LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE

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1 FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on 11 th November 2015 from 2.00pm 5.10pm in Room 004, Ground Floor, Pentland House Present: Dr M Corretge Consultant Geriatrician, St John s Hospital, Livingston A Gilchrist Lead Pharmacist, Medicines Management Team Dr SC Hornibrook General Practitioner, NHS Lothian Dr S Hurding General Practitioner, NHS Lothian arrived at S Kerr Site Lead Pharmacist, Western General Hospital I Mohammed Clinical Effectiveness Pharmacist, NHS Fife Dr E Morrison Clinical Pharmacology Trainee, Royal Infirmary of Edinburgh J Pearson Formulary Pharmacist, NHS Lothian L Shaw Lead Pharmacist, Royal Hospital for Sick Children (in the chair) G Todd Lead Pharmacist, Royal Edinburgh Hospital and Roodlands Hospital Dr R Williams General Practitioner, NHS Lothian arrived at Dr D Wilks Consultant in Infectious Diseases, Western General Hospital In attendance: K Nielsen Apologies for absence: L Angell Dr J Dear Dr W Jamieson L Leitch F McIntyre L Renshaw Absent: Prof M Taylor Medicines Optimisation team lead, NHS Cumbria Clinical Commissioning Group Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh General Practitioner, NHS Lothian Formulary Pharmacist, NHS Borders Site Lead Pharmacist, Royal Infirmary of Edinburgh Clinical Nurse Specialist, Oncology Department, Western General 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. No interests declared. 1. Minutes of the previous meeting held on 7 th October 2015 The minutes were approved as an accurate record of that meeting. 2. Matters arising from previous minutes Nothing to note. Page 1 of 16

2 3. SMC Recommendations 3.1 aflibercept (Eylea ) The committee noted and discussed the previously circulated submission and SMC report. One declaration of interest was included with the application and noted by the committee aflibercept 40mg/mL solution for injection (Eylea ) SMC No. (1074/15) aflibercept (Eylea ) is accepted for use within NHS Scotland. Indication under review: for adults for the treatment of visual impairment due to macular oedema secondary to branch retinal vein occlusion. Aflibercept was associated with significant improvements over laser in visual acuity during a 6-month, randomized, double-masked phase III study in patients with branch retinal vein occlusion. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of aflibercept. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower. Aflibercept has previously been accepted by SMC for macular oedema secondary to central retinal vein occlusion. This advice now extends its use to patients with macular oedema secondary to branch retinal vein occlusion The committee noted the FAF1 submission for the use of aflibercept (Eylea ) in management of macular oedema secondary to BRVO It was noted that a local protocol has not been developed. Prescribing will take place in secondary care The committee agreed to include aflibercept (Eylea ) on the LJF, on the additional list, specialist use only, for the indication in question. 3.2 colistimethate sodium (Colobreathe ) The committee noted and discussed the previously circulated submission and NICE MTA report. Three declarations of interest were included with the application and noted by the committee. colistimethate sodium 1,662,500 IU dry powder inhalation (Colobreathe ) NICE MTA 276 NICE (multiple Technology Appraisal Guidance No 276 colistimethate sodium and tobramycin dry powders for inhalation for treating pseudomonas lung infection in cystic fibrosis Colistimethate sodium DPI is recommended as an option for treating chronic pulmonary infection caused by P. aeruginosa in people with cystic fibrosis only if: they would clinically benefit from continued colistimethate sodium but do not tolerate it in its nebulised form and thus tobramycin therapy would otherwise be considered and the manufacturer provides colistimethate sodium DPI with the discount agreed as part of the patient access scheme to primary, secondary and tertiary care in the NHS Page 2 of 16

3 3.2.2 The committee noted the FAF1 submission from paediatrics for colistimethate sodium (Colobreathe ) use in patients over 6 years old chronically infected with Pseudomonas aeruginosa, with suitable manual dexterity and technique to use a turbohaler and who do not tolerate nebulised Colomycin ; or who receive tobramycin via a dry powder device (Tobi podhaler ) and would otherwise require nebulised Colomycin on their non-tobramycin months It was noted that a local protocol is in development. Prescribing will be initiated in secondary care. Subsequent supplies will be prescribed in primary care under directions from the CF team It was noted that colistimethate sodium (Colobreathe ) will be used second line after nebulised colistimethate It was noted that the adult CF service have positioned the use of colistimethate sodium (Colobreathe ) differently to this application. The submission from adults was approved in October The committee agreed to include colistimethate sodium (Colobreathe ), on the additional list, specialist use only, for the indication in question in paediatrics The clinical team will be asked to submit a protocol for a future FC meeting. 3.3 secukinumab (Cosentyx ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were included and noted by the committee. secukinumab 150mg pre-filled syringe, 150mg pre-filled pen (Cosentyx ) SMC No. (1054/15) secukinumab (Cosentyx ) is accepted for restricted use within NHS Scotland. Indication under review: treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SMC restriction: for patients who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contra-indication to these treatments. secukinumab was superior to placebo and to a tumour necrosis factor (TNF) antagonist for improving symptoms of patients with moderate to severe plaque psoriasis. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of secukinumab. It is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower The committee noted the FAF1 submission for secukinumab (Cosentyx ) as treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Patients who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate and phototherapy), are intolerant to, or have a contra-indication to these treatments It was noted that a local protocol has not been developed. Prescribing will take place in secondary care. Page 3 of 16

4 3.3.4 The committee agreed to classify secukinumab (Cosentyx ) as not included pending protocol The clinical team will be asked to provide further information on place in therapy in comparison with the other biologics approved for use in plaque psoriasis. 3.4 apremilast (Otezla ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were included and noted by the committee. apremilast 10mg, 20mg and 30mg film-coated tablets (Otezla ) SMC No. (1052/15) apremilast (Otezla ) is accepted for use within NHS Scotland. Indication under review: for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-a light (PUVA). In two phase III, randomised, placebo-controlled studies in patients with moderate to severe plaque psoriasis, a significantly greater proportion of patients who received apremilast achieved at least 75% improvement in the Psoriasis Area and Severity Index (PASI) score at 16 weeks compared with those who received placebo The committee noted the FAF1 submission for the use of apremilast (Otezla ) as treatment of moderate to severe plaque psoriasis in adults who have failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-a light (PUVA) It was noted that a local protocol has not been developed. Prescribing will take place in secondary care It was noted that the applicants wish to prescribe apremilast (Otezla ) before other biologic therapies and also after biologics. The positioning after biologics is not within the SMC approved indication therefore cannot be approved The committee agreed to classify apremilast (Otezla ) as not included pending protocol The clinical team will be asked to provide further information on place in therapy relative to the biologics approved for use in plaque psoriasis. See also item 3.3 Page 4 of 16

5 3.5 dolutegravir, abacavir plus lamivudine (Triumeq ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were submitted. dolutegravir 50mg, abacavir 600mg plus lamivudine 300mg film-coated tablets (Triumeq ) SMC No. (1009/14) dolutegravir, abacavir plus lamivudine tablets (Triumeq ) are accepted for use within NHS Scotland. Indication under review: for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age weighing at least 40 kg. In patients for whom this combination is appropriate, it offers a single tablet at a lower cost per dose compared with the individual components. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of (Triumeq ). This advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower The committee noted the FAF1 submission from paediatrics for the use of dolutegravir, abacavir plus lamivudine tablets (Triumeq ) as treatment for perinatally acquired HIV, where no documented resistance for this medicine is seen 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 dolutegravir, abacavir plus lamivudine tablets (Triumeq ) will replace existing medicines for this indication The committee agreed to include dolutegravir, abacavir plus lamivudine (Triumeq ) on the additional list, specialist use only, for the indication in question. 3.6 nintedanib (Ofev ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were submitted and noted by the committee. nintedanib 100mg and 150mg capsules (Ofev ) SMC No. (1076/15) nintedanib (Ofev ) is accepted for restricted use within NHS Scotland. Indication under review: in adults for the treatment of idiopathic pulmonary fibrosis (IPF). SMC restriction: For use in patients with a predicted forced vital capacity (FVC) less than or equal to 80%. Nintedanib, compared to placebo, reduces the decline in pulmonary function assessed by forced vital capacity in patients with IPF. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of nintedanib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting. Page 5 of 16

6 3.6.2 The committee noted the FAF1 submission for the use of nintedanib (Ofev ) as treatment of mild to moderate definite idiopathic pulmonary fibrosis or probable idiopathic pulmonary fibrosis It was noted that a local protocol has been developed and that this is consistent with SMC recommendations. Prescribing will be decided by the Lothian interstitial lung disease MDM team It was noted that there is another brand of nintedanib available that is licensed for a different indication The committee agreed to include nintedanib (Ofev ) on the additional list, specialist use only, for the indication in question. 3.7 tiotropium (Spiriva Respimat ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were submitted and noted by the committee. tiotropium, 2.5 microgram, solution for inhalation (Spiriva Respimat ) SMC No. (1028/15) tiotropium (Spiriva Respimat ) is accepted for use within NHS Scotland. Indication under review: As add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids ( 800 micrograms budesonide/day or equivalent) and long-acting beta 2 agonists and who experienced one or more severe exacerbations in the previous year. Two phase III RCTs demonstrated that the addition of tiotropium significantly improved lung function and increased the time to the first severe exacerbation compared with placebo in patients with uncontrolled asthma despite treatment with high dose inhaled corticosteroid and a long acting beta 2 agonist The committee noted the FAF1 submission for the use of tiotropium (Spiriva Respimat ) as a treatment option in patients with a clinical diagnosis of asthma which is not controlled on a maintenance combination of inhaled corticosteroid ( 800 micrograms budesonide/day or equivalent) and long-acting beta 2 agonist, and/or who experienced one or more exacerbations in the previous year It was noted that tiotropium (Spiriva Respimat ) will be incorporated in the respiratory Managed Clinical Network asthma guideline. Prescribing will take place in both primary and secondary care It was noted that tiotropium (Spiriva Respimat ) will not displace any specific treatment and will be an additional therapy in patients with difficult and severe asthma. Specialist opinion would place Spiriva Respimat as a treatment option at step 4 in the British Thoracic Society guideline of the management of asthma The committee agreed to include tiotropium (Spiriva Respimat ) on the LJF for the indication in question Concerns regarding cost being chiefly in primary care, while the submission was made by secondary care clinicians, were raised. This issue will be flagged to the clinical team and a letter will be written to ADTC highlighting this issue in general. Page 6 of 16

7 3.8 aclidinium/formoterol fumarate (Duaklir Genuair ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were submitted and noted by the committee. aclidinium/formoterol fumarate dihydrate 340/12 micrograms inhalation powder (Duaklir Genuair ) SMC No. (1034/15) aclidinium/formoterol fumarate dihydrate (Duaklir Genuair ) is accepted for use within NHS Scotland. Indication under review: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. In two 24-week comparator- and placebo-controlled phase III studies, treatment with aclidinium/formoterol 340/12 microgram resulted in statistically significant improvements in FEV1 % predicted pre-dose (versus a LABA) and post-dose (versus a LAMA) The committee noted the FAF1 submission for the use of aclidinium/formoterol (Duaklir Genuair ) in patients with COPD and an FEV1 50% who have persistent exacerbations or breathlessness despite LABA or LAMA inhaled therapy who cannot tolerate, or do not wish to use, a combination LABA/ICS inhaler and patients with COPD and an FEV1<50% who have exacerbations or persistent breathlessness despite SABA or SAMA inhaled therapy who cannot tolerate or who do not wish to use, a combination LABA+ICS inhaler It was noted that a local protocol has been developed and that this is consistent with SMC recommendation. Prescribing will take place in both primary and secondary care It was noted that aclidinium/formoterol (Duaklir Genuair ) will represent a step up in treatment from a LABA or LAMA inhaler The committee agreed to classify aclidinium/formoterol fumarate dihydrate (Duaklir Genuair ) as not included pending protocol, Please see item for further explanation. 3.9 umeclidinium (Incruse ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were submitted and noted by the committee. umeclidinium, 55 micrograms, powder for inhalation (Incruse ) SMC No. (1004/14) umeclidinium (Incruse ) is accepted for use within NHS Scotland. Indication under review: as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Two randomised controlled, phase III studies demonstrated that after 12 and 24 weeks of treatment umeclidinium improved lung function compared with placebo in patients with moderate to severe COPD. There was also improvement in symptomatic outcomes such as dyspnoea. Umeclidinium is an alternative to other long-acting muscarinic antagonists (LAMAs). Page 7 of 16

8 3.9.2 The committee noted the FAF1 submission for the use of umeclidinium (Incruse ) in Patients with COPD with exacerbations or persistent breathlessness despite inhaled SABA or SAMA use on an as required basis It was noted that a local protocol has been developed and that this is consistent with SMC recommendation. Prescribing will take place in both primary and secondary care It was noted umeclidinium (Incruse ) will represent a step up in therapy from SABA or SAMA inhaler The committee agreed to classify umeclidinium (Incruse ) as not included pending protocol, Please see item for further explanation umeclidinium/vilanterol (Anoro ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were submitted and noted by the committee. umeclidinium / vilanterol, 55/22 micrograms, inhalation powder (Anoro ) SMC No. (978/14) umeclidinium/vilanterol (Anoro ) is accepted for use within NHS Scotland. Indication under review: As a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. Two randomised controlled studies demonstrated that after 24 weeks of treatment, umeclidinium/vilanterol significantly improved lung function compared with an inhaled longacting muscarinic antagonist in patients with moderate to very severe COPD. Indirect comparisons demonstrated comparable efficacy with other combinations of long acting muscarinic antagonist plus long acting beta agonist The committee noted the FAF1 submission for the use of umeclidinium/vilanterol (Anoro ) in patients with COPD and an FEV1 50% who have persistent exacerbations or breathlessness despite LABA or LAMA inhaled therapy who cannot tolerate, or do not wish to use, a combination LABA/ICS inhaler and patients with COPD and an FEV1<50% who have exacerbations or persistent breathlessness despite SABA or SAMA inhaled therapy who cannot tolerate or who do not wish to use, a combination LABA+ICS inhaler It was noted that a local protocol has been developed and that this is consistent with SMC recommendation. Prescribing will take place in both primary and secondary care It was noted that umeclidinium/vilanterol (Anoro ) will represent a step up in treatment from a LABA or LAMA inhaler The committee agreed to classify umeclidinium/vilanterol (Anoro ) as not included pending protocol The committee discussed items and agreed that the potential approval of these drugs will be made after a meeting with the respiratory LJF working group and its review of the LJF section. It was unclear to the committee the rationale for needing to include all products. Page 8 of 16

9 3.11 sugammadex (Bridion ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were submitted. sugammadex 100mg/mL (1mL, 2mL, 5mL) solution for injection (Bridion ) SMC No. (527/09) sugammadex (Bridion ) is accepted for restricted use within NHS Scotland for the routine reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults and rocuronium in children and adolescents. Indication under review: Reversal of neuromuscular blockade induced by rocuronium or vecuronium. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents. This resubmission is for the part of the indication relating to routine reversal of neuromuscular blockade. SMC restriction: only for use in the routine reversal setting in high-risk patients (e.g. morbid obesity, significant respiratory disease or reduced respiratory reserve, significant coronary disease, major abdominal/chest surgery) or where prompt reversal of neuromuscular block is required. Sugammadex, when administered after rocuronium or vecuronium, has been shown to provide more rapid reversal of moderate and profound neuromuscular blockade than an anti-cholinesterase comparator. Sugammadex is significantly more expensive than conventional treatments used to reverse neuromuscular blockade The committee noted the FAF1 submission for the use of sugammadex (Bridion ) in patients undergoing diagnostic rigid bronchoscopy, interventional bronchoscopy, rigid bronchoscopies for removal of foreign objects or lung biopsy and those undergoing thymectomy for myasthenia gravis It was noted that a local protocol has been developed and that this is not consistent with the SMC recommendation. An explanation has been given. Prescribing will take place in secondary care The committee agreed to classify sugammadex (Bridion ) as not included in the LJF because the NHS Board decision is that the medicine does not represent sufficient added benefit to other comparator medicines to treat the condition in question which are already available in the formulary The committee agreed that the submission made for sugammadex (Bridion ) is outwith SMC advice which states that it should be used in high risk patients. 4. SMC latest Not Recommended Medicines (October 2015) 4.1 pembrolizumab (Keytruda ) SMC No. 1087/15, is not recommended for use within NHS Scotland. Page 9 of 16

10 4.2 regorafenib (Stivarga ) SMC No. 1118/15, 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 everolimus (Certican ) SMC No. 1117/15, 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 Multivitamin (Vitamin A, D, E and K) supplement (AquADEKs) The committee noted the FAF3 submission to add AquADEKs as a first choice multivitamin supplement in paediatric patients with cystic fibrosis 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 care with dose adjustment on specialist recommendation It was noted that AquADEKs will be used in pancreatic-insufficient patients and would allow administration of a single preparation instead of separate vitamin BPC, vitamin A&D and vitamin E supplements It was noted that this submission relates to the liquid and soft capsule formulations only The committee agreed to include Multivitamin (Vitamin A, D, E and K) supplement (AquADEKs) on the LJF, classified as GREEN unrestricted general use under the ADTC Policy for the use of unlicensed (and off label use) Medicines in NHS Lothian, for the indication in question. 5.2 iloprost trometamol (Ventavis ) This item was taken off the agenda as the drug has not yet been discussed by D&T. 5.3 nicardipine 10mg/10mL injection The committee noted the FAF2 submission to add nicardipine as treatment of acute life-threatening hypertension, particularly in the event of: Malignant arterial hypertension/hypertensive encephalopathy Aortic dissection, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective Nicardipine is also indicated for the treatment of post-operative hypertension 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 secondary care It was noted that nicardipine will be used in aortic dissection patients, patients with malignant hypertension resistant to labetalol and management of acute type B aortic dissection for critical care It was decided to classify nicardipine 10mg/10mL as not included pending protocol The clinical team will be asked to clarify current practice, patient selection and numbers, comparators and place in therapy. 5.4 alteplase (Actilyse ) The committee noted the FAF3 submission to add alteplase (Actilyse ) as treatment of iliofemoral DVT No declarations of interest were included with the submission. Page 10 of 16

11 5.4.3 It was noted that a local protocol has been developed. Prescribing will take place in secondary care It was noted that alteplase (Actilyse ) will be used in addition to systemic anticoagulation The committee agreed to include alteplase (Actilyse ) on the LJF, 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. alteplase (Actilyse ) is approved for use by interventional radiologist consultants only. 6. SMC Abbreviated Submissions 6.1 atazanavir/cobicistat (Evotaz ) atazanavir/cobicistat 300mg/150mg film-coated tablets (Evotaz ) SMC No. (1098/15) atazanavir/cobicistat (Evotaz ) is accepted for use within NHS Scotland. Indication under review: in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir. Pharmacokinetic studies have demonstrated that atazanavir plus cobicistat is bioequivalent (in terms of atazanavir exposure) to ritonavir-boosted atazanavir. For patients in whom atazanavir is an appropriate treatment, atazanavir/cobicistat (Evotaz ) provides a combination product at a small cost premium compared to ritonavirboosted atazanavir Included on the additional list for the indication in question. 6.2 tiotropium/olodaterol (Spiolto Respimat ) tiotropium/olodaterol 2.5 microgram/ 2.5 microgram inhalation solution (Spiolto Respimat ) SMC No. (1099/15) tiotropium/olodaterol (Spiolto Respimat ) is accepted for use within NHS Scotland. Indication under review: maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Spiolto Respimat should be used in patients for whom tiotropium and olodaterol are appropriate choices of antimuscarinic and long-acting beta 2 -agonist respectively. Tiotropium/olodaterol (Spiolto Respimat ) is available at a lower cost than the individual inhalers given separately Not included on the LJF because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine. Page 11 of 16

12 6.3 raltegravir (granules for oral suspension) (Isentress ) raltegravir granules for oral suspension 100mg (Isentress ) SMC No. (1102/15) raltegravir granules for oral suspension (Isentress ) are accepted for restricted use within NHS Scotland. Indication under review: in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, children, toddlers and infants from the age of 4 weeks. SMC restriction: patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions; raltegravir granules should be prescribed under the supervision of specialists in paediatric HIV. The granules for oral suspension are licensed for use in patients weighing 3kg to 20kg and provide an alternative formulation for infants where chewable tablets are not suitable. Because the formulations are not bioequivalent, neither the granules for oral suspension nor the chewable tablets should be substituted for the 400 mg film-coated tablet. SMC has previously accepted raltegravir 25mg and 100mg chewable tablets and raltegravir 400mg film-coated tablets for restricted use in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in adolescents and children aged 2 to 17 years and in adult patients. Raltegravir is listed in the British National Formulary for Children for the treatment of HIV infection Included on the additional list, specialist use only, for the indication in question. Page 12 of 16

13 6.4 raltegravir chewable tablets (Isentress ) raltegravir chewable tablets 25mg, 100mg (Isentress ) SMC No. (1113/15) raltegravir chewable tablets (Isentress ) are accepted for restricted use within NHS Scotland. Indication under review: in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in children from the age of 4 weeks to <2 years. SMC restriction: patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions; raltegravir chewable tablets should be prescribed under the supervision of specialists in paediatric HIV. The chewable tablets are not bioequivalent to the film-coated tablets and therefore are not interchangeable. SMC has previously accepted raltegravir 25mg and 100mg chewable tablets and raltegravir 400mg film-coated tablets for restricted use in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in adolescents and children aged 2 to 17 years and in adult patients. Raltegravir is listed in the British National Formulary for Children for the treatment of HIV infection Included on the additional list, specialist use only, for the indication in question. 6.5 triamcinolone (Hexacetonide ) triamcinolone hexacetonide 20mg/mL suspension for injection SMC No. (1103/15) triamcinolone hexacetonide is accepted for use within NHS Scotland. Indication under review: juvenile idiopathic arthritis (JIA). This submission relates to a new licence extension for JIA where previously an unlicensed preparation has been used. This is the first intra-articular corticosteroid licensed for JIA Included on the LJF for the indication in question. Page 13 of 16

14 6.6 levonorgestrel (Levosert ) LOTHIAN FORMULARY COMMITTEE levonorgestrel (Levosert ) 20 micrograms/24 hours intrauterine delivery system SMC No. (1058/15) ADVICE: following an abbreviated submission levonorgestrel (Levosert ) intrauterine delivery system is accepted for use within NHS Scotland. Indication under review: Contraception. Heavy menstrual bleeding. Levosert may be particularly useful in women with heavy menstrual bleeding requiring (reversible) contraception. Levosert intrauterine delivery system (IUS) contains the same total amount of levonorgestrel with the same release profile as an existing levonorgestrel-containing IUS at a lower unit cost Not included on the LJF as clinicians do not support the formulary inclusion. LJF choice is Mirena. 7. Non-submissions to Formulary Committee (September 90-day target) 7.1 abiraterone acetate (Zytiga ) SMC No. 873/ Not included, pending protocol. Clinicians confirm submission pending. 7.2 ciclosporin (Ikervis ) SMC No. 1089/ Not included, pending protocol. Clinicians confirm submission pending. 7.3 insulin degludec/liraglutide (Xultophy ) SMC No. 1088/ Not included on the LJF, because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine. 7.4 radium-223 dichloride (Xofigo ) SMC No. 1077/ Not included, pending protocol. Clinicians confirm submission pending. 7.5 trastuzumab (Herceptin ) SMC No. 623/ Not included, pending protocol. Clinicians confirm submission pending. 8. Formulary Additions and Amendments 8.1 Formulary Additions Section 4.10 Drugs used in substance dependence The committee discussed and approved the changes. The LJF website will be updated. Page 14 of 16

15 8.2 Formulary amendment request forms Xailin Night eye ointment The committee noted the request for the inclusion of Xailin Night for lubrication of dry eyes No declarations of interest were included with the submission It was noted that Xailin Night will replace Lacrilube for this indication The committee agreed to include Xailin Night eye ointment on the LJF, for the indication in question mirabegron (Betmiga ) tablets The committee noted the request to add a new prescribing note regarding mirabegron as treatment of urinary frequency due to bladder instability Two declarations of interest were included with the submission and noted by the committee It was noted that the new information will be in relation to the use of mirabegron in patients with overactive bladders who have a high anticholinergic load The committee agreed to include mirabegron on the LJF, as a prescribing note. 9. NICE/SIGN/NHS QIS Clinical Guidance 9.1 SIGN 100: a handbook for patient and carer representatives Noted. A link to this can be added to the LJF website patient zone. 9.2 STA355 Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation Noted. 9.3 TA356 Ruxolitinib for treating polycythaemia vera (terminated appraisal) Noted. 9.4 TA357 Pembrolizumab for treating advanced melanoma after disease progression with ipilimumab Noted. 10. Drug Safety Issues MHRA Advice 10.1 MHRA Drug Safety Update, Volume 8, Issue 15, October Noted. 11. For Information Only 11.1 Formulary Committee Reports and Letters The committee noted the following Formulary Committee reports and letters: adalimumab/infliximab/golimumab/vedolizumab apixaban darunavir/cobicistat (Rezolsta ) misoprostol (Mysodelle ) pasireotide (as pamoate) (Signifor ) lisdexamfetamine dimesylate (Elvanse Adult ) Page 15 of 16

16 ledipasvir/sofosbuvir (Harvoni ) bortezomib (Velcade ) insulin glargine (Abasaglar ) tedizolid phosphate (Sivextro ) Humalog (insulin lispro) colecalciferol 800units (tablet) colecalciferol 2,400units (liquid) colecalciferol 20,000units (capsule) sodium bicarbonate 12. AOCB 13. Date of Next Meeting The committee noted that the next meeting would be held on Wednesday, 16 December 2015, at 2pm. (The deadline for submission of papers for this meeting is Tuesday 1 st December 2015.) Apologies are to be sent to Committee Administrator prior to the submissions deadline. Page 16 of 16