Documents
Resources
Learning Center
Upload
Plans & pricing Sign in
Sign Out

Guideline

VIEWS: 7 PAGES: 8

									                                                                 NHS Sheffield
                                                           Framework of NICE Guidance
                                                                   July 2011
Guideline   Title                     Summary                                                                               Implications                    Review     Local
No                                                                                                                                                           Date      Action
TA228       Bortezomib and            1 Thalidomide in combination with an alkylating agent and a corticosteroid is         NICE state that this is        July 2014
            thalidomide for the       recommended as an option for the first-line treatment of multiple myeloma in          excluded from PbR
            first-line treatment of   people for whom high-dose chemotherapy with stem cell transplantation is
            multiple myeloma          considered inappropriate.

                                      2 Bortezomib in combination with an alkylating agent and a corticosteroid is          Implementation support:-
                                      recommended as an option for the first-line treatment of multiple                     Costing tool and template
                                      myeloma if:                                                                           Audit tool
                                      • high-dose chemotherapy with stem cell transplantation is considered
                                      inappropriate and
                                      • the person is unable to tolerate or has contraindications to thalidomide.
TA229       Dexamethasone             1 Dexamethasone intravitreal implant is recommended as an option for the              NICE do not state whether      Jan 2100
            intravitreal implant      treatment of macular oedema following central retinal vein occlusion.                 this impacts on PbR or not.
            for the treatment of
            macular oedema            2 Dexamethasone intravitreal implant is recommended as an option for the              The cost of the drug per 700
            secondary to retinal      treatment of macular oedema following branch retinal vein occlusion when:             microgram injection is £870
            vein occlusion            • treatment with laser photocoagulation has not been beneficial, or
                                      • treatment with laser photocoagulation is not considered suitable because of         Implementation support:-
                                          the extent of macular haemorrhage.                                                Costing template

                                      3 People currently receiving dexamethasone intravitreal implant for the
                                      treatment of macular oedema secondary to branch retinal vein occlusion
                                      who do not meet the criteria specified in 2 above should have the option to
                                      continue treatment until they and their clinicians consider it appropriate to stop.
TA230       Bivalirudin for the       Bivalirudin in combination with aspirin and clopidogrel is recommended for the        NICE do not state whether      July 2014
            treatment of ST-          treatment of adults with ST-segment-elevation myocardial infarction                   this impacts on PbR or not.
            segment-elevation         undergoing primary Percutaneous coronary intervention.
            myocardial infarction                                                                                           Implementation support:-
                                                                                                                            Costing tool and template
                                                                                                                            Audit tool
TA231       Agomelatine for the       NICE is unable to recommend the use in the NHS of agomelatine for the                 N/A                            Jan 2100
            treatment of major        treatment of major depressive episodes because no evidence submission was
            depressive episodes       received from the manufacturer or sponsor of the technology.
            (terminated
            appraisal)




783a2f62-61af-4b7e-9364-f511685c0df0.doc                                                                                                                                1
                                                                NHS Sheffield
                                                          Framework of NICE Guidance
                                                                  July 2011
Guideline   Title                    Summary                                                                              Implications                      Review     Local
No                                                                                                                                                           Date      Action
TA232       Retigabine for the       Retigabine is recommended as an option for the adjunctive treatment of partial       NICE do not state whether          June
            adjunctive treatment     onset seizures with or without secondary generalisation in adults aged 18            this impacts on PbR or not.        2014
            of partial onset         years and older with epilepsy, only when previous treatment with
            seizures in epilepsy     carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam,                     Implementation support:
                                     oxcarbazepine, sodium valproate and topiramate has not provided an                   Costing statement
                                     adequate response, or has not been tolerated.
CG125       Peritoneal dialysis      The recommendations are presented in algorithm form so please refer to the           NICE state this will impact on   July 2014
            Peritoneal dialysis in   following document for further clarification at                                      PbR
            the treatment of         http://www.nice.org.uk/nicemedia/live/13524/55496/55496.pdf
            stage 5 chronic                                                                                               Implementation support:-
            kidney disease           Recommendations:-                                                                    Baseline assessment tool
                                     Information and support                                                              Costing report
                                     1.1.1 Offer patients with stage 5 chronic kidney disease (CKD) and their             Costing template
                                     families and carers information and support in line with ‘Chronic kidney             Slide set
                                     disease’ (NICE clinical guideline 73, 2008).                                         Clinical case scenarios
                                     1.1.2 Offer patients and their families and carers oral and written information
                                     about pre-emptive transplant, dialysis, and conservative care to allow them to
                                     make informed decisions about their treatment.
                                     1.1.3 To enable patients to make informed decisions, offer balanced and
                                     accurate information about all dialysis options. The information should include:
                                      a description of treatment modalities (assisted automated peritoneal
                                         dialysis [aAPD], automated peritoneal dialysis [APD], continuous
                                         ambulatory peritoneal dialysis [CAPD], and home or in-centre
                                         haemodialysis) including:
                                           - efficacy
                                           - risks
                                           - potential benefits, based on the person’s prognosis
                                           - potential side effects and their severity
                                           - changing the modality of dialysis and the possible consequences (that
                                              is, the impact on the person’s life or how this may affect future
                                              treatment or outcomes)
                                      a discussion about how treatment fits into people’s lives, including:
                                           - the patient's and/or carer's ability to carry out and adjust the treatment
                                              themselves
                                           - integration with daily activities such as work, school, hobbies, family




783a2f62-61af-4b7e-9364-f511685c0df0.doc                                                                                                                                2
                                                         NHS Sheffield
                                                   Framework of NICE Guidance
                                                           July 2011
Guideline   Title             Summary                                                                            Implications   Review   Local
No                                                                                                                               Date    Action
                                      commitments and travel for work or leisure
                                   - opportunities to maintain social interaction
                                   - the impact on body image
                                   - how the dialysis access point on the body may restrict physical activity
                                   - if their home will need to be modified to accommodate treatment
                                   - distance and time spent travelling for treatment
                                   - flexibility of treatment regimen
                                   - any additional support or services that might be needed from others.

                              1.1.4 Explain to patients and check they understand that CKD is a lifelong
                              disease, and that during the course of renal replacement therapy they are
                              likely to need to switch between treatment modalities depending on clinical or
                              personal circumstances.
                              1.1.5 When providing information about treatment options, healthcare
                              professionals should discuss and take into account any information the patient
                              has obtained from other patients, families and carers and all other sources,
                              and how this information has influenced their decision.
                              1.1.6 Make sure that healthcare professionals offering information have
                              specialist knowledge about CKD and the necessary skills to support decision-
                              making. This may include training in:
                               using decision aids to help patients make decisions about their care and
                                   treatment
                               presenting information to children in a form suitable for their
                                   developmental stage, such as play therapies.

                              1.1.7 Trained healthcare professionals (see recommendation 1.1.6) should be
                              available to discuss the information provided both before and after the start of
                              dialysis.
                              1.1.8 Offer all patients who have presented late, or started dialysis treatment
                              urgently, an enhanced programme of information, at an appropriate time, that
                              offers the same information and choices as those who present at an earlier
                              stage of chronic kidney disease.

                              Choosing dialysis
                              1.1.9 Offer all people with stage 5 CKD a choice of peritoneal dialysis or




783a2f62-61af-4b7e-9364-f511685c0df0.doc                                                                                                  3
                                                               NHS Sheffield
                                                         Framework of NICE Guidance
                                                                 July 2011
Guideline   Title                   Summary                                                                              Implications            Review   Local
No                                                                                                                                                Date    Action
                                    haemodialysis, if appropriate, but consider peritoneal dialysis as the first
                                    choice of treatment modality for:
                                     children 2 years old or younger
                                     people with residual renal function
                                     adults without significant associated comorbidities.

                                    1.1.10 When discussing choice of treatment modalities, healthcare
                                    professionals should take into account that people’s priorities are not
                                    necessarily the same as their own clinical priorities.
                                    1.1.11 Before starting peritoneal dialysis, offer all patients a choice, if
                                    appropriate, between CAPD and APD (or aAPD if necessary).
                                    1.1.12 For children for whom peritoneal dialysis is appropriate, offer APD in
                                    preference to CAPD if they are on a liquid diet, especially if they have low
                                    residual renal function.

                                    Switching treatment modalities
                                    1.1.13 Do not routinely switch patients on peritoneal dialysis to a different
                                    treatment modality in anticipation of potential future complications such as
                                    encapsulating peritoneal sclerosis. However, healthcare professionals should
                                    monitor risk factors such as loss of ultrafiltration and discuss with patients
                                    regularly the efficacy of all aspects of their treatment.
                                    1.1.14 Consider switching treatment modality if the patient, their family or carer
                                    asks.
                                    1.1.15 When considering switching treatment modality, offer information on
                                    treatment options described in recommendations 1.1.1–1.1.8. This should also
                                    include how any decision to switch may affect future treatment options.
                                    1.1.16 Switching between treatment modalities should be planned if possible.

IPG401      Selective internal      This document replaces previous guidance on Selective internal radiation             Arrangement - Special
            radiation therapy for   therapy for colorectal metastases in the liver (interventional procedure
            non-resectable          guidance 93).
            colorectal
            metastases in           1.1 Current evidence on the safety of selective internal radiation therapy
            the liver               (SIRT) for non-resectable colorectal metastases in the liver is adequate.
                                    1.2 The evidence on its efficacy in chemotherapy-naïve patients is inadequate




783a2f62-61af-4b7e-9364-f511685c0df0.doc                                                                                                                   4
                                                         NHS Sheffield
                                                   Framework of NICE Guidance
                                                           July 2011
Guideline   Title             Summary                                                                               Implications   Review   Local
No                                                                                                                                  Date    Action
                              in quantity. Clinicians should offer eligible patients who have not been
                              previously treated by chemotherapy entry into well-designed research studies
                              such as the FOXFIRE trial (www.octo-oxford.org.uk/alltrials/
                              trials/FOXFIRE). For patients who are not eligible or who prefer not to enter a
                              research trial, the procedure should be used with special arrangements for
                              clinical governance, consent and audit.
                              1.3 For patients who have previously been treated with chemotherapy, there is
                              evidence that SIRT can prolong time to progression of hepatic metastases, but
                              more evidence is required on survival and quality of life (see section 1.7).
                              Therefore for patients who have been previously treated with chemotherapy
                              this procedure should be used with special arrangements for clinical
                              governance, consent and audit.
                              1.4 Clinicians undertaking the procedure for patients outside research studies
                              should take the following actions.
                              • Inform the clinical governance leads in their Trusts.
                              • Ensure that patients and their carers 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/guidance/IPG401/publicinfo).
                              • Audit and review clinical outcomes of all patients having SIRT for non-
                                  resectable colorectal metastases (see section 3.1).
                              1.5 Patients should be selected for SIRT or entry into trials by a hepatobiliary
                              cancer multidisciplinary team including an interventional
                              radiologist, in liaison with a colorectal cancer multidisciplinary team.
                              1.6 SIRT should only be carried out by clinicians with specific training in its use
                              and in techniques to minimise the risk of side effects of the procedure.
                              1.7 The Committee considered that SIRT is a potentially beneficial treatment
                              for patients with non-resectable colorectal metastases in the liver, but that
                              more research and data collection are required to demonstrate its efficacy. A
                              recommendation about research trials for chemotherapy-naïve patients is
                              given in 1.2 above. For patients who have previously been treated with
                              chemotherapy, comparative trials are needed to determine whether SIRT
                              prolongs survival compared with best standard treatment, and to determine its
                              effect on quality of life. There is also a need to identify which subgroups of




783a2f62-61af-4b7e-9364-f511685c0df0.doc                                                                                                     5
                                                               NHS Sheffield
                                                         Framework of NICE Guidance
                                                                 July 2011
Guideline   Title                   Summary                                                                               Implications           Review   Local
No                                                                                                                                                Date    Action
                                    patients are likely to derive clinical benefit from SIRT. Research studies should
                                    clearly describe the characteristics of treated patients, and the extent and
                                    histological details of their tumours. Outcomes should include survival and
                                    quality of life. Downstaging of metastases allowing resection or ablation should
                                    be clearly documented.
                                    1.8 NICE may review the procedure on publication of further evidence.
IPG402      Percutaneous            This document replaces previous guidance on cryotherapy for renal cancers             Arrangement - Normal
            cryotherapy for renal   (interventional procedure guidance 207).
            cancer
                                    1.1 Current evidence on the efficacy and safety of percutaneous cryotherapy
                                    for renal cancer is adequate to support the use of this procedure provided that
                                    normal arrangements are in place for clinical governance, consent and audit.
                                    1.2 This procedure should only be offered after assessment by a specialist
                                    urological cancer multidisciplinary team.
                                    1.3 NICE encourages collection and publication of data on the outcomes of
                                    this procedure in the long term. Further research should compare the long-
                                    term outcomes of cryotherapy with those of other treatments for renal cancer.
IPG403      Open femoro–            This document replaces previous guidance on open femoro–acetabular                    Arrangement - Normal
            acetabular surgery      surgery for hip impingement syndrome (interventional procedure guidance
            for hip impingement     203).
            syndrome
                                    1.1 Current evidence on the efficacy of open femoro–acetabular surgery for
                                    hip impingement syndrome is adequate in terms of symptom relief in the short
                                    and medium term. With regard to safety, there are well recognised
                                    complications. Therefore this procedure may be used provided that normal
                                    arrangements are in place for clinical governance, consent and audit with local
                                    review of outcomes.
                                    1.2 The British Hip Society is establishing a register for open femoro–
                                    acetabular surgery for hip impingement syndrome and clinicians should
                                    submit details of all patients undergoing this procedure to the register once it is
                                    available. One of the main purposes of the register is to provide information
                                    about long-term outcomes. It is important that both the register and other
                                    studies report details of patient selection to allow clear understanding of these
                                    outcomes.
                                    1.3 Open femoro–acetabular surgery for hip impingement syndrome involves




783a2f62-61af-4b7e-9364-f511685c0df0.doc                                                                                                                   6
                                                             NHS Sheffield
                                                       Framework of NICE Guidance
                                                               July 2011
Guideline   Title                 Summary                                                                             Implications                   Review   Local
No                                                                                                                                                    Date    Action
                                  major surgery with the potential for serious complications and should only be
                                  undertaken by surgeons who are well-trained and highly experienced in this
                                  type of procedure.
IPG404      Endoluminal           This document replaces previous guidance on endoluminal gastroplication             Arrangement - Special
            gastroplication for   forgastro-oesophageal reflux disease (interventional procedure guidance 115).
            gastro-oesophageal
            reflux disease        1.1 The evidence on endoluminal gastroplication for gastro-oesophageal reflux
                                  disease (GORD) raises no major safety concerns. Evidence from a number of
                                  randomised controlled trials (RCTs) shows a degree of efficacy in terms of
                                  reduced medication requirement in the short term, but changes in other
                                  efficacy outcomes are inconsistent and there is no good evidence of sustained
                                  improvement in oesophageal pH measurements. Therefore, this procedure
                                  should only be used with special arrangements for clinical governance,
                                  consent and audit or research.
                                  1.2 Clinicians wishing to undertake endoluminal gastroplication for GORD
                                  should take the following actions.
                                      • Inform the clinical governance leads in their Trusts.
                                      • Ensure that patients and their carers understand the uncertainty about the
                                         procedure’s efficacy, particularly in the long term, 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/guidance/IPG404/publicinfo).
                                      • Audit and review clinical outcomes of all patients having endoluminal
                                         gastroplication for GORD (see section 3.1).
                                  1.3 Any further studies should include measurements of oesophageal pH and
                                  report long-term outcomes.
MTG5        The MIST Therapy      1.1 The MIST Therapy system shows potential to enhance the healing                  NICE state they are unable
            system for the        of chronic, ‘hard-to-heal’, complex wounds, compared with standard methods          to predict the impact on PbR
            promotion of wound    of wound management. If this potential is substantiated then MIST could offer
            healing               advantages to both patients and the NHS.                                            MIST therapy is a device for
                                  1.2 The amount and quality of published evidence on the relative effectiveness      the treatment for chronic
                                  of the MIST Therapy system is not sufficient, at the time of writing, to support    hard to heal complex
                                  the case for routine adoption of the MIST Therapy system in the NHS.                wounds. It is estimated
                                  1.3 Comparative research is recommended in the UK to reduce uncertainty             approximately 165,000




783a2f62-61af-4b7e-9364-f511685c0df0.doc                                                                                                                       7
                                                           NHS Sheffield
                                                     Framework of NICE Guidance
                                                             July 2011
Guideline   Title               Summary                                                                              Implications                    Review   Local
No                                                                                                                                                    Date    Action
                                about the outcomes of patients with chronic, ‘hard-toheal’, complex wounds           patients may be affected by
                                treated by the MIST Therapy system compared with those treated by standard           this.
                                methods of wound care. This research should define the types and chronicity
                                of wounds being treated and the details of other treatments being used. It           This recommendation is not
                                should report healing rates, durations of treatment (including debridement)          intended to preclude the use
                                needed to achieve healing, and quality of life measures (including quality of life   of the technology in the NHS
                                if wounds heal only partially). It is recommended that centres using the MIST        but to identify further
                                Therapy system take part in research that delivers these outcomes. Current           evidence which, after
                                users of the MIST Therapy system who are unable to join research studies             evaluation, could support a
                                should use NICE’s audit criteria to collect further information on healing rates,    recommendation for wider
                                duration of treatment and quality of life and publish their results.                 adoption.
                                1.4 NICE will review this guidance when new and substantive evidence
                                becomes available
MTG6        Ambulight PDT for   Ambulight PDT offers a means of delivering photodynamic therapy (PDT) for            NICE state this will not
            the treatment of    patients with small non-melanoma skin cancers in an ambulatory care setting,         impact on PbR
            non-melanoma        including patients’ homes, and its use may be associated with less pain than
            skin cancer         conventional PDT.                                                                    No change in current practice
                                However, the case for routine use of Ambulight PDT in achieving a more               is anticipated and therefore
                                efficient service is not supported by the evidence submitted by the                  there are no funding
                                manufacturer. The quantity of clinical evidence on its use is limited and the        considerations associated
                                cost consequences of adoption, when compared with conventional PDT,                  with this guidance
                                ranged from a saving (per patient) of £195 to a cost increase of £536.
                                NHS organisations should take this into account, alongside other features of         The specific
                                the technology, when considering whether to use Ambulight PDT.                       recommendations on
                                                                                                                     individual technologies are
                                                                                                                     not intended to limit use of
                                                                                                                     other relevant technologies
                                                                                                                     which may offer similar
                                                                                                                     advantages.




783a2f62-61af-4b7e-9364-f511685c0df0.doc                                                                                                                       8

								
To top