POLICY ON THE USE OF DEEP BRAIN STIMULATION TO TREAT
ADULTS WITH MOVEMENT DISORDERS
On behalf of: Primary Care Trusts in the Yorkshire and Humber area
Author: Kim Cox
Specialised Services Commissioning Manager
Correspondence to: Cathy Edwards
Director of Yorkshire and Humber SCG and Head of
C/o Barnsley PCT
Date completed: May 2008
Review Date: May 2011
Conflicts of Interest: None
Acknowledgements Tim Allison, Director of Public Health East Yorkshire
and Yorkshire Wolds & Coast PCTs
Tracy Denby, Research Officer, Institute of Health
Sciences and Public health Research, University of
National Institute for Health and Clinical Excellence
Dr Richard Grunewald and the staff of the
Neurosciences Service, Sheffield Teaching Hospitals
NHS Foundation Trust
Page 1 of 17
1. AIM OF PAPER
2. MOVEMENT DISORDERS
3. DEEP BRAIN STIMULATION
4. REVIEW OF EVIDENCE
5. SERVICE PROVIDERS
6. CRITERIA FOR TREATMENT
7. COMMISSIONING IMPLICATIONS
8. POLICY STATEMENT
APPROPRIATE OUTCOME MEASUREMENT
Page 2 of 17
ADL Activities of Daily Living
DBS Deep Brain Stimulation
EBCC Evidence Based Commissioning
FT Foundation Trust
NICE National Institute for Health and Clinical
NSCAG National Specialist Commissioning
MDT Multi-disciplinary Team
MRC Medical Research Council
QALY Quality Adjusted Life Year
SCG Specialist Commissioning Group
Appropriate Medical Dopaminergic drugs such as Sinemet, Madopar,
Treatment bromocriptine, pergolide, pramipexole, ropinirole
Thalamotomy Surgical destruction of a selected part of the
thalamus region of the brain
Page 3 of 17
Pallidotomy Surgical destruction of a selected part of the globus
pallidus region of the brain
Failure to respond Intolerable response fluctuations, dyskinesia or psychotic
adequately to, or be adverse effects of medication
unable to tolerate,
Page 4 of 17
1 AIM OF THE PAPER
1.1 This paper represents the commissioning policy for the use of Deep Brain
Stimulation (DBS) in the treatment of movement disorders in adults for Primary Care
Trusts in the Yorkshire and Humber area. It has been produced in the context of and
in accordance with National Institute for Health and Clinical Excellence (NICE)
Interventional Procedure Guidance no.19 (Deep brain stimulation for Parkinson’s
disease) and Interventional Procedure Guidance no. 188 (Deep brain stimulation for
tremor and dystonia excluding Parkinson’s disease).
2 MOVEMENT DISORDERS
2.1 PARKINSON’S DISEASE1
2.1.1 Parkinson’s disease is a chronic disease of the brain characterised by gradual
worsening tremor, muscle rigidity and difficulty in starting and stopping
movements, resulting in poor quality of life. The condition is usually treated with
drugs. Surgery may be considered in people who have responded poorly to drugs,
who have severe side effects from medication or who have severe fluctuations in
response to drugs.
2.1.2 Parkinson’s disease is common, affecting about 0.5% of people aged 65 to 74
years and 1-2% of people aged 75 years and older. Based on the 2001 census
data there are 493,000 people aged 65 to 74 in the Yorkshire and Humber area,
and 436,000 aged 75 and over. It is estimated that 2465 people aged 65 to 74 and
between 4360 and 8720 people aged over 75 in Yorkshire and the Humber may
have Parkinson’s disease2.
2.1.3 Between 1% and 10% of people with Parkinson’s disease may be suitable for
surgery. This means that anywhere between 683 and 1119 Parkinson’s disease
sufferers in the Yorkshire and Humber area may be suitable for surgery.
2.1.4 Surgery for Parkinson’s disease is carried out on structures in the brain that are
responsible for the modification of movements. Surgery alters, through either
destruction or electrical modification, the function of brain nuclei.
2.1.5 Deep brain stimulation is one form of surgery for Parkinson’s disease. Pallidotomy
and thalamotomy are other surgical procedures that may be used.
2.2 TREMOR AND DYSTONIA3
2.2.1 Tremor and dystonia are symptoms that can arise in a number of different
neurological diseases. These include essential tremor, multiple sclerosis, idiopathic
focal dystonia and primary generalised dystonia.
Page 5 of 17
126.96.36.199 Tremor is an involuntary rhythmic repetitive movement, most frequently affecting
the upper limbs. It can occur at rest or can be brought on (or made worse) by
posture or intentional movement.
188.8.131.52 Severe tremor can be disabling because it affects fine movement control.
184.108.40.206 Tremor can be treated by rehabilitation and drug therapy. Appropriate treatment
can minimise functional disability.
220.127.116.11 Anti-tremor drugs occasionally reduce the amplitude, of tremor, but this does not
always translate into functional improvement and medication may be poorly
18.104.22.168 Surgery is usually reserved for patients with severe disabling tremor and
functional disability that interferes with daily living, and for tremor that is refractory
to the highest tolerated doses of medication.
22.214.171.124 Prevalence of essential tremor is estimated to be 500 per 100,000, although data
from the United States gives a range of between 8 and 22,000 per 100,000. This
wide range may be due to issues of diagnostic threshold, overlooked diagnosis or
unclear diagnostic criteria4. Using the 2001 census populations, the estimated
prevalence of significant essential tremor for the Yorkshire and Humber
population is 26,000.
126.96.36.199 Dystonia is a neurological disorder characterised by sustained muscle spasma
and contractions. It may be painful and can lead to abnormal movements and
postures. It may be limited to a particular group of muscles (focal dystonia), or
may affect most of the body (generalised dystonia).
188.8.131.52 Dystonia cannot be cured but it can be managed medically or surgically. Current
medical management options (botulinum toxin or other drugs) may improve the
symptoms but do not cure the underlying neurological disorder. These drugs may
have unpleasant side effects.
184.108.40.206 Deep brain stimulation is one form of surgery for dystonia. Pallidotomy and
thalamotomy are other surgical procedures that may be used.
220.127.116.11 The prevalence of focal dystonia is estimated to be 1 in 3,400, with generalised
dystonia estimated to be 1 in 30,0005. Using the 2001 census data, it is estimated
that there are 1529 cases of focal dystonia and 173 cases of general dystonia in
the Yorkshire and Humber area.
Page 6 of 17
3 DEEP BRAIN STIMULATION
3.1 Deep brain stimulation (DBS) can be carried out on nuclei within the brain that are
responsible for modifying movements. These structures are all bilateral and surgery
can be performed on either one or both sides.
3.2 The function of the nuclei is altered during DBS through the application of an electric
3.3 The procedure involves inserting very fine needles into the brain through small holes
in the skull to determine the exact nuclei to be stimulated. The procedure may be
carried out under local or general anaesthetic as appropriate to the patient’s
3.4 Once the appropriate stimulation sites and parameters have been identified, the
electrodes are connected to a pulse generator implanted in the anterior chest wall.
3.5 Further operations will be required over time to replace the pulse generator or if
leads break. This will only be undertaken if there is clear evidence of clinical benefit.
4 REVIEW OF THE EVIDENCE
4.1.1 Evidence reported by NICE in Interventional Procedure Guidance no 19 showed
that DBS results in improved motor skills, function and movement in patients with
4.1.2 NICE also reported in Interventional Procedure Guidance no.188 that there was
evidence of improvement in both total tremor score and activities of daily living in
patients with tremor treated with DBS3.
4.1.3 Significant improvements in the Burke-Fahn-Marsden dystonia rating scale and in
global disability scores were recorded in patients with dystonia treated with DBS.
4.1.4 NICE Specialist Advisors have noted concerns over long-term efficacy of DBS as
tremor may become resistant to stimulation.
4.1.5 The NSCAG designated MRC PDSurg trial aims to determine whether early
surgery (either through electrical stimulation or radio-frequency lesioning) is more
cost effective for advanced Parkinson’s disease than medical therapy alone (with
4.2 COST EFFECTIVENESS
4.2.1 There is a lack of evidence of the cost effectiveness of DBS. NICE did not consider
the cost effectiveness of DBS for any form of movement disorder.
Page 7 of 17
4.2.2 The EBCC review conducted a cost benefit analysis of DBS for non-Parkinson’s
disease movement disorders, however this was not considered to be a formal
economic evaluation as it provided ‘no information on the incremental costs and
benefits of DBS compared to alternative management strategies’4.
4.2.3 The review reported that the cost per Quality Adjusted Life Year (QALY) using the
total cost of the surgery was £33,980. Whilst this figure is slightly over the
maximum NICE recommended figure of £30,000, the review noted that the
approach used to the calculation was ‘quite different to that taken by NICE in the
UK.’ The evaluation did not take account of the periodic need for replacement
4.3.1 The EBCC review concluded that commissioners had five options, these being:
• Restrict the use of DBS on the grounds that the evidence of effectiveness was
inadequate. This option does not take account of the trend in evidence
• Continue to consider requests for DBS on a case by case basis. This option
would perpetuate inequity and commissioners would continue to face
• Commission further research. Whilst further research is clearly needed, this
option would not produce an interim commissioning position.
• Create clear pathways and referral criteria. This option would allow a limited
level of activity whilst targeting those most likely to benefit. The evidence for
which groups are most likely to benefit remains weak.
• Commission a full service. This option would potentially remove inequity but
would be based on little evidence of effectiveness.
4.3.2 After consideration of the alternatives, this policy attempts to provide clear criteria
for referral so as to enable a service to be provided to those considered most likely
to benefit from DBS.
5 SERVICE PROVIDERS
5.1 NSCAG has designated 10 centres in England as meeting the required standards
for participation in the PDSurg trial.
5.2 The centres in England are:
• Radcliffe Infirmary, Oxford
• Frenchay Hospital, Bristol
• Queen Elizabeth Hospital, Birmingham
• Kings College Hospital, London
• Walton Centre, Liverpool
• Newcastle General Hospital
• National Hospital for Neurology and Neurosurgery, London
• Hope Hospital, Salford
• Royal Hallamshire Hospital, Sheffield
Page 8 of 17
• Addenbrookes Hospital, Cambridge
5.3 Yorkshire and Humber Primary Care Trusts wish to commission all DBS treatment
from providers meeting the rigorous NSCAG standards.
5.4 Yorkshire and Humber commissioners have primarily commissioned services from
Sheffield, Oxford and Birmingham. Ad hoc requests for treatment have also been
received from the Walton Centre and Newcastle.
6 CRITERIA FOR TREATMENT
6.1.1 Indications for the use of DBS for movement disorders fall primarily into 3
categories, these being Parkinson’s disease, tremor and dystonia.
6.1.2 All patients to be considered for DBS will be discussed by the multi-disciplinary
team (MDT). The MDT should believe that the patient would gain significant benefit
from DBS, i.e. regaining lost functions and/or restoring independence. The MDT
should also have agreed what expected benefit the patient is likely to gain and how
it will be measured.
6.1.3 All patients considered appropriate for DBS should be medically fit for surgery
when the decision to undertake DBS is made.
6.2 PARKINSON’S DISEASE
6.2.1 All patients considered for DBS should:
18.104.22.168 Have an established diagnosis of idiopathic Parkinson’s disease and
22.214.171.124 Have no evidence of significant cognitive decline and
126.96.36.199 Be in good general health and be considered to have a reasonable life
188.8.131.52 Have received and failed to respond adequately to, or be unable to tolerate
appropriate medical therapy and
184.108.40.206 Have symptoms severe enough to significantly compromise quality of life and
activities of daily living. Quality of life and activities of daily living must be
measured pre-operatively using an appropriate tool.
6.3.1 Essential Tremor (Normal Cranial Anatomy)
220.127.116.11 Patients should have severe medically refractory essential tremor causing
disability, despite the use of appropriate medical therapy.
18.104.22.168 Functional disability must be severe enough to significantly compromise quality of
life and activities of daily living as measured using an appropriate tool.
Page 9 of 17
22.214.171.124 Treatment of tremor should be likely to produce a functionally useful improvement
126.96.36.199 All other medical and surgical interventions need to have been considered and
6.3.2 Cerebellar Tremor (Abnormal Cranial Anatomy)
188.8.131.52 Tremor should have an established aetiology and be significantly disabling.
184.108.40.206 Functional disability must be severe enough to significantly compromise quality of
life and activities of daily living as measured using an appropriate tool.
220.127.116.11 All other medical and surgical interventions need to have been considered and
18.104.22.168 It must be clear that there are no other co-morbidities that would prevent the
patient from gaining significant benefit. Any other co-morbidities (i.e. those that
will not prevent the patient gaining significant benefit) must be being treated
6.4.1 The patient must exhibit focal or generalised dystonia of sufficient severity to
compromise quality of life and activities of daily living despite appropriate medical
therapy. Quality of life and activities of daily living must be measured pre-
operatively using an appropriate tool.
6.4.2 Dystonia appropriate for DBS will principally be idiopathic in nature, though it is
accepted that, on occasion, patients with secondary dystonia may be appropriate.
6.4.3 Patients must not have significant postural defects or significant fixed joint
deformities which would preclude useful benefit from the treatment
6.4.4 Patients must not have had an adequate response to botulinum toxin treatment;
have failed to tolerate botulinum toxin treatment; require such large or frequent
treatments with botulinum toxin as to make such treatment impractical; or be
unsuitable for botulinum toxin treatment.
6.4.5 Laryngeal dystonia with significant risk of aspiration pneumonia is a particular
indication as DBS may be the only effective treatment and the condition may be life
6.4.6 Patients with psychogenic dystonia are not appropriate for DBS.
Page 10 of 17
7 COMMISSIONING IMPLICATIONS
7.1 The following table shows the numbers of new patients who have been approved for
DBS since 2004/05.
Page 11 of 17
Total 12 17 21 50
7.2 During the period 2004/05 to 2007/08, DBS has been commissioned on a cost-per-
case with prior approval basis.
7.3 The treatment criteria contained in this policy now express a summary of the
patients considered appropriate and approved by PCTs over the period. This policy,
therefore, does not suggest a change to existing practice in terms of eligibility
criteria. Whilst the numbers of patients approved for DBS has gradually increased,
there are no trend increases in any one PCT. Consequently it is considered unlikely
that patient numbers will rise significantly.
7.4 Payment for DBS, for patients with Parkinson’s Disease has previously been
structured in relation to the PDSurg trial. Patients admitted to the trial had funding
supplied from the national subvention fund and PCTs paid only the excess costs of
£12,828 per patient (at 2008/09 prices). The PDSurg trial is no longer taking new
patients. However, PCTs will need to continue to pay excess costs for any patients
currently in the trial and who will have surgery up to 31st October 2008. All other
patients (PD and non-PD) incur a charge to PCTs of national tariff A04 (£5,645 for
2008/09) plus excess costs for the full implant. The excess cost at Sheffield
Teaching Hospitals is £27,739 for 2008/09. Costs at other providers may vary.
7.5 As no new patients are now being admitted to the PDSurg trial, the expected cost of
DBS new patients in 2008/09 is £701,064 (assuming 21 patients treated). This
comprises £118,545 within tariff and £582,519 excess costs for the implants.
7.6 In addition the pulse generator, implanted subcutaneously in the patient’s chest wall,
periodically requires replacement at a cost of £9,600 (at Sheffield 2008/09 prices)
per generator in addition to the cost of HRG A02 (£3,287 for 2008/09) totalling
£12,887. Patients who have previously been approved for DBS will not require prior
approval for the replacement generator. However, the appropriate PCT must be
explicitly informed when a replacement generator has been supplied. Pulse
generator life is difficult to determine as it is very much dependent upon the strength
of setting required by an individual patient. On average, between 4 and 5 pulse
generators have been replaced in Sheffield each year for the past three years. This
equates to approximately one replacement generator for every 3 new patients
treated. Across Yorkshire and the Humber this translates to 7 replacement pulse
generators per year. The expected cost for 2008/09 will be £90,209. This comprises
£23,009 within tariff and £67,200 excess costs for the generators.
Page 13 of 17
8 POLICY STATEMENT
8.1 The following statement sets out the position of Primary Care Trusts in the Yorkshire
and Humber area in respect of commissioning DBS for movement disorders in
8.2 There is evidence that DBS can improve motor function and movement, reduce
disability and improve activities of daily living in patients with Parkinson’s disease,
tremor or dystonia.
8.3 Patients fitting the treatment criteria (detailed in section 6 of this policy) and
considered by the MDT likely to receive significant benefit will be eligible for DBS.
8.4 DBS will be commissioned on a cost-per-case without prior approval basis from
providers who meet the NSCAG designation requirements. Commissioners
recognise that, under current national tariff rules, an excess cost per patient will be
charged in addition to the national tariff. Patients undergoing DBS will be classified
under national tariff A04. Excess costs may vary between providers
8.5 Patients previously receiving DBS (either in Sheffield or from another of the
approved providers listed in section 5.2 of this policy) requiring replacement pulse
generators will receive them without prior approval. Providers will inform the
patient’s PCT as soon as a replacement generator has been supplied.
8.6 This policy will be reviewed in May 2011 or when further significant information
becomes available, either from clinical trials, technological development, NICE or
the Yorkshire and Humber SCG.
Page 14 of 17
Appropriate Outcome Measurement Tools
Reduction in severity of symptoms as measured on the Unified Parkinson's Disease
Reduction in interference in daily living- increase in independence and functionality
measured by FIM or ADLcompared to pre implantation scores
Rate of infection/ complication/ revision
Pre and Post DBS physiotherapy/occupational therapy assessment
Pre and post EuroQol
Improvement in Global Disability Score
Improvement measured on Burke Fahn and Marsden Dystonia Rating Scale
Improvement in Toronto Western Spasmodic Torticollis Rating Scale ( TWSTRS )
Improvement in Global Disability Score
Rate of infection/complication/revision
Improvement in total tremor score ( Fahn Tolosa Marin score) over baseline
Improvement in ADL over baseline
Improvement in Euroqol over baseline
Rates of complication/infection/revision
Page 15 of 17
Page 16 of 17
NICE Interventional Procedure Guidance number 19 Deep Brain Stimulation for Parkinson’s
disease November 2003
2001 Census Population data
NICE Interventional Procedure Guidance number 188 Deep Brain Stimulation for Tremor
and Dystonia (excluding Parkinson’s disease) August 2006
Deep Brain Stimulation for Movement Disorders other than Parkinson’s Disease Evidence
Based Commissioning Collaborative Sept 2004
A prevalence study of primary dystonia in eight European countries
Journal of Neurology, vol. 247, no.10, October 2000, pages 787-792
PDSurg Trial Protocol ISRCTN 34111222 October 2003