MINUTES OF THE 137th MEETING OF THE THERAPEUTIC ADVISORY SERVICE Held on Tuesday, 26th February 2013 Apologies: Prof I Squire, Ms C Clarke, Dr L Dabydeen, Mr P Golightly, Dr P Topham, Dr A Palfreeman, Mr M Qualie, Dr B Collett, Ms L Gant, Mr D Harris, Ms J Islam, Mrs S Khalid
1 Minutes of last Meeting Dr N Langford and Ms B Pattani attended, with these additions Minutes approved Matters arising Dabigatran / Rivaroxaban update Members were given an update on the managed entry progress for these drugs. It was also noted that the FAD for apixaban supports use. Stroke and haematology consultants reported that they had identified small numbers of patients who would benefit from use who currently were not included in local criteria. It was agreed that an “other” box should be included on the new drug forms with justification required. However this should only include NICE criteria at present. Local guidance and potential recommended choices will be updated when audit data is supplied and reviewed. A request from Dr Strong to extend prescribing to nurse prescribers in the DVT clinic was not supported until there is more experience of use / traffic light status moves to green. Action: Subject to LMSG endorsement KC to amend forms and advise approved prescribers. KC to feedback to Dr Strong
Pramipexole SR audit Members had requested more data on outcome measures and benefits but feedback from neurology is that this data is not recorded routinely. Members noted that cost differential between standard and sustained release products could be up to £2000 per annum per patient and as 24 patients were prescribed the SR product in a 6/12 period this has a substantial cost impact. The committee needs to be reassured that benefits are being realised. It was agreed that prospective audit should take place with a baseline assessment of symptoms and review to show changes using e.g. an appropriate Parkinson’s disease assessment tool. TAS Decision: Further information required as detailed Action: KC to advise Dr Critchley Salofalk granules audit Members had requested further details of outcome measures from Professor Jankowski. He has advised that he is no longer in a position to collect this data. Dr DeCaestecker has reported that Salofalk granules are being used and effective and have a lower cost than the previously used product, Pentasa. Members agreed that it was appropriate to continue use without further audit. Action: KC to feedback to GI consultants and reinforce formulary choices New Product Requests
8Y factor VIII for TTP requested by Dr Gooding (Consultant Haematologist) Members noted that although evidence is limited to case reports, outcomes were positive without adverse effects. Shorter duration time for administration and possibility of home administration would be a significant benefit to the patient. Governance issues of homecare would need to be acceptable to the homecare team TAS decision: Supported for use subject to homecare team assessment Action: KC to advise requestor, CBU lead and homecare pharmacist For a full review of this product and supporting papers relating to this submission visit www.tas-leicester.org Tocilizumab (without methotrexate) for Rheumatoid Arthritis requested by Dr Kinder (Consultant Rheumatologist) Members noted that since a negative verdict by NICE TA247, trials have been undertaken which show efficacy in patients who were intolerant to methotrexate or where continued use of methotrexate is inappropriate. The SMC has also supported use and it has been confirmed that patient access scheme conditions will also apply to this indication TAS decision: Supported for use as above Action: KC to advise requestor and liaise with CCGs for funding support For a full review of this product and supporting papers relating to this submission visit www.tas- leicester.org Fampridine for Multiple Sclerosis requested by Dr Nikfekr (Consultant Neurologist). Members agreed that that the evidence for efficacy was very limited even in the third of patients who responded to treatment. Side effects of note included falls, insomnia and fatigue and those causing discontinuation of treatment in one study included ankle fracture, balance disorder confusional state and dizziness.
TAS decision: Not supported for use Action: NL to advise requestor For a full review of this product and supporting papers relating to this submission visit www.tas- leicester.org
Dexmedetomidine for sedation in one child requested by Mr Peek. A full application has been requested
Rituximab in ILD requested by due to dermatomyositis requested by Dr
Amikacin eye drops for atypical mycobacterial keratitis requested by Mr Savant. A full application has been requested
Members endorsed the Chairman’s action to support the above in one patient only
Recent NICE Guidance
TA 271 Diabetic macular oedema: Fluocinoone acetonide intravitreal implant. Not supported by NICE, not currently used at UHL
TA 272 Urothelial tract carcinoma: vinflunine, not recommended. Not used at UHL
TA 273 Hyperplasia (benign prostatic) – tadalafil (terminated appraisal). Not used at UHL
TAS decision for above: Not supported for use
Outstanding TAs: the only NICE TAs where drugs are not currently in use at UHL are TA 157/170/245 dabigatran, rivaroxaban and apixaban for use post hip and knee surgery. Use of abatacept as part of TA 195 will be reviewed when NICE produces further TAS Audit
Wilate (Dr Pavord): Members acknowledged submission of audit data for 2 patients where this has been used and asked that audit data continues to be collected over the next 12 months in order to assess more fully Action: KC to advise Dr Pavord
Eczmol (Dr Alexandroff): Members noted that where use was in line with TAS approval outcomes were positive in 80% of cases. There had been considerable use outside of approved indications and outcomes were much poorer. Use should be within in the approved indications only and further audit data is required in 6 months. Action: Alexandroff
Acenocoumarol ( Salinder Gill) Members noted that use was appropriate and as anticipated with good outcomes No further action required
MHRA Drug Safety Updates January 13 – suggested actions accepted.
AOB Terms of Reference Minor changes accepted Action: KC to forward to Medicines Management Board /LMSG for endorsement Date and Time of Next Meeting Date: 16th April 2013 Time: 4pm Place: Beech Room Knighton Street Office, LRI
DC-DC Step-Up Converter for White LED DESCRIPTION APPLICATIONS The SP1938 is a step-up DC/DC converter for white LED driver with over voltage protection. The device can driver one to four LEDs in series from a single cell Internal functions include current limiting; thermal shutdown; OVP and soft-start to prevent damage operate status. The SP1938 operates at 0.8MHz and from low
Gail A Greendale, Nancy P Lee, Edgar R Arriola Menopause is diagnosed after 12 months of amenorrhoea resulting from the permanent cessation of ovarian function. The mean age at menopause is 51 years. The perimenopause, a time of changing ovarian function, precedes the finalmenses by several years. The physiology and clinical manifestations of this transition to menopause are not wellunderstood;
MINUTES OF THE 137th MEETING OF THE