South East London Area Prescribing Committee (APC) 13 June 2013 Final approved minutes 1. Welcome and Introductions and Apologies received. 2. Conflicts of Interest declarations HS clarified the understanding of what is expected to be declared. The declaration is there to protect members of the APC and demonstrates to the public that the influence of the pharmaceutical industry has been considered by this committee: a. Any support by the pharmaceutical industry for educational events or research to be declared as referenced in Enclosure B; b. Declarations should be made at the start of the meeting regarding items on the agenda in order that members are given the opportunity to comment on the appropriateness of attendance whilst discussing that item. All returns, including nil returns to be sent to Medicines Management Team at lamccg.medicinemanagement@nhs.net or by post to 1 Lower Marsh, SE1 7NT. 3. Minutes of Last Meeting. NK asked for a correction to the minutes that he represents SLHT and not QEW. MS highlighted that PCTs were still in existence and were only CCGs in shadow form. A note will be added to the minutes to this effect. Action VB/KM 4. Action Log -Matters Arising i. HS is awaiting a response with regard to the involvement of NHS Commissioning Board Action: HS ii. Lay representation. SC to contact Healthwatch organisations when all contact details known. Action: SC iii. Public Website. VB advised work is ongoing to establish a public website for APC minutes and queried whether these should be anonymised or not. Discussions are also taking place regarding an intranet site for the uploading of documents. This is a work in progress. Concerns were raised with regard to these being easily available and not accessed by having to have yet another password log-in. A password protected link should be available, i.e. as is available to CCGs to the GSTT website Action: VB/AER iv. SEL Clinical Strategy review group. AE agreed a six monthly APC report to this committee would be appropriate. 1
v. MOU. SC to discuss with AE. She has approached SE London Collaborative Commissioning PMO to put addendum to collaboration agreement to six CCGs Action: SC vi. Transfer of Care documents. Discussed as agenda item 5 vii. New Drugs Panel. The NDP will meet for the first time on 18 th July, chaired by AG & MK to assess any new drug applications prioritised via triage. CA asked if templates were agreed for the new drug forms as SLHT s comments had not been included. The draft has combined various organisations forms however it will evolve over time and therefore these comments should be considered at the next review. Action: MK/AG 5. SLCSN Guidance for approval presented by Anna Hodgkinson (AH) All enclosed guidance has been received by acute Trusts and CCG prescribing leads or committees for comments. 5.1 Prescribing Ivabradine as an adjunct for the management of on-going symptoms in patients with chronic stable angina. A request was made for the guidance to state that there is separate network guidance on the use of ivabradine in heart failure pending amendment above Action: HW The purpose of such guidance was queried as NICE TAs or guidelines exist for most of these drugs. However the committee was advised that although it is statutory for CCGs to implement NICE TAs, NICE does not generally specify a drug s place in therapy but simply that it is an option. Individual medicines committees should think about how they are working with partners and practices to try and influence implementation of guidelines. It would be useful to know that guidelines have passed through all appropriate routes before coming to the APC. At this stage of the meeting the Chair asked that in future a front sheet is appended to papers advising which groups papers have passed through, their comments, and what is being asked of the APC. Action: VB/KM 5.2 Guidance on the use of apixaban for stroke prevention in AF. This guidance follows NICE TA, to be considered in line with its licensed indications as an alternative to warfarin for SPAF in patients with CHADS 2 1 who are unstable on warfarin therapy. A comment was made that as there are now three sets of guidance for three new drugs in this indication, can the Network advise on 1 st /2 nd /3 rd line agents. The Committee was advised that the network plan to amalgamate these three sets of guidance into a treatment algorithm for providers. Action: HW 2
This raised the suggestion that a treatment pathway incorporating guidance with a checklist is required for GPs to follow. HS has spoken to NICE about the possibility of having a pathway tool on a GP computer system. AG advised that EMIS Web shows a link to NICE guidance but cannot link to local guidance which is what would be more effective. The Chair asked that a working group of the APC scope out if it is possible, what resources would be required and put pressure on those that could influence change. MS offered to set up a sub-group which must include IT and clinicians. Other interested volunteers were RM/CF Action: MS to lead the working group. Note : AE raised via Community Based Care IT workstream. 5.3. Prescribing of ranolazine as an adjunct for the management of on-going symptoms in patients with chronic stable angina 5.4. It was not clear this drug should be initiated by a specialist i.e. AMBER, and at what point GPs would take on the prescribing.. Action: HW to review adding this to the document. 5.5. SLCSN combined algorithm for lipid management The algorithm was updated in December 2012 with a review due in June 2013. Changes have been made now that atorvastatin can be used as alternative if simvastatin 40mg is not tolerated. The MHRA guidance on simvastatin interactions has also been added. This raised the issue of how long is a guidance approved for. It was agreed to review after three years, unless there is a significant change in evidence or national guidance. It was agreed that if changes are required due to NICE guidance amendments that Chair s action be sought if this occurs before the next APC meeting is due. The appropriate risk tool to be used was discussed. NHS health checks and the network advocate JBS and thus it would be useful to add this to the guidance as the results are so variant according to the tool used.. The Network to be asked to clarify the current situation regarding JBS 3. Action: HW 3
5.6. Lipid Management for Familial Hyperlipidaemia in Adults The algorithm applies only to adults with familial hyperlipidaemia. Of note, there is a separate diagnostic pathway. 5.7. Lipid Management in patients following an Acute Coronary Syndrome If atorvastatin 40-80mg is contraindicated or not tolerated a lower dose or an alternative agent is suggested. 5.8. Lipid Management for Primary Prevention of Cardiovascular Disease 5.9. Lipid Management for the Secondary Prevention of Cardiovascular Disease Minor typographical error to be amended (top box of flow chart) otherwise 5.10. Prescribing Anti-Platelet Agents following an Ischaemic Stroke or TIA The guidance clarifies NICE TAs, with use of clopidogrel monotherapy being first line post stroke. Post TIA NICE recommends use of aspirin/dipyridamole. However, the Royal College of Physicians recommends the use of clopidogrel monotherapy post TIA on the basis that stroke and TIA are different manifestations of the same disease and should be treated in a uniform manner. There was concern that this could mean that CCGs would not be complying with NICE but that clinically this seemed appropriate and therefore CCGs should be made aware of this in the guidance. There is no consensus regarding risk of co-prescribing omeprazole and esomeprazole with clopidpogrel (no matter what salt used) and therefore it was agreed to accept the guidance as it stood but to review if there was any change in the evidence base. 5.11. Rivaroxaban for treatment of acute DVT and secondary prevention of VTE The Committee was asked for agreement on the Transfer of Prescribing Responsibility form, which has been produced based on the AF form, and the Screening Checklist and Notification of Initiation to GP. The papers have been produced for Kings/ GSTT and Lewisham only as SLHT clinicians do not propose to use it first line at the present time (they will continue to use warfarin). There was discussion regarding how we promote a uniform approach not only within the merging trusts but also across the SEL CCGs. A minor typographical error on page 2 4
was noted duraction for duration., subject to noted comment, FOR LSL/GST/KCH/LHT 6. Dementia Shared Care Guideline Proposal SLAM clinician presented the proposed shared care guideline, which is a Lambeth and Southwark proposal.. He has met with consultant psychiatrists in Southwark and Lambeth memory and older people clinics. Lambeth have discussed with the LMC and JS. The expectation is that the guidelines provide sufficient information to enable GPs to be confident to take clinical responsibility for both initiating and the ongoing prescribing of these drugs. JS advised that it is expected that 90% of GPs in Lambeth and Southwark would initiate prescribing. There are changes within the country with regard to services surrounding dementia drugs which are not as complex as thought when originally introduced and are generally well tolerated. Lewisham advised that they have a pharmacist who works with the memory clinic but there is concern that this is not just about prescribing but how a patient is managed in a pathway. GPs do not have the skill to initiate and monitor. In primary care there is desire to help but there is an educational need and time constraints. It requires support with a commissioning element. There was concern about the level of knowledge in primary care at undertaking cognitive checks and the reproducibility of results. In one practice a practice nurse could produce very different scores to another practice nurse for the same patient. It was felt that scoring in memory clinics would result in more reproducible and hence meaningful individual scores. The principles outlined in the shared care agreement were agreed for Lambeth and Southwark CCGs. The detail of the shared care guideline should be finally approved via the DTC at SLAM. SLAM to also consider the comments regarding cognitive checks. Action : JS AB raised concerns that this issue had not been discussed with memory clinics serving BBG and Lewisham before being brought to this meeting. There is no representative present from the memory clinics in the BBG area. Action: JS/AB to discuss with B,B,G & Lewisham memory clinics & services along with B,B,G and Lewisham CCGs with a view to ultimately moving towards a common agreement across SEL. 7. Shared care guidelines for IBD Proposal The proposal, is to determine acceptability to local GPs and gauge interest in taking over prescribing and monitoring responsibility for those patients that have been stable for at least 4 months. This will improve patient experience and create capacity in clinics. The shared care agreement provides guidance for practices who are willing to undertake 5
ongoing monitoring, however the clinic would retain this where the practice was unwilling. However, it was suggested that a number of SCAs create significant extra work especially where monitoring is required without extra resources and the view of the LMC should be sought regarding activity flows follow from secondary care into primary care. However it was noted that funding for ongoing monitoring was not within tariffs paid to secondary care. DA advised that a funding for shared care guidelines for rheumatology DMARD prescribing have been agreed and some other CCGs also noted that this was in place locally. SLHT asked if this has been discussed with other Trust s gastroenterologists and were advised that it was discussed with Guy s and St Thomas. It was noted that the APC is still picking up pieces of work initiated and provisionally agreed before the existence of the APC, thus we do need to accept a pace of change model. AE noted that whilst all future papers should undergo full consultation across SEL, the APC needs to be flexible enough to move at a fast pace for early adopters where this is felt to be appropriate. Several issues were discussed with regard to monitoring: blood tests results in Greenwich are not shared between from QEW to GPs, but are shared from GP to QEW. Same between GSTT/ Kings and BBG. what is a decline in renal failure titration must be more specific rather than up or down patients must be stabilised before transfer, as there is often creep patients and GPs need appropriate access to specialist support out of hours and at weekends. The Committee was advised that there is an IBD helpline and email address which is given to patients and is on their letterhead. it was also suggested that patients should be encouraged to take ownership of their care which would include monitoring. A vote was taken at the meeting as to whether in principle the SCG once ratified could be used by GPs who would be willing to participate in shared care :. 17 in favour with 2 against. Principles of Shared Care Guideline, with amendments and comments as noted. Action: BH - Final Shared Care Guideline to be formally ratified via Trust DTCs (GSTT and KCH) It was agreed that discussions should ideally take place amongst all gastro specialists within SEL trusts, working alongside the 6 CCGs to achieve consistency in approach. Regarding this, Post meeting, 13 th June 2013.: Dear all 6
After the Medicines Management meeting today, I realised that there was a fundamental misunderstanding that I failed to pick up on. These shared care guidelines are intended for patients under the care of King s and GSTT only, as we have agreed a common protocol and work closely together. I echo the concerns of some of the panel members regarding guideline creep. This would be more of a risk if other secondary care sites, with which we have no clinical relationship, are asked to participate. Indeed the guidelines were designed to be used strictly for patients who access the KCH/GSTT services. I therefore do not intend, as suggested, to discuss this with colleagues at Lewisham and Woolwich at this stage: until we have rolled out and gauged demand for shared care from GPs with patients linked our two hospital sites. I hope you agree that this is a reasonable and, above all, safe approach. I would be grateful if you could forward this on to the relevant committee members for their opinion. I was pleased that the guidelines were otherwise ratified today. It was agreed that some joint working between specialists and CCGs on the IBD pathway would be helpful, to incorporate discussions about shared care across SEL and also to agree management within secondary care of the more complex secondary care therapies such as TNFs. A short life working group could be set up to enable this. Action : Lambeth and Bromley CCGs to co-ordinate, with GP reps, presenting clinician and colleagues from other SEL Trusts (consultants, other specialist clinicians and pharmacists). 8. Anti VEGF Guideline draft guideline from KCH and GSTT and review of Aflibercept No representatives could attend to present this application, thus it could not be discussed in detail. The business case for use of Aflibercept by King s and Guy s as an alternative to Lucentis ahead of NICE TA being issued was agreed by the CCG/CSU service development process in February. The patient group in which it was to be used needed further clarification after receiving further information regarding cost effectiveness. In addition the CSU are currently negotiating how the wet AMD service is commissioned regarding bundling service and drugs, which influences cost effectiveness. The NICE TA is now due in July. A holding position is required before the October meeting as King s are already initiating treatment and GSTT would like to do the same MK suggested asking the JFC for an opinion on this. Action : VB to check the JFCs view, & defer the item to the October meeting, when the NICE TA and commissioning arrangements will be clearer. Post meeting note : JFC have approved its use subject to commissioners agreeing funding. Subsequent request for an APC interim decision : 7
Email to APC sent 17/06/2013 Dear All You will recall that we deferred a decision on the draft guidelines for treatment of wet AMD (attached) at the APC last week as the ophthalmology consultants were not able to be present to discuss. We discussed briefly the need to hold a consistent line with providers in that some have begun to use aflibercept already, prior to the guidelines being approved, and it was decided to ask the JFC s view on this. The JFC did discuss aflibercept in Feb this year, minutes attached ; in summary the JFC supported its use subject to agreement with commissioners. As further background, the 2013/14 Service Development process did consider a submission by KCH and GSTT for the use of aflibercept in wet AMD this was approved, pre-nice, subject to renegotiation of the wet AMD tariff locally and the targeting of aflibercept to the most cost effective patients, ie those patients who would otherwise be receiving very frequent ranibizumab injections a guideline was requested for this which would be approved. The cost impact of this is complex currently ranibizumab is the cheapest drug cost; however aflibercept is administered less often (which may be an advantage for some) and there are capacity issues in the clinics providing this service; also the final details of the local tarrif for wet AMD are pending. To ensure a consistent message to providers, we need an interim position before the October meeting. 2 options; 1. Given the support of the JFC and the positive service development submission, we agree for KCH/GSTT to use aflibercept from now onwards in line with their draft guideline to be further discussed with experience of use to date at the October APC (clinicians must come to discuss, need to aim towards a SEL consensus). 2. Ask all providers to use ranibizumab only until the October APC when the guidelines can be discussed. Please note it has recently been flagged to us that KCH already using some aflibercept so this would cause some issues. All of the above would be subject amendment following the NICE decision (due July 2013) please note this is unlikely to give a preferred agent between ranibizumab and aflibercept so still likely to need some local interpretation. Either way we should consider scheduling into one of the the New Drugs Panel meetings in July or Sept to work up further. Please could I have your views on options 1 or 2, or any alternative suggestions for chairs action by Thursday at the latest?. 14 responses supporting Option 1 were received. There were no responses supporting Option 2. The committee agreed to Option 1 as an interim position until the guideline can be fully discussed at the next APC on 15 July 2013. 8
9. SEL Interface Prescribing Policy The following comments were noted : Item 4.3 It was agreed after a discussion, that 3 working days should be allowed for GPs to produce a prescription upon receiving the out-patient referral form. Item 8.2 unlicensed drugs, specials. The cost to primary care of these drugs is significantly higher than to secondary care. In addition, what is on a specialist hospital s formulary does not automatically make it suitable for primary care prescribing. Thus it was felt that this line should be removed and that consultants should continue treatment except under exceptional circumstances where the GP agrees. Concern was raised that a significant number of clinicians in hospital will not have read this policy. Patients should not be made to go back and forward between primary and secondary care whilst ongoing prescribing is resolved. A supporting document and standardised letters are required, for example unlicensed drugs patient information leaflet. Process of agreement needs to take place whereby GPs are not put in a situation where patients attend the surgery on a Friday afternoon asking for medication which the practice is not aware of and has to sort it out. SLHT has a standard letter. following noted amendments Action: CF amend and recirculate final document to members. 10. NICE TAs DE and DS were thanked for work on this document and it will be reviewed by the new drugs panel on July 18 th. 11. Papers for Information i. CCG Proposal for South London Cardiac Consultant Pharmacist ii. Terms of Reference, revised. SEL APC iii. Chairs action Sativex shared care iv. PBre Policy, inner & outer SEL Appendix 1 All noted, no comments. 12. AOB. SEL Clinical Guideline for Rheumatoid Arthritis including Biologic Drug Treatment Pathway. AB advised that lead rheumatology consultants at SLHT were happy to adopt the King s/ GSTT/Lewisham algorithm as it was similar to their current draft guideline. This would reduce IFRs for Tocilizumab monotherapy and Abatacept monotherapy where an anti- 9
TNF is contraindicated (6.2). This does not follow NICE TAs but would reduce inequalities in treatment across SEL as the algorithm is already agreed by LSL. Version 16 is being worked on currently if there are major changes which require commissioner input, updates will be add to future agendas. Funding these treatments should be off-set by increasing the use first line of certolizumab (Cimzia). The algorithm will be presented at the next SLHT DUG to ensure buy in from local clinicians as there needs to be an increase in the percentage of new initiations being for certolizumab. MS felt this was a secondary care pathway which has large economic costs for CCGs. Biologics used in rheumatological conditions constitute the highest spend for CCGs on PbRe drugs. The acute trusts w be providing audit data to the CCGs on use within 2013/14 as part on ongoing contract reviews. 13. Date of Next Meeting Note rescheduled. Now to be held on Tuesday 15 October from 1.00pm 3.00 pm in Room 407, 1 Lower Marsh SE1 7NT (not 29 October). Future meetings: Tuesday 28 January 2014 Tuesday 18 March 2014 Tuesday 3 June 2014 All meetings are between 1.00pm-3.00pm in Room 407, 1 Lower Marsh SE1 7NT. 10