COVENTRY & WARWICKSHIRE AREA PRESCRIBING COMMITTEE

COVENTRY & WARWICKSHIRE AREA PRESCRIBING COMMITTEE MINUTES OF THE COVENTRY AND WARWICKSHIRE AREA PRESCRIBING COMMITTEE HELD ON 17 TH NOVEMBER 2017 AT 12.30 PM IN THE CLINICAL SCIENCES BUILDING (CSB) AT UHC&W NHS TRUST PRESENT: - Simon Fletcher University Hospitals Coventry & Warwickshire NHS Trust (SF) Chair Richard Lambert South Warwickshire GP (RL) Vice-chair Altaz Dhanani Coventry & Rugby CCG (AD) - Interim secretary Joe Booker Coventry LMC (JB) Jane Smith Coventry GP (JS) Claire Keane Coventry GP (CK) Rita Sanghera Arden & GEM CSU representing Warwickshire North and South Warwickshire CCG (RS) Nigel Johnson Warwickshire LMC (NJ) Caroline Coupe South Warwickshire NHS Trust (CC) Sumara Parvez South Warwickshire NHS Trust (SP) Portia Chikwanha South Warwickshire NHS Trust (PC) Ashwin Hindocha Coventry LPC (Ahi) Satyan Kotecha Warwickshire LPC (SK) Mark Easter - University Hospitals Coventry & Warwickshire NHS Trust (ME) Cath Sansby - University Hospitals Coventry & Warwickshire NHS Trust (CS) Paul Mills George Eliot Hospital NHS Trust (PM) Loay David George Eliot Hospital NHS Trust (LD) David Tait Coventry & Warwickshire Partnership Trust (DT) Ian Bayman Lay Member (IB) Terry Spicer Lay Member (TS) IN ATTENDANCE: Anita Hunjan (AH), Susan Dhesi (SD) Sheena Vithlani CRCCG Pharmacist observing Jo Brader SWFT Community Matron observing 1. APOLOGIES Franco Cappuccio, Paula Harris, Kim Panting, Sukhi Dhesi, Priti Ved, Bernhard Usselmann SF announced that TS will be retiring at the end of December 2017 and PC will be leaving her SWFT community post, he thanked them both for their contribution to the meetings. Also, SF introduced Sheena Vithlani CRCCG Prescribing Support Pharmacist who attended today s meeting as an observer. 1

2. MINUTES OF THE LAST MEETING The minutes of the last meeting held Friday 15 th September 2017 were agreed with the exception of a minor grammatical change to 9.2 sentences which was to be amended prior to publication of the minutes. 3. MATTERS ARISING There were no items for discussion. 4. APC Development 4.1 - RMOC Update AD confirmed that Midlands and East Regional Medicines Optimisation Committee (RMOC) had held their first meeting; three key areas discussed were Antimicrobial Resistance, Biosimilars, Polypharmacy. The next meeting is scheduled for 5 th December 2017. AD assumed that RMOC updates will disseminate APC priorities in the near future. AD informed the committee that RMOC have issued a useful update on Freestyle Libre, item 5.5 to be discussed later in the meeting. 4.2 - APC Appeals Process AD reported that he has received a request from Birmingham, Sandwell, Solihull and environs (BSSE) APC asking if this committee (as an independent APC) would participate in their appeal cases and likewise they would do the same for our committee, if we wish to pursue this route. SF opinion was not to partake in the appeals process; he felt that BSSE should have their own appeal procedure in place. AD asked the committee what their views were; a brief discussion took place; 4.2.1 - IB thought it would be difficult to assess appeals if we were unable to view the full evidence and background information 4.2.2 - DT wondered why BSSE could not follow this in their own health economy 4.2.3 - LD said that time constraints were already tight for our own meetings 4.2.4 - CK questioned what our appeal procedure was, AD replied that the process was done through the Decision review request application 4.2.5 - SF added that this request would need to be carried out with extreme caution The committee agreed to reject this request and felt it more appropriate for BSSE APC to submit their appeal process to their local RMOC. Section 4 Decisions 4A Write an outcome appeals process response to BSSE APC AD 2

5. Drug Positioning Statements 5.1 - Eluxadoline - A DPS for treatment of the licensed indication of irritable bowel syndrome with diarrhoea (IBS-D) was brought to the committee for consideration; 5.1.1 - AH summarised the contents of the draft DPS; the evidence comes from 3 double-blinded RCTs. NICE TA recommends it is started in secondary care when the condition is not responsive to other pharmacological treatments or these are contraindicated or not tolerated. She added that NICE specifically do not state the duration of pharmacological action 5.1.2 - SF queried the efficacy against placebo, was there any evidence vs existing treatments. AH answered that it was only against placebo 5.1.3 - IB pointed out an anomaly within the NICE statements stop eluxadoline at 4 weeks if there is inadequate relief of the symptoms but then states NICE observed that the benefit appeared to occur within 4 weeks to 6 weeks 5.1.4 - SF felt sceptical about the 11% response rate. AH mentioned that the limitations were discussed in-depth in the NICE TA, however, due to the quality of life aspect for these patients it highlights that the individual outcomes were important The committee agreed for the verdict to read as specialist initiation (SI) and to include a statement around stabilisation. 5.2 - Mysimba A DPS for use as adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients was brought to the committee for consideration; 5.2.1 - AH summarised the contents of the draft DPS Naltrexone/bupropion. It is given with an increasing dosing regime over 4 weeks and should be evaluated after 16 weeks. The drug has not been compared with other products. There is an EMEA risk management plan for cardiovascular risk and the increased risk of seizures. NICE final appraisal still has not been fully published, and to date NICE states it is not recommended due to the safety concerns and limitations to the cardiovascular sub-analysis 5.2.2 - CS informed that the pharmaceutical company does have a prescribing checklist that includes all of the contraindications 5.2.3 - LD suggested to wait for NICE recommendation especially because of the vast side-effects 5.2.4 - AD pointed out that the pharmaceutical company states that this drug will not be available on the NHS but be used for private patients. SF had reservations regarding this due to monitoring and following guidelines 5.2.5 - SK had concerns around safety element and felt that the DPS should have a robust statement around lack of patient safety evidence 3

5.2.6 - CS mentioned that UHCW specialists would only prescribe the drug for 6 months because of the short-term evidence of use The committee agreed that the DPS verdict should read as not recommended until further NICE guidance was published 5.3 - IDegLira A revised DPS for treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products was brought to the committee for consideration; 5.3.1 - AH briefly stated that the minor changes to the DPS were requested by George Eliot Hospital (GEH) Professor Vinod Patel. These were costs, and in line with the NICE guidance she also added that the verdict paragraph required clarification relating to the trial period or rewording of the sentence. The drug no longer has a specialist initiation drug checklist (SIDC) 5.3.2 - LD agreed with AH, he felt that the trial period was required because insulin degludec is supposed to improve hypoglycaemia 5.3.3 - A brief discussion took place around the duration of the trial period. The suggestion was to have a stabilisation period of 6 months otherwise it could impact on primary care prescribing. It was also noted that the combination product costs less than the single products The committee agreed the DPS verdict paragraph to include the 6 months trial period and to keep the the SI classification. 5.4 - Trimbow A DPS for treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) was brought to the committee for consideration; 5.4.1 - AH briefly updated the Beclometasone/formoterol/glycopyrronium item was discussed at the last meeting and that the committee had agreed to devise a draft DPS which was to be sent to members for virtual ratification. AH stated that the process has taken a little longer than anticipated and therefore tabled the paper at today s meeting. 5.4.2 - IB noted that the document appears to have a duplicated sentence in the pharmacological section and the TRINITY study percentage figures were incorrect At this point the committee decided to also discuss item 7.3 COPD guidance which also includes the Trimbow device 5.4.3 - LD wondered what the benefits were for having a triple therapy combination A brief discussion took place around steroid products and therapeutic trials and whether the single devices would benefit some patients 5.4.4 - PC asked where in therapy they would sit for patients who have underlying asthma and stressed the value of compliance 4

5.4.5 - AH commented that there is currently a lot of work around ICS therapies therefore NICE have delayed their guidance to 2018 The committee agreed the verdict should read as suitable for primary care prescribing. 5.5 - FreeStyle Libre - A draft interim positioning statement (IPS) and a formulary application from UHCW and GEH consultants, along with a statement issued from RMOC were brought to the committee for consideration; 5.5.1 - AD started the discussion by stating that there appears to be political motivation around the recent launch, Diabetes UK are already promoting the device to their patients. He felt it was crucial the committee make the right clinical decision for the whole health economy AD summarised the contents of the RMOC statement, who recommend that Freestyle Libre should only be used for patients with Type 1 diabetes, aged four and above, attending specialist care setting, using multiple daily injections or insulin pump therapy and who have been assessed by the specialist clinician and deemed to meet one or more of the following criteria; Patients who undertake intensive monitoring >8 times daily Those who meet the current NICE criteria for insulin pump therapy (HbA1c >8.5% (69.4mmol/mol) or disabling hypoglycaemia as described in NICE TA151) where a successful trial of FreeStyle Libre may avoid the need for pump therapy 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 Frequent admissions (>2 per year) with DKA or hypoglycaemia Those who require third parties to carry out monitoring and where conventional blood testing is not possible AD pointed out that this device does not get rid of the need for blood glucose testing 5.5.2 - JS had concerns around the effectiveness of the device 5.5.3 - JB questioned the accuracy of the monitoring reading 5.5.4 - SK mentioned that since the launch of the device on the NHS, the pharmaceutical companies have increased the shipping cost; he felt that this was not fair for those patients who wished to buy the device direct from Community Pharmacy 5.5.5 - A general discussion took place about the formulary application, lack of evidence, cost effectiveness and how primary care would fund it AD asked the committee if a specialist classification should be defined. He suggested specialist only (SO) status for the interim period or prescribing in limited and controlled 5

settings to ensure that patients were monitored regularly. The classification to be reviewed again once a commissioning policy had been devised 5.5.6 - SK felt that on the IPS frequent question page, the last sentence should read as Patients who choose to self-fund Freestyle Libre may continue to do so 5.5.7 - SF clarified that the RMOC statement was a reasonable guidance to follow, he questioned the long-term funding. AD concluded that each CCG will develop a commissioning policy around the use of the device for primary care 5.5.8 - GP members thought the frequently asked questions (FAQ) would be a useful appendix to the IPS The committee agreed for FreeStyle Libre to be designated as specialist only (SO) and should only be initiated and prescribed through specialist secondary care centres. The four DPSs and one IPS would be reformatted into the correct template before publication. Section 5 Decisions 5A Write eluxadoline DPS verdict & send out for virtual ratification, format document and publish, then add to netformulary 5B Write Mysimba DPS verdict & send out for virtual ratification, format document and publish, then add to netformulary 5C Re-write IDegLira DPS verdict & send out for virtual ratification, format document and publish, then add to netformulary 5D Write Trimbow DPS verdict & send out for virtual ratification, format document and publish, then add to netformulary 5E Write Freestyle Libre IPS verdict & send out for virtual ratification, format document and publish, then add to netformulary 5F Write to specialist regarding Freestyle Libre decision review outcome AD 6. Specialist Drugs List 6.1 - NOACs A decision review request submitted by UHCW Consultant Cardiologists along with supporting information to remove the SA classification of NOACs for use in non-valvular atrial fibrillation (AF) and allow GPs to initiate NOAC therapy was brought to the committee for consideration; 6.1.1 AD summarised the background to the application; commissioning and provider groups are looking at transforming the whole stroke pathway especially around the treatment of AF. The consensus is that we should be treating patients quickly with anticoagulants to prevent and reduce stroke. An AF working group consisting of representatives of the West Midlands Academic Health Network, secondary care cardiologists, GPs and CRCCG, 6

WNCCG and SWCCG commissioners and Medicines Management pharmacist are looking at the progress of de-classification. AD asked the committee what their views were 6.1.2 - JS advised that they had a PLT session few weeks ago, where an NHS Northampton GP representative attended. The GP informed them that in Northampton they treat AF patients within 3 hours of diagnosis and have reduced their stroke rate by 25%. JS confirmed that, compared with national data, Coventry was very poor; she felt that this was an important drive to improve anticoagulation rates in AF patients 6.1.3 - JB expressed concerns around the anticoagulation prescribing for Coventry in that GPs do not have enough experience to initiate anticoagulant drugs. AD clarified that those GPs who feel competent to prescribe would be able to do so and those GPs who feel less confident would still have the choice to follow the SA pathway. He added that the Haematology department also confirmed that they would still continue the current service 6.1.4 - A lengthy discussion took place, key issues and concerns raised were; prescribing in primary care GPs needed to be skilled Appropriate education training to be formalised GPs must follow NOAC guidance if they are confident to diagnose and initiate Commissioning funding issues LMC agreement Best approach to improve the anticoagulation service Appears to be difference in prescribing across the patch Discussed ideas of best way forward STP document for AF is a key priority for the STP 6.1.5 - RL informed that in South Warwickshire most GP practices are already initiating NOACs. They are also looking at primary and secondary care collaboration in terms of improving anticoagulation service. He believed that the big delay for patients is between diagnosis and initiation and his view was that SA status should be removed 6.1.6 - SF asked the committee if the definition of SA should be changed. JS answered that the SA should remain for the interim period but to have additional statement that the specialist might be a GP who feels confident to prescribe 6.1.7 - AD concluded that it seems that there are 2 options; 1. Remove the SA classification and change it to suitable for primary care prescribing 2. Keep the SA classification along with checklist but have a caveat for those GPs who feel confident they could prescribe and initiate by following the NOAC guidelines At this point, committee decided to vote on the 2 options, the majority vote was for Option 2 The committee agreed for the 4 NOAC DPS verdicts to be re-written and send out for virtual ratification. 6.2 SDL Amendments - Two proposed amendments from UHCW were brought to the committee for consideration to remove the shared care agreements (SCA) for tacrolimus and flutamide; 7

6.2.1 - CS highlighted that tacrolimus is currently SO as renal patients have been repatriated back to secondary care. The SCA indication is for liver and heart transplant patients; our region does not perform these transplants. Flutamide is indicated for the treatment of advanced prostatic carcinoma, this drug is no longer in use in secondary care. Therefore a shared care agreement was no longer required and the shared care status should be changed to non-formulary classification The committee agreed for both proposals to be changed on the netformulary. 6.3 - SDL Amendments - Sixteen proposed amendments from ArdenGEM CSU were brought to the committee for consideration; 6.3.1 - RS highlighted that most of these drugs were recommended as SO except for the two raloxifene preparations which were recommended as specialist advised (SA) for licensed and unlicensed indications 6.3.2 - JS questioned why raloxifene was classified as SA, as it was not prescribed much in primary care The committee agreed for these proposals to be included on the netformulary, except for raloxifene treatment of osteoporotic fragility fracture to be classified as preferred choice. 6.4 - SDL Amendment - One proposed amendment from SWFT Dermatologist along with supporting guidance from the British Association of Dermatologists was brought to the committee for consideration; 6.4.1 - RS highlighted the request that Efudix 5% cream for treatment of actinic keratosis be changed from SO to SI so that GPs can prescribe in primary care when treatment initiated by dermatologist 6.4.2 - CS noted that there were 2 other drugs on the netformulary with the same indication; she thought the change should apply to the whole disease rather than just one drug The committee agreed to this proposal and for all 3 drugs to be amended on the netformulary. 6.5 - SDL Amendment - TNP/SL - DT briefly summarised that currently Topical Negative Pressure Therapy (TNPT) and Sterile Larvae (SL) is SO. The issue in primary care is that secondary care colleagues are recommending the therapy and then asking the district nurses to administer who are not clinical specialists. DT added that the consumables must be prescribed by secondary care not in primary care which results in a huge problem. CWPT are alerting UHCW and the community tissue viability team. The committee agreed to include a statement on the netformulary. 8

Section 6 Decisions 6A Re-write NOACs DPS verdicts & send out for virtual ratification, format document and republish, then update netformulary 6B Write to specialist regarding NOACs decision review outcome AD 6C Publish the agreed SDL amendments to the netformulary AD/SD 6D Send additional statement for TNP/SL SO status to APC office, update netformulary DT/SD 7. Guidelines/Resource Documents 7.1 - Local Blacklist amendment One proposed amendment from CRCCG was brought to the committee for consideration; 7.1.1 - AH briefly explained the inclusion of the non-acbs all branded Comfort milks The committee agreed to include this addition to the netformulary. 7.2 - Prescribing of Specialist Infant formula AD briefly summarised the changes to the revised guidance in conjunction with the Comfort milks blacklist amendment form. 7.2.1 - SK suggested that it would be useful to include a cost price per tin because some of these milks are extremely expensive The committee agreed for revised guidance to be republished. 7.3 - COPD - This item was discussed earlier along with item 5.4 7.4 - First Line Nutrition Support A revised patient leaflet developed by joint collaboration between SWFT Prescribing Support Dietitian and CRCCG Medicines Management Dietitian with the close involvement of the SWFT dietetic patient information working group and UHCW community dietitians was brought to the committee for reconsideration; 7.4.1 - AD informed that this leaflet replaces the current resource associated documents RD017: AD02, AD08 and AD09. It was produced in order for GPs across Coventry and Warwickshire to update patients with nutritional information The committee agreed for the patient leaflet to be published in the resource section and remove the relevant associated documents. 7.5 - Buccolam Prescribing A revised guidance from CWPT was brought to the committee for approval. DT informed that this includes the new licensed pre-filled oral syringe product Epistatus. The neurologists have agreed to keep Buccolam as first-line therapy and to use Epistatus for those patients who failed on Buccolam The committee agreed for the guidance to be republished and update the netformulary. 9

7.6 - Blood Glucose Testing Strips - A revised CRCCG preferred prescribing list was brought to the committee for reconsideration; 7.6.1 - AD highlighted the following changes; new Contour test-strips have been included ketone meter changed to Glucomen Areo 2K as much more cost-effective preparation Wording for different patient categories made clearer and now emphasises patient choice and also includes a link to document RD003 AD also informed the committee that he is looking to have one united guideline for Coventry and Warwickshire and that work will begin with the CCG teams and diabetologists across the patch to devise a single guidance. The committee agreed to republish this guidance. 7.7 - PCSK9i Pathway - A request from the 3 trust endocrinologists for prescribing PCSK9 inhibitors was brought to the committee for approval. The pathway has already been agreed by the cardiologists across the patch. 7.7.1 - CS commented that UHCW High-Cost Drugs (HCD) Pharmacist informed her that she was not aware of this document, her comments were; both drugs have NICE TAs so preference would not be feasible and only Evolocumab is set-up on the homecare system No reference to both HCDs being approved via the Blueteq system and there was no mention of this in the document The committee agreed that document should be approved at the 3 trust DTCs then submitted to APC meeting. Section 7 Decisions 7A Publish the agreed blacklist addition to the netformulary AD/SD 7B Republish specialist infant formula guidance & quick reference guide AD/SD 7C Republish revised COPD guidance to both websites AD/SD 7D Publish first line nutrition support patient leaflet in resource section, remove relevant associated documents AD/SD 7E Amend and send final revised buccolam prescribing guidance to APC office, then publish and add to netformulary DT/SD 7F Republish revised blood glucose testing strips PPL AD/SD 7G Draft PCSK9i pathway to be submitted to the 3 DTCs, then brought back to meeting AD/PM/SP/ME 8. Shared Care Agreements Due to time constraints the seven revised shared care agreements (SCA) for rheumatology indication were deferred until January 2018 meeting. The committee were asked to send any comments to APC office. 10

Section 8 Decisions 8A Add rheumatology SCAs item to January agenda AD/SD 8B Send SCAs comments to Anita Hunjan before next meeting 9. AOB 9.1 - New Medicines & Pathway Committee This item was briefly discussed at the last meeting, ME summarised the contents of the proposal paper; to ensure that the NICE approved and non-nice drugs are accessed through a single mechanism route for the whole health economy and actively invite the relevant clinician to represent their colleagues from across the patch as and when required. 9.1.1 - AD questioned whether commissioner s representation was required 9.1.2 - LD suggested the committee name was confusing and that it should be renamed as High Cost Drug Committee. He also said the remit should also address tariff and non-tariff items 9.1.3 - PM confirmed that at the last meeting the outcome was that approval was required from the commissioners The committee agreed to send their comments to ME before the final proposal was agreed. 9.2 - SF concluded the meeting by reminding the committee to ensure they complete the annual declaration of interest form and hand them to SD. Also, to note next year s meeting schedule and requested the committee to respond to the meeting invites accordingly. 9.3 - ME reported that there was a world-wide shortage of Clexane 20 mg and 40 mg dosages. With effect from Monday 20 th November 2017, UHCW will be switching to the biosimilar drug Inhixa for the 20 mg or 40 mg dosage. Key issue for primary care nurses is that the needle mechanism is different to Clexane. 9.4 - PC introduced her replacement - Jo Brader, SWFT Community Matron who attended today s meeting as an observer. Section 9 Decisions 9A Send comments to ME regarding the proposal of Medicines and Pathway committee 9B Committee to bring completed declaration of interest form to January meeting 10. Date of next meeting The date and time of the next meeting is Friday 19 th January 2018 at 12.30 pm until 3pm. 11