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: A Gilchrist Dr SC Hornibrook Dr S Hurding L Leitch F McIntyre J Pearson L Shaw Prof M Taylor G Todd Dr R Williams Dr D Wilks In attendance: D Murray K Nielsen Apologies for absence: L Angell Dr M Corretge Dr J Dear Dr W Jamieson S Kerr I Mohammed Dr E Morrison L Renshaw Lead Pharmacist, Medicines Management Team General Practitioner, NHS Lothian General Practitioner, NHS Lothian Formulary Pharmacist, NHS Borders Site Lead Pharmacist, Royal Infirmary of Edinburgh Formulary Pharmacist, NHS Lothian Lead Pharmacist, Royal Hospital for Sick Children (in the chair) Consultant Psychiatrist, IHTT, Royal Edinburgh Hospital and Honorary Senior Lecturer, University of Edinburgh Lead Pharmacist, Royal Edinburgh Hospital and Roodlands Hospital General Practitioner, NHS Lothian Consultant in Infectious Diseases, Western General Hospital Formulary Support Pharmacist Medicines Optimisation team lead, NHS Cumbria Clinical Commissioning Group Consultant Geriatrician, St John s Hospital, Livingston Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh General Practitioner, NHS Lothian Site Lead Pharmacist, Western General Hospital Clinical Effectiveness Pharmacist, NHS Fife Clinical Pharmacology Trainee, Royal Infirmary of Edinburgh Clinical Nurse Specialist, Oncology Department, Western General Hospital Declarations of interest: The Chair reminded members to declare any interests in any of the products to be discussed. A member declared an interest in relation to vortioxetine (item 9.10.) This was noted by the Chair. 1. Minutes of the previous meeting held on 11 th November 2015 The minutes were approved with the following amendments: 1.1 See item 2.2 Page 1 of 12

2 2. Matters arising from previous minutes th November 2015 FC minutes - colistimethate sodium (Colobreathe ) The committee noted the feedback from the clinical team that guidelines for use of nebulised antibiotics in cystic fibrosis are being developed The committee was made aware that a joint paediatrics and adults Shared Care Agreement for colistimethate sodium (Colobreathe ) has been in place before this drug was approved by FC for paediatrics It was agreed that this is a concern that will be fed back to D&TC and GPPC th November 2015 FC minutes - apremilast (Otezla ) At the meeting 11 th November 2015 the committee categorised apremilast (Otezla ) as Not included, pending protocol It was brought to attention that the SMC advice circulated for the meeting was not up to date as apremilast (Otezla ) has been re-classified from restricted to unrestricted use The committee agreed that information from the clinical team is still needed on several other issues and therefore the classification remains the same The minutes will be amended accordingly. 3. SMC Recommendations 3.1 trastuzumab (Herceptin ) The committee noted and discussed the previously circulated submission and SMC report. Two non-personal, non-specific declarations of interest were included with the application and noted by the committee trastuzumab 150mg powder for concentrate for solution for infusion (Herceptin ) SMC No. 623/10 trastuzumab (Herceptin ) is accepted for restricted use within NHS Scotland. Indication under review: in combination with capecitabine or fluorouracil and cisplatin for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastrooesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. It is indicated for use only in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay. SMC restriction: for use in patients whose tumours have HER2 overexpression defined by immunohistochemistry (IHC) 3+ ( HER2 high expresser ). The addition of trastuzumab to doublet chemotherapy improved overall and progressionfree survival and tumour response. 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 trastuzumab (Herceptin ) as first line palliative chemotherapy in combination with cisplatin and capecitabine Page 2 of 12

3 patients with advanced oesophago-gastric adenocarcinoma whose tumours have HER2 overexpression as defined by IHC It was noted that a local protocol has been developed and that this is consistent with SMC recommendation It was noted that trastuzumab (Herceptin ) will replace first-line combination palliative chemotherapy using epirubicin, oxaliplatin and capecitabine in this patient group The committee agreed to include trastuzumab (Herceptin ) on the additional list, specialist use only, for the indication in question. 3.2 idelalisib (Zydelig ) The committee noted and discussed the previously circulated submission and SMC report. One declaration of interests were included with the application and noted by the committee. idelalisib, 100mg and 150mg film-coated tablets (Zydelig ) SMC No. 1039/15 idelalisib (Zydelig ) is accepted for use within NHS Scotland. Indication under review: Monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment. Idelalisib demonstrated clinical activity, measured by overall response rate, in a phase II noncomparative study. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of idelalisib 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 (PACE) meeting The committee noted the FAF1 submission for the use of idelalisib (Zydelig ) in adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment and who are fit enough to proceed with and have no contraindications to idelalisib treatment It was noted that a local protocol has not been developed as the National Scottish Follicular Guideline is currently under review, but that this will be consistent with SMC recommendation It was noted that replaced therapy is dependant on the individual patient s prior therapies The committee agreed to include idelalisib (Zydelig ) on the additional list, specialist use only, for the indication in question. Page 3 of 12

4 3.3 radium-223 dichloride (Xofigo ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were included. radium-223 dichloride 1000kBq/mL solution for injection (Xofigo ) SMC No. (1077/15) radium-223 dichloride (Xofigo ) is accepted for use within NHS Scotland. Indication under review: for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. In a randomised phase III study of adult men with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastases, treatment with radium-223 dichloride was associated with a significant improvement in overall survival compared to placebo. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of radium-223 dichloride. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. 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 radium-223 dichloride (Xofigo ) in patients with castration-resistant metastatic prostate cancer and painful bone metastases without known visceral metastases and PS0-2 and life expectancy of at least 6 months It was noted that a local protocol has been developed and that this is consistent with SMC recommendation. Prescribing will take place in secondary care It was noted that radium-223 dichloride (Xofigo ) will be considered in particular when bone pain is the predominant symptom and patient progressing or not appropriate for other systemic treatments The committee agreed to include radium-223 dichloride (Xofigo ) on the additional list, specialist use only, for the indication in question The clinical team will be asked to clarify issues regarding infrastructure and funding. Page 4 of 12

5 3.4 abiraterone acetate (Zytiga ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were included with the submission. abiraterone acetate 250mg tablets (Zytiga ) SMC No. (873/13) abiraterone acetate (Zytiga ) is accepted for use within NHS Scotland. Indication under review: abiraterone acetate is indicated with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. In a randomised, double-blind phase III study of adult men with chemotherapy-naive mcrpc, treatment with abiraterone acetate in combination with corticosteroid was associated with a statistically significant extended progression-free survival and overall survival when compared with placebo plus corticosteroid. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of abiraterone acetate. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. 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 abiraterone acetate (Zytiga ) in adult men (PS 0-1) with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated It was noted that a local protocol has been developed and that this is consistent with SMC recommendation. Prescribing will take place in secondary care It was noted that abiraterone acetate (Zytiga ) will be used in men who meet the above criteria and have no contraindication to abiraterone. LHRH analogue will continue alongside abiraterone treatment The committee agreed to include abiraterone acetate (Zytiga ) on the additional list, specialist use only, for the indication in question. Page 5 of 12

6 3.5 bevacizumab (Avastin ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest were included with the submission and noted by the committee. bevacizumab 25mg/mL concentrate for solution for infusion, (Avastin ) SMC No. (1063/15) bevacizumab (Avastin ) is accepted for restricted use within NHS Scotland. Indication under review: in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents. SMC restriction: to use in combination with paclitaxel. The addition of bevacizumab to chemotherapy improved progression free survival in patients with platinum-resistant ovarian cancer in an open-label phase III randomised study. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of bevacizumab. 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 bevacizumab (Avastin ) in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents It was noted that a local protocol has been developed and that this is consistent with SMC recommendation. Prescribing will take place in secondary care It was noted that bevacizumab (Avastin ) will replace treatment in patients receiving single agent paclitaxel only It was noted that the PAS scheme for bevacizumab (Avastin ) is relatively complex and may require additional resource to achieve the savings The committee agreed to include bevacizumab (Avastin ) on the additional list, specialist use only, for the indication in question. Page 6 of 12

7 3.6 ciclosporin (Ikervis ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were included with the submission. ciclosporin 1mg/mL (0.1%) eye drops emulsion (Ikervis ) SMC No. (1089/15) ciclosporin 1mg/mL (0.1%) eye drops emulsion (Ikervis ) is accepted for use within NHS Scotland. Indication under review: treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes. Ciclosporin eye drops, compared to vehicle, improved signs of corneal surface damage but not symptoms in patients with severe keratitis associated with dry eye disease The committee noted the FAF1 submission for the use of ciclosporin (Ikervis ) as treatment of severe ocular surface disease, due to severe dry eyes, which is not controlled by lubricants alone and requires the addition of long term topical steroids to control symptoms It was noted that a local protocol has not been developed. Prescribing will be initiated in secondary care and continued in primary care It was noted that ciclosporin (Ikervis ) will replace unlicensed medicines for this indication (ciclosporin veterinary ointment (Optimmune ) and Restasis ) The committee agreed to include ciclosporin (Ikervis ) on the additional list, specialist initiation, for the indication in question. 4. SMC latest Not Recommended Medicines (November 2015) 4.1 anakinra (Kineret ) SMC No. 1116/15, is not recommended for use within NHS Scotland as the holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. 4.2 co-careldopa (Duodopa ) intestinal gel SMC No. 316/06, is not recommended for use within NHS Scotland. 4.3 denosumab (Xgeva ) SMC No. 1119/15, is not recommended for use within NHS Scotland as the holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. 5. Other Medicines Proposed for Use 5.1 Calcium and vitamin D supplement (theical-d3 ) The committee noted the FAF2 submission to add calcium and vitamin D supplement (theical-d3 ) onto the additional list, for prevention and treatment of calcium and vitamin D deficiency. It will be used as an adjunct to specific osteoporosis treatments in patients at risk of calcium and vitamin D deficiency. Page 7 of 12

8 5.1.2 One declaration of interest was included with the submission and noted by the committee It was noted that no local protocol has been developed. Prescribing will take place in both primary and secondary care The committee agreed to classify calcium and vitamin D supplement (theical-d3 ) as Not Included on the LJF because the NHS Lothian decision is that the medicine does not represent sufficient added benefit to other comparator medicines to treat the condition in question. 6. SMC Abbreviated Submissions (November 2015) 6.1 atomoxetine (Strattera ) atomoxetine oral solution 4mg/mL (Strattera ) SMC No. (1107/15) atomoxetine oral solution (Strattera ) is accepted for restricted use within NHS Scotland. Indication under review: treatment of attention-deficit/hyperactivity disorder (ADHD) in children of 6 years and older, in adolescents and in adults as part of a comprehensive treatment programme. Treatment must be initiated by a specialist in the treatment of ADHD, such as a paediatrician, child/adolescent psychiatrist, or psychiatrist. Diagnosis should be made according to current DSM criteria or the guidelines in ICD. SMC restriction: to use in patients who are unable to swallow capsules. Atomoxetine oral solution demonstrated bioequivalence to atomoxetine capsules. The availability of the oral solution will provide a formulation acceptable to patients who cannot swallow capsules. Any overall budget impact is likely to be small Included on the Lothian Joint Formulary for the indication in question. Should only be prescribed for patients who cannot swallow capsules. Page 8 of 12

9 6.2 efavirenz (Sustiva ) LOTHIAN FORMULARY COMMITTEE efavirenz 50mg, 100mg and 200mg hard capsules and 600mg film-coated tablets (Sustiva ) SMC No. (1125/15) efavirenz (Sustiva ) is accepted for use within NHS Scotland. Indication under review: antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected children aged 3 months to 3 years and weighing at least 3.5kg. For patients at least 3 months old and weighing at least 3.5kg who cannot swallow capsules, the capsule contents can be administered with a small amount of food using the capsule sprinkle method of administration. Efavirenz is listed in the British National Formulary for Children for the treatment of HIV infection Included on the additional list for the indication in question. 6.3 glatiramer acetate (Copaxane ) glatiramer acetate 40mg/mL solution for injection prefilled syringes (Copaxone ) SMC No. (1108/15) glatiramer acetate 40mg/mL (Copaxone ) is accepted for use within NHS Scotland. Indication under review: treatment of relapsing forms of multiple sclerosis (MS). This new formulation of glatiramer actetate (40mg/ml) given three times a week costs the same as the currently available formulation (glatiramer acetate 20mg/ml) that is given daily Included on the LJF as a prescribing note, for the indication in question. 7. Non-submissions to Formulary Committee (October 90-day target) 7.1 bevacizumab (Avastin ) SMC No. 806/ Not included pending protocol. Clinicians confirm submission pending. 7.2 edoxaban (Lixiana ) SMC No. 1090/ Not included on the LJF because clinicians do not support the formulary inclusion. LJF choice is apixaban. 7.3 edoxaban (Lixiana ) SMC No. 1095/ Not included on the LJF because clinicians do not support the formulary inclusion. LJF choice is apixaban. 7.4 pembrolizumab (Keytruda ) SMC No. 1086/ Not included pending protocol. Clinicians confirm submission pending. Page 9 of 12

10 7.5 Report on Formulary Committee process and 90-day target Apr15 Sep The committee noted and discussed the previously circulated process report for April 2015 September The report will be sent to ADTC for information. 8. Formulary Additions and Amendments 8.1 Formulary Additions None. 8.2 Formulary amendment request forms cefuroxime (Aprokam ) 50mg powder for solution for injection The committee noted the amendment request form for the inclusion of Aprokam as antibiotic prophylaxis for ophthalmology surgery as per current protocols agreed with NHS Lothian Antimicrobial team. At time of writing the procedures in which it is to be used are: Cataract surgery (Aprokam is licensed for this) Glaucoma or corneal grafts (off-label use) Penetrating eye injury (off-label use) No declarations of interest were included with the submission It was noted that Aprokam will replace cefuroxime 250mg powder for solution for injection, for this indication. Prescribing will take place in secondary care Aprokam is not recommended by SMC due to non-submission by the company. However, in line with ADTC policy a licensed medicine should be used where one exists in preference to an unlicensed medicine. There is no other cefuroxime product licensed for intracameral injection The committee agreed to include cefuroxime (Aprokam ) on the additional list, specialist use only, for the indication in question. 9. NICE/SIGN/NHS QIS Clinical Guidance 9.1 STA358 Tolvaptan for treating autosomal dominant polycystic kidney disease Noted 9.2 STA359 Idelalisib for treating chronic lymphocytic leukaemia Noted 9.3 STA360 Paclitaxel as albumin-bound nanoparticles in combination with gemcitabine for previously untreated metastatic pancreatic cancer Noted 9.4 TA361 Simeprevir in combination with sofosbuvir for treating genotype 1 or 4 chronic hepatitis C (terminated appraisal) Noted 9.5 TA362 Paclitaxel as albumin-bound nanoparticles with carboplatin for untreated non-small-cell lung cancer (terminated appraisal) Noted Page 10 of 12

11 9.6 STA363 Ledipasvir sofosbuvir for treating chronic hepatitis C Noted 9.7 STA364 Daclatasvir for treating chronic hepatitis C Noted 9.8 STA365 Ombitasvir paritaprevir ritonavir with or without dasabuvir for treating chronic hepatitis C Noted 9.9 STA366 Pembrolizumab for advanced melanoma not previously treated with ipilimumab Noted 9.10 STA367 Vortioxetine for treating major depressive episodes Noted 9.11 STA368 Apremilast for treating moderate to severe plaque psoriasis Noted 9.12 NG23 Menopause: diagnosis and management Noted 9.13 NG25 Preterm labour and birth Noted 9.14 NG28 Type 2 diabetes in adults: management Noted 10. Drug Safety Issues MHRA Advice 10.1 MHRA Drug Safety Update, Volume 9, Issue 4, November Noted. 11. For Information Only 11.1 Formulary Committee Reports and Letters The committee noted the following Formulary Committee reports and letters: aflibercept (Eylea ) colistimethate sodium (Colobreathe ) sekucinumab (Cosentyx ) apremilast (Otezla ) dolutegravir, abacavir, lamivudine (Triumeq ) nintedanib (Ofev ) tiotropium (Spiriva Respimat ) aclidinium/formoterol furoate (Duaklir Genuair ) umeclidinium (Incruse ) umeclidinium/vilanterol (Anoro ) sugammadex (Bridion ) Page 11 of 12

12 Multivitamin (vitamin A, D, E and K) supplement (AquADEKs) nicardipine alteplase (Actilyse ) Xailin Night Eye Ointment mirabegron 12. AOCB 13. Date of Next Meeting The committee noted that the next meeting would be held on Wednesday, 20 th January 2016 at 2pm. (The deadline for submission of papers for this meeting is Tuesday 5 th January 2016.) Apologies are to be sent to Committee Administrator prior to the submissions deadline. Page 12 of 12

LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE

LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on 11 th November 2015 from 2.00pm 5.10pm in Room 004, Ground Floor, Pentland House Present: Dr M Corretge Consultant Geriatrician, St