STEREOTACTIC RADIOSURGERY COMMISSIONING POLICY Release Version 3.1 Date: 21 st September 2006 Author: Owner: Client: Ian Langfield, Service Group Commissioner, HCW Ian Langfield, Service Group Commissioner, HCW Simon Dean, Chief Executive HCW Document History Revision History : Revision date Previous revision date 22 nd May 2006 N/A Summary of Changes 8 th June 2006 22 nd May 2006 Following NCAB meeting, reference to SBNS working group meeting deleted. 20 th Sept 2006 8 th June 2006 Formatted to new template. Revision to specific criteria for other Intracranial tumours Changes marked No No Date of next revision May 2007 Approvals Name Date of Issue Version HCW National Commissioning Advisory Board 7 th June 2006 2 HCW Clinical Policy Group 20 th Sept 2006 3 HCW Management / Team Directors Group Distribution This document has been distributed to: Name By Date of Issue Version Cardiff and Vale NHS Trust Ian Langfield Summer 2006 3 Swansea NHS Trust Ian Langfield Summer 2006 3 Walton Centre for Neurology and Neurosurgery NHS Trust Ian Langfield Summer 2006 3 Sheffield Teaching Hospitals NHS Foundation Trust Ian Langfield Summer 2006 3 Comisiwn Iechyd Cymru (Gwasanaethau Arbenigol) Health Commission Wales (Specialist Services) Asiantaeth Weithredol Llywodraeth Cynulliad Cymru An Executive Agency of Welsh Assembly Government Page 1
Contents 1 Introduction... 3 1.1 Relationship with other Commissioning Policies... 3 1.2 HCW approach to Prioritisation... 3 1.3 Priority Given to this service... 3 1.4 Review... 4 2 Service Definition... 4 3 Commissioning Responsibility... 4 4 Service Provision... 5 4.1 Epidemiology... 5 4.2 Approach to providing services and expected outcomes... 5 4.3 Quality... 5 4.4 Performance Management... 5 4.5 Waiting Times... 5 4.6 Referral Pathway... 5 4.7 Preferred Providers... 6 5 Access Criteria... 6 5.1 Access criteria/ rationale... 6 5.2 Exclusions... 7 5.3 Exceptional circumstances and access to alternative providers... 7 Page 2
1 Introduction The purpose of this is to: clearly set out the circumstances under which patients will be able to access the services specified, clarify the referral process, indicate which organisations are able to provide a service for Welsh patients and define the criteria that patients must meet in order to be referred. In addition to provide background information to support the proposed level of access, this includes the epidemiology and anticipated outcomes. 1.1 Relationship with other Commissioning Policies This policy should be read in conjunction with the following policies: Fractionated Stereotactic Radiotherapy (in development) Interventional Neuroradiology (in development) 1.2 HCW approach to Prioritisation Health Commission Wales is responsible for commissioning a wide and diverse range of services. These include services, which are highly specialised (such as neurosurgery), and those, which are commissioned by HCW because they serve the whole of Wales (such as cervical screening). As with all other commissioners of health care services, HCW is required to make choices as to how it spends its funds in order not to overspend. The growth in demand, and the pace of development of services, means that there will always be limits on the services which HCW can commission at any given point in time. HCW needs to balance considerations such as equity, accessibility, clinical effectiveness, cost effectiveness, national policy and the delivery of Ministerial targets. A more detailed explanation of the HCW approach to prioritisation together with an explanation of the annual planning cycle is available on request. 1.3 Priority Given to this service The conditions for which patients are typically considered for Stereotactic Radiosurgery (SRS) are vascular anomalies, acoustic neuromas, and meningiomas. More recent indications include cerebral metastases and trigeminal neuralgia. Patients with vascular anomalies are all treated either by neurosurgery, sometimes by neuroradiological intervention, but for deeper inaccessible anomalies that must be treated to prevent stroke SRS is essential. Acoustic neuromas and meningiomas cannot be left untreated and the choice of modality depends on tumour size, contact with adjacent brain structures, and judgements on the relative requirements for surgery, radiotherapy or SRS. Page 3
For cerebral metastases, judgements about potential survival without treatment are an issue, and the management of pain depends on the failure of alternative treatment options including micro vascular decompression. 1.4 Review The HCW Group will review this policy annually or following the publication of relevant guidance, for example, from NICE. Date of next review May 2007. 2 Service Definition HCW is identified as the responsible commissioner for neurosurgery and other treatment modalities for key conditions in WHC (2003) 63: NHS Planning and Commissioning Guidance. is used to define a form of radiation treatment that allows the treatment of small lesions with pinpoint accuracy using three-dimensional stereotactic imaging and the delivery of multiple thin radiation beams through an arc or sphere with the target lesion as the focal point. There are two types of stereotactic radiosurgery Gamma Knife and LINAC. Both treatments are methods of radiotherapy, which aim to deliver ionising radiation to destroy cells or to alter cell function whilst minimising the risk to adjacent normal tissue. The Gamma Knife consists of 201 sources of radioactive cobalt, which are channelled into the centre of a helmet in which the patient s head is placed. LINAC uses high-energy, narrowly focused beams of x-rays that are emitted by a single source, which rotates slowly around the patient s head. Whilst gamma knife treatment requires only one treatment, LINAC based SRS may be delivered either as a single treatment or through multiple treatments (multifractionated) to increase safety and effectiveness. The decision to use single or multiple treatments using LINAC-based SRS is based on the type and location of the lesion being treated. 3 Commissioning Responsibility HCW is responsible for the funding of the patient assessment, the Stereotactic Radiosurgery procedure, postoperative care up until discharge, and the follow up and care provided by the local neurosurgical services. Page 4
4 Service Provision 4.1 Epidemiology SRS is used for a range of conditions with varying incidences. Based on historical activity it is estimated that approximately 30 to 60 patients will have conditions that are considered indications for SRS. 4.2 Approach to providing services and expected outcomes HCW propose to adopt the service specification and standards, which have been agreed as part of the designation process for SRS at Sheffield and the two London centres by SSCG and the SBNS. 4.3 Quality Providers of services should have in place: Effective clinical governance procedures Operational procedures for the use of radioactive materials which accord with statutory legislation 4.4 Performance Management HCW will be responsible for commissioning services in line with this policy. This will include agreeing appropriate information and procedures to monitor the performance of organisations. This service will be performance managed through feedback from clinicians regarding patient outcomes. 4.5 Waiting Times It is extremely critical in terms of management of patients with vascular malformations at risk of bleeding and tumours where the expansion or tumour progression is rapid. Assessment delays beyond 6 weeks are unacceptable for patients requiring SRS or FSRT as during this time the patient s condition may deteriorate to such an extent that they are no longer suitable for SRS or FSRT and consequently receive surgery, which is only partially curative. 4.6 Referral Pathway All referrals should be assessed for suitability and need for referral by consultant neurosurgeons at Cardiff and Vale NHS Trust, Swansea NHS Trust or Walton Centre for Neurology and Neurosurgery NHS Trust. The assessment pathway will include a specific referral form with electronic copies of images and clinical reports to support decision about why neurosurgery at one of the Page 5
Welsh centres is not possible and to consider whether fractionated stereotactic radiotherapy (FSRT) is possible. SRS is therefore the modality of choice only after exclusion of surgery and FSRT. 4.7 Preferred Providers 4.7.1 Criteria for Designating a Provider Health Commission Wales holds a Service Level Agreement with the National Centre for, Sheffield. The Service Level Agreement allows Health Commission Wales to monitor performance and activity, and also the quality and clinical governance standards expected from the centre. This centre has been accredited to provide services to the NHS by the SBNS and SSCG. 5 Access Criteria 5.1 Access criteria/ rationale HCW will not consider referrals for SRS unless surgery, fractionated stereotactic radiotherapy, and interventional neuroradiology have been excluded on clinical grounds by a multidisciplinary team. HCW will not consider referrals for SRS where the decision on treatment modality has been based solely on patient preference. HCW commissions for the following conditions using the specified criteria: 5.1.1 One Arteriovenous Malformations less than 4cm diameter compact nidus eloquent site 5.1.2 Cavernous Venous Malformations less than 2.5cm diameter located in surgically high risk territory brain stem, midbrain, thalamus, basal ganglia, or the patient is medically unfit for surgery 5.1.3 Acoustic Neuromas less than 3.5cm diameter no clinical signs of brainstem compression 5.1.4 Meningioma high risk site invasion of cavernous sinus, other venous sinuses, and intraventricular site. Page 6
less than 4cm diameter (less than 3.5cm in the posterior fossa) suitable shape. 5.1.5 Pituitary Adenomas not suitable for open surgery recurrent or persisting parts of adenomas following surgery extension into cavernous sinus 5.1.6 Other Intracranial Tumours single well circumscribed high or low grade tumour, recurrent or residual after surgery maximum diameter of mass less than 3.5cm Karnofsky Performance Status equal to or greater than 70% 5.2 Exclusions Referral under this policy does not cover patients with the following diagnoses: 5.2.1 Brain Metastases 5.2.2 Trigeminal Neuralgia 5.3 Exceptional circumstances and access to alternative providers In the rare or exceptional circumstances where a patient or clinician feel that the patient represents a special case then application can be made to Health Commission Wales, where the case will be considered by the Individual Commissioning Panel. The Health Commission Wales Policy for reviewing cases is available on the HCW web site. http://www.wales.gov.uk/subihealthcom/index.htm Page 7