Specialised Services Policy: CP22 Document Author: Assistant Director of Planning Executive Lead: Director of Planning ad Performance Approved by: Management Group Issue Date: 01 July 2015 Review Date: July 2018 Document No: CP22 Page 1 of 15
Document History Revision History Version No. Revision date Summary of Changes Updated to version no.: 10/02/14 Incorporation of core components from evidence 0.1 appraisal. 0.1 Updated following consultation 0.2 0.2 25/06/15 Approved by Management Group 1.0 Date of next revision July 2018 Consultation Name Date of Issue Version Number Stakeholders 17/11/2014 0.1 Management Group 25/06/2015 0.2 Approvals Name Date of Issue Version No. Management Group 01/07/2016 1.0 Page 2 of 15
Policy Statement Background Statement (SRS) 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. SRS aims to destroy cells or to alter cell function whilst minimising the risk to adjacent normal tissue. It can be used to treat a range of conditions, including various types of tumour and vascular anomalies. WHSSC funds SRS for a range of conditions including vascular abnormalities and tumours according to the specific criteria set out in section 3.2 (criteria for treatment) and 3.4 of this policy. WHSSC will not consider referrals for SRS surgery unless, fractionated stereotactic radiotherapy, and interventional neuroradiology have been excluded on clinical grounds by a multidisciplinary team. WHSSC will not consider referrals for SRS where the decision on treatment modality has been based solely on patient preference. WHSSC funds SRS for the following conditions and specified criteria: One Arteriovenous Malformations less than 4cm diameter compact nidus eloquent site 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 Acoustic Neuromas less than 3.5cm diameter no clinical signs of brainstem compression Meningioma Page 3 of 15
high risk site invasion of cavernous sinus, other venous sinuses, and intraventricular site. less than 4cm diameter (less than 3.5cm in the posterior fossa) suitable shape. Pituitary Adenomas not suitable for open surgery recurrent or persisting parts of adenomas following surgery extension into cavernous sinus 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% Cerebral Metastases Diagnosis of cancer must be established and there must be absent or controllable primary disease. Primary cancer and single cerebral metastasis confirmed by MRI or CT Karnofsky Performance Status equal to or greater than 70% Pressure symptoms which would be best relieved by surgery are excluded. Pre-treatment scans must not show a tumour volume of more than 20cc. This will usually mean that no individual tumour has a diameter in excess of 3cm. Responsibilities Clinicians wishing to refer patients for SRS should refer through the tertiary referral management arrangements at the designated neurosurgery centres. 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 Page 4 of 15
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 request. For North Wales, all referrals should be submitted to the neurosurgical service at the Walton Centre Foundation NHS Trust. For South Wales, all referrals should be submitted to the neurosurgical service at Cardiff and Vale University Health Board. Page 5 of 15
Table of Contents 1. Aim... 7 1.1 Introduction... 7 1.2 Relationship with other Policies and Service Specifications... 7 2. Scope... 7 2.1 Definition... 7 2.2 Codes... 8 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... 10 3.6 Responsibilities... 11 4. Putting Things Right: Raising a Concern... 11 5. Equality Impact and Assessment... 12 Annex (i)... 14 Page 6 of 15
1. Aim 1.1 Introduction The document has been developed as the policy for the planning of 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 services; clarify the referral process and; define the 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) 2. Scope 1. Purpose 2.1 Definition is used to define a form of radiation treatment that allows the treatment of small lesions with pinpoint accuracy using threedimensional 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. Page 7 of 15
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. 2.2 Codes OPCS 4 Codes Code Category Code Description OPCS 4 A03% Stereotactic ablation of tissue of brain 3. Access Criteria 3.1 Clinical Indications 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 may be treated either by neurosurgery or by neuroradiological intervention. For deeper inaccessible anomalies that must be treated to prevent stroke, SRS is essential. Acoustic neuromas and meningiomas cannot be left untreated. The choice of treatment modality depends on tumour size, contact with adjacent brain structures and judgements on the relative requirements for surgery, standard radiotherapy or SRS. 3.2 Criteria for Treatment WHSSC will not consider referrals for SRS unless surgery, fractionated stereotactic radiotherapy, and interventional neuroradiology have been excluded on clinical grounds by a multidisciplinary team. WHSSC will not consider referrals for SRS where the decision on treatment modality has been based solely on patient preference. WHSSC funds SRS for the following conditions and specified criteria: Arteriovenous Malformations less than 4cm diameter compact nidus eloquent site Page 8 of 15
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 Acoustic Neuromas less than 3.5cm diameter no clinical signs of brainstem compression Meningioma high risk site invasion of cavernous sinus, other venous sinuses, and intraventricular site. less than 4cm diameter (less than 3.5cm in the posterior fossa) suitable shape. Pituitary Adenomas not suitable for open surgery recurrent or persisting parts of adenomas following surgery extension into cavernous sinus 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% Cerebral Metastases Diagnosis of cancer must be established and there must be absent or controllable primary disease. Primary cancer and single cerebral metastasis confirmed by MRI or CT Karnofsky Performance Status equal to or greater than 70% Pressure symptoms which would be best relieved by surgery are excluded. Pre-treatment scans must not show a tumour volume of more than 20cc. This will usually mean that no individual tumour has a diameter in excess of 3cm. 3.3 Referral Pathway WHSSC commissions SRS through its contracts with the National Centre for, Sheffield Teaching Hospitals NHS Foundation Trust, and the Walton Centre NHS Foundation Trust. Page 9 of 15
All referrals should be assessed for suitability and need for referral by consultant neurosurgeons at Cardiff and Vale University Health Board or Walton Centre NHS Foundation Trust. Referral should be initially to the local neuro-science multi disciplinary teams (MDT) at Cardiff and Vale University Health Board or Walton Centre NHS Foundation Trust. The MDT will make the decision on the appropriateness of onward referral to an agreed SRS centre/mdt, and where appropriate a referral will be made. The selection of patients for SRS/SRT must be made by an MDT with an understanding of the systemic and neurological disease processes and must include consideration of surgical treatment if appropriate. All patients being considered for SRS /SRT must also be discussed by the specialist MDT at the stereotactic treatment centre and must have both specialist neurosurgery and specialist oncology input. The MDT must confirm that the patient s life expectancy from extracranial disease is expected to be greater than 6 months; SRS/SRT must be recommended with the collective agreement of the MDT to ensure that the criteria regarding systemic disease and prognosis are fulfilled and that there is clarity about the place of SRS/SRT in the patient s overall management plan. 3.4 Exclusions In exceptional circumstances, where the referring clinicians believe a patient represents a special case, an application may be made for consideration of individual patient funding in accordance with the All Wales Policy for Making Decisions on Individual Patient Funding Requests. WHSSC does not commission SRS /SRT for the treatment of: Cerebral Metastases for patients with: Karnofsky Performance Status (KPS) <70; or Estimated survival less than 6 months. Trigeminal Neuralgia 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 Page 10 of 15
3.6 Responsibilities Clinicians wishing to refer patients for SRS should refer through the tertiary referral management arrangements at the designated neurosurgery centres. 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 request. For North Wales, all referrals should be submitted to the neurosurgical service at the Walton Centre Foundation NHS Trust. For South Wales, all referrals should be submitted to the neurosurgical service at Cardiff and Vale University Health Board. 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 Individual Patient Funding Request Panel. The request will normally be made by the patient s GP or Hospital Consultant in writing. A patient information leaflet is available via the following link, which explains Page 11 of 15
the process http://www.wales.nhs.uk/sites3/page.cfm?orgid=898&pid=59092. The leaflet also explains how to make a complaint. 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 http://www.wales.nhs.uk/sites3/home.cfm?orgid=932for 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 the Welsh Health Specialised Service Committee. 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) http://www.wales.nhs.uk/sitesplus/documents/867/all%20wales% 20NHS%20IPFR%20Policy.pdf, must be clearly stated. The Local Health Board (LHB) in which the patient is resident should undertake the review. 5. Equality Impact and Assessment The Equality Act 2010 places a positive duty on public authorities to promote equality for nine protected groups 1 and to demonstrate how they pay due regard to equality when carrying out their functions and activities. In the context of this work, health organisations are required to pay due regard to promoting equality when they are designing and/or reviewing policies and services. In the context of this work, the commissioning and procurement of services is viewed as a public function. WHSCC is therefore required to pay due regard to equality when procuring and commissioning services. There is a specific duty to assess the relevance and impact of this Policy on equality and human rights and to ensure that as far as possible, in the delivery the SRS service across Wales, the opportunities for promoting equality, human rights and the Welsh language are maximised and negative impact is eliminated or minimised. 1 Race; Sex; Gender Re-assignment; Disability; Religion, belief/non belief; Sexual orientation; Age; Pregnancy and Maternity and Marriage and Civil Partnerships Page 12 of 15
This policy has been subjected to consultation with stakeholders, and no evidence has been highlighted to suggest that this Policy has a negative effect on the Equality Act. Page 13 of 15
Annex (i) North Wales Referral to Neurosurgery Service at WCFT Consultant MDT decision to refer for SRS No: Return to referrer for alternative treatment Gatekeeper Decision: Is the referral consistent to the policy? Yes Gatekeeper authorises referral to WCFT Page 14 of 15
South Wales Referral to Neurosurgery Service at UHW Consultant MDT decision to refer for SRS No: Return to referrer for alternative treatment Gatekeeper Decision: Is the referral consistent to the policy? Yes Gatekeeper authorises referral to Velindre Cancer Centre /National SRS Centre, Sheffield Page 15 of 15