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: Krista Clubb Nurse Prescribing Coordinator, NHS Lothian Dr Maria Corretge Consultant Geriatrician, St John s Hospital, Livingston (arrived at 14.30) Anne Gilchrist Lead Pharmacist, Medicines Management Team Carol Holmes Primary Care Pharmacist, NHS Lothian Dr Sara Hornibrook General Practitioner, NHS Lothian Dr Walter Jamieson General Practitioner, NHS Lothian Janet Mack Clinical Pharmacist, Western General Hospital Fiona McIntyre Site Lead Pharmacist, Royal Infirmary of Edinburgh (left meeting at 16.05) Alison Rowe Formulary Pharmacist, NHS Lothian Laura Shaw Lead Pharmacist, Royal Hospital for Sick Children (in the chair) Dr Lucy Wall Consultant Medical Oncologist, Western General Hospital Dr Andrew Watson Consultant Psychiatrist, Royal Edinburgh Hospital Dr Richard Williams General Practitioner, NHS Lothian (left meeting at 16.05) In attendance: Clare Andrews Zuzana Krajčovič Apologies for absence: Dr James Dear Dr Jane Goddard Dr Peter Hall Dr Simon Hurding Liz Leitch Ishtiaq Mohammed Dr Emma Morrison Garry Todd Clinical Pharmacist, Western General Hospital Medicines Management Committee Administrator Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh Renal Consultant, Royal Infirmary of Edinburgh Consultant Medical Oncologist, Western General Hospital General Practitioner, NHS Lothian Formulary Pharmacist, NHS Borders Clinical Effectiveness Pharmacist, NHS Fife Clinical Pharmacology Trainee, Royal Infirmary of Edinburgh Lead Pharmacist, Royal Edinburgh Hospital and Roodlands Hospital Welcome The Chair welcomed Ms Clare Andrews, Clinical Pharmacist as an observer at the meeting. Members introduced themselves in turn. Membership It was noted that Janet Mack has resigned as a member of the committee. The committee thanked Janet for her contributions and wished her well in her new job. Page 1 of 14

2 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 5 th October The minutes were approved as an accurate record of the meeting. 2. Matters arising from previous minutes 2.1 dexamethasone (Ozurdex ) A FAF1 submission was made to the Formulary Committee in August 2016 for the use of dexamethasone (Ozurdex ) for the treatment of adult patients with visual impairment due to diabetic macular oedema who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy The applicants were asked to provide additional information on how the patient numbers were estimated, patient selection criteria and the place in therapy in relation to the other medicines being currently used The committee discussed correspondence received from the clinical team. It was noted that the response was very comprehensive and included all requested information The committee agreed to Include dexamethasone (Ozurdex ) on the LJF as second choice, Specialist Use only, for the indication in question. 3. SMC Recommendations 3.1 levofloxacin (Quinsair ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were included with the application and noted by the committee. Page 2 of 14

3 levofloxacin 240mg nebuliser solution (Quinsair ) SMC No. (1162/16) ADVICE: following a full submission under the orphan equivalent process: levofloxacin (Quinsair ) is accepted for restricted use within NHS Scotland. Indication under review: the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis. SMC restriction: for use as a third line treatment option after colistimethate sodium (first line) and tobramycin (second line). In a phase III open-label randomised study, levofloxacin was non-inferior to another inhaled antimicrobial for change in lung function, measured by relative change in forced expiratory volume in one second (FEV1) percent predicted. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of levofloxacin. 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 the FAF1 submission for the use of levofloxacin (Quinsair ) for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis (CF) It was noted that the Guidelines for use of antimicrobials in adult CF will be updated to include levofloxacin as fifth-line treatment after all standard options, including both nebulised and dry powder formulations of colistimethate sodium and tobramycin, have been tried and ruled out. Prescribing will be initiated in secondary care The committee noted that levofloxacin would be considered as an alternative to nebulised aztreonam lysine. Levofloxacin is only taken twice daily compared to three times daily and comes as ready-made solution rather than powder for reconstitution It was noted that a PAS is available for the use of this medicine It was noted that shared care is usually suitable for inhaled treatments for CF and the committee noted that a shared care would be appropriate for this medicine The committee agreed to Include levofloxacin (Quinsair ) on the Additional List, Specialist initiation, for the indication in question The authorising Clinical Director is asked to liaise with the appropriate budget holder in primary care to ensure that funding is in place. 3.2 brivaracetam (Briviact ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were included with the application. Page 3 of 14

4 brivaracetam 10mg, 25mg, 75mg, 100mg film-coated tablets; 10mg/mL oral solution; 10mg/mL solution for injection/infusion (Briviact ) SMC No. (1160/16) ADVICE: following a full submission: brivaracetam (Briviact ) is accepted for restricted use within NHS Scotland. Indication under review: Adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy. SMC restriction: for use in patients with refractory epilepsy and treatment should be initiated by physicians who have appropriate experience in the treatment of epilepsy. In a pooled analysis of three fixed-dose, placebo-controlled, phase III studies there were statistically significant reductions in the frequency of partial-onset seizures with brivaracetam versus placebo The committee noted the FAF1 submission for the use of brivaracetam (Briviact ) as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy It was noted that a local protocol has not been developed. Prescribing will be initiated in secondary care, on specialist advice, and then continued in primary care The committee noted that this medicine will be used in patients with intractable epilepsy who have failed to show improvement in seizure frequency on at least two other established anti-epileptic drugs It was noted that no substitution costs were provided in the application and that this should be clarified by the clinical team The committee agreed to Include brivaracetam (Briviact ) on the Additional List, Specialist initiation, for the indication in question The authorising Clinical Director is asked to liaise with the appropriate budget holder in primary care to ensure that funding is in place. 3.3 naloxegol (Moventig ) It was agreed to not review the application for naloxegol at this meeting due to the absence of Clinical Director s authorisation. 3.4 ibrutinib (Imbruvica ) CLL The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were included with the application and noted by the committee. Page 4 of 14

5 ibrutinib 140mg hard capsules (Imbruvica ) SMC No. (1151/16) ADVICE: following a full submission assessed under the end of life and orphan medicine process: ibrutinib (Imbruvica ) is accepted for restricted use within NHS Scotland. Indication under review: treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. SMC restriction: patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy. In an open-label, phase III study, ibrutinib significantly increased progression-free survival compared with an anti-cd20 antibody in patients with relapsed or refractory CLL. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ibrutinib. 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 the FAF1 submission for the use of ibrutinib (Imbruvica ) for the treatment of adult patients with CLL and with 17p deletion or TP53 mutation, who are unsuitable for chemo-immunotherapy, in the first-line or relapsed setting It was noted that a local protocol has been developed. Prescribing will take place in secondary care only It was noted that there are currently very limited treatment options for this patient group The committee noted that ibrutinib will not directly replace any existing treatments. It will offer a new licensed option for this patient group and will supersede alemtuzumab in the first-line setting and rituximab-idelalisib in the relapsed setting. Alemtuzumab and rituximab-idelalisib treatment options may still be considered further down the treatment pathway It was noted that a PAS is available for the use of this medicine The committee agreed to Include ibrutinib (Imbruvica ) on the Additional List, Specialist Use only, for the indication in question noted under of these minutes. 3.5 ibrutinib (Imbruvica ) MCL The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were included with the application and noted by the committee. Page 5 of 14

6 ibrutinib 140mg hard capsule (Imbruvica ) SMC No. (1150/16) ADVICE: following a full submission assessed under the end of life and ultra-orphan medicine process: ibrutinib (Imbruvica ) is accepted for use within NHS Scotland. Indication under review: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). In a randomised, open-label, phase III study ibrutinib significantly prolonged progressionfree survival, the primary endpoint, compared to a chemotherapy treatment, in patients with relapsed or refractory MCL. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ibrutinib. 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 the FAF1 submission for the use of ibrutinib (Imbruvica ) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma It was noted that a local protocol has been developed. Prescribing will take place in secondary care only It was noted that there is currently no SMC approved standard of care in the relapsed or refractory MCL setting, although depending on patient performance status various chemotherapy options may be offered through the non-formulary route. Ibrutinib will therefore not replace any existing approved treatment options It was noted that a PAS is available for the use of this medicine The committee agreed to Include ibrutinib (Imbruvica ) on the Additional List, Specialist Use only, for the indication in question. 3.6 lenvatinib (Lenvima ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were included with the application. Page 6 of 14

7 lenvatinib 4mg and 10mg hard capsules (Lenvima ) SMC No. (1179/16) ADVICE: following a full submission assessed under the end of life and ultra-orphan medicine process: lenvatinib (Lenvima )is accepted for use within NHS Scotland. Indication under review: treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Lenvatinib, compared with placebo, significantly improved progression free survival in adults with RAI-refractory DTC. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of lenvatinib. 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 the FAF1 submission for the use of lenvatinib (Lenvima ) for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/hürthle cell) thyroid carcinoma, refractory to radioactive iodine It was noted that the protocol for all of thyroid cancer is in process of development. Prescribing will take place in secondary care only It was noted that lenvatinib is likely to become first-line choice of treatment for the majority of thyroid cancer patients. It will displace sorafenib, which will move to second-line treatment It was noted that a PAS is available for the use of this medicine The committee agreed to Include lenvatinib (Lenvima ) on the Additional List, Specialist Use only, for the indication in question. 3.7 secukinumab (Cosentyx ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were included with the application. Page 7 of 14

8 secukinumab 150mg solution for injection in pre-filled pen and pre-filled syringe (Cosentyx ) SMC No. (1167/16) ADVICE: following a full submission: secukinumab (Cosentyx ) is accepted for restricted use within NHS Scotland. Indication under review: alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. SMC restriction: Use in patients whose disease has not responded to adequate trials of at least two standard DMARDs either individually or in combination. In phase III, randomised, placebo-controlled studies in patients with active psoriatic arthritis, a significantly greater proportion of patients who received secukinumab achieved at least 20% improvement in the American College of Rheumatology response criteria (ACR20) at 24 weeks compared with those who received placebo. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of secukinumab. 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 the FAF1 submission for the use of secukinumab (Cosentyx ) alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying antirheumatic drug (DMARD) therapy has been inadequate It was noted that a local protocol has been developed and provided with the application. Prescribing will take place in secondary care with supply and nurse education for self-administration, where required, provided through pre-existing clinic and hospital dispensing service. It was proposed that this could be later moved to homecare services It was noted that patients will be screened for eligibility for biologic treatment as per established British Society for Rheumatology recommendations It was noted that a PAS is available for the use of this medicine The committee agreed to Include secukinumab (Cosentyx ) on the LJF as first choice, Specialist Use only, for the indication in question. 3.8 ulipristal acetate (Esmya ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were included with the application. Page 8 of 14

9 ulipristal acetate, 5mg, tablet (Esmya ) SMC No. (1128/16) ADVICE: following a full submission: ulipristal acetate (Esmya ) is accepted for use within NHS Scotland. Indication under review: for the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. A phase III study demonstrated that treatment with the licensed dose of ulipristal acetate controlled uterine bleeding in approximately three-quarters of patients with symptomatic uterine fibroids after four intermittent treatment courses The committee noted the FAF1 submission for the use of ulipristal acetate (Esmya ) for the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age It was noted that ulipristal acetate will be used in adult women with heavy menstrual bleeding (HMB) associated with uterine fibroids that do not wish to undergo a surgery, or are unsuitable for surgery, or are in an age group where surgery can be avoided altogether by using medical treatment until they reach the menopause. This medicine has already been approved for pre-operative shrinkage of fibroids where surgery is indicated (FC July 2013) The committee noted that ulipristal acetate will be used as an alternative to other medical treatment for HMB such as levonorgestrel intrauterine system, tranexamic acid and cyclical progestogens It was noted that no other medical treatment is specific for ongoing management of HMB associated with fibroids but GnRH analogues can be used preoperatively It was noted that a local protocol has not been developed, due to the fact that the NICE guidance on treatment of fibroids is yet to be published The clinical team proposed that the treatment would be recommended by secondary care but all prescribing can be carried out in primary care It was noted that patients should not become pregnant while taking this medicine and an ultrasound scan would need to be carried out annually The committee agreed that a treatment protocol needs to be produced, including clear guidelines on contraception counselling and organisation of the ultrasound scan. The committee thought that perhaps ulipristal acetate should be initiated in secondary care before patients are referred to primary care It was estimated that approximately 300 patients will be treated with this medicine per annum, however the committee considered it to be too high. Therefore it was agreed to ask the applicants to clarify how the patient numbers were estimated The committee agreed to Not include ulipristal acetate (Esmya ) on the LJF, pending protocol. It was agreed to ask the applicants to provide clarification on patient numbers and a treatment protocol. 3.9 apremilast (Otezla ) The committee noted and discussed the SMC report. Page 9 of 14

10 apremilast 10mg, 20mg and 30mg film-coated tablets (Otezla ) SMC No. (1052/15) ADVICE: following a full submission: 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 and discussed the feedback received from the clinical team regarding the use of apremilast (Otezla ) 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 The committee agreed to Not include apremilast (Otezla ) on the LJF because clinicians do not support the formulary inclusion. 4. SMC latest Not Recommended Medicines 4.1 adalimumab (Humira ) SMC No. 1208/16 is not recommended for use within NHS Scotland for the treatment of moderately active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. 4.2 adalimumab (Humira ) SMC No. 1209/16 is not recommended for use within NHS Scotland for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. 4.3 canakinumab (Ilaris ) SMC No. 1210/16 is not recommended for use within NHS Scotland for the treatment of active Still's disease including Adult-Onset Still's Disease who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids. Ilaris can be given as monotherapy or in combination with methotrexate. 4.4 fampridine (Fampyra ) SMC No. 789/12 is not recommended for use within NHS Scotland for the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS [expanded disability status scale] 4 to 7). Page 10 of 14

11 4.5 lenalidomide (Revlimid ) SMC No. 1211/16 is not recommended for use within NHS Scotland for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. 4.6 nivolumab (Opdivo ) SMC No. 1188/16 is not recommended for use within NHS Scotland as monotherapy for the treatment of advanced renal cell carcinoma after prior therapy in adults. 5. Other Medicines Proposed for Use 5.1 NexoBrid The committee noted the FAF2 submission for the use of NexoBrid for the removal of eschar in adults with deep partial and full thickness thermal burns up to a maximum of 15% total body surface area (TBSA) No declarations of interest were included with the submission It was noted that a local protocol has been developed and that prescribing will take place in secondary care by a specialist with prescribing authority within the Burns Team It was noted that this is a novel medicine which has no existing medicine to replace. NexoBrid replaces surgical debridement which is performed in a theatre setting NexoBrid will be used in patients admitted with a thermal burn injury requiring debridement where the burn injury is not older than 72 hours and the TBSA per procedure is less than 15%. NexoBrid is contraindicated in patients with an allergy to pineapple and bromelain The committee considered the evidence on clinical effectiveness of NexoBrid, and noted the declared interests. The committee would like to see other independent clinical trial evidence; any supporting evidence from clinical practice; and information on use in other burns centres The committee agreed to Not include NexoBrid on the LJF, pending protocol. Additional information is required on clinical effectiveness of this product. 6. SMC Abbreviated Submissions 6.1 pegaspargase (Oncaspar ) pegaspargase (Oncaspar ) 750U/mL solution for injection/infusion SMC No. (1197/16) pegaspargase (Oncaspar ) is accepted for use within NHS Scotland. Indication under review: as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients. Pegaspargase (Oncaspar ) has been used in NHS Scotland as an unlicensed medicine Included on the LJF as first choice, Specialist Use only, for the indication in for the treatment of ALL in children and adults; it has now been granted a product question. license. Page 11 of 14

12 6.1.1 Included on the LJF as first choice, Specialist Use only, for the indication in question. 7. Non-submissions to Formulary Committee (90-day target) 7.1 aflibercept (Eylea ) SMC No. 1186/ The committee noted and discussed the feedback received from the clinical team prior to the meeting It was agreed to Not include aflibercept (Eylea ) on the LJF because clinicians do not support the formulary inclusion. 7.2 budesonide (Cortiment ) SMC No. 1093/ Not included on the LJF, because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine. 7.3 dasatinib (Sprycel ) SMC No. 370/ It was noted that the clinical team are preparing a FAF1 submission Not included on the LJF, pending protocol. 7.4 nivolumab (Opdivo ) SMC No. 1180/ It was noted that the clinical team are preparing a FAF1 submission Not included on the LJF, pending protocol. 7.5 progesterone (Lutigest ) SMC No. 1185/ Not included on the LJF, because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine. 8. Formulary Additions and Amendments 8.1 Formulary Additions ADULT Section Prostate cancer and gonadorelin analogues The committee discussed and approved the changes to this section. The LJF website will be updated Wound Formulary The committee discussed and approved the changes to the formulary. The LJF website will be updated. Page 12 of 14

13 8.2 Formulary amendment request forms Proton Pump Inhibitors information leaflet for patients The committee reviewed and approved the information leaflet for patients Managing Cough and Sore Throat in Adults and Children in your Community Pharmacy The committee reviewed and approved the above information leaflet. 9. NICE/SIGN/NHS QIS Clinical Guidance None to note. 10. Drug Safety Issues MHRA Advice 10.1 MHRA Drug Safety Update, Volume 10, Issue 3, October The committee noted the drug safety update. 11. Briefing on Business Conduct and Risk Assessment 11.1 The committee discussed and noted the briefing note It was agreed to include the recommended prompt message at the top of every agenda reminding the committee members to identify and declare any financial and non-financial interests they may have in the items of business for consideration. 12. For Information Only 12.1 Formulary Committee Letters and Reports The committee noted the following Formulary Committee reports and letters: secukinumab (Cosentyx ) fulvestrant (Faslodex ) nivolumab (Opdivo ) blinatumomab (Blincyto ) crizotinumib (Xalkori ) insulin degludec (Tresiba ) nivolumab (Opdivo ) zoledronic acid (Zerlinda ) secukinumab (Cosentyx ) alirocumab (Praluent ) idarucizumab (Praxbind ) vitamin A oral solution Page 13 of 14

14 13. AOCB 13.1 FC and the budgetary sign off of application forms It was agreed to write to the ADTC and ask them for an update on this issue. 14. Date of Next Meeting Wednesday 14 th December 2016, 2.00pm, Room 004, Ground Floor, Pentland House (Please note submission date for papers is Tuesday 29 th November 2016). Apologies are to be sent to Committee Administrator prior to the submission deadline. Apologies: Dr Sara Hornibrook, Dr Lucy Wall Page 14 of 14