MINUTES MEETING OF THE BORDERS FORMULARY COMMITTEE HELD ON WEDNESDAY, P.M. IN THE ESTATES MEETING ROOM

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MINUTES MEETING OF THE BORDERS FORMULARY COMMITTEE HELD ON WEDNESDAY, 11/06/2014 @ 12.30 P.M. IN THE ESTATES MEETING ROOM Attendees: Alan Brown (minutes), Liz Leitch, Alison Wilson, Paul Neary, Ros Anderson, Adrian Mackenzie, Craig Wheelans.

1 MINUTES MEETING OF THE BORDERS FORMULARY COMMITTEE HELD ON WEDNESDAY, P.M. IN THE ESTATES MEETING ROOM Attendees: Alan Brown (minutes), Liz Leitch, Alison Wilson, Paul Neary, Ros Anderson, Adrian Mackenzie, Craig Wheelans. Observing: Adam Smith 1. Apologies: Catherine Scott, Item No. Situation Background Assessment Recommendation Person Responsible 2. Declaration of Interest: - None 3. Minute of BFC meeting Minute from last BFC meeting. Read and noted for accuracy. Minutes from last Minute of meeting was agenda taker from last meeting Alan to round Timescale Within 24 hours 4. Matters Arising From Previous Minute: Thiotepa Eye drops 5. New Medicine Applications: Denosumab Osteoporotic fractures, needs bone protecting medication (off label use in male patient with poor renal function) Generic Name: Denosumab. Brand Name: Prolia. Formulation Strength: 60mg. Manufacturer: Amgen. To be removed from agenda. discussed with ophthalmologists Noted and approved as CAT B. AW will speak with KG AW complete 1

2 Nicotine Strips Ensure Compact - Cost effective alternative to current formulary choice. Botulinum Toxin A - Off label for anal fissure It is indicated to aid smokers wanting to quit. Generic Name: Ensure Compact. Brand Name: Ensure Compact. Formulation Strength: 300kcal (125ml) bottles. Dosage: 300kcal, 13g protein per 125ml. Cost per month: per month based on 125mls daily for 30 days Generic Name: Botulinum Toxing A. Brand Name: Xeomin. Cost per month: 30 per month. Number of patients in first year: off label use for 1 male patient. Generic Name: Nicotine Strips. Brand Name: NiQuitin. Cost per month: per month. Number of patients in first year: 100 hard to estimate. All products have been on our formulary, difficult to stop as it goes through community pharmacy. Provides quick release of cravings and alternative product is unavailable at the moment. No economic argument though could approve for max 3 months use only. To replace product from another manufacturer and we will get higher rebate. Continuing to monitor the prescribing. Committee given overview. Lasts 3 months to allow healing and healing rate 80% Not recommended Reflect on all products and review everything that is on the formulary. To review the whole products in terms of cost efficiency. Information will need to go to community pharmacy on NHS Borders recommended products. Recommendation Cat A Approved but we will need clarification AW 2

3 True you mini testing strips - Cost effective alternative to current formulary choice. Deferasirox - For treatment of chronic overload associated with the treatment of rare acquired or inherited anaemias requiring recurrent blood transfusions. Formulation Strength: 50 unit vial. Dosage: 50 units injected directly into the internal anal sphincter. Cost per month: 72 (cheapest preparation available). small number of patients at least 10. Generic Name: True you mini. Brand Name: True you mini. Formulation Strength: N/A. Dosage: as per NHS Borders blood glucose monitoring policy. Cost per month: Pot of 50 strips TBC Generic Name: Deferasirox. Brand Name: Exjade Formulation Strength: 125, 250, 500mg dispersible tablets. Dosage: The usual recommended initial daily dose is 20mg/kg body weight. The maintenance dose should be tailored to the individual patient s response and therapeutic goals Cost per month: Dose is weight related cost of 10mg/kg for 50kg adult would be /month. fewer than 5 patients in the first Training and risks were questioned and discussed. It was suggested that Botox may be a better option. Committee given overview of these strips. Cost effective. Discussed promoting this in primary care which might have to be done opportunistically Committee given overview of application, this product is SMC approved. Effective oral alternative. will speak with Mr Pal about duration of treatment with diltiazem cream and confirm whether there are training issues. Specialist use only off label Recommendation Red Approved as Cat A Plan required for a more cost effective testing. Approved specialist use only cat B to review the application form. AMacK 3

4 year. Methyl-5- aminolevulinate - Agent used in Photodynamic therapy Ibuprofen Gel 5% - Topical NSAID Sofosbuvir - Treatment of chronic hepatitis C Generic Name: Methyl-5- aminolevulinate. Brand Name: Metvix. Formulation Strength: 16% cream Dosage: 2 gram tube covers an area of 20m 2, can be used for several patients. Cost per month: 1 tube (2gram) patients. Generic Name: Ibuprofen. Brand Name: N/A. Formulation Strength: 5%. Dosage: Apply up to 3 times daily. Cost per month: 30g = 1.28, 50g = 2.11, 100g = Unable to estimate. Generic Name: Sofosbuvir. Brand Name: Sovaldi. Formulation Strength: 400mg Cost per course: 37,400 74,801 Up to 6. Committee given overview, SMC approval from This may be part of the repatriation programme from Lothian. Cost effective option for the formulary. Overall safer and lower dose. Concerns expressed with use in older people High treatment success rate in combination with other products. First in class and recently approved by SMC. Approved specialist use only Cat B Not approved Approved specialist use only. Need to go to BET as individual cost per patient over 25k. RA AW 6. SCOTTISH MEDICINE CONSORTIUM RECOMMENDATIONS: SMC ACCEPTED MEDICINE Recommended for use within NHS Scotland Embargoed Indication Formulary Decision & Rationale for non-inclusion Date 4

5 canagliflozin (Invokana ) is accepted for restricted use within NHS Scotland. Indication under review: In adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as add-on therapy with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. Not included in formulary local specialist team do not support new medicines application. sofosbuvir (Sovaldi ) is accepted for restricted use within NHS Scotland. Indication under review: in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. Included in NHS Borders formulary fluticasone furoate / vilanterol (Relvar Ellipta ) is accepted for use within NHS Scotland. Indication under review: the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta 2 -agonist and inhaled corticosteroid) is appropriate in patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta 2 -agonists. Awaiting new medicines application from respiratory specialist team. There was no statistically significant difference between fluticasone furoate/vilanterol 92/22 micrograms daily and another inhaled corticosteroid/long acting beta 2 -agonist combination (ICS/LABA) inhaler for 0 to 24 hour serial weighted mean forced expiratory volume in one second, at 24 weeks. Some alternative ICS/LABA combination inhalers are available at a lower daily cost. defibrotide (Defitelio ) is accepted for use within NHS Scotland. Indication under review: Treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. NHS Borders would not expect to use this medicine In a phase III open-label study, defibrotide was associated with improved complete response rate and survival in patients with severe VOD, compared with a historical control group. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of defibrotide. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. 5

6 budesonide gastroresistant granules (Budenofalk ) is accepted for use within NHS Scotland. dolutegravir (Tivicay ) is accepted for use within NHS Scotland. Indication under review: induction of remission in patients with mild to moderate active Crohn s disease affecting the ileum and/or ascending colon. Budesonide gastro-resistant granules provide a once daily alternative to budesonide gastro-resistant 3mg capsules three times daily at no additional cost. The granules may have advantages for patients who have difficulty swallowing. Indication under review: in combination with other antiretroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age. Not included in formulary local specialist team do not support new medicines application Would not be initiated in NHS Borders NHS Borders would support ongoing prescription In phase III clinical studies, dolutegravir has demonstrated non-inferiority or superiority to three comparator antiretroviral medicines in treatmentnaïve adults with HIV, and superiority to an alternative integrase inhibitor in treatment-experienced adults. (All study patients also received two nucleoside reverse-transcriptase inhibitors). This SMC advice takes account of the benefits of a patient access scheme (PAS) that improves the cost-effectiveness of dolutegravir. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC RECOMMENDED MEDICINES FOR RESTRICTED USE Recommended for Restricted use within NHS Scotland Embargoed botulinum toxin type A (BOTOX ) is accepted for restricted use within NHS Scotland. frequency. botulinum toxin type A (Botox ) is not recommended for use within NHS Scotland. Indication under review: The management of bladder dysfunctions in adult patients who are not adequately managed with anticholinergics: overactive bladder with symptoms of urinary incontinence, urgency and Indication under review: focal lower limb spasticity, including the treatment of ankle disability due to lower limb spasticity associated with stroke in adults The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot NHS Borders would not currently expect to use this medicine for this indication Not SMC approved not included in NHS Borders formulary. 06/06/ /06/2014 6

7 dapoxetine hydrochloride (Priligy ) is not recommended for use within NHS Scotland. Is not Recommended for Use within NHS Scotland paclitaxel albumin (Abraxane ) is not recommended for use within NHS Scotland. recommend its use within NHSScotland. Indication under review: treatment of premature ejaculation (PE) in adult men aged 18 to 64 years. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. SMC MEDICINES NOT RECOMMENDED Indication under review: in combination with gemcitabine for the firstline treatment of adult patients with metastatic adenocarcinoma of the pancreas. In a randomised, phase III, open-label study paclitaxel albumin plus gemcitabine treatment improved median overall survival by 1.8 months compared with gemcitabine alone. Not SMC approved not included in NHS Borders formulary. Not approved for use in NHS Borders for this indication. 06/06/2014 pomalidomide (Imnovid ) is not recommended for use within NHS Scotland. The submitting company s justification of the treatment s cost in relation to its benefits was not sufficient to gain acceptance by SMC. Indication under review: in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. Not SMC approved not included in NHS Borders formulary. 06/06/2014 Pomalidomide plus dexamethasone significantly increased progression-free survival compared with high-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The submitting company did not present a sufficiently robust economic analysis and in addition their justification of the treatment s cost in relation to its benefits was not sufficient to gain acceptance by SMC. natalizumab (Tysabri ) is not recommended for use within NHS Scotland. Indication under review: single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) for adult patients aged 18 years and over with high disease activity despite treatment with Not approved for use in NHS Borders for this indication. 7

8 glatiramer acetate. SMC has previously not recommended natalizumab for use in patients with high disease activity despite treatment with beta-interferon. The marketing authorisation has now been extended to include use in patients with high disease activity despite treatment with glatiramer. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland. avanafil (Spedra ) is not recommended for use within NHS Scotland. SMC has previously accepted natalizumab (Tysabri ) for restricted use as a single disease modifying therapy in highly active RRMS in patients with rapidly evolving severe RRMS and this advice remains in place. Indication under review: treatment of erectile dysfunction in adult men. The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. Not approved for use in NHS Borders. The sponsor company plans to make a submission to SMC in November Item No. Situation Background Assessment Recommendation Person Respons ible 7. Borders Joint Formulary Updates: Updates to Borders Joint Formulary For review Approval GP colleagues advice to be sought. Text changes been made and noted. Timescale 8. Changes to CD Legislation for Tramadol and to Tamazepam The home office has announced changes to the legal classification of certain medicines, includingtramadol which will come into affect on the 10 th June Committee discussed. Review the choice of weak opioids in formulary. 8

9 9. Immunoglobulin request form 10. Information for ADTCs Update on PPIs and CDI risk 11 Patient Access Schemes: Defibrotide Certolizumab pegol Dolutegravir To use for non formulary / off label applications for immunoglobulins. PPIs have been identified as a risk factor for CDI but, historically, the evidence has been conflicting. The Scottish Antimicrobial Prescribing Group (SAPG) have prepared a briefing paper detailing the recent evidence from four published meta-analyses and suggested actions to address the issues raised. At SAPG it was agreed that the information should be shared with boards via ADTCs to support review of long term PPI therapy. This paper follows a previous paper on CDI and PPI use prepared by SAPG and shared with ADTCs in Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. Treatment of adult patients with severe active axial spondyloarthritis treatment of HIV infected adults or adolescents above 12 in combination with other antiretrovirals National form Use for prescribing and supply of all immunoglobulins apart from the 2 most frequently used Recommended trial of form to be organised H. This should go to ADTC 12. A.O.C.B. update with formulary document on inter and intranet Liz explained how it is getting along. Alison will speak with Jackie. Noted AW AB 9

10 Mr Tiemessen application missed deadline deferred to ADTC. 13. Next Meeting: 13 th August 2014 at 12:30pm in Estates Meeting Room 10

April May For adults for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion.

April May For adults for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion. April May 2014 Recommended for use within NHS Scotland April May 2014 aflibercept intravitreal (Eylea ) 954/14 For adults for the treatment of visual impairment due to macular oedema secondary to central