Regional Medicines Optimisation Committee (North)

Transcription

1 Present: Regional Medicines Optimisation Committee (North) October 26 th 2017 Minutes Quarry House, Leeds 10:00-1:00 pm Name Title Organisation Jun Oct Dr Mike Prentice (MP) Chair Michele Cossey (MC) Dr Matthew Grove (MG) Dr Shafie Kamaruddin(SK) Dr Matthew Van Miert (MVM) Prof Simon Thomas (ST) nne (H) Rachel (R) Helen (HS) Henshaw inger Seymour Neil Watson (NW) Regional Medical Director (North) Regional Pharmacist (North) & Head of Clinical Strategy NHS England (North) NHS England (North) Consultant Rheumatologist Northumbria Healthcare NHS Foundation Trust Consultant Physician in Diabetes & Endocrinology County Durham and Darlington NHS Foundation Trust Consultant naesthetist rrow Park Hospital - Merseyside; Countess of Chester Hospital Professor of Clinical Pharmacology and therapeutics Senior Medicines Commissioning Pharmacist Strategic Lead Pharmacist Senior Medicines Optimisation Pharmacist Clinical Director of Pharmacy and Medicines Optimisation Liz Kay (LK) Professor of Pharmaceutical Care/Clinical Director Kashif Haque (KH) Dr Shaun O' Connnell (SO C) Dr Tony Naughton (TN) Chief Pharmacist, Clinical Director Joint Medical Director, Lead for Prescribing and Planned Care Clinical Chief Officer and GP Partner The Newcastle Upon Tyne Hospitals NHS Foundation Trust Midlands and Lancashire CSU North Yorkshire & WC Medicines Management Team North of England Commissioning Support The Newcastle Upon Tyne Hospitals NHS Foundation Trust Leeds Teaching Hospitals NHS Trust East Cheshire NHS Trust NHS Vale of York Clinical Commissioning Group Fylde and Wyre Clinical Commissioning Group Dr Ian Davidson (ID) Director of Quality & Safety NHS North Durham CCG Dr Vicci Owen- Clinical Director of Public Health NHS Stockport CCG Smith (VOS) Peter Marks Board Member/Locality Lead Stockport Greater Manchester Local Pharmaceutical Committee. Paul McManus Observers (Non-Voting) Specialised Commissioning Pharmacy Lead ngela Parkin Medicines Education Regional Technical dviser NHS England NICE H Potter Jonathan underhill 1

2 Harriet Lewis NHS Partnership Manager for North of England ssociation of the British Pharmaceutical Industry (BPI) Paul Fleming Technical Director British Generic Manufacturers ssociation (BGM) Support Staff (Non-Voting) Bhavana Reddy (Professional Secretary) Specialist Pharmacist/ Head of Prescribing Support NHS England/ Regional Drug and Therapeutics Centre (SPS) Sue Dickinson Director of Pharmacy Regional Drug and Therapeutics Centre (SPS) In attendance: Phil Thomas, Head of Policy, NHS England Dr Justine Scanlan, Head of Specialist Pharmacy Service, NHS England Dr ndrew Lowey, Lead Clinician - Clinical Pharmacy & Preparative Services, Leeds Teaching Hospitals NHS Trust for agenda item 5 1. General Business 1.1 pologies pologies had been received as per the attendance list above. It was noted that the meeting was quorate. 1.2 Welcome and Introductions The Chair welcomed members and invited them to introduce themselves again as there were some deputies in attendance today. 1.3 Declarations of Interest No declarations of interest on today s agenda had been received. One member declared a professional non-financial interest in the freestyle libre agenda item and another member declared a professional non-financial interest in the biosimilars agenda item. 2. Matters arising a) Draft Minutes of June 28th 2017 for approval. The group approved the draft minutes from the June meeting with no changes. b) Feedback from Member s day. MP noted that the slides had been shared with the papers and a write up would soon be available. One member fed back that introductions would have been useful for the panel session. c) Polypharmacy update The secretary fed back that this would be brought back to the next RMOC meeting along with Care Homes when a more in-depth discussion could be had. The national lead for Care Homes had been invited to attend the next North RMOC meeting in February to aid discussions. 3. FreeStyle Libre Flash Monitoring System The secretary introduced this item. It was noted that this had been prioritised for review as eight requests to review had been received via the shadow topic submission process on the SPS website. National advice via the RMOC s on a topical issue was felt to be useful for CCGs. dummy system was available for members to view at the meeting. In addition following documents had been shared with the papers to inform discussions: 2

3 NICE MIB 110 Diabetes UK Consensus Statement on Flash Glucose Monitoring BCD FreeStyle Libre formulary case Draft proposed costings query had arisen around why a separate evidence review by SPS hadn t been undertaken, however it was noted that the NICE MIB document was in date and covered all the available evidence and as the intention was to reduce duplication a separate evidence review document was not deemed to be necessary. The group noted the following points: General FreeStyle Libre is a new innovative flash glucose monitoring (FGM) system which monitors glucose levels using interstitial fluid levels rather than the standard capillary blood glucose from finger prick testing. It consists of a handheld reader and a sensor which is sited on the back of the arm. When the reader unit is passed over the sensor the reader shows a reading based on interstitial fluid glucose levels. Users can also scan the sensor using the LibreLinkUp app on an ndroid smartphone. The intended place in therapy is FreeStyle Libre is calibrated as part of the production process and so does not require calibration using finger prick testing. The reader can also indicate glucose level trends over time; it can show a trace for the last eight hours and displays and arrow showing the direction the reading is heading. The intended place in therapy is as an alternative to routine blood glucose monitoring in people (aged 4 and above) with type 1 and 2 diabetes who use insulin injections. Finger-prick blood glucose measurements are sometimes still needed, such as when a person is ill or to meet the current requirements of the Driver and Vehicle Licensing gency (DVL) in assessing fitness to drive. The innovative aspect is that FreeStyle Libre measures glucose levels from a sensor applied to the skin as an alternative to routine finger-prick blood glucose testing, and can produce a near-continuous record of measurements which can be accessed on demand. The FreeStyle Libre sensor will be added to section 9 of the National Drug Tariff from the 1st of November Users will need support and training from healthcare professionals on how to use FreeStyle Libre and how to interpret and act upon the readings. The company does offer e-learning for healthcare professionals and online tutorials and videos are available for patients however some training around how to interpret readings will need to be considered. Flash Glucose Monitoring (FGM) is not the same as continuous glucose monitoring (CGM) and FGM does not include an alarm to indicate when in hyperglycaemia, hypoglycaemia or impending hypoglycaemia. Clinical Evidence The main points regarding the evidence were discussed as below: The NICE MIB document summarises clinical evidence from 5 studies (6 papers) involving 700 people; these include two randomised controlled trials, one including people with type 1 diabetes (n=241; the IMPCT study) and one including people with type 2 diabetes (n=242; the REPLCE study) Three of the studies reported device accuracy compared with self-monitored blood glucose, with results ranging from 84% to 88% accuracy and from 99% to 100% clinical 3

4 acceptability, using an error grid. One study reported device accuracy and acceptability of 97% to 99% compared with venous blood sampling. Key points from the IMPCT (type 1) study were: - Patients using FreeStyle Libre experienced less time in hypoglycaemia than patients using SMBG, averaging 1.24 hours per day or 38% less time (p<0.0001) in hypoglycaemia and 1 hour more per day in euglycaemia (p=0.0006). The number of hypoglycaemic events per day reduced by mean of 0.45 (by over 25%; p<0.0001). - There were no differences in Hb1c between the 2 groups and no differences in mean glucose levels. - The mean number of SMBG tests per day reduced from 5.5 (SD 2.0) to 0.5 (SD 0.7) in the intervention group. - 8% of FreeStyle Libre sensor users had non-serious device-related adverse events (itchiness/rash allergy, erythema and oedema). The 12-month data from REPLCE RCT showed the time in hypoglycaemia reduced by 50% compared with baseline, and the frequency of these events was reduced by 41%. There was no change in the time in hyperglycaemia. The number of SBMG tests reduced from 3.9 tests per day at baseline to 0.1 tests per day at 12 months. The limited evidence available suggests that using FreeStyle Libre for 6-12 months reduces the time spend in hypoglycaemia compared with self-monitoring of blood glucose using finger prick testing and it also reduced the average number of concomitant finger prick blood glucose tests needed. The group discussed the limitations of the clinical data as below: Trials contain only small numbers (n=700) of patients in mainly well controlled patients No improvements in Hb1c were seen in the clinical trials. Limited trial duration (6-12 months only) Limited data comparing to Continuous Glucose Monitoring Limited or no data of use in unstable patients, pregnancy, young people and children. No data suggesting that FreeStyle Libre can reduce hospital admissions. The secretary introduced the costing document that had been shared. comparison of costs with self-monitoring of blood glucose test strips in various scenarios had been costed and presented in the tables. Several key assumptions were made in the costing data that members needed to be aware of: It was assumed that as advised by specialists most type1 patients will be on a self-glucose monitoring test strip within a cost range of (Most expensive test strips in the scenario s presented). Type 2 patients were more likely to be on the lower cost ( 10 or less) meters. It is assumed that blood glucose strip use reduced to 0.5 per day in those using FreeStyle Libre as per the clinical trial data. Bearing in mind the above assumptions it was noted that for those testing 8 or more times per day then use of FreeStyle Libre is cost neutral. The group discussed the costings and felt that projected reductions in finger-prick testing are unrealistic given the need to test before driving (current DVL requirement) and during illness. They felt that a reduction to 2 tests per day was probably more realistic but recognised that there isn t any data to support this view. The group also felt that the costing information with regard to testing strips does not reflect the significant reductions that have already been achieved in this area of prescribing. It was however noted that the cost benefits of reducing hypoglycaemia cannot be quantified. Patients are currently purchasing the device at a higher cost than that which the NHS will be charged; this has led to inequitable access to a device. 4

5 The secretary informed the group that several statements from across the country had been received on freestyle libre however opinions were varied with some not approving at all, with others approving almost in-line with the BCD statement. It was also noted London were looking to model cost effectiveness data based on hypoglycaemia reductions however this wouldn t be available straight away. The secretary also fed back on the local diabetes UK position as below: Flash Glucose Monitoring (FGM) devices should be made available to any adult or child with Type 1 diabetes and to people with other forms of diabetes when intensive insulin therapy becomes necessary because of severely reduced pancreatic function. Ongoing funding for Flash glucose monitoring sensors should be made available on the condition the person demonstrates active management of their glucose levels or progress towards achieving and maintaining their personalised treatment target. This should be assessed at least annually. People who use FGM should have a good understanding of intensive insulin therapy and how to self-manage their diabetes. The completion of a structured diabetes education programme, as recommended by NICE, is highly recommended. It is essential that people using FGM have education to make sure they can best use the information the system provides to improve management of their glucose levels. Healthcare professionals will also need training on how to interpret the information on glucose trends in relation to patients daily living and in insulin dose adjustment MP summarized the messages heard so far and stated that this felt like a disruptive innovation that had the potential to improve diabetes care however at present there were limitations in the clinical evidence and the price was prohibitive so couldn t be used for all patients. SK fed back to the group that he agreed with the points raised in that there is limited evidence for use of this device currently and it is relatively expensive in comparison to blood glucose monitoring strips, however his experience and that of colleagues was that it is an innovative device that does have the potential to empower patients and enable them to manage their diabetes better. They currently have data showing improvements in hypoglycaemic episodes and in Hb1c improvement. He also noted that whilst there is no alarm on the device for hypoglycaemia the arrow does indicate whether the glucose reading was going up or down and the trend predicted. It had also been shown to be useful in those who experience hypoglycaemia in their sleep. It had also been used pre-insulin pump and prevented the user from progressing onto insulin pump therapy.sk pointed out however that those that are already suitable for a pump should still be given an insulin pump and that freestyle libre would not change this requirement. It was felt that whilst there is only one device available currently several of these devices will eventually come to market and devices will become more affordable. It was noted that whilst current guidelines require finger prick testing for DVL requirements for driving this is currently being reviewed by the DVL so may change in the future. robust discussion around the pros and cons of the device took place with all members taking part. The group was aware of the limitations of the current data but agreed that the device was innovative and therefore should be introduced into the NHS in a managed way and in patients who are most likely to benefit and where costs are likely to be cost neutral in comparison to blood glucose monitoring test strips. The group did note the following areas of concerns: Current spend on test strips varies across regions. It was noted that some areas had already done significant work on reducing spend for blood glucose testing strips therefore the figures used would need to be adapted on a local level. It was noted that specialists had indicated that type 1 diabetics are often given the higher price range of test strips ( 10 or above) The cost benefit of a reduction in hypoglycaemia cannot currently be quantified. The group agreed that it would be useful for the RMOC to issue pragmatic advice taking into consideration all the points raised and the differing views across the country. 5

6 It was felt that further data on real world use of FreeStyle Libre would be useful and that a trial could be considered in the same way that this is done in specialised commissioning i.e. commissioning through evaluation. The group agreed that Freestyle Libre could be used in limited and controlled settings where patients are attending for Type 1 diabetes care on a six month trial basis. It was agreed that this could be in secondary or primary care but that use should be restricted to use in type 1 patients, using multiple daily injections or those on insulin pump therapy who meet one or more of the following patient groups as outlined in the BCD statement: 1. Patients who undertake intensive monitoring >8 times daily 2. Those who meet the current NICE criteria for insulin pump therapy (Hb1c >8.5% (69.4mmol/mol) or disabling hypoglycaemia as described in NICE T151) where a successful trial of FreeStyle Libre may avoid the need for pump therapy. 3. Those who have recently developed impaired awareness of hypoglycaemia. It is noted that for persistent hypoglycaemia unawareness, NICE recommend continuous glucose monitoring with alarms and Freestyle Libre does currently not have that function. 4. Frequent admissions (>2 per year) with DK or hypoglycaemia. 5. Those who require third parties to carry out monitoring and where conventional blood testing is not possible. Whilst the group agreed that there is currently limited data for use in the above patient groups it was felt that it was most likely to be cost neutral in these patients and they would also be more likely to benefit than other patient groups currently. It was also agreed that the statement should include specifications around audit data to be monitored so that this can be done on a national level. The importance of patient education was also stressed as an important factor and should form part of any contract with patients around starting freestyle libre and continuing on the 6 month trial. It was noted that NHS England Diabetes Clinical Directors had been contacted by NHS Clinical Commissioners around FreeStyle Libre and its inclusion onto the drug tariff. suggestion had been made that this would be a good item to be discussed by RMOCs. MC agreed to feed into these conversations. The group agreed that in the interests of timeliness a recommendation should be issued within the next week i.e. by 2 nd November at the latest. CTION: Professional Secretary to draft recommendation and share with members for comments and feedback as soon as possible. 4. Biosimilars Phil Thomas introduced this agenda item and talked through the slide pack which highlighted the contents of the biosimilar framework and other ongoing work. The purpose of the framework is to support commissioners to act promptly to make the most of the opportunity presented by increased competition amongst biological medicines, including biosimilar medicines. It also sets out what patients, prescribers and provider organisations can do to play their part. The framework is available via the following link NHS England and NHS Improvement regional and central teams will work alongside RMOCs to support the development of plans around biosimilar use. It was noted that the individual drugs would be reviewed by the RMOCs with recommendations around switching. PT discussed the progress made since launch of the framework: NHSE Regional Directors are engaged with DCOs to look at the Scale of opportunity and potential savings in each region. data pack is available at Trust and STP footprint for infliximab, etanercept, rituximab and adalimumab. CSU support has been mobilised. They will be working with regional pharmacists to identify and work with outlier health economies. n adalimumab working group has been established to aid rapid implementation. 6

7 There is engagement with patient organisations (nationally and biosimilar communications subgroup) and Royal Colleges around both the medicines value programme and biosimilars. Further discussion took place around the following areas: The group agreed that clinicians and patients needed to be informed early to ensure quicker adaptation. working group looking at the new adalimumab biosimilar has been set up. There were some discussions around mixed messages and the term best value biologic but there was also included a target for switching patients to a biosimilar. This would need reviewing and a better indicator found. The group also noted the unknown area of biosimilar to biosimilar switches as more biosimilars come onto the market. The aim of this work was to decrease waste and increase efficiency. more sophisticated view around switching was needed. There is a need to look at all aspects such as ready to administer products, dose standardisation, expiry times and antibody monitoring (particularly for infliximab in GI). Need to also agree what good looks like and how we do this in conjunction with specialists and patients. CCG template has been devised to assess CCG readiness in relation to the uptake of best value biologics. PT asked for feedback on the template as CCGs would be expected to complete this information prior to the end of the year. ction: Members to feedback on draft CCG template. 5. Unlicensed, oral liquid medicines for the treatment of tuberculosis. ndrew Lowey (L) from Leeds Teaching Trust presented this agenda item. The item was being raised on behalf of the NHS Pharmaceutical Quality ssurance Committee. The issue had been brought to the RMOC as there is a need to agree standardised strengths of high risk, unlicensed oral liquid formulations for anti-tb medicines. L gave the group some background on the issue being discussed; there is a huge variation in both strengths and formulations being used across the country, and also between primary, secondary and tertiary care. Data shows that there are eight different concentrations of ethambutol in use, being individually prepared under the supervision of a pharmacist. There is no quality control when preparations are made in this way. Patients are therefore being exposed to multiple different formulations, leading to risk adverse events and calculation errors. The lack of standardisation also means that the supply chain is not efficient or robust. Supply problems are also very common. consensus has been achieved in support of a standardised specification for the three man agents (isoniazid, pyrazinamide, ethambutol) from a working group which includes all the key clinical stakeholders. This consensus has been translated into manufacturing specifications for submission to the NHS Production committee. Consideration should be given to adding these standardised products to the British Pharmacopoeia with standardised concentrations, in order to decrease risks of medicines error, particularly at interfaces of care. L asked for the endorsement of the RMOC for this approach. The group discussed the above and agreed that the approach described sounded sensible and were happy to endorse the approach outlined. CTION: RMOC endorsed the standardisation of strengths of three liquid anti-tb formulations. 6. ntimicrobial Resistance (MR) BR and MC gave the group an update on activities that have taken place regarding MR since the last meeting. letter had been sent to health and wellbeing boards and DCO leads highlighting the various interventions that had been discussed at the last 7

8 meeting. briefing paper had also been prepared for acute trust boards highlighting the importance of antimicrobial stewardship. The group also noted the draft terms of reference for a regional antimicrobial stewardship network. These networks were to report to the RMOCs. This agenda item would be discussed further at the meeting in February. CTION:BR to add to agenda for February Meeting. 7. OB Dates of future meetings had been shared with the group. It was noted that the October meeting may fall in half term so this would be re-looked at. The date of the next meeting is February 28 th pm in the board room at Blenheim House. 8