Guideline

SHEFFIELD PCT Framework of NICE Guidance February 2009 Guideline No TA167 Title Endovascular stent–grafts for the treatment of abdominal aortic aneurysms Summary This guidance refers to the use of endovascular stent–grafts or open surgical repair only for the treatment of infra-renal abdominal aortic aneurysms. This guidance should be read in conjunction with „Stent–graft placement in abdominal aortic aneurysm‟ (NICE interventional procedure guidance 163).  Endovascular stent–grafts are recommended as a treatment option for patients with unruptured infra-renal abdominal aortic aneurysms, for whom surgical intervention (open surgical repair or endovascular aneurysm repair) is considered appropriate.  The decision on whether endovascular aneurysm repair is preferred over open surgical repair should be made jointly by the patient and their clinician after assessment of a number of factors including: – aneurysm size and morphology – patient age, general life expectancy and fitness for open surgery – the short- and long-term benefits and risks of the procedures including aneurysmrelated mortality and operative mortality.  Endovascular aneurysm repair should only be performed in specialist centres by clinical teams experienced in the management of abdominal aortic aneurysms. The teams should have appropriate expertise in all aspects of patient assessment and the use of endovascular aortic stent–grafts.  Endovascular aortic stent–grafts are not recommended for patients with ruptured aneurysms except in the context of research. Given the difficulties of conducting randomised controlled trials, it is recommended that data should be collected through existing registries to enable further research. NOTE: This guidance replaces „NICE technology appraisal guidance 58‟ issued in February 2003. The review and re-appraisal of amantadine, oseltamivir and zanamivir for the treatment of influenza has resulted in a change in the guidance. Specifically:  people with chronic neurological conditions and people with chronic liver disease are now considered ‘at risk’  zanamivir is now recommended as a treatment option for children between the ages of 5 and 12 years in ‘at risk’ groups if influenza is circulating and they can start treatment within 36 hours of first symptoms  oseltamivir and zanamivir are now recommended as treatment options for ‘atrisk’ people in long-term and residential nursing homes during localised Implications NICE state that this guidance is for both primary and acute care. Aortic stents are currently outside PbR. NICE state that there will be no significant impact on resources Review Date January 2012 Local Action TA168 Amantadine, oseltamivir and zanamivir for the treatment of influenza (review of NICE technology appraisal guidance 58) NICE state that this guidance is for both primary and acute care. NICE state that this guidance will impact on PbR. NICE state that there will be no November 2013 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 1 SHEFFIELD PCT Framework of NICE Guidance February 2009 Guideline No Title Summary outbreaks (when influenza is not circulating), if there is a high level of certainty that the causative agent is influenza. This guidance has been prepared in the expectation that vaccination against influenza is undertaken in accordance with national guidelines. Vaccination has been established as the first-line intervention to prevent influenza and its complications, and the use of drugs described in this guidance should not in any way detract from efforts to ensure that all eligible people receive vaccination. This guidance does not cover the circumstances of a pandemic, impending pandemic, or a widespread epidemic of a new strain of influenza to which there is little or no community resistance.  Oseltamivir and zanamivir are recommended, within their marketing authorisations, for the treatment of influenza in adults and children if all the following circumstances apply: – national surveillance schemes indicate that influenza virus A or B is circulating – the person is in an „at-risk‟ group as defined as below – the person presents with an influenza-like illness and can start treatment within 48 hours (or within 36 hours for zanamivir treatment in children) of the onset of symptoms as per licensed indications.  For the purpose of this guidance, people „at risk‟ are defined as those who have one of more of the following: – chronic respiratory disease (including asthma and chronic obstructive pulmonary disease) – chronic heart disease – chronic renal disease – chronic liver disease – chronic neurological conditions – diabetes mellitus. People who are aged 65 years or older and people who might be immunosuppressed are also defined as „at-risk‟ for the purpose of this guidance.  The choice of either oseltamivir or zanamivir in the circumstances described above should be made after consultation between the healthcare professional, the patient and carers. The decision should take into account the patient‟s preferences regarding drug delivery and potential adverse effects and contraindications. If all other considerations are equal, the drug with the lowest acquisition cost should be offered.  During localised outbreaks of influenza-like illness (outside the periods when national Implications significant impact on resources Review Date Local Action 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 2 SHEFFIELD PCT Framework of NICE Guidance February 2009 Guideline No Title Summary surveillance indicates that influenza virus is circulating in the community), oseltamivir and zanamivir may be offered for the treatment of influenza in „at-risk‟ people who live in long-term residential or nursing homes. However, these treatments should be offered only if there is a high level of certainty that the causative agent in a localised outbreak is influenza (usually based on virological evidence of influenza infection in the initial case).  Amantadine is not recommended for the treatment of influenza. Key Recommendations Referral for specialist treatment  Refer for specialist opinion any person with suspected persistent synovitis of undetermined cause.  Refer urgently if any of the following apply: – the small joints of the hands or feet are affected – more than one joint is affected – there has been a delay of 3 months or longer between onset of symptoms and seeking medical advice. Disease-modifying and biological drugs  In people with newly diagnosed active RA, offer a combination of disease-modifying antirheumatic drugs (DMARDs) (including methotrexate and at least one other DMARD, plus shortterm glucocorticoids) as first-line treatment as soon as possible, ideally within 3 months of the onset of persistent symptoms.  In people with newly diagnosed RA for whom combination DMARD therapy is not appropriate (for example, because of comorbidities or pregnancy, during which certain drugs would be contraindicated), start DMARD monotherapy, placing greater emphasis on fast escalation to a clinically effective dose rather than on the choice of DMARD.  In people with recent-onset RA receiving combination DMARD therapy and in whom sustained and satisfactory levels of disease control have been achieved, cautiously try to reduce drug doses to levels that still maintain disease control. Monitoring disease  In people with recent-onset active RA, measure C-reactive protein (CRP) and key components of disease activity (using a composite score such as DAS28) monthly until treatment has controlled the disease to a level previously agreed with the person with RA. Implications Review Date Local Action CG79 Rheumatoid arthritis NICE state that this guidance is for both primary and acute care. NICE state that this guidance will impact on PbR. NICE state that this guidance will cost £127,000 per 100,000 population t.b.c. 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 3 SHEFFIELD PCT Framework of NICE Guidance February 2009 Guideline No Title Summary The multidisciplinary team  People with RA should have access to a named member of the multidisciplinary team (MDT) (for example, the specialist nurse) who is responsible for coordinating their care. This guideline updates and replaces the following technology appraisals: TA107 Breast cancer (early) - trastuzumab (published August 2006) TA108 Breast cancer (early) - paclitaxel (published September 2006) TA109 Breast cancer (early) - docetaxel (published September 2006). Key priorities for implementation Preoperative assessment of the breast  Offer magnetic resonance imaging (MRI) of the breast to patients with invasive breast cancer: – if there is discrepancy regarding the extent of disease from clinical examination, mammography and ultrasound assessment for planning treatment – if breast density precludes accurate mammographic assessment – to assess the tumour size if breast conserving surgery is being considered for invasive lobular cancer. Staging of the axilla  Pretreatment ultrasound evaluation of the axilla should be performed for all patients being investigated for early invasive breast cancer and, if morphologically abnormal lymph nodes are identified, ultrasound-guided needle sampling should be offered. Surgery to the axilla  Minimal surgery, rather than lymph node clearance, should be performed to stage the axilla for patients with early invasive breast cancer and no evidence of lymph node involvement on ultrasound or a negative ultrasound-guided needle biopsy. Sentinel lymph node biopsy is the preferred technique. Breast reconstruction  Discuss immediate breast reconstruction with all patients who are being advised to have a mastectomy, and offer it except where significant comorbidity or (the need for) adjuvant therapy may preclude this option. All appropriate breast reconstruction options should be offered and discussed with patients, irrespective of whether they are all available locally. Adjuvant therapy planning  Start adjuvant chemotherapy or radiotherapy as soon as clinically possible within 31 Implications Review Date Local Action CG80 Early and locally advanced breast cancer NICE state that this guidance is for both primary and acute care. NICE state that this guidance will impact on PbR. NICE state that fully implementing this guidance will save £1,291 per 100,000 population t.b.c. 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 4 SHEFFIELD PCT Framework of NICE Guidance February 2009 Guideline No Title Summary days of completion of surgery in patients with early breast cancer having these treatments. Aromatase inhibitors  Postmenopausal women with oestrogen receptor-positive early invasive breast cancer who are not considered to be at low risk should be offered an aromatase inhibitor, either anastrozole or letrozole, as their initial adjuvant therapy. Offer tamoxifen if an aromatase inhibitor is contraindicated or not tolerated. Assessment of bone loss  Patients with early invasive breast cancer should have a baseline dual energy X-ray absorptiometry DEXA) scan to assess bone mineral density if they: – are starting adjuvant aromatase inhibitor treatment – have treatment-induced menopause – are starting ovarian ablation/suppression therapy. Primary systemic therapy  Treat patients with early invasive breast cancer, irrespective of age, with surgery and appropriate systemic therapy, rather than endocrine therapy alone, unless significant comorbidity precludes surgery. Follow-up imaging  Offer annual mammography to all patients with early breast cancer, including ductal carcinoma in situ, until they enter the NHS Breast Screening Programme/Breast Test Wales Screening Programme. Patients diagnosed with early breast cancer who are already eligible for screening should have annual mammography for 5 years. Clinical follow-up  Patients treated for breast cancer should have an agreed, written care plan, which should be recorded by a named healthcare professional (or professionals), a copy sent to the GP and a personal copy given to the patient. This plan should include: – designated named healthcare professionals – dates for review of any adjuvant therapy – details of surveillance mammography – signs and symptoms to look for and seek advice on – contact details for immediate referral to specialist care, and – contact details for support services, for example support for patients with lymphoedema. Implications Review Date Local Action 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 5 SHEFFIELD PCT Framework of NICE Guidance February 2009 Guideline No CG81 Title Advanced breast cancer Summary Key priorities for implementation Diagnosis and assessment  Positron emission tomography fused with computed tomography (PET-CT) should only be used to make a new diagnosis of metastases for patients with breast cancer whose imaging is suspicious but not diagnostic of metastatic disease.  Assess oestrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2) status at the time of disease recurrence if receptor status was not assessed at the time of initial diagnosis. In the absence of tumour tissue from the primary tumour, and if feasible, obtain a biopsy of a metastasis to assess ER and HER2 status. Systemic disease-modifying therapy  Offer endocrine therapy as first-line treatment for the majority of patients with ERpositive advanced breast cancer.  For patients with advanced breast cancer who are not suitable for anthracyclines (because they are contraindicated or because of prior anthracycline treatment either in the adjuvant or metastatic setting), systemic chemotherapy should be offered in the following sequence: – first line: single-agent docetaxel – second line: single-agent vinorelbine or capecitabine – third line: single-agent capecitabine or vinorelbine (whichever was not used as second-line treatment).  For patients who are receiving treatment with trastuzumab for advanced breast cancer, discontinue treatment with trastuzumab at the time of disease progression outside the central nervous system. Do not discontinue trastuzumab if disease progression is within the central nervous system alone. Supportive care  Healthcare professionals involved in the care of patients with advanced breast cancer should ensure that the organisation and provision of supportive care services comply with the recommendations made in „Improving outcomes in breast cancer: manual update‟ (NICE cancer service guidance [2002]) and „Improving supportive and palliative care for adults with cancer‟ (NICE cancer service guidance [2004]), in particular the following two recommendations: – „Assessment and discussion of patients‟ needs for physical, psychological, social, spiritual and financial support should be undertaken at key points (such as Implications NICE state that this guidance is for both primary and acute care. NICE state that this guidance will impact on PbR. NICE state that fully implementing this guidance will save £21,094 per 100,000 population Review Date t.b.c. Local Action 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 6 SHEFFIELD PCT Framework of NICE Guidance February 2009 Guideline No Title Summary diagnosis; at commencement, during, and at the end of treatment; at relapse; and when death is approaching).‟ – „Mechanisms should be developed to promote continuity of care, which might include the nomination of a person to take on the role of “key worker” for individual patients.‟ Managing complications  A breast cancer multidisciplinary team should assess all patients presenting with uncontrolled local disease and discuss the therapeutic options for controlling the disease and relieving symptoms.  Consider offering bisphosphonates to patients newly diagnosed with bone metastases, to prevent skeletal-related events and reduce pain.  Use external beam radiotherapy in a single fraction of 8Gy to treat patients with bone metastases and pain.  Offer surgery followed by whole brain radiotherapy to patients who have a single or small number of potentially resectable brain metastases, a good performance status and who have no or well-controlled other metastatic disease. Recommendation 1 Planning, needs assessment and community engagement Who should take action?  Local strategic partnerships (LSPs), local drug partnerships (including drug [and alcohol] action teams [D(A)ATs]), drug joint commissioning managers and primary care trust (PCT) commissioners.  Public health practitioners with a remit for substance misuse. What action should they take?  With the help of the Health Protection Agency and public health observatories, collect and analyse local data to estimate the: – prevalence and incidence of infections related to injecting drug use (for example, hepatitis C) and other problems caused by injecting drug use (for example, number of people overdosing) – numbers, demographics, types of drugs used and other characteristics of injecting drug users (for example, the number of sex workers or homeless people who are crack and speedball injectors) – number and percentage of injections „covered‟ by sterile needles and syringes (that is, the number and percentage of occasions when sterile equipment was available to use) Implications Review Date Local Action PH18 Needle and syringe programmes NICE state that this guidance is for primary care, mental health trusts, acute care and other organisations. NICE state that this guidance will not impact on PbR. NICE state that this guidance will have no significant impact on t.b.c. 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 7 SHEFFIELD PCT Framework of NICE Guidance February 2009 Guideline No Title Summary – the number and percentage of individuals who had more sterile needles and syringes than they needed (over 100% coverage) – number and percentage of people who inject drugs and who are in regular contact with an NSP (that is, at least once a month). Use these data to ensure NSP services meet local need (for example, in terms of opening times and locations), taking the geography of the location into account (for example, whether it is in an urban or rural area). Consult people who inject drugs to help assess the need for – and to plan – NSPs. Consult local communities about how best to implement new or reconfigured NSPs. Promote the benefits of the service. For example, explain how it will help reduce drugrelated litter by providing safe disposal facilities and sharps bins. Actively involve them in implementation. For further recommendations on community engagement, see „Community engagement to improve health‟ (NICE public health guidance 9). Implications resources. Review Date Local Action    Recommendation 2 Meeting need Who should take action?  LSPs, local drug partnerships (including D[A]ATs), drug joint commissioning managers and PCT commissioners. What action should they take?  Commission a mix of generic and targeted NSP services to meet local need within the area covered by the LSP (see recommendation 1). Targeted services should focus on specific groups (for example, homeless people and women who inject drugs). Services should aim to: – increase the proportion of people who have over 100% „coverage‟ (that is, the number who have more than one sterile needle and syringe available for every injection) – increase the proportion of people from each group of injecting drug users who are in contact with NSPs – ensure syringes and needles are available in a range of sizes and at a range of locations throughout the area – offer advice and information on, and referrals to, services which aim to: reduce the harm associated with injecting drug use; encourage people to stop using drugs or to switch to non-injecting methods (for example, opioid substitution therapy); and address their other health needs. 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 8 SHEFFIELD PCT Framework of NICE Guidance February 2009 Guideline No Title Summary     Develop plans for needle and syringe disposal, in line with „Tackling drug-related litter‟ (Department for Environment, Food and Rural Affairs 2005). Encourage identification schemes (involving, for example, the use of coloured syringes). Commission „integrated care pathways‟ for people who inject drugs. Audit and monitor services to ensure they meet the health needs of people who inject drugs and address the concerns of the local community. Implications Review Date Local Action Recommendation 3 Types of service Who should take action?  LSPs, local drug partnerships (including D[A]ATs), drug joint commissioning managers and PCT commissioners. What action should they take?  Use pharmacies, specialist NSPs and other healthcare settings to provide a balanced mix of the following levels of service: – level one: distribution of injecting equipment either loose or in packs, with written information on harm reduction (for example, on safer injecting or overdose prevention) – level two: distribution of „pick and mix‟ (bespoke) injecting equipment plus health promotion advice (including advice and information on how to reduce the harms caused by injecting drugs) – level three: level two plus provision of, or referral to, specialist services (for example, vaccinations, drug treatment and secondary care).  Coordinate services to ensure injecting equipment is available throughout the LSP area for a significant time during any 24-hour period. As an example, PCTs could ensure that NSPs form part of the ‟necessary enhanced services„ offered by ‟100 hour„ pharmacies. Commissioners could also consider providing NSPs through community pharmacies that operate extended opening hours.  Ensure services offering opioid substitution therapy also make needles and syringes available to their clients, in line with the National Treatment Agency „Models of care‟ (2006). Recommendation 4 Equipment and advice Who should take action? 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 9 SHEFFIELD PCT Framework of NICE Guidance February 2009 Guideline No Title Summary  NSP providers (community pharmacies and specialist NSPs). What action should they take?  Provide people who inject drugs with needles, syringes and other injecting equipment. The quantity dispensed should not be subject to an arbitrary limit but, rather, should meet their needs. Where possible, needles and syringes should be made available in a range of sizes.  Ensure people who use NSPs are provided with sharps bins and advice on how to dispose of needles and syringes safely.  Ensure safer injecting advice and information are available when providing long needles and other equipment that could be used for more dangerous practices. (Long needles, for example, could be used for injecting into the groin.)  Provide other injecting equipment associated with illicit drug use and encourage people who inject drugs to switch to other methods of drug use. (At the time of publication, legally permitted equipment included filters, mixing containers and sterile water.)  Encourage people who inject drugs to mark their syringes and other injecting equipment or to use easily identifiable equipment to prevent mix-ups.  Encourage people who inject drugs to use services which aim to: reduce the harm associated with injecting drug use; encourage them to stop using drugs or to switch to non-injecting methods (for example, opioid substitution therapy); and address their other health needs. Advise them where they can access these services. Recommendation 5 Community pharmacy-based NSPs Who should take action?  Community pharmacies that run an NSP (regardless of the level of service they offer – see recommendation 3).  Coordinators of community pharmacy-based NSP services. What action should they take?  Provide sharps bins and advice on how to dispose of needles and syringes safely. In addition, provide a service for safe disposal of used equipment.  Ensure staff who dispense needles and syringes receive appropriate training for the level of service they offer. As a minimum, this should include awareness training on the need for discretion and the need to respect the privacy of people who inject drugs. It should also include training on how to treat them in a non-stigmatising way. Implications Review Date Local Action 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 10 SHEFFIELD PCT Framework of NICE Guidance February 2009 Guideline No Title Summary     Ensure staff providing level two or three services (see recommendation 3) are trained to provide health promotion advice, in particular, advice on how to reduce the harm caused by injecting. Ensure staff have health and safety training. Ensure hepatitis B vaccination is available for staff. Ensure staff can provide people who inject drugs with information about local agencies offering further support (this includes details about local opioid substitution therapy services). Implications Review Date Local Action Recommendation 6 Specialist NSPs: level three services Who should take action?  Specialist NSPs. What action should they take?  Provide sharps bins and advice on how to dispose of needles and syringes safely. In addition, provide a service for safe disposal of used equipment.  Ensure staff receive appropriate training for the level of service on offer.  Ensure a selection of individual needles, syringes and other injecting equipment is available.  Offer comprehensive harm-reduction services including advice on safer injecting practices, assessment of injection-site infections, advice on preventing overdoses and help to stop injecting drugs. Where appropriate, offer a referral to opioid substitution therapy services.  Offer (or help people to access): – opioid substitution therapy – treatment of injection-site infections – vaccinations and boosters (including those offering protection from hepatitis A, hepatitis B and tetanus) – testing (and counselling, where appropriate) for hepatitis B, hepatitis C and HIV – psychosocial interventions – primary care services (including condom provision and general sexual health services, dental care and general health promotion advice) – secondary care services (for example, treatment for hepatitis C and HIV) – welfare and advocacy services (for example, advice on housing and legal issues). 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 11 SHEFFIELD PCT Framework of NICE Guidance February 2009 Guideline No IPG287 Title Laparoscopic cystectomy Summary Implications Acute care only Review Date - Local Action IPG288 IPG289  Current evidence on the safety and efficacy of laparoscopic cystectomy appears adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.  Patient selection for laparoscopic cystectomy should involve a multidisciplinary team experienced in the management of bladder cancer.  Clinicians undertaking laparoscopic cystectomy should have special training. The British Association of Urological Surgeons (BAUS) has produced training standards (www.baus.org.uk/baus_subspecialty_sections/section_of_endourology/guidelines__a udit_committee.phtml).  Clinicians should submit data on all patients undergoing this procedure to the BAUS Cancer Registry & Sections Audit with a view to further publication on long-term survival outcomes (www.baus.org.uk/baus_subspecialty_sections/baus_cancer_registry__sections_audit .phtml). Extracorporeal  Current evidence on extracorporeal photopheresis (ECP) for Crohn‟s disease is based photopheresis for on reports that include a very small number of patients. These reports describe no Crohn‟s disease major safety issues but they provide little evidence of efficacy. Therefore, this procedure should not be used outside the context of research. Intraocular lens  Current evidence on intraocular lens (IOL) insertion for correction of refractive error, insertion for with preservation of the natural lens is available for large numbers of patients. There is correction of good evidence of short-term safety and efficacy. However, there is an increased risk refractive error, of cataract, corneal damage or retinal detachment and there are no long-term data with about this. Therefore, the procedure may be used with normal arrangements for preservation of clinical governance and audit, but with special arrangements for consent. the natural lens  Clinicians wishing to undertake IOL insertion for correction of refractive error, with preservation of the natural lens should ensure that patients understand the risks of having an artificial lens implanted for visual impairment that might otherwise be corrected using spectacles or contact lenses. They should understand the possibility of cataract, corneal damage or retinal detachment, and the lack of evidence relating to long-term outcomes. Patients should be provided with clear information.  Both clinicians and manufacturers are encouraged to collect long-term data on people who undergo IOL insertion, and to publish their findings. NICE may review the procedure on publication of further evidence. Acute care only - Acute care only - 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 12 SHEFFIELD PCT Framework of NICE Guidance February 2009 4290fea1-dcef-4fba-8a98-507b1c2e5592.doc Page 13