Apologies for absence were noted for Mr David Binyon, Dr Helen Hellewell, Dr David Reid.

Transcription

1 Fife NHS Board CONFIRMED MINUTES OF THE MEETING OF THE FIFE FORMULARY COMMITTEE HELD AT 1.00PM ON WEDNESDAY 31 MAY 2017 IN THE SEMINAR ROOM, WHYTEMAN S BRAE HOSPITAL, KIRKCALDY Present: Dr Steve Rogers, Consultant Haematologist (Chair) Dr Sean Ainsworth, Consultant Paediatrician Ms Pauline Buchanan, Dermatology Nurse Practitioner Dr Emma Christmas, GP Ms Fiona Eastop, Primary Care Development Pharmacist Dr Lorna Fleming, GP, Local Medical Committee Representative Dr Linda McGourty, GP Mr Ishtiaq Mohammed, Clinical Effectiveness Pharmacist (Professional Secretary) Mr Fraser Notman, Prescribing Support Pharmacist Mr Euan Reid, Acute Pharmacy Representative Mr Iain Rivans, Acute Pharmacy Representative Ms Kirsten Smith, Dispensary Manager In attendance: Mrs S MacDonald (minutes) 1 APOLOGIES FOR ABSENCE ACTION Apologies for absence were noted for Mr David Binyon, Dr Helen Hellewell, Dr David Reid. 2 MINUTES OF PREVIOUS MEETING ON 29 MARCH 2017 The minutes from the meeting on 29 March 2017 were confirmed as a true record. 3 MATTERS ARISING 3.1 Formulary Submission - emtricitabine/tenofovir disoproxil 200mg/245mg film-coated tablets (Truvada ) Mr Notman gave a verbal update on discussions at the MSDTC and ADTC in relation to emtricitabine/tenofovir disoproxil (Truvada ) which was approved in principle at the Formulary Committee meeting in March. The guideline for HIV Pre-Exposure Prophylaxis was discussed at the MSDTC in April and changes were requested including the removal of event based use. The revised guideline will go back to the MSDTC in June for approval. The ADTC noted the submission/guideline and the ongoing work by the Blood Borne Virus Team to explore affordability of Truvada. It was agreed that no further action was required by the Formulary Committee.

2 4 DECLARATION OF INTERESTS There were no declarations of interests. 5 FORMULARY SUBMISSIONS 5.1 Formulary Submission - Ibrutinib (Imbruvica ) Mr Rivans advised that a Formulary submission for ibrutinib (Imbruvica ) was completed and forwarded to Dr Chris McKenna, Clinical Director for sign-off. Dr McKenna has not signed the submission at present and has proposed that due to the small number of patients who would be considered suitable for treatment and a concern around potential increased use, any requests to use ibrutinib (Imbruvica ) should go through the non Formulary process which would provide a degree of governance. The Formulary Committee noted that it is anticipated that approximately 10 patients per annum would be considered suitable for treatment and the non Formulary request process would be difficult to sustain. Mr Mohammed highlighted the SMC decision making template and the expectation that medicines going through the SMC process should be discussed at local Committees and either approved/not approved for use. The concern around governance was noted, however Mr Reid advised that a tracker could be set up within Acute pharmacy to monitor use and produce regular reports. Dr Rogers and Mr Mohammed as Formulary Committee Secretariat to discuss further with Dr McKenna. SR/IM 5.2 Formulary Submission - DEKAS Plus Liquid Mr Notman introduced the Formulary submission for DEKAS Plus Liquid for vitamin supplementation in cystic fibrosis patients and briefed the Committee on the background to this. The proposed indication for use is vitamin supplementation in pancreatic-insufficient cystic fibrosis patients aged 0-3 years or those who cannot swallow tablets and capsules. The current Formulary choice for this indication is AquADEKS which has been discontinued. DEKAS Plus Liquid allows supplementation of all four fat-soluble vitamins in a single preparation and is more cost effective and convenient for patients than giving individual vitamins separately. This treatment is in line with guidance on the Cystic Fibrosis Trust website and is standard practice within the Royal Hospital for Sick Children in Edinburgh for this indication. Following discussion the Formulary Committee approved the request to include DEKAS Plus Liquid in the Fife Formulary for vitamin supplementation in pancreatic-insufficient cystic fibrosis patients aged 0-3 2

3 years or those who cannot swallow AquADEKS capsules. 5.3 Formulary Submission - Idebonone (Raxone ) Mr Mohammed introduced the Formulary submission for idebonone (Raxone ) for treatment of visual impairment in adolescent and adult patients with Leber s Hereditary Optic Neuropathy and briefed the Committee on the background to this. Idebonone (Raxone ) was accepted by the SMC in April 2017 for restricted use for the treatment of visual impairment in adolescent and adult patients with Leber s Hereditary Optic Neuropathy (LHON). Use restricted to patients with LHON who do not meet the UK criteria to be registered as severely sight impaired. Idebonone (Raxone ) is an ultra orphan medicine and patient numbers are estimated to be approximately 1 per annum. There is little robust trial evidence on the efficacy of idebenone. In a 24 week study patients who received idebenone had numerical improvements in visual acuity over placebo. There is no other licensed treatment available for this indication. Idebonone has a good safety profile and is well tolerated. Confirmation that the Clinical Director is supportive of the submission is awaited. Subject to sign-off by the Clinical Director, the Formulary Committee approved in principle the request to include idebonone (Raxone ) in the Fife Formulary for treatment of visual impairment in adolescent and adult patients with Leber s Hereditary Optic Neuropathy. Restricted to use in patients with LHON who do not meet the UK criteria to be registered as severely sight impaired; hospital use only. 5.4 Formulary Amendment - Fluoride Toothpaste Mr Notman introduced the Formulary amendment for fluoride toothpaste and briefed the Committee on the background to this. The Consultant in Dental Public Health in consultation with the Scottish Clinical Dental Effectiveness Programme has recently issued new recommendations on the use of fluoride toothpaste and fluoride supplements in Scotland. High strength fluoride toothpaste should normally only be prescribed by a general dental practitioner following an assessment of caries risk and taking into consideration behavioural and lifestyle factors. There are two strengths of high concentration fluoride toothpaste available for prescription, 2800 ppm F and 5000 ppm F. The 2800 ppm F strength should be used initially unless the level of clinical need is substantial. The Formulary amendment updates and clarifies the advice within the 3

4 Formulary around the prescribing of fluoride preparations. The Formulary submission states that high fluoride toothpaste should be used on a short term basis, however the time period is not quantified. It was noted that high fluoride toothpaste is also prescribed for oral cancer patients and a prescribing note should be added to the Formulary in relation to this. Subject to clarification on the period of short-term use and addition of a bullet point regarding use in oral cancer patients, the Formulary Committee approved the Formulary Amendment for fluoride toothpaste. 5.5 Formulary Amendment - NRT Smoking Cessation Guidelines Ms Eastop introduced the Formulary amendment for nicotine replacement therapy (NRT) and amended NHS Fife Stop Smoking Prescribing Guidance. The Formulary amendment has arisen following a recent national tendering process by NSS for all NRT products used in NHS Scotland. The Fife Formulary product choices have been rationalised to reduce the number of choices available. There was a concern around potential increased use of the NRT Inhalator and proposed that this be monitored. It was proposed that the nicotine mouth spray be removed from the Formulary. Potential significant cost savings on NRT expenditure were noted. The Stop Smoking Prescribing Guidance has been amended to reflect the Formulary choices. Following discussion the Formulary Committee approved the Formulary amendment for nicotine replacement therapy and the updated Stop Smoking Prescribing Guidance. 5.6 Formulary Amendment - Atorvastatin Mr Reid introduced the Formulary amendment for atorvastatin and briefed the Committee on the background to this. It is proposed that the Formulary status of atorvastatin be amended to first line choice statin for the management of cholesterol. Simvastatin would be the second line Formulary choice statin. This will be applicable for new patients. Minimal budget impact is anticipated. It was noted that updated Management of Cholesterol Guidance is awaiting approval and would be consistent with this Formulary 4

5 change. Following discussion the Formulary Committee approved the change in Formulary status for atorvastatin. 5.7 Formulary Amendments - Chapter 7 Tamsulosin M/R Alfuzosin M/R Mr Notman introduced the Formulary Amendments for Tamsulosin M/R and Alfuzosin M/R for the treatment of lower urinary tract symptoms associated with benign prostatic hypertrophy (BPH). The proposed place in therapy is tamsulosin M/R first line choice and alfuzosin M/R second line choice for use in patients who have symptoms of BPH. The current first line choice for this indication is doxazosin. Tamsulosin M/R was previously the first line agent for this indication until a decision was made at the Formulary Rapid Improvement event in December 2016 to change this to doxazosin. It was noted that there was no representation from Urology Consultants at the Formulary Rapid Improvement Event. Studies have shown tamsulosin and alfuzosin to be effective in improving urinary flow rate. Tamsulosin is uro-selective. Alfuzosin would be used in patients in whom tamsulosin is not tolerated or ineffective and would be preferable to doxazosin as there is no requirement for dosing titration and less likely to cause postural hypotension. Doxazosin could be considered for use in patients who also have hypertension. Following discussion the Formulary Committee approved the Formulary Amendments for tamsulosin M/R (first line choice) and alfuzosin M/R (second line choice) for the treatment of lower urinary tract symptoms associated with BPH. Doxazosin to be removed from the Formulary for the management of BPH. Mirabegron Mr Notman introduced the Formulary Amendment request for mirabegron for the symptomatic treatment of urgency/increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder syndrome. Mirabegron was approved by the SMC in May 2013 and is included in the Fife Formulary for specialist initiation only for patients in whom 1st and 2nd choice formulary antimuscarinics are ineffective, not tolerated or contraindicated. The Formulary Amendment request is for the specialist 5

6 initiation restriction to be removed and for mirabegron to be available for general use by GPs prior to patients being referred to urology. GPs present at the meeting were concerned that initiation of mirabegron in General Practice prior to referral to urology would result in a lengthy delay prior to patients being seen by a specialist for investigation. The Male Lower Urinary Tract Symptoms Pathway details several investigations not available in Primary Care (flow rate/residual, cytoscopy) that should be carried out prior to treatment with mirabegron being considered. There is lack of clarity around the role of Urology/General Practice in terms of investigations prior to initiation of mirabegron and ongoing monitoring. General Practice workforce implications associated with additional blood pressure monitoring requirements were also highlighted. A request to change the Formulary status where there are implications for General Practice would require to be discussed at the Local Medical Committee. The Formulary Committee did not approve the Formulary Amendment request for mirabegron. 6 SMC RECOMMENDATIONS ISSUED APRIL 2017 The Formulary Committee decisions are recorded in Appendix 1. 7 SBAR - REQUEST FOR ADDITION OF ORAL SYSTEMIC ANTI- CANCER THERAPIES (SACT) FOR THE TREATMENT OF RENAL CELL CARCINOMA TO THE FIFE FORMULARY Mr Mohammed introduced the SBAR requesting the addition of oral systemic anti-cancer therapies for the treatment of renal cell carcinoma to the Fife Formulary and briefed the Committee on the background to this. When the oncology section of the Fife Formulary was last reviewed it was agreed that oncology drugs not being prescribed in NHS Fife should be removed from the Formulary. Renal cell carcinoma patients had previously been treated in Lothian however following the appointment of a uro-oncology consultant within NHS Fife it is proposed that oral systemic anti-cancer therapies for the treatment of renal cell carcinoma (Axitinib, Pazopanib and Sunitinib) be included in the Fife Formulary. These medicines are recommended by the SMC and have been approved for use by the Lothian Formulary Committee on behalf of SCAN. The Formulary Committee approved the request for the addition of oral systemic anti-cancer therapies for the treatment of renal cell carcinoma to the Fife Formulary. 8 SCAN FORMULARY SUBMISSIONS The SCAN Formulary Submissions approved by the Lothian Formulary Committee April 2017 were noted. Budgetary impact to be highlighted to ADTC. 6

7 9 NICE MULTIPLE TECHNOLOGY APPRAISAL (MTA) GUIDANCE NO 45 - CERTOLIZUMAB PEGOL AND SECUKINUMAB FOR TREATING ACTIVE PSORIATIC ARTHRITIS AFTER INADEQUATE RESPONSE TO DMARDs The Committee noted NICE Multiple Technology Appraisal (MTA) Guidance No 45 - certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs. 10 UPDATED FORMULARY SECTION 9.4, NUTRITIONAL PRODUCTS Mr Notman introduced the revised Formulary Section 9.4, Nutritional Products and highlighted the key changes. Changes include the inclusion of more cost effective products, addition of a paediatric section and amendment to a more straightforward layout. Dr Ainsworth highlighted that neonatal formula milk is prescribed in General Practice on specialist recommendation and proposed that this should be included in the paediatric section. Mr Notman to feed back comments regarding neonatal formula milk to dietetics for consideration. Subject to clarification on this, the Formulary Committee approved the updated Formulary Section 9.4. FN 11 SINGLE NATIONAL FORMULARY Dr Rogers provided a verbal update from the Single National Formulary Stakeholder Event held in May. The target for implementation of the Single National Formulary is Autumn It is anticipated that it will be an adult Formulary in the first instance. 12 STANDARD TEMPLATE FOR NEW MEDICINES DECISIONS Mr Mohammed highlighted the standard template for new medicines decisions produced by the ADTC Collaborative, Healthcare Improvement Scotland and the decision taken previously at the Formulary Committee to use option 5 not routinely available as local clinical experts do not wish to add the medicine to the formulary at this time or there is a local preference for alternative medicines as the default position in NHS Fife. Following further discussions between Mr Mohammed, Mr Notman, Dr Reid and Dr Rogers it is proposed that the default statement should be option 6 not routinely available as local implementation plans are being developed or the ADTC is waiting for further advice from local clinical experts. Option 5 should only be used when there is no intention to make a Formulary submission or it is beyond the 90 day submission deadline. This is in line with other Health Board areas. The Formulary Committee agreed to amend the default statement to option 6. 7

8 13 FIFE FORMULARY APP This item was carried forward to the next meeting. 14 MEMBERSHIP Dr Rogers highlighted the Terms of Reference of the Formulary Committee and went through the membership to identify any potential gaps. It was agreed that additional representation from Acute Medicine and Acute Nursing would be desirable. Mr Rivans advised that potential representation from Acute Nursing had previously been discussed and agreed to explore this further. It was noted that with the retiral of Dr Reid the Chair required to be elected by a ballot of members of the Formulary Committee. The Committee members nominated Dr Rogers as Chair and this was accepted. Nominations for the role of Vice-Chair to be considered and discussed at the next Formulary Committee meeting. IR ALL 15 MHRA DRUG SAFETY UPDATE MHRA Drug Safety Updates March 2017 and April 2017 were noted. 16 ITEMS FOR NOTING 16.1 Fife Medicines Focus March For information Minutes of other Regional Committee Meetings a Lothian Formulary Committee: 19 April For information. 17 ANY OTHER COMPETENT BUSINESS Formulary Amendment - infliximab (Inflectra ) Mr Reid introduced the Formulary Amendment request for infliximab (Inflectra ) for rheumatoid arthritis, adult and paediatric Crohn s Disease and ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis and briefed the Committee on the background to this. The current Formulary choice infliximab product for these indications is Remsima. Following a price review and tendering process by National Procurement, Inflectra is the most cost effective infliximab product for NHS Scotland for at least the next 13 months. Inflectra is the same manufactured product as Remsima, is manufactured in the same facility but marketed and distributed as two different brands in the UK. National Procurement is developing a leaflet with further background information confirming that Remsima and Inflectra are identical products, which can be shared with clinical and pharmacy staff. Fife Clinicians are supportive of the switch from Remsima to Inflectra. 8

9 The Formulary Committee approved the Formulary Amendment for inflximab (Inflectra ). 18 DATE OF NEXT MEETING The next meeting is to be held on Wednesday 26 July 2017 at 1.00pm in the Seminar Room, Whyteman s Brae Hospital, Kirkcaldy. 9

10 National Guidance - Formulary Decisions Scottish Medicines Consortium Recommendations Medicine Condition being treated Decision of FFC Date of NHS Board decision belimumab, 120mg and 400mg powder for Indication under review: Add-on therapy in adult patients with Not routinely available as local implementation plans are concentrate for solution for infusion active, autoantibody-positive systemic lupus erythematosus being developed or the ADTC is waiting for further (Benlysta ) (SLE) with a high degree of disease activity (e.g. positive antidsdna advice from local clinical experts - decision expected by 775/12 SMC Advice and low complement) despite standard therapy. 26 July SMC restriction: patients with evidence of serological disease activity (i.e. positive anti-dsdna and low complement) and a Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score 10. idebenone (Raxone ) 150mg film-coated tablets 1226/17 SMC Advice Indication under review: Treatment of visual impairment in adolescent and adult patients with Leber s Hereditary Optic Neuropathy (LHON). SMC restriction: to patients with LHON who are not yet blind i.e. they do not meet the UK criteria to be registered as severely sight impaired. Not routinely available as local implementation plans are being developed or the ADTC is waiting for further advice from local clinical experts - decision expected by 26 July micronised progesterone vaginal capsules 200mg (Utrogestan ) 935/13 SMC Advice Indication under review: in women for supplementation of the luteal phase during Assisted Reproductive Technology (ART) cycles. Routinely available from a specialist centre in another health board. nepafenac 3mg/mL eye drops, suspension (Nevanac ) 1228/17 SMC Advice talimogene laherparepvec (Imlygic ) 10 6 and 10 8 plaque forming units (PFU)/mL solution for injection 1248/17 SMC Advice Indication under review: reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients. Indication under review: Treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. Not routinely available as local implementation plans are being developed or the ADTC is waiting for further advice from local clinical experts - decision expected by 26 July Not routinely available as not recommended for use in NHSScotland SMC Advice alectinib hydrochloride (Alecensa ) 150mg hard capsules 1257/17 SMC Advice Indication under review: As monotherapy for the treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer previously treated with crizotinib. Not routinely available as not recommended for use in NHSScotland SMC Advice liraglutide (Saxenda ) 6mg/mL solution for injection in pre-filled pen 1247/17 SMC Advice Indication under review: as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index of 30kg/m² (obese), or 27kg/m² to < 30kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea. Not routinely available as not recommended for use in NHSScotland SMC Advice NICE (Multiple) Technology Appraisal (MTA) Recommendations Certolizumab pegol NICE MTA 445 Active psoriatic arthritis after inadequate response to DMARDs Routinely available in line with national guidance NICE MTA

11 Secukinumab NICE MTA 445 National Guidance - Formulary Decisions Active psoriatic arthritis after inadequate response to DMARDs Routinely available in line with national guidance NICE MTA 445 Summary of Approved Lothian Formulary Committee Decisions for SCAN Medicines April 2017 Product Name SMC Advice Place in therapy Lothian formulary Committee Decision Cabazitaxel (Jevtana ) Cabazitaxel in combination with prednisone or prednisolone is indicated for the treatment of adult patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. SMC restriction: for use in patients who have received at least 225mg/m2 (three cycles) of docetaxel and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This will be additional treatment for metastatic castrate resistant prostate cancer patients and will not routinely displace any existing treatment options. Approved for specialist use only. Add to Fife Formulary Yes / No Rationale Yes To be prescribed in line with SCAN protocol. Patients will be treated in NHS Fife. Everolimus (Afinitor ) for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease. Patients with advanced and progressing nonfunctional neuroendocrine tumours (over the previous 12 months) who are, or are likely to become symptomatic on the basis of disease volume will be identified at the MDT and the treatment option will be discussed with them. It will also be considered in young fit patients who present with high volume disease that is not suitable for somatostatin analogue therapy. Approved for specialist use only. Yes To be prescribed in line with SCAN protocol. Patients will be treated in NHS Fife. Treatment will be in addition to current treatment options. Osimertinib (Tagrisso ) Trifluridine/Tipiracil (Lonsurf ) The treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall-cell lung cancer (NSCLC). SMC Restriction: in patients who have received previous treatment with an EGFR tyrosine kinase inhibitor. The treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecanbased chemotherapies, anti vascular endothelial growth factor agents, and anti-epidermal growth factor receptor agents. Osimertinib represents an additional line of therapy before systemic chemotherapy. Patients will continue to be treated with this medicine as long as they do not show progression which, if patients continue beyond 12 months, could have significant implications on service given the high costs of this treatment. Will be used in patients with metastatic CRC who have been previously treated with, or are not considered as candidates for first or second-line therapy. Approved for specialist use only. Approved for specialist use only. Yes To be prescribed in line with SCAN protocol. Patients will be treated in NHS Fife. Yes To be prescribed in line with SCAN protocol. Patients will be treated in NHS Fife. 11