LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE

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1 FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on from in Room 004, Ground Floor, Pentland House Present: Clare Andrews Clinical Pharmacist, Western General Hospital Krista Clubb Nurse Prescribing Coordinator, NHS Lothian Anne Gilchrist Lead Pharmacist, Medicines Management Team (left at 15.00) Dr Jane Goddard Renal Consultant, Royal Infirmary of Edinburgh (arrived at 14.15) Dr Peter Hall Consultant Medical Oncologist, Western General Hospital Carol Holmes Primary Care Pharmacist, NHS Lothian Dr Sara Hornibrook General Practitioner, NHS Lothian Dr Simon Hurding General Practitioner, NHS Lothian (left at 15.00) Dr Walter Jamieson General Practitioner, NHS Lothian (in the chair) Ishtiaq Mohammed Clinical Effectiveness Pharmacist, NHS Fife Dr Emma Morrison Clinical Pharmacology Trainee, Royal Infirmary of Edinburgh Alison Rowe Formulary Pharmacist, NHS Lothian Dr Richard Williams General Practitioner, NHS Lothian In attendance: Zuzana Krajčovič Fraser Notman Medicines Management Committee Administrator Prescribing Support Pharmacist, NHS Fife Apologies for absence: Dr Maria Corretge Dr James Dear Liz Leitch Laura Shaw Garry Todd Dr Lucy Wall Dr Andrew Watson Consultant Geriatrician, St John s Hospital, Livingston Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh Formulary Pharmacist, NHS Borders Lead Pharmacist, Royal Hospital for Sick Children Lead Pharmacist, Royal Edinburgh Hospital and Roodlands Hospital Consultant Medical Oncologist, Western General Hospital Consultant Psychiatrist, Royal Edinburgh Hospital Welcome The Chair welcomed back Ishtiaq Mohammed after long-term leave and also welcomed Fraser Notman, Prescribing Support Pharmacist from NHS Fife as an observer at the meeting. Members introduced themselves in turn. Membership It was noted that Dr Richard Williams has resigned as a member of the committee. The Chair thanked him for his contributions and wished him well. Dr Walter Jamieson has announced that he will stand down as Co-chair of the committee in September 2017 after his term is over. At the same time he will also resign as a member of the committee. Nominations for new Co-chair will be invited by the ADTC Chair over the next couple of Page 1 of 12

2 months. It was noted that the Chair of the committee will contact LMC and GPPC Chairs to invite nominations for GP representatives on Formulary Committee. Declarations of interest: The Chair reminded members to declare any interests in any of the products to be discussed. 1. Minutes of the previous meeting held on 25 th January The minutes were approved as an accurate record of the meeting. 2. Matters arising from previous minutes 2.1 pegylated liposomal doxorubicin hydrochloride (PLDH) (Caelyx ) in combination with carboplatin A FAF1 submission was made to the Formulary Committee in January 2017 for the use of Caelyx in combination with carboplatin in patients with relapsed platinum sensitive ovarian cancer with no contraindications to the use of carboplatin and PLDH It was noted that at the time of the meeting it was not clear from the submission that the applicants are asking for Caelyx to be used in combination with carboplatin Following a correspondence received from the applicants and further discussion at the meeting the committee agreed that the formulary classification remains unchanged. 3. SMC Recommendations 3.1 isavuconazole (Cresemba ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were included with the application. isavuconazole 200mg powder for concentrate for solution for infusion and 100mg hard capsules (Cresemba ) SMC No. (1129/16) ADVICE: following a full submission considered under the orphan process: isavuconazole (Cresemba ) is accepted for use within NHS Scotland. Indication under review: in adults for the treatment of: invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate Page 2 of 12

3 A phase III, randomised, double-blind, non-inferiority study demonstrated that, in the treatment of invasive aspergillosis, isavuconazole was non-inferior to a triazole antifungal for all-cause mortality through day 42, and had a similar overall response at the end of treatment. A phase III, open-label, single-arm study demonstrated that, in the treatment of mucormycosis, isavuconazole had a treatment effect on all-cause mortality and overall response. The treatment effect was considered to be comparable to that observed in external control studies of a polyene antifungal. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of isavuconazole. 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 The committee noted the FAF1 submission for the use of isavuconazole (Cresemba ) in adults for the treatment of invasive aspergillosis, or mucormycosis in patients for whom amphotericin B is inappropriate It was noted that the local clinical monograph has been developed and the prescribing will take place in secondary care only It was noted that treatment will be initiated on advice of microbiology and will be reserved for occasions where alternative treatment options are unsuitable It was noted that isavuconazole is better tolerated and has fewer drug interactions in comparison with voriconazole It was agreed to ask the applicants to provide a clear treatment algorithm and clarify the place in therapy in relation to existing medicines It was noted that a PAS is available for the use of this medicine The committee agreed to classify isavuconazole (Cresemba ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only pending clarification of the treatment pathway The committee agreed to Include isavuconazole (Cresemba ) on the Additional List, Specialist Use only, for the indication in question, pending clarification of the treatment pathway. 3.2 beclometasone/formoterol (Fostair NEXThaler ) The committee noted and discussed the previously circulated submission. Two declarations of interest were included with the application and noted by the committee. beclometasone with formoterol 100/6 micrograms/dose (Fostair NEXThaler ) NICE ESNM53 Fostair NEXThaler is an inhaled corticosteroid (ICS) / long-acting beta-2 agonist (LABA) combination dry powder inhaler containing extrafine beclometasone/formoterol. Evidence from an 8-week randomised controlled trial suggests that in adults with stable asthma it is non-inferior to the pressurised metered dose inhaler (Fostair ), and superior to non-extrafine beclometasone dry powder inhaler in terms of change from baseline in mean pre-dose morning peak expiratory flow with no difference in adverse events. There Page 3 of 12

4 are no published comparative studies at the higher licensed dose, or with other available ICS/LABA combination inhalers or studies with patient orientated primary outcomes. Regulatory status: Fostair pressurised metered dose inhaler has been licensed in the UK since Fostair NEXThaler is a new dry powder formulation inhaler licensed for the regular treatment of asthma in adults aged 18 years and over where use of a combination product (ICS and LABA) is appropriate. It was launched in September The committee noted the FAF1 submission for the use of beclometasone/formoterol (Fostair NEXThaler ) for the treatment of asthma in adults where MDI formulation is not suitable It was noted that a local Lothian treatment protocol has not been developed. Prescribing will take place in primary and secondary care The committee agreed to classify beclometasone/formoterol (Fostair NEXThaler ) as routinely available in line with national guidance. Included on the LJF as second choice, for General Use, pending clarification as per point of these minutes The committee agreed to Include beclometasone/formoterol (Fostair NEXThaler ) on the LJF as second choice, for General Use, for the indication in question, pending clarification as per point of these minutes It was noted that the budgetary position within primary care is not confirmed for the use of the medicine It was noted that subsequently, after the meeting, further discussions took place and it was agreed to ask the LJF Working Group for clarification on the place in therapy in relation to the current formulary recommendation. 3.3 mepolizumab (Nucala ) The committee noted and discussed the previously circulated submission and SMC report. Six declarations of interest were included with the application and noted by the committee. mepolizumab 100mg powder for solution for injection (Nucala ) SMC No. (1149/16) ADVICE: following a full submission: mepolizumab (Nucala ) is accepted for restricted use within NHS Scotland. Indication under review: as an add-on treatment for severe refractory eosinophilic asthma in adult patients. SMC restriction: patients who have eosinophils of at least 150 cells per microlitre (0.15 x10 9 /L) at initiation of treatment and have had at least four asthma exacerbations in the preceding year or are receiving maintenance treatment with oral corticosteroids. Mepolizumab, compared to placebo, decreased the incidence of asthma exacerbations and permitted reductions in doses of maintenance oral corticosteroid in adult patients with severe eosinophilic asthma. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of mepolizumab. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower. Page 4 of 12

5 3.3.2 The committee noted the FAF1 submission for the use of mepolizumab (Nucala ) as an add-on treatment for severe refractory eosinophilic asthma in adult patients It was noted that the local Lothian protocol has been developed and provided with the application. Prescribing will take place in secondary care only It was noted that the other biologic therapy available for severe asthma is omalizumab. However, the patient populations for omalizumab and mepolizumab are different and very rarely overlap It was noted that a PAS is available for the use of this medicine The committee agreed to classify mepolizumab (Nucala ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only The committee agreed to Include mepolizumab (Nucala ) on the Additional List, Specialist Use only, for the indication in question. 3.4 iron (III) isomaltoside 1000 (Diafer ) The committee noted and discussed the previously circulated SMC report. iron III isomaltoside 1000 (contains 50mg iron per ml) (Diafer ) solution for injection SMC No. (1177/16) ADVICE: following a resubmission: iron III isomaltoside % (Diafer ) is accepted for use within NHS Scotland. Indication under review: for the treatment of iron deficiency in adults with chronic kidney disease (CKD) on dialysis, when oral iron preparations are ineffective or cannot be used. Iron III isomaltoside 1000 at a higher (10%) concentration has been shown to be noninferior to another intravenous iron product in maintaining haemoglobin concentration in adult patients with CKD who are iron deficient and are receiving haemodialysis. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of iron III isomaltoside %. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower The committee noted and discussed the feedback received from the clinical team regarding the use of iron (III) isomaltoside 1000 (Diafer ) for the treatment of iron deficiency in adults with CKD on dialysis, when oral iron preparations are ineffective or cannot be used It was noted that a PAS is available for the use of this medicine The committee agreed to classify iron (III) isomaltoside 1000 (Diafer ) as not routinely available as local clinical experts do not wish to add the medicine to the formulary at this time or there is a local preference for alternative medicines The committee agreed to Not include iron (III) isomaltoside 1000 (Diafer ) on the LJF because clinicians do not support the formulary inclusion. Page 5 of 12

6 4. SMC latest Not Recommended Medicines 4.1 desmopressin oral lyophilisate (Noqdirna ) SMC No. 1218/17 is not recommended for use within NHS Scotland for symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults. 4.2 pitolisant (Wakix ) SMC No. 1229/17 is not recommended for use within NHS Scotland for the treatment of narcolepsy with or without cataplexy in adults. 4.3 vernakalant (Brinavess ) SMC No. 1222/17 is not recommended for use within NHS Scotland for rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults for non-surgery patients: atrial fibrillation 7 days duration, for post-cardiac surgery patients: atrial fibrillation 3 days duration. 5. Other Medicines Proposed for Use 5.1 lidocaine plaster 5% (Versatis ) The committee noted the FAF3 submission for the off-label use of lidocaine plaster 5% (Versatis ) for the symptomatic relief of adults >65 years of age with musculoskeletal pain (e.g. osteoporotic vertebral fracture) in whom topical therapy is considered appropriate but are not able to use topical NSAIDs (e.g. severe renal impairment or hypersensitivity) One declaration of interest was included with the submission and noted by the committee It was noted that a local protocol has been developed and provided with the application. Prescribing will be initiated in secondary care It was noted that the evidence of clinical effectiveness of lidocaine patches is limited and benefit is small. The applicants would like to use the patches as a last resort, monitor response carefully and stop the treatment if there is no improvement The committee noted that the practice shows that lidocaine patches are often prescribed inappropriately and used incorrectly. Therefore the committee would like to receive reassurance that the patches will be stopped if patients show no benefit from using them It was also proposed to consider including an article in the Lothian Prescribing Bulletin on the use of lidocaine patches and education The committee agreed to classify lidocaine plaster 5% (Versatis ) as routinely available in line with local or regional guidance. Included on the Additional List, for Specialist initiation, classified as AMBER under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian The committee agreed to Include lidocaine plaster 5% (Versatis ) on the Additional List, Specialist initiation, classified as AMBER under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian It was noted that the budgetary position within primary care is not confirmed for the use of the medicine. Page 6 of 12

7 5.2 miconazole 2% cream (Daktarin ) for adults The committee noted the FAF3 submission for the off-label use of miconazole 2% cream (Daktarin ) for the treatment of breast and nipple thrush in lactating women No declarations of interest were included with the submission It was noted that the Lothian nipple thrush treatment in breastfeeding women guideline has been updated to include this preparation. Prescribing will take place mainly in primary care by midwifes in breastfeeding clinics and General Practitioners (GPs) It was noted that in relation to currently used medicines, nystatin suspension is not considered as effective and clotrimazole cream is associated with allergic reactions The committee noted that current advice is to use miconazole cream, as gel is not well absorbed topically The committee agreed to classify miconazole 2% cream (Daktarin ) as routinely available in line with local or regional guidance. Included on the LJF as a prescribing note, for General Use, classified as GREEN under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian The committee agreed to Include miconazole 2% cream (Daktarin ) on the LJF as a prescribing note, for General Use, classified as GREEN under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian It was noted that the budgetary position within primary care is not confirmed for the use of the medicine. 5.3 miconazole oral 2% gel (Daktarin ) for babies The committee noted the FAF3 submission for the off-label use of miconazole oral 2% gel (Daktarin ) for the treatment of oral thrush in breastfed infant 4 months of age as well as those > 4months of age No declarations of interest were included with the submission It was noted that the Lothian nipple thrush treatment in breastfeeding women guideline has been updated to include this preparation. Prescribing will take place mainly in primary care by midwifes and infant feeding advisors in breastfeeding clinics and GPs where appropriate It was noted that topical miconazole is first-line treatment for baby and mother. The miconazole 2% gel will be used in babies as nystatin suspension has been shown to be ineffective The committee noted that assessment will be carried out by a skilled practitioner to ensure baby and mum fulfil the criteria for treatment, ensure mum has been clearly instructed in the safe administration of the gel, and where possible bacterial mastitis has been excluded as a possible cause The committee agreed to classify miconazole 2% gel (Daktarin ) as routinely available in line with local or regional guidance. Included on the LJF as a prescribing note, for General Use, classified as GREEN under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian The committee agreed to Include miconazole 2% gel (Daktarin ) on the LJF as a prescribing note, for General Use, classified as GREEN under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian It was noted that the budgetary position within primary care is not confirmed for the use of the medicine. Page 7 of 12

8 6. SMC Abbreviated Submissions None. LOTHIAN FORMULARY COMMITTEE 7. Non-submissions to Formulary Committee (90-day target) 7.1 buprenorphine (Budec ) SMC No. 1213/ Not routinely available as local clinical experts do not wish to add the medicine to the formulary at this time or there is a local preference for alternative medicines Not included on the LJF because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine. 7.2 dalbavancin (Xydalba ) SMC No. 1105/ Not routinely available as local clinical experts do not wish to add the medicine to the formulary at this time or there is a local preference for alternative medicines Not included on the LJF because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine. 7.3 deferasirox (Exjade ) SMC No. 347/ Not routinely available as local clinical experts do not wish to add the medicine to the formulary at this time or there is a local preference for alternative medicines Not included on the LJF because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine. 7.4 pembrolizumab (Keytruda ) SMC No. 1204/ The committee noted and discussed the feedback received from the clinical team regarding the use of this medicine The committee agreed to classify pembrolizumab (Keytruda ) as not routinely available as local clinical experts do not wish to add the medicine to the formulary at this time or there is a local preference for alternative medicines The committee agreed to classify pembrolizumab (Keytruda ) as Not included on the LJF because clinicians do not support the formulary inclusion. 8. Formulary Additions and Amendments 8.1 Formulary Additions ADULT Section 4.10(h) alcohol dependence It has been confirmed the baclofen is not on the protocol used at RIE. The committee discussed and approved the changes to this section. The LJF website will be updated. Page 8 of 12

9 8.1.2 Section 4.11 Drugs for dementia The committee discussed the amendments to this section It was noted that currently it is not clear from this section who is responsible for the monitoring and dose titration It was discussed that there is no agreement to move the monitoring of these medicines from secondary care to primary care, therefore dose titration, assessment of efficacy and tolerability should continue to be undertaken by the specialist service It was therefore agreed to ask the Working Group for clarification and to update the LJF section to include this information. 8.2 Formulary amendment request forms ibuprofen 5% gel The committee noted the amendment request form to include the use of ibuprofen 5% gel for the treatment of acute musculoskeletal (MSK) pain No declarations of interest were included with the submission It was noted that the recent Cochrane review showed evidence of clinical effectiveness of topical NSAIDs for acute MSK pain. This would be used in preference to lidocaine plasters in the frail elderly patient group with acute MSK pain The applicants have provided an inpatient analgesic strategy for severe or distressing acute MSK pain in patients aged >65 years old It was noted that this strategy excluded oral NSAIDs and the committee would like to know the reasons for this exclusion. It was also suggested that advice in patients with renal impairment should be referenced in the box with paracetamol and oxycodone guidance The committee agreed to classify ibuprofen 5% gel as routinely available in line with local or regional guidance. Included on the LJF as a prescribing note, for Specialist Use only The committee agreed to Include ibuprofen 5% gel on the LJF as a prescribing note, for Specialist Use only, for the indication in question DEKAs PLUS liquid The committee noted the amendment request form to include DEKAs PLUS liquid on the LJF as vitamin supplementation for pancreatic insufficient cystic fibrosis in paediatric patients No declarations of interest were included with the submission It was noted that DEKAs PLUS will replace AquADEKs TM that has been discontinued The committee agreed to classify DEKAs PLUS liquid as routinely available in line with local or regional guidance. Included on the LJF as first choice, for General Use, classified as GREEN under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian The committee agreed to Include DEKAs PLUS liquid on the LJF as first choice, General Use, classified as GREEN under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian. Page 9 of 12

10 8.2.3 senna; macrogol oral powder 3350 ; naloxegol The committee noted the amendment request form to include senna, macrogol oral powder 3350 and naloxegol on the LJF for pharmacological management of opioid-induced constipation No declarations of interest were included with the submission It was noted that a FAF1 submission for the use of naloxegol (Moventig ) has been discussed at the meeting in December The medicine has been approved for use subject to clarification of the place in therapy and the dose escalation of standard treatment before choosing naloxegol It was noted that the applicants have provided comprehensive information within this amendment form to clarify these points. A prescribing note will be added to LJF section 1.6(d) The committee agreed to classify senna in combination with macrogol 3350 as routinely available in line with local or regional guidance. Included on the LJF for General Use The committee agreed to Include senna in combination with macrogol 3350 on the LJF for General Use, for the indication in question The classification of naloxegol (Moventig ) has been updated to routinely available in line with national guidance. Included on the Additional List, for Specialist initiation The classification of naloxegol (Moventig ) has been updated to Included on the Additional List, for Specialist initiation, for the indication in question It was noted that the budgetary position within primary care is not confirmed for the use of naloxegol (Moventig ) Nicotinell TTS 10 (7mg/24hrs), 20 (14mg/24hrs) and 30 (21mg/24hrs) patch The committee noted the amendment request form to include Nicotinell TTS patches on the LJF as replacement therapy for Nicotine No declarations of interest were included with the submission It was noted that this preparation will replace NiQuitin 7mg/24hrs, 14mg/24hrs and 21mg/24hrs patches The committee agreed to classify Nicotinell TTS patches as routinely available in line with local or regional guidance. Included on the LJF as first choice for General Use The committee agreed to Include Nicotinell TTS patches on the LJF as first choice, for General Use, for the indication in question Nicotinell 2mg lozenge The committee noted the amendment request form to include Nicotinell 2mg lozenge on the LJF as replacement therapy for Nicotine No declarations of interest were included with the submission It was noted that this preparation will be used alongside other nicotine replacement therapies The committee agreed to classify Nicotinell 2mg lozenge as routinely available in line with local or regional guidance. Included on the LJF as first choice, for General Use The committee agreed to Include Nicotinell 2mg lozenge on the LJF as first choice, for General Use, for the indication in question. Page 10 of 12

11 8.2.6 Nutilis Clear powder The committee noted the amendment request form to include Nutilis Clear powder on the LJF as nutritional supplement It was noted that Nutilis Clear is a food for Special Medical Purposes for use under medical supervision. Nutilis Clear is a xanthan gum based food and fluid thickening powder designed to maintain the normal appearance of fluids. This product is designed for the dietary management of dysphagia and can be used to modify the texture of both food and fluids. It is not suitable for children under 3 years No declarations of interest were included with the submission The committee agreed to classify Nutilis Clear powder as routinely available in line with local or regional guidance. Included on the LJF as a prescribing note, for Specialist Use only The committee agreed to Include Nutilis Clear powder on the LJF as a prescribing note, for Specialist Use only, for the indication in question. 9. NICE/SIGN/NHS QIS Clinical Guidance 9.1 SIGN146 Cutaneous melanoma The committee noted and discussed the SIGN guideline It was noted that the LJF recommendations are in line with this guideline. 10. Drug Safety Issues MHRA Advice 10.1 MHRA Drug Safety Update, Volume 10, Issue 6, January The committee noted the drug safety update It was agreed to highlight the warning issued regarding the use of apremilast (Otezla ) and risk of suicidal thoughts and behaviour to the Working Group MHRA Drug Safety Update, Volume 10, Issue 7, February The committee noted the drug safety update It was suggested to consider including an article in the Lothian Prescribing Bulletin to raise awareness of the risk of serious adverse effects in patients with underlying cardiac disease when using hyoscine butylbromide (Buscopan ) injection. 11. For Information Only 11.1 Formulary Committee Letters and Reports The committee noted the following Formulary Committee reports and letters: NexoBrid nivolumab (Opdivo ) olaparib (Lynparza ) nivolumab (Opdivo ) pegylated liposomal doxorubicin hydrochloride (PLDH) (Caelyx ) Page 11 of 12

12 elbasvir / grazoprevir (Zepatier ) dehydrated alcohol (absolute alcohol) BP for injection pregabalin colecalciferol tablets 4000units (Desunin ) ADEKplus 12. AOCB 12.1 Revised patient group direction for varenicline It was brought to the committee s attention that the revised national patient group direction (PGD) for the supply of varenicline through the community pharmacy public health service states that a client can be considered for either NRT or varenicline, along with support from a recognised stop smoking service. Discussion of both options will take into account the client s preferred choice and their suitability for treatment It was noted that cessation support plus NRT is currently recommended as firstline treatment on the LJF and varenicline should only be prescribed when NRT has failed on the recommendation of specialist smoking cessation services A request has been made for a review of the position of varenicline in the LJF taking the revised national PGD into consideration It was agreed to ask the Working Group to review the formulary section. 13. Date of Next Meeting Wednesday 12 th April 2017, 2.00pm, Room 004, Ground Floor, Pentland House (Please note submission date for papers is Tuesday 2). Apologies are to be sent to Committee Administrator prior to the submission deadline. Apologies: K Clubb, C Holmes, Dr W Jamieson, I Mohammed, A Rowe Page 12 of 12