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					                                                                   SHEFFIELD PCT
                                                              Framework of NICE Guidance
                                                                                                                                                          August 2008

Guideline   Title                              Summary                                                                         Implications                  Review    Local
No                                                                                                                                                            Date     Action
TA153       Entecavir for the treatment of     This guidance does not apply to people with chronic hepatitis B who also        NICE state that this         February
            chronic hepatitis B                have hepatitis C, hepatitis D or HIV.                                           guidance is for both           2009
                                                                                                                               acute and primary care.
                                                Entecavir, within its marketing authorisation, is recommended as an
                                                 option for the treatment of people with chronic HBeAg-positive or             Entecavir is currently
                                                 HBeAg-negative hepatitis B in whom antiviral treatment is indicated.          excluded from PbR and
                                                                                                                               remains subject to local
                                                                                                                               negotiation and
                                                                                                                               agreement.

                                                                                                                               NICE state that this
                                                                                                                               guidance is unlikely to
                                                                                                                               result in a significant
                                                                                                                               change in resource use
                                                                                                                               in the NHS.
TA154       Telbivudine for the treatment of   This guidance does not apply to people with chronic hepatitis B who also        NICE state that this         February
            chronic hepatitis B                have hepatitis C, hepatitis D or HIV.                                           guidance is for both           2009
                                                                                                                               acute and primary care.
                                                Telbivudine is not recommended for the treatment of chronic hepatitis
                                                 B.
                                                People currently receiving telbivudine should have the option to
                                                 continue therapy until they and their clinicians consider it appropriate to
                                                 stop.
TA155       Ranibizumab and pegaptanib for      Ranibizumab, within its marketing authorisation, is recommended as an         NICE state that this          August
            the treatment of age-related         option for the treatment of wet age-related macular degeneration if:          guidance is for acute          2011
            macular degeneration                  – all of the following circumstances apply in the eye to be treated:         care only.
                                                      o the best-corrected visual acuity is between 6/12 and 6/96
                                                      o there is no permanent structural damage to the central fovea           NICE state that this
                                                      o the lesion size is less than or equal to 12 disc areas in greatest     guidance is likely to be
                                                          linear dimension                                                     excluded from PbR,
                                                      o there is evidence of recent presumed disease progression
                                                          (blood vessel growth, as indicated by fluorescein angiography,       NICE state that the cost
                                                          or recent visual acuity changes)                                     of implementing this
                                                 and                                                                           guidance in England is:




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                                                                 SHEFFIELD PCT
                                                            Framework of NICE Guidance
                                                                                                                                                        August 2008

Guideline   Title                            Summary                                                                         Implications                  Review   Local
No                                                                                                                                                          Date    Action
                                                 –     the cost of ranibizumab beyond 14 injections in the treated eye is    First Year - £259,000
                                                       met by the manufacturer.                                              Second year - £446,000
                                              It is recommended that treatment with ranibizumab should be
                                                continued only in people who maintain adequate response to therapy.          Per 100,000 population
                                                Criteria for discontinuation should include persistent deterioration in
                                                visual acuity and identification of anatomical changes in the retina that
                                                indicate inadequate response to therapy. It is recommended that a
                                                national protocol specifying criteria for discontinuation is developed.
                                              Pegaptanib is not recommended for the treatment of wet age-related
                                                macular degeneration.
                                              People who are currently receiving pegaptanib for any lesion type
                                                should have the option to continue therapy until they and their clinicians
                                                consider it appropriate to stop.
TA156       Routine antenatal anti-D         NOTE: This guidance replaces ‘NICE technology appraisal guidance 41’            NICE state that this           May
            prophylaxis for women who are    issued in May 2002.                                                             guidance is for both           2011
            rhesus D negative                                                                                                acute and primary care.
                                              Routine antenatal anti-D prophylaxis (RAADP) is recommended as a
                                               treatment option for all pregnant women who are rhesus D (RhD)                NICE state that this
                                               negative and who are not known to be sensitised to the RhD antigen.           guidance is outside
                                              When a decision has been made to give RAADP, the preparation with             PbR.
                                               the lowest associated cost should be used. This cost should take into
                                               account the lowest acquisition cost available locally and costs               NICE indicate that there
                                               associated with administration.                                               is no change regarding
                                                                                                                             to the cost of this
                                                                                                                             recommendation
CG71        Familial hypercholesterolaemia   Diagnosis                                                                       NICE state that this          T.B.C.
                                              A family history of premature coronary heart disease should always be         guidance is for both
                                                assessed in a person being considered for a diagnosis of FH.                 acute and primary care.
                                              In children at risk of FH because of one affected parent, the following
                                                diagnostic tests should be carried out by the age of 10 years or at the      NICE state that this
                                                earliest opportunity thereafter.                                             guidance impacts on
                                                – A DNA test if the family mutation is known.                                PbR.
                                                – LDL-C concentration measurement if the family mutation is not
                                                     known. When excluding a diagnosis of FH a further LDL-C                 NICE calculate that this




286249ab-8522-4ae5-87bc-6168637a037c.doc                                                                                                                   Page 2
                                                               SHEFFIELD PCT
                                                          Framework of NICE Guidance
                                                                                                                                                    August 2008

Guideline   Title                          Summary                                                                         Implications                Review   Local
No                                                                                                                                                      Date    Action
                                                    measurement should be repeated after puberty because LDL-C             guidance will cost the
                                                    concentrations change during puberty.                                  NHS in England:
                                            Coronary heart disease risk estimation tools such as those based on
                                              the Framingham algorithm should not be used because people with FH           First year - £15921
                                              are already at a high risk of premature coronary heart disease.              Second Year - £21318
                                           Identifying people with FH using cascade testing                                Third Year - £26725
                                            Healthcare professionals should offer all people with FH a referral to a
                                              specialist with expertise in FH for confirmation of diagnosis and            Per 100,000
                                              initiation of cascade testing.
                                            Cascade testing using a combination of DNA testing and LDL-C
                                              concentration measurement is recommended to identify affected
                                              relatives of those index individuals with a clinical diagnosis of FH. This
                                              should include at least the first- and second- and, when possible, third-
                                              degree biological relatives.
                                            The use of a nationwide, family-based, follow-up system is
                                              recommended to enable comprehensive identification of people
                                              affected by FH.
                                           Management
                                           Adults
                                            Healthcare professionals should consider prescribing a high-intensity
                                              statin to achieve a recommended reduction in LDL-C concentration of
                                              greater than 50% from baseline (that is, LDL-C concentration before
                                              treatment).
                                           Children and young people
                                            Healthcare professionals should offer all children and young people
                                              diagnosed with, or being investigated for, a diagnosis of FH a referral to
                                              a specialist with expertise in FH in children and young people. This
                                              should be in an appropriate child/young person-focused setting that
                                              meets the standards within the ‘National service framework for children,
                                              young people and maternity services’ (available from www.dh.gov.uk).
                                           Information needs and support
                                           Information and counselling on contraception for women and girls with FH
                                            When lipid-modifying drug therapy is first considered for women and
                                              girls, the risks for future pregnancy and the fetus while taking lipid-




286249ab-8522-4ae5-87bc-6168637a037c.doc                                                                                                               Page 3
                                                                SHEFFIELD PCT
                                                           Framework of NICE Guidance
                                                                                                                                           August 2008

Guideline   Title                            Summary                                                                        Implications      Review   Local
No                                                                                                                                             Date    Action
                                               modifying drug therapy should be discussed. This discussion should be
                                               revisited at least annually.
                                             Ongoing assessment and monitoring
                                             Review
                                              All people with FH should be offered a regular structured review that is
                                               carried out at least annually.
IPG271      Total wrist replacement           There is evidence that total wrist replacement relieves pain, but this is                         -
                                               based on small numbers of patients and there is insufficient evidence
                                               of its efficacy in the long term. The procedure is associated with a risk
                                               of the recognised complications of prosthetic joint replacement.
                                              Therefore total wrist replacement should only be used with special
                                               arrangements for clinical governance, consent and audit or research.
                                              Clinicians wishing to undertake total wrist replacement should take the
                                               following actions.
                                               – Inform the clinical governance leads in their Trusts.
                                               – Ensure that patients understand the possible alternatives to total
                                                     wrist replacement and the uncertainty about its efficacy in the long
                                                     term, such that further surgery may be required, including fusion of
                                                     the wrist joint. They should provide them with clear written
                                                     information.
                                               – Audit and review clinical outcomes of all patients having total wrist
                                                     replacement.
                                              This procedure should be undertaken only on carefully selected
                                               patients, by surgeons with special expertise in interventions for the
                                               hand and wrist.
                                              Further publication of safety and efficacy outcomes will be useful. The
                                               Institute may review the procedure upon publication of further evidence
IPG272      Implantation of miniature lens    Evidence on the efficacy of implantation of miniature lens systems for                            -
            systems for advanced age-          advanced age-related macular degeneration (AMD) shows that the
            related macular degeneration       procedure can improve both vision and quality of life in the short term.
                                               Short-term safety data are available for limited numbers of patients.
                                              There is currently insufficient long-term evidence on both efficacy and
                                               safety. Therefore this procedure should only be used with special
                                               arrangements for clinical governance, consent and audit or research.




286249ab-8522-4ae5-87bc-6168637a037c.doc                                                                                                      Page 4
                                                                    SHEFFIELD PCT
                                                               Framework of NICE Guidance
                                                                                                                                                       August 2008

Guideline   Title                                Summary                                                                       Implications                Review   Local
No                                                                                                                                                          Date    Action
                                                  Clinicians wishing to undertake implantation of miniature lens systems
                                                    for advanced AMD should take the following actions.
                                                    – Inform the clinical governance leads in their Trusts.
                                                    – Ensure that patients understand the need to adapt to having a lens
                                                         system implanted into one eye, the risk of early complications and
                                                         the uncertainties about long-term efficacy and safety. They should
                                                         provide clear information.
                                                    – Audit and review clinical outcomes of all patients having
                                                         implantation of miniature lens systems for advanced AMD.
                                                  Patient selection is crucial and should include detailed assessment to
                                                    predict the patient’s ability to process visual stimuli following the
                                                    operation.
                                                  Further publication of safety and efficacy outcomes would be useful,
                                                    specifically with regard to longer term follow-up. The Institute may
                                                    review the procedure upon publication of further evidence.
PSG002      Technical patient safety solutions   Mechanically ventilated patients who are intubated should be positioned       NICE state that this        T.B.C.
            for ventilator-associated            with their upper body elevated (in a semi-recumbent or seated position) for   guidance is for acute
            pneumonia in adults                  as much of the time as possible. For some patients this will not be           care only.
                                                 appropriate (for example, those with spinal injuries).
                                                 Oral antiseptics (for example, chlorhexidine) should be included as part of   This pilot recommends
                                                 the oral hygiene regimen for all patients who are intubated and receiving     the position of patients
                                                 mechanical ventilation.                                                       who are mechanically
                                                                                                                               ventilated and intubated,
                                                                                                                               and the use of oral
                                                                                                                               antiseptic. Critical care
                                                                                                                               services are currently
                                                                                                                               outside the scope of
                                                                                                                               PbR.




286249ab-8522-4ae5-87bc-6168637a037c.doc                                                                                                                   Page 5

				
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