Spinal Cord Stimulation (SCS) for chronic pain in adults

Spinal Cord Stimulation (SCS) for chronic pain in adults Reference No: EMSCG P031v1 Version: 1 Ratified by: EMSCG Board Date ratified: 26/03/20...
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Spinal Cord Stimulation (SCS) for chronic pain in adults Reference No:

EMSCG P031v1

Version:

1

Ratified by:

EMSCG Board

Date ratified:

26/03/2010

Name of originator/author:

Dr Samia Latif – Specialist Registrar in Public Health, Derbyshire County PCT.

Name of responsible committee/individual:

East Midlands Clinical Priorities Advisory Group (CPAG).

Date issued:

31/03/2010

Review date:

26/03/2012

Target audience:

PCTs and relevant provider Trusts.

Distributed via:

Postmaster Email Website; www.emscg.nhs.uk

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Summary Spinal Cord Stimulation is recommended by the National Institute for Health and Clinical Excellence (NICE) as a treatment option for pain that lasts longer than several months (chronic), which is caused by damage to the nervous system (neuropathic). SCS works by modifying the perception of pain by stimulating part of the spinal cord. SCS will not be used for patients with pain which is caused by a reduction in oxygen delivery to the tissues, usually caused by reduction in blood flow because of constriction of a vessel (ischaemic). This is because NICE do not recommend it for ischaemic pain due to lack of evidence. The criteria in this policy for treatment with SCS fully integrates the NICE guidance as well as adding some further detail also taken from the full version of the NICE document (Technology Appraisal Guidance number 159). The policy recommendation criteria have been tightened further by adding clear exceptions and a special consideration category based on evidence from The European Consensus on Neuromodulation of Pain.

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East Midlands Specialised Commissioning Group Spinal Cord Stimulation (SCS) for chronic pain in adults Version Control Sheet Draft

Section/Para/ Appendix

0.1

Whole document

0.2

1. Introduction

6. Clinical Indications

0.3

Version/Description of Amendments

Date

Author/Amended by

-

-

Dr Samia Latif

Recommendations made that the policy does not apply to SNS, and inclusion of a paragraph to explain what it and what is not taken from the NICE TAG. All indications apart from those that are ‘good’ or ‘unresponsive’ have been deleted.

02/12/2009

Dr Samia Latif

15/01/2010

Ami Faulkner, EMSCG

8. Demand for The addition of predicted SCS in the EM spinal cord activity for the East Midlands for financial year 2009/10.

4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

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East Midlands Specialised Commissioning Group Spinal Cord Stimulation (SCS) for chronic pain in adults Contents i.

ii.

Version control sheet Policy statement

Section

Page

1

Introduction

6

2

Chronic Pain defined

6

3

Epidemiology

6

4

What is Spinal Cord Stimulation (SCS)?

6

5

Components of the SCS system

6

6

Clinical Indications

7

7

Criteria for Treatment

7

8

Demand for Spinal Cord Stimulation in the East Midlands region

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9

Clinical Effectiveness

10

10

Cost effectiveness

11

11

Glossary

13

12

References

15

Appendix A

Equality Impact Assessment: Test for relevance

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Appendix B

Human Rights assessment tool

19

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East Midlands Specialised Commissioning Group Spinal Cord Stimulation (SCS) for chronic pain in adults Policy Statement

Background

This commissioning policy has been written following the publication of the National Institute for Health and Clinical Excellence (NICE) Technology Appraisal Guidance 159, Spinal Cord Stimulation for Chronic Pain of Neuropathic or Ischaemic Origin (NICE, 2008). This policy will cover all 9 PCTs within the East Midlands region.

Statement

Spinal Cord Stimulation is recommended by NICE as a treatment option for chronic pain of neuropathic origin. It will only be commissioned if all of the criteria in section 7. It will not be commissioned for pain of ischaemic origin.

Responsibilities

Each Primary Care Trust in the East Midlands to adopt this policy and its criteria, and incorporate into Service Level Agreements and contracts with providers as appropriate. Clinicians to comply with the policy. It is anticipated that there will be no exceptions to this policy.

Training

There are no known training issues as this service is already being commissioned.

Dissemination

To all Primary Care Trusts (PCTs) in the East Midlands. It is the PCTs responsibility to share this policy with the relevant providers. It will also be published on the EMSCG website www.emscg.nhs.uk.

Resource implication

Based upon EMSCG activity data, the forecast out turn for the financial year 2009/10 is 38 procedures with a total cost of £551, 502. The majority of these will be undertaken at the Nottingham University Hospital (NUH). Based upon NICE costing estimates, they estimate the current provision for the region to cost approximately £1,045,706, with future provision anticipated to cost approximately £1,684,723.

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1. Introduction This commissioning policy has been written following the publication of the National Institute for Health and Clinical Excellence (NICE) Technology Appraisal Guidance 159, Spinal Cord Stimulation for Chronic Pain of Neuropathic or Ischaemic Origin (NICE, 2008). This policy will cover all 9 PCTs within the East Midlands region. The recommendations made in this policy do not apply to sacral nerve stimulation. This policy is modelled on the NICE TAG 159 and the European Consensus on Neuromodulation of Pain, 1998v; The criteria for treatment fully incorporate the NICE guidance (item 7 where font is bold and italicised) as well as adding some further detail also taken from the full version of the NICE document. The policy recommendation criteria have been tightened further by adding clear exceptions and a special consideration category (reference: The European Consensus). 2. Chronic Pain Definedi Pain that persists for more than several months, or beyond the normal course of a disease or expected time of healing is often defined as chronic. Neuropathic pain is initiated or caused by nervous system damage or dysfunction and includes failed back surgery syndrome (FBSS) and complex regional pain syndrome (CRPS). Ischaemic pain is caused by a reduction in oxygen delivery to the tissues, usually caused by reduction in blood flow because of constriction of a vessel or its obstruction by atheroma or embolus. 3. Epidemiology Estimates of the prevalence of this condition in the UK vary from less than 10% to greater than 30% depending on the specific definition of chronic pain used. The goal of treatment for chronic pain is to make pain tolerable and to improve functionality and quality of life. Conventional medical management (CMM) includes pharmacological interventions such as non-steroidal anti-inflammatory drugs, tricyclic antidepressants, anticonvulsants, analgesics and opioids. Non-pharmacological interventions, such as physiotherapy, acupuncture, transcutaneous electrical nerve stimulation, psychological therapies and repeat surgery are also part of CMM. 4. What Is Spinal Cord Stimulation (SCS)? Spinal cord stimulation (SCS) is a treatment for chronic pain that is usually considered after standard treatments have failed. SCS modifies the perception of neuropathic and ischaemic pain by stimulating the dorsal column of the spinal cord. 5. Components of the SCS System • A neurostimulator that generates an electrical pulse (or receives radio frequency pulses) is surgically implanted under the skin in the abdomen or in the buttock area. • An electrode(s) implanted near the spinal cord either surgically or percutaneously (the latter via puncture, rather than through an open surgical incision, of the skin). • A lead that connects the electrode(s) to the neurostimulator. • A remote controller that is used to turn the neurostimulator on or off and to adjust the level of stimulation.

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Neurostimulators may be either implantable pulse generators (IPGs), which use either a non-rechargeable or a rechargeable internal battery, or radio frequency pulses from an external device powered by a rechargeable battery. The radio frequency device is being less commonly used due to inconveniences of the external power source.ii 6. Clinical Indications The British Pain Society Indications for Spinal Cord Stimulation iii Good indications for SCS (likely to respond) are as follows: • neuropathic pain in leg or arm following lumbar or cervical spine surgery (FBSS/FNSS) • complex regional pain syndrome • neuropathic pain secondary to peripheral nerve damage • pain associated with peripheral vascular disease • refractory angina • brachial plexopathy: traumatic (partial, not avulsion), post irradiation. Unresponsive to SCS • complete spinal cord transection • non-ischaemic nocioceptive pain • nerve root avulsion. 7. Criteria for treatment In accordance with NICE Tag 159i and the European Consensus on Neuromodulation of Pain, 1998v; This treatment should only be offered to those who meet all of the following criteria: • adults with chronic pain of neuropathic origin • continue to experience chronic pain (measuring at least 50 mm on a 0–100 mm visual analogue scale) for at least 6 months despite appropriate conventional medical management (CMM). CMM includes: Pharmacological interventions (e.g.non-steroidal anti-inflammatory drugs, tricyclic antidepressants, anticonvulsants, analgesics and opioids), Nonpharmacological interventions (e.g. physiotherapy, acupuncture, transcutaneous electrical nerve stimulation), Psychological therapies and surgery if indicated. AND • who have had a successful trial of stimulation as part of the assessment. This usually involves implanting the electrode(s) and leads with a temporary external device, used to mimic the effects of an implanted neurostimulator. A stimulation trial assesses tolerability and the degree of pain relief likely to be achieved with full implantation. A successful stimulation trial is where the pain relief is more than 50% (in contrast to 30% which has been used to describe successful CMM). AND • this stimulation trial data should be routinely recorded to inform the decision about type of the system for implantation

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AND • Spinal cord stimulation should be provided only after an assessment by a multidisciplinary team experienced in chronic pain assessment and management of people with spinal cord stimulation devices, including experience in the provision of ongoing monitoring and support of the person assessed. AND • Tests to assess pain and response to spinal cord stimulation should take into account a person’s disabilities (such as physical or sensory disabilities), or linguistic or other communication difficulties, and may need to be adapted thereby ensuring equality of access to treatment. AND • Patients should have been thoroughly informed of the neuromodulation treatment and its practical consequences, including possible side-effects. AND • Patients must be genuinely motivated and must have realistic expectations on the possible outcomes. AND • If different spinal cord stimulation systems are considered to be equally suitable for a person, the least costly should be used. AND • Assessment of cost should take into account acquisition costs, the battery life and anticipated replacement period, the stimulation requirements of the person with chronic pain and the support package offered. Price and longevity may be interdependent and longevity varies depending on an individual’s pain characteristics. In addition the following people should be excluded from receiving this treatment: • Spinal cord stimulation is not recommended as a treatment option for adults with chronic pain of ischaemic origin. • The recommendations made in this policy do not apply to sacral nerve stimulation In addition these patients require specific consideration: • Certain patients with learning difficulties, disability, cognitive impairment or severe mental health problems require specific consideration because implantation of a device has the potential to cause harm if the patient is unable to cooperate with the technical demands of the process.

• It is the responsibility of the Specialist Clinician in charge to evaluate what patient limitations exist in those with poor compliance and/or insufficient understanding of the therapy. A patient may be excluded if implantation of a neuromodulator device would pose a risk of harm to the patient that would outweigh the intended benefit. This policy recommends formal psychological assessment if necessary.

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8. Demand for Spinal Cord Stimulation in the East Midlands region The following two tables are based upon the NICE costing template for spinal cord stimulation for chronic pain of neuropathic or ischaemic origin (TA 159). They outline both the current and likely future demand for SCS in the East Midlands region. These figures are derived from inputting all 9 PCT’s into the costing template. NICE advise that the likely future demand is based on full implementation and likely to take a number of years. Also, due to the uncertainty around the battery life of the device (which could range from 4-10 years), this has been factored out of these calculations. The amount of complications following SNS is based upon an estimation of 21.5% of patients (Kumar et al, 2006). However, it is noted that complication rates may now be lower then this. The estimated costs of a trial simulation and the permanent implant costs have been calculated by NICE in the two tables below as follows:

Trial stimulation Implant procedure (HRG R11 ‘spinal cord surgery’ uplifted by the average MFF of 1.1248. Lead pack (Estimated average prices per lead, a proportion of patients may require 2 leads). Total cost Permanent implant Permanent implant controller and charger (Estimated average cost per lead, taken from FAD). Lead pack (Assumed the lead from the trial stimulation can be used). Implant procedure Total cost

National Cost (£) 4, 737 1, 340 6, 077 National Cost (£) 9, 282 0 4, 737 14, 019

Table 1. Current demand for Spinal Cord Stimulation for chronic pain of neuropathic origin in the East Midlands PCT population per year*: Description Units Cost (£) Total population in the East Midlands 4, 293, 293. Estimated current number of implants for chronic pain of 47 neuropathic origin. Number of patients assessed and trialled for SCS, due to pain 59 of neuropathic origin. Trial stimulation costs (estimated cost of trial stimulation). 59 358, 543 Permanent implant costs (estimated cost of a permanent 47 658, 893 implant). Complications – displaced electrode (number of patients 12 12, 384 requiring attention). Reprogramming sessions, (2 sessions per implant). 94 15, 886 Estimated current cost of SCS for pain of neuropathic origin: 1, 045, 706 * This table does not include the additional 8 patients with chronic ischaemic conditions that NICE predicts would have SCS treatment, as this is not recommended. Therefore, it should be noted that the proportions of patients with complications etc may in reality be slightly smaller as NICE is being this on 55 patients undergoing SCS, rather than the 47 for chronic pain of neuropathic origin.

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Table 2. Estimated future demand for Spinal Cord Stimulation for chronic pain of neuropathic origin in the East Midlands PCT population*: Description Units Cost (£) Total population in the East Midlands 4, 293, 293. Number of patients assessed and trialled for SCS, due to pain 95 of neuropathic origin. Number of permanent implants for pain of neuropathic origin. 76 Trial stimulation costs: estimated cost of trial stimulation 95 577, 079 Permanent implant costs: estimated cost of a permanent 76 1, 065, 444. implant Complications – displaced electrode (number of patients 16 16, 512 requiring attention). Reprogramming sessions, (2 sessions per implant). 152 25, 688 Estimated future cost of SCS for pain of neuropathic origin: 1, 684, 723 * This is based on an estimated uptake of 10% year on year growth for 5 years based on an increase in the current use (as shown in table 1).

Table 3 shows that spend so far for Spinal Cord Stimulation (SCS) based upon the EMSCG activity data. Spend for the financial year 2009/10 is at £368, 379. The forecast out turn for the end of the year is predicted to be around a total of 38 procedures performed (this is SCS surgical procedure and does not include the trial of stimulation), most of these being performed at Nottingham University Hospitals (NUH) with a total annual cost of approximately £551, 502 for the year end. Table 3: Spinal Cord Stimulator (SCS) activity 2009/10 Actual activity so far for 09/10 Forecast out turn (Predicted Provider number for the end of the 09/10 financial year) Activity £ Activity £ Sheffield Teaching 4 35, 817 7 61, 401 Basildon and Thurrock 1 17, 483 1 17, 483 Nottingham University 13 170, 079 20 255, 119 Hospitals (NUH) Oxford Radcliffe 7 145, 000 11 217, 500 Total 38 551, 502 9. Clinical effectiveness NICE have recommended SCS as a treatment option for adults with chronic pain of neuropathic origin who: • continue to experience chronic pain (measuring at least 50 mm on a 0– 100 mm visual analogue scale) for at least 6 months despite appropriate conventional medical management, and • who have had a successful trial of stimulation as part of their assessment. The British Pain Society concurs with this assessment, as well as agreeing that SCS is not recommended for chronic pain of ischaemic origin except in the context of research as part of a clinical trial (British Pain Society, 2009). This NICE assessment was based on The Health Technology Assessment (HTA) review carried out by Simson et al iv on behalf of NICE. They retrieved approximately 60,000 citations and included three randomised control trials (RCTs) on neuropathic

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pain. Comparators were relevant to UK practice. Good quality, adequately powered trials were available for the neuropathic conditions FBSS and CRPS type I suggesting that SCS was more effective than CMM or reoperation in reducing chronic pain. It was unclear whether this can be generalised to other forms of neuropathic pain. All three trials reported a statistically significant benefit in terms of those experiencing 50% pain relief, favouring SCS in comparison with CMM or reoperation (p