PROTECTIVE MARKING: NONE NHS GRAMPIAN Minute of Formulary Group Meeting Tuesday 15 August 2017 at 14:30 in the Board Room, Aberdeen Royal Infirmary

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1 NHS GRAMPIAN Minute of Formulary Group Meeting Tuesday 15 August 2017 at 14:30 in the Board Room, Aberdeen Royal Infirmary PRESENT APOLOGIES APPROVED Dr D Culligan Dr D Counter Ms A Davie Dr J Fitton Ms F Doney Mrs L Harper Dr L Elliot Dr A MacDonald Mrs J Jordan Dr W Moore Professor J McLay (Chairman) Mr M Paterson Mrs L Montgomery Mr C Rore Mr R Sivewright There were insufficient members present to constitute a quorum. IN ATTENDANCE Dawn Bruce, Specialist Pharmacy Technician, Formulary Team Sally-Ann Chadha, Secretary, Formulary Team The Chairman opened the meeting, welcomed everyone and noted that attendance did not achieve a quorum. A note of the discussion will be ed to members requesting comment on the recommendations. The recommendations will be ratified at the next quorate meeting. 1. APOLOGIES Apologies for absence were requested and noted. 2. DRAFT MINUTE OF THE MEETING HELD 18 JULY 2017 The draft minute was issued the day of the meeting so members were given a week to return any comments to Ms Doney. Members ratified the minute subject to any changes required due to comments received. All FD 3. PRESENTATION NONE 4. MATTERS ARISING 4.1. NEOMAG 4MMOL CHEWABLE TABLETS Mr Rore will confirm if Neomag is required locally and provide an update for the September meeting. CR 4.2. NICE TA455 - ADALIMUMAB, ETANERCEPT AND USTEKINUMAB FOR TREATING PLAQUE PSORIASIS IN CHILDREN AND YOUNG PEOPLE Ms Doney reported that Healthcare Improvement Scotland (HIS) confirmed that the recommendations of TA455 are as valid for Scotland as for England and Wales, and issued its advice before publication of the Formulary Group decision SMC 1256/17 - CILODEX (CIPROFLOXACIN/DEXAMETHASONE) Just after the July meeting, the service confirmed that there is a local need for Cilodex (ciprofloxacin/dexamethasone). The Group s decision was published as the ADTC is waiting for further advice from local clinical experts, not non-formulary. 5. FORMULARY GROUP DECISIONS JULY PUBLISHED 01/08/2017 Members noted the published July decisions. 6. NETFORMULARY/FORMULARY REVIEW 6.1. SIGN RISK-ESTIMATION-AND-THE-PREVENTION-OF-CARDIOVASCULAR-DISEASE Ms Doney confirmed that the Clinical Effectiveness Team is currently liaising with services to confirm compliance or otherwise with the recommendations of SIGN 149. At the end of UNCONTROLLED WHEN PRINTED Formulary Group 15 August 2017 Page 1 of 7

2 the consultation, a gap analysis will be submitted to the Clinical Governance Committee. Members noted the recommendations in relation to lipid-lowering agents: atorvastatin is the preferred/first choice statin for both primary and secondary prevention asymptomatic individuals should be considered at high risk if they are assessed as having a 20% risk of a first cardiovascular event within ten years adults who are assessed as being at high cardiovascular risk, but with no established cardiovascular disease, should be offered treatment with atorvastatin 20mg/day all patients with established atherosclerotic cardiovascular disease should be offered intensive statin therapy with atorvastatin 80mg/day following an informed discussion of risks and benefits between the individual and responsible clinician (consider a lower dose of atorvastatin in patients at increased risk of adverse effects or drug-drug interactions) Ms Doney confirmed that a flowchart for the initiation of statins in secondary prevention is in draft, it complies with the recommendations of SIGN 149 and is will be sent out for consultation. Members reviewed the suggested possible ScriptSwitch messages for lipid lowering meds - messages are relevant for Primary Care prescribers AMINOSALICYLATES (5-ASAS) WEST OF SCOTLAND PRESCRIBING SUB GROUP Mesalazine is included in the Grampian Joint Formulary as an option for the induction and maintenance of remission in ulcerative colitis and for Crohn's disease affecting the colon. Members noted the recommendations of the West of Scotland Gastroenterology Prescribing Sub Group regarding the prescribing of mesalazine in the treatment of ulcerative colitis. Members supported the recommendations of the West of Scotland Gastroenterology Prescribing Sub Group and ratified the following positions: Salofalk is the first-line choice agent for new patients (at doses of 1.5g maintenance and 1.5-3g acute episodes) where Salofalk is not suitable, alternative formulary choices for new patients are Pentasa and Octasa patients currently taking Asacol should be switched to Octasa. If the switch to Octasa is not tolerated due to patient preference or due to a clinical reason, the patient is switched to Salofalk and not back to Asacol. The Chairman asked if patients on Asacol could be switched to Salofalk rather than Octasa. Ms Doney confirmed that the dissolution profile of Asacol and Octasa are virtually identical. When asked previously the GI service supported the recommendations as presented in the West of Scotland paper, however the service will be asked to confirm if patients could be switched from Asacol to Salofalk rather than Octasa. FD There were no declarations of interest recorded in relation to Salofalk. Salofalk 250mg, 500mg tablets, 500mg, 1g, 1.5g, 3g modified release granules is the preferred solid oral mesalazine for use in the treatment and maintenance of remission of ulcerative colitis. It was classified 1b - available for restricted use under specialist supervision and 8d - treatment may be initiated in community on the recommendation of a consultant/specialist. 7. OTHER BUSINESS 7.1. NICE (M)TA459 - NICE (MULTIPLE) TECHNOLOGY APPRAISAL GUIDANCE NO 459. COLLAGENASE CLOSTRIDIUM HISTOLYTICUM FOR TREATING DUPUYTREN S CONTRACTURE Members noted HIS s advice that the recommendations are as valid for Scotland as for England and Wales. UNCONTROLLED WHEN PRINTED Formulary Group 15 August 2017 Page 2 of 7

3 Members ratified the recommendations of TA459 for collagenase clostridium histolyticum for treating Dupuytren s contracture NICE (M)TA460 - NICE (MULTIPLE) TECHNOLOGY APPRAISAL GUIDANCE NO 460, ADALIMUMAB AND DEXAMETHASONE FOR TREATING NON-INFECTIOUS UVEITIS HIS has not published advice regarding TA460, adalimumab and dexamethasone for treating non-infectious uveitis. Ms Doney reported that if the NICE advice is applicable for NHS Scotland, this would be more restrictive than currently proposed by the Scottish Uveitis Network BIOSIMILAR RITUXIMAB AVAILABLE (INFUSION FORMULATION ONLY) Biosimilar rituximab medicines are now licensed and available in the infusion formulation. Dr Culligan confirmed that the oncology/haematology service is in the process of introducing biosimilar rituximab. An update regarding the introduction and use of biosimilar medicines is planned for a future meeting SUGAR TAX AND CHANGES TO OPTIONS FOR ORAL GLUCOSE TOLERANCE TESTS There were no declarations of interest recorded in relation to Rapilose OGTT Solution. Members reviewed the information submitted regarding Rapilose OGTT Solution The new sugar tax regulations have brought about changes to the formulation of high-sugar drinks, particularly fizzy drinks. The changes have affected the choice of product for the Oral Glucose Tolerance Test (OGTT) process. Lucozade Energy Original now contains approximately 50% less glucose-based carbohydrates. The new formulation makes Lucozade unsuitable for OGTTs. The Diabetic Managed Clinical Network updated its recommendations to: Rapilose OGTT Solution is the product of choice in Primary Care or where occasional OGTTs are being performed Polycal may be suitable where a series of OGTTs are being done, but needs accurate measurement of 113mLs (made up to mLs) Members supported the recommendations of the Diabetic Managed Clinical Network for OGTTs. 8. NEW PRODUCT REQUESTS 8.1. FG1 SMC 1145/16 - BLINATUMOMAB (ALL) There were no declarations of interest recorded in relation to this product. Members considered the submission for blinatumomab, a monoclonal antibody licensed for the treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). Members noted: blinatumomab: was granted a conditional marketing authorisation 1 for the indication under review has an orphan designation in the European Union and meets SMC end-of-life and ultra-orphan criteria was accepted for use in NHS Scotland following the output from the PACE process, and after application of the appropriate SMC modifiers will provide an option for patients that have failed other therapies, potentially a last 1 The approval of a medicine that address unmet medical needs of patients on the basis of less comprehensive data than normally required. The available data must indicate that the medicine s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future. UNCONTROLLED WHEN PRINTED Formulary Group 15 August 2017 Page 3 of 7

4 line treatment option is an additional line of treatment so will be a new/additional cost the adverse event profile, and that blinatumomab is a toxic medicine hospitalisation is recommended for initiation at a minimum for the first 9 days of the first cycle (14 days for some patients) and at least the first 2 days of the second cycle (time in hospital will be dependent on the patients tolerance to the first cycle of treatment). patients may require to be hospitalised for the whole treatment period ALL has a pattern of highest incidence rates in children, teenagers and young adults, which is the opposite to most cancers the high treatment cost, and that patients can receive up to five cycles of treatment Members accepted the restricted local need for blinatumomab (Blincyto ) as outlined in SMC 1145/16. SMC 1145/16 - Blinatumomab 38.5micrograms powder for concentrate and solution for solution for infusion (Blincyto ) is routinely available in line with national guidance (SMC 1145/16). Indication under review: the treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). In a non-comparative phase II study of patients with relapsed or refractory Philadelphia chromosome-negative B-precursor ALL, blinatumomab was associated with clinically relevant complete remission rates. Controlled data with clinical outcomes are currently lacking. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of blinatumomab and is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower. It was classified 1b- available for restricted use under specialist supervision and 8b recommended for hospital use only. Treatment should be initiated under the direction of and supervised by physicians experienced in the treatment of haematological malignancies FG1 SMC 775/12 - BELIMUMAB (SYSTEMIC LUPUS ERYTHEMATOSUS) There were no declarations of interest recorded in relation to this product. Members considered the submission for belimumab, a monoclonal antibody licensed as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE). Members noted: SLE is a chronic, autoimmune, multisystem disorder with a relapsing-remitting clinical course. It is a difficult disease, and belimumab used in addition to current therapy may improve disease control and allow a reduction in steroid dose. treatment with belimumab would be ongoing and is not curative belimumab: is administered intravenously by infusion, infused over a 1-hour period requires aseptic preparation the total time from reconstitution to completion of infusion should not exceed 8 hours so treatment will be limited to day case at Aberdeen Royal Infirmary is used as add-on therapy, so is an additional cost the submission noted that regular blood monitoring prior to treatment is advisable, and blood tests would be done in Primary Care Members queried the requirement for monitoring by Primary Care, usual practice would be that monitoring is managed by the managed service. FD Members accepted the restricted local need for belimumab as outlined in SMC 775/12. UNCONTROLLED WHEN PRINTED Formulary Group 15 August 2017 Page 4 of 7

5 SMC 775/12 - Belimumab 120mg, 400mg powder for concentrate for solution for infusion (Benlysta ) is routinely available in line with national guidance (SMC 775/12). Indication under review: add-on therapy in adult patients with active, autoantibodypositive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-dsdna and low complement) despite standard therapy. Restriction: patients with evidence of serological disease activity (i.e. positive antidsdna and low complement) and a Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score 10. Belimumab, in addition to standard of care, modestly improved disease control in patients with SLE in two phase III studies. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of belimumab and is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower. It was classified 1b- available for restricted use under specialist supervision and 8b recommended for hospital use only. Treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE. Infusions should be administered by a qualified healthcare professional trained to give infusion therapy FG1 SMC 1172/16 - DIAMORPHINE NASAL SPRAY (ACUTE SEVERE NOCICEPTIVE PAIN IN CHILDREN AND ADOLESCENTS) There were no declarations of interest recorded in relation to this product. Members reviewed the request for Ayendi a diamorphine hydrochloride nasal spray licensed for use in children aged from 2 years to under 16 years. Members noted: Ayendi Nasal Spray: was accepted for use in NHS Scotland following review of an abbreviated submission will replace the off-label use of intranasal diamorphine is licensed for the treatment of acute severe nociceptive pain in children and adolescents (2 to <16 years of age) in a hospital setting should be administered in the emergency setting by practitioners experienced in the administration of opioids in children and with appropriate monitoring is available in two strengths and two bottle sizes: 5mL and 10mL 720microgram - 68 dose (5mL bottle) ; 160 dose (10mL bottle) ; 1600microgram - 68 dose (5mL bottle) ; 160 dose (10mL bottle) is a multiple-patient use product, which must be reconstituted before use. Priming before first and subsequent use is required. patients receive a single dose using a total of 2 to 4 sprays (must be administered into alternating nostrils), patients should be monitored for signs of respiratory depression for at least 30 minutes following administration diamorphine is a Schedule 2 Controlled Drug so is subject to the full controlled drug requirements relating to prescriptions, safe custody, destruction, the need to keep registers, etc the accompanying information from the Controlled Drugs Team regarding the potential introduction of this product, including draft guidance and confirmation that the risk of contamination is low Members noted the suggestions of the NHS Grampian Controlled Drugs Team: 1) Develop a policy regarding correct handing and record keeping, and policy for use. All staff involved in the use and handling of Ayendi must be aware of and follow the agreed policies. 2) Initially trial the smaller size of both strengths to assess appropriate size to stock and limit waste Members accepted the restricted local need for the use of Ayendi Nasal Spray in the Paediatric Emergency Department. Introduction locally is subject to liaison with the NHS Grampian Controlled Drugs Team to ensure compliance with legal and best practice UNCONTROLLED WHEN PRINTED Formulary Group 15 August 2017 Page 5 of 7

6 requirements for Schedule 2 Controlled Drugs. SMC 1172/16 - Diamorphine hydrochloride 720microgram/actuation, 1600microgram/actuation nasal spray (Ayendi ) is routinely available in line with national guidance (SMC 1172/16). Indication under review: treatment of acute severe nociceptive pain in children and adolescents in a hospital setting. Diamorphine hydrochloride nasal spray (Ayendi ) should be administered in the emergency setting by practitioners experienced in the administration of opioids in children and with appropriate monitoring. Unlicensed intranasal diamorphine has been used in the NHS in Scotland for the treatment of severe pain in children in the emergency setting. The availability of diamorphine hydrochloride nasal spray (Ayendi ) provides a licensed preparation. It was classified 1b- available for restricted use under specialist supervision and 8a licensed for hospital use only (restricted to the RACH paediatric emergency department). Ayendi Nasal Spray should be administered in the emergency setting by practitioners experienced in the administration of opioids in children and with appropriate monitoring. 9. SCOTTISH MEDICINES CONSORTIUM PROVISIONAL ADVICE - ISSUED AUGUST 2017 Members noted the SMC provisional advice issued August If published next month the negative SMC recommendation, for etelcalcetide (Parsabiv ) SMC 1262/17 and roflumilast (Daxas ) SMC 635/10 and the non-submission statements for, bevacizumab (Avastin ) SMC 1275/17 will not be included on the Grampian Joint Formulary for the indications in question. 10. SCOTTISH MEDICINES CONSORTIUM PRESS STATEMENTS - PUBLISHED AUGUST 2017 Members noted the SMC advice published August Following publication of the negative SMC recommendation, for 5-aminolaevulinic acid (as hydrochloride) (Ameluz ) SMC 1260/17, and the non-submission statements, for canakinumab (Ilaris ) SMC 1268/17, follitropin delta (Rekovelle ) SMC 1269/17 and sufentanil citrate (Zalviso ) SMC 1270/17, these medicines will not be included on the Grampian Joint Formulary for the indications in question. The following SMC accepted medicines have not been processed within a 60-day timescale: SMC 1242/17 carfilzomib (Kyprolis ) SMC1218/17 desmopressin (Noqdirma ) SMC 1249/17 venetoclax (Venclyxto ) Local advice for these medicines and indications will be included in the August 2017 decisions as Not routinely available as local implementation plans are being developed or the ADTC is waiting for further advice from local clinical experts. 11. GENERAL INFORMATION FROM SMC AUGUST 2017 NIL OF NOTE 12. DOCUMENTS FOR INFORMATION ITEM 12.1 (DRUG SAFETY UPDATE JULY 2017) The Chairman highlighted the article Daclizumab (Zinbryta ) and risk of severe liver injury: initiation in multiple sclerosis now restricted, promptly review patients already on treatment. Ms Doney confirmed the neurology service is aware of the new prescribing restrictions, and the daclizumab formulary entry reflects the changes. ITEM 12.2 (PREGABALIN, HOW TO REDUCE THE RISKS, GUIDANCE FOR PEOPLE WORKING WITH PREGABALIN USERS) Members discussed the information, noting that the booklet is mainly aimed at people who work with those who use pregabalin that is not prescribed to them. UNCONTROLLED WHEN PRINTED Formulary Group 15 August 2017 Page 6 of 7

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