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					NHS Sheffield Framework of NICE Guidance August 2009
Guideline No TA176 Title Cetuximab for the first-line treatment of metastatic colorectal cancer Summary  Cetuximab in combination with 5-fluorouracil (5-FU), folinic acid and oxaliplatin (FOLFOX), within its licensed indication, is recommended for the first-line treatment of metastatic colorectal cancer only when all of the following criteria are met: o The primary colorectal tumour has been resected or is potentially operable. o The metastatic disease is confined to the liver and is unresectable. o The patient is fit enough to undergo surgery to resect the primary colorectal tumour and to undergo liver surgery if the metastases become resectable after treatment with cetuximab. o The manufacturer rebates 16% of the amount of cetuximab used on a per patient basis. Cetuximab in combination with 5-FU, folinic acid and irinotecan (FOLFIRI), within its licensed indication, is recommended for the first-line treatment of metastatic colorectal cancer only when all of the following criteria are met: o The primary colorectal tumour has been resected or is potentially operable. o The metastatic disease is confined to the liver and is unresectable. o The patient is fit enough to undergo surgery to resect the primary colorectal tumour and to undergo liver surgery if the metastases become resectable after treatment with cetuximab. o The patient is unable to tolerate or has contraindications to oxaliplatin. Patients who meet the criteria above should receive treatment with cetuximab for no more than 16 weeks. At 16 weeks, treatment with cetuximab should stop and the patient should be assessed for resection of liver metastases. People with metastatic colorectal cancer with metastatic disease confined to the liver who receive cetuximab should have their treatment managed only by multidisciplinary teams that involve highly specialised liver surgical services. Alitretinoin is recommended, within its licensed indication, as a treatment option for adults with severe chronic hand eczema that has not Implications NICE state that this guidance is for acute care only. As it is a cancer drug then it is outside of PbR tariff. NICE have not provided any costing information at the time this summary was produced. Review Date August 2012 Local Action

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TA177

Alitretinoin for the treatment of severe

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NICE state that this guidance is for acute care only and

August 2012

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NHS Sheffield Framework of NICE Guidance August 2009
Guideline No Title chronic hand eczema  Summary responded to potent topical corticosteroids if the person has: o severe disease, as defined by the physician’s global assessment (PGA) and o a dermatology life quality index (DLQI) score of 15 or more. Alitretinoin treatment should be stopped: o as soon as an adequate response (hands clear or almost clear) has been achieved or o if the eczema remains severe (as defined by the PGA) at 12 weeks or o if an adequate response (hands clear or almost clear) has not been achieved by 24 weeks. Only dermatologists, or physicians with experience in both managing severe chronic hand eczema and the use of systemic retinoids, should start and monitor treatment with alitretinoin. When using the DLQI, healthcare professionals should take into account any physical, sensory or learning disabilities, or other communication difficulties that could affect the responses to the DLQI. In such cases, healthcare professionals should ensure that the DLQI continues to be a sufficiently accurate measure. Implications recommends that only dermatologists with specialist experience in managing severe hand eczema should start and monitor treatment with alitretinoin. NICE state that the guidance is in PbR tariff. NICE state that there is a net saving from implementing this guidance of £6,000 per 100,000 population. A move in patients to alitretinoin treatment may save on dermatologic services due to increased time to reoccurrence and fewer patients being treated with resource intensive alternatives. NICE state that this guidance is for acute care only. As it is a cancer drug then it is outside of PbR tariff. NICE state that this guidance is unlikely to result in a significant change in resource use in the NHS. Acute care only Review Date Local Action

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TA178

IPG309

Bevacizumab (firstline), sorafenib firstand second-line), sunitinib (secondline) and temsirolimus (firstline) for the treatment of advanced and/or metastatic renal cell carcinoma Percutaneous mitral valve leaflet repair for mitral

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Bevacizumab, sorafenib and temsirolimus are not recommended as firstline treatment options for people with advanced and/or metastatic renal cell carcinoma. Sorafenib and sunitinib are not recommended as second-line treatment options for people with advanced and/or metastatic renal cell carcinoma. People who are currently being treated with bevacizumab (first-line), sorafenib (first- and second-line), sunitinib (second-line) and temsirolimus (first-line) for advanced and/or metastatic renal cell carcinoma should have the option to continue their therapy until they and their clinicians consider it appropriate to stop. Evidence on the safety and efficacy of percutaneous mitral valve leaflet repair for mitral regurgitation is currently inadequate in quality and quantity. Therefore, this procedure should only be used:

June 2011

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NHS Sheffield Framework of NICE Guidance August 2009
Guideline No Title regurgitation Summary with special arrangements for clinical governance, consent and research for patients who are well enough for surgical mitral valve leaflet repair to treat their mitral regurgitation, or o in the context of research for patients who are not well enough for surgical mitral valve leaflet repair to treat their mitral regurgitation.  Clinicians wishing to undertake percutaneous mitral valve leaflet repair for mitral regurgitation in patients who are well enough for surgical mitral valve leaflet repair to treat their mitral regurgitation should take the following actions. o Inform the clinical governance leads in their Trusts. o Ensure that patients and their carers understand the uncertainty about the procedure’s safety and efficacy and provide them with clear written information.  The NHS Information Centre for Health and Social Care runs the UK Central Cardiac Audit Database. Clinicians should enter details about patients who are well enough to have surgical mitral valve leaflet repair to treat their mitral regurgitation and who are treated by percutaneous mitral valve leaflet repair onto this database (www.ccad.org.uk).  Clinicians wishing to undertake percutaneous mitral valve leaflet repair for mitral regurgitation in patients who are not well enough for surgical mitral valve leaflet repair should do so in the context of research studies. Research outcomes should include the effect on symptoms, change in functional status, and effective measures of cardiac function, in addition to clear documentation of adverse events and survival.  Patient selection and treatment should be carried out in specialist units (with access to emergency cardiac surgery) by a multidisciplinary team, including an interventional cardiologist (with expertise in echocardiography or with support from an echocardiologist) and a cardiac surgeon.  This procedure should only be carried out by clinicians with specific training.  NICE is aware of current clinical trials involving this procedure, and may review the procedure on publication of further evidence. This document replaces previous guidance on minimally invasive o Implications Review Date Local Action

IPG310

Placement of pectus

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NHS Sheffield Framework of NICE Guidance August 2009
Guideline No Title bar for pectus excavatum (also known as MIRPE or the Nuss procedure) Summary placement of pectus bar (interventional procedure guidance 3).  Current evidence on the safety and efficacy of placement of pectus bar for pectus excavatum (also known as MIRPE [minimally invasive repair of pectus excavatum] or the Nuss procedure) is adequate to support its use provided that normal arrangements are in place for clinical governance, consent and audit.  Placement of pectus bar for pectus excavatum should be carried out only by surgeons with cardiac and thoracic training and experience, who are capable of managing cardiac or liver injury, and where there are facilities for this.  This procedure should be carried out only by surgeons with specific training in inserting the device, and they should perform their initial procedures with an experienced mentor. This document replaces previous guidance on extracorporeal shockwave therapy for refractory tendinopathies (plantar fasciitis and tennis elbow) (interventional procedure guidance 139). Implications Review Date Local Action

IPG311

Extracorporeal shockwave therapy for refractory plantar fasciitis

Acute care only

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The evidence on extracorporeal shockwave therapy (ESWT) for refractory plantar fasciitis raises no major safety concerns; however, current evidence on its efficacy is inconsistent. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research. Clinicians wishing to undertake ESWT for refractory plantar fasciitis should take the following actions. • Inform the clinical governance leads in their Trusts. • Ensure that patients understand the uncertainty about the procedure’s efficacy and provide them with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPG311publicinfo). • Audit and review clinical outcomes of all patients having ESWT for refractory plantar fasciitis (see section 3.1). NICE encourages further research into ESWT for refractory plantar fasciitis. Future research should take the form of clinical studies with

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NHS Sheffield Framework of NICE Guidance August 2009
Guideline No Title Summary Implications Review Date Local Action

clearly described patient selection and treatment protocols, including a description of local anaesthesia use and the type of energy applied (see section 2.5). The studies should include validated outcome measures and be based on a minimum of 1-year follow-up. NICE may review the procedure on publication of further evidence.
IPG312 Extracorporeal shockwave therapy for refractory Achilles tendinopathy

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IPG313

Extracorporeal shockwave therapy for refractory tennis

The evidence on extracorporeal shockwave therapy (ESWT) for refractory Achilles tendinopathy raises no major safety concerns: there have been reports of occasional tendon rupture in treated patients, but this may also occur when the procedure has not been used. However, current evidence on efficacy of the procedure is inconsistent. Therefore, ESWT for refractory Achilles tendinopathy should only be used with special arrangements for clinical governance, consent and audit or research.  Clinicians wishing to undertake ESWT for refractory Achilles tendinopathy should take the following actions. o Inform the clinical governance leads in their Trusts. o Ensure that patients understand the uncertainty about the procedure’s efficacy, and about its safety in relation to a possible risk of tendon rupture, and provide them with clear written information. o Audit and review clinical outcomes of all patients having ESWT for refractory Achilles tendinopathy.  NICE encourages further research into ESWT for refractory Achilles tendinopathy. Future research should take the form of clinical studies with clearly described patient selection and treatment protocols, including a description of local anaesthesia use and the type of energy applied. The studies should include validated outcome measures and be based on a minimum of 1-year follow-up. NICE may review the procedure on publication of further evidence. This document replaces previous guidance on extracorporeal shockwave therapy for refractory tendinopathies (plantar fasciitis and tennis elbow) (interventional procedure guidance 139).

Acute care only

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Acute care only

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NHS Sheffield Framework of NICE Guidance August 2009
Guideline No Title elbow Summary Implications Review Date Local Action

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IPG314

Ultrasound-guided foam sclerotherapy for varicose veins

The evidence on extracorporeal shockwave therapy (ESWT) for refractory tennis elbow raises no major safety concerns; however, current evidence on its efficacy is inconsistent. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.  Clinicians wishing to undertake ESWT for refractory tennis elbow should take the following actions. o Inform the clinical governance leads in their Trusts. o Ensure that patients understand the uncertainty about the procedure’s efficacy and provide them with clear written information. o Audit and review clinical outcomes of all patients having ESWT for refractory tennis elbow.  NICE encourages further research into ESWT for refractory tennis elbow. Future research should take the form of clinical studies with clearly described patient selection and treatment protocols, including a description of local anaesthesia use and the type of energy applied. The studies should include validated outcome measures and be based on a minimum of 1-year follow-up. NICE may review the procedure on publication of further evidence. This document replaces previous guidance on ultrasound-guided foam sclerotherapy for varicose veins (interventional procedure guidance 217).  Current evidence on ultrasound-guided foam sclerotherapy for varicose veins shows that it is efficacious in the short term. The evidence on safety includes systemic side effects in some patients. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit.  Clinicians wishing to undertake ultrasound-guided foam sclerotherapy for varicose veins should take the following actions. o Inform the clinical governance leads in their Trusts. o Ensure that patients understand the potential side effects of the procedure, including those thought to be associated with

Acute care only

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NHS Sheffield Framework of NICE Guidance August 2009
Guideline No Title Summary Implications Review Date Local Action

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foam embolisation, and provide them with clear written information, which should include other treatment options. o Audit and review clinical outcomes of all patients having ultrasound-guided foam sclerotherapy for varicose veins. The procedure should only be undertaken using sclerosants licensed for varicose veins. The practice of mixing liquid sclerosant with air or other gas constitutes off-label use. Current evidence of long-term efficacy is limited and clinicians are encouraged to collect longer-term follow-up data.

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