Notes from the Area Prescribing Committee Meeting held on Friday 17 th February 2017 Room 5, 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 February 2017 Room 5, Education Centre, E level, Queen Alexandra Hospital Present: Katie Hovenden (chair), Janet Brember (secretary), Simon Cooper, Jason Peett, Amanda Cooper, Dr Michael Stewart, Jon Durand, Paul Bennett, Dr Kevin Vernon, Dr Keith Barnard, Sarah Nolan (Solent NHS Trust, on behalf of Raj Prakesh), Dr Matthew Puliyel, Dr Jonathan Lake Apologies for absence: Dr Alastair Bateman, Paul Bennett, Raj Prakesh Welcome: The chair welcomed Dr Jonathan Lake to his first meeting. Dr Lake is a GP and member of Portsmouth CCG Clinical Executive Declarations of Interest: none DRAFT Notes of last meeting 16th December 2016: Agreed as an accurate record Matters arising: 1. Vitamin D products summary information on agreed formulary products has been published. 2. C.difficile management guidance final version for publication has been requested from the author. 3. Blood glucose testing equipment guidance developed by Southampton CCG amended wording on safety needles and lancets has been agreed. Awaiting feedback form Dr Iain Cranston regarding local adoption. 4. Dermatology quick reference guides have been finalised and published. 5. Generic imatinib - community pharmacies that have previously dispensed imatinib have been notified of plans to repatriate supply to PHT. 6. Change in time of warfarin administration at UHS incidents are being reported back via Hampshire Medicines Safety Group and raised at CQRM. Feedback from F&M January 20 th. The following hospital only items were supported for addition to the formulary (classified as RED): (i) Lanreotide (Somatuline Autogel) - off-licence use to reduce secretions from pancreatic/enterocutaneous fistulae when more than 4 weeks treatment is required. Replaces multiple daily injections of octreotide in selected patients with no additional cost. (ii) Methylthioninium chloride (methylene blue) - licensed product Proveblue to replace unlicensed injection as an antidote for methaemoglobinaemia. Also used off-licence for ifosfamide induced encephalopathy and as a vasopressor in septic shock. (iii) Nithiodote (co-packaged sodium thiosulphate injection and sodium nitrite injection) for use as an antidote in cyanide poisoning to replace unlicensed products. (iv) Morphine sulphate 10mg in 10ml Intrasite gel for acute painful skin reactions following radiotherapy. Ready to use special to replace mixture made by patients at home. (v) Zoledronic acid 4mg infusion for adjuvant treatment of postmenopausal breast cancer to reduce risk of recurrence and mortality (off- licence use see below) (vi) Ketamine 100mg in 10ml pre-filled syringes for emergency use in cardiac arrest.

2 (vii) Bupivacaine 0.1% with fentanyl 2mcg/ml for epidural injection/ PCEA contains a lower concentration of fentanyl for renal patients Formulary Management applications for approval Bisphosphonates for adjuvant use in breast cancer: Dr Caroline Archer and Dr Jack Broadfoot attended to present this item. A formulary application and shared care guidance for ibandronic acid and a patient information leaflet were reviewed. Dr Archer explained that no bisphosphonates are licensed for this indication but use of iv zoledronic acid or oral ibandronic acid is supported by evidence from a large collaborative meta-analysis (involving 18,766 women of whom 11,767 were post-menopausal). For post-menopausal women with early breast cancer adjuvant bisphosphonates significantly reduced the rate of breast cancer recurrence and improved breast cancer survival. Eligible women will be offered either IV zoledronic acid 6-monthly for 3 years or oral ibandronate 50mg daily for 3 years. Dr Archer confirmed that the choice of treatment will be led by patient preference and that experience has shown that women with breast cancer are sufficiently motivated to comply with the oral treatment regimen. Treatment with bisphosphonates will reduce the adverse effects on bone density associated with aromatase inhibitors and avoid the need for DXA scans. If oral treatment is preferred the hospital specialist will arrange the first prescription for ibandronic acid 50mg daily and will request ongoing prescribing by the GP. APC decision: Ibandronic acid 50mg tablets will be added to the formulary for adjuvant treatment of post-menopausal breast cancer (amber with shared care). The shared care guidance for ibandronic acid tablets and the patient information leaflet on adjuvant bisphosphonates were approved for publication subject to agreed minor amendments. Financial impact: Estimated maximum cost based on 90 women per annum receiving ibandronic acid at year 3 (steady state) 19, (using current Drug Tariff price). These cost are likely to be offset by a reduction in the women requiring treatment and care for metastatic disease. There will also be a reduction in the number of DXA scans required Brivaracetam for adjunctive treatment of epilepsy: Dr Sean Slaght, consultant neurologist, made an application to include brivaracetam on the formulary in June The APC decided due to concerns about the evidence base and place in treatment that brivaracetam should not be added to the formulary. The chair of F&M agreed to consider non-formulary requests for individual patients under the care of Dr Slaght where patients had exhausted other treatment options. It was agreed that this position would be reviewed after 12 months or earlier if requested. A request has now been received from Dr Slaght to review the position of brivaracetam and consider adding it to the formulary in line with the position at UHS (amber). Dr Slaght provided supporting information in a letter and the original formulary application, the evaluation carried out for the MEC and the recommendations of the MEC and DPC were made available to the committee. Brivaracetam is proposed for initiation in secondary care by a neurologist, with primary care taking on the prescribing once the patient has been stabilised and shown to benefit from treatment. Brivaracetam will be an option for patients with drug refractory epilepsy where there are otherwise few treatments available. The likelihood of it being helpful in an individual is not very high; however for 5-10% of patients there may be a significant reduction in seizures. Use of brivaracetam is likely to be cost neutral, as it will generally replace other newer anti-epileptic medications (e.g. lacosamide, zonisamide or perampanel) which have similar monthly costs. A summary of the outcome for the seven patients who have started on treatment at PHT was provided. APC decision: Brivaracetam tablets will be added to the formulary for adjunctive treatment of partial onset seizures in refractory epilepsy, line with

3 the licensed indication. Brivaracetam will be initiated by consultant neurologists only (AMBER) for patients with inadequate seizure control or where other antiepileptic drugs are contraindicated, not tolerated or inappropriate. The specialist should ensure the patient has a positive response and is stabilised on treatment before asking the patient s GP to take responsibility for ongoing prescribing. A brief report summarising the outcomes for patients initiated over the next 12 months was requested Odefsey (tenofovir alafenamide 25mg, emtricitabine 200mg, rilpivirine 25mg) tablets for HIV treatment: Solent NHS Trust have requested that Odefsey is added to the formulary for prescribing in line with NHS England commissioning policy 16043/P. Tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) together with emtricitabine are considered the preferred option of NRTI backbone for treatment of HIV1 infection. However TDF is associated with proximal renal tubulopathy and reductions in bone mineral density. Tenofovir alafenamide (TAF) is a prodrug of tenofovir and can be administered in much lower doses than TDF while maintaining efficacy. TAF has been shown to have a lower risk of kidney and bone side effects compared to TDF. Odefsey tablets will be used in place of Eviplera (emtricitabine/tdf/ rilpivirine) in an estimated 25% of patients. APC decision: Odefsey tablets will be added to the formulary for prescribing by Solent NHS Trust HIV specialists in line with the criteria in NHSE policy 16043/P. Odefsey tablets will be classified as RED on the formulary, Financial impact: Cost neutral Drug therapy and shared care guidance for approval Denosumab (XGEVA ) for the treatment of Bone Metastases in patients with solid tumours other than prostate: This shared care agreement has been reviewed as it was out-of-date and minor amendments have been made to ensure it is in line with the current SPC for Xgeva. APC decision: Approved for publication on local websites Denosumab (Prolia) for Osteoporosis in adults: This shared care agreement has been reviewed as it was out-of-date and minor amendments have been made to ensure it is in line with the current SPC for Prolia. There was some uncertainty about whether continuing treatment beyond three years is now generally recommended. JB agreed to ask Dr Steven Young-Min for clarification. APC decision: Approved for publication on local websites subject to the above Hampshire Wound Formulary: The final version of the revised and updated Hampshire Wound Formulary document was noted. The document has been uploaded to local websites and the products will be individually listed in Chapter 19 of netformulary to enable searching Items for note/consultation NICE Guidance Guidance published in December 2016: TA 420 Ticagrelor for preventing atherothrombotic events after myocardial infarction: Ticagrelor, in combination with aspirin, is recommended as an option for preventing atherothrombotic events in adults who have had a myocardial infarction and who are at high risk of a further event. Treatment should be stopped when clinically indicated or at a maximum of 3 years. The cost from 2022/23 (once steady state reached) is equivalent to 15,600 per 100,000 population. Action: Formulary entry for ticagrelor to be amended with reference to TA 420. The dose for this indication is 60mg twice daily. TA 421 Everolimus with exemestane for treating advanced breast cancer after endocrine therapy: Recommended as an option for treating advanced human epidermal growth factor receptor 2 (HER2)-negative, hormonereceptor-positive breast cancer in postmenopausal women without

4 symptomatic visceral disease that has recurred or progressed after a nonsteroidal aromatase inhibitor. This TA is a Cancer Drugs Fund reconsideration of everolimus in combination with exemestane for treating advanced HER2- negative hormone receptor-positive breast cancer after endocrine therapy and replaces TA295. NHSE commissioned cancer drug. PAS discount applies. Action: Everolimus tablets (Afinitor) to be added to the formulary for prescribing in line with TA 421. TA 422 Crizotinib for previously treated anaplastic lymphoma kinasepositive advanced non-small-cell lung cancer: Recommended as an option for previously treated anaplastic lymphoma kinase-positive advanced nonsmall-cell lung cancer in adults. This TA is a Cancer Drugs Fund reconsideration of crizotinib for previously treated non-small-cell lung cancer associated with an anaplastic lymphoma kinase fusion gene and replaces TA296. NHSE commissioned cancer drug. PAS discount applies. Action: The formulary entry for crizotinib capsules will be amended with reference to TA 422. TA 423 Eribulin for treating locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens: Recommended as an option for treating locally advanced or metastatic breast cancer in adults, when it has progressed after at least 2 chemotherapy regimens. Replaces NICE guidance on eribulin for the treatment of locally advanced or metastatic breast cancer (TA250). NHSE commissioned cancer drug. PAS discount applies. Action: Eribulin injection to be added to the formulary for prescribing in line with TA 423. TA 424 Pertuzumab for the neoadjuvant treatment of HER2-positive breast cancer: Recommended in combination with trastuzumab and chemotherapy as an option for the neoadjuvant treatment of adults with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. NHSE commissioned cancer drug. PAS discount applies. Action: Pertuzumab for infusion to be added to the formulary for prescribing in line with TA 424. TA 425 Dasatinib, nilotinib and high-dose imatinib for treating imatinibresistant or intolerant chronic myeloid leukaemia: Dasatinib and nilotinib are recommended as options for treating only chronic- or accelerated-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults, if they cannot have imatinib, or their disease is imatinib-resistant. High-dose imatinib is not recommended in adults whose disease is imatinib-resistant. This is a Cancer Drugs Fund reconsideration of dasatinib, high-dose imatinib and nilotinib for the treatment of imatinib-resistant CML. This guidance replaces TA241 and partially updates TA70. NHSE commissioned cancer drugs, PAS discounts apply for dasatinib and nilotinib. Action: Formulary entries for dasatinib, nilotinib and imatinib to be amended with reference to TA 426. TA 426 Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia: Imatinib is recommended as an option for untreated, chronicphase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults. Dasatinib and nilotinib are also recommended as options subject to PAS discounts. NHSE commissioned cancer drugs. This guidance is a Cancer Drugs Fund reconsideration of dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia; it replaces TA251 and partially updates TA 70. Action: The formulary entries for imatinib, dasatinib and nilotinib to be amended with reference to TA 426. Guidance published in January 2017: TA 427 Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomib: recommended (with low-dose dexamethasone) as an option for treating multiple myeloma in adults at third or subsequent relapse. This appraisal is a review of TA338, which did not recommend pomalidomide for this indication. Pomalidomide was available

5 through the Cancer Drugs Fund until November NHSE commissioned cancer drug. PAS discount applies. Action: Pomalidomide tablets to be added to the formulary for prescribing in line with TA 427. TA 428 Pembrolizumab for treating PD-L1-positive non-small-cell lung cancer after chemotherapy: recommended as an option in adults who have had at least one chemotherapy regimen only if pembrolizumab is stopped at 2 years of uninterrupted treatment and no documented disease progression. NHSE commissioned cancer drug, previously available under EAMS scheme. PAS discount applies. Action: Formulary entry for pembrolizumab injection to be amended with reference to TA 428 TA 429 Ibrutinib for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation: recommended as an option in adults who have had at least one prior therapy or who have a 17p deletion or TP53 mutation, if chemoimmunotherapy is unsuitable. NHSE commissioned, previously via CDF. PAS discount applies. Action: Ibrutinib tablets to be added to the formulary for prescribing in line with TA 429. TA 430 Sofosbuvir velpatasvir for treating chronic hepatitis C Sofosbuvir velpatasvir is recommended as an option for treating chronic hepatitis C in adults in line with specified criteria. NHSE commissioned high cost drug. PAS discount applies. Action: Sofosbuvir-velpatasvir (Epclusa) tablets to be added to the formulary for prescribing in line with TA 430. TA 431 Mepolizumab for treating severe refractory eosinophilic asthma: Recommended as an add-on to optimised standard therapy in adults in line with specified criteria. Mepolizumab should only be started in tertiary specialist commissioned centres. NHSE commissioned high cost drug. PAS discount applies. Action: Mepolizumab injection to be added to the formulary for prescribing in line with TA 431. Unlikely to be prescribed at PHT. The NICE bites summary of prescribing recommendations from CG59 (November 2016) was noted. This guideline covers the assessment and management of low back pain with or without sciatica in people aged from 16 years and includes a number of do not do recommendations NHS England Commissioning policies: none DPC update (December 2016): It was noted that the DPC have supported the use of all three concentrated insulin products: insulin lispro (Humalog U200), insulin degludec (Tresiba U200) and insulin glargine (Toujeo U300) following recommendation from a specialist. The DPC also supported use of ciclesonide inhalers and lecicarbon A suppositories with similar criteria to that previously agreed by the APC Hampshire Medicines Safety Group: Notes from the November 2106 meeting were available and a verbal update from January 2017 meeting was given. Nothing additional was highlighted for action by the APC Drug Safety Update and Patient Safety Alerts: The warning regarding an increased risk of psychiatric symptoms in some patients taking apremilast was noted. Reported symptoms include depression and suicidal thoughts and behaviour. Apremilast is starting to be prescribed locally for patients with psoriasis following recent NICE TA recommendation. The advice is to stop treatment if patients have new psychiatric symptoms or if existing symptoms worsen. The MHRA have clarified a previous warning (February 2016) about concomitant use of spironolactone and renin-angiotensin system drugs in heart failure and the risk of potentially fatal hyperkalaemia. The have stated that concomitant use of spironolactone with ACEi or ARB increases the risk of severe hyperkalaemia, particularly in patients with marked renal impairment, and should be used with caution. The article now also clarifies that the same advice applies for concomitant use of the aldosterone antagonist eplerenone

6 with ACEi or ARB in heart failure Regional Medicines Optimisation Committees: A series of regional workshops have been organised to provide an opportunity for stakeholders to engage with and contribute to the establishment of RMOCs. JB has registered attend the workshop on 20 th February in Reading Any other business: Outpatient prescribing: JP and AC raised this in connection with a recent complaint. The LMC have published an information leaflet for patients including information about prescribing for outpatients that differs from current local practice. In addition there are some changes in the contract regarding outpatient prescribing specifying that providers must supply medication following a patient s attendance at clinic, where clinically indicated, for the period required in local protocols but at least sufficient to meets the patient s immediate needs. It was agreed that there needs to be a review of outpatient prescribing arrangements overall and that this requires a discussion with contracting together with some clinical input. The discussion should include PHT and CCGs contracting teams and medicines management together with the LMC and Solent. Action: KH agreed to co-ordinate a meeting as above and to request agenda items Dates of future meetings: KH Dates for 2017: Friday 28 th April 2017 Friday 16 th June 2017 Friday 18 th August 2017 Friday 20 th October 2017 Friday 15 th December 2017

NICE TECHNOLOGY APPRAISAL MEDICINES REPORT 2017

NICE TECHNOLOGY APPRAISAL MEDICINES REPORT 2017 NICE TECHNOLOGY PPRISL MEDICINES REPORT St George s Healthcare NHS Trust key for medicine-related NICE Technology ppraisals. has been approved by the Drugs and Therapeutics Committee as recommended within