A cost-effectiveness analysis of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain.

BMI, body mass index EQ-5D, EuroQol 5-Dimension 5-level ESI, epidural steroid injection MCS, mental component summary N/A, not applicable ODI, Oswestry Disability Index PCS, physical component summary QALY, Quality adjusted life year,APC, Ambulatory Payment Classification SD, standard deviation SF36v2®, Short Form 36 Version 2 SMART, Surgical Multi-center Assessment of Radiofrequency Ablation for the Treatment of Vertebrogenic Back Pain VAS, visual analog scale,BVNA, Basivertebral nerve ablation WTP, Willingness to pay

Journal

The spine journal : official journal of the North American Spine Society
ISSN: 1878-1632
Titre abrégé: Spine J
Pays: United States
ID NLM: 101130732

Informations de publication

Date de publication:
25 Sep 2024
Historique:
received: 26 06 2024
accepted: 20 09 2024
medline: 28 9 2024
pubmed: 28 9 2024
entrez: 27 9 2024
Statut: aheadofprint

Résumé

Randomized trials have demonstrated the superiority of intraosseous basivertebral nerve ablation (BVNA) compared with sham and standard care in terms of improvements in pain, disability, and health-related quality of life in patients with vertebrogenic chronic low back pain (cLBP). To assess the cost effectiveness of BVNA in patients with vertebrogenic cLBP compared to standard care alone. A model-based economic analysis. Base case analysis used INTRACEPT, a randomized trial comparing BVNA with standard care in 140 patients with vertebrogenic cLBP, recruited from 23 sites across the United States, with a follow-up, up to 5 years. Scenario analyses compared data from the Surgical Multi-center Assessment of Radiofrequency Ablation for the Treatment of Vertebrogenic Back Pain (SMART) randomized trial against a sham control, and a single-arm study. Costs and quality-adjusted life years (QALYs) were calculated to determine the incremental cost-effectiveness ratio (ICER). A cost-effectiveness model was built in Microsoft Excel® to evaluate the costs and health outcomes of patients undergoing BVNA using the Intracept Procedure (Relievant Medsystems) to treat vertebrogenic cLBP from a US payor perspective. Alternative scenario sensitivity analyses and probabilistic sensitivity analyses were conducted to assess the robustness of the model results. QALYs were discounted at 3.0% per year. Base case analysis showed that BVNA relative to standard care alone was a cost-effective strategy for the management of patients with vertebrogenic cLBP, with an ICER of US$11,376 per QALY at a 5-year time horizon from introduction of the procedure. Modeling demonstrated a >99% probability that this was cost effective in the US, based on a willingness-to-pay threshold of US$100,000 to US$150,000. Various sensitivity and scenario analyses produced ICERs that all remained below this threshold. BVNA with the Intracept Procedure offers patients with vertebrogenic cLBP, clinicians, and healthcare systems a cost-effective treatment compared to standard care alone.

Sections du résumé

BACKGROUND CONTEXT BACKGROUND
Randomized trials have demonstrated the superiority of intraosseous basivertebral nerve ablation (BVNA) compared with sham and standard care in terms of improvements in pain, disability, and health-related quality of life in patients with vertebrogenic chronic low back pain (cLBP).
PURPOSE OBJECTIVE
To assess the cost effectiveness of BVNA in patients with vertebrogenic cLBP compared to standard care alone.
STUDY DESIGN/SETTING METHODS
A model-based economic analysis.
PATIENT SAMPLE METHODS
Base case analysis used INTRACEPT, a randomized trial comparing BVNA with standard care in 140 patients with vertebrogenic cLBP, recruited from 23 sites across the United States, with a follow-up, up to 5 years. Scenario analyses compared data from the Surgical Multi-center Assessment of Radiofrequency Ablation for the Treatment of Vertebrogenic Back Pain (SMART) randomized trial against a sham control, and a single-arm study.
OUTCOME MEASURES METHODS
Costs and quality-adjusted life years (QALYs) were calculated to determine the incremental cost-effectiveness ratio (ICER).
METHODS METHODS
A cost-effectiveness model was built in Microsoft Excel® to evaluate the costs and health outcomes of patients undergoing BVNA using the Intracept Procedure (Relievant Medsystems) to treat vertebrogenic cLBP from a US payor perspective. Alternative scenario sensitivity analyses and probabilistic sensitivity analyses were conducted to assess the robustness of the model results. QALYs were discounted at 3.0% per year.
RESULTS RESULTS
Base case analysis showed that BVNA relative to standard care alone was a cost-effective strategy for the management of patients with vertebrogenic cLBP, with an ICER of US$11,376 per QALY at a 5-year time horizon from introduction of the procedure. Modeling demonstrated a >99% probability that this was cost effective in the US, based on a willingness-to-pay threshold of US$100,000 to US$150,000. Various sensitivity and scenario analyses produced ICERs that all remained below this threshold.
CONCLUSIONS CONCLUSIONS
BVNA with the Intracept Procedure offers patients with vertebrogenic cLBP, clinicians, and healthcare systems a cost-effective treatment compared to standard care alone.

Identifiants

pubmed: 39332685
pii: S1529-9430(24)01040-4
doi: 10.1016/j.spinee.2024.09.016
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Conflict of Interest None

Auteurs

Matthew Smuck (M)

Department of Orthopaedic Surgery, Division of Physical Medicine & Rehabilitation, Stanford University, 430 Broadway Street, Redwood City, CA, 94063, USA. Electronic address: msmuck@stanford.edu.

Zachary L McCormick (ZL)

Department of Physical Medicine and Rehabilitation, University of Utah School of Medicine, Salt Lake City, UT 84108, USA.

Chris Gilligan (C)

Office of the Chief Medical Officer, Robert Wood Johnson University Hospital, New Brunswick, NJ 08903, USA.

Mary K Hailey (MK)

Relievant Medsystems, Inc. Corporate Headquarters, 7201 Metro Blvd #300, Edina, MN 55439, USA.

Michelle L Quinn (ML)

Relievant Medsystems, Inc. Corporate Headquarters, 7201 Metro Blvd #300, Edina, MN 55439, USA.

Anthony Bentley (A)

Mtech Access Limited, Bicester, Oxfordshire, OX26 4PP, UK.

Kaylie Metcalfe (K)

Mtech Access Limited, Bicester, Oxfordshire, OX26 4PP, UK.

Benjamin Bradbury (B)

Mtech Access Limited, Bicester, Oxfordshire, OX26 4PP, UK.

Dylan J Lukes (DJ)

Bright Research, Minneapolis, MN, 55042, USA.

Rod S Taylor (RS)

MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, University of Glasgow, Glasgow, G12 8QQ, UK.

Classifications MeSH