BORDERS FORMULARY COMMITTEE. Minutes of a Meeting held on Wednesday, 13 th October 2010 At p.m. in the Committee Room, Education Centre

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BORDERS FORMULARY COMMITTEE Minutes of a Meeting held on Wednesday, 13 th October 2010 At 12.30 p.m.

1 BORDERS FORMULARY COMMITTEE Minutes of a Meeting held on Wednesday, 13 th October 2010 At p.m. in the Committee Room, Education Centre Present: Alison Wilson (Chair) (AW), Ros Anderson (RA), Liz Leitch (LL), Declan Hegarty (DH), Catherine Scott (CS), Tom Cripps (TC) In attendance: Jakki Faccenda 1. Apologies and Announcements: Vince Summers, Olive Herlihy, Adrian Mackenzie 2. Declaration of Interest: None 3. Minutes of previous meeting held on: 11 th August 2010 These were read and approved. 4. Matters Arising: Calcium Supplements RA informed the meeting that Dr Andrew Pearson was still on sick leave so nothing further has been progressed. The community pharmacists are having difficulty supplying Dekristol and sunvitd3 to patients but they can order from the BGH pharmacy dept. It was agreed that when Dr A Pearson returns to work we need to look at this. TC asked should we go back to Clinical Management to say not acceptable when someone is of sick and nothing is done in the meantime. RA agreed to put something in the next bulletin to inform community pharmacists. Sartans LL has looked at the evidence but not sufficient to support the switch to Losartan no savings would be made in the short term. SMC Approvals SH reported that these can be viewed on the intranet under Medicines then go to the ADTC section. Prescribing of Ulipristal to a Patient LL has spoken to Dr Ailsa Wylie and she said that they generally go with the patient s history and if they felt necessary they would carry out a pregnancy test before prescribing. Episil Medical Device More supporting evidence has been requested from Dr Tucker and will be sent to SH for the next meeting of the ADTC. Sitagliptin LL reported that she has not yet met with Dr Peter Leslie or Dr Olive Herlihy. 5. Applications for approval: i) Adrenaline Autoinjector (Anapen ) Dr Jakki Faccenda informed the meeting that they would like to change all patients who use an Epipen to an Anapen. The supporting evidence is that Anapen has a longer shelf life than Epipen so would reduce wastage, it can also be administered as a 500mcg dose rather than a 300mcg dose so preventing a second dose having to be administered cutting down costs. It was agreed to update the leaflet that goes out to patients, community pharmacists, GP s etc and Linda Taylor in her role could do training if required in the practices. Once this has been approved by the Clinical Executive we shall set a start date. It was also suggested that Jakki Faccenda come along to one of our NES pharmacy training evenings to give a short presentation. Recommended As CAT A Recommended for general use hospital and general practice Action RA LL 1

2 ii) Apriprazole (Abilify ) LL explained that this is for the treatment of schizophrenia in adolescents 15 years of age and older (Licensed indication) and for control of behavioural problems in younger children with specific special needs unlicensed indication). These are two indications one is licensed and the other is unlicensed. The committee approved the licensed indication and AW agreed to write to the applicant to suggest approval for the unlicensed indication is dependant on the Consultants either maintaining responsibility for prescribing and monitoring of these patients or developing a shared care protocol. Recommended As CAT B Specialist Use Only with Shared Care Protocol (this will need updated pending response from applicant) iii) Ertapenem (Invanz ) TC informed the group that this can be administered by intravenous infusion in once daily dosage whereas others are administered three or four times daily. Recommended As CAT B Specialist Use Only iv) Adalimumab (Humira ) LL talked on this application from David McKay, consultant dermatologist for treatment of plaque psoriasis, in line with SMC approval. This item should be added to the GPASS system and an alert on the emergency care summary. Recommended As CAT B Specialist Use Only v) Normal Human Immunoglobulin (Subgam) CS read through this application which is to be administered by the parents of the patient. Do we want all immunoglobulin applications to come through this committee asked LL and the answer from the group was yes. National guidelines should be adhered to and we shall review at the next BFC meeting. Recommended As CAT B Specialist Use Only for this one patient vi) Dronedarone (Multaq ) LL talked on behalf of this application and read out the SMC advice. It is not as effective as amiodarone, but is better tolerated. Agreed to approve on the basis of use in for patients who are not tolerant of amiodarone. If this is not how the applicant is intending to use it then it has to come back to the ADTC. Recommended As CAT F For Consultant initiation and subsequent general use hospital and general practice vii) Dutasteride+Tamsulosin (Combodart ) LL read out this application and DH advised that this was not recommended as combination therapy only for patients who can tolerate them both. The protocol is to put patients on both at the same time, so is for patients who are already on this combination. No major advantages can be seen. Recommended to be prescribed to established patients only and a check to be made on the patent expiry date, which would be picked up through prescribing. viii) Febuxostat (Adenuric ) DH talked on behalf of this application and said it was for use in patients who can not tolerate allopurinol. We would need to have indications on when to use it. It was agreed to approve for general use and bring to the ADTC and then it could go into the formulary bulletin. Recommended As CAT A General Use Hospital and General Practice 6. Scottish Medicines Consortium Recommendations a) SMC Decisions (advice & embedded below) Recommended for use within NHS Scotland No. EMBARGOED UNTIL 11 TH OCTOBER

3 590/09 certolizumab pegol, 200 mg/ml solution for injection (prefilled syringe) (Cimzia ) ADVICE: following a resubmission certolizumab pegol (Cimzia ) is accepted for use within NHS Scotland. Indication under review: - in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease modifying anti-rheumatic drugs, including methotrexate, has been inadequate. - monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. In patients who continued to receive methotrexate despite an incomplete response, the addition of certolizumab pegol for 24 weeks produced a rapid and sustained reduction in the signs and symptoms of rheumatoid arthritis, inhibited structural joint damage progression and improved physical function compared with placebo. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of certolizumab pegol. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland. 643/10 ethinylestradiol 20microgram / desogestrel 150microgram (Gedarel 20/150 microgram) film-coated tablets ethinylestradiol 30microgram / desogestrel 150microgram (Gedarel 30/150 microgram) film-coated tablets ADVICE: following an abbreviated submission ethinylestradiol 20microgram/desogestrel 150microgram and ethinylestradiol 30microgram/desogestrel 150microgram (Gedarel ) is accepted for use within NHS Scotland. Indication under review: oral contraception. For patients in whom ethinylestradiol /desogestrel is an appropriate contraceptive, Gedarel provides an alternative to existing preparations at lower cost. 644/10 ethinylestradiol 20 microgram / gestodene 75microgram (Millinette 20/75microgram) film-coated tablets ethinylestradiol 30 microgram / gestodene 75microgram (Millinette 30/75microgram) film-coated tablets ADVICE: following an abbreviated submission ethinylestradiol 20microgram/gestodene 75microgram and ethinylestradiol 30microgram/gestodene 75microgram (Millinette ): is accepted for use within NHS Scotland. 3

4 Indication under review: oral contraception. For patients in whom ethinylestradiol /gestodene is an appropriate contraceptive, Millinette provides an alternative to existing preparations at lower cost. 645/10 Ethinylestradiol 30/40microgram/levonorgestrel 50/75/125microgram (TriRegol ) ADVICE: following an abbreviated submission ethinylestradiol 30/40 plus levonorgestrel 50/75/125 microgram (TriRegol ): is accepted for use within NHS Scotland. Indication under review: oral contraception. For patients in whom phasic ethinylestradiol and levonorgestrel is an appropriate contraceptive, TriRegol provides an alternative to the existing preparation at lower cost. 646/10 ethinylestradiol 30microgram and levonorgestrel 150microgram (Rigevidon 30/150 microgram) film-coated tablets ADVICE: following an abbreviated submission ethinylestradiol 30microgram/levonorgestrel 150microgram (Rigevidon ): is accepted for use within NHS Scotland. Indication under review: oral contraception. For patients in whom ethinylestradiol/levonorgestrel is an appropriate contraceptive, Rigevidon provides an alternative to existing preparations at a lower cost. Recommended for restricted use within NHS Scotland No. EMBARGOED UNTIL 13 TH SEPTEMBER /09 imatinib, 100mg and 400mg film-coated tablets (Glivec ) ADVICE: following a re-submission imatinib (Glivec ) is accepted for restricted use within NHS Scotland. Indication under review: adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumours (GIST). Patients who have a low or very low risk of recurrence should not receive adjuvant treatment. SMC restriction: Imatinib is restricted to use in patients at high risk of recurrence following complete resection (according to the Armed Forces Institute of Pathology (AFIP) risk criteria). Imatinib, given for a period of one year, significantly improved the estimated one 4

5 year recurrence-free survival compared with placebo and was associated with an increase of 16.4 months in median time to recurrence in patients at high risk of relapse following resection. The economic case was demonstrated for a one-year adjuvant treatment duration only. 636/10 dronedarone, 400mg, film-coated tablets (Multaq ) dronedarone (Multaq ) is accepted for restricted use within NHS Scotland. Indication under review: in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. SMC restriction: for the prevention of recurrence of AF in patients in whom conventional first-line anti-arrhythmic medicines are ineffective, contra-indicated or not tolerated. Treatment should be initiated on specialist advice only. Dronedarone appears less effective than amiodarone in reducing atrial fibrillation recurrence but has the potential for improved tolerability compared to comparator medicines. 637/10 febuxostat 80mg and 120mg tablets (Adenuric ) febuxostat (Adenuric ) is accepted for restricted use within NHS Scotland. Indication under review: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence, of tophus and/or gouty arthritis). SMC restriction: when treatment with allopurinol is inadequate, not tolerated or contra-indicated. Febuxostat is superior to allopurinol 300mg daily in reducing serum uric acid to <6mg/dL, (360micromol/L) in patients with hyperuricaemia and gout. (NB The maximum licensed daily dose of allopurinol is 900mg.) The economic case was demonstrated for second line use of febuxostat in patients who had an inadequate response to allopurinol, or when allopurinol is contraindicated or not tolerated. 638/10 bivalirudin 250mg powder for concentrate for solution for injection or infusion (Angiox) bivalirudin (Angiox) is accepted for restricted use within NHS Scotland. 5

6 Indication under review: as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. Bivalirudin should be administered with aspirin and clopidogrel. Restriction: patients who would have been considered for treatment with heparin in combination with a glycoprotein IIb/IIIa inhibitor. It should not be used as an alternative to heparin alone. In patients with STEMI undergoing PCI, bivalirudin, compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with significantly lower rates of major bleeding, cardiac death and thrombocytopenia. LL has spoken to Dr Neary and he does not wish to proceed with this. Not recommended for use within NHS Scotland No. EMBARGOED UNTIL 13 TH SEPTEMBER /09 agomelatine, 25mg film-coated tablets (Valdoxan ) ADVICE: following a re-submission agomelatine (Valdoxan ) is not recommended for use within NHS Scotland. Indication under review: Treatment of major depressive episodes in adults. When used in a flexible dosing schedule, agomelatine significantly reduced the symptoms of depression and increased the number of patients who responded to treatment compared with placebo. There are no comparative data from clinical studies with existing second line antidepressants using depression as the primary outcome. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. LL has passed this information to our colleagues in Mental Health. 634/10 trabectedin, 250 microgram, 1mg powder for concentrate for solution for infusion (Yondelis ) trabectedin (Yondelis) is not recommended for use within NHS Scotland. Indication under review: Trabectedin in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinumsensitive ovarian cancer. In an open-label randomised controlled study trabectedin in combination with PLD was significantly superior to PLD monotherapy in terms of progression free survival. There was a significant difference in an exploratory interim analysis of overall survival in the sub-group of patients with partially platinum-sensitive disease. The manufacturer s justification of the treatment s cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition, the manufacturer did not present a sufficiently robust economic case to gain 6

7 acceptance by SMC. No. EMBARGOED UNTIL 11 TH OCTOBER /10 roflumilast 500 microgram tablets (Daxas ) roflumilast (Daxas ) is not recommended for use within NHS Scotland. Indication under review: maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (forced expiratory volume in 1 second [FEV 1 ] postbronchodilator <50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. Roflumilast has been associated with improved lung function and reduced the rate of moderate and severe COPD exacerbations compared to placebo in studies of patients representing the licensed population. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. LL reported respiratory team have been informed that this has not been approved. 640/10 lanthanum carbonate, 500mg, 750mg, 1,000mg, chewable tablets (Fosrenol ) lanthanum carbonate (Fosrenol ) is not recommended for use within NHS Scotland. Indication under review: as a phosphate binding agent for use in the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphate levels 1.78mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels. When compared with placebo, in patients with chronic kidney disease not yet on dialysis, more patients treated with lanthanum carbonate achieved a serum phosphate concentration 1.49mmol/L. The manufacturer did not present a sufficiently robust clinical or economic analysis to gain acceptance by SMC. LL reported that the renal consultant has been informed and updated. 642/10 pemetrexed, 100mg, 500mg powder for concentrate for solution for infusion (Alimta) pemetrexed (Alimta) is not recommended for use within NHS Scotland. Indication under review: monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. First-line 7

8 treatment should be a platinum doublet with gemcitabine, paclitaxel or docetaxel. In a sub-group analysis of patients with non-squamous NSCLC, progression free survival and overall survival (secondary endpoint) were significantly longer for pemetrexed plus best supportive care (BSC) compared to placebo plus BSC. However, the manufacturer did not present a sufficiently robust economic case and their justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC. 7. Patient Safety: RA reported that she has talked to Dr Simon Watkins about Lithium and this will be going to the Internal Governance meeting. MHRA drug safety update for Nexplanon LL will discuss with Dr Ailsa Wylie. We need to look at how much Implanon in the system and this should be used up first. 8. Formulary Update: - LL Amendments to Formulary - LL went over the changes to the formulary. The entry for Movicol is to be changed to generic compound macrogol powder (Laxido). Primary care pharmacists need to do searches and change patients from Movicol. A clear message to go out to all pharmacists informing them that we are going to be moving and set a date and let the District Nurses know. Respiratory Section Prednisolone EC to be removed from formulary and the addition of Fostair bullet points. Dental Formulary David Clouting to be asked to change erythromycin to clarithromycin (local macrolide of choice). The draft guidelines are currently circulated round to dentists for comments. Nystatin Could we put in sugar free only as it is much cheaper? It has also come to light that some private patients are still receiving NHS prescriptions. ADHD Shared Care Protocol and Ritalin to be withdrawn. Looking to update the first option on the intranet. Guideline approved Melatonin Shared Care Protocol - LL to circulate this to paediatricians between now and the next ADTC make them aware of the cost of the different drugs. Once finalised this needs to go out to GP s and community pharmacists. Stoma Products in Formulary RA is encouraging the continence service to put in applications for items that are already in use but not in the formulary and has advised Verna Henderson. LL asked if there is a need to encourage a stoma formulary section and LL agreed to meet with Verna Henderson to organise a stoma section for the formulary. Action: LL Borders Formulary on Internet It was agreed to keep charging for the moment for hard copies and if it gets easier we shall discuss putting on the internet in due course. 9. Lothian Formulary Committee Minutes 18 th August 2010 (for information) LL asked the group to note the antiretroviral, are we happy to accept or do we want DC to apply for use and if Lothian approve for use could they send us something for noting. 10. NICE GUIDANCE: (for information) - Noted NICE (Multiple) Technology Appraisal Guidance No 200 Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C (part review of technology appraisal guidance 75 and 106) Any Other Business: DH said I propose that Keith Maclure and I talk to LL 8

9 about Cisteen (Cisplatin) Action: DH/KMacl 12. Date Of Next Meeting: 8 th December p.m. Discussion Room 1, Education Centre 9

10 NAME RA LL LL DH ACTION TABLE Problems with the supply of Dekristol & SunvitD3 Community Pharmacists can order from the BGH pharmacy dept. RA to put something in the next bulletin to inform community pharmacists. To meet with Dr Peter Leslie or Dr Olive Herlihy to discuss Sitagliptin. LL to meet with Verna Henderson to discuss a stoma section in the formulary. To meet with Keith Maclure and LL to talk about Cisteen 10

LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE

LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on 29 September 2010 in Room 004, Ground Floor, Pentland House Present: J Carson Dr J Dear Dr J Forbes Dr H Gillett Dr W Jamieson S Kerr