FORMULARY UPDATES ABUHB s Drug Formulary is at:

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1 ANEURIN BEVAN UNIVERSITY HEALTH BOARD MEDICINES & THERAPEUTICS COMMITTEE PRESCRIBING enewsletter 28 September 2016 ARCHIVE at: Dear Gwent Prescriber In the first section of this prescribing newsletter (pages 1 to 4) there is a selection of the Formulary decisions made by ABUHB s Medicines & Therapeutics Committee during the course of its last two meetings (9 th June and 29 th July 2016). For OTHER PRESCRIBING NEWS (e.g. shared care, Traffic Light classification, safety advice and local guidelines) go to pages 4 to 6. FORMULARY UPDATES ABUHB s Drug Formulary is at: Formulary section IVERMECTIN (Soolantra ) cream for papulopustular rosacea ADDED in accordance with AWMSG Advice No This recommends ivermectin 10mg/g cream as an option for the topical treatment of inflammatory lesions of rosacea (papulopustular) in adult patients. Soolantra is considered suitable for initiation by all prescribers (i.e. Green in the local Traffic Light classification). Full prescribing information on Soolantra is at: NEW LOCAL GUIDELINES (1 page) ON THE MANAGEMENT OF ROSACEA IN PRIMARY CARE ARE AVAILABLE AT: ABUHBmanagementGuidelinesFINAL.pdf Formulary section FEXOFENADINE (e.g. Telfast ) for seasonal allergic rhinitis (120mg) & chronic urticaria (180mg) ADDED following a local appraisal. Formulary inclusion applies to both licensed indications. It was agreed to advise that fexofenadine is appropriate for prescribing by all prescribers in Gwent (i.e. Green in the local Traffic Light classification). 1. Acquisition costs (September 2016 Drug Tariff) for, although higher than cetirizine and loratadine, are low at 1.95 for 30 fexofenadine 120mg tablets and 3.13 for 30 fexofenadine 180mg tablets. 2. ABUHB Dermatology support the inclusion of fexofenadine in ABUHB s Formulary particularly for those finding cetirizine unacceptably sedating. Fexofenadine is included as an option in all other Welsh Health Board Formularies. 3. The 2015 BSACI guidelines for the management of chronic urticaria (at: urticaria and angioedema) include a recommendation to consider higher dose of H1 antihistamine up to four times recommended dose or add in second antihistamine in the stepped management plan. The MTC have reminded specialists in Dermatology that when initiating antihistamines at off label doses GMC professional guidance should be followed and informed consent should be obtained and documented. 4. The local Hay Fever Prescribing Guidelines will be updated to include advice on fexofenadine for the 2017 season. Full prescribing information on fexofenadine is at: Page 1 of 6

2 Formulary section PRUCALOPRIDE (Resolor ) 1mg & 2mg tablets for constipation in MEN AWMSG Advice No 0816 now recommends prucalopride as an option for the treatment of chronic constipation in men prucalopride is already included in ABUHB s Formulary for treating chronic constipation in women (in accordance with advice in NICE TA211). The NICE conditions for use remain prucaloride should only be considered an option where treatment with at least TWO laxatives from different classes, at the highest tolerated recommended doses for AT LEAST 6 MONTHS, had failed to provide adequate relief and invasive treatment for constipation was being considered. Consistent with previous discussions around the experience of GPs in treating chronic constipation, it was agreed to advise that prucalopride was appropriate for initiation in men by all prescribers (i.e. Green in the local Traffic Light classification). Full prescribing information on prucalopride is at: Formulary section FOSFOMYCIN 3g granules (Monuril ) for uncomplicated UTIs NOW AVAILABLE AS THE LICENSED PRODUCT In the previous edition of the MTC s enewsletter (May 2016) it was advised that fosfomycin tromental was not available commercially as a licensed product in the UK. This is no longer the case. The company have advised the NHS Business Services Authority of this and this should lead to it being listed on GP practice clinical systems at some point in the near future. The cost is now significantly less than previously advised and is 4.86 a 3g sachet. Key prescribing point: Fosfomycin granules should be prescribed only on advice from local microbiologists it is designated Amber in the local Traffic Light classification. As fosfomycin is not routinely tested against MSU/ CSU samples, primary care prescribers can assume a course can be initiated if they get a sensitivity report for it i.e. a telephone call from a microbiologist is not a requirement. Full prescribing information on Monuril is at: Formulary section DULAGLUTIDE ( Trulicity ) 0.75 & 1.5mg injection for type 2 diabetes ADDED in accordance with AWMSG Advice No This recommends dulaglutide as an option for restricted use in the following subpopulation/circumstances within its licensed indication for the treatment of type 2 diabetes in adults: After failure, intolerance or where there is a contraindication to, standard triple therapy (metformin and two other antidiabetic medicines) as an alternative to insulin therapy. In combination with other glucose lowering drugs but not including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control, in line with current NICE guidance. MTC advice is that dulaglutide is appropriate only for initiation within a consultant led team (i.e. Amber in the local Traffic Light classification) or by accredited GPs with a special interest in diabetes including GPs based in practices that have a relevant accreditation to provide an advanced diabetic service. Diabetic Specialist Nurses with a Non medical Prescribing qualification may also initiate GLP 1 agonists. Amber is consistent with previous advice for GLP 1 agonists. The local Treatment Options for Glucose Control in Patients with Type 2 Diabetes will be updated to set out the place of dulaglutide (compared to other GLP 1s) in the pathway. Full prescribing information on dulaglutide is at: Page 2 of 6

3 Formulary section IBANDRONIC ACID 150mg tablets (e.g. Bonviva ) ALENDRONIC ACID 70mg EFFERVESCENT tablets (BINOSTO ) ADDED (both) as options for treating osteoporosis in postmenopausal women following a local appraisal. MTC s advice is that ibandronic acid is considered appropriate for prescribing by all prescribers in Gwent (i.e. Green in the local Traffic Light classification) but that effervescent Binosto should only be initiated on the recommendation of a specialist (Amber). Important considerations in this decision (Bonviva had last failed to gain local approval in 2009) were: 1. Ibandronic acid s less frequent monthly administration (compared to weekly alendronic acid / residronate) was considered an improvement in patient acceptability terms, especially for those experiencing adverse effects related to administration. Ibandronic acid is now an additional option to consider in advance of parenterally administered options (zoledronic acid 5mg or denosumab 60mg) or strontium ranelate. SEE NEW LOCAL PATHWAY. 2. The low acquisition cost of ibandronic acid ( 1.13 per month). It should be noted that the effect of ibandronic acid on the risk of hip fracture is unclear because hip fracture was not a separately reported outcome in trials of this agent. content/351/bmj.h3783 The MTC also accepted that access to Binosto would allow a group of patients with difficulties swallowing standard weekly alendronic acid tablets an additional option in advance of parenterally administered options although swallowing difficulties affecting adherence to bisphosphonate therapy would first present to health professionals in Primary Care, the MTC agreed to advise that effervescent Binosto should be designated Amber in consideration of the significant acquisition cost of Binosto (more than the annual cost of zolendronic acid 5mg [Aclasta ]), compared to generic alendronic acid 70mg. It should be noted that there are still complexities in administering Binosto and that there is no evidence of superior gastrointestinal tolerability over the plain alendronic acid 70mg tablets. Full prescribing information on ibandronic acid is at: Full prescribing information on Binosto is at: A NEW LOCAL PATHWAY ON THE MANAGEMENT OF OSTEOPOROSIS (2 pages) IS AVAILABLE AT: Page 2 of the pathway includes the all Wales pathway for reviewing bisphosphonate therapy plus the latest advice on this from NICE (NG56). Formulary section 2.12 ALIROCUMAB ( Praluent ) pen & EVOLOCUMAB ( Repatha ) pen and PFS ADDED (both) as options for treating primary hypercholesterolaemia or mixed dyslipidaemia, in accordance with their respective NICE TA recommendations (TA393 and TA394). Following consultation with ABUHB s specialist lipidologist MTC advice is that alirocumab and evolocumab should until further notice be most appropriately prescribed and monitored by specialists within secondary care (i.e. designated Red in the local Traffic Light classification). In NICE s cost effectiveness analyses it is assumed that patients will stay under secondary care (as the proposed simple discount patient access scheme do not apply when drugs are prescribed by GPs using FP10 [or WP10] prescriptions). NICE s conditions for these PCSK9 inhibitors being initiated (and ABUHB Formulary inclusions) are: LDL concentrations are persistently above the thresholds specified (in table 1 on P. 4 of their respective TA guidelines) despite maximal tolerated lipid lowering therapy. That is, either the maximum dose has been reached or further titration is limited by intolerance (as defined in NICE CG71). Alirocumab and evolocumab are respectively provided at the discount agreed in their patient access schemes. The evolocumab dosage used is 140mg every 2 weeks (and not 420mg once monthly). Page 3 of 6

4 Formulary section SACUBITRIL/VALSARTAN ( Entresto ) tablets for symptomatic CHRONIC HEART FAIL URE ADDED in accordance with NICE TA388. This recommends sacubitrl/valsartan as an option for treating symptomatic chronic heart failure with reduced ejection fraction. It was agreed to advise that sacubitril/valsartan should most appropriately be prescribed and monitored by specialists within secondary care (i.e. designated Red in the local Traffic Light classification) and that this advice should be reviewed in 6 months. NICE TA388 advises that use should be restricted to those with NYHA class II to IV symptoms, and to those with a left ventricular ejection fraction of 35% and who are already taking a stable dose of ACE inhibitors or ARBs. It also advises that Treatment with sacubitril valsartan should be started by a heart failure specialist with access to a multidisciplinary heart failure team. Dose titration and monitoring should be performed by the most appropriate team member as defined in NICE's guideline on chronic heart failure in adults: management (NICE CG108 of 2010). In June 2014 the MHRA advised that if combination use of medicines from different classes of renin angiotensin system blocking agents is considered absolutely necessary, it must be carried out under specialist supervision and with close monitoring of blood pressure, renal function, and electrolyte levels (particularly potassium) and to consider monitoring patients on a monthly basis, (and additionally after changing dose and during intercurrent illness). safety update/combination use of medicines from different classes of renin angiotensin system blocking agents risk of hyperkalaemia hypotension and impaired renal function new warnings GUANFACINE ( Intuniv ) prolonged release tablets for ADHD NOT INCLUDED in accordance with AWMSG Advice This advice did NOT recommended guanfacine for the treatment of ADHD in children and adolescents 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. The case for cost effectiveness was not proven. O T H E R P R E S C R I B I N G N E W S SHARED CARE PROTOCOLS (SCPs) Prescribers should note the following changes to Gwent Protocols: 1. SUFASALAZINE in RA UPDATED SCP. The protocol now includes additional detail on use of sufasalazine in pregnancy (in line with the 2016 BSR guidance on use of DMARDs in pregnancy and breastfeeding). The protocol also now includes the revised Secondary Care monitoring arrangements post initiation, as previously agreed for oral methotrexate, and the lower neutrophil level of 1.7 x10 9 /L in the monitoring section. 2. MIDODRINE (Bramox ) in severe orthostatic hypotension SCP UNDER REVIEW All the Gwent Shared Care Protocols can be found at: From Thursday 22nd September 2016, letters to GP practices (and inclusions such a Shared Care Protocols) that are sent electronically will no longer additionally be printed from MedSecs for posting to the 14 GP practices in Gwent (currently piloting the electronic transmission of ABUHB MedSecs letters via the Welsh Clinical Communications Gateway). Page 4 of 6

5 TRAFFIC LIGHT* CHANGE Formulary section ULIPRSTAL (Esmya ) 5mg tablets Now Amber. AWMSG Advice No 0716 now recommends Esmya as an option for intermittent use of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Esmya is already a Formulary option for the pre operative treatment of moderate to severe symptoms of uterine fibroids (in accordance with AWMSG Advice No 1913) Following consultation with ABUHB Obstetrics and Gynaecology [O&G]) it was agreed to revise the local Traffic Light classification of Esmya it is now considered suitable for GP repeat prescribing on specialist recommendation (i.e. Amber). Esmya had previously been classed as a Red drug (the pre operative duration of treatment was limited to 3 months). ABUHB O&G are currently developing a local guideline on the use of Esmya and a patient information sheet with the aim of ensuring patients receiving Esmya via their GPs are aware of the requirement for treatment free intervals and a uterine biopsy after 12 months use. Non specialist prescribers should note that the Esmya SmPC highlights that repeated intermittent treatment has only been studied up to 4 intermittent courses (of up to 3 months each). Full prescribing information on Esmya is at: * Definitions of ABUHB s Traffic Light drug classifications can be found at SAFETY ALERT Minimising the risk of medication errors with high strength, fixed combination and biosimilar insulins This Welsh Patient Safety Alert (PSA0005) was circulated in July 2016 KEY POINTS TO NOTE: prescribe insulin by brand, specifying the product strength and device. The dose of insulin should be expressed as units and, where applicable, as dose steps. provide patients and/or their carers with written and verbal information on the prescribed insulin, strength, use of the device, dose of insulin and monitoring of blood glucose. carefully check the product strength selected in electronic systems The Alert (3 pages) can be accessed at: Acute Kidney Injury (AKI) The MTC discussed whether ABUHB should adopt a more systematic approach to increase uptake of sick day rules guidance by certain groups of patients at increased risk of AKI (e.g. those with CKD, heart failure, or those taking ACE inhibitors/arbs, diuretics, metfomin or NSAIDs). It was agreed that until there is evidence that sick day rules guidance makes a positive difference (and is considered best practice) a wider ABUHB driven uptake should NOT be adopted due to the concerns around potential unintended consequences. The latest version of the Think Kidneys Interim Position statement* (Version 8, November 2015) states that a literature review is at present being undertaken to assess the effectiveness of advice given to patients on the reduction of risk of AKI. The statement also highlights the need to define how any guidance is operationalised. * content/uploads/sites/2/2015/07/think Kidneys Sick Day Guidance v pdf This decision should not deter individual clinicians from providing sick day rules guidance on temporary cessation of medicines to patients deemed at high risk of AKI based on an individual risk assessment. To support health professionals in primary care (over half of incidences of AKI begin in the community) the Committee wish to highlight a new (July 2016) online e learning module for AKI in primary care (at: This accredited module, which takes around 30 minutes to complete, describes which patients are at greater risk of AKI, explains how to identify them, and how to detect AKI and initiate appropriate actions. Page 5 of 6

6 BNF section 2.12 EZETIMIBE UPDATED local guidance The local one page guidance on use of ezetimibe (2013) has now been updated following the publication of NICE TA385 (at: KEY PRESCRIBING MESSAGES FOR EZETIMIBE: Ezetimibe monotherapy is an option for treating primary hypercholesterolaemia in adults: In whom statins are contraindicated* Who cannot tolerate statins. Statin intolerance defined as clinically significant adverse effects that represent an unacceptable risk to the patient or that may reduce compliance with therapy. For those at high risk of CVD NICE CG181 advises try three different statins first. Ezetimibe in combination with a Statin is an option for treating primary hypercholesterolaemia in adults when: Serum total or LDL cholesterol is not appropriately controlled (based on individual risk assessment according to NICE CG181 on managing CVD in the relevant populations) or because dose titration is limited by intolerance to the initial statin therapy A change from initial statin therapy to an alternative statin is being considered Ezetimibe should always be prescribed on the basis of lowest acquisition cost** use of the fixeddose combination Inegy (ezitimibe+simvastatin 10mg/20mg, 10mg/40mg, or 10mg/80mg) is not recommended in ABUHB. USE OF EZETIMIBE FOR THE RECENTLY EXTENDED INDICATION OF REDUCING RISK OF CARDIOVAS CULAR EVENTS (in patients with CHD and a history of ACS when added to ongoing statin therapy or initiated concomitantly with a statin), OUTSIDE OF A DIAGNOSIS OF PRIMARY HYPERCHOLESTEROL AEMIA, HAS NOT YET BEEN APPRAISED BY AWMSG AND IS NOT A USE COVERED BY ABUHB S FOR MULARY EZETIMIBE SHOULD NOT BE PRESCIBED ROUTEINLY FOR THIS INDICATION. ** Acquisition cost of 28 tablets ezetimibe 10mg (Drug Tariff July 2016) Ezetrol patent expiry due October 2017, Inegy patent expiry due April See full guidance document (1 page) at: ABUHBguidelineFINAL%5BSept2016%5D.pdf MANAGEMENT OF DRY EYE NEW local guidelines A reminder, as these were circulated to practices via on 14 th July. There are 2 version (both available on the MTC s website on Guidelines/Resources page, row ): 1. Full guidance (2 sides) at: 2. Treatment algorithm (1 side, best printed on A3 size paper designed to be displayed on a consulting room wall) at: ABUHBmanagementGuideONEpageFINAL%5BMay2016%5D.pdf Prescribers are requested to prescribe in line with these guidelines. In addition the guidance has been circulated to Gwent optometrists with the reminder that if they recommend products that are NOT included in the Guidelines (i.e. not on the ABUHB Formulary aneurinbevanhb.inform.wales.nhs.uk/) or start treatment with a second line preparation before trying a first line preparation, patients who approach their GPs for NHS prescriptions are likely to be disappointed. Ikervis (ciclosporin 0.1%) drops (Amber) should not be recommended by optometrists for GPs to prescribe. Feedback on any item in this enewsletter is welcome. Suggested agenda items for the MTC are also welcome. Trevor Batt Pharmacist & Professional Secretary to: Aneurin Bevan HB Medicines & Therapeutics Committee Aneurin Bevan Health Board Based at Victoria House, Corporation Rd, Newport NP19 0BH trevor.batt@wales.nhs.uk Tel: (DIRECT LINE) Web: Page 6 of 6