LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE

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1 FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on from 14:15 in Room (6+7), 5 th Floor, Waverley Gate Present: Dr Thulani Ashcroft General Practitioner, NHS Lothian (arrived 14:45) Dr Drummond Begg General Practitioner, NHS Lothian Dr Maria Corretge Consultant Geriatrician, St John s Hospital, Livingston Carol Holmes Primary Care Pharmacist, NHS Lothian Jane Pearson Lead Pharmacist, NHS Lothian Alison Rowe Formulary Pharmacist, NHS Lothian Laura Shaw Lead Pharmacist, Royal Hospital for Sick Children (in the chair) Garry Todd Lead Pharmacist, Royal Edinburgh Hospital and Roodlands Hospital Dr Peter Hall Consultant Medical Oncologist, Western General Hospital In Attendance: Aiswarya Balakrishnan Claire Houston Medicines Management Committee Administrator Medicines Management Committee Administrator Apologies for absence: Dr James Dear Dr Jane Goddard Dr Sara Hornibrook Dr Simon Hurding Dr Emma Morrison Liz Leitch Dr Lucy Wall Dr Andrew Watson Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh Renal Consultant, Royal Infirmary of Edinburgh General Practitioner, NHS Lothian General Practitioner, NHS Lothian Clinical Pharmacology Trainee, Royal Infirmary of Edinburgh Formulary Pharmacist, NHS Borders Consultant Medical Oncologist, Western General Hospital Consultant Psychiatrist, Royal Edinburgh Hospital Welcome: The Chair announced that Ishtiaq Mohammed has now left his post in NHS Fife, so has resigned from the committee. Fraser Notman will attend on behalf of NHS Fife until their vacant post is officially filled. The Chair also welcomed Claire Houston to her first meeting as a new member of the Medicines Management Team. Declarations of interest: The Chair reminded members to declare any interests in any of the products to be discussed. Page 1 of 9

2 1. Minutes of the previous meeting held on 08 th November Infliximab brand should be Remsima, not Remicade as noted Minutes accepted with the above correction. 2. Matters arising from previous minutes Nil 3. SMC Recommendations 3.1 idebenone (Raxone ) The committee noted and discussed the previously circulated submission and SMC report. Declarations of interest forms were included with the application and noted by the committee It was noted that the decision is subject to availability of PAS. idebenone (Raxone ) 150mg film-coated tablets SMC No. (1226/17) ADVICE: following a full submission assessed under the ultra-orphan medicine process idebenone (Raxone ) is accepted for restricted use within NHS Scotland. Indication under review: Treatment of visual impairment in adolescent and adult patients with Leber s Hereditary Optic Neuropathy (LHON). SMC restriction: to patients with LHON who are not yet blind i.e. they do not meet the UK criteria to be registered as severely sight impaired. In a 24-week double-masked randomised placebo-controlled study, patients who received idebenone had numerical improvements in visual acuity over placebo. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of idebenone. 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 views from a Patient and Clinician Engagement (PACE) meeting The committee noted that the financial section in the FAF only asks for one year s information. This treatment is being proposed for 3 years The committee noted that patient response will be reviewed at 6 months and 1 year. It was agreed to clarify treatment length, and whether patients would continue treatment for 3 years regardless of changes in response. Also clarity would be sought as to why the local numbers are much higher than those in the SMC DAD The committee noted that there is no clinical data beyond 6 months The committee agreed to classify idebenone (Raxone ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only Page 2 of 9

3 3.2 glecaprevir-pibrentasvir (Maviret ) The committee noted and discussed the previously circulated submission and SMC report. Declarations of interest forms were included with the application and noted by the committee. glecaprevir 100mg, pibrentasvir 40mg film-coated tablet (Maviret ) SMC No 1278/17 ADVICE: following a full submission glecaprevir-pibrentasvir (Maviret ) is accepted for use within NHS Scotland. Indication under review: Treatment of chronic hepatitis C virus (HCV) infection in adults. Glecaprevir-pibrentasvir is associated with high rates of sustained virologic suppression in patients with all genotypes of chronic HCV infection. In treatment-naïve non-cirrhotic patients with genotype 3 infection it was non-inferior to a direct acting anti-viral regimen that included a non-structural protein 5B (NS5B) inhibitor plus NS5A inhibitor. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of glecaprevir-pibrentasvir. 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 discussed the application and noted that there may be a change in the Scottish Government patient treatment targets. All prescribing for hepatitis C is tracked and the team continue to manage treatment and budget allocation The committee agreed to classify glecaprevir-pibrentasivir (Maviret ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only. 3.3 pegvisomant (Somavert ) The committee noted and discussed the previously circulated submission and SMC report. Declarations of interest forms were included with the application and noted by the committee. pegvisomant 10mg, 15mg, 20mg, 25mg and 30mg powder and solvent for solution for injection (Somavert ) SMC No 158/05 ADVICE: following a second resubmission considered under the ultra-orphan process pegvisomant (Somavert ) is accepted for use within NHS Scotland. Indication under review: Treatment of adult patients with acromegaly who have had an inadequate response to surgery and / or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalise IGF-1 [insulin-like growth factor 1] concentrations or was not tolerated. In a phase III study, there were significant reductions in IGF-1 levels and improvements in some of the clinical manifestations of acromegaly with pegvisomant compared with placebo. SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of pegvisomant and 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 Page (PACE) 3 of 9 meeting.

4 3.3.2 It was noted that there is a local protocol is in place A typo was noted in the protocol document, which will be fed back to the clinical team The committee agreed to classify pegvisomant (Somavert ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only. 4. SMC latest Not Recommended Medicines 4.1 reslizumab (Cinqaero ) SMC 1233/17 is not recommended for use within NHS Scotland as an add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment. 4.2 brodalumab (Kyntheum ) SMC 1283/17 is not recommended for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. 4.3 bezlotoxumab (Zinplava ) SMC 1293/17 is not recommended for use within NHS Scotland as prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI. 4.4 fulvestrant (Faslodex ) SMC 1294/17 is not recommended for use within NHS Scotland as a treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. 5. Other Medicines Proposed for Use 5.1 Freestyle Libre Glucose Sensor The committee noted the FAF2 submission for Freestyle Libre, a wearable technology to monitor interstitial glucose levels in type 1 diabetes patients The committee noted that there is data from a Lothian pilot including 25 patients There is very little good clinical evidence and no robust data on cost effectiveness The committee noted the request for the device to be prescribed in primary care following recommendation from secondary care clinician. Eligible patients would be as per the Scottish Diabetes Group (SDG) guidance for the device The committee noted and agreed with the comment from the clinical team, around the disappointment that there is not more clinical data available The committee noted that from a patient perspective, they could see the perceived advantages this product could have Concern was expressed that if GPs start prescribing for type 1 patients then type 2 patients might also be prescribed the device and this would have a significant cost implication After a prolonged discussion it was agreed that prescribing should initially take place in secondary care. As per the application and SDG guidance, patients would be assessed at 6 months to ensure compliance with the required conditions for continuing long term prescribing of Free Style Libre. This would be contingent upon evidence of compliance with the criteria and that use of the Freestyle Libre is Page 4 of 9

5 demonstrably improving an individual s diabetes care. If treatment deemed to be appropriate, continued prescribing could then transfer to primary care on the recommendation of the secondary care clinician It was noted that the costs detailed in the application would be different, as secondary care don t necessarily pay the drug tariff price The committee agreed that there needs to be confirmation that there is no additional costs for blood glucose testing strips The committee agreed to classify Freestyle Libre Glucose Sensor as routinely available in line with national Scottish Diabetes Group guidance. Included on the Additional List, for Specialist use only for the first six months, then prescribing in primary care. 6. SMC Abbreviated Submissions 6.1 tiotropium 2.5mcg inhalation solution (Spiriva Respimat ) (SMC No.411/07) tiotropium 2.5 microgram inhalation solution (Spiriva Respimat ) ADVICE: following an abbreviated resubmission tiotropium (Spiriva Respimat ) is accepted for use within NHS Scotland. SMC No 411/07 Indication under review: as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD). Tiotropium (Spiriva Respimat ) was previously accepted for restricted use in patients who have poor manual dexterity and therefore have difficulty using the HandiHaler device. Since tiotropium (Spiriva) Respimat is now available at no additional cost compared with tiotropium (Spiriva) HandiHaler the restriction has been removed It was noted the respiratory chapter has recently been reviewed and is expected to come to FC in January The committee agreed to classify tiotropium 2.5mcg inhalation solution (Spiriva Respimat ) as routinely available in line with national guidance. Included in the Lothian Joint Formulary. 7. Non-submissions to Formulary Committee (90-day target) 7.1 olaratumab (Lartruvo ) SMC No 1273/ Not routinely available as local clinical experts do not wish to add the medicines to the formulary at this time or there is a local preference for alternative medicines. Page 5 of 9

6 8. Formulary Additions and Amendments 8.1 Formulary additions Adult Section 4.10 smoking cessation The committee discussed deleting (Nicorette Invisi) from this section LJF website will be updated Section Drugs for urinary frequency, enuresis and incontinence The committee discussed amendments to this section It was noted that tolterodine will be made the first choice and the change has been already approved by the working group LJF website will be updated Appendix 8 Breast feeding The committee heard of a proposal to add a new appendix on drugs in breastfeeding and approved the same LJF website will be updated Chapter 13 Skin The committee discussed amendments to this chapter to align the LJF with Scottish Dermatology treatment pathways LJF website will be updated Child Chapter 13 Skin The committee discussed amendments to this chapter to align the LJF with Scottish Dermatology treatment pathways LJF website will be updated Section 3.2 (b) prednisolone The committee discussed the amendment to this section clarifying the formulations to be used LJF website will be updated 8.2 Formulary amendment request forms ticagrelor (Brilique ) orodispersible tablets The committee noted the amendment request form to include the use of orodispersible ticagrelor tablets in high risk patients presenting with acute coronary syndrome, who are experiencing swallowing difficulties Two declaration of interest forms were noted It was noted that the tablets are only to be stocked within cardiac catheterisation laboratory. Page 6 of 9

7 The committee agreed to classify orodispersible ticagrelor tablets as routinely available in line with local or regional guidance. Included on the LJF as a prescribing note, for Specialist Use only The committee noted that this product will be included in the LJF section as part of the current review of the cardiovascular chapter Cavilon TM barrier film foam applicator The committee noted the amendment request form to add an additional pack size to an existing formulary choice One declaration of interest form was noted The committee agreed to include this additional pack size of Cavilon TM barrier film foam applicator on the LJF in the wound section ChloraPrep TM with HiLite Orange Tint The committee noted the amendment request form for ChloraPrep TM with HiLite Orange Tint It was noted that colourless ChloraPrep TM was already approved for use The committee heard that the clinical teams are reporting that application of ChloraPrep TM is difficult to see and results in multiple applications It was noted that this addition is cost effective as need only single application It was agreed to liaise with clinical teams to ascertain if both products are required The committee agreed to classify ChloraPrep TM with HiLite Orange Tint as routinely available in line with local or regional guidance. Included on the LJF as Additional List, Specialist Use only etanercept (Erelzi ) pre-filled syringe/pen The committee noted the request to change to a more cost effective biosimilar The committee agreed to classify etanercept (Erelzi ) as routinely available in line with local or regional guidance. Included on the LJF, Specialist Use only The LJF section will be updated and paediatrics contacted to ascertain if they will also be using this product rituximab (Truxima ) The committee noted the request to change to a more cost effective biosimilar The committee agreed to classify rituximab (Truxima ) as routinely available in line with local or regional guidance. Included on the LJF, Specialist Use only The LJF section will be updated and paediatrics contacted to ascertain if they will also be using this product Page 7 of 9

8 9. NICE/SIGN/HIS Clinical Guidance 9.1 TA483 - nivolumab for previously treated squamous non-small-cell lung cancer The committee noted and discussed the NICE technology appraisal. 9.2 TA484 - nivolumab for previously treated non-squamous non-small-cell lung cancer The committee noted and discussed the NICE technology appraisal. 9.3 TA485 - sarilumab for moderate to severe rheumatoid arthritis The committee noted and discussed the NICE technology appraisal. 9.4 TA486 - aflibercept for treating choroidal neovascularisation The committee noted and discussed the NICE technology appraisal. 9.5 TA487 - venetoclax for treating chronic lymphocytic leukaemia The committee noted and discussed the NICE technology appraisal. 9.6 TA488 - regorafenib for previously treated unresectable or metastatic gastrointestinal stromal tumours The committee noted and discussed the NICE technology appraisal. 9.7 TA489 - vismodegib for treating basal cell carcinoma The committee noted and discussed the NICE technology appraisal. 9.8 TA490 - nivolumab for treating squamous cell carcinoma of the head and neck afterplatinum-based chemotherapy The committee noted and discussed the NICE technology appraisal. 9.9 TA491 - Ibrutinib for treating Waldenstrom s macroglobulinaemia The committee noted and discussed the NICE technology appraisal. 10. Drug Safety Issues MHRA Advice 10.1 Volume 11, Issue 4, November The committee noted the drug safety update This advice regarding branded prescribing of tacrolimus is already included in the prescribing notes in the LJF. Page 8 of 9

9 11. Single National Formulary 11.1 The committee noted the recent update on the Single National Formulary at the Scottish Formulary Network meeting The slides were shared with the committee members The Scottish Government are providing updates to the SNF project on the website of the Effective Prescribing and Therapeutics Branch For Information Only 12.1 Formulary Committee Reports and Letters: sofosbuvir-velpatasvir (Epclusa ) stiripentol (Diacomit ) daratumumab (Darzalex ) midazolam (Epistatus PFS) raltegravir 600mg film-coated tablets (Isentress ) 13. AOCB 14. Date of Next Meeting Wednesday 24 th January 2018, 2.00pm, Meeting Room (6+7), Waverley Gate. (Please note submission date for papers is Tuesday 9 th January 2018). Apologies are to be sent to Committee Administrator prior to the submission deadline. Page 9 of 9