PROTECTIVE MARKING: NONE NHS GRAMPIAN Minute of Formulary Group Meeting Tuesday 20 June 2017 at 14:30 in the Board Room, Aberdeen Royal Infirmary

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1 NHS GRAMPIAN Minute of Formulary Group Meeting Tuesday 20 June 2017 at 14:30 in the Board Room, Aberdeen Royal Infirmary PRESENT APOLOGIES APPROVED Dr D Counter Dr J Fitton Dr D Culligan (from item 8.2) Mrs L Harper Ms A Davie Dr C Hind Ms F Doney Dr A MacDonald Dr L Elliot Dr W Moore Mrs J Jordan Dr A Sun Professor J McLay (Chairman) Mrs L Montgomery Mr M Paterson Mr C Rore Mr R Sivewright The Chairman opened the meeting, welcomed everyone, and noted that a quorum was present. 1. APOLOGIES Apologies for absence were requested and noted. 2. DRAFT MINUTE OF THE MEETING HELD 18 APRIL 2017 The Group accepted the draft note of the meeting held 18 April as an accurate record of the meeting. The corrected approved minute will be in the public domain within 21 days. FD 3. PRESENTATION - NONE 4. MATTERS ARISING 4.1. SINGLE FORMULARY MEETING 16 MAY 2017 Dr Elliot and Ms Doney provided members with a brief summary of the Single Formulary event. Further meetings are planned for patient/public representatives and the Pharmaceutical Industry, information from Scottish Government is awaited CONFLICTS OF INTEREST, 2016 DISCLOSURES Ms Doney reminded members that any transfers of value recorded in 2016 will be published on the central database, Disclosure UK. Disclosure UK is a searchable database that shows payments and benefits in kind made by the pharmaceutical industry to doctors, nurses and other health professionals and organisations in the UK. Individuals or services/organisations named in the pharmaceutical companies' 2016 disclosures will have received log in details, giving them the opportunity to check the data before it goes live on 30 June. 5. FORMULARY GROUP DECISIONS APRIL PUBLISHED 02/05/2017 The Group noted the April decisions previously ratified via NETFORMULARY/FORMULARY REVIEW 6.1. MELATONIN Melatonin is not a hypnotic but a natural hormone involved in the coordination of the body s sleep-wake cycle. It should only be prescribed for children and adolescents, or adults with learning difficulties, on the advice of a specialist in line with formulary acceptance. Current formulary choices are Circadin 2mg prolonged-release tablets (off-label use) and the unlicensed product Bio-Melatonin 3mg tablets. The agreed price listed for unlicensed melatonin in the Scottish Drug Tariff (SDT) is UNCONTROLLED WHEN PRINTED Formulary Group 20 June 2017 Page 1 of 8

2 considerably higher than that previously available for unlicensed Bio-Melatonin 3mg tablets. The SDT now includes a melatonin 3mg capsule that has a lower cost than the agreed price for the unlicensed 3mg tablet (e.g. Bio-Melatonin ). Child and Family Mental Health Services (CAMHS) and Royal Aberdeen Children s Hospital (RACH) are reviewing a proposal to agree a maximum dose for melatonin (there is no evidence that increasing the dose increases effect), use Circadin off-label as the firstchoice product, with unlicensed immediate-release melatonin 3mg capsules second-line. The Group supported the proposed change in melatonin use. 7. OTHER BUSINESS 7.1. NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE MULTIPLE TECHNOLOGY APPRAISALS FOR INFORMATION The SMC confirmed that from 1 October 2017, National Institute for Health and Care Excellence (NICE) Multiple Technology Appraisals (MTAs) will no longer be assessed by Healthcare Improvement Scotland (HIS) for applicability to NHS Scotland. Any new medicines that are going through the NICE MTA process and have not been assessed by the Scottish Medicines Consortium (SMC) will require a submission to SMC. This change has no bearing on MTAs that have been endorsed by HIS to date; the advice from these MTAs will continue to apply. Where there are price changes because of the NICE appraisal process, National Procurement will continue to provide up-to-date pricing information to Area Drug and Therapeutics Committees (ADTCs) to support local formulary decisionmaking NICE MTA CERTOLIZUMAB PEGOL AND SECUKINUMAB FOR TREATING ACTIVE PSORIATIC ARTHRITIS AFTER INADEQUATE RESPONSE TO DMARDS The Group noted that the recommendations of NICE and SMC are consistent, and the local formulary recommendations are in line with the SMC advice. The Group ratified the NICE advice as published SBAR STRONTIUM The Group noted the press release from Servier advising that production and distribution of strontium will cease by the end of August This is a strategic decision based on falling patient numbers. The company has intimated that it expects supplies of strontium to be exhausted before the end of the year. Strontium ranelate is a formulary medicine restricted to patients for whom there are no other treatments for osteoporosis. The Osteoporosis service is aware of the decision to cease production and has switched or stopped treatment for patients seen recently. Patients that remain on strontium will be reviewed individually. General practices are taking this forward with information highlighted to colleagues in the Osteoporosis Service. The Group noted that strontium ranelate 2g granules (Protelos ) is to be withdrawn throughout the European Union and recorded it as non-formulary ORAL REHYDRATION SOLUTIONS IN THE MANAGEMENT OF SHORT BOWEL SYNDROME Mr Rore declared a personal, non-specific interest in Nestlé. The Group discussed the UK Medicines Information Medicines Q&A 88.5, What is St Mark s Electrolyte Mix (solution), and oral rehydration solutions used in the management of Short Bowel Syndrome. St Mark s Electrolyte Mix is a glucose-electrolyte mix, containing 90mmol/L of sodium and no potassium. Patients make up fresh solution every day using set measurements of glucose, sodium bicarbonate (or sodium citrate) and sodium chloride dissolved in a litre of water. Patients drink the solution through the day, and may require two or three litres per day to maintain hydration. For patients that cannot make up St Mark s solution double strength Dioralyte (two sachets of Dioralyte in 200mLs of water) is used. Glucodrate, manufactured by Vitaflo Ltd (Nestlé Health Science), is a food for medical UNCONTROLLED WHEN PRINTED Formulary Group 20 June 2017 Page 2 of 8

3 purposes that must only be given under medical supervision to patients with a diagnosis of short bowel-associated intestinal failure and intestinal insufficiency. It is suitable for adults 18 years and older. Electrolyte and bicarbonate levels should be monitored when initiating Glucodrate. The Group accepted the restricted local need for Glucodrate for patients that cannot make up St Mark s solution. Glucodrate sachets is routinely available in line with local guidance. Indication under review: for adults in the dietary management of short bowelassociated intestinal failure and intestinal insufficiency. 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. 8. NEW PRODUCT REQUESTS 8.1. FG1 SMC 1216/17 - DACLIZUMAB (ZINBRYTA ) (RRMS) There were no declarations of interest recorded in relation to this product. The Group considered the submission for daclizumab (Zinbryta ) for the treatment of adults with relapsing forms of multiple sclerosis, noting that the SMC advice restricts use to patients with rapidly evolving severe relapsing remitting multiple sclerosis (RRMS) or patients with RRMS with an inadequate response to disease modifying therapy. The Group noted: daclizumab: is a humanised IgG1 monoclonal antibody that modulates IL-2 signalling is injected subcutaneously at a recommended dose of 150mg every 28 days would be considered a drug of high efficacy (Category 2) ref Association of British Neurologists: revised (2015) guidelines for prescribing disease-modifying treatments in multiple sclerosis the service wishes to use daclizumab, in line with the SMC restrictions multiple sclerosis is a fluctuating life-long progressive condition with no cure however the availability of disease modifying agents can reduce relapse rate and disease progression 9 June 2017 the European Medicines Agency (EMA) started a review of daclizumab following the death from fulminant liver failure of a patient treated in an ongoing observational study, as well as four cases of serious liver injury. The risk of liver damage was known at the time of licensing and several measures had been taken to manage this risk, including providing educational materials for healthcare professionals and for patients on how to prevent or reduce liver damage. experience with other disease modifying agents has highlighted the increased risk of Progressive Multifocal Leukoencephalopathy the choice of agent is usually made along with the patient after the discussion of risks and benefits The Group acknowledged that daclizumab would provide another disease-modifying agent with a different mode of action and an alternative route of administration that would allow treatment at home. The Group accepted the restricted local need for daclizumab as outlined in SMC 1216/17 noting a review of daclizumab is ongoing. SMC 1216/17 - Daclizumab 150mg/mL solution for injection in prefilled syringe/pen (Zinbryta ) is routinely available in line with national guidance (SMC 1216/17). Indication under review: in adult patients for the treatment of relapsing forms of multiple sclerosis. Restriction: for use in patients with rapidly evolving severe (RES) relapsing remitting multiple sclerosis (RRMS) or in patients with RRMS with an inadequate response to disease modifying therapy In a phase III study, the adjusted annualised relapse rate (over a period of 144 weeks) UNCONTROLLED WHEN PRINTED Formulary Group 20 June 2017 Page 3 of 8

4 was statistically significantly lower for daclizumab than for an interferon beta treatment in patients with RRMS. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of daclizumab 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 by a physician experienced in the management of multiple sclerosis. [09/06/2017] The European Medicines Agency has started a review of daclizumab following the death from fulminant liver failure of a patient treated in an ongoing observational study, as well as four cases of serious liver injury. While the review is ongoing, healthcare professionals using Zinbryta should closely monitor their patients and discuss with them the risk of liver damage and possible symptoms. Patients should contact their doctor promptly should they develop any symptoms of liver problems, such as unexplained nausea, vomiting, abdominal pain, tiredness, loss of appetite, yellowing of the skin and eyes, and dark urine FG1 SMC 320/06 - ENTECAVIR (CHRONIC HEPATITIS B IN ADULTS) 8.3. SBAR SMC 1049/15 - ENTECAVIR (CHRONIC HEPATITIS B IN PAEDIATRICS) There were no declarations of interest recorded in relation to this product. The Group considered the two SMC detailed advice documents for entecavir, SMC 320/06 and SMC 1049/15, for the treatment of chronic hepatitis B virus infection. The Group noted that: it is over 10 years since entecavir for the treatment of chronic hepatitis B virus infection in adults was reviewed by the SMC. Since this review, entecavir tablets are now available as a generic product and the oral solution is only available as the branded product Baraclude. entecavir and tenofovir for chronic hepatitis B virus infection are NAs with a high barrier to resistance; lamivudine, adefovir and telbivudine are considered low barrier resistance NAs. for adults: the request is limited to use in compensated liver disease (and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis). Entecavir in decompensated liver disease is not accepted for use in NHS Scotland (SMC 747/11, Published January 2012). patient numbers are expected to be low, tenofovir disoproxil remains the preferred agent, switching to entecavir if tenofovir is not tolerated. However there may be patients for whom entecavir may offer a better first line option, e.g. those with preexisting bone or renal disease due to the adverse effects associated with tenofovir. the submission places entecavir as the second-choice agent however the European Association for the Study of the Liver (EASL) guidance, puts both entecavir and tenofovir as first line options for children and adolescents: SMC 1049/15 is abbreviated advice for the entecavir licence extension to include nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease. The paediatric service has confirmed there are no patients currently requiring treatment but inclusion on formulary would prevent delay in treatment if patients were identified. tenofovir 245mg tablets and 33mg/g oral granules are available for the treatment of hepatitis B infection in adolescents 12 to <18 years with compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis. [Granules restricted to patients for whom a solid dosage form is not appropriate]. the availability of entecavir will provide a licensed NA for children and adolescents aged 2 to <12 years of age A member questioned if entecavir requires additional monitoring by Primary Care. The UNCONTROLLED WHEN PRINTED Formulary Group 20 June 2017 Page 4 of 8

5 service has confirmed that there are no monitoring requirements for Primary Care. Patients are seen at clinic every three months for the first year, then six-monthly. Tenofovir has additional monitoring requirement for Primary Care due to its renal effects. The Group accepted the restricted local need for entecavir for the treatment of chronic hepatitis B virus infection in children, adolescents and adults as outlined in SMC 320/06 and SMC 1049/15. SMC 320/06 - Entecavir 0.5 mg and 1.0 mg film coated tablets is routinely available in line with local guidance. Indication under review: for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. It was classified 1b- available for restricted use under specialist supervision and 8b recommended for hospital use only. Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection. SMC 1049/15 Entecavir 0.5mg, 1mg film-coated tablets, 0.05mg/mL oral solution (Baraclude ) is routinely available in line with national guidance (SMC 1049/15). Indication under review: treatment of chronic hepatitis B virus infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum alanine aminotransferase levels, or histological evidence of moderate to severe inflammation and/or fibrosis. Restriction: to be prescribed under the supervision of specialists in paediatric infectious diseases. While the benefits of viral suppression in adults are acknowledged the benefits of anti-viral treatment in children are less well established. In clinical studies, the antiviral efficacy of entecavir in children is reported to be lower than in adults. However, there is a potential need for treatment in a very small number of paediatric patients and this is the first licensed medicine for hepatitis B in this age group. It was classified 1b- available for restricted use under specialist supervision and 8b recommended for hospital use only. Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection FG1 SMC 856/13 - INSULIN DEGLUDEC (TRESIBA ) (DIABETES MELLITUS) There were no declarations of interest recorded in relation to this product. The Group considered the late paper submitted for insulin degludec 100units/mL solution for injection in pre-filled pen or cartridge. The Group noted that: degludec: is an ultra-long acting basal insulin given once-daily by subcutaneous injection it has a duration of action of at least 42 hours; steady state is reached after 2 3 days of dose administration allows flexible dosing, preferred if taken once-daily at the same time every day, but it can be taken at any time as long as a minimum of 8 hours has passed since the last injection is available as 100units/mL and 200units/mL preparations but the use of high strength insulin is not supported locally so the request is limited to the 100units/mL preparation in type 1 diabetes mellitus, degludec must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements The Group noted that other long-acting preparations are available at a lower cost, however the long duration of action (at least 42 hours at therapeutic dose) may provide a particular advantage for patients that cannot adhere to or manage a regular once daily, at the same time of day, regimen. The Group accepted the restricted local need for insulin degludec 100units/mL for the UNCONTROLLED WHEN PRINTED Formulary Group 20 June 2017 Page 5 of 8

6 treatment of diabetes mellitius in adults as outlined in SMC 856/13. Insulin degludec 100units/mL solution for injection in pre-filled pen or cartridge (Tresiba ) is routinely available in line with national guidance (SMC 856/13). Indication under review: treatment of diabetes mellitus in adults. In three phase III studies in adults with type 1 diabetes mellitus, and five phase III studies in adults with type 2 diabetes mellitus, insulin degludec was non-inferior to other long-acting insulin analogues, assessed by the mean change in glycosylated haemoglobin (HbA1c). Insulin degludec is also indicated for the treatment of diabetes mellitus in adolescents and children from the age of 1 year.. It was classified 1b- available for restricted use under specialist supervision and 8d - treatment may be initiated in the community on the recommendation of a consultant/specialist. 9. SCOTTISH MEDICINES CONSORTIUM PROVISIONAL ADVICE - ISSUED JUNE 2017 The Group noted the SMC provisional advice issued June If published next month the negative SMC recommendation, for selexipag (Uptravi ) SMC 1235/17, and the non-submission statements, for emtricitabine/tenofovir disoproxil (Truvada ) SMC 1263/17 and trametinib (Mekinist ) SMC 1264/17, will not be included on the Grampian Joint Formulary for the indications in question. 10. SCOTTISH MEDICINES CONSORTIUM PRESS STATEMENTS - PUBLISHED MAY AND JUNE 2017 The Group noted the SMC advice published May Following publication of the non-submission statements, for alectinib (Alecensa ) SMC 1257/17, liraglutide (Saxenda ) SMC 1247/17 and talimogene laherparepvec (Imlygic ) SMC 1248/17, these 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 775/12 belimumab (Benlysta ) (submission received) SMC 1226/17 idebenone (Raxone ) (submission expected) SMC 935/13 micronised progesterone (Utrogestan Vaginal ) SMC 1228/17 nepafenac (Nevanac ) Local advice for these medicines and indications will be included in the June 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. SCOTTISH MEDICINES CONSORTIUM PRESS STATEMENTS - PUBLISHED JUNE 2017 The Group noted the SMC advice published June Following publication of the negative SMC recommendation, for pertuzumab (Perjeta ) SMC 897/13, and the non-submission statements, for ibrutinib (Imbruvica ) SMC1258/17 and safinamide (Xadago ) SMC 1259/17, these 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 1241/17 aprepitant (Emend ) SMC 1244/17 Symbicort SMART (budesonide/formoterol) SMC 1245/17 buprenorphine (Espranor ) (submission expected) SMC 1234/17 cabozantinib (Cabometyx ) (submission expected) SMC 1246/17 deferasirox (Exjade ) (submission expected) SMC 1188/16 nivolumab (Opdivo ) (submission expected) SMC 1232/17 obeticholic acid (Ocaliva ) Local advice for these medicines and indications will be included in the June 2017 decisions UNCONTROLLED WHEN PRINTED Formulary Group 20 June 2017 Page 6 of 8

7 as Not routinely available as local implementation plans are being developed or the ADTC is waiting for further advice from local clinical experts. SBAR SMC 1243/17 - ADALIMUMAB (HUMIRA ) (ADOLESCENT HS) There were no declarations of interest recorded in relation to this product. The Group discussed abbreviated SMC advice, SMC 1243/17, that accepts the licence extension of adalimumab for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic hidradenitis suppurativa therapy. The Group noted that: adalimumab is the first biologic medicine licensed for the treatment of hidradenitis suppurativa in October 2016, it was accepted to formulary for adults for the treatment of moderate to severe hidradenitis suppurativa [SMC 1143/16] hidradenitis suppurativa has a profound and detrimental effect on the life of the patient The Group accepted the restricted local need for adalimumab, as outlined in SMC 1243/17, as a treatment option for hidradenitis suppurativa in adolescents from 12 years. SMC 1243/17 - Adalimumab 40mg/0.4mL pre-filled syringe, pre-filled pen, 40mg/0.8mL vial for paediatric use (Humira ) is routinely available in line with national guidance (SMC 1243/17). Indication under review: treatment of active moderate to severe hidradenitis suppurativa (HS) (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy. 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 specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated. Patients should be given the special alert card. 11. GENERAL INFORMATION FROM SMC JUNE 2017 LICENCE EXTENSIONS Aprepitant: SMC issued advice for the use of aprepitant for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin chemotherapy in adults in November 2004 (132/04). The licence was extended to cover prevention of nausea and vomiting associated with highly emetogenic non-cisplatin based chemotherapy in January SMC does not plan to assess this licence change. Ranibizumab: In December 2016 the licence for ranibizumab was extended to cover the treatment of patients with visual impairment due to choroidal neovascularisation (CNV) associated with causes other than neovascular (wet) age-related macular degeneration (AMD) or pathologic myopia (PM). SMC does not intend to evaluate this change to the marketing authorisation at this time. We anticipate that Boards would apply existing advice for visual impairment due to CNV associated with AMD and PM to patients with CNV independent of the underlying etiology. The services will be contacted to confirm if there is a local need for these medicines and indications. FD UNCONTROLLED WHEN PRINTED Formulary Group 20 June 2017 Page 7 of 8

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