methodo_vf.pdf
Guide pour le suivi de la masse salariale. 2014. http://social-sante.gouv.fr/IMG/pdf/Guide_suivi_masse_salariale_23-03-15.pdf
ENC MCO | Stats ATIH. Scan Santé. 2020 https://www.scansante.fr/applications/enc-mco
Consultations en métropole: vos remboursements. Ameli.fr. 2020. https://www.ameli.fr/assure/remboursements/rembourse/consultations/metropole
Base des médicaments et informations tarifaires - BdM_IT. L'Assurance Maladie. 2020. http://www.codage.ext.cnamts.fr/codif/bdm_it/index_presentation.php?p_site=AMELI
Liste des produits et des prestations. L'Assurance Maladie. 2020. http://www.codage.ext.cnamts.fr/codif/tips/index.php?p_site=AMELI
EQ-5D-3L. Euroqol. 2020. https://euroqol.org/eq-5d-instruments/eq-5d-3l-about/
Invalidité. Ameli.fr. 2020. https://www.ameli.fr/assure/remboursements/pensions-allocations-rentes/invalidite
Arrêt maladie du salarié. Ameli.fr. 2020. https://www.ameli.fr/assure/remboursements/indemnites-journalieres/arret-maladie-salarie
Glick HA. Sample size and power for cost-effectiveness analysis (part 1). Pharmacoeconomics 2011;29:189-198. https://doi.org/10.2165/11585070-000000000-00000.
World Health Organization. Macroeconomics and health: investing in health for economic development. 2001. https://apps.who.int/iris/bitstream/handle/10665/42435/924154550X.pdf;jsessionid=723A3998BC14744AEED4680E80545818?sequence=1
NICE The guidelines manual, process and methods, assessing cost effectiveness. 2020. https://www.nice.org.uk/process/pmg6/chapter/assessing-cost-effectiveness#economic-evidence-and-guideline-recommendations
Gupta N, Verma R, Dhiman RK, Rajsekhar K, Prinja S. Cost-effectiveness analysis and decision modelling: a tutorial for clinicians. J Clin Exp Hepatol 2020;10:177-184. https://doi.org/10.1016/j.jceh.2019.11.001.
Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Mak Int J Soc Med Decis Making 1993;13:322-338. https://doi.org/10.1177/0272989X9301300409.
Buxton MJ, Drummond MF, van Hout BA et al. Modelling in economic evaluation: An unavoidable fact of life. Health Econ 1997;6:217-227.
Mueller O, Diener H-C, Dammann P et al. Occipital nerve stimulation for intractable chronic cluster headache or migraine: a critical analysis of direct treatment costs and complications. Cephalalgia Int J Headache. 2013;33:1283-1291. https://doi.org/10.1177/0333102413493193.
Gaul C, Finken J, Biermann J et al. Treatment costs and indirect costs of cluster headache: a health economics analysis. Cephalalgia Int J Headache 2011;31:1664-1672. https://doi.org/10.1177/0333102411425866.
Miller S, Watkins L, Matharu M. Treatment of intractable chronic cluster headache by occipital nerve stimulation: a cohort of 51 patients. Eur J Neurol 2017;24:381-390. https://doi.org/10.1111/ene.13215.