LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE

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1 FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on from in Room 021, Ground Floor, Pentland House Present: Dr M Corretge Dr S Hurding Dr W Jamieson S Kerr L Leitch I Mohammed Dr E Morrison J Pearson L Shaw Dr R Williams Dr D Wilks In attendance: Dr Henry Fok Dr J Goddard J Main K Nielsen Apologies for absence: L Angell Dr J Dear A Gilchrist Dr SC Hornibrook F McIntyre L Renshaw G Todd Absent: Prof M Taylor Consultant Geriatrician, St John s Hospital, Livingston General Practitioner, NHS Lothian General Practitioner, NHS Lothian (in the chair) Site Lead Pharmacist, Western General Hospital Formulary Pharmacist, NHS Borders Clinical Effectiveness Pharmacist, NHS Fife Clinical Pharmacology Trainee, Royal Infirmary of Edinburgh Formulary Pharmacist, NHS Lothian Lead Pharmacist, Royal Hospital for Sick Children General Practitioner, NHS Lothian Consultant in Infectious Diseases, Western General Hospital Specialist Registrar, Clinical Pharmacology, Royal Infirmary of Edinburgh Renal Consultant, Royal Infirmary of Edinburgh Pharmacy Pre-Registration Pharmacist Trainee Medicines Optimisation Team Lead, NHS Cumbria Clinical Commissioning Group Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh Lead Pharmacist, Medicines Management Team General Practitioner, NHS Lothian Site Lead Pharmacist, Royal Infirmary of Edinburgh Clinical Nurse Specialist, Oncology Department, Western General Hospital Lead Pharmacist, Royal Edinburgh Hospital and Roodlands Hospital Consultant Psychiatrist, IHTT, Royal Edinburgh Hospital and Honorary Senior Lecturer, University of Edinburgh Declarations of interest: The Chair reminded members to declare any interests in any of the products to be discussed. One member declared a personal non-specific interest in item 3.2 lipefilgrastim. This was noted by the chair. Page 1 of 15

2 Membership: Dr David Wilks, Consultant in Infectious Diseases, Western General Hospital, has resigned from the committee as of this meeting. Dr Jane Goddard will take his place starting May Sheena Kerr, Site Lead Pharmacist, Western General Hospital, informed the committee that she wishes to resign. She agreed to stay on as a member until replacement is found. A member from oncology is still being sought. 1. Minutes of the previous meeting held on 16 th December 2015 The minutes were approved as an accurate account of the meeting. 2. Matters arising from previous minutes th November 2015 FC minutes - colistimethate sodium (Colobreathe ) The committee noted the submitted decision tree for the use of dry-powder colistin (Colobreathe). 3. SMC Recommendations 3.1 empagliflozin (Jardiance ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were included with the application and noted by the committee empagliflozin 10mg and 25mg tablet (Jardiance ) SMC No. (993/14) empagliflozin (Jardiance ) is accepted for restricted use within NHS Scotland. Indication under review: Treatment of type 2 diabetes to improve glycaemic control in adults as add-on combination therapy: in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. SMC restriction: to use in the following situations: dual therapy in combination with metformin, when a sulphonylurea is inappropriate triple therapy in combination with metformin plus standard of care add-on to insulin therapy in combination with insulin plus standard of care Empagliflozin was superior to placebo for glycaemic control in combination with various anti-diabetic medicines (metformin; metformin plus sulphonylurea; thiazolidinedione ± metformin; and insulin) and it was non-inferior to a sulphonylurea in combination with metformin. Empagliflozin is also indicated as monotherapy in patients who cannot tolerate metformin. SMC cannot recommend the use of empagliflozin as monotherapy as the company s submission did not include evidence of cost-effectiveness in this setting The committee noted the FAF1 submission for the use of empagliflozin (Jardiance ) as first line treatment in patients with Type 2 diabetes and pre-existing cardiovascular disease. Page 2 of 15

3 3.1.3 It was noted that a local protocol has been developed and that this is consistent with SMC recommendation. Prescribing will take place in primary care by clinicians with specialist knowledge of diabetes and in secondary care It was noted that empagliflozin (Jardiance ) is suggested to be placed as a joint first line option for patients with Type 2 diabetes who require treatment with a SGLT2 medication and who have pre-existing cardiovascular disease The committee agreed to include empagliflozin (Jardiance ) on the LJF, as first choice, for the indication in question Empagliflozin (Jardiance ) will replace dapagliflozin as the first choice, however the committee highlights that patients already receiving dapagliflozin do not need to be switched. 3.2 lipegfilgrastim (Lonquex ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were included with the application. lipegfilgrastim, 6mg, solution for injection (Lonquex ) SMC No. (908/13) lipegfilgrastim (Lonquex ) is accepted for restricted use within NHS Scotland. Indication under review: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). SMC restriction: where a long-acting granulocyte-colony-stimulating factor is appropriate. In a randomised, double-blind study, in adults with breast cancer given myelosuppressive chemotherapy associated with a high risk of febrile neutropenia, lipegfilgrastim was compared with another long-acting granulocyte colony-stimulating factor when used as primary prophylaxis against febrile neutropenia. The study found lipegfilgrastim was non-inferior to the comparator preparation in terms of the mean duration of severe neutropenia in the first chemotherapy cycle The committee noted the FAF1 submission for the use of lipegfilgrastim (Lonquex ) in patients suitable for primary or secondary prophylaxis against neutropenic sepsis with GCSF It was noted that a local protocol has been developed and that this is consistent with SMC recommendation. Prescribing will take place in secondary care It was noted that lipegfilgrastim (Lonquex ) will replace pegfilgrastim as the longacting GCSF product of choice The committee agreed to include lipegfilgrastim (Lonquex ) on the additional list, Specialist use only, for the indication in question. 3.3 guanfacine (Intuniv ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were included with the application and noted by the committee. Page 3 of 15

4 guanfacine, 1mg, 2mg, 3mg and 4mg prolonged-release tablets (Intuniv ) SMC No. (1123/16) guanfacine (Intuniv ) is accepted for use within NHS Scotland. Indication under review: treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. Treatment must be used as part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures. Two phase III studies in children and adolescents aged 6 to 17 years with ADHD demonstrated that guanfacine improved the symptoms of ADHD compared with placebo The committee noted the FAF1 submission for the use of guanfacine (Intuniv ) in children over 6 years of age with ADHD who have failed to respond adequately or not tolerated CNS stimulants methylphenidate and dexamfetamine It was noted that a local protocol has not been developed. Prescribing will take place in primary and secondary care via a Shared Care Agreement in line with other ADHD treatments for children It was noted that guanfacine (Intuniv ) will be an alternative licensed non-stimulant treatment option for the management of ADHD in children and adolescents, with a different mechanism of action to atomoxetine The committee agreed to include guanfacine (Intuniv ) on the LJF as a prescribing note, Specialist initiation, for the indication in question. 3.4 fluticasone furoate/vilanterol (Relvar Ellipta ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were included with the application and noted by the committee. fluticasone furoate / vilanterol 92/22, 184/22 micrograms inhalation powder (Relvar Ellipta ) SMC No. (966/14) fluticasone furoate/vilanterol (Relvar Ellipta ) is accepted for use within NHS Scotland. Indication under review: the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta 2 -agonist and inhaled corticosteroid) is appropriate in patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta 2 - agonists. There was no statistically significant difference between fluticasone furoate/vilanterol 92/22 micrograms daily and another inhaled corticosteroid/long acting beta 2 -agonist combination (ICS/LABA) inhaler for 0 to 24 hour serial weighted mean forced expiratory volume in one second, at 24 weeks. Some alternative ICS/LABA combination inhalers are available at a lower daily cost. Page 4 of 15

5 3.4.2 The committee noted the FAF1 submission for the use of fluticasone furoate/vilanterol (Relvar Ellipta ) for the management of asthmatics at step 3 (92/22micrograms) and 4 (184/22micrograms) of the British Thoracic Society Guidelines for the management of asthma It was noted that these inhalers will be included in the asthma guidelines and that these are consistent with SMC recommendation. Prescribing will take place in primary and secondary care It was noted that fluticasone furoate/vilanterol (Relvar Ellipta ) will replace seretide accuhaler and symbicort turbohaler as the dry powder inhaler of choice for all new patients The in use shelf-life of 6 weeks and possible implications of this was discussed. The need for education in use was also highlighted The committee agreed to include fluticasone furoate/vilanterol (Relvar Ellipta ) on the LJF, as first choice, for the indication in question. 3.5 tolvaptan (Jinarc ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were included with the application and noted by the committee. tolvaptan 15mg, 30mg, 45mg, 60mg and 90mg tablets (Jinarc ) SMC No. (1114/15) tolvaptan (Jinarc ) is accepted for use within NHS Scotland. Indication under review: to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease. In a phase III placebo-controlled study tolvaptan, after 3 years, had significantly slowed the rate of disease progression as measured by impact on the rate of increase in total kidney volume (TKV) in ADPKD patients who were deemed to be at high risk of disease progression and had relatively preserved renal function. The study inclusion criteria included (list not exhaustive): age 18 to 50 years old, TKV 750ml and creatinine clearance 60ml/minute. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of tolvaptan. This advice is contingent upon the continuing availability of the patient access scheme or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting The committee noted the FAF1 submission for the use of tolvaptan (Jinarc ) in adult patients diagnosed with polycystic kidney disease stage It was noted that a local protocol has been developed and that this is consistent with SMC recommendation. Prescribing will take place in secondary care until clinical experience is established. Prescribing can then take place in primary care if deemed appropriate It was noted that tolvaptan (Jinarc ) will be the first medicine to address the underlying cause of ADPKD. Page 5 of 15

6 3.5.5 The committee agreed to include tolvaptan (Jinarc ) on the additional list, Specialist use only, for the indication in question. Because of the training requirements involved in the safe administration of this medicine it is likely to remain a specialist use only prescription for the foreseeable future. 3.6 Information from February 2016 SMC advice Oral ursodeoxycholic acid products It was noted that SMC will not review the new oral ursodeoxycholic acid products that are currently being launched as there are only minor variations between the products It was noted that NHS Boards should review the available product range and make decisions locally to meet Formulary requirements. 4. SMC latest Not Recommended Medicines (Jan/Feb 2016) 4.1 eculizumab (Soliris ) SMC No. 767/12 is not recommended for use within NHS Scotland. 4.2 pixantrone (Pixuvri ) SMC No. 1138/16 is not recommended for use within NHS Scotland as the holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. 4.3 teduglutide (Revestive ) SMC No. 1139/16 is not recommended for use within NHS Scotland as the holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. 4.4 pertuzumab (Perjeta ) SMC No. 1121/16 is not recommended for use within NHS Scotland. 4.5 nivolumab (Opdivo ) SMC No. 1120/16 is not recommended for use within NHS Scotland. 4.6 capsaicin (Qutenza ) SMC No. 1140/16 is not recommended for use within NHS Scotland as the holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. 4.7 daptomycin (Cubicin ) SMC No. 1141/16 is not recommended for use within NHS Scotland as the holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. 5. Other Medicines Proposed for Use 5.1 magnesium sulphate The committee noted the FAF3 for the inclusion of magnesium sulphate nebuliser solution for acute severe asthma attack in patients aged 2 years or older who are unresponsive to an initial bronchodilator No declarations of interest were included with the submission It was noted that a local protocol has been developed. Prescribing will take place in secondary care. Page 6 of 15

7 5.1.4 It was noted that a magnesium sulphate will be added in the protocol for use in combination with salbutamol and ipratropium The committee decided to include magnesium sulphate on the LJF, as first choice, classified as RED, Specialist use only, under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian, for the indication in question The clinical team will be asked for their opinion on the possibility to include magnesium sulphate in primary care, for use in emergency settings while awaiting transfer of the patient to hospital. 5.2 aztreonam (Azactam ) The committee noted the FAF2 for the inclusion of aztreonam (Azactam ) for treatment of severe infection caused by susceptible aerobic Gram-negative microorganisms; especially in those with a documented penicillin allergy No declarations of interest were included with the submission It was noted that aztreonam (Azactam ) will be classified as an Alert Antibiotic and will be used as an alternative to a carbapenem antibiotic on the advice of microbiology or infectious diseases teams It was noted that a local protocol has not been developed as prescribing will be on specialist advice as outlined in item Prescribing will take place in secondary care The committee agreed to include aztreonam (Azactam ) on the additional list, Specialist use only, for the indication in question. 5.3 midazolam 40mg/mL and lidocaine 2mg/mL intra-nasal solution The committee noted the FAF3 for the inclusion of intranasal midazolam and lidocaine for sedation in special care patients in dental clinics, who do not tolerate cannulation and refuse or are unable to drink oral midazolam No declarations of interest were included with the submission It was noted that a local protocol has not been developed. Prescribing will take place in primary and secondary care Concerns were raised regarding administration and safety protocols The committee agreed to classify midazolam and lidocaine as Not included pending protocol. The clinical team will be asked to clarify procedures and provide a protocol. Page 7 of 15

8 6. SMC Abbreviated Submissions (Dec15/Feb16) 6.1 insulin detemir (Levemir ) insulin detemir 100units/mL, solution for injection in cartridge (Penfill), pre-filled pen (FlexPen) and pre-filled pen (InnoLet) (Levemir ) SMC No. 1126/16 insulin detemir (Levemir ) is accepted for restricted use within NHS Scotland. Indication under review: for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. SMC restriction: in patients unable to achieve good glycaemic control with established insulins. Insulin detemir has previously been accepted for restricted use by SMC in adults, adolescents and children from 2 years of age. Insulin detemir is included in the British National Formulary for Children (November 2015) Included on the LJF for the indication in question. 6.2 oseltamivir (Tamiflu ) oseltamivir 30mg, 45mg, 75mg capsules and 6mg/mL powder for oral suspension (Tamiflu ) SMC No 1127/16 oseltamivir (Tamiflu ) is accepted for use within NHS Scotland. Indication under review: Treatment of influenza in children aged <1 year including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms. Oseltamivir is listed in the British National Formulary for Children (November 2015) for use in children aged <1 year including neonates. Oseltamavir has previously been accepted for use for this indication in patients aged 1 year in NHS Scotland as NHS Healthcare Improvement Scotland advised that NICE Multiple Technology Appraisal No. 168 was valid for Scotland Included on the additional list for the indication in question. Page 8 of 15

9 6.3 ustekinumab (Stelara ) LOTHIAN FORMULARY COMMITTEE ustekinumab 45mg solution for injection and prefilled syringe (Stelara ) SMC No. 1115/15 ustekinumab (Stelara ) is accepted for restricted use within NHS Scotland. Indication under review: treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. SMC restriction: continued treatment should be restricted to patients who achieve at least 75% improvement in their Psoriasis Area and Severity Index (PASI 75) within 16 weeks. Ustekinumab has previously been accepted for restricted use in adults for this indication. For the small number of adolescent patients weighing >100kg that require a dose of 90mg, a 90mg prefilled syringe is available at the same price as the 45mg prefilled syringe Included on the additional list, Specialist use only, for the indication in question The clinical team need to highlight any identified cost pressure with the introduction in use in children age 12 years and older, to the clinical management team. 7. Non-submissions to Formulary Committee (October 90-day target) 7.1 albiglutide (Eperzan ) SMC No. 1024/ Not included on the LJF, because clinicians have not responded to an invitation to 7.2 ceritinib (Zykadia ) SMC No. 1097/ Not included pending protocol. Clinicians confirm submission pending This decision was made 7 January 2016 in order to stay within the 90-day target. 7.3 dulaglutide (Trulicity ) SMC No. 1110/ Not included on the LJF, pending protocol. A submission has been received for the next Formulary Committee meeting. 7.4 fulvestrant (Faslodex ) SMC No. 114/ Not included on the LJF, because clinicians have not responded to an invitation to 7.5 gefitinib (Iressa ) SMC No. 615/ Not included on the LJF, because clinicians have not responded to an invitation to This decision was made 7 January 2016 in order to stay within the 90-day target. 7.6 golimumab (Simponi ) SMC No. 1124/ Not included on the LJF, because clinicians have not responded to an invitation to Page 9 of 15

10 7.7 ivermectin (Soolantra ) SMC No. 1104/ Not included on the LJF, because clinicians have not responded to an invitation to This decision was made 7 January 2016 in order to stay within the 90-day target. 7.8 lenalidomide (Revlimid ) SMC No. 1096/ Not included pending protocol. Clinicians confirm submission pending This decision was made 7 January 2016 in order to stay within the 90-day target. 7.9 naloxegol (Moventig ) SMC No. 1106/ Not included on the LJF, because clinicians have not responded to an invitation to This decision was made 7 January 2016 in order to stay within the 90-day target netupitant/palonostron (Akynzeo ) SMC No. 1109/ Not included on the LJF, because clinicians have not responded to an invitation to 7.11 panobinostat (Farydak ) SMC No. 1122/ Not included on the LJF, because clinicians have not responded to an invitation to 7.12 sorafenib (Nexavar ) SMC No. (482/08) Not included pending protocol. Clinicians confirm submission pending ulipristal acetate (Esmya ) SMC No. 1128/ Not included on the LJF, because clinicians have not responded to an invitation to 7.14 The committee noted that five drugs provisionally listed for consideration at this meeting had been withdrawn at short notice as they had not received financial sign off. The application form requires the Clinical Director to sign that the necessary budget provision is in place if Formulary Committee approve the medicine for use. It was agreed to review the impact this was having on local processes for new drug approval, with a view to taking concerns about trying to separate out the clinical and financial assessments to ADTC for further guidance. 8. Formulary Additions and Amendments 8.1 Formulary Additions ADULT Chapter 3 Respiratory System The committee discussed and approved the changes. The LJF website will be updated The committee noted that approving this amended chapter would now allow the inhalers discussed at the Formulary Committee meeting in November 2015 to be classified. Page 10 of 15

11 8.1.2 Section Insulins The committee discussed and approved the changes. A comment on clarifying the wording around biosimilars was made and in particular high strength Toujeo. The LJF website will be updated Section and Urology The committee discussed and approved the changes. The LJF website will be updated New section Hyperphosphataemia in Chronic Renal Impairment The committee discussed and approved the new section. The LJF website will be updated New text for the front page of each chapter on the LJF website The committee discussed and approved the changes. The LJF website will be updated New text for the FC New Drug Decisions page on the LJF website The committee discussed and approved the changes. The LJF website will be updated. 8.2 Formulary amendment request forms Sodium Chloride 1mmol/mL oral solution The committee noted the amendment request form for the inclusion of Sodium Chloride as sodium supplementation in infants with cystic fibrosis and in other paediatric specialities for sodium depletion Three declarations of interest were included with the submission and noted by the committee It was noted that Sodium Chloride will replace the currently used unlicensed oral solution The committee agreed to include Sodium Chloride on the LJF, as first choice, Specialist initiation, for the indication in question Forceval capsule and adult soluble tablet The committee noted the amendment request form for the inclusion of Forceval as a vitamin and trace element supplement for patients at risk of re-feeding No declarations of interest were included with the submission It was noted that a medicine for this indication is not currently available on the LJF The committee agreed that further information is needed. The applicants will be asked to complete a FAF2 application form lanreotide autogel The committee noted the amendment request form for the inclusion of lanreotide for the management of neuroendocrine tumours One declaration of interest was included with the submission and noted by the committee It was noted that lanreotide would replace sandostatin as first choice for this indication. Page 11 of 15

12 The committee agreed to include lanreotide autogel on the LJF, as first choice, for the indication in question The committee agreed to change the status of sandostatin to LJF second choice methotrexate 2mg/mL oral solution The committee noted the amendment request form for the inclusion of methotrexate as treatment of acute lymphoblastic leukaemia and inflammatory arthritis No declarations of interest were included with the submission It was noted that methotrexate will replace the currently used unlicensed preparation The committee agreed to include methotrexate on the LJF: For acute lymphoblastic leukaemia: on the additional list. For inflammatory arthritis: as first choice, Specialist initiation tobramycin 300mg/4mL (Bramitob ) The committee noted the joint adult and paediatric amendment request form for the inclusion of tobramycin (Bramitob ) as treatment of chronic pulmonary Pseudomonas aeruginosa infection in children and adults (6 years and older) Five declarations of interest were included with the submission and noted by the committee It was noted that tobramycin (Bramitob ) will replace the Tobi nebuliser solution The committee agreed to include tobramycin (Bramitob ) on the LJF, as first choice, Specialist initiation, for the indication in question diazepam 5mg tablets The committee noted the amendment request form for the inclusion of diazepam 5mg tablets for the treatment of substance dependence No declarations of interest were included with the submission The committee discussed the recent change where 5mg and 10mg diazepam was removed from the LJF section due to the high street value and to allow for easier reduction regimes This application was to request the addition of the 5mg strength back in to the formulary, as there is a large cost implication of changing all prescriptions to 2mg tablets The committee noted NHS Lothian s prescribing patterns of 5mg and 10mg strength diazepam are out of line with other Health Boards in Scotland The committee agreed to an interim decision and will re-evaluate the use of 5mg diazepam in 12 months and amend its decision if appropriate. It was agreed that the reintroduction of the 5mg strength in the short term may allow work to be undertaken to reduce doses, so that when the 5mg strength is removed the cost implication is not as large The committee agreed to include diazepam 5mg on the LJF, for the indication in question. 8.3 Survey on the usage of the Abbreviated Drug list and LJF App A survey was circulated to assess the usage of the Abbreviated Drug list and LJF App across NHS Lothian anonymous responses were received and these were discussed by the committee. Page 12 of 15

13 8.3.3 It was agreed not to print hard copies of the Abbreviated Drug list as the survey showed 49% never use it and 77% would not be hindered in their work if the list was not printed. 9. NICE/SIGN/NHS QIS Clinical Guidance The Co-Chairs agreed to remove the NICE Single Technology Appraisals from the agenda from this meeting onwards as these are not applicable in Scotland. 9.1 MTA373 abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis It was noted that this MTA supersedes the following SMC advice: 618/10, 533/09, 738/11, 881/13, 1050/15, 782/12, 842/13 and 930/ There is no material difference between the MTA and the previous SMC advice The web tables will be updated accordingly. 9.2 MTA374 erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy It was noted that this MTA supersedes the following SMC advice: 220/05 for erlotinib The web tables will be updated accordingly. 9.3 MTA375 adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed It was noted that this MTA supersedes the following SMC advice: 719/11, 888/13, 81/03, 590/09, 305/06, 733/11, 1006/14, 1007/14, 593/09 and 774/ It was noted that there is a material difference between the NICE advice and previous SMC advice The clinical teams will be contacted and web tables will be updated accordingly. 9.4 MTA383 TNF-alpha inhibitors for ankylosing spondylitis and nonradiographic axial spondyloarthritis It was noted that this MTA supersedes the following SMC advice: 960/14, 858/13 and 721/11. It also superseded NICE MTA 143. (MTA 143 superseded SMC advice 300/06, 212/05, 303/06 and 101/04.) It was noted that there is a material difference between the NICE advice and previous SMC advice The clinical teams will be contacted and web tables will be updated accordingly. 9.5 NG29 Intravenous fluid therapy in children and young people in hospital Noted Paediatric and Neonatal Drugs and Therapeutics Committee should ensure that any fluid guidelines take into account the advice in NG29. Page 13 of 15

14 9.6 NG31 Care of dying adults in the last days of life Noted 9.7 NG33 Tuberculosis Noted 9.8 NG35 Myeloma: diagnosis and management Noted 9.9 NG36 Cancer of the upper aerodigestive tract: assessment and management in people aged 16 and over Noted 9.10 HTA13 Antimicrobial wound dressings for chronic wounds It was noted that the evidence was insufficient in terms of quality and quantity to draw conclusions on the use of antimicrobial dressings. Consensus statements based on expert opinion were developed The review of wound LJF section is in progress and will take into account this HTA. 10. Drug Safety Issues MHRA Advice 10.1 MHRA Drug Safety Update, Volume 9, Issue 5, December Noted. The committee was informed that an article on safety concerns around Mycophenolate mofetil was published in issue 78 of the Lothian Prescribing Bulletin MHRA Drug Safety Update, Volume 9, Issue 6, January Noted 10.3 Valproate and risk of abnormal pregnancy outcomes: new communication materials The material states clearly that valproate should not be used in female children as well as females of childbearing potential The LJF will be updated accordingly. 11. Hepatitis C 11.1 Revised National Guidance on the Place of Hepatitis C Medicines in Treatment Protocols (December 2015) Noted 11.2 Criteria for the use of Hepatitis C treatment regimens in adults with chronic HCV in NHS Lothian Noted 12 For Information Only 12.1 Formulary Committee Reports and Letters The committee noted the following Formulary Committee reports and letters: trastuzumab (Herceptin ) Page 14 of 15

15 13 AOCB Nothing to note. LOTHIAN FORMULARY COMMITTEE idelalisib (Zydelig ) radium 223 dichloride (Xofigo ) abiraterone (Zytiga ) bevacizumab (Avastin ) ciclosporin (Ikervis ) Calcium and Vitamin D supplement (theical-d3) atomoxetine oral solution 4mg/mL (Strattera ) efavirenz (Sustiva ) glatiramer acetate (Copaxone ) edoxaban (Lixiana ) VTE edoxaban (Lixiana ) - NVAF 14 Date of Next Meeting The committee noted that the next meeting would be held on Wednesday, 13 th April 2016 at 2pm. (The deadline for submission of papers for this meeting is Tuesday 29 th March 2016.) Apologies are to be sent to Committee Administrator prior to the submissions deadline. Page 15 of 15