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 Disclosures

Richard B. North, MDRichard B. North, MD Research support to Johns Hopkins University and Research support to Johns Hopkins University and

Sinai Hospital (former and current employers)Sinai Hospital (former and current employers)

Support to nonprofit Neuromodulation Foundation, Support to nonprofit Neuromodulation Foundation, Inc. (unpaid officer), 2007 - presentInc. (unpaid officer), 2007 - present

Autonomic Technologies, Inc.Bioness, Inc.Boston Scientific Corp.Medtronic, Inc.Microtransponder, Inc.St. Jude Medical Neuromodulation, Inc.

Consulting/equityAlgostim, LLC

JHU-APL 1975

JHU-APL-Pacesetter 1979

Primary cell capacity

- Botero

Charging Made SimpleCharging Made Simple– Portable- cordless & Portable- cordless &

lightweightlightweight– Charge on the goCharge on the go– Stimulation on while Stimulation on while

chargingcharging– Charge every couple of Charge every couple of

days or every couple of days or every couple of weeks-as patient prefersweeks-as patient prefers

(now Boston Scientific) 2004

2005

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

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

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 non-rechargeables that last <4 years.

NICE Model

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.

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.

UK vs. US

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.

Study Question

Methods: Model

The two-stage EXCEL model involves a 6-month 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 SourcesFor the probability of clinical events occurring and the probable effect of treatment on quality of life, we used data from RCTs, systematic reviews, and long-term 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 quality-adjusted 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):262-278, 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 CostHornberger 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 cost-effective versus CMM and dominant versus reoperation. The cost-effectiveness of SCS is sensitive to IPG longevity.

Comparative efficacy - Marketing

Economic modelingEconomic modeling

Rechargeable cell Rechargeable cell powerpower PROPRO

– Surgical replacement deferred Surgical replacement deferred – Less bulk, as smaller cell adequateLess bulk, as smaller cell adequate– Power availability Power availability

CONCON– Recharging Recharging

InconvenienceInconvenience NoncomplianceNoncompliance