LOTHIAN FORMULARY COMMITTEE

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1 FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on from to 16:00 in Room 8, 5 th Floor, Waverley Gate Present: Dr Thulani Ashcroft Dr Maria Corretge Dr James Dear Neil Fontaine Carol Holmes Liz Leitch Jane Pearson Alison Rowe Laura Shaw Garry Todd Dr Lucy Wall Dr Andrew Watson General Practitioner, NHS Lothian Consultant Geriatrician, St John s Hospital, Livingston Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh Nurse Practitioner, St John s Hospital, Livingston Primary Care Pharmacist, NHS Lothian, NHS Borders Lead Pharmacist, NHS Lothian, NHS Lothian Lead Pharmacist, Royal Hospital for Sick Children (in the chair) Lead Pharmacist, Royal Edinburgh Hospital and Roodlands Hospital Consultant Medical Oncologist, Western General Hospital Consultant Psychiatrist, Royal Edinburgh Hospital Apologies for absence: Dr Jane Goddard Dr Peter Hall Dr Sara Hornibrook Dr Simon Hurding Fraser Notman Renal Consultant, Royal Infirmary of Edinburgh Consultant Medical Oncologist, Western General Hospital General Practitioner, NHS Lothian General Practitioner, NHS Lothian Prescribing Support Pharmacist, NHS Fife Membership 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 18 th April In the minutes from the last meeting, item 5.4 Rapilose was listed as Additional List, for Specialist use only. This should be for General Use. Webtables will be updated with this information 2. Matters arising from previous minutes 2.1 Oncology Service implications The committee noted the statement from the Lead Cancer Care Pharmacist that all submitted formulary applications are only approved once service awareness has been considered. The applications are shared with other health boards in SCAN at the time of submission to Formulary Committee to enable them to consider service implications. 2.2 Relvar Ellipta As per April SMC advice, the licence for Relvar Ellipta has recently been extended to include use in the regular treatment of asthma in adults and adolescents aged 12 years and over where use of a combination medicinal product is appropriate for patients already adequately controlled on both inhaled corticosteroid and long acting beta2 agonist. Page 1 of 11

2 2.2.2 This change will not be assessed by SMC. The respiratory working group has been informed. 2.3 Adoport (tacrolimus) Following a Formulary Amendment Request form discussed at the last meeting, the committee agreed to add the Adoport brand of tacrolimus to the LJF The transplant unit has requested that this change does not go live until this switch is widely communicated to GPs and community pharmacists. 3. SMC Recommendations 3.1 cladribine (Mavenclad ) The committee noted and discussed the previously circulated submission and SMC report. cladribine (Mavenclad ) SMC No. 1300/18 ADVICE: following a full submission cladribine (Mavenclad ) is accepted for restricted use within NHS Scotland. Indication under review: treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features. SMC restriction: * Patients with rapidly evolving severe relapsing-remitting MS: patients with two or more relapses in the prior year whether on treatment or not, and at least one T1 gadolinium-enhancing lesion. * Patients with sub-optimal therapy relapsing-remitting MS: patients with one or more relapses in the previous year while on disease modifying therapy, and at least one T1 gadolinium-enhancing lesion or nine T2 lesions. In a phase III study cladribine showed superiority over placebo in terms of annualised relapse rate in patients with high disease activity relapsing-remitting multiple sclerosis The committee noted the treatment course consisting of one week of treatment at the start of year. The oral formulation is convenient for patients. The submitted treatment protocol is in line with SMC advice Trials have compared cladribine to placebo rather than other drugs, but the evidence is robust Expenditure on cladribine will be monitored through the Acute Prescribing Forum and MURG The committee agreed to classify cladribine (Mavenclad ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only. Page 2 of 11

3 3.2 olaratumab (Lartruvo ) The committee noted and discussed the previously circulated submission and SMC report. olaratumab 10mg/mL concentrate for solution for infusion (Lartruvo ) SMC No. 1273/17 ADVICE: following a full submission considered under the end of life and ultra-orphan process: olaratumab (Lartruvo ) is accepted for restricted use within NHS Scotland. Indication under review: In combination with doxorubicin for the treatment of adult patients with advanced soft-tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin. SMC restriction: for use in combination with doxorubicin as first-line treatment for advanced soft-tissue sarcoma not amenable to curative treatment with surgery or radiotherapy. In an open-label phase II study, olaratumab in combination with doxorubicin improved progressionfree and overall survival compared with doxorubicin alone in patients with advanced soft-tissue sarcoma not amenable to surgery or radiotherapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of olaratumab. 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 It was noted that the incidence is 25 patients per year; the cost in the financial spreadsheet is therefore overestimated As there is no phase III data, only conditional marketing approval is in place at present. The committee agreed that patients should be informed of this It was noted that it was a good quality phase II trial that was described in the SMC advice The committee agreed to classify olaratumab (Lartruvo ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only. 3.3 nivolumab (Opdivo ) The committee noted and discussed the previously circulated submission and SMC report. nivolumab (Opdivo ) SMC No. 1261/17 ADVICE: following a full submission assessed under the end of life and ultra-orphan medicine process: nivolumab (Opdivo ) is accepted for restricted use within NHS Scotland. Indication under review: As monotherapy, for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy. SMC restriction: treatment with nivolumab is subject to a two year clinical stopping rule. A phase III randomised study demonstrated significantly improved overall survival in patients receiving nivolumab compared with investigator choice of treatment (taxane, folic acid antagonist or epidermal growth factor receptor monoclonal antibody) in adults with SCCHN who had progressed within six months after platinum-based therapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of nivolumab. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower. Page 3 of 11

4 3.3.2 Selected patients fit the SMC criteria. Treatment is with a 60-minute infusion every two weeks. Patients would be treated for three months It was noted the total for SCAN is 5 patients, but the costs are based on treating 10 patients which requires clarification by the clinical team The committee agreed to classify nivolumab (Opdivo ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only. 3.4 pembrolizumab (Keytruda ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interests were included with the application. pembrolizumab (Keytruda ) SMC No. 1291/18 ADVICE: following a full submission assessed under the end of life and orphan medicine process: pembrolizumab (Keytruda ) is accepted for restricted use within NHS Scotland. Indication under review: as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy. SMC restriction: treatment with pembrolizumab is subject to a two-year clinical stopping rule. In a phase III study of patients with measurable urothelial carcinoma with progressive disease on or after platinum-based chemotherapy, treatment with pembrolizumab was associated with a statistically significant improvement in overall survival when compared with investigator s choice of single-agent chemotherapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of pembrolizumab. 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 discussed the application and noted that the treatment options for this patient group are limited as they may not be sufficiently fit for chemotherapy. Patient numbers are estimated at per year The SMC restriction of a two-year clinical stopping rule was noted. Patient response would require to be monitored and the committee queried what would happen if duration of treatment was longer than planned. It should be used as per the SMC restriction The committee agreed to classify pembrolizumab (Keytruda ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only. Page 4 of 11

5 3.5 eliglustat (Cerdelga ) The committee noted and discussed the previously circulated submission and SMC report. eliglustat 84mg hard capsules (Cerdelga ) SMC No. 1277/17 ADVICE: following a full submission considered under the ultra-orphan process: eliglustat (Cerdelga ) is accepted for use within NHS Scotland. Indication under review: for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 poor metabolisers, intermediate metabolisers or extensive metabolisers. In a phase III, randomised, controlled study in patients with GD1 who were previously stabilised on enzyme replacement therapy (ERT), comparable proportions of patients treated with eliglustat versus ERT maintained stability of haemoglobin concentration, platelet count, spleen and liver volumes at a non-inferiority margin of 25% in the protocol-specified analysis. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of eliglustat. 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 Eliglustat will be funded by NHS National Services Scotland and is proposed to be provided by homecare services The convenience and advantage of a tablet formulation over an infusion was noted The committee noted the SMC advice is applicable to adults only. If paediatric services wish to use eliglustat, a FAF3 would be required The committee agreed to classify eliglustat (Cerdelga ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only. Page 5 of 11

6 3.6 teduglutide (Revestive ) The committee noted and discussed the previously circulated submission and SMC report. teduglutide 5mg and 1.25mg vials of powder and solvent for solution for injection (Revestive ) SMC No 1139/16 ADVICE: following a full submission assessed under the ultra-orphan medicine process: teduglutide (Revestive ) is accepted for restricted use within NHS Scotland. Indication under review: for the treatment of patients aged one year and above with short bowel syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery. SMC restriction: initiation in paediatric patients (aged 1 to 17 years). Results of one phase III randomised study in adults demonstrated that significantly more patients treated with teduglutide compared with placebo achieved at least a 20% reduction in parenteral support at weeks 20 and 24. A 12-week open-label, non-randomised study in paediatric patients also found parenteral support was reduced with teduglutide compared with standard of care. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of teduglutide. 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 It was noted this is the only licensed medicine for short bowel syndrome and this medicine provides an unmet need Patient selection criteria in the FAF fit the SMC criteria The limitations with cost analysis data were noted; patient numbers are small as short bowel syndrome is rare The risks of home TPN were acknowledged. Teduglutide provides a safer alternative which is cost neutral after 77 days of TPN are avoided It was noted that treatment is lifelong and that these patients starting treatment in the paediatric service will transition to adult services The committee agreed to classify teduglutide (Revestive ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only. Page 6 of 11

7 3.7 dimethyl fumarate (Skilarence ) The committee noted and discussed the previously circulated submission and SMC report. dimethyl fumarate 30mg and 120mg gastro-resistant tablets (Skilarence ) SMC No 1313/18 ADVICE: following a full submission: dimethyl fumarate (Skilarence ) is accepted for restricted use within NHS Scotland. Indication under review: for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. SMC restriction: for use in patients in whom other non-biologic systemic treatments (methotrexate, ciclosporin and acitretin) are not appropriate or have failed and who are considered unsuitable for biologic therapy given their current disease state or personal preference. In a 16 week, double-blind, phase III study, dimethyl fumarate was superior to placebo and non-inferior to a fumaric acid ester product at improving the symptoms of moderate to severe plaque psoriasis in adults The committee noted this replaces Fumaderm which is not licensed for this indication. Dimethyl fumarate has been shown to be non-inferior to Fumaderm and the incidence of side-effects is similar Dimethyl fumarate would be offered before treatment with biologic agents The committee agreed to classify dimethyl fumarate (Skilarence ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only. 3.8 sofosbuvir 400mg, velpatasvir (Epclusa ) The committee noted and discussed the previously circulated submission and SMC report. Declaration of interest forms were included with the application and noted by the committee. sofosbuvir 400mg, velpatasvir 100mg film-coated tablets (Epclusa ) ADVICE: following a resubmission: SMC No 1271/17 sofosbuvir-velpatasvir (Epclusa ) is accepted for restricted use within NHS Scotland. Indication under review: treatment of chronic hepatitis C virus (HCV) infection in adults. SMC restriction: in patients with genotype 1 or 4 HCV infection. Sofosbuvir-velpatasvir was associated with high rates of sustained virologic suppression in adults with genotype 1 and 4 chronic HCV infection, including those with decompensated cirrhosis. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of sofosbuvir-velpatasvir. 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 Epclusa would be used after other regimes have been tried or are considered unsuitable due to drug interactions The high percentage of adverse reactions in the trials was noted Small patient numbers are estimated by the clinical team. Page 7 of 11

8 3.8.5 National guidance is not yet published; local treatment protocol will follow these once they are available The committee agreed to classify sofosbuvir 400mg, velpatasvir (Epclusa ) as routinely available in line with national guidance. Included on the Additional List, for Specialist Use only. 3.9 sofosbuvir 400mg, velpatasvir 100mg, voxilaprevir 100mg (Vosevi ) The committee noted and discussed the previously circulated submission and SMC report. Declaration of interest forms were included with the application and noted by the committee. sofosbuvir 400mg, velpatasvir 100mg, voxilaprevir 100mg film-coated tablet (Vosevi ) SMC No 1317/18 ADVICE: following a full submission: sofosbuvir-velpatasvir-voxilaprevir (Vosevi ) is accepted for restricted use within NHS Scotland. Indication under review: Treatment of chronic hepatitis C virus (HCV) infection in adults. SMC restriction: for patients who: (1) have failed to achieve a sustained virologic response (SVR) with a direct-acting antiviral (DAA) or (2) are DAA-naïve, have genotype 3 (GT3) HCV infection, with or without cirrhosis, and are suitable for treatment with an eight-week course. Sofosbuvir-velpatasvir-voxilaprevir was associated with high rates of SVR in adults with chronic HCV who had failed to achieve a response with DAA medicines and in those who were naïve to these medicines. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of sofosbuvir-velpatasvir-voxilaprevir. 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 acknowledged the lack of licensed treatment options for this patient group As for 3.8 above, national guidance and a local protocol is awaited The committee discussed the need to ensure treatment compliance and monitoring. To ensure treatment failure is not due to non-compliance The committee agreed to classify sofosbuvir 400mg, velpatasvir 100mg, voxilaprevir 100mg (Vosevi ) 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 brentuximab vedotin 50mg powder for concentrate for solution for infusion (Adcetris ) SMC No is not recommended for use within NHS Scotland as monotherapy for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant. Page 8 of 11

9 4.2 naltrexone hydrochloride / bupropion hydrochloride 8mg / 90mg (Mysimba ) SMC No is not recommended for use within NHS Scotland as an adjunct to a reducedcalorie diet and increased physical activity, for the management of weight in adult patients ( 18 years) with an initial Body Mass Index (BMI) of 30 kg/m² (obese), or 27 kg/m² to < 30 kg/m² (overweight) in the presence of one or more weight-related comorbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension) 5. Other Medicines Proposed for Use 5.1 ranibizumab (Lucentis ) The committee noted the FAF3 submission for ranibizumab as treatment for advanced retinopathy of prematurity It was noted ranibizumab is already being used within the service The committee noted the reasons for wanting to use ranibizumab rather than bevacizumab No financial information was included with the application. The clinical team will be asked to submit this The committee agreed to classify ranibizumab as routinely available in line with local guidance Added to the Additional List for Specialist use only. It has been categorised RED under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian. Included on the Additional List, for Specialist Use only. 6. SMC Abbreviated Submissions 6.1 icatibant acetate, 30mg, solution for injection in pre-filled syringe (Firazyr ) icatibant acetate, 30mg, solution for injection in pre-filled syringe (Firazyr ) SMC No. 1332/18 ADVICE: following an abbreviated submission icatibant acetate (Firazyr ) is accepted for use within NHS Scotland. Indication under review: symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency. SMC has previously accepted icatibant acetate for use in adults SMC have previously approved icatibant for use in adults (SMC 476/08) but this is not included in the LJF because clinicians did not respond to an invitation to apply for formulary inclusion If paediatric services wish to use icatibant acetate, a FAF1 would be required. The clinical team will be advised. It would be preferable for the FAF1 to incorporate adult and paediatric patient populations The committee agreed to classify icatibant acetate (Firazyr ) as Not Routinely available as local clinical experts do not wish to add the medicine to the formulary at this time. Page 9 of 11

10 7. Non-submissions to Formulary Committee (90-day target) 7.1 sarilumab (Kevzara ) SMC No 1314/ The clinical team have advised that a submission will be made and are aiming for the next Formulary Committee meeting Not routinely available as local implementation plans are being developed or the ADTC is waiting for further advice from local clinical experts - decision expected by July Formulary Additions and Amendments 8.1 Formulary additions prednisolone SBAR An SBAR was presented discussing options for oral prednisolone formulations when patients cannot swallow tablets. Soluble tablets are now more cost effective than liquid in primary care only. The standard prednisolone tablets remain the most cost effective option when a patient is able to swallow The committee agreed to add prednisolone soluble 5mg tablets to the LJF. This will provide flexibility for prescribers and patients in selecting the most appropriate formulation The LJF will be updated. An article will be included in the Lothian Prescribing Bulletin to highlight the change. 8.2 Formulary amendment request forms None 9. NICE/SIGN/HIS Clinical Guidance 9.1 TA517 Avelumab for treating metastatic Merkel cell carcinoma (for info) TA518Tocilizumab for treating giant cell arteritis (for info) TA519 Pembrolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy (for info) or-metastatic-urothelial-carcinoma-after-platinumcontaining-chemotherapy-pdf SIGN 151 Management of stable angina April 2018, full guideline The committee noted that further detail may be needed in the LJF section regarding course lengths of aspirin and clopidogrel in patients with stents. The working group will be contacted to review the current LJF advice. 10. Drug Safety Issues MHRA Advice 10.1 Drug Safety Update Volume 11, Issue 9 (April 2018) The committee noted valproate medicines are contraindicated in women and girls of childbearing potential unless conditions of the Pregnancy Prevention Programme are met. Page 10 of 11

11 This follows an EU-wide review into the significant harms from use of valproate medicines in pregnancy Amendments to relevant LJF sections advising of the new measures are being sent to all relevant working groups for approval. The updates will not be required to be approved by Formulary Committee before the LJF is updated The LJF will be updated. 11. Single National Formulary 11.1 The committee noted the invite to attend the next ADTC meeting to hear the presentation on the work of the SNF. 12. For Information Only 12.1 Formulary Committee Reports and Letters: The committee noted the following Formulary Committee reports and letters: adrenaline (Emerade ) Calci-D and Accrete D3 adalimumab (Humira ) venetoclax (Venclyxto ) daratumumab (Darzalex ) nivolumab (Opdivo ) tofacitinib (Xeljanz ) adalimumab (Humira ) dexamethasone intraviteal implant aviptadil phentolamine mesilate (Invicorp ) levenorgestrel (Kyleena ) rituximab thiopenta carmustine R-DA-EPOCH Rapilose celecoxib fluticasone furoate, umeclidinium, vilanterol (Trelegy Ellipta ) lacosamide (Vimpat ) lopinavir, ritonavir (Kaletra ) sevelamer carbonate (Renvela ) recombinant E.coli asparaginase (Spectrila ) ciprofloxacin (Cetralax ) 5aminolaevulinic acid (Ameluz ) pembrolizumab (Keytruda ) ribociclib (Kisqali ) Keya tacrolimus (Adoport ) dorzolamide (Eydelto ) dorzolamide timolol (Eylamdo ) povidone iodine minims 5% 13. AOCB None 14. Date of Next Meeting Wednesday 4 th July 2018, 2.00pm, Meeting Room 8, Waverley Gate. (Please note submission date for papers is Tuesday 19 th June 2018). Apologies are to be sent to the prior to the submission deadline. Page 11 of 11