Deep Brain Stimulation Policy by l1ve65


									                          Deep Brain Stimulation Policy                              DD
                                       Board Meeting

                                         1 July 2008

1     Introduction/Background

      Details of the Deep Brain Stimulation Policy are included with the attached papers.

2     Recommendations

      The Board is asked to formally adopt the Deep Brain Stimulation Policy as agreed
      at the Specialised Commissioning Group meeting held on 16 May 2008.

Paper prepared by:

Jill Dentith, Head of Corporate Services

On behalf of:

Jan Sobieraj, Chief Executive

18 June 2008

                        NHS Sheffield is the Sheffield Primary Care Trust
                                   Friday, 16 May 2008

                                    BRIEFING PAPER


1.   As part of the programme of work to produce commissioning polices, a policy has
     been drafted to cover the commissioning of DBS for patients with movement
     disorders. The policy encompasses and endorses recommendations in
     Interventional Procedure Guidance numbers 19 and 188, issued by the National
     Institute for Health and Clinical Excellence, which concluded that DBS can be an
     effective treatment for patients with Parkinson’s disease, tremor or dystonia.

     This policy was previously considered by Yorkshire and the Humber SCG in
     November 2007. In the light of information brought to the meeting, further work on
     the treatment eligibility criteria was requested.

2.   DBS has previously been commissioned on a cost-per-case with prior approval
     basis. The treatment criteria contained in the policy express a summary of the
     patients previously considered appropriate and approved by PCTs. In addition, the
     policy reflects criteria previously included in the North Yorkshire and York PCT
     service specification. The policy, therefore, does not suggest a change to existing
     practice in terms of eligibility criteria.

3.   The policy has been reissued for consultation to Directors of Public Health and
     Directors of Commissioning across the Yorkshire and Humber area, Bassetlaw and
     Derbyshire County PCT, the Neurological Alliance, the Parkinson’s Disease
     Society, the Dystonia Society, the National Tremor Foundation and the two lead
     consultant surgeons performing DBS at the Oxford Radcliffe Hospital (Professor
     Tipu Aziz) and Newcastle General Hospital (Mr Patrick Mitchell).

4.   Responses have been received from North Yorkshire and York PCT, North
     Lincolnshire PCT, Sheffield PCT, Barnsley PCT, the Dystonia Society and
     Professor Aziz and some amendments have been made to the policy have been
     made as a result.

     North Lincolnshire PCT commented that, whilst agreeing with the policy, the PCT
     wished to maintain financial controls by retaining prior approval of DBS.

5.   The policy recommends commissioning the service only from those providers that
     meet the rigorous standards required to participate in the PDSurg trial. Sheffield
     Teaching Hospitals NHS Foundation Trust is the only provider in Yorkshire and
     Humber designated to take part in the trial. The trust only has sufficient capacity to
     perform 24 cases per year. This, combined with the fact that the proposed
     treatment criteria have been made more specific, suggests that numbers of
     patients will not increase significantly.

6.   North Yorkshire and York PCT commented that there should be more detail around
     the measurement of effectiveness of DBS, particularly in relation to the proposed
     outcome report. Treatment thresholds and outcome measures using measures of
     quality of life (QoL) and/or activities for daily living (ADL) have not yet been
     included. A range of appropriate measures is included as an appendix to the
     policy. It is recommended that further work be undertaken during the following year
     to develop these measures in detail and to put in place an annual outcome report.

7.   Given the numbers of patients involved and the distribution across the SCG, it is
     not recommended that the costs of DBS be risk shared across the full SCG.

8.   Recommendation

     SCG is requested to:
     • Recommend adoption of the DBS policy to PCT Boards.
     • Approve the continuation of the work to develop outcome measures for
       QoL/ADL and an annual outcome report.

Kim G Cox
Specialised Services Commissioning Manager
Yorkshire and the Humber SCG
16 May 2008

On behalf of:            Primary Care Trusts in the Yorkshire and Humber area

Author:                  Kim Cox
                         Specialised Services Commissioning Manager
                         Yorkshire & the Humber Specialised Commissioning
Correspondence to:       Cathy Edwards
                         Director of Yorkshire and Humber SCG
                         C/o Barnsley PCT
                         Hillder House
                         S75 2PY

Date completed:

Review Date:

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 13
                       CONTENTS                  D
ABBREVIATIONS                               3

DEFINITIONS                                 3

1   AIM OF PAPER                            4

2   MOVEMENT DISORDERS                      4

3   DEEP BRAIN STIMULATION                  6

4   REVIEW OF EVIDENCE                      6

5   SERVICE PROVIDERS                       7

6   CRITERIA FOR TREATMENT                  8


8   POLICY STATEMENT                        11


    REFERENCES                              13

                         Page 2 of 13
ABBREVIATIONS                                                                               D
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
                                               Advisory Group

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 and

Thalamotomy                    Surgical destruction of a selected part of the thalamus
                               region of the brain

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 unable    adverse effects of medication
to tolerate, maximal medical

                                        Page 3 of 13
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).



2.1.1 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

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.


2.2.1 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.

2.2.2 TREMOR 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. Severe tremor can be disabling because it affects fine movement control.
                                        Page 4 of 13 Tremor can be treated by rehabilitation and drug therapy. Appropriate treatment
        can minimise functional disability. Anti-tremor drugs occasionally reduce the amplitude, of tremor, but this does not
        always translate into functional improvement and medication may be poorly
        tolerated. 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. 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.

2.2.3 DYSTONIA 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). 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. Deep brain stimulation is one form of surgery for dystonia. Pallidotomy and
        thalamotomy are other surgical procedures that may be used. 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 5 of 13
3     DEEP BRAIN STIMULATION                                                                      D
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 condition.

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.



4.1.1 Evidence reported by NICE in Interventional Procedure Guidance no 19 showed that
      DBS results in improved motor skills, function and movement in patients with
      Parkinson’s disease1.

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 surgery


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.

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.

                                         Page 6 of 13
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 pulse generators.


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 available.
      • Continue to consider requests for DBS on a case by case basis. This option
         would perpetuate inequity and commissioners would continue to face challenging
      • 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.


5.1    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
      • 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.

                                         Page 7 of 13
6     CRITERIA FOR TREATMENT                                                                          D

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

6.1.3 All patients considered appropriate for DBS should be medically fit for surgery when
      the decision to undertake DBS is made.


6.2.1 All patients considered for DBS should: Have an established diagnosis of idiopathic Parkinson’s disease and Have no evidence of significant cognitive decline and Be in good general health and be considered to have a reasonable life expectancy
        and Have received and failed to respond adequately to, or be unable to tolerate
        appropriate medical therapy and 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   TREMOR

6.3.1 Essential Tremor (Normal Cranial Anatomy) Patients should have severe medically refractory essential tremor causing
        disability, despite the use of appropriate medical therapy. Functional disability must be severe enough to significantly compromise quality of
        life and activities of daily living as measured using an appropriate tool. Treatment of tremor should be likely to produce a functionally useful improvement
        in disability. All other medical and surgical interventions need to have been considered and

                                          Page 8 of 13
6.3.2 Cerebellar Tremor (Abnormal Cranial Anatomy)                                               D Tremor should have an established aetiology and be significantly disabling. Functional disability must be severe enough to significantly compromise quality of
        life and activities of daily living as measured using an appropriate tool. All other medical and surgical interventions need to have been considered and
        exhausted. 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 appropriately.


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 9 of 13
7     COMMISSIONING IMPLICATIONS                                                                    D
7.1   The following table shows the numbers of new patients who have been approved for
      DBS since 2004/05.
                                 2004/05          2005/06           2006/07           Total

        Barnsley                     2                   1             2                5
        Bassetlaw                    0                   0             0                0
        Bradford & Airedale          0                   1             0                1
        Calderdale                   0                   0             0                0
        Derbyshire County            0                   3             2                5
        Doncaster                    0                   0             1                1
        East Riding                  0                   0             1                1
        Hull                         1                   0             0                1
        Kirklees                     0                   1             0                1
        Leeds                        0                   2             2                4
        North East                   1                   0             1                2
        North Lincolnshire           0                   1             1                2
        North Yorkshire &            2                   2             2                6
        Rotherham                   1                0                  1                2
        Sheffield                   4                6                 6                16
        Wakefield                   1                0                 2                 3
        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.
                                         Page 10 of 13
      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.


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 adults.

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 2009 or when further significant information
      becomes available, either from clinical trials, technological development, NICE or the
      Yorkshire and Humber SCG.

                                         Page 11 of 13
Appendix 1                                                                                D
                      Appropriate Outcome Measurement Tools

Parkinson's Disease
Reduction in severity of symptoms as measured on the Unified Parkinson's Disease Rating
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 12 of 13
References                                                                               D
 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

                                     Page 13 of 13

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