Cost-effectiveness of Prednisolone to Treat Bell Palsy in Children: An Economic Evaluation Alongside a Randomized Controlled Trial.

Child Humans Prednisolone / therapeutic use Cost-Benefit Analysis Bell Palsy / diagnosis Drug Therapy, Combination Australia

Journal

Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060

Informations de publication

Date de publication:
13 06 2023
Historique:
received: 27 09 2022
accepted: 27 02 2023
pmc-release: 13 06 2024
medline: 14 6 2023
pubmed: 19 4 2023
entrez: 18 4 2023
Statut: ppublish

Résumé

Bell palsy is the third most frequent diagnosis in children with sudden-onset neurologic dysfunction. The cost-effectiveness of treating Bell palsy with prednisolone in children is unknown. We aimed to assess the cost-effectiveness of prednisolone in treating Bell palsy in children compared with placebo. This economic evaluation was a prospectively planned secondary analysis of a double-blinded, randomized, placebo-controlled superiority trial (Bell Palsy in Children [BellPIC]) conducted from 2015 to 2020. The time horizon was 6 months since randomization. Children aged 6 months to <18 years who presented within 72 hours of onset of clinician-diagnosed Bell palsy and who completed the trial were included (N = 180). Interventions were oral prednisolone or taste-matched placebo administered for 10 days. Incremental cost-effectiveness ratio comparing prednisolone with placebo was estimated. Costs were considered from a health care sector perspective and included Bell palsy-related medication cost, doctor visits, and medical tests. Effectiveness was measured using quality-adjusted life-years (QALYs) based on Child Health Utility 9D. Nonparametric bootstrapping was performed to capture uncertainties. Prespecified subgroup analysis by age 12 to <18 years vs <12 years was conducted. The mean cost per patient was A$760 in the prednisolone group and A$693 in the placebo group over the 6-month period (difference A$66, 95% CI -A$47 to A$179). QALYs over 6 months were 0.45 in the prednisolone group and 0.44 in the placebo group (difference 0.01, 95% CI -0.01 to 0.03). The incremental cost to achieve 1 additional recovery was estimated to be A$1,577 using prednisolone compared with placebo, and cost per additional QALY gained was A$6,625 using prednisolone compared with placebo. Given a conventional willingness-to-pay threshold of A$50,000 per QALY gained (equivalent to US$35,000 or £28,000), prednisolone is very likely cost-effective (probability is 83%). Subgroup analysis suggests that this was primarily driven by the high probability of prednisolone being cost-effective in children aged 12 to <18 years (probability is 98%) and much less so for those <12 years (probability is 51%). This provides new evidence to stakeholders and policymakers when considering whether to make prednisolone available in treating Bell palsy in children aged 12 to <18 years. Australian New Zealand Clinical Trials Registry ACTRN12615000563561.

Sections du résumé

BACKGROUND AND OBJECTIVES
Bell palsy is the third most frequent diagnosis in children with sudden-onset neurologic dysfunction. The cost-effectiveness of treating Bell palsy with prednisolone in children is unknown. We aimed to assess the cost-effectiveness of prednisolone in treating Bell palsy in children compared with placebo.
METHODS
This economic evaluation was a prospectively planned secondary analysis of a double-blinded, randomized, placebo-controlled superiority trial (Bell Palsy in Children [BellPIC]) conducted from 2015 to 2020. The time horizon was 6 months since randomization. Children aged 6 months to <18 years who presented within 72 hours of onset of clinician-diagnosed Bell palsy and who completed the trial were included (N = 180). Interventions were oral prednisolone or taste-matched placebo administered for 10 days. Incremental cost-effectiveness ratio comparing prednisolone with placebo was estimated. Costs were considered from a health care sector perspective and included Bell palsy-related medication cost, doctor visits, and medical tests. Effectiveness was measured using quality-adjusted life-years (QALYs) based on Child Health Utility 9D. Nonparametric bootstrapping was performed to capture uncertainties. Prespecified subgroup analysis by age 12 to <18 years vs <12 years was conducted.
RESULTS
The mean cost per patient was A$760 in the prednisolone group and A$693 in the placebo group over the 6-month period (difference A$66, 95% CI -A$47 to A$179). QALYs over 6 months were 0.45 in the prednisolone group and 0.44 in the placebo group (difference 0.01, 95% CI -0.01 to 0.03). The incremental cost to achieve 1 additional recovery was estimated to be A$1,577 using prednisolone compared with placebo, and cost per additional QALY gained was A$6,625 using prednisolone compared with placebo. Given a conventional willingness-to-pay threshold of A$50,000 per QALY gained (equivalent to US$35,000 or £28,000), prednisolone is very likely cost-effective (probability is 83%). Subgroup analysis suggests that this was primarily driven by the high probability of prednisolone being cost-effective in children aged 12 to <18 years (probability is 98%) and much less so for those <12 years (probability is 51%).
DISCUSSION
This provides new evidence to stakeholders and policymakers when considering whether to make prednisolone available in treating Bell palsy in children aged 12 to <18 years.
TRIAL REGISTRATION INFORMATION
Australian New Zealand Clinical Trials Registry ACTRN12615000563561.

Identifiants

DOI: 10.1212/WNL.0000000000207284 PMID: 37072220 PMC: PMC10264054
pubmed: 37072220
pii: WNL.0000000000207284
doi: 10.1212/WNL.0000000000207284
pmc: PMC10264054
doi:

Substances chimiques

Prednisolone 9PHQ9Y1OLM

Types de publication

Randomized Controlled Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e2432-e2441

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2023 American Academy of Neurology.

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Auteurs

Xiuqin Xiong (X)

From the Centre for Health Policy (X.X., L.H., K.D.), Melbourne School of Population and Global Health, The University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.W.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.B.), University of Western Australia, Perth; Department of Emergency Medicine (A.D., S.H., M.T.M., J.A.C., F.E.B.), Royal Children's Hospital; Murdoch Children's Research Institute (A.D., M.T.M., K.J.L., J.A.C., F.E.B., S.H.), Parkville, Victoria; Department of Anesthesia (A.D.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria; Department of Pediatrics (K.J.L.), Melbourne Medical School, University of Melbourne, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand; and Departments of Paediatrics and Critical Care (J.A.C., F.E.B.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia.

Li Huang (L)

From the Centre for Health Policy (X.X., L.H., K.D.), Melbourne School of Population and Global Health, The University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.W.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.B.), University of Western Australia, Perth; Department of Emergency Medicine (A.D., S.H., M.T.M., J.A.C., F.E.B.), Royal Children's Hospital; Murdoch Children's Research Institute (A.D., M.T.M., K.J.L., J.A.C., F.E.B., S.H.), Parkville, Victoria; Department of Anesthesia (A.D.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria; Department of Pediatrics (K.J.L.), Melbourne Medical School, University of Melbourne, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand; and Departments of Paediatrics and Critical Care (J.A.C., F.E.B.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia.

David W Herd (DW)

From the Centre for Health Policy (X.X., L.H., K.D.), Melbourne School of Population and Global Health, The University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.W.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.B.), University of Western Australia, Perth; Department of Emergency Medicine (A.D., S.H., M.T.M., J.A.C., F.E.B.), Royal Children's Hospital; Murdoch Children's Research Institute (A.D., M.T.M., K.J.L., J.A.C., F.E.B., S.H.), Parkville, Victoria; Department of Anesthesia (A.D.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria; Department of Pediatrics (K.J.L.), Melbourne Medical School, University of Melbourne, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand; and Departments of Paediatrics and Critical Care (J.A.C., F.E.B.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia.

Meredith L Borland (ML)

From the Centre for Health Policy (X.X., L.H., K.D.), Melbourne School of Population and Global Health, The University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.W.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.B.), University of Western Australia, Perth; Department of Emergency Medicine (A.D., S.H., M.T.M., J.A.C., F.E.B.), Royal Children's Hospital; Murdoch Children's Research Institute (A.D., M.T.M., K.J.L., J.A.C., F.E.B., S.H.), Parkville, Victoria; Department of Anesthesia (A.D.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria; Department of Pediatrics (K.J.L.), Melbourne Medical School, University of Melbourne, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand; and Departments of Paediatrics and Critical Care (J.A.C., F.E.B.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia.
ORCID: 0000-0002-5326-5008

Andrew Davidson (A)

From the Centre for Health Policy (X.X., L.H., K.D.), Melbourne School of Population and Global Health, The University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.W.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.B.), University of Western Australia, Perth; Department of Emergency Medicine (A.D., S.H., M.T.M., J.A.C., F.E.B.), Royal Children's Hospital; Murdoch Children's Research Institute (A.D., M.T.M., K.J.L., J.A.C., F.E.B., S.H.), Parkville, Victoria; Department of Anesthesia (A.D.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria; Department of Pediatrics (K.J.L.), Melbourne Medical School, University of Melbourne, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand; and Departments of Paediatrics and Critical Care (J.A.C., F.E.B.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia.

Stephen Hearps (S)

From the Centre for Health Policy (X.X., L.H., K.D.), Melbourne School of Population and Global Health, The University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.W.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.B.), University of Western Australia, Perth; Department of Emergency Medicine (A.D., S.H., M.T.M., J.A.C., F.E.B.), Royal Children's Hospital; Murdoch Children's Research Institute (A.D., M.T.M., K.J.L., J.A.C., F.E.B., S.H.), Parkville, Victoria; Department of Anesthesia (A.D.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria; Department of Pediatrics (K.J.L.), Melbourne Medical School, University of Melbourne, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand; and Departments of Paediatrics and Critical Care (J.A.C., F.E.B.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia.
ORCID: 0000-0003-2984-1172

Mark T Mackay (MT)

From the Centre for Health Policy (X.X., L.H., K.D.), Melbourne School of Population and Global Health, The University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.W.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.B.), University of Western Australia, Perth; Department of Emergency Medicine (A.D., S.H., M.T.M., J.A.C., F.E.B.), Royal Children's Hospital; Murdoch Children's Research Institute (A.D., M.T.M., K.J.L., J.A.C., F.E.B., S.H.), Parkville, Victoria; Department of Anesthesia (A.D.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria; Department of Pediatrics (K.J.L.), Melbourne Medical School, University of Melbourne, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand; and Departments of Paediatrics and Critical Care (J.A.C., F.E.B.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia.

Katherine J Lee (KJ)

From the Centre for Health Policy (X.X., L.H., K.D.), Melbourne School of Population and Global Health, The University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.W.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.B.), University of Western Australia, Perth; Department of Emergency Medicine (A.D., S.H., M.T.M., J.A.C., F.E.B.), Royal Children's Hospital; Murdoch Children's Research Institute (A.D., M.T.M., K.J.L., J.A.C., F.E.B., S.H.), Parkville, Victoria; Department of Anesthesia (A.D.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria; Department of Pediatrics (K.J.L.), Melbourne Medical School, University of Melbourne, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand; and Departments of Paediatrics and Critical Care (J.A.C., F.E.B.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia.

Stuart R Dalziel (SR)

From the Centre for Health Policy (X.X., L.H., K.D.), Melbourne School of Population and Global Health, The University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.W.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.B.), University of Western Australia, Perth; Department of Emergency Medicine (A.D., S.H., M.T.M., J.A.C., F.E.B.), Royal Children's Hospital; Murdoch Children's Research Institute (A.D., M.T.M., K.J.L., J.A.C., F.E.B., S.H.), Parkville, Victoria; Department of Anesthesia (A.D.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria; Department of Pediatrics (K.J.L.), Melbourne Medical School, University of Melbourne, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand; and Departments of Paediatrics and Critical Care (J.A.C., F.E.B.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia.

Kim Dalziel (K)

From the Centre for Health Policy (X.X., L.H., K.D.), Melbourne School of Population and Global Health, The University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.W.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.B.), University of Western Australia, Perth; Department of Emergency Medicine (A.D., S.H., M.T.M., J.A.C., F.E.B.), Royal Children's Hospital; Murdoch Children's Research Institute (A.D., M.T.M., K.J.L., J.A.C., F.E.B., S.H.), Parkville, Victoria; Department of Anesthesia (A.D.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria; Department of Pediatrics (K.J.L.), Melbourne Medical School, University of Melbourne, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand; and Departments of Paediatrics and Critical Care (J.A.C., F.E.B.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia.

John A Cheek (JA)

From the Centre for Health Policy (X.X., L.H., K.D.), Melbourne School of Population and Global Health, The University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.W.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.B.), University of Western Australia, Perth; Department of Emergency Medicine (A.D., S.H., M.T.M., J.A.C., F.E.B.), Royal Children's Hospital; Murdoch Children's Research Institute (A.D., M.T.M., K.J.L., J.A.C., F.E.B., S.H.), Parkville, Victoria; Department of Anesthesia (A.D.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria; Department of Pediatrics (K.J.L.), Melbourne Medical School, University of Melbourne, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand; and Departments of Paediatrics and Critical Care (J.A.C., F.E.B.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia.
ORCID: 0000-0002-3615-3821

Franz E Babl (FE)

From the Centre for Health Policy (X.X., L.H., K.D.), Melbourne School of Population and Global Health, The University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.W.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.B.), University of Western Australia, Perth; Department of Emergency Medicine (A.D., S.H., M.T.M., J.A.C., F.E.B.), Royal Children's Hospital; Murdoch Children's Research Institute (A.D., M.T.M., K.J.L., J.A.C., F.E.B., S.H.), Parkville, Victoria; Department of Anesthesia (A.D.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria; Department of Pediatrics (K.J.L.), Melbourne Medical School, University of Melbourne, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand; and Departments of Paediatrics and Critical Care (J.A.C., F.E.B.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, Australia. franz.babl@rch.org.au.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Enfant › Cost-effectiveness of Prednisolone to Treat...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Cost-effectiveness of Prednisolone to Treat...
questionsmedicales.fr › Composés polycycliques › Composés à cycles fusionnés › Stéroïdes › Prégnanes › Prégnadiènes › Prégnadiènetriols › Prednisolone › Cost-effectiveness of Prednisolone to Treat...
questionsmedicales.fr › Organisations et économie des soins de santé › Économie › Coûts et analyse des coûts › Analyse coût-bénéfice › Cost-effectiveness of Prednisolone to Treat...
questionsmedicales.fr › Maladies du système nerveux › Atteintes des nerfs crâniens › Atteintes du nerf facial › Paralysie faciale de Bell › Cost-effectiveness of Prednisolone to Treat...
questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Association de médicaments › Cost-effectiveness of Prednisolone to Treat...
questionsmedicales.fr › Régions géographiques › Océanie › Australasie › Australie › Cost-effectiveness of Prednisolone to Treat...