Transcript Cost-effectiveness of Spinal Cord Stimulation for Failed Back

Cost-effectiveness of Spinal Cord
Stimulation for Failed Back Surgery
Syndrome Using Rechargeable Equipment
Richard B. North, MD1  Rod S. Taylor, PhD2
Jane Shipley, BA3  Anthony Bentley, BSc4
1Berman
Brain & Spine Institute, Baltimore, MD
2Peninsula Medical School, Universities of Exeter and Plymouth, Exeter, UK
3The Neuromodulation Foundation, Baltimore, MD
4Abacus International, Bicester, UK
This study is sponsored by Medtronic, Inc.
Disclosures
Richard B. North, MD
Research support to Johns Hopkins University and Sinai
Hospital (former and current employers)
Support to nonprofit Neuromodulation Foundation, Inc.
(unpaid officer), 2007 - present
Autonomic Technologies,
Inc.
Bioness, Inc.
Boston Scientific Corp.
Medtronic, Inc.
Microtransponder, Inc.
St. Jude Medical
Neuromodulation, Inc.
Consulting/equity
Algostim, LLC
JHU-APL 1975
JHU-APL-Pacesetter 1979
Primary cell capacity
- Botero

Charging Made Simple
– Portable- cordless &
lightweight
– Charge on the go
– Stimulation on while
charging
– Charge every couple of
days or every couple of
weeks-as patient prefers
(now Boston Scientific) 2004
2005
Introduction
SCS cost-effectiveness is affected by the
battery life of the implanted pulse
generator (IPG) because battery
replacement requires new equipment and
a surgical procedure.
Introduction
Rechargeable IPGs are more costly than
non-rechargeable systems, but they offer
clinical advantages by:
• reducing the need for surgical procedures
(expense, risk)
•accommodating treatment of patients with
high energy demands
•supporting complex programming
NICE Model
In 2008, the United Kingdom’s (UK)
National Institute for Health & Clinical
Excellence (NICE) evaluated SCS.
Using the NICE cost-effectiveness model,
we reported that rechargeable IPGs are
more cost-effective than nonrechargeables that last <4 years.
Taylor RS, et al. The cost-effectiveness of spinal cord stimulation in the treatment of
failed back surgery syndrome. Clin J Pain 26(6):463-469, 2010.
UK vs. US
Practice and cost differences between
the US and the UK mean that the NICE
model is only generally relevant to the
UK.
Incorporating these differences into
the model allows us to test the impact
in the US of several variables,
including IPG longevity.
Study Question
From the perspective of US healthcare
payers, we examined the impact of using a
rechargeable IPG on the cost-effectiveness
of SCS plus conventional medical
management (CMM) versus 1) reoperation
and 2) CMM alone.
Methods: Model
The two-stage EXCEL model involves a 6month decision tree and a long-term
Markov model.
We conducted 1) probabilistic sensitivity
analyses to account for uncertainty in
assumptions and 2) one-way sensitivity
analyses for each SCS indication (tornado
diagram) to test impact of changes on the
base case assumptions.
6-Month Decision Tree
Methods: Data Sources
For the probability of clinical events
occurring and the probable effect of
treatment on quality of life, we used data
from RCTs, systematic reviews, and longterm observational studies.
We obtained US reimbursement figures
from MarketScan® and Medicare, used
midpoint cost values, and applied a 3.5%
discount rate to costs and health benefits.
Results
Assuming an implant cost of $25,997 and 9-year
longevity for a rechargeable system :
SCS is dominant compared with reoperation
(both less expensive and more effective).
SCS versus CMM yields an incremental cost
effectiveness ratio (ICER) of $31,343 per qualityadjusted life-year (QALY), which is cost-effective
at a maximum willingness to pay threshold of
$50,000.
SCS vs. reoperation
SCS vs. CMM
References – Literature on Use
Bernstein CA,, et al. Spinal cord stimulation in conjunction with peripheral nerve field
stimulation for the treatment of low back and leg pain: a case series.
Neuromodulation 11(2):116-123, 2008.
Deer T, et al.. Initial experience with a new rechargeable generator: A report of twenty
systems at 3 months status postimplant in patients with lumbar postlaminectomy
syndrome. Abstracts of the 9th Annual Meeting of the North American
Neuromodulation Society, Nov 10-12, 2005, Washington, D.C.
Frank L, et al. Rechargeable SCS systems with independent current control benefit
patients and the health care system: Case reports [abst]. Eur J Pain 11(S1):S144, 2007.
North RB, et al. A clinical study of spinal epidural stimulation for the treatment of
intractable pain. Baltimore, MD: Johns Hopkins University Applied Physics Laboratory,
1977.
Oakley JC, et al. A new spinal cord stimulation system effectively relieves chronic,
intractable pain: A multicenter prospective clinical study. Neuromodulation 10(3):262278, 2007.
Prager J. New rechargeable spinal cord stimulator systems offer advantages in CRPS
treatment. Pain Practitioner, 16(1): 68-70, 2006.
Van Buyten JP, et al. The restore rechargeable, implantable neurostimulator: Handling and
clinical results of a multicenter study Clin J Pain 24(4):325-334, 2008.
References-Literature on Cost
Hornberger J, et al. Rechargeable spinal cord stimulation
versus non-rechargeable system for patients with failed
back surgery syndrome: a cost-consequences analysis.
Clin J Pain 24(3):244-252, 2008.
Kemler MA, et al. The cost-effectiveness of spinal cord
stimulation for complex regional pain syndrome. Value
Health 13(6):735-742, 2010.
Kumar K, Bishop S. Financial impact of spinal cord
stimulation on the healthcare budget: a comparative
analysis of costs in Canada and the United States. J
Neurosurg Spine 10(6):564-573, 2009.
Taylor RS, et al. The cost-effectiveness of spinal cord
stimulation in the treatment of failed back surgery
syndrome. Clin J Pain 26(6):463-469, 2010.
Conclusions
In the US, our model shows that SCS
using a rechargeable IPG is costeffective versus CMM and dominant
versus reoperation. The costeffectiveness of SCS is sensitive to
IPG longevity.
Comparative efficacy - Marketing
Economic modeling
Rechargeable cell power

PRO
– Surgical replacement deferred
– Less bulk, as smaller cell adequate
– Power availability

CON
– Recharging
Inconvenience
 Noncompliance
