Notes from the Area Prescribing Committee Meeting held on Friday 17 th June 2016 Room 1, Education Centre, E level, Queen Alexandra Hospital

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1 NHS Portsmouth CCG South Eastern Hampshire CCG Fareham and Gosport CCG Portsmouth Hospitals NHS Trust Southern Health NHS Foundation Trust Solent NHS Trust Notes from the Area Prescribing Committee Meeting held on Friday 17 th June 2016 Room 1, Education Centre, E level, Queen Alexandra Hospital Present: Dr Alastair Bateman (chair), Janet Brember (secretary), Katie Hovenden, Dr Michael Stewart, Amanda Cooper, Dr Keith Barnard, Paul Bennett, Sarah Nolan, Simon Cooper, Dr Matthew Puliyel, Jon Durand, Jason Peett, Vanessa Lawrence Apologies for absence: Luke Groves, Dr Kevin Vernon, Dr Sally Robins, Ewan Maule (Southern Health) Declarations of Interest: AC reported that Chief Pharmacists meetings are held on Bayer premises in Newbury. Apart from providing a room Bayer have no involvement in the meetings. Recorded as a standing declaration DRAFT Notes of last meeting 15 th April 2016: Agreed as an accurate record with the addition of Dr Michael Stewart to the list of attendees Matters arising: Chronic pain guidelines PHT specialist Dr Mike Williams will be consulted before the final draft is presented at the August meeting. Dronedarone SCA MS awaiting feedback from cardiology colleagues. Capimune (ciclosporin) implementation under discussion with dermatologists Formulary Management applications for approval Taptiqom (tafluprost/timolol) eye drops: Taptiqom is a fixed combination of tafluprost and timolol indicated for the reduction of intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to topical monotherapy with beta-blockers or prostaglandin analogues and who would benefit from preservative-free eye drops. Use of combination drops is expected to improve adherence when patients require treatment with more than one agent to control IOP. There are currently limited options for providing combination treatment for people with sensitivity to preservatives. APC decision: Taptiqom eye drops were approved for addition to the formulary for prescribing in accordance with the licensed indication. Use of Taptiqom should be restricted to patients who require combination treatment to control IOP and also need a preservative-free formulation. It was recognised that use of combination eye drops has a practical benefit for patients and that the cost of Taptiqom is lower than other options for providing a prostaglandin analogue plus beta blocker as preservative-free drops. Financial impact: None anticipated Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction (TA 388): Dr Paul Kalra and Dr Paul Haydock attended to discuss this item and summarised the current management of chronic heart failure, the mechanism of action of sacubitril valsartan and the results of the pivotal PARADIGM-HF trail comparing sacubitril valsartan with enalapril in combination with standard care. NICE TA 388 recommends sacubitril valsartan as an option for treating symptomatic chronic heart failure with reduced ejection fraction in people with NYHA class II to IV symptoms and left ventricular ejection fraction of 35% or less. Patients must be taking a stable dose of ACE inhibitor or ARBs before sacubitril valsartan is considered. Three documents were submitted for review. A Screening/Eligibility Checklist with Initiation and Uptitrating Recommendations is intended for use within cardiology and will be filed in patients notes. It will be used to confirm that the 1

2 patient meets the NICE criteria and gives advice on baseline monitoring, stopping existing ACEI or ARB and dose titration. This form can also be used to collect information for audit purposes. A second document describes the pathway for treating CHF with reduced ejection fraction and gives general guidance on prescribing. A draft shared care document was also discussed. There were some questions regarding the numbers of patients to be initiated on sacubitril valsartan and the specialists explained that they are likely to start treatment in patients already being seen in clinic or people referred in or admitted due to poor control of symptoms. It is important to ensure that patients current treatment is optimised and to check that they are adhering to a standard regimen before sacubitril valsartan is considered. Concern was expressed about limited evidence for use in older patients over 75. This is typical due to populations selected for trials and confirms the need to collect data from usual clinical practice. APC decision: Sacubitril valsartan tablets will be added to the formulary for treating symptomatic chronic heart failure with reduced ejection fraction in line with the criteria in NICE TA 388. Treatment should only be initiated by a consultant cardiologist in a heart failure clinic at present. Prescribing may be continued in primary care once titration to a stable maintenance dose has been achieved under the supervision of a cardiologist. The shared care guideline requires some modifications for local use. Dr Kalra agreed to send the final version to AB and JB for review prior to publication. A quick reference guide for GPs was also requested to include important points relevant for clinic referral, prescribing in primary care and whether to stop or continue existing drugs. Consideration should be given to providing information to community pharmacists to facilitate appropriate support and counselling for patients. Financial impact: Treatment with sacubitril valsartan is estimated to cost around 1,200 per person per year. Sacubitril valsartan is commissioned by CCGs and providers are NHS hospital trusts and GPs in primary care. There are no additional tests or investigations needed for sacubitril valsartan compared with existing therapies. NICE estimate the resource impact will be 23,000 in rising to 127,000 in per 100,000 population. There are expected to be some cost-savings from reduced hospital admissions Brivaracetam for epilepsy: Dr Sean Slaght, consultant neurologist has made an application to include brivaracetam on the formulary. Brivaracetam is licensed for 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. As Dr Slaght provides a service across both UHS and PHT he requested that the application is considered jointly by the DPC and APC. The formulary application, the evaluation carried out for the Medicines Evaluation Committee and the recommendation of the MEC were discussed. The committee expressed concerns about the evidence base the comparative cost and the place of brivaracetam in the management of epilepsy. The evidence suggests that patients who have previously been on levetiracetam are less responsive to therapy but brivaracetam may have a limited role for patients who cannot tolerate levetiracetam. It is likely that brivaracetam will be tried for patients who have exhausted all other available options. APC decision: Due to concerns about the evidence base and place in treatment it was agreed that brivaracetam would not be added to the formulary at present. MS agreed to consider non-formulary requests for individual patients under the care of Dr Slaght. This position will be reviewed after 12 months or earlier if requested by Dr Slaght. Financial impact: Not significant due to small patient numbers. Brivaracetam is similar in cost to other branded anti-epileptics but considerably more expensive than generic levetiracetam Guanfacine for ADHD: Mr Ray Lyon attended to present this item and 2

3 explained that guanfacine is a new non-stimulant drug licensed for the treatment of ADHD in children and adolescents from 6 to 17 years. Addition of guanfacine to the formulary is being requested by Sussex Partnership CAMHS specialists who provide the CAMHS service in South Eastern Hampshire and Fareham and Gosport areas. SN reported that Solent NHS Trust CAMHs clinicians have not considered the place of guanfacine as yet. Guanfacine has a novel mode of action and is similar to clonidine which is occasionally used off-licence if other licensed drugs are not suitable. No studies comparing guanfacine with other ADHD treatments have been published and the proposed place would be where atomoxetine would usually be prescribed (after use of stimulant medications) or where unlicensed clonidine is being considered to treat ADHD symptoms. Guanfacine has a faster onset of action than atomoxetine but there are practical disadvantages such as the need to retitrate if more than two doses are missed and the need for gradual withdrawal. Guanfacine is not suitable for use in combination with other ADHD drugs. APC decision: It was agreed that prescribing of guanfacine should be restricted to CAMHs consultants only for a period of 12 months. This will allow specialists to gain experience and to collect data for audit. Guanfacine will not be included in shared care arrangements at present but suitability for shared care will also be reviewed after 12 months. Financial impact: Not significant due to small patient numbers likely to be eligible for treatment and because guanfacine may be used in place of atomoxetine at similar cost Drug therapy and shared care guidance for approval Rotigotine patches for Parkinson s disease shared care agreement: This shared care agreement has been reviewed as it was out of date and minor updates have been made. The risk of precipitating neuroleptic malignant syndrome with abrupt discontinuation and the need for gradual withdrawal has been included APC decision: Approved for publication on PHT and primary care websites Riluzole for amylotrophic lateral sclerosis shared care agreement: This shared care agreement has been reviewed as it was out of date and minor updates have been made. The statement Not recommended for use in patients with impaired renal function was questioned. The SPC explains this his is due to lack of information on administration of repeated doses to people with impaired renal function but no further information is given. APC decision: Approved for publication on PHT and primary care websites Melatonin for sleep disorders in children shared care agreement: SN explained that this shared care guidance has been developed in consultation with CAMHS providers in Hampshire and the main objective is to support ongoing prescription of the recommended cost-effective products. Treatment needs to be kept under review and only continued while there is evidence of benefit. There are no melatonin products licensed for children but Circadin tablets are considered first-line (off-licence) with specified unlicensed products as second and third-line alternatives. Repatriation of melatonin prescribing to CAMHS clinics with direct supply to patients will be discussed outside this meeting. APC decision: Approved for publication on local websites. Contact details for the relevant specialists and clinics need to be added Licensed ADHD Medications for the Treatment of Childhood ADHD shared care agreement review (Sussex Partnership): The shared care agreement has been reviewed as it was out-of-date. Information on guanfacine was included but this will be removed as it has been agreed that guanfacine will only be prescribed by CAMHS specialists for a period of 12 months. APC decision: Approved for publication subject to removal of information on guanfacine as this drug is not considered suitable for shared care at present. 3

4 Guanfacine prescribing guidance: The prescribing guidance and associated audit data collection form was noted. The intention is that all patients to be prescribed guanfacine will be recorded on a Trust database and follow-up audit will be completed to assess level of use and effectiveness. Solent NHS Trust requested access to the audit data when available Nebulised Antibiotics (Gentamicin and Colomycin) for Non-CF Bronchectasis shared care agreement: Dr Ben Green and Adel Sheikh attended to present this shared care guidance that has been developed in response to queries from primary care about taking on prescribing responsibility. The aim of the guidance is to provide information and clarify the roles of the specialist and GP. There are practical benefits for patients in obtaining ongoing supplies of the antibiotics from their GP as they only require clinic review every 6 months. Test doses, training in administration and supply of the nebuliser and consumables are the responsibility of the respiratory clinic. Ongoing monitoring of lung function and toxicity, including ototoxicity, is also carried out by the clinic. Gentamicin levels are not measured and Dr Ben Green confirmed that systemic adverse effects have not been observed to date. GPs are requested to prescribe the antibiotics after the first 28 days (offlicence use) and saline or water for injections as required. GPs should also report any changes in renal function to the specialist. Prescriptions should specify that the injectable antibiotics are for administration via nebuliser and wording to this effect should be included in the SCA. APC decision: Approved for publication subject to the above. A patient information sheet should be considered Shared Care Guidelines for Prescribing and Monitoring of Lithium Solent): These updated guidelines clarify that not all patients are seen by the lithium clinic and there are different arrangements for prescribing and monitoring. A few minor changes were requested including removal of reference to QOF adherence, clarifying that the national lithium booklet is provided to patients and that transfer of prescribing to primary care is conditional upon the GP agreeing to a request to take over prescribing responsibility. APC decision: Approved for publication subject to agreed minor changes and formatting Items for note/consultation NICE Guidance Guidance published in April 2016: TA387 Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated: Abiraterone ( with steroid) is recommended as an option for treating metastatic hormone-relapsed prostate cancer in people who have no or mild symptoms after androgen deprivation therapy has failed, and before chemotherapy is indicated. PAS scheme applies where the company rebates the drug cost of abiraterone from the 11th month until the end of treatment. NHSE commissioned high cost drug. Action: The formulary entry for abiraterone will be updated with reference to TA 387. TA388 Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction see above. TA389 Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer: Paclitaxel in combination with platinum or as monotherapy is recommended as an option for treating recurrent ovarian cancer. Pegylated liposomal doxorubicin hydrochloride (PLDH) as monotherapy and in combination with platinum is also recommended as an option. Gemcitabine, trabectedin and topotecan are not recommended. NHSE commissioned (chemotherapy). Action: Formulary entries will be updated with reference to TA 389 and references to TA 91 and TA 222 deleted. NG46 Controlled drugs: safe use and management: This guideline covers 4

5 systems and processes for using and managing controlled drugs safely in all NHS settings except care homes. It aims to improve working practices to comply with legislation and have robust governance arrangements. It also aims to reduce the safety risks associated with controlled drugs. Action: For review by all organisations. Guidance published in May 2016 TA 391 Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel: NICE did not recommend cabazitaxel for this indication in Since then, additional evidence has been published and the company has agreed a new patient access scheme. Cabazitaxel (with steroid) is now recommended as an option for treating metastatic hormone-relapsed prostate cancer in accordance with specific criteria. The guidance also states that NHS trusts should purchase cabazitaxel in pre-prepared intravenous infusion bags. NHSE commissioned, previously CDF. PAS discount applies. Action: Cabazitaxel for infusion will be added to the formulary for prescribing in line with TA 391. TA 390 Canagliflozin, dapagliflozin and empagliflozin as monotherapies for treating type 2 diabetes: Canagliflozin, dapagliflozin and empagliflozin as monotherapies are recommended as options for treating type 2 diabetes in adults for whom metformin is contraindicated or not tolerated if DPP-4 inhibitor would otherwise be prescribed and a sulfonylurea or pioglitazone is not appropriate. NICE state that the cost impact of this is not likely to be significant because the cost of the SGLT-2 inhibitors is similar to the glitpins that may otherwise be prescribed. NB this option is not included in NG28. Action: Formulary entries to be updated with reference to TA 390. CG 152 Crohn's disease: management (update): New recommendation added on induction of remission with adalimumab or infliximab. When a person with Crohn's disease is starting infliximab or adalimumab discuss options of monotherapy with one of these drugs or combined therapy (infliximab or adalimumab with an immunosuppressant) and explain that there is uncertainty about the comparative effectiveness and long-term adverse effects of monotherapy and combined therapy. Action: for noting TA 217 Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease (update): In line with an updated recommendation in CG 42, drug treatment may be initiated by healthcare professionals such as GPs, nurse consultants and advanced nurse practitioners with specialist expertise in diagnosing and treating Alzheimer's disease and well as secondary care specialists. Action: for noting Alirocumab and evolocumab: A summary of the NICE FAD recommendations, a comparison of product features and available supply routes was discussed in preparation for implementation of final NICE guidance due to be published next week. There is little to distinguish the products clinically, from a patient perspective or on cost grounds. The NICE criteria for initiation are the same for both drugs. Alirocumab will only be available via hospital pharmacies or homecare and with evolocumab there is also the option of supply on GP prescription via community pharmacies. It was agreed that both products should be supplied via homecare initially with the option to review when the drugs are established in practice. Data collection for audit purposes was thought to be important and restricting prescribing to secondary care should facilitate this. Both companies provide nurse-led patient support services and educational materials NHS England Commissioning policies: SSC1620 Primary Care Responsibilities in Prescribing and Monitoring Hormone Therapy for Transgender and Non-Binary Adults (updated) reiterates the advice in a previous SSC (No issued March 2014) that GPs should co-operate with the specialist Gender Identity Clinics and prescribe hormone therapy 5

6 (feminising or virilising endocrine therapy) recommended for their patients by the Gender Identity Clinic. The SSC was noted DPC update (April 2016): It was noted that the DPC did not support the use of fentanyl iontophoretic transdermal system (Ionsys ) on the grounds that it offers no real benefit over current options at greater cost. Following an evaluation of the latest evidence the DPC agreed that nortriptyline should no longer be recommended as an alternative to amitriptyline for neuropathic pain. If an alternative is required then imipramine should be considered based on evidence and cost. This recommendation will be taken into account in the current review of local chronic pain guidelines AHSN APC Monthly update: These newsletters summarise published and imminent NICE guidance, new medicines safety information from the MHRA and EMA, new medicines on the market and licensing changes (positive opinions, licence extensions etc.). These will be included on the agenda in future to inform committee members of recent developments, as a replacement for locally produced summaries Hampshire Medicines Safety Group: The notes of the meeting held on 23 rd May were reviewed. SC confirmed that that the community palliative care charts are now available as templates within GP systems. Medicines management teams are supporting work in GP practices to include drugs that are prescribed in secondary care on patient prescribing records. UHS are piloting administration of warfarin at 2pm instead of 6pm. There was concern about the impact when patients are transferred e.g. to Solent units or PHT where warfarin is still given at 6pm. There is risk that patients may get two doses and that the timing of blood tests will be affected. SN agreed to discuss these concerns with UHS Establishing Regional Medicines Optimisation Committees: NHS England held a workshop on 20th April 2016 to begin the process of agreeing the principles which will form the foundations of the committees. A report from this workshop was published in May (gateway ref ) that will form the basis of the next phase of consultation on the establishment of the committees. The report was noted, no further information is available at present Diabetes sub-group: The minutes from the meeting held on 25 th May 2016 were reviewed. JB attended this meeting to maintain links with the APC but PHT specialists have decided that they no longer wish to participate. There are still concerns about the introduction of concentrated insulin products in some areas due to the risk of incorrect administration in hospital inpatients. A small increase in amputations, mostly of the toe, has been observed in a large ongoing cardiovascular outcomes study of canagliflozin (CANVAS). The FDA has issued a Drug Safety Communication and the EMA has begun a review. It was agreed that no local action was required until the outcome of the EMA review is available. Provision of patient information to support appropriate blood glucose testing in line with current NICE recommendations (particularly for type 2 diabetics) was discussed and options will be reviewed at the next meeting. Local recommendations on choice of GLP-I are being developed but were not available at the meeting. The recent price reduction for Tresiba (insulin degludec) was discussed and it was agreed that the formulary classification should remain as amber (specialist initiation or recommendation required). An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease and warnings have been added to drug labels in the US. It was agreed that planned switches to alogliptin should not be progressed but no other action is required at present Any other business: none SN Dates of future meetings: 6

7 Dates for 2016: Friday 19 th August 2016 Friday 21 st October 2016 Friday 16 th December 2016 Dates for 2017 will be confirmed in August. 7

Notes from the Area Prescribing Committee Meeting held on Friday 17 th February 2017 Room 5, Education Centre, E level, Queen Alexandra Hospital

NHS Portsmouth CCG South Eastern Hampshire CCG Fareham and Gosport CCG Portsmouth Hospitals NHS Trust Southern Health NHS Foundation Trust Solent NHS Trust Notes from the Area Prescribing Committee Meeting