Agenda Item 12 Title of the Committee Paper Lymphovenous Anastamosis (LVA) for the treatment of primary and secondary lymphoedema Commissioning Policy and Service Specification Executive Lead: Medical Director Author: Specialised Planner North Wales Contact Details for further information: Mrs Kamala Williams, Specialised Planner E-mail: Kamala.williams@Wales.nhs.uk Telephone: 01352 803340 Purpose of the Committee Paper To provide the WHSSC with an update on the LVA development; To summarise the feedback received and resultant amendments made to the Commissioning Policy and Services Specification following the formal consultation exercise; and To seek WHSSC approval to implement the Commissioning Policy and Service Specification. / Committee Resolution (insert ) to: APPROVE ENDORSE SUPPORT NOTE Recommendation Members are asked to : NOTE the contents of the report; NOTE the results of the formal consultation on the LVA Clinical Commissioning Policy and Service Specification and the resultant amendments made to both documents; APPROVE the LVA Clinical Commissioning Policy and Service Specification with immediate effect enabling the surgical service to commence on the 1 st September 2015; SUPPORT further work with ABMUHB to agree implementation, delivery and Page 1 of 8
performance management arrangements for the LVA service. Governance Link to WHSSC Strategic Objective(s) Link to Integrated Commissioning Plan Supporting evidence This report aligns with WHSSC s strategic objectives. The development of a LVA service is included in the WHSSC 2015/16 IMPTP. A business case has been received from the Lymphoedema Network Wales, IMPTP ref:bco28 Lymphoedema Network Wales Business Case, Curing Lymphoedema through Technology Programme Brief The Commissioning Policy and Service Specification are included in Annex 1 Engagement Who has been involved in this work? Lymphoedema Network Wales, Public Health Wales Project Management Unit, ABMUHB Plastic Surgery Department Clinical and Operational staff, WHSSC Planning and Medical Directorate. Formal consultation on the policy and specification concluded on 17 th June 2015. The parties listed below were invited to participate in the consultation: All members of the Management Group All members of the WHSSC Cancer and Blood Programme Team WHSSC Clinical Evidence and Evaluation Group Expert Clinicians in Wales All Wales Medical Directors Curing Lymphoedema though Technology Programme Board ABMUHB Finance Director Expert clinicians in Wales This paper has been considered and supported by: Finance X Clinical Evidence Evaluation Group Programme Team Х Executive Board Management Group Joint Committee Х Other Х Commissioner Health Board affected Page 2 of 8
Abertawe Bro Morgannwg Aneurin Bevan Betsi Cadwaladr Cardiff and Vale Cwm Taf Hwyel Dda Powys Provider Health Board affected Abertawe Bro Morgannwg Aneurin Bevan Х Betsi Cadwaladr Х Cardiff and Vale Х Cwm Taf Х Hwyel Dda Х Powys Х Summarise the Impact of the Committee Paper Equality and diversity Legal implications Population Health Quality, Safety & Patient Experience An EQUIA has been completed. N/A Under this development LVA treatment will be available to patients across Wales that suffer from mild to moderate primary or secondary lymphoedema and who fulfil the eligibility criteria specified in Commissioning Policy CP087b. Implementation of the clinical commissioning policy and service specification will ensure that a consistent, high quality LVA service is provided. Resources Risks and Assurance Standards for Health Services Workforce The policy includes clear access criteria, quality measures and arrangements for audit and evaluation. The Business Case identified the costs of the surgical element of the LVA service at 0.188m per annum. WHSSC has proposed that in year 1 costs of the service should be allocated against the plastic surgery element of the ABMUHB SLA under the current agreed contractual terms, see letter in Annex 2. Activity and waiting lists associated with the LVA service are to be separately reported and there is agreement with ABMUHB that action will undertaken should demand increase beyond the capacity available i.e. 42 surgical cases p.a. This paper links to the following Standards for Health: 5. Care Planning and Provision N/A Page 3 of 8
LYMPHOVENOUS ANASTAMOSIS (LVA) FOR THE TREATMENT OF PRIMARY AND SECONDARY LYMPHOEDEMA COMMISSIONING POLICY AND SERVICE SPECIFICATION 1. SITUATION / PURPOSE OF REPORT The Management Group supported the policy and service specification at it s meeting on 25 June 2015. Given the discussions at the last meeting of the and subsequent correspondence, the policy and service specification is attached for approval. The are asked to approve the LVA Commissioning Policy and Service Specification, Annex (i). 2. BACKGROUND / INTRODUCTION The Curing Lymphoedema through Innovation and Technology Programme (CLP) developed a business case to establish an all Wales super-micro surgery service for the treatment of patients with primary and secondary lymphoedema. The Welsh Chief Executive s Peer Review Group requested that WHSSC consider as a specialist service development and consequently the business case has been included in the WHSSC 2015-2018 IMTP. Lymphoedema is a chronic condition currently affecting around 9,000 people in Wales. Symptoms include gross swelling mainly affecting the limbs, pain and decreased mobility. Patients have a 29% risk of developing cellulitis infections, which can lead to A&E attendances, inpatient admissions and necessitate antibiotic treatment. Quality of life is negatively affected with up to 80% of sufferers unable to continue their normal employment. Treatment of symptoms include skin care, exercise, massage and compression either multilayer bandages or garments. Compression garments need to be worn daily, for a minimum of 12-23 hours, for the whole of the patient s life. Lymphovenous Anastamosis (LVA) is a super micro surgical technique, which is potentially curative for a sub set of lymphoedema patients. Assessment of suitable patients utilises new technology to detect lymphatic flow using in real time infra red permitting the identification of potential anastomosis between non functioning lymphatics, which can be reconnected to a functioning vein using super-micro surgical techniques. Page 4 of 8
3. ASSESSMENT / GOVERNANCE AND RISK ISSUES 3.1 Ministerial support The Minister has taken a personal interest in the development of a LVA service for Wales and receives regular briefings on the Programme s progress. The Minister has cited the development of the service as a prime example of prudent healthcare in action. The capital funding for the development has already been secure following a successful bid to the Health Technology Fund and funding support from the third sector. 3.2 Evidence evaluation WHSSC completed an evidence evaluation of LVA in August 2014. The evaluation concluded that whilst in overall terms the GRADE of available evidence was poor, due to the majority of studies being of case series type, the data appeared to provide evidence of consistent quantitative improvements postoperatively with a relatively wide safety margin. The Prioritisation Panel considered LVA in February 2015 and the development did not score highly relative to the other schemes considered. In light of the issues outlined in 3.1 WHSSC put a proposal to ABMUHB to deliver the service within existing resources for year 1. 3.3 Funding implications WHSSC has proposed that in year 1 costs of the service should be allocated against the plastic surgery element of the provider Service Level Agreement (SLA). The plastic surgery element of the SLA has not achieved baseline activity for a number of years resulting in financial underperformance. ABMUHB (the Provider) has confirmed that the financial and contractual arrangements for the LVA development should not result in any additional financial liability for commissioners above planned levels in 2015/16. 3.4 Impact on Referral to Treatment (RTT) ABMUHB has advised that the capacity requirements for the LVA service will be established over and above the baseline plastic surgery capacity outlined in the Health Board s delivery plan for plastic surgery RTT i.e. Page 5 of 8
the consultant sessions required for LVA will be over and above the sessions for delivery of the plastic surgery service. 3.5 Implementation, delivery and Performance Management of the service Work is ongoing between WHSSC and ABMUHB to agree implementation, delivery and performance management arrangements for the service. 4.0 FEEDBACK FROM CONSULTATION EXERCISE Responses were received from BCUHB, CTUHB and the National Clinical Lead for Lymphoedema services. The response from the National Clinical Lead was received after the consultation had concluded. Members of the Management Group were provided with a verbal update summarising the comments from the National Lead/subsequent amendments to the policy at the meeting on the 25 th June 2015. 4.1 Betsi Cadwaladr University Health Board (BCUHB) response Challenge location of the surgical service in Swansea and impact on access to the service for North Wales patients. NHS Wales, Specialised Commissioning advice - LVA surgery is currently only available at 3 other NHS providers: The Royal Marsden; Nuffield Hospital - Oxford University Hospitals NHST and Broomfield Hospital - Mid Essex Hospitals NHST. At present there is no service available in the North/North West. Screening to identify eligible patients will be undertaken locally using the TENOVUS mobile screening unit. 4.2 Cwm Taf University Health Board (CTUHB) response CTHB response 1. The service specification and access criteria are too wide, given this is for mild to moderate lymphoedema. NHS Wales, Specialised Commissioning advice NOTED - Access criteria will result in the selection of a small sub set of patient with mild to moderate lymphoedema (see commissioning policy CP870b inclusion criteria sections 3.1.1-3.1.2 and exclusion criteria section 3.1.3). Access criteria will be subject to review as part of the agreed evaluation process. Page 6 of 8
2. We do not think there should be direct access from GPs or from therapists (physios), other than the lymphoedema therapists. 3. This will raise expectations and end up creating a waiting list as 42 is a very small number. 4. This service needs to interface with the local lymphoedema service and they should be the only ones to refer to ABMU and each LHB should nominate a gatekeeper from within each LHB Lymphoedema team, who will assess against the criteria and only refer if met. 5. Evidence evaluation did not include children. Treatment should be restricted to adults only. 6. The cost needs to be agreed at the price of the existing plastics contract and contained within the existing contract envelope. 7. We would want to look at the risk share arrangement to ensure there is no halo effect of being within ABMU. 8. We would want to look and either retrospective audit or prior approval of cases. If retrospective audit payment will be with held for any cases which do not fulfil the audit criteria. AGREED policy and specification have been amended in light of comment (see, flow diagram Annex A of policy) NOTED - Advice provided by Programme is that the modelling suggests that the eligibility criteria will constrain the number of eligible patients to circa 42 cases p.a. ABMUHB have agreed that the activity and waiting list relating to LVA will be reported separately and action will be taken if it appears that the 42 cases p.a. will be exceeded. AGREED policy and specification have been amended in light of comment (see, flow diagram Annex A of policy). AGREED Policy amended to remove paediatric access criteria. Access criteria will be subject to review as part of the agreed evaluation process As per WHSSC proposal. ONGOING discussion between ABMUHB and WHSSC Director of Finance to resolve. ONGOING - WHSSC and Clinical Lead for National Lymphoedema service discussing arrangements for prior approval. Page 7 of 8
4.3 National Clinical Lead for Lymphoedema Correction of frequency of follow up to include 36 months, 48 and 60 months; Confirmation that surgical service will be delivered at Neath Port Talbot Hospital; and Clarification that service will be delivered in line with nationally agreed RTT targets. 5. RECOMMENDATIONS Members are asked to : NOTE the contents of the report; NOTE the results of the formal consultation on the LVA Clinical Commissioning Policy and Service Specification and resultant amendments made to both documents; APPROVE the LVA clinical commissioning policy and service specification with immediate effect enabling the surgical service to commence on the 1 st September 2015; SUPPORT further work with ABMUHB to agree implementation, delivery and performance management arrangements for the LVA service. Page 8 of 8