Notes from the Area Prescribing Committee Meeting, held on Friday 15 th August 2014 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 15 th August 2014 Education Centre, E level, Queen Alexandra Hospital Present: Dr Alastair Bateman (chair), Janet Brember (secretary), Julia Wright, Dr Kevin Vernon, Dr Matthew Puliyel, Amanda Cooper, Grace Quaye, Katie Hovenden, Jason Peett, Dr Michelle Clarke, Apologies for absence: Jeremy Savage, Steve Bleakley, Sarah Billington, Dr Matthew Smith, Dr Michael Stewart, Jon Durand, Caroline Bowyer. Welcome: The chair welcomed Dr Michelle Clarke, GP Prescribing Lead for Fareham and Gosport CCG. MC has joined the APC in place of Dr Paul Howden who has move on to a different role in the CCG. The committee wished to convey thanks to Dr Howden for his contribution to the work of the APC over a number of years Declarations of Interest: JB attended a meeting about the long-term conditions toolkit sponsored by Pfizer DRAFT Notes of last meeting 13 th June 2014: Agreed as a correct record Matters arising 1. EHC: The EMA has concluded its review into the effectiveness of levonorgestrel and ulipristal EHC in relation to bodyweight and advised that levonorgestrel and ulipristal acetate can be used for emergency hormonal contraception regardless of the woman s weight or BMI. Solent NHS Trust are also awaiting the outcome of a review to establish whether there is any evidence of increased efficacy of EllaOne at high-risk times (mid cycle) to support wider use, as discussed at the June meeting. For further discussion on October, meanwhile there will be no change to the formulary criteria. 2. Lithium clinic: CB has reported via that she is still gathering information regarding the lithium clinic and has suggested that there needs to be meeting for stakeholders on the future of the service. 3. Enoxaparin and DNs: CB reported by that data collection is still ongoing and she will update the committee in October. 4. Formulary and Medicines Group July 18 th : It was agreed that fosaprepitant injection should be added to the formulary for the prevention of chemotherapy-induced nausea and vomiting only for patients who meet the criteria for treatment with aprepitant but are unable to tolerate any oral medication. The PHT CINV drug therapy guideline has been updated. The cost of the injection is the same as oral aprepitant Formulary Management applications for approval Canagliflozin in combination therapy for type 2 diabetes (NICE TA 315): Canagliflozin in a dual therapy regimen in combination with metformin is recommended as an option for treating type 2 diabetes if a sulfonylurea is contraindicated or not tolerated or there is significant risk of hypoglycaemia or its consequences. Canagliflozin in a triple therapy regimen is recommended as an option for treating type 2 diabetes in combination with metformin and a sulfonylurea or metformin and a thiazolidinedione. Canagliflozin in combination with insulin with or without other antidiabetic drugs is also recommended as an option for treating type 2 diabetes. Neither NICE nor the SMC have made a recommendation on monotherapy with canagliflozin although it is licensed for monotherapy. Dapagliflozin is recommended as dual therapy with metformin, but

2 not as triple therapy with metformin and a sulphonyurea (TA 288). Local diabetologists have indicated that potential advantages over dapagliflozin are that canagliflozin may be continued in patients where the egfr falls to 45-60ml/min during treatment and that canagliflozin can be used in combination with pioglitazone. It was noted that there is a significantly increased cost related to use of the 300mg dose, with a minimal increased efficacy in terms of Hb1Ac reduction; however the 300mg dose is included in both NICE and SMC recommendations. APC decision: Canagliflozin tablets will be added to the formulary for prescribing in primary and secondary care in line with the recommendations in NICE TA 315. When NICE recommendations on the third agent in this class (empagliflozin) are published summary local guidance comparing the SGLT -2 inhibitors should be developed. Financial impact: Based on the standard assumptions in the NICE TA 315 costing model, the annual cost associated with implementing the recommendations on the use of canagliflozin as an option for the treatment of type 2 diabetes is estimated at 26,400 for a population of 100,000. The additional cost is predominantly driven by increased drug spending, where canagliflozin is used as an alternative to other oral antidiabetics Salofalk (mesalazine) granules: Dr Tim Trebble presented this proposal to the July F&M meeting on behalf of PHT gastroenterologists. F&M supported the proposal to add Salofalk granules to the formulary for the treatment of acute episodes and to maintain remission in ulcerative colitis. There are already a number of oral and rectal mesalazine products on the formulary and a choice of products is necessary both for disease in different parts of the colon and to support adherence by patients. There is no comparative evidence but clinical experience is that there is no significant difference in efficacy between oral mesalazine products. The factors that influence choice are therefore cost and features of the product such as formulation, dosage regimen etc. Salofalk granules can be taken once daily and may be preferred by patients who have difficulty with large tablets. Granules are taken by placing on the tongue and swallowing with plenty of liquid. The cost of acute or maintenance treatment with Salofalk granules is comparable to or less than other mesalazine preparations. The gastroenterologists intend to offer Salofalk granules for new initiations and also if patients are not well controlled or are experiencing difficulty complying with existing treatment. APC decision: Salofalk granules will be added to the formulary as an alternative mesalazine product (secondary care initiated). All mesalazine should be prescribed by brand name to ensure the patient receives the intended product. It was requested that consideration is given to rationalising the range of aminosalicylate products on the formulary. Financial impact: No additional impact; may be cost-saving in primary care depending on products displaced Lubiprostone for treating chronic idiopathic constipation (NICE TA 318): Lubiprostone is recommended as an option for treating chronic idiopathic constipation in adults when treatment with at least 2 laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and for whom invasive treatment for constipation is being considered. If treatment with lubiprostone is not effective after 2 weeks, the person should be re-examined and the benefit of continuing treatment reconsidered. Lubiprostone should only be prescribed by a clinician with experience of treating chronic idiopathic constipation, who has carefully reviewed the person's previous courses of laxative treatments. Lubiprostone is not currently licensed for the treatment of opioid-induced constipation. APC decision: Lubiprostone capsules will be added to the Portsmouth and South East Hampshire Formulary for use in line with the recommendations in TA 318. The diagnosis, prior treatment and stopping rules must be adhered to. Financial impact: Services for chronic idiopathic constipation are commissioned

3 by CCGs. NICE have issued a costing statement for TA 318 because the guidance is unlikely to result in a significant change in resource use in the NHS. Lubiprostone is an additional treatment option at a similar cost to prucalopride which is recommended by NICE at a similar position in the treatment pathway. The costing statement also advises that lubiprostone can be prescribed in primary or secondary care settings. Cost savings may result from a potential reduction in referrals to secondary care for more invasive procedures or surgery. It may also reduce the number of people presenting for non-elective treatment for acute episodes of obstructions Enzalutamide for metastatic hormone-relapsed prostate cancer previously treated with a docetaxel-containing regimen (NICE TA 316): Enzalutamide is recommended within its marketing authorisation as an option for treating metastatic hormone-relapsed prostate cancer in adults whose disease has progressed during or after docetaxel-containing chemotherapy, only if the manufacturer provides enzalutamide with the discount agreed in the patient access scheme. The use of enzalutamide in men previously treated with abiraterone is not covered by this guidance because the NICE appraisal committee were not presented with sufficient evidence to inform a decision on the clinical- or cost-effectiveness of sequential use of enzalutamide after abiraterone. There is some concern among clinicians and patients about this restriction as there is a cohort of men who have already received abiraterone and will not be eligible for treatment with enzalutamide. APC decision: Enzalutamide capsules will be added to the Portsmouth and South East Hampshire formulary for prescribing in line with the recommendations in TA 316. Financial impact: The responsible commissioner is NHS England. NICE have issued a costing statement for TA 316 as the resource impact is not expected to be significant. This is because people eligible to receive treatment with enzalutamide will also be eligible to receive abiraterone at similar cost, and the guidance does not cover the use of enzalutamide for patients previously treated with abiraterone. Enzalutamide will be available to the NHS with a PAS discount (commercial in confidence) Umeclidinium/vilanterol inhaler for COPD ( Anoro Ellipta): Dr Ben Green and Adel Sheikh attended to present this item and explained that combination inhaled treatment with LABA+ LAMA has a higher place in the management of COPD due to an increased emphasis on maximising treatment of breathlessness and delaying the introduction of inhaled corticosteroids. Anoro Ellipta is the first combination LABA+LAMA inhaler to be considered for addition to the formulary. There are going to be a number of other single agents and combinations coming to market in the Ellipta device portfolio and Relvar Ellipta (ICS+LABA) has already been accepted for use locally. This offers the potential for patients to receive escalating inhaled treatment delivered via a single device. There is evidence of efficacy of Anoro Ellipta vs tiotropium. Trials have also shown a decrease in rescue medication use and improvements in QOL scores. Anoro Ellipta will be considered for new patients with persistent breathlessness after trying individual bronchodilator therapy and patients currently on separate LAMA and LABA inhalers to improve compliance and reduce costs. APC decision: Anoro Ellipta (umeclidinium/vilanterol 55/22mcg) inhaler will be added to the formulary for prescribing in primary and secondary care as maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD, in line with revised local COPD guidelines (see below). Financial impact: Anoro Ellipta cost for 30 days. This is comparable to other LAMA inhalers but will be cost saving compared with prescribing separate LAMA and LABA inhalers Umeclidinium bromide inhaler for COPD (Incruse Ellipta): Dr Ben Green and Adel Sheikh explained that LAMA therapy is appropriate for all COPD patients of any severity when symptoms are not controlled by SABAs alone and this product

4 gives an additional choice of LAMA-containing device. Umeclidinium bromide is a once daily treatment and offers equivalent efficacy to current LAMA treatments, at the same cost as glycopyrronium bromide (current first line LAMA) and at lower cost than tiotropium bromide. As for Anoro above there is the potential for patients to change agents while retaining the same device therefore aiding compliance and decreasing device confusion. APC decision: Umeclidinium bromide (Incruse Ellipta) inhaler will be added to the formulary for prescribing in primary and secondary care as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD, in line with revised local COPD guidelines (see below). It was noted that the product will not be available to prescribe until mid-september. Financial impact: Incruse Ellipta costs for 30 days. No additional costs are anticipated and there may be some cost savings if umeclidinium is used in place of tiotropium Olodaterol inhaler for COPD (Striverdi Respimat): Br Ben Green and Adel Sheikh explained that olodaterol is a new LABA agent in the Respimat device. Olodaterol is used once daily and has a faster onset of action compared to salmeterol. Clinical efficacy is comparable to formoterol. A combination of LABA+LAMA in the Respimat device is in the pipeline and other Respimat products are planned. The Respimat device provides an option for patients who are unable to generate the inspiratory flow necessary for a DPI. Only limited numbers of patients with COPD are managed with LABA monotherapy. There was some discussion about the need for this product and whether it had any significant advantage over LABA inhalers already available. Previous safety concerns about the Respimat device (with tioptropium) were also raised. APC decision: Olodaterol hydrochloride (Striverdi Respimat) inhaler will not be added to the formulary at this stage. The committee were not convinced of the clinical need for this product and felt that potential advantages based on the inhaler portfolio argument were limited. It was also understood that only a small number of patients would be affected as few patients require LABA monotherapy and formoterol is available in different devices. This decision can be reviewed when the combination olodaterol with tiotropium inhaler becomes available and when safety concerns about the Respimat device are confirmed to be unfounded. Financial impact: not applicable Drug therapy and shared care guidance for approval Management of Chronic obstructive pulmonary disease (COPD): Dr Ben Green and Adel Sheikh introduced the updated guideline and explained that the treatment algorithm is now based on the GOLD (Global Initiative for Chronic Obstructive Lung Disease) 2014 guideline. Using GOLD principles provides a more individualised treatment choice for patients by assessing symptom severity (using the mmrc breathlessness score and the COPD Assessment Tool (CAT score) and risk (using stage of airways obstruction and exacerbation risk). The current guideline is based on NICE CG 101 and treatment choice is based on FEV1 which is not a good measure of overall severity. The main aim is to reduce exacerbations as these have a high cost and impact on quality of life. Triple therapy including ICS has a lower place in the revised guidelines and there is a higher place for LABA+LAMA which can now be provided in a single inhaler. Due to the lack of comparative data factors such as dose regimen, inhaler device, patient preference and cost guide choice of inhaled therapy. Further new inhalers will be coming to market in the near future and there will be increased opportunity for a portfolio approach with patients using the same inhaler device as treatment is escalated. APC decision: The revised guidelines were approved for publication subject to the removal of olodaterol inhaler as a LAMA treatment option (see above). A brief introduction to the new guidelines to explain the rationale for the new approach and introduce the new inhalers was requested to support dissemination in primary care.

5 Items for note/consultation NICE guidance 1. Guidance published in June 2014 TA 315 Canagliflozin in combination therapy for treating type 2 diabetes see above. CG 180 Atrial fibrillation: the management of atrial fibrillation the new treatment recommendations were discussed. Routine calculation and reporting of TTR was a concern. It was also agreed that reassessment of anticoagulation in the light of results indicating poor control on warfarin does not necessarily mean that the patient should be changed to a NOAC. NICE are shortly to publish guidance on the use of self-monitoring of anticoagulation and it has been noted that the anticoagulation clinic have been discussing this option with some patients, resulting in queries in primary care about prescribing the test strips. The issue of self-monitoring or local GP practice monitoring will need further discussion and agreement and needs to be reviewed in the light of the NICE diagnostics guidance (due for publication September 2014). 2. Guidance published in July 2014 TA 318 Lubiprostone for treating chronic idiopathic constipation see above. TA 316 Enzalutamide for metastatic hormone relapsed prostate cancer previously treated with a docetaxel containing regimen - see above. CG 81 Advanced breast cancer (update) - no new or updated recommendations for pharmacological management, no action required. CG 181 Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease It was agreed that a short local guideline summarising the pharmacological treatment recommendations only would be useful. Treatments not to be used should also be highlighted. TA 319 Ipilimumab for previously untreated advanced (unresectable or metastatic) melanoma ipilimumab is now recommended as an option for patients with previously untreated advanced melanoma. NICE TA 268 recommends ipilimumab for patients who have received prior therapy for advanced melanoma. The formulary entry will be updated. TA 317 Prasugrel with percutaneous coronary intervention for treating acute coronary syndromes (review of technology appraisal guidance 182) Prasugrel is recommended within its marketing authorisation to prevent atherothrombotic events in adults with ACS (unstable angina, NSTEMI or STEMI) having primary or delayed PCI. (TA 182 only recommended prasugrel for people having primary PCI, a stent blockage while on clopidogrel, or for people with diabetes.) NHS England Commissioning policies: It was noted that NHSE will commission the use of SC rituximab when used as maintenance single agent therapy in follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma and lymphoplasmacytic lymphoma (SSC 1434). There have been some changes to the list of high cost medicines and indications commissioned by NHS England Specialised Services and these are described in SC The only issue that has an impact on CCGs is the prescribing of lanreotide and octreotide for acromegaly. These drugs are currently funded by CCGs but the indication is listed in the Manual as falling under specialised commissioning. SSC 1437 states that these are listed for clarification but it is recommended that current funding streams should remain in place until April (Locally octreotide and lanreotide for acromegaly are prescribed by GPs

6 under a shared care agreement with endocrinology) DPC update (June 2014): The recommendations of the DPC were noted. The diabetes stepped approach document will be considered for adoption locally with the permission of the author New drugs update: It was noted that a third SGLT2 inhibitor (empaglaflozin, Jardiance tablets) has been launched and the NICE TA is due in March Vedolizumab (Entyvio) infusion is a new biologic agent for the treatment of active ulcerative colitis and active Crohn s disease. (NICE TA for ulcerative colitis due April 2015, Crohn s June 2015). Aflibercept (Eylea) intravitreal injection will shortly be granted a licence extension for the treatment of DMO (NICE TA due June 2015). Dexamethasone (Ozurdex) intravitreal implant also has a positive opinion for a licence extension to include treatment of DMO in patients with an artificial lens or unsuitable for non-steroid treatment (NICE TA due April 2015). Tocilizumab (RoActemra) infusion has received a positive opinion for a licence extension to include severe active and progressive RA in methotrexate-naïve patients. Denosumab (Prolia) subcutaneous injection is now licenced in the UK for the treatment of osteoporosis in men. Local guidelines and shared care agreement require updating. Dabigatran (Pradaxa) capsule are now licensed for the treatment of DVT and PE and prevention of recurrent DVT and PE in adults (NICE TA due October 2014). Apixaban (Eliquis) tablets also have a licence extension to cover treatment of DVT and PE, and the prevention of recurrent DVT and PE in adults (NICE TA due June 2015) Medication safety update: Advice issued by the MHRA in June and July 2014 was noted including new warnings on combination use of renin-angiotensin system blocking agents following an EU-wide review. Combination use of medicines from different classes of renin-angiotensin system blocking agents is associated with an increased risk of hyperkalaemia, hypotension, and impaired renal function. Prescribers are advised that patients with diabetic nephropathy should not be given an ACE-inhibitor with an angiotensin-receptor blocker as they are already prone to developing hyperkalaemia. Combining aliskiren with an ACEinhibitor or angiotensin-receptor blocker is contraindicated in people with kidney impairment or diabetes Draft Area Prescribing Committee Annual Report : The draft Annual Report was approved for publication Guidance on the use of biologic agents for the treatment of Crohn s Disease: This guidance was developed by clinical consensus through a process facilitated by JW and has been approved by the DPC. None of the gastroenterologists from PHT was involved in the discussions but JW agreed to approach Dr Amanda Quine to ask if the PHT specialists would be interested in adopting the pathway. An approach via the planned care team could also be considered if necessary Any other business: LMC representative on the APC: It was agreed that it would be desirable to have an LMC representative on the committee. The DPC have an LMC rep; and both APC and DPC invite the LPC chief officer to attend meetings. KH agreed to ask for nominations Dates of future meetings: JW KH Friday 17 th October 2014 Friday 19 th December 2014 Meeting dates for 2015:

7 Friday 13 th February 2015 Friday 24 th April 2015 Friday 19 th June 2015 Friday 21 st August 2014 Friday 16 th October 2014 Friday 18 th December 2015

Notes from the Area Prescribing Committee Meeting held on Friday 11 th April 2014 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