Specialised Services Policy: CP28 Deep Brain Stimulation Document Author: Specialist Services Planning Manager for Neurosciences and Complex Conditions Executive Lead: Director of Planning Approved by: Management Group Issue Date: 14 February 2013 Review Date: February 2016 Document No: CP28 Page 1 of 23
Document History Revision History Version Revision No. date 0.2 8 th June 2006 Summary of Changes 1. Wording in section 5.2 revised 2. Chapter numbering revised Updated to version no.: 1.2 1.2 28 th September 2006 1.9 8 th July 2008 Format revised in line with standard template. 2. References to NICE clinical guidelines and interventional procedure guidelines added Policy revised following non recurrent allocation for commissioning deep brain stimulation for patients with movement affecting disorders in 2008/9 1.9 2 July 2009 Policy updated to reflect 2009/10 2.0 commissioning intentions. 2.2 07/12/12 Revisions to provider prior approval 2.3 proforma OPCS4 Codes updated Minor text ammendments 2.3 06/02/13 Inclusion of eligibility criteria for Status 2.4 Dystonia 2.4 14/02/13 Ratified by Management Group 3.0 3.0 28/06/13 New Clinical Gatekeeping arrangements for Mid, West and South Wales 4.0 Date of next revision February 2016 Consultation Name Date of Issue Version Number Wales Neurological Alliance 14/12/12 2.3 Parkinson s UK 14/12/12 2.3 Approvals Name Date of Issue Version No. HCW National Commissioning Advisory Board 07/06/06 0.2 Deep Brain Stimulation Clinical Advisory Panel 04/07/06 1.2 HCW Commissioning Business Meeting 24/06/09 1.8 HCW Management / Team Directors Group National Commissioning and Advisory Board 16/07/09 1.9 WHSSC Management Group 14/02/13 3.0 WHSSC Management Group (Chair s action) 30/09/13 4.0 Distribution this document has been distributed to Name By Date of Issue Version No. 1.8 Page 2 of 23
Policy Statement Background Summary of Access Criteria Deep Brain Stimulation (DBS) is a procedure in which stimulating electrodes are placed stereotactically into the deep structures of the brain. The electrodes are connected to an implanted pulse generator which is battery powered. Typically the electrodes are secured to the skull, and a cable tunnelled to a pulse generator situated in the front of the chest, though other positions are used. WHSSC funds DBS for the treatment of movement disorders including Parkinson s Disease, Tremor and Dystonia. Treatment for other disorders is not normally funded. Responsibilities All referrers should: Inform the patient that this treatment is not routinely funded outside the criteria in this policy Refer via the agreed gatekeeper pathway Referrers in North Wales should: Submit copies of the appropriate referral proforma (annex iii) together with copies of relevant clinic letters and clinical history, to the designated gatekeeper for North Wales Referrers in South Wales should: Submit copies of the appropriate referral proforma (annex iii) together with copies of relevant clinic letters and clinical history, to the designated gatekeeper for South Wales Following receipt of a stamped, approved letter of authorisation from the gatekeeper, make a direct referral to the neurosurgical treatment centre Clinicians considering treatment should: Discuss all alternative treatments with the patient Advise the patient of any side effect and risks of the potential treatment Inform the patient that treatment is not Page 3 of 23
routinely funded outside of the criteria in the policy. Confirm that there is contractual agreement with WHSSC for the treatment In all other circumstances submit an IPFR request. The receiving clinician at both treatment centres should: Assess the patient using the criteria as set out in annex iv). Complete and submit criteria based access form (annex iv) and submit to the WHSSC patient care team for approval through the prior approvals process. Page 4 of 23
Table of Contents 1. Aim... 6 1.1 Introduction... 6 1.2 Relationship with other Policies and Service Specifications... 6 2. Scope... 7 2.1 Definition... 7 2.2 Codes... 7 3. Access Criteria... 8 3.1 Clinical Indications... 8 3.2 Criteria for Treatment... 8 3.3 Referral Pathway... 9 3.4 Exclusions... 10 3.5 Exceptions... 11 3.6 Responsibilities... 11 4. Putting Things Right: Raising a Concern... 12 5. Equality Impact and Assessment... 13 Annex (i) Referral Pathway... 14 Annex (ii) Checklist... 15 Annex (iii) Deep Brain Stimulation Gatekeeper Referral Proforma. 17 Annex (iv) Deep Brain Stimulation Prior Approval Proforma... 20 Page 5 of 23
1. Aim 1.1 Introduction The document has been developed as the policy for the planning of Deep Brain Stimulation for Welsh patients. The policy applies to residents of all seven Health Boards in Wales. The purpose of this document is to: Set out the circumstances under which patients will be able to access Deep Brain Stimulation surgery; clarify the referral process and; define the eligibility criteria that patients must meet in order to access treatment. 1.2 Relationship with other Policies and Service Specifications This document should be read in conjunction with the following documents: All Wales Policy: Making Decisions on Individual Patient Funding Requests (IPFR) Page 6 of 23
2. Scope 1. Purpose 2.1 Definition Deep brain stimulation (DBS) is a neurosurgical intervention for the management of severe movement disorders in patients whose symptoms are resistant to medical therapy. These conditions are usually treated with drugs but 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 (on-off syndrome). DBS involves the implantation of a wire into a target area in the brain. The wire is connected to a programmable pulse generator, which is inserted under the skin of the chest wall. The pulse generator can then be switched on and off by the patient, and the pulse width, stimulation amplitude and frequency can be adjusted by medical staff to optimise the effect of the stimulation. The battery will last up to approximately 5 years, at which time the entire pulse generator has to be replaced. Rechargeable systems have now been developed, with a battery life of 10 years.. 2.2 Codes ICD-10 Codes Code Category Code Description ICD-10 G20X Parkinson s Disease ICD-10 G24 Dystonia ICD-10 G250 Essential tremor ICD-10 G35X Multiple Sclerosis OPCS 4 Codes Code Category Code Description OPCS 4 A091 Implantation of DBS OPCS 4 A095 Insertion of DBS Electrodes OPCS 4 A093 Removal of DBS OPCS 4 A092 Maintenance of DBS Page 7 of 23
3. Access Criteria 3.1 Clinical Indications The clinical indications for DBS under this policy are: Parkinson s disease Tremor Dystonia 3.2 Criteria for Treatment If the patient wishes to be referred to a provider out of the agreed pathway, an IPFR should be submitted. Replacement generators: WHSSC will fund the replacement of pulse generators on the grounds that the device is no longer functioning and that withdrawal of treatment would be to the detriment of the patient. WHSSC will fund new treatment in patients with a diagnosis of: Parkinson s Disease, Generalised Dystonia, Status Dystonicus, Laryngeal Dystonia, Cervical Dystonia, Essential or Dystonic Tremor, Mid Brain Tremor The following criteria must be met: Patients should be in good general health and be considered to have a reasonable life expectancy AND Symptoms must be severe enough to significantly compromise quality of life and the activities of daily living. Patients should not have evidence of dementia or current serious non drug related psychopathology. In addition patients with a diagnosis of Idiopathic Parkinson s disease or Essential Tremor should be poorly controlled on specialist directed best possible medical therapy. In patients with Parkinson s disease, the symptoms should continue to be dopamine responsive with the possible exclusion of tremor predominant patients. Page 8 of 23
3.3 Referral Pathway If the patient wishes to be referred to a provider out of the agreed pathway, an IPFR should be submitted. Referrals and requests for funding DBS surgery should be made by consultant neurosurgeons, consultant neurologists or consultant physicians with a special interest in Parkinson s disease. All referrals for DBS are managed through a clinical gatekeeping process. If the referring clinician believes that the patient meets the access criteria stipulated in section 3.2, they should contact the designated gatekeeper for their area as set out in the table below. The referral should be accompanied by a completed proforma (annex iii) with copies of relevant clinic letters and clinical history to support the referral. The role of the gatekeeper is to ensure that the referral meets the agreed criteria. North Wales Patients in North Wales receive DBS surgery from the Walton Centre Foundation Trust, and the referral and gatekeeping functions are undertaken as part of the wider neurology service commissioned from Trust. As part of the commissioning arrangements with the Trust, all referrals are managed within the neurology service, and subsequent to assessment against the criteria are referred as appropriate on to the movement disorders service for assessment for Deep Brain Stimulation. South Wales Patients in South Wales receive DBS surgery from the North Bristol NHS Trust. There are no commissioning arrangements in place for the neurology service provided by North Bristol NHS Trust, and therefore gatekeeping function is undertaken by a Consultant Neurologist based in the service provided by the Aneurin Bevan Health Board. If a clinician is considering a referral into the North Bristol service they must first contact the South Wales gatekeeper for approval to refer. The referring clinician must provide a copy of the appropriate referral proforma (annex iii) together with copies of relevant clinic letters and clinical history. If the referral meets the criteria, the clinical gatekeeper will approve the referral, and will provide the referrer with a stamped letter of authorisation so that the referring clinician can proceed with the referral to the treatment centre. Page 9 of 23
The North Bristol service will only accept referrals accompanied by a stamped letter of authorisation from the gatekeeper. Clinicians cannot refer directly to North Bristol NHS Trust. All Wales The receiving clinician at the both treatment centres will assess the patient using the criteria as set out in annex iv. If the patient meets the criteria, the receiving clinician at the treatment centre should complete the criteria based access form and submit to the WHSSC patient care team for approval through the prior approvals process. If the referring clinician believes that there are exceptional grounds for treatment an Individual Patient Funding Request (IPFR) can be made to WHSSC under the All Wales Policy for Making Decisions on Individual Patient Funding Requests (IPFR). Clinical gatekeeper North Wales Dr Nick Fletcher, Consultant Neurologist, Divisional Clinical Director (Neurology), Walton Centre NHS Foundation Trust, Liverpool, L9 7LJ Mid, West and South Dr Ken Dawson, Wales Consultant, Aneurin Bevan Health Board, Neville Hall Hospital, NP7 7EW Treatment Centre Walton Centre NHS Foundation Trust Aneurin Bevan Health Board If the patient wishes to be referred to a provider out of the agreed pathway, an IPFR should be submitted. 3.4 Exclusions WHSSC does not fund DBS for the following indications: Neuropathic pain OR Epilepsy OR Cluster headache OR Psychiatric disorders (e.g. severe depression, Tourette s Syndrome, eating disorders) OR Patient with evidence of dementia or current serious non drug related psychopathology. Page 10 of 23
3.5 Exceptions If the patient does not meet the criteria for treatment, but the referring clinician believes that there are exceptional grounds for treatment an Individual Patient Funding Request (IPFR) can be made to WHSS under the All Wales Policy for Making Decisions on Individual Patient Funding Requests (IPFR). If the patient wishes to be referred to a provider out of the agreed pathway, an IPFR should be submitted. Guidance on the IPFR process is available at www.whssc.wales.nhs.uk 3.6 Responsibilities Referrers should: Inform the patient that this treatment is not routinely funded outside the criteria in this policy Refer via the agreed pathway Clinician considering treatment should: Discuss all the alternative treatment with the patient Advise the patient of any side effect and risks of the potential treatment Inform the patient that treatment is not routinely funded outside of the criteria in the policy. Confirm that there is contractual agreement with WHSSC for the treatment In all other circumstances submit an IPFR. Page 11 of 23
4. Putting Things Right: Raising a Concern Whilst every effort has been made to ensure that decisions made under this policy are robust and appropriate for the patient group, it is acknowledged that there may be occasions when the patient or their representative are not happy with decisions made or the treatment provided. The patient or their representative should be guided by the clinician, or the member of NHS staff with whom the concern is raised, to the appropriate arrangements for management of their concern: When a patient or their representative is unhappy with the decision that the patient does not meet the criteria for treatment further information can be provided demonstrating exceptionality. The request will then be considered by the All Wales IPFR Panel. If the patient or their representative is not happy with the decision of the All Wales IPFR Panel the patient and/or their representative has a right to ask for this decision to be reviewed. The grounds for the review, which are detailed in the All Wales Policy: Making Decisions on Individual Patient Funding Requests (IPFR), must be clearly stated. The review should be undertaken, by the patient's Local Health Board; When a patient or their representative is unhappy with the care provided during the treatment or the clinical decision to withdraw treatment provided under this policy, the patient and/or their representative should be guided to the LHB for NHS Putting Things Right. For services provided outside NHS Wales the patient or their representative should be guided to the NHS Trust Concerns Procedure, with a copy of the concern being sent to WHSSC. Page 12 of 23
5. Equality Impact and Assessment The Equality Impact Assessment (EQIA) process has been developed to help promote fair and equal treatment in the delivery of health services. It aims to enable Welsh Health Specialised Services Committee to identify and eliminate detrimental treatment caused by the adverse impact of health service policies upon groups and individuals for reasons of race, gender re-assignment, disability, sex, sexual orientation, age, religion and belief, marriage and civil partnership, pregnancy and maternity and language (welsh). This policy has been subjected to an Equality Impact Assessment. The Assessment has shown that there will be positive impact on the individuals with disability arising from a movement disorder. Page 13 of 23
Annex (i) Referral Pathway Referral Pathway Consultant with recognised subspecialty interest directed request for DBS Does patient require referral for DBS No End Yes Request assessed by Clinical Gatekeeper Does request meet commissioning policy No Referral returned to referring clinicians End Yes Is Patient likely to benefit from procedure No Referral returned to referring clinician End Yes Referring clinician notified that referral meets criteria and authorised to proceed with referral to the treatment centre Referring clinician refers to treatment centre with copy of authorisation from Clinical Gatekeeper Page 14 of 23
Annex (ii) Checklist CP28 Deep Brain Stimulation The following checklist should be completed and retained as evidence of policy compliance by the receiving centre. It is expected that this evidence will be provided at the point of invoicing by the receiving centre. i) Patient meets criteria but contracted exclusion requiring prior approval. ii) Patient does not meet criteria, in which there needs to be an IPFR Form completed. iii) Patient meets criteria but wishes to be referred to a non contracted provider. iv) Where patient meets criteria, procedure is included in the contract and is received by the treating centre, and for audit. Page 15 of 23
To be completed by the referring gatekeeper or treating clinician The following checklist should be completed for all patients to whom the policy applies, before treatment, by the responsible clinician. Please complete the appropriate boxes: Patient NHS No: Patient is Welsh Resident Patient is English Resident registered with NHS Wales GP Post Code: GP Code: Patient meets following access criteria for referral for assessment for DBS surgery: Patients should be in good general health and be considered to have a reasonable life expectancy AND Symptoms must be severe enough to significantly compromise quality of life and the activities of daily living. AND Patients should not have evidence of dementia or current serious non drug related psychopathology. Patient wishes to be referred to non-contracted provider If the patient wishes to be referred to a non-contracted provider an Individual Patient Funding Request (IPFR) must be completed and submitted to WHSSC for approval prior to treatment. The form must clearly demonstrate why funding should be provided on the basis of exceptionality. The form can be found at http://www.wales.nhs.uk/sites3/docopen.cfm?orgid=898&id=181 455 Patient does not meet access criteria but is exceptional An Individual Patient Funding Request (IPFR) must be completed and submitted to WHSSC for approval prior to treatment. The form must clearly demonstrate why funding should be provided as an exception. The form can be found at http://www.wales.nhs.uk/sites3/docopen.cfm?orgid=898&id=181 455 Yes No Name: Designation: Signature: Date: Authorised by TRM Gatekeeper Authorised by Patient Care Team? Authorised by Agreed Other? (Please state) Patient care Team/IPFR TRM Reference number: Name (printed): Signature: Date: Yes No Page 16 of 23
Annex (iii) Deep Brain Stimulation Gatekeeper Referral Proforma Patient Medical History Pro Forma 1. Patient initials: 2. Date of Birth: 3. Gender: 4. Postcode: 5. NHS No: 6. Diagnosis 7. Summary of History Relevant Medical History General Health (physical and mental) Page 17 of 23
Current medication Degree of symptom control on current medication Page 18 of 23
Impact of condition on activities of daily living and quality of life Signed. Name... Date../../ Please return this form together with copies of relevant clinic letters and clinical history to: Clinical Gatekeeper Page 19 of 23
Annex (iv) Deep Brain Stimulation Prior Approval Proforma Patient Medical History Pro Forma 1. Patient initials: 2. Date of Birth: 3. Gender: 4. Postcode: 5. NHS No: Please tick the boxes and sign to confirm the patient meets the appropriate criteria for their specific clinical presentation. General Parkinson s Disease The following criteria should be met: Generalised Dystonia The following criteria should be met: The patient is fit to undergo DBS surgery under general anaesthesia with no contra-indications for surgery (e.g. sepsis/coagulopathy) Be considered to have a life expectancy of 5 or more years as assessed by a detailed medical history and post liaison with other professionals An established diagnosis of Parkinson s Disease as assessed by the UK Parkinson s Disease Society Brain Bank Criteria Have symptoms of motor complications severe enough to significantly compromise function and quality of life -on/off fluctuations; L-dopa induced dyskinesias or medication resistant functionally impairing tremor. All other medical and surgical interventions have been considered and exhausted or are not felt to be applicable Patient is free from clinically significant cognitive impairment An established clinical diagnosis of generalised Dystonia as determined by a consultant neurologist Please tick one of the two options The generalised dystonia is felt to be primary The generalised dystonia is felt to be secondary AND Exhibits focal or generalised dystonia of sufficient severity to compromise quality of life The dystonia is the primary cause of the disability There are no significant postural defects or significant fixed joint deformities Has had a 2 month trial of appropriate dose levodopa to exclude dopa responsive dystonia or not felt to be clinically indicated. Page 20 of 23
All other medical and surgical interventions have been considered and exhausted. In the case of medical interventions dystonia will have been shown to be refractory to the use of tolerated or applicable best medical therapy (BMT) post assessment by a movement disorder consultant neurologist A diagnosis of psychogenic dystonia should have been considered and excluded as far as clinically possible. Status Dystonia The following criteria should be met: Laryngeal Dystonia The following criteria should be met: Please tick one or more of the following four boxes: Did not have had an adequate response to botulinum toxin treatment Failed to tolerate botulinum toxin treatment Requires such large or frequent treatments with botulinum toxin as to make such treatment impractical Unsuitable for botulinum toxin treatment. Patient is seen by a consultant neurologist (paediatric) and neurosurgeon to arrive at final decision. Patient has severe and frequent episodes of generalised dystonia which require urgent hospital admission with or without systemic complications (e.g. respiratory or renal compromise, rhabdomyoysis) Presence of an established diagnosis for the underlying disease resulting in status for example primary / secondary dystonia and a cause for secondary if possible. Any underlying trigger for the status dystonicus has been identified and treated if this is possible. Patient s condition is refractory to medical management which includes sedation, muscle relaxation and supportive treatment. Patient is fit to undergo deep brain stimulation surgery under general anaesthesia without contra-indication to DBS surgery (significant brain atropy or pathology in anatomical area targeted for dystonia) 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 threatening. Page 21 of 23
Cervical Dystonia The following criteria should be met: Essential or Dystonic Tremor The following criteria should be met: An established diagnosis of cervical dystonia as determined by a consultant neurologist The patient is fit to undergo DBS surgery under general anaesthesia (which is assessed by an anaesthetic opinion) with no contra-indications for surgery (e.g. sepsis/coagulopathy). Exhibits cervical dystonia of sufficient severity to compromise quality of life The dystonia is the primary cause of the disability There are no significant postural defects or significant fixed joint deformities Please tick one or more of the following four boxes: Did not have had an adequate response to botulinum toxin treatment Failed to tolerate botulinum toxin treatment Requires such large or frequent treatments with botulinum toxin as to make such treatment impractical Unsuitable for botulinum toxin treatment. An established diagnosis of essential tremor or dystonic tremor as determined by a consultant neurologist Tremor sufficient to significantly impair activities of daily living to an extent that impairs quality of life The patient is fit to under DBS surgery under general anaesthesia (assessed by an anaesthetic opinion) with no contra-indications for surgery (e.g. sepsis/ coagulopathy) All other medical and surgical interventions have been considered and exhausted or are not felt to be applicable post assessment by a movement disorder consultant neurologist in a functional neurosurgery for movement disorders team. Treatment of tremor is likely to produce a functionally useful improvement in disability. For Essential Tremor please tick the following four boxes if able. Beta blockers have been tried and failed or not tolerated or not applicable Primidone has been tried and failed or not tolerated or not applicable Gabapentin has been tried and failed or not tolerated or not applicable Topirimate has been tried and failed or not tolerated or not applicable For Dystonic Tremor please tick the following box Page 22 of 23
Mid Brain Tremor The following criteria should be met: if able. Anti cholinergics have been tried and failed or not tolerated or not applicable An established diagnosis of mid brain tremor as determined by a consultant neurologist Mid brain tremor should have an established aetiology and be severe enough to significantly compromise quality of life and performance of activities of daily living The patient is fit to under DBS surgery under general anaesthesia (by anaesthetic opinion) with no contraindications for surgery (e.g. sepsis/coagulopathy). All other medical and surgical interventions have been considered and exhausted or are not felt to be applicable post assessment by a movement disorder consultant neurologist Medication should have been tried and failed, or not tolerated or applicable. An MRI has been performed which does not demonstrate pathological involvement /destruction of the target site for DBS. Please tick one of the below two boxes The underlying diagnosis is multiple sclerosis (MS) and the predominant functional impairment is felt to be due to tremor rather than ataxia plus there is not sufficient spasticity, weakness, numbness or proprioceptive loss to prevent a return of function if tremor is removed. OR The underlying diagnosis is infarction and there is not sufficient spasticity, weakness, numbness or proprioceptive loss to prevent a return of function if tremor is removed. Signed. Name... Date../../.. Please return this form to: Patient Care Team, Welsh Health Specialised Services Committee, Unit 3a, Caerphilly Business Park, Van Road Caerphilly, CF83 3ED Page 23 of 23