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 Anne Gilchrist Lead Pharmacist, Medicines Management Team Dr Jane Goddard Renal Consultant, Royal Infirmary of Edinburgh Dr Peter Hall Consultant Medical Oncologist, Western General Hospital Dr Sara Hornibrook General Practitioner, NHS Lothian Dr Simon Hurding General Practitioner, NHS Lothian (arrived at 14.10) Dr Walter Jamieson General Practitioner, NHS Lothian (in the chair) Liz Leitch Formulary Pharmacist, NHS Borders (arrived at 14.25) Dr Emma Morrison Clinical Pharmacology Trainee, Royal Infirmary of Edinburgh Alison Rowe Formulary Pharmacist, NHS Lothian Dr Richard Williams General Practitioner, NHS Lothian In attendance: Zuzana Krajčovič Apologies for absence: Lesley Angell Dr James Dear Carol Holmes Janet Mack Fiona McIntyre Ishtiaq Mohammed Laura Shaw Garry Todd Dr Lucy Wall Dr Andrew Watson Medicines Management Committee Administrator Medicines Optimisation Team Lead, NHS Cumbria Clinical Commissioning Group Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh Primary Care Pharmacist, NHS Lothian Clinical Pharmacist, Western General Hospital Site Lead Pharmacist, Royal Infirmary of Edinburgh Clinical Effectiveness Pharmacist, NHS Fife Lead Pharmacist, Royal Hospital for Sick Children Lead Pharmacist, Royal Edinburgh Hospital and Roodlands Hospital Consultant Medical Oncologist, Western General Hospital Consultant Psychiatrist, Royal Edinburgh Hospital Welcome The Chair welcomed new member of the Formulary Committee, Ms Alison Rowe, Formulary Pharmacist. Members introduced themselves in turn. Membership It was noted that Ms Lesley Angell, Medicines Optimisation Team Lead from NHS Cumbria has resigned as a member of the committee. Page 1 of 10

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 6 th July The minutes were approved as an accurate account of the meeting. 2. Matters arising from previous minutes None. 3. SMC Recommendations 3.1 bevacizumab (Avastin ) The committee noted and discussed the previously circulated submission and SMC report. One declaration of interest from a member of the committee was noted at the meeting. bevacizumab 25mg/mL concentrate for solution for infusion (Avastin ) SMC No. (1135/16) ADVICE: following a resubmission considered under the end of life and ultra orphan medicine process: bevacizumab (Avastin ) is accepted for restricted use within NHS Scotland. Indication under review: in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix. Restriction: for use in combination with cisplatin and paclitaxel. In an open-label, randomised, phase III study, the addition of bevacizumab to combination chemotherapy increased overall survival. This 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 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 and Engagement (PACE) meeting The committee noted the FAF1 submission for the use of bevacizumab (Avastin ) in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix. Page 2 of 10

3 3.1.3 It was noted that a local protocol has been developed and provided with the application. Prescribing will take place in secondary care only The committee noted that bevacizumab (Avastin ) will be used in patents with progressive, relapsed or newly diagnosed metastatic cervical cancer who are suitable for treatment with systemic platinum based chemotherapy and have no contraindications to treatment with bevacizumab It was noted that a PAS is available for the use of this medicine The committee agreed to Include bevacizumab (Avastin ) on the Additional List, Specialist Use only, for the indication in question. 3.2 dexamethasone (Ozurdex ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interest were included with the application. dexamethasone 700 micrograms intravitreal implant in applicator (Ozurdex ) SMC No. (1046/15) ADVICE: following a full submission: dexamethasone intravitreal implant (Ozurdex ) is accepted for use within NHS Scotland. Indication under review: 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. Intravitreal dexamethasone improved visual acuity more than sham treatment in adult patients who were pseudophakic or had received prior treatment for diabetic macular oedema, based on subgroup analyses The committee noted the FAF1 submission 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 It was noted that a local protocol has not been developed. Prescribing will take place in secondary care in a sterile environment. Due to the risk of inducing elevated intraocular pressure, patients would need to be assessed for steroid responsiveness prior to using this drug. Patient should also be pseudophakic so earlier cataract surgery may be needed prior to using this medicine The clinical team proposed to use dexamethasone as second-line treatment of diabetic patients with macular oedema who have not respondend to anti-vegf intravineal injections, or are not suitable for their use The committee noted that fluocinolone acetonide was added to the Additional List in May 2014, however it was not mentioned in the FAF as an alternative treatment. It was therefore agreed to ask the clinical team to provide more information on the place in therapy in relation to the existing medicines and provide a treatment algorithm It was noted that the estimated patient numbers from the SMC advice were significantly higher than those noted in the FAF. The committee would therefore like Page 3 of 10

4 the clinical team to clarify the patient numbers and explain the rationale on how these were estimated The committee agreed to Not include dexamethasone (Ozurdex ) on the LJF, pending protocol. Additional information is required from the applicants on how the patient numbers were estimated, patient selection criteria and the place in therapy in relation to the other medicines being currently used. 4. SMC latest Not Recommended Medicines 4.1 human alpha 1 -proteinase inhibitor (Respreeza ) SMC No. 1157/16 is not recommended for use within NHS Scotland for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha 1 -proteinase inhibitor (A1-PI) deficiency. 4.2 elotuzumab (Empliciti ) SMC No. 1183/16 is not recommended for use within NHS Scotland for the treatment of multiple myeloma in combination with lenalidomide and dexamethasone in adult patients who have received at least one prior therapy. 4.3 necitumumab (Portrazza ) SMC No. 1184/16 is not recommended for use within NHS Scotland in combination with gemcitabine and cisplatin chemotherapy for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition. 5. Other Medicines Proposed for Use 5.1 zoledronic acid The committee noted the FAF3 submission for the inclusion of zoledronic acid for the treatment of patients with osteogenesis imperfecta, juvenile idiopathic osteoporosis, recurrent fractures due to osteopaenia No declarations of interest were included with the submission The applicants have provided protocol for the use of this preparation produced by the Birmingham Children s Hospital. Prescribing will take place in secondary care only The committee noted that zoledronic acid is not licensed for use in children but is currently used off-label for a number of conditions associated with increased bone fragility The advantage of the newer and more potent zoledronic acid is that it can be given on a single day as minutes infusion every 3-6 months compared to pamidronate which must be given over several days It was noted that the evidence suggests that there is no difference in the desired treatment effect or side-effects, between pamidronate disodium and zoledronic acid Zoledronic acid will be used first-line in preference to pamidronate, however some patients will be treated with pamidronate first. Page 4 of 10

5 5.1.8 The committee agreed to Include zoledronic acid on the LJF as a first choice drug, for Specialist Use only, classified as RED under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian. 5.2 thrombin (Floseal ) The committee noted the FAF3 submission for the inclusion of thrombin (Floseal ) injections for bleeding gastric and ectopic varices It was noted that Floseal is a medical device which will be used of-label. It is a two component product and only the thrombin component should be used. The other syringe containing the gelatine matrix should be discarded No declarations of interest were included with the submission It was noted that the Lothian guidelines for the treatment of bleeding gastric and ectopic varices using thrombin have been provided with the application. Prescribing will take place in secondary care only The committee noted that the currently used product, Tisseel, has been discontinued in its current formulation The committee agreed to Include thrombin (Floseal ) on the Additional List, for Specialist Use only, classified as RED under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian. 6. SMC Abbreviated Submissions 6.1 diamorphine hydrochloride (Ayendi ) diamorphine hydrochloride 720 microgram/actuation and 1600 microgram/ actuation nasal spray (Ayendi ) SMC No. (1172/16) diamorphine hydrochloride (Ayendi ) is accepted for use within NHS Scotland. Indication under review: treatment of acute severe nociceptive pain in children and adolescents in a hospital setting. Diamorphine hydrochloride nasal spray (Ayendi ) should be administered in the emergency setting by practitioners experienced in the administration of opioids in children and with appropriate monitoring. Unlicensed intranasal diamorphine has been used in the NHS in Scotland for the treatment of severe pain in children in the emergency setting. The availability of diamorphine hydrochloride nasal spray (Ayendi ) provides a licensed preparation Included on the Additional List, Specialist Use only, for the indication in question. Page 5 of 10

6 6.2 emtricitabine/tenofovir alafenamide (Descovy ) emtricitabine/tenofovir alafenamide 200mg/25mg, 200mg/10mg film-coated tablets (Descovy ) SMC No. (1169/16) emtricitabine/tenofovir alafenamide (Descovy ) is accepted for use within NHS Scotland. Indication under review: in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35kg) infected with human immunodeficiency virus type 1. For adult patients in whom emtricitabine/tenofovir is an appropriate combination, Descovy (emtricitabine/tenofovir alafenamide) offers an alternative to Truvada (emtricitabine/tenofovir disoproxil) at no additional cost, and may also be used in patients from 12 years of age Included on the Additional List, Specialist Use only, for the indication in question. 6.3 rilpivirine hydrochloride (Edurant ) rilpivirine 25mg film-coated tablet (Edurant ) SMC No. (1168/16) rilpivirine (Edurant ) is accepted for use within NHS Scotland. Indication under review: in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients aged 12 to 18 years of age and older with a viral load (VL) 100,000 HIV-1 RNA copies/ml. The Scottish Medicines Consortium has previously accepted rilpivirine in this indication in adult patients Included on the Additional List, Specialist Use only, for the indication in question. 7. Non-submissions to Formulary Committee (90-day target) 7.1 brivaracetam (Briviact ) SMC No. 1160/ Not included on the LJF, because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine. 7.2 crizotinib (Xalkori ) SMC No. 1152/ It was noted that the clinical team are preparing a FAF1 submission Not included on the LJF, pending protocol. 7.3 nivolumab (Opdivo ) SMC No. 1144/ It was noted that the clinical team are preparing a FAF1 submission Not included on the LJF, pending protocol. Page 6 of 10

7 7.4 secukinumab (Cosentyx ) SMC No. 1159/ It was noted that the clinical team are preparing a FAF1 submission Not included on the LJF, pending protocol. 7.5 vortioxetine (Brintellix ) SMC No. 1158/ It was noted that the clinical team are preparing a FAF1 submission Not included on the LJF, pending protocol. 8. Formulary Additions and Amendments 8.1 Formulary Additions ADULT Section Oral anticoagulants The committee discussed the above formulary section and it was agreed to verify with the Working Group whether the egfr for patients with severe renal impairment is correct and in line with the guidelines. The term creatinine clearance should be replaced by egfr It was also suggested to add a warning box (similar to the one made for the older patients) at the end of the section to highlight key safety messages in treatment of renal patients The committee approved the changes to this section subject to amendments. The LJF website will be updated Section 4.5 Drugs used in the treatment of obesity The committee discussed and approved the changes to this section. The LJF website will be updated Section Mood stabilisers in the treatment of mania The committee discussed and approved the changes to this section. The LJF website will be updated Section Iron-deficiency anaemias The committee discussed and approved the changes to this section. The LJF website will be updated. CHILD Section Iron-deficiency anaemias The committee discussed and approved the changes to this section. The LJF website will be updated. Page 7 of 10

8 8.1.6 Section 10.1 Drugs used in rheumatic diseases The committee discussed the above formulary section and it was agreed to check with the working group if diclofenac e/c tablets are administered to children from 6 months old and if a different formulation is required It was also agreed to make a note under biologic therapies highlighting that these medicines must be initiated, prescribed and monitored by secondary care professionals The committee approved the changes to this section subject to amendments. The LJF website will be updated. 8.2 Formulary amendment request forms Tisseel Ready to Use (RTU) fibrin glue The committee noted the amendment request form to include Tisseel RTU fibrin glue on the Additional List for the ophthalmic surgery involving conjunctiva and cornea as tissue adhesive. This product will replace the Tisseel kit which has been discontinued No declarations of interest were included with the submission It was noted that Tisseel RTU fibrin glue does not require reconstitutionin comparison to the Tisseel kit The committee agreed to Include Tisseel RTU fibrin glue on the Additional List, for Specialist Use only, classified as RED under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian prednisolone 10mg/mL oral solution and prednisolone 5mg tablets The committee noted the amendment request form to add prednisolone 10mg/mL oral solution and prednisolone 5mg tablets on the LJF as a first choice preparation for the steroid responsive inflammatory conditions in children It was noted that this product will replace prednisolone soluble tablets. The new product is more palatable and cost-efficient. Plain 5mg tablets can also be used in older patients No declarations of interest were included with the submission The committee agreed to Include prednisolone 10mg/mL oral solution and prednisolone 5mg tablets on the LJF as a first choice, for Specialist Use only, for the indication in question prednisolone 1mg/mL oral solution and prednisolone 5mg tablets The committee noted the amendment request form to add prednisolone 1mg/mL oral solution and prednisolone 5mg tablets on the LJF as a joint first choice preparation for the acute wheeze in children It was noted that this product will replace prednisolone soluble tablets. The new product is more palatable and cost-efficient. Plain 5mg tablets can also be used in older patients No declarations of interest were included with the submission The committee agreed to Include prednisolone 1mg/mL oral solution and prednisolone 5mg tablets on the LJF as a first choice, for Specialist Use only, for the indication in question. Page 8 of 10

9 8.2.4 hypertonic sodium chloride 7% (Resp-Ease TM ) The committee noted the amendment request form to add hypertonic sodium chloride 7% (Resp-Ease TM ) nebuliser solution on the LJF as a first choice for mobilise lower respiratory tract secretions in mucous consolidation It was noted that this product will replace Nebusal hypertonic saline 7% nebuliser solution Two declarations of interest were included with the submission and noted by the committee The committee agreed to Include hypertonic sodium chloride 7% (Resp-Ease TM ) on the LJF as a first choice drug, Specialist initiation, for the indication in question 9. NICE/SIGN/NHS QIS Clinical Guidance None to note. 10. Drug Safety Issues MHRA Advice 10.1 MHRA Drug Safety Update, Volume 9, Issue 12, July The committee noted the drug safety update The suspected drug interactions associated with the use of citalopram and cocaine were noted by the committee and it was agreed to highlight this to the Substance Misuse Directorate Team MHRA Drug Safety Update, Volume 10, Issue 1, August The committee noted the drug safety update. 11. For Information Only 11.1 Formulary Committee Reports and Letters The committee noted the following Formulary Committee reports and letters: adapalene / benzoyl peroxide (EpiDuo ) panobinostat (Farydak ) secukinumab (Cosentyx ) elvitegravir, cobicistat, embracitabine, tenofovir alafenamide (Genvoya ) eribulin (Halaven ) everolimus (Afinitor ) netupitant / palonosetron (Akynzeo ) Forceval adalimumab (Humira ) co-careldopa (Duodopa ) febuxostat (Adenuric ) methotrexate (Zlatal ) fluorescein (Anatera ) tobramycin (Tymbrineb ) Page 9 of 10

10 12. Feedback from the ADTC regarding funding for primary care medicines 12.1 It was noted that the ADTC discussed the letter received from the Formulary Committee at the meeting on 5 th August 2016 and agreed to escalate the concerns to the Healthcare Governance Committee and other groups for information and action. 13. AOCB None to note. 14. Date of Next Meeting Wednesday 5 th October 2016, 2.00pm, Room 004, Ground Floor, Pentland House (Please note submission date for papers is Tuesday 20 th September 2016). Apologies are to be sent to Committee Administrator prior to the submission deadline. Apologies: MC, SHo Page 10 of 10