Nottinghamshire Joint Formulary Group Meeting Minutes Thursday 9th June 2016, 2-5pm A01, Duncan Macmillan House

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1 Nottinghamshire Joint Formulary Group Meeting Minutes Thursday 9th June 2016, 2-5pm A01, Duncan Macmillan House Present: Esther Gladman (EG) GP Prescribing Lead, Nottingham City CCG (chair); Daniel Shipley (DKS) and Nick Sherwood (NS) Interface/formulary Pharmacists, APC; Felicity Armitage (FA) GP, Local Medical Committee; David Kellock (DK) Consultant, SFHT; Tanya Behrendt (TB) Deputy AD Medicines Management, Notts City CCG; John Lawton (JL) Clinical Pharmacy Services Manager, Nottingham Healthcare NHS Trust; Laura Catt (LC) Prescribing Interface advisor, Nottinghamshire County CCGs; Judith Gregory (JG) Assistant Head of Pharmacy, NUH. Also in attendance: Katie Midwinter (KM) Consultant Rhinologist, NUH; Monito Morgan (MM) ENT Clinical Lead Consultant, NUH Apologies: Nicky Bird (NB), Senior Prescribing and Interface Advisor, Nottinghamshire County CCGs; Debbie Storer (DS) Lead Pharmacist DTC and MI, NUH; Steve May (SM) Chief Pharmacist, SFHT; Steve Haigh (SH) MI Pharmacist, SFHT. Agenda item Notes 1. Apologies Noted (see above). 2. Declarations of N/A. interest 3. Minutes of Approved. previous meeting 4. Matters arising a) Ciclosporin eye drops (NICE TA 369) and action log NS has circulated information to prescribers for comment. No correspondence received as of yet. NS to liaise with NUH ophthalmologists. NS to re-circulate information. b) JFG Chair and meeting schedule Position of JFG chair to continue to rotate. Many JFG members declared they would be absent for the next meeting. LC to propose a new set of possible dates. Chair to be allocated on a rotational basis. c) Abasaglar Abasaglar prescribing has been promoted. Uptake to be monitored through EPACT data. d) Patient representation The representative who came to APC has been consulted with and will continue to attend that meeting. However it was felt that representation at JFG was less appropriate. e) Ullipristal The Heavy Menstrual Bleeding NICE guideline is not due until August. NS has contacted the original submitter to assess an appropriate timescale for proceeding with this submission. Submission to be on hold until NICE guidance is available. 1

2 5. Dymista nasal spray appeal KM and MM kindly attended the JFG meeting to promote the inclusion of Dymista on the formulary. A submission was made to the JFG in June A month later, the APC upheld a recommended traffic light status of GREY. Clinically there were only modest benefits versus monotherapy along with an overall lack of comparative data. MM explained that comparative trials were not of great importance because the main advantage of Dymista is use of a single device thereby promoting compliance in a cohort of patients who have all but exhausted their therapeutic options. KM and MM provided a prescribing pathway for the treatment of rhinitis. The proposed place in therapy of Dymista is in refractory allergic rhinitis patients who have failed on conventional treatment. Dymista is more costly than conventional therapy but less expensive than using two nasal spray devices. KM explained however that separate devices would not routinely be prescribed because the vehicle volume entering the nasal passage is too large. Dymista provides a solution to this problem. Other areas of the country including Doncaster have designated a GREEN traffic light classification for Dymista. KM estimated that she personally sees three people a week in her clinic that would benefit from the preparation, thereby constituting several hundred patients per year in secondary care. The group discussed the appropriateness of GP prescribing ahead of referral and considered the option of AMBER 3 alongside a treatment pathway. Interim classification of RED to be recommended. NS to work with the submitters to refine the treatment pathway provided. NS to liaise with Doncaster to ascertain their rational for classifying the product differently. 6. Primary Care Responsibilities in Prescribing and Monitoring Hormone Therapy for Transgender and Non-Binary Adults 7. Vitamin D for children formulary options The Specialised Services Circular from NHSE was presented. This states that general practitioners need to actively undertake prescribing of hormone therapy in Transgender and Non-Binary Adults who request treatment. TB suggested that separate shared care protocol and GMC links are appropriately added to the formulary. DKS and NS to liaise with TB to update the formulary accordingly. TB/LC to work up a position statement to draw attention to this information. Fultium-D3 liquid and Invita-D3 drops have been recommended for use in the NUH Children Hospital guide for vitamin D deficiency, and the APC s investigation and treatment of vitamin d deficiency in children guidelines which are currently still in draft. Neither product is listed on the Joint Formulary. It was recommended that both products be added to the formulary and that the two guidelines should be amalgamated into one. 8. Denosumab traffic light amendment for Rushcliffe CCG NS to amalgamate the guidelines into one document and take to APC. Prospective classifications to be discussed at meeting. A submission has been received from Rushcliffe CCG to reclassify the traffic light status of denosumab for patients managed by their CCGs Fracture Liaison Service only. The medication is to be used for OA protection in post-menopausal women with a classification of AMBER 2 for a limited number of patients (maximum of 5 patients over 12 months) within Rushcliffe CCG. The group suggested that the Fracture Liaison Service should provide feedback on 2

3 prescribing and outcomes in 12 months. AMBER 2 to be recommended to APC. LC to source feedback from practitioners following change to ascertain effects of change. 9. New applications a) Sacubitril Valsartan (Entresto ) The NICE TA for Sacubitril was discussed at the May APC, where a RED classification was agreed upon with a prospective change to AMBER 2 once its place in therapy could be confirmed. The formulary has since been updated, pending further information from the secondary care clinicians. Cardiology consultants were informed of the APC decision and had suggested a GREEN status so as to allow GPs and specialist nurses to initiate. NICE TA specified that Entresto should be initiated by a specialist and the patient should have on-going access to a specialist team. NS to liaise with cardiology consultants to update the local Heart Failure Guideline. Once in place and safe usage is established, a second submission for an AMBER 2 status can take place. b) Lurasidone (Latuda ) A submission has been received for inclusion of the atypical antipsychotic; lurasidone on the formulary. The medication is for the long-term treatment of nontreatment resistant schizophrenia where patients have not been able to tolerate other antipsychotics, including a trial on aripiprazole or where patients have a preference for this drug. Request for medication to be made available as AMBER 2. JL explained that it shouldn t be used in treatment failure but as an alternative when aripiprazole has caused intolerable side effects. Very few guidelines exist when initiating atypical antipsychotics and selection tends to be based around side effect profile, patient preference and compliance. JL felt addition of lurasidone to the formulary would provide clinicians with another agent to trial. Clinical effectiveness: There is a lack of established use and comparative clinical trials (i.e. no head to head with aripiprazole); however efficacy is considered to be non-inferior to established treatment. 12 people at Wells Road have been prescribed the medication already despite having no classification. 10 patients remain on the therapy and continue to report good results. There have been 2 discontinuations due to side effects. Safety: Non-inferior to established treatment. Cost effectiveness: Markedly more expensive: 28 days' treatment with lurasidone at a dose of mg daily is estimated to be to NICE approved: Evidence summary produced. Affordability: Very small scale use anticipated. Pharmacy led prescribing group at Wells Road would authorise use or not. Significant benefits to patients: Difficult to predict. It does however provide patients with another treatment option. RED classification to be recommended. Usage and efficacy to be monitored and the medication reviewed in 12 months by JL. 3

4 c) Calcium carbonate 250mg dispersible tablets Calcium carbonate 250mg dispersible tablets requested by NUH for use in hyperphosphatemia of chronic kidney disease in paediatric patients unable to swallow/chew tablets. Currently the standard treatment is calcium carbonate 10% solution manufactured under section 10 of the medicines act by NUH, which the submitters wish to switch to second line behind this submission. The submission request the medication is added as AMBER 2. The group discussed ongoing monitoring and the Amber 1 status of the same medication for adults. To be recommended as RED. NS to speak to submitting clinicians to develop a shared care protocol and guidance on how to prescribe the product with a recommendation of an AMBER 1 status. d) Guanfacine (Intuniv ) A submission has been received for guanfacine by an associate specialist in community paediatrics based at NUH; this is currently GREY on the Joint Formulary. The proposed classification is AMBER 1. Proposed place in therapy is where stimulant drugs have failed and as an alternative to the non-stimulant atomoxetine. Clinical effectiveness: Good evidence against placebo. Data indicates a significant reduction in ADHD scores in one study vs atomoxetine, no comparison to stimulants. Safety: Safety data seems incomplete, with lack of evidence difficult to predict full safety profile. Proposed reduced risk of suicidal ideation and anorexia. Cost effectiveness and affordability: Significantly more expensive than alternative. NICE approved: No guidelines. Evidence summary available. Significant benefits to patients: Alternative treatment option to atomoxetine; the only available non-stimulant. The group agreed that there was limited safety and efficacy data so it was difficult to justify the medication in terms of cost effectiveness. Recommend medication to remain as GREY on the formulary. DKS to ask submitting clinician to re-confirm place in therapy and expected patient numbers. Trial duration data to be included on review papers. e) Nepafenac (Nevanac ) A formulary submission was received for nepafenac 1mg/ml suspension from SFHT ophthalmologists for reducing the risk of macular oedema in diabetic cataract patients. Request the medication be made available as RED. The submission is not supported by NUH and has previously been rejected by their DTC. Clinical effectiveness: Lack of evidence for use only one trial available. Safety: No concerns. Cost effectiveness: Very expensive, only licensed product for indication. NICE approved: No. Affordability: Poor. 4

5 Significant benefits to patients: Only licensed medication for indication. 10. Formulary amendments Recommend a GREY classification. a) FOR INFORMATION - Log of minor amendments carried out - Calci D: Calcium/Vitamin D section of formulary needs to be streamlined. JG to send DKS and NS further information regarding prices to the trusts. - Levetiracetam Granules: DKS and NS to double check cost compared to syrup. If normal dosing is comparable, add granules to the formulary under the same traffic light classification. Price graphs to be updated. 11. Horizon scanning 12. Any other business - Melatonin: The term intellectual disabilities requires better definition. LC to review previous submission for melatonin and liaise with JL. Meeting overran. Horizon scanning will be addressed at the July APC. a) Position statements for metolozone and ezetimibe. LC to remove metolozone information and to liaise with TB regarding ezetimibe. b) Sucralfate tablets and liquid are now unlicensed and supply is markedly expensive. NS and DKS to amend tablets and liquid on formulary from GREEN to GREY in light of expense and licensing. LC to raise awareness to primary care. 9. Date and time of TBA. next meeting The meeting ended at 5.20pm. 5

Nottinghamshire Joint Formulary Group Meeting Minutes 9 th October 2014, 2-5pm Room 1, Hawthorne House NG18 4LE

Nottinghamshire Joint Formulary Group Meeting Minutes 9 th October 2014, 2-5pm Room 1, Hawthorne House NG18 4LE Present: Steve May (SM) Chief Pharmacist, SFHT (chair); Amanda Rawlings (AR) Prescribing