Minutes of the Lancashire Medicines Management Group Meeting Held on Thursday 12 th October 2017 at Preston Business Centre

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PRESENT: Minutes of the Meeting Held on Thursday at Preston Business Centre Dr Tony Naughton (TN) Chair of LMMG Lancashire CCG Network Alastair Gibson (AG) Director of Pharmacy Blackpool Teaching Hospitals NHS Foundation Trust Christine Woffindin (CW) Medicines Information Manager East Lancashire Hospitals NHS Trust David Jones (DJ) Assistant Director of Pharmacy Lancashire Teaching Hospitals NHS Foundation Trust Janet Walsh (JW) Medicines Optimisation Pharmacist West Lancashire CCG Melanie Preston (MP) Assistant Director - Medicines NHS Blackpool CCG Optimisation Dr Lisa Rogan (LR) Head of Medicines Commissioning NHS East Lancashire CCG Clare Moss (CM) Head of Medicines Optimisation NHS Greater Preston CCG, NHS Chorley and South Ribble CCG Graham Atkinson (GA) Senior Manager Medicines NHS Morecambe Bay CCG Optimisation Tara Gallagher (TG) Deputy Clinical Pharmacist Lancashire Care NHS Foundation Trust Andrea Scott (AS) Medicines Management Pharmacist University Hospitals of Morecambe Bay NHS Foundation Trust Julie Lonsdale (JL) Head of Medicines Optimisation NHS Fylde and Wyre CCG IN ATTENDANCE Joanne McEntee (JM) Medicines Information Lead North West Medicines Information Centre Dr Angela Manning Deputy Medical Director NHS England (North) Dr Paul Sedgwick Deputy Medical Director NHS England (North) Suzanne Penroze (SP) Medicines Optimisation Pharmacist NHS Greater Preston CCG, NHS Chorley and South Ribble CCG Brent Horrell (BH) Head of Medicines Commissioning NHS Midlands and Lancashire CSU Dr David Prayle (DP) Senior Medicines Commissioning NHS Midlands and Lancashire CSU Pharmacist Adam Grainger (AGR) Senior Medicines Performance NHS Midlands and Lancashire CSU Pharmacist Jane Johnstone (Minutes) Medicines Management Administrator NHS Midlands and Lancashire CSU 2017/154 Welcome & apologies for absence The Chair welcomed everyone to the meeting. Apologies for absence were received on behalf of Sonia Ramdour, Nicola Baxter and Julie Kenyon. It was noted that Tara Gallagher was in attendance on behalf of Sonia Ramdour and Janet Walsh was in attendance on behalf of Nicola Baxter. Dr Angela Manning, Deputy Medical Director and her successor Dr Paul Sedgwick, Joanne McEntee, Medicines 1

Information Lead for North West Medicines Information Centre and Suzanne Penroze, Medicines Optimisation Pharmacist from Greater Preston and Chorley and South Ribble CCG were also in attendance to observe the meeting. 2017/155 Declaration of any other urgent business None. 2017/156 Declarations of interest pertinent to agenda None. 2017/157 Minutes of the last meeting 14 th September 2017 The minutes of the meeting dated 14 th September 2017 were agreed as a true and accurate record. 2017/158 Matters arising (not on the agenda) LMMG development proposal GA fed back following his attendance at the Collaborative Commissioning Board (CCB) to discuss medicines decision making. The CCB has accepted phase I of the proposal which is for single decisions to be taken across the STP where appropriate. GA will draft a paper for the phase II proposal and share with CCG MM Leads before it is taken to the CCB. NEW MEDICINES REVIEWS 2017/159 Beclometasone/formoterol/glycopyrronium bromide pressurised metered dose inhaler (Trimbow ) DP discussed the paper summarising the evidence and the draft recommendations which had been consulted on as follows: Recommendation: Black Beclometasone/formoterol/glycopyrronium bromide pressurised metered dose inhaler (Trimbow ) is not recommended for use by the NHS in Lancashire for the maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD), who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2- agonist. Recommendation: Green Beclometasone/formoterol/glycopyrronium bromide pressurised metered dose inhaler (Trimbow ) is recommended for use by the NHS in Lancashire for the maintenance treatment in adult patients 2

with moderate to severe chronic obstructive pulmonary disease (COPD), who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. Five of eight CCGs and three of four Acute trusts responded by the closing date. Five of the eight responding consultees indicated a preference for a Green classification; three responding consultees indicated a preference for a Black classification. Consultees preferring the Green classification supported this classification as the triple inhaler device could offer flexibility, especially in patients with frequent exacerbations and symptoms affecting their daily lives requiring one device containing the three drug classes. Decision The group agreed on a Green restricted colour classification with the restriction that triple therapy should be reserved for patients who have failed to achieve or maintain an adequate response to an appropriate course of dual therapy. Action The Respimat pathway in the COPD pharmacological treatment guidelines will be updated to include Trimbow in line with the discussions above. 2017/160 Secukinumab (Cosentyx ) for treatment of palmoplantar psoriasis DP discussed the paper summarising the evidence and the draft recommendation which has been consulted on as follows: Recommendation: Red Secukinumab (Cosentyx ) is recommended for the treatment of moderate to severe palmoplantar psoriasis that has not responded (refractory) to at least two standard systemic treatments and photochemotherapy, or when standard treatments cannot be used because of intolerance or contra-indications. Five of eight CCGs and three of four Acute trusts responded by the closing date. All consultees agreed with the proposed classification. Decision The group agreed with the recommendation of Red colour classification. Action Secukinumab (Cosentyx ) will be made Red colour classification on to the LMMG website. 3

2017/161 LMMG New Medicines Reviews Work Plan update DP discussed the paper; updating the group on the current status of the work plan as follows: Medications for discussion at the November meeting Metformin M/R reduction in the risk or delay of the onset of type II diabetes mellitus. New Medicine Reviews on hold, awaiting licensing or launch details Naltrexone/bupropion Obesity negative FAD in July 17. Lacosamide (Vimpat ) Monotherapy in the treatment of partialonset seizures with or without secondary generalisation in epilepsy this will be prioritised if a request is received by a specialist. Oxycodone/naloxone (Targinact ) Chronic pain (back/neck) a request has been received, awaiting an application from the specialist scoping the place in therapy.. Fluticasone furoate + umeclidinium + vilanterol (Trelegy) inhaler COPD this will be prioritised if a request is received by a specialist. Freestyle Libre Diabetes monitoring a review is currently being undertaken by MLCSU. JM highlighted that the Regional Medicines Optimisation Committee (RMOC) will be making a recommendation for Freestyle Libre and this will discussed under an agenda item at the next meeting on 26 th October. The group discussed and agreed that a short paper will be drafted by MLCSU to confirm that Freestyle Libre has been prioritised for reviewed by MLCSU and that a recommendation is awaited from the RMOC, the paper will be circulated to LMMG members. In the meantime, Freestyle Libre will be put on to the LMMG website as Grey colour classification. BH DP Patiromer for hyperkalaemia in adults will be added the new medicines work plan. GUIDELINES and INFORMATION LEAFLETS 2017/162 Osteoporosis guideline DP presented the Osteoporosis guideline together with a summary of the main responses to the consultation. 4

7 of 8 CCGs and all provider trusts responded by the closing date. 5 CCGs and four responding provider Trusts disagreed with the guideline. Decisions The group discussed and decided upon the following actions: NICE and NOGG - due to the conflicting guidance between NICE TA464 and the National Osteoporosis Guideline Group s 2017 guidance regarding treatment intervention threshold, DP will discuss this further with the specialists to agree on which guidance to include. Reducing IFRs - there is a lack of evidence base for measuring bone turnover makers as an alternative to a DEXA scan for patients who fall outside of NICE guidance. In a previous consultation, consultees did not agree with a proposal to change the inclusion criteria for teriparatide prescribing for women. DP will refer this back to the specialists and ask them to submit a case if they can provide evidence for a review of teriparatide. Algorithms - DP discussed algorithm 1 and 2. The group agreed that the algorithm 1 is in line with NICE and is clear. Steroids - due to the original Rheumatology Alliance pathway stating age 65 for the consideration of treatment with bone protection and the more recent NOGG guidance stating 70 years of age, DP will refer this back to the specialists to ask if they are in agreement for the guidance to state 70 years of age. Target audience - DP will add in further clarification in to the title of who the target audience is aimed at. Length of treatment/drug holidays - The group discussed the differences between the NOGG and NICE guidance documents in time periods for length of treatment/drug holidays. It was recognised that there is a lack of evidence base to determine the precise time period for length of treatment/drug holidays. DP will refer this back to the specialists for clarification. Risk factors - The group discussed the risk factors in the box Clinical Risk Factors for Osteoporosis. DP explained that the risk factors in bold are the risk factors which are included as tick boxes in the FRAX calculation. DP will seek clarification from the specialists whether additional risk factors in NOGG are required or whether the FRAX risk factors are adequate. Type of specialist - DP will remove the reference to the Rheumatology Alliance to avoid any implication that Rheumatologists are the only specialists who may prescribe medicines classified as specialist. All actions DP 5

2 nd line options - DP will add in a caveat to the 2 nd line options box to state that all the medications listed as a 2 nd line option are available equally and are used depending on clinical condition. There is no particular order of priority for their use. For clarity the 2 nd line options box will be amended to include a reference to RAG rating to avoid confusion over the initiation of treatment. Bone turnover markers - there is no definitive evidence for the use of bone turnover makers therefore the group agreed that this will not be included in the guideline. Action The Osteoporosis guideline will be updated in line with the discussions above and further clarification sought from specialists. The osteoporosis guideline will be brought back to LMMG for approval. 2017/163 Crohn s disease pathway update DP discussed the Crohn s disease pathway which was updated following the updated NICE TA456 Ustekinumab for moderately to severely active Crohn s disease. 3 of 8 CCGs and 3 of 5 provider trusts responded by the closing date. All consultees agreed with the guideline update, Lancashire Care Trust stated that it would be guided by other Trusts. Decision The group discussed and approved the rewording in the box next to the 1 st line treatment for Infliximab to state that the most cost effective biologic should be initiated. The amendments made following consultation responses were discussed and approved by the group. Action The Crohn s disease pathway will be amended in line with the discussion above will be uploaded to the LMMG website. DP 2017/164 LMMG Guidelines Work Plan update AGR discussed the paper, updating LMMG on the current status of the work plan as follows: For discussion at the November meeting Update ophthalmology pathway with aflibercept from branch and full review of the guidance currently out to consultation. Penicillamine SCG update currently out to consultation. Non-pharmacological COPD guidance section to be added to 6

the COPD pharmacological treatment. NRT position statement a query has been received from Lancashire County Council regarding the NRT position statement with regards to the exclusion criteria. AGR is looking at this and will also link in with local councils in Blackpool, Cumbria and Blackburn with Darwen. GA and MP will send the appropriate contact details of their Public Health links in the local councils to AGR. GA/MP For discussion at the December meeting Melatonin update the guidance is currently being updated following the recommendations made at the September LMMG meeting. Audit data is awaited from Blackpool; upon its receipt, LMMG will consider the RAG status for new patients, children and adults with learning disabilities and neurodevelopmental disorders. Denosumab guideline this will be updated once the osteoporosis guidance has been approved. Dementia guideline (scope) a pharmacological management of dementia guideline has been requested by EL CCG. Psoriatic arthritis or ankylosing spondylitis guideline this is in development. Prescribing guidelines for specialist infant formula feeds work is being conducted in GP/CSR. Type II diabetes guidance in the process of liaising with clinicians. To be presented at the January meeting Stoma appliances guideline (scope update to existing guidance) spend on appliances in Lancashire (2017/17) approximately 10 million. Roflumilast prescribing information sheet NICE TA 461 approved Amber 0 at the September meeting. Eluxadoline (NICE TA 471) guideline (scope) - a guideline was requested at the September meeting by LTH. Asthma guidance update NICE guidance is due in October 2017. Treatment of glaucoma guideline (scope) NICE update was due August 2017. Spend on treatment of glaucoma in Lancashire (2017/17) approximately 3.3 million. 7

To be presented at the February meeting Type I and II DM leaflets work is ongoing on full diabetes guidance, to reconsider content of the leaflets once guideline is approved at LMMG. Familial hypercholesterolaemia guideline (scope) NICE guidance is due in October 2017. To be presented at a future meeting of the LMMG Allergic rhinitis guideline draft guidance has been completed and shared with the applicant. A response is awaited. NATIONAL DECISIONS FOR IMPLEMENTATION 2017/165 New NICE Technology Appraisal Guidance for Medicines (September 2017) AGR presented the NICE TA guidance paper. TA474 Sorafenib for treating advanced hepatocellular carcinoma this guidance replaces TA189. This is an NHSE commissioning responsibility and will be put on to the LMMG website as Red colour classification. TA475 Dimethyl fumarate for treating moderate to severe plaque psoriasis this is a CCG commissioning responsibility and will be put on to the LMMG website as Red colour classification. A Blueteq form will be developed. TA476 Paclitaxel as albumin-bound nanoparticles with gemcitabine for untreated metastatic pancreatic cancer this guidance replaces TA360 this is an NHSE commissioning responsibility. TA360 will be replaced with TA476 and given a Red colour classification. 2017/166 New NHS England medicines commissioning policies (September 2017) None published in September 2017. 2017/167 Evidence reviews published by SMC or AWMSG (September 2017) DP discussed the SMC and AWMSG recommendations published during September 2017 and meeting LMMG criteria as follows: SMC 524/08 stiripentol (Diacomit ) SMC accepted 524/08 stiripentol (Diacomit ) in conjunction with 8

OTHER PROPOSALS clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patient with severe myoclonic epilepsy in infancy (SMEI; Davet s syndrome) whose seizures are not adequately controlled with clobazam and valproate NICE CG137 covers this indication, the group decided that no action was required unless issues arise it will be brought back for discussion. The remaining SMC and AWMSG recommendations for September 2017 did not meet LMMG criteria; therefore the group agreed that no further action was necessary. 2017/168 Review of 2016/17 Annual Declarations BH provided a review of the annual declarations of interest. The chair and convener of LMMG have reviewed all declarations and there were no concerns of note. The group agreed that no further action was required. 2017/169 LMMG Annual Report 2016/17 BH presented the annual report which gave an overview of the LMMG s activity in the 2016-17 financial year. BH highlighted that there is a broad consensus of agreement of the vast majority of the decisions. TN commended the work that LMMG members have undertaken in the last financial year. TN will then take the updated annual report to the Collaborative Commissioning Board. ITEMS FOR INFORMATION 2017/170 Minutes of the Lancashire Care FT Drug and Therapeutic Committee (22 nd September 2017) The group noted these minutes. 2017/171 Any other business JL raised concerns regarding the monitoring in the DMARD shared care guideline which had been agreed by the group at the September meeting. Concerns were raised about the amount of monitoring in secondary care which is required before primary care take on the prescribing. 9

The group were cognisant of the local issues raised regarding the monitoring in secondary care but recognised that this should be discussed in local health economies regarding commissioning arrangements. It was felt that there was no new material evidence to reconsider a review of the current LMMG approved guideline. It was suggested by JL that further discussion could take place at the Lancashire Medicines Management Commissioning Leads Network meeting. A further suggestion was made for a proforma to be developed. This would be sent from secondary care to the patients GP (alongside the shared care document) then signed and returned to the specialist once the GP has agreed to take over prescribing and monitoring of the patient. Date and time of the next meeting 9 th November 2017, 9.30 am to 11.30 am, Meeting Room 253, Preston Business Centre 10

ACTION SHEET FROM THE LANCASHIRE MEDICINES MANAGEMENT GROUP MINUTE NUMBER DESCRIPTION ACTION DATE STATUS AT 12 th October 2017 ACTION SHEET FROM THE 8 th JUNE 2017 MEETING 2017/103 LMMG New Medicines identified by Horizon scanning for prioritisation Sodium zirconium cyclosilicate treatment of hyperkalaemia in adults. Action: DJ will speak with Renal specialists from LTH to see if this is something that they would like to use. Update: Renal specialists have said that they would also like to use Patiromer for hyperkalaemia in adults. DP will look produce a scoping paper for both Sodium zirconium cyclosilicate and Patiromer. Update: There is a manufacturing issue with Sodium zirconium cyclosilicate, Patiromer will be added to the new medicines work plan. DP 28.09.2017 Closed ACTION SHEET FROM THE 13 th JULY 2017 MEETING 2017/131 LMMG work plan update Antipsychotic SCG update Action: MLCSU will send an email on behalf of LMMG (initial draft by CF, CCG Leads will be copied in) to Debbie Nixon, STP Lead for Mental Health. Action: CCG MM Leads will highlight the discussions to their Mental Health leads. Update: CF said that there is a national CQUIN in relation to physical health monitoring for this patient cohort. CF will speak with Debbie Nixon to gain clarity regarding the monitoring of physical health in secondary care as this information is not readily available in primary care. Update: BH is meeting with Sonia in the next two weeks to discuss the actions above. BH/SR 02.11.2017 Open 11

ACTION SHEET FROM THE 13 th SEPTEMBER 2017 MEETING 2017/142 LMMG New Medicine Reviews Work Plan update Targinact for neck pain and chronic back pain Action: DP will contact the requesting consultants to ask them to submit an application for a medicine review. CM will provide DP with contact details. Update: a response is awaited from the requesting consultants. This will remain on the new medicines work plan. DP/CM 28.09.2017 Closed 2017/143 Melatonin update and draft recommendation Melatonin for new patients; children with ADHD Action: CF will liaise with BH to develop review guidance to ensure that there is rigor around the prescribing pathway and a regular audit is undertaken with evidence of patient benefit. This will be brought to the December LMMG meeting. CF/BH 07.12.2017 Open Melatonin for current ADHD patients, children and adults Action: CF will set a criteria for review for the current prescribing and benefits of Melatonin for the ADHD patients in adults and children. This will be brought to the December LMMG. CF 07.12.2017 Open Melatonin for patients with neurodevelopmental disorders / LD Action: MLCSU await the receipt of audit data from BTH and a review of national guidance will be carried out. This will be brought to the December LMMG meeting. AGR 07.12.2017 Open Action: The Melatonin position statement in relation to neurodevelopmental disorders / LD will be split into two - children with ADHD and children and adults with neurodevelopmental disorders / LD. Update: this has been actioned. AGR 28.09.2017 Closed 12

2017/145 Prevention of stroke and systemic embolism in non-valvular atrial fibrillation guideline Action BH will draft a paper to the CCB and the Stroke Prevention Group on behalf of LMMG to confirm that the guideline has been approved and to highlight the financial risks involved with increasing use of NOACs. Update: a paper has been drafted; BH will send this to Nicola Baxter to confirm that this is in line with the discussions at the Stroke Prevention Group. The paper will then be taken to the Stroke Prevention Group and the CCB. BH 28.09.2017 Open 2017/150 New NICE Technology Appraisal Guidance for Medicines (July/August 2017) TA459 Collagenase clostridium histolyticum for treating Dupuytren s contracture Action: CCG Leads will highlight the change in practice in their CCGs. Update: TN reminded the group to highlight this in the organisation. CCG representatives 28.09.2017 Closed ACTION SHEET FROM THE 12 th OCTOBER 2017 MEETING 2017/161 LMMG New Medicines Reviews Work Plan update Freestyle Libre The RMOC will be reviewing Freestyle Libre. Action: BH will prepare a statement for LMMG members and the LMMG website to confirm that a recommendation is awaited from RMOC and this will be given a Grey colour classification. JM/BH 02.11.2017 Open 2017/164 LMMG Guidelines Work Plan update NRT position statement a request has been received from Public Health to update the NRT position statement. AGR will update the NRT position statement and also link in with Blackpool, 13

Cumbria and Blackburn with Darwen councils. AGR 02.11.2017 Open GA and MP will send the appropriate contact details of their Public Health links in the local councils to AGR. GA/MP 02.11.2017 Open 14