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					                                                              NHS Sheffield
                                                        Framework of NICE Guidance
                                                                April 2010

Guideline   Title                 Summary                                                                                      Implications               Review     Local
No                                                                                                                                                         Date      Action
TA187       Infliximab (review)   This guidance replaces Technology Appraisal 40 (Crohn's disease – infliximab)                NICE state that this      September
            and adalimumab        issued in April 2002.                                                                        guidance is for primary     2011
            for the treatment                                                                                                  and acute care.
            of Crohn’s               Infliximab and adalimumab, within their licensed indications, are recommended as
            disease                   treatment options for adults with severe active Crohn’s disease (see below) whose        NICE state that the
                                      disease has not responded to conventional therapy (including immunosuppressive           guidance does not
                                      and/or corticosteroid treatments), or who are intolerant of or have contraindications    impact on PbR.
                                      to conventional therapy. Infliximab or adalimumab should be given as a planned
                                      course of treatment until treatment failure (including the need for surgery), or until   NICE state that the
                                      12 months after the start of treatment, whichever is shorter. People should then         cost of implementing
                                      have their disease reassessed (see below) to determine whether ongoing                   this guidance is, on
                                      treatment is still clinically appropriate.                                               average, £47,721 per
                                     Treatment as described above should normally be started with the less expensive          100,000 population.
                                      drug (taking into account drug administration costs, required dose and product
                                      price per dose). This may need to be varied for individual patients because of
                                      differences in the method of administration and treatment schedules.
                                     Infliximab, within its licensed indication, is recommended as a treatment option for
                                      people with active fistulising Crohn’s disease whose disease has not responded to
                                      conventional therapy (including antibiotics, drainage and immunosuppressive
                                      treatments), or who are intolerant of or have contraindications to conventional
                                      therapy. Infliximab should be given as a planned course of treatment until
                                      treatment failure (including the need for surgery) or until 12 months after the start
                                      of treatment, whichever is shorter. People should then have their disease
                                      reassessed (see below) to determine whether ongoing treatment is still clinically
                                      appropriate.
                                     Treatment with infliximab or adalimumab (see above) should only be continued if
                                      there is clear evidence of ongoing active disease as determined by clinical
                                      symptoms, biological markers and investigation, including endoscopy if necessary.
                                      Specialists should discuss the risks and benefits of continued treatment with
                                      patients and consider a trial withdrawal from treatment for all patients who are in
                                      stable clinical remission. People who continue treatment with infliximab or
                                      adalimumab should have their disease reassessed at least every 12 months to
                                      determine whether ongoing treatment is still clinically appropriate. People whose
                                      disease relapses after treatment is stopped should have the option to start
                                      treatment again.




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                                                             NHS Sheffield
                                                       Framework of NICE Guidance
                                                               April 2010

Guideline   Title               Summary                                                                                        Implications              Review     Local
No                                                                                                                                                        Date      Action
                                    Infliximab, within its licensed indication, is recommended for the treatment of
                                     people aged 6–17 years with severe active Crohn’s disease whose disease has
                                     not responded to conventional therapy (including corticosteroids,
                                     immunomodulators and primary nutrition therapy), or who are intolerant of or have
                                     contraindications to conventional therapy. The need to continue treatment should
                                     be reviewed at least every 12 months.
                                 For the purposes of this guidance, severe active Crohn’s disease is defined as
                                     very poor general health and one or more symptoms such as weight loss, fever,
                                     severe abdominal pain and usually frequent (3–4 or more) diarrhoeal stools daily.
                                     People with severe active Crohn’s disease may or may not develop new fistulae or
                                     have extra-intestinal manifestations of the disease. This clinical definition normally,
                                     but not exclusively, corresponds to a Crohn’s Disease Activity Index (CDAI) score
                                     of 300 or more, or a Harvey-Bradshaw score of 8 to 9 or above.
                                 When using the CDAI and Harvey-Bradshaw Index, healthcare professionals
                                     should take into account any physical, sensory or learning disabilities, or
                                     communication difficulties that could affect the scores and make any adjustments
                                     they consider appropriate.
                                 Treatment with infliximab or adalimumab should only be started and reviewed by
                                     clinicians with experience of TNF inhibitors and of managing Crohn’s disease.
CG97        The management      Initial assessment                                                                             NICE state that this       t.b.c.
            of lower urinary     At initial assessment, offer men with LUTS an assessment of their general medical            guidance is for primary
            tract symptoms in        history to identify possible causes of LUTS, and associated comorbidities. Review         and acute care.
            men                      current medication, including herbal and over-the-counter medicines, to identify
                                     drugs that may be contributing to the problem.                                            NICE state that
                                 At initial assessment, offer men with LUTS a physical examination guided by                  surgery for severe
                                     urological symptoms and other medical conditions, an examination of the abdomen           voiding symptoms may
                                     and external genitalia, and a digital rectal examination (DRE).                           have some impact on
                                 At initial assessment, ask men with bothersome LUTS to complete a urinary                    PbR.
                                     frequency volume chart.
                                 Refer men for specialist assessment if they have LUTS complicated by recurrent or            NICE state that
                                     persistent urinary tract infection, retention, renal impairment that is suspected to be   implementing this
                                     caused by lower urinary tract dysfunction, or suspected urological cancer.                guidance will, on
                                Conservative management                                                                        average, cost £13,000
                                 Offer men with storage LUTS (particularly urinary incontinence) temporary                    per 100,000
                                                                                                                               population.




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                                                             NHS Sheffield
                                                       Framework of NICE Guidance
                                                               April 2010

Guideline   Title               Summary                                                                                      Implications   Review     Local
No                                                                                                                                           Date      Action
                                    containment products (for example, pads or collecting devices) to achieve social
                                    continence until a diagnosis and management plan have been discussed.
                                 Offer men with storage LUTS suggestive of overactive bladder (OAB) supervised
                                    bladder training, advice on fluid intake, lifestyle advice and, if needed, containment
                                    products.
                                Surgery for voiding symptoms
                                 If offering surgery for managing voiding LUTS presumed secondary to benign
                                    prostate enlargement (BPE), offer monopolar or bipolar transurethral resection of
                                    the prostate (TURP), monopolar transurethral vaporisation of the prostate (TUVP)
                                    or holmium laser enucleation of the prostate (HoLEP). Perform HoLEP at a centre
                                    specialising in the technique, or with mentorship arrangements in place.
                                 If offering surgery for managing voiding LUTS presumed secondary to BPE, do not
                                    offer minimally invasive treatments (including transurethral needle ablation [TUNA],
                                    transurethral microwave thermotherapy [TUMT], high-intensity focused ultrasound
                                    [HIFU], transurethral ethanol ablation of the prostate [TEAP] and laser coagulation)
                                    as an alternative to TURP, TUVP or HoLEP (see above).
                                Providing information
                                 Make sure men with LUTS have access to care that can help with:
                                     o their emotional and physical conditions and
                                     o relevant physical, emotional, psychological, sexual and social issues.
                                 Provide men with storage LUTS (particularly incontinence) containment products at
                                    point of need, and advice about relevant support groups.




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                                                            NHS Sheffield
                                                      Framework of NICE Guidance
                                                              April 2010

Guideline   Title               Summary                                                                                   Implications              Review     Local
No                                                                                                                                                   Date      Action
CG98        Neonatal jaundice   Information                                                                               NICE state that this       t.b.c.
                                 Offer parents or carers information about neonatal jaundice that is tailored to their   guidance is for primary
                                    needs and expressed concerns. This information should be provided through             and acute care.
                                    verbal discussion backed up by written information. Care should be taken to avoid
                                    causing unnecessary anxiety to parents or carers. Information should include:         At this moment NICE
                                     o factors that influence the development of significant hyperbilirubinaemia          are unable to say
                                     o how to check the baby for jaundice                                                 whether this guidance
                                     o what to do if they suspect jaundice                                                impacts on primary
                                     o the importance of recognising jaundice in the first 24 hours and of seeking        care.
                                       urgent medical advice
                                     o the importance of checking the baby’s nappies for dark urine or pale chalky        NICE state that there
                                       stools                                                                             are non-recurrent
                                     o the fact that neonatal jaundice is common, and reassurance that it is usually      costs of £10,200 and
                                       transient and harmless                                                             recurrent costs of
                                     o reassurance that breastfeeding can usually continue.                               £2,398 per 100,000
                                Care for all babies                                                                       population, on
                                 Identify babies as being more likely to develop significant hyperbilirubinaemia if      average.
                                    they have any of the following factors:
                                     o gestational age under 38 weeks
                                     o a previous sibling with neonatal jaundice requiring phototherapy
                                     o mother’s intention to breastfeed exclusively
                                     o visible jaundice in the first 24 hours of life.
                                 In all babies:
                                     o check whether there are factors associated with an increased likelihood of
                                       developing
                                     o significant hyperbilirubinaemia soon after birth
                                     o examine the baby for jaundice at every opportunity especially in the first 72
                                       hours.
                                 When looking for jaundice (visual inspection):
                                     o check the naked baby in bright and preferably natural light
                                     o examination of the sclerae, gums and blanched skin is useful across all skin
                                       tones.
                                Additional care
                                 Ensure babies with factors associated with an increased likelihood of developing
                                    significant hyperbilirubinaemia receive an additional visual inspection by a




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                                                             NHS Sheffield
                                                       Framework of NICE Guidance
                                                               April 2010

Guideline   Title               Summary                                                                                     Implications         Review     Local
No                                                                                                                                                Date      Action
                                     healthcare professional during the first 48 hours of life.
                                Measuring bilirubin in all babies with jaundice
                                 Do not rely on visual inspection alone to estimate the bilirubin level in a baby with
                                     jaundice.
                                How to measure the bilirubin level
                                 When measuring the bilirubin level:
                                      o use a transcutaneous bilirubinometer in babies with a gestational age of 35
                                        weeks or more and postnatal age of more than 24 hours
                                      o if a transcutaneous bilirubinometer is not available, measure the serum bilirubin
                                      o if a transcutaneous bilirubinometer measurement indicates a bilirubin level
                                        greater than
                                      o 250 micromol/litre check the result by measuring the serum bilirubin
                                      o always use serum bilirubin measurement to determine the bilirubin level in
                                        babies with
                                      o jaundice in the first 24 hours of life
                                      o always use serum bilirubin measurement to determine the bilirubin level in
                                        babies less than 35 weeks gestational age
                                      o always use serum bilirubin measurement for babies at or above the relevant
                                        treatment
                                      o threshold for their postnatal age, and for all subsequent measurements
                                      o do not use an icterometer.
                                How to manage hyperbilirubinaemia
                                 Use the bilirubin level to determine the management of hyperbilirubinaemia in all
                                     babies (see threshold table in the quick reference guide and treatment threshold
                                     graphs on the NICE website).
                                Care of babies with prolonged jaundice
                                 Follow expert advice about care for babies with a conjugated bilirubin level greater
                                     than 25 micromol/litre because this may indicate serious liver disease.
IPG338      Laparoscopic        This document replaces previous guidance on laparoscopic radical                               Acute Care Only     -
            radical             hysterectomy for early stage cervical cancer (interventional procedure guidance
            hysterectomy for    24).
            early
            stage cervical         Current evidence on the efficacy and safety of laparoscopic radical hysterectomy
            cancer                  for early stage cervical cancer is adequate to support the use of this procedure
                                    provided that normal arrangements are in place for clinical governance, consent




d657d617-88c3-4e9e-8497-8d2019883237.doc                                                                                                           Page 5
                                                             NHS Sheffield
                                                       Framework of NICE Guidance
                                                               April 2010

Guideline   Title                Summary                                                                                   Implications         Review     Local
No                                                                                                                                               Date      Action
                                     and audit.
                                    Patient selection should be carried out by a multidisciplinary gynaecological
                                     oncology team. The procedure should be carried out in units specialising in the
                                     treatment of gynaecological malignancies.
                                  Advanced laparoscopic skills are required for this procedure and clinicians should
                                     undergo special training and mentorship. The Royal College of Obstetricians and
                                     Gynaecologists has developed an Advanced Training Skills Module, which is
                                     available from www.rcog.org.uk/curriculummodule/advanced-laparoscopic-surgery-
                                     excisionbenign-disease. This needs to be supplemented by further training to
                                     achieve the skills required for laparoscopic radical hysterectomy for early stage
                                     cervical cancer.
IPG339      Limited macular      This document partially replaces previous guidance on macular translocation for              Acute Care Only     -
            translocation for    age-related macular degeneration (interventional procedures guidance 48).
            wet
            age-related             Current evidence on limited macular translocation for wet age-related macular
            macular                  regeneration (AMD) shows that this procedure is efficacious in only a proportion of
            degeneration             patients and that there is a potential for serious adverse events. Therefore the
                                     procedure should only be used with special arrangements for clinical governance,
                                     consent and audit or research.
                                  Clinicians wishing to undertake limited macular translocation for wet AMD 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 information about
                                        both this procedure and alternative treatments.
                                      o Audit and review clinical outcomes of all patients having limited macular
                                        translocation for wet AMD.
IPG340      Macular              This document partially replaces previous guidance on macular translocation for              Acute Care Only     -
            translocation with   age-related macular degeneration (interventional procedures guidance 48).
            360° retinotomy
            for wet age-            Current evidence on macular translocation with 360° retinotomy for wet age-related
            related macular          macular degeneration (AMD) shows that this procedure is efficacious in only a
            degeneration             proportion of patients and that there is a potential for serious adverse events.
                                     Therefore the procedure should only be used with special arrangements for clinical
                                     governance, consent and audit or research.




d657d617-88c3-4e9e-8497-8d2019883237.doc                                                                                                          Page 6
                                                              NHS Sheffield
                                                        Framework of NICE Guidance
                                                                April 2010

Guideline   Title                 Summary                                                                                     Implications         Review     Local
No                                                                                                                                                  Date      Action
                                     Clinicians wishing to undertake macular translocation with 360° retinotomy for wet
                                      AMD 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 information about
                                         both this procedure and alternative treatments.
                                       o Audit and review clinical outcomes of all patients having macular translocation
                                         with 360° retinotomy for wet AMD.
IPG341      Prosthetic            This document replaces previous guidance on prosthetic intervertebral disc                     Acute Care Only     -
            intervertebral disc   replacement in the cervical spine (interventional procedure guidance 143).
            replacement in
            the cervical spine       Current evidence on the efficacy of prosthetic intervertebral disc replacement in the
                                      cervical spine shows that this procedure is as least as efficacious as fusion in the
                                      short term and may result in a reduced need for revision surgery in the long term.
                                      The evidence raises no particular safety issues that are not already known in
                                      relation to fusion procedures. Therefore this procedure may be used provided that
                                      normal arrangements are in place for clinical governance, consent and audit.
                                     This procedure should only be carried out in specialist units where surgery of the
                                      cervical spine is undertaken regularly.
                                     NICE encourages further research into prosthetic intervertebral disc replacement in
                                      the cervical spine. Research outcomes should include longterm data on
                                      preservation of mobility, occurrence of adjacent segment disease and the
                                      avoidance of revision surgery.
IPG342      Haemorrhoidal            Current evidence on haemorrhoidal artery ligation shows that this procedure is an          Acute Care Only     -
            artery ligation           efficacious alternative to conventional haemorrhoidectomy or stapled
                                      haemorrhoidopexy in the short and medium term, and that there are no major
                                      safety concerns. Therefore this procedure may be used provided that normal
                                      arrangements are in place for clinical governance, consent and audit.




d657d617-88c3-4e9e-8497-8d2019883237.doc                                                                                                             Page 7