Service Breast Cancer Services Commissioner Lead Name Provider Lead Name Integrated Cancer System Period 2012/2013 Date of Review Annually 1. Purpose of Service 1.1 Aims and objectives of service The overall aim of the service is “to improve cancer outcomes through seamlessly delivered pathways, providing high quality care to patients with breast cancer throughout their journey”. The service will have the following objectives: Enhance the management of patients within the system, and actively manage the demand for secondary care and follow-up services ensuring patients have speedy access to appropriate treatment. Reduce variation in access to and experience of care through consistent application of best practice. Improve the patient experience. Provide clinical assessment and treatment within an Integrated Cancer System. Monitor and review agreed models of care and pathways for breast cancer patients across the Integrated Cancer Systems. 1.2 Whole pathway commissioning Improving cancer outcomes through seamlessly delivered pathways that run from prevention through to end of life care remains an important vision for commissioning cancer. It is important, therefore, that cancer site specific pathways are collaboratively commissioned and delivered by providers working in partnership in an integrated system. This requirement is covered in Schedule 20 of the NHS Contract. The nature of the disease and its treatment means that there will be a plurality of providers. This approach ensures that all parties, commissioners, service users and providers recognise the whole patient pathway, the duty for partnership working and the need for seamless care across organisational boundaries. The ICS pathway groups will be responsible for managing the whole pathway, agreeing the approach to delivering clinical best practice pathways, and providing clinical leadership to coordinate delivery across the Integrated Cancer Systems. 2. Scope The service specification covers both early and locally advanced disease and advanced disease and covers the patient pathway from point of referral to follow – up / end of life care. 1 of 10 Specifications for prophylactic surgery pathways and for benign disease patients are out of scope. The service description does not cover emergency presentations based on the assumption that Acute Oncology Services (AOS) will pick up this cohort of patients. Providers will have in place co-morbidity assessment pathways to all relevant specialities that demonstrate minimised pathway delay. Co-morbidity pathways are not covered in the service description. 3. Service description – early and locally advanced breast cancer 3.1 Service model - general The required service model is outlined in the clinically effective pathway on map of medicine. In addition to this specification, there are a number of other criteria set out in NICE guidance that must be met by any provider offering services for breast cancer patients. Different elements of the cancer treatment might be delivered on different provider sites. There are a number of criteria that must be met by any provider offering services for breast cancer patients ensuring high quality cost effective care and in accordance with NICE Guidance. Ref. Appendix 1 Commissioning best practice pathway for early and locally advanced breast cancer Ref.1-3. Presentation ICSs are required to meet the national average for presentation through screening (21%) Ref.4 Referral Referral processes are required to follow the current NICE guidelines for breast cancer symptoms ensuring that all patients are seen within 14 days of the referral. Patients diagnosed though the national screening programme are required to be referred onto the breast cancer service for further assessment, and treatment must commence within the 62 day deadline specified in the cancer waiting time targets for an urgent referral. This is calculated from the date of the decision to refer for assessment. Ref.5 Triple assessment All patients who require triple assessment should have a consultation and clinical examination, mammography and/or ultrasound, and core biopsy/fine needle aspiration cytology. There should be a risk stratification approach to triple assessment so only those patients requiring all three assessments undergo them and these should be provided on the same day. Ref.7 Multidisciplinary team (MDT) NICE guidance states that MDTs should see 100 new cancer cases p.a., 30 of which should 2 of 10 be screening cases. If caseloads are large enough then there should be separate MDTs for screening, symptomatic, and advanced disease. The MDT should record disease staging and percentage of new patients entered into clinical trials. The MDT should also ensure that the results of ER and HER2 assessments are available and recorded at the MDT meeting to inform decisions about systemic treatment. ICSs should ensure that all MDTs are given a central role in coordinating patient care. The age of the patient should not be a deciding factor for the treatment plan by the clinical team. The fitness of the patient and the presence or otherwise of co-morbidities is of far greater importance when making treatment recommendations. The issues of patient fitness and co-morbidities should become a routine part of the multidisciplinary team discussion. The MDT should record disease staging based on diagnostic and staging tests before surgery, and correct this if necessary after surgery and pathological analysis of the specimen. The breast IOG states a recommended minimum volume of 30 procedures per surgeon per year.1 As multidisciplinary teams should not rely solely on one surgeon, each multidisciplinary team should be advising at least 60 procedures a year. Ref.6 Staging tests NICE guidance sets out a selective approach to undertaking staging tests. Only if staging is not clear, should patients be offered an MRI. PET-CT should only be used to make a new diagnosis of metastases, if there is suspicious imaging. Pre-treatment ultrasound evaluation of the axilla should be performed for all patients being investigated for early invasive breast cancer and, if abnormal lymph nodes are identified, ultrasound-guided needle sampling should be offered. Ref.8 Second outpatient Patients should attend two outpatient appointments pre-surgery unless further appointments are clinically required. Patients requiring more psychological support and reassurance may warrant several pre-op outpatient appointments. A holistic needs assessment should be undertaken whereby the patient should have an agreed, written care plan, recorded by a named healthcare professional (or professionals), with a copy sent to the GP and a personal copy given to the patient. All patients should be assigned to a named breast care nurse specialist and be offered prompt access to specialist psychological support. Ref. 9a-9e. Surgery Low complexity breast surgery should be available locally to patients, as a day case where clinically appropriate. The patient’s personal circumstances must be taken into account when planning surgical interventions on the 23-hour model. It must be ensured that appropriate support arrangements are fully in place prior to discharge. Intra-operative sentinel node biopsy (SNB) should be considered for all women and adopted to avoid a second operation. Sentinel node biopsy should be offered to all women who are eligible. A combination of patent blue dye and technetium colloid should be used to maximise the likelihood of identification of the sentinel node. 9a. Conservation surgery: Treatment should be as a 12 hour day case procedure for conservation surgery with Sentinel Node Biopsy (SNB) and 23 hour surgery for conservation 1 NICE, Improving outcomes in breast cancer: manual update, 2002 3 of 10 surgery with Axillary Lymph Node Clearance (ALNC). 9b / 9d. Mastectomy: A 23-hour stay model for mastectomy without reconstruction should be available locally to patients, where appropriate. 9c / 9e. Mastectomy with reconstruction: All patients undergoing mastectomy should have the opportunity to discuss their breast reconstruction options and have immediate breast reconstruction if appropriate. Complex immediate breast reconstructive surgery, specifically free flap surgery, should be undertaken in specialist centres with dedicated plastic surgery and rehabilitation teams. Rapid-access pathways must be in place across Integrated Cancer Systems between providers offering reconstructive surgery and those who do not provide the full range of breast cancer surgery options. Complex surgery service co-dependencies The breast cancer surgical service must be collocated with the following support services, as set out in the cancer co-dependencies framework: pathology, specialist imaging (for IMRT and EMRT), CNS support, and lymphoedema (specifically for procedures involving lymph node dissection). There are a number of additional desirable service collocation requirements for the specialist surgical service and the ICS will agree service configuration and location with commissioners. Ref. 10a. Radiotherapy After mastectomy radiotherapy should not be offered to patients at low risk of local recurrence. Ref.10b Systemic therapy Chemotherapy should be delivered in a community setting and close to home, where appropriate. Adjuvant chemotherapy or radiotherapy should commence as soon as clinically possible within 31 days of completion of surgery in patients with early breast cancer having these treatments. Ref. 11 - Third outpatient Patients should attend a post-operative clinic to receive results from the surgeon and discuss further MDT treatment options. The patient should then be referred to a clinical or medical oncologist for further treatment if required. Ref. 12 / 13. Follow-up, survivorship, End of life care Providers will participate in the Inpatient Management Programme outlined in the Cancer Reform Strategy. This includes access to enhanced recovery programmes, reduced length of stay for breast surgery, and initiatives to reduce follow up in acute settings. With the emerging national guidance cancer care pathways must include new models of long term follow up and survivorship care. Bespoke follow up in a primary care setting is recommended. An annual mammography to all patients with early breast cancer, until they enter the NHS Breast Screening Programme is the preferred care plan. Patients diagnosed with early breast cancer who are already eligible for screening should have an annual mammography for 5 years. The supportive and palliative care IOG should be implemented in London. All patients should be offered a range of supportive care including psychosocial support and individualised patient information. Where appropriate, and in line with national guidance, all patients will have access to End of 4 of 10 Life Care Services. All pathways and specifications will be assumed to link to the separate pathway and specification for End of Life Care. 4. Service description – Advanced breast cancer Ref. Appendix 2 Commissioning best practice pathway for advanced breast cancer All service structure elements described for early and locally advanced disease and relevant to the advanced breast cancer pathway must be followed. In addition: - Imaging and pathological assessment may need to be undertaken for visceral and bone metastases - Those patients having biologics should have three MUGA scans during the course of their treatment - The management of complications should be discussed at the MDT meeting and coordinated by the MDT including lymphoedema, cancer related fatigue, uncontrolled local disease, and bone metastases 5. Quality Requirements 2.1 Service Description There are a number of criteria that must be met by any provider offering services for breast cancer patients ensuring high quality cost effective care and in accordance with NICE Guidance. 1.1. There must be an established weekly MDT meeting, where all patients have their treatment and care agreed, including any significant change to the treatment plan. MDTs will consider each patient for the potential of entry into clinical trials. 1.2. Providers will formally adopt the agreed best practice clinical pathway and the underlying clinical guidelines within their organisations’ clinical governance process. These pathways will represent the key elements of the service being commissioned and, together with guidelines and protocols, demonstrate the quality required. 1.3. All patients will have a named key worker to provide support at each stage of the pathway. 1.4. Each patient must have their holistic needs assessed at key stages of the pathway including survivorship and/or end of life care with formal care plans developed that are communicated to all teams/professionals involved in the patient’s care and shared with the patient (who will be free to share this with their carers/family) 1.5. The service must meet all current national quality standards, the recommendations set out in the cancer model of care, and the relevant NICE Improving Outcome Guidance. The service must be fully compliant with peer review measures. 5 of 10 6. Key Service Outcomes The key service outcome of this service specification is to “deliver high quality clinical services for patients with breast cancer, following the agreed best practice breast cancer pathway to ensure cancer survival rates in London are equal to or better than the best rates in Europe”. Any patient presenting with breast cancer will be placed on an agreed clinical pathway, to receive the most appropriate care for their condition. The implementation of these pathways will not only provide the best possible outcomes for the patients, but also allow NHS London to use resources effectively within the health economy. The key performance and quality indicators are listed below: Pathway Measure Data source Reporting Benchmark Presentation Percentage patients diagnosed with cancer who first present as an emergency HES Quarterly tbc → Percentage patients seen within 2 weeks for urgent referral CWT Quarterly tbc Diagnostics Number of patients diagnosed at each stage and proportion of all cancers Percentage patients treated within 31 days (from diagnosis to treatm nt) Percentage patients treated within 62 days from urgent referral Number of new cases seen per annum Percentage patients entered into clinical trials Patient finds i easy to contact their CNS / keyworker Survival 30 days after surgery TCR Quarterly tbc CWT Quarterly tbc CWT Quarterly tbc Trust data Annual tbc NCRN Annual tbc NCPES Annual tbc HES & ONS HES Quarterly tbc Annual tbc Trust data Annual tbc Percentage uptake immediate reconstruction HES Annual tbc Percentage of patients receiving radiotherapy delivered within 45 minutes of home Trust data Annual tbc Percentage of patients receiving IMRT Percentage patients being treated by breast conservation receiving radiotherapy for invasive cancer HES Quarterly tbc HES Annual tbc → MDT → Surgery Percentage re-operation and readmission rates within 30 days Percentage uptake 23 hour surgery Radiotherapy 6 of 10 Chemotherapy Percentage of patients receiving chemotherapy episodes delivered within 30 minutes of home Trust data Quarterly tbc Trust data Quarterly tbc Trust data Quarterly tbc Survival Door to needle for neutropenic sepsis Percentage patients undergoing holistic needs assessment 1 year survival by stage TCR Annual tbc Survival 5 year survival by stage TCR Annual tbc Survivorship 10 year survival by stage TCR Annual tbc System Percentage patients and carers given clear and understandable written and verbal information at relevant stages of the pathway NCPES Annual 100% Follow up 7. Service structure – Informatics requirements Recording and collection of high quality data is essential to commissioners and providers. It allows the quality of care to be assessed and determines the improvements required. The providers within the Integrated Cancer Systems will provide agreed performance monitoring data against the metrics below on a quarterly basis. Where any elements of this deviate from the agreed plan, the service will provide a brief explanation accompanying the submission of the report. The provider shall ensure that standards of performance are routinely monitored and that remedial action is promptly taken where these standards are not attained. Providers, and their MDTs, will collect and submit data in line with both national and locally agreed requirements and as per the requirements of Section 29 and Schedule 5 of the NHS Contract. In 2012/13 ICSs will be required to ensure the data collection systems and protocols are in place to provide the following information to commissioners: Informing commissioners for new patients: o the date a patient is diagnosed with breast cancer o the stage at diagnosis o their NHS number or an agreed pseudonymised alternative. Informing commissioners for existing patients: o the date the stage of the cancer is diagnosed as having changed o the new stage. Informing commissioners for all patients: o the date a MDT ceases to have overall responsibility for the care of the patient o the reason for this (e.g. death/move away/patient chooses to stop having treatment etc). In addition: Providers within the ICS will complete the Cancer Registration Dataset 7 of 10 (CRDS) for all patients. Providers within the ICS will submit the CRDS to the Thames Cancer Registry, commissioners and local cancer network quarterly seven weeks after the quarter end. MDTs will be responsible for the completeness, quality and timeliness of data. 8 of 10 Appendix 1. Commissioning best practice pathway for early and locally advanced breast cancer 8b Re-excision of margins 8a 9. Neoadjuvant systemic therapy no cancer 10. Radiotherapy 9. Adjuvant Systemic Therapy Advanced disease 9a Mastectomy 5. Staging tests (Imaging + histology) 1. A&E 10. Radiotherapy 13.Survivorship 9b 4. 1st OPA: Triple assessment 2. GP 7. 2nd OPA: Surgical 6. Breast MDT (weekly) 4a. Biopsy 3. Screening Programme Conservation surgery Mastectomy 11. Outpatient appt. Reconstruction 12. Follow up 14.End of Life 9c Mastectomy 4b. CT scan 4c. Examination 10. Radiotherapy advanced disease 15. Palliative care 9d Mastectomy Reconstruction 9 of 10 Appendix 2 Commissioning best practice pathway for advanced breast cancer 10 of 10