LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE

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1 FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on 30 th January 2013 from 2.00pm 4.00pm in Room 004, Ground Floor, Pentland House Present: J Carson Lead Directorate Pharmacist, Royal Infirmary of Edinburgh Dr J Dear Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh Dr J Forbes Formulary Committee Co-Chair and Reader in Health Economics, University of Edinburgh (in the chair) Dr H Gillett Consultant Gastroenterologist, St John s Hospital Dr SC Hornibrook General Practitioner, Lothian Dr S Hurding General Practitioner, NHS Lothian S Kerr Lead Pharmacist, Western General Hospital I Mohammed Clinical Effectiveness Pharmacist, NHS Fife J Pearson Formulary Pharmacist, NHS Lothian L Shaw Lead Directorate Pharmacist, Royal Infirmary of Edinburgh T Slaughter Clinical Effectiveness Pharmacist, North Cumbria Medicines Management Group G Todd Lead Pharmacist, Royal Edinburgh Hospital and Roodlands Hospital Dr D Wilks Consultant in Infectious Diseases, Western General Hospital Dr R Williams General Practitioner, Lothian In attendance: Z Stofankova Apologies for absence: J Bradie Dr E Brown Dr W Jamieson Professor S Lawrie L Leitch Clinical Nurse Manager, Royal Infirmary of Edinburgh Consultant Oncologist, Western General Hospital General Practitioner, Lothian Formulary Committee Co-Chair and Professor and Honorary Consultant Psychiatrist, Royal Edinburgh Hospital Formulary Pharmacist, NHS Borders Declarations of interest: The Chair reminded members to declare any interests in any of the products to be discussed. 1. Minutes of the previous meeting held on 19 th December The minutes of the meeting of 19 th December 2012 were approved as an accurate record of that meeting.

2 2. Matters arising from previous minutes 2.1 Diabetes section It was noted that in November 2012 the committee approved amendments to LJF section antidiabetes drugs, keeping sitagliptin as a first choice drug gliptin and removing the prescribing notes for saxagliptin The committee members discussed correspondence received asking the committee to reconsider their decision and to add saxagliptin back to the LJF as an alternative treatment option. It was suggested to list saxagliptin as a prescribing note It was noted that although saxagliptin costs slightly less than sitagliptin it has no real additional clinical benefits compare to sitagliptin. Sitagliptin has the widest range of indications with SMC approval and therefore it was suggested as first choice drug The committee noted that saxagliptin is only approved by SMC for use in combination with metformin and that prescribers would need to change gliptin if the combination of medicines was to change. This was thought to be confusing for both the prescriber and patient It was agreed that the LJF section antidiabetes drugs remains as approved in November Formulary Committee Constitution The members of the Formulary Committee (FC) noted and discussed the amended version of the FC Constitution which has been revised to incorporate comments made at the Area Drug and Therapeutic Committee (ADTC) meeting The main amendment was in relation to the criteria of committee quorum It was noted that the members of the formulary committee are encouraged to attend as many meetings as possible to avoid unnecessary cancellation of the meetings The constitution will be added to the LJF website. 3. SMC Recommendations 3.1 aclidinium bromide (Eklira Genuair ) The committee noted and discussed the previously circulated submission and SMC report. Seven declarations of interests (personal specific and personal nonspecific) were included with the submission and noted by the committee. aclidinium 322 micrograms inhalation powder (Eklira Genuair ) No. 810/12 ADVICE: following a full submission: aclidinium bromide (Eklira Genuair ) is accepted for use within NHS Scotland. Indication under review: as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). In two phase III studies, aclidinium was statistically superior to placebo in improving lung function (forced expiratory volume in 1 second [FEV 1 ]) after 12 weeks and 24 weeks.

3 3.1.2 The committee noted the FAF1 submission for the use of aclidinium bromide (Eklira Genuair ) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) It was noted that a local Lothian protocol has not been developed however guidance of the Lothian Respiratory MCN is available and the general principles given by the British Thoracic Society and NICE will be followed It was noted that the only currently available long-acting muscarinic antagonist (LAMA), is tiotropium bromide however this is available through a device that requires individual dose loading with a capsule and significant manual dexterity, and has a high inspiratory resistance It was noted that aclidinium bromide is administered twice daily compare to tiotropium bromide administered only once daily. Concern was highlighted that this could potentially create confusion if patients are switched from tiotropium to aclidinium. However this confusion should be minimal as there is no need to switch patients to aclidinium if they are stable The committee noted that aclidinium bromide will be used as a step up treatment in patients who are already taking short-acting beta-agonists (SABA) or shortacting muscarinic agonists (SAMA) as required, experience exacerbations or persistent breathlessness The committee noted that the evidence to support the efficacy of aclidinium in COPD comes from two similarly designed phase III studies proving its clinical effectiveness against placebo. Since the studies excluded patients with certain cardiovascular conditions, aclidinium should be used with caution in those patients It was noted that there are no published comparative studies with tiotropium however a late paper was submitted by the clinical team summarising data from a six week trial comparing aclidinium, tiotropium and placebo The committee noted that aclidinium bromide has evidence to show it is clinically as effective as tiotropium, has a good safety profile, and has advantages with regards to costs and the inhaler device which is easy to use even for patients with dexterity difficulties The committee agreed to Include aclidinium bromide (Eklira Genuair ) on the LJF as first choice drug for the indication in question. ACTION: JF/JP

4 3.2 ranibizumab (Lucentis ) LOTHIAN FORMULARY COMMITTEE The committee noted and discussed the previously circulated submission and SMC report. No declarations of interests were included with the application. ranibizumab, 10mg/mL solution for injection (Lucentis ) No. 711/11 ADVICE: following a full resubmission: ranibizumab (Lucentis ) is accepted for restricted use within NHS Scotland. Indication under review: Treatment of visual impairment due to diabetic macular oedema (DMO) in adults. SMC restriction: treatment of visual impairment due to DMO in adults with best corrected visual acuity (BCVA) 75 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or less at baseline. Ranibizumab significantly improved visual acuity over 12 months compared with standard laser photocoagulation treatment. Open label extension results up to 3 years suggest maintenance of effect. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ranibizumab. This SMC advice is contingent upon the continuing availability of the patient access scheme or a list price that is equivalent or lower The committee noted the FAF1 submission for the use of ranibizumab (Lucentis ) for the treatment of visual impairment due to DMO in adults with best corrected visual acuity (BCVA) 75 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or less at baseline It was noted that a local Lothian protocol has not yet been developed and that the treatment will take place in secondary care The committee noted that ranibizumab will be used in diabetic patients with centre involving diabetic macular oedema, visual acuity between 6/10 and 6/60, and macular thickening on OCT images It was noted that ranibizumab can be only administered by ophthalmologist experienced in giving intravitreal injections and that a sterile theatre environment is mandatory for its safe delivery Concern was highlighted about the extra capacity needed to accommodate the amount of patients who are to be treated with this drug. It was noted that this could have a big impact on theatre/sterile room lists Ranibizumab 0.5mg is administered monthly as a single intravitreal injection and will be continued until patient s visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment. If there is no improvement in visual acuity over the course of the first three injections, continued treatment is not recommended. Thereafter patients should be monitored monthly for visual acuity Treatment will be resumed when monitoring indicates loss of visual acuity due to DMO The committee noted that on average patients will require 7 injections in their first year, 4 injections in their second year and 3 injections in their third year.

5 It was noted that costs provided in the application have not included additional expenses for theatre/sterile room lists and staff support. The costs were also not quantified to include new patients starting treatment in year two and three The committee would therefore agreed to highlight to the ADTC the potential risks around capacity of service and the associated costs It was noted that Patient Access Scheme (PAS) for ranibizumab is available The committee agreed to Include ranibizumab (Lucentis ) on the Additional List, Specialist Use only, for the indication in question. ACTION: JF/JP 4. SMC latest Not Recommended Medicines (December 2012 January 2013) The committee noted the following medicine not recommended for use by SMC in NHS Scotland: 4.1 ivacaftor (Kalydeco ), Report No. 827/12, is not recommended for use within NHS Scotland for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene A letter from the Scottish Government was received stating that the Health Minister has stated that all patients eligible to ivacaftor should receive the treatment It was noted that the use of ivacaftor will be funded through the newly announced orphan drug fund, however only for the period of one year from 1 March 2013 until The discussions around implementing this are still ongoing and it was agreed that we need to wait on the further guidance being issued. 4.2 inhaled mannitol (Bronchitol ), Report No. 837/13, is not recommended for use within NHS Scotland for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care. 4.3 NON-SUBMISSIONS brentuximab vedotin (Adcetris ), Report No. 845/12, is not recommended for use within NHS Scotland for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following autologous stem cell transplant (ASCT) or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option and treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (salcl). decitabine (Dacogen ), Report No. 846/12, is not recommended for use within NHS Scotland for the treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.

6 etoricoxib (Arcoxia ), Report No. 847/12, is not recommended for use within NHS Scotland for short-term treatment of moderate pain associated with dental surgery. hydrocortisone (Plenadren ), Report No. 848/12, is not recommended for use within NHS Scotland for the treatment of adrenal insufficiency in adults. tadalafil (Cialis ), Report No. 849/12, is not recommended for use within NHS Scotland for the treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. 5. Other Medicines Proposed for Use 5.1 digoxin immune fab (Digifab ) The committee noted the FAF2 submission for the use of digoxin immune fab (Digifab ) for the treatment of life threatening digoxin toxicity No declarations of interests were included with the application It was noted that digoxin immune fab will be used in patients with life threatening digoxin toxicity associated with ventricular arrhythmias, bradyarrhythmias or second or third degree heart block not responsive to atropine It was noted that currently there is no other drug available as the previously used preparation Digibind has been discontinued The committee noted that a local Lothian protocol has not been developed and that the prescribing will take place in secondary care only It was noted that digoxin immune fab has 3 years shelf life and will be stocked at the Royal Infirmary of Edinburgh The committee agreed that a clear process should be put in place to ensure that all other hospital sites are aware of where they can obtain a supply of this medicine when needed It was noted that digoxin immune fab is clinically effective and has a good safety profile The committee agreed to add digoxin immune fab (Digifab ) to the Additional List for Specialist Use only. ACTION: JF/JP 5.2 cefazolin sodium (Kefzol ) The committee noted the FAF3 submission for the use of cefazolin sodium (Kefzol ) for the treatment of meticillin-sensitive Staph aureus (MSSA) bacteraemia in renal patients No declarations of interests were included with the application It was noted that the local Lothian protocol has not been developed however this treatment option will be incorporated in to the current line care protocol for renal patients It was noted that renal patients are currently treated with either flucloxacillin (which prevents early discharge from hospital) or with vancomycin (which is less effective) The committee noted that in renal patients cefazolin sodium allows IV administration in direct relation to dialysis, compared to a need for additional

7 interdialytic (6 hourly) IV administration for flucloxacilin. The therapeutic drug level monitoring is not required for cefazolin but is required for vancomycin It was noted that cefazolin sodium should be included in the Alert Antibiotic Policy for the indication stated in the application only The committee agreed to add cefazolin sodium (Kefzol ) to the Additional List, for Specialist Use only, categorised RED under the ADTC policy for unlicensed and off label medicines. The Alert Antibiotic Policy should be updated accordingly. ACTION: JF/JP 5.3 propranolol The committee noted the FAF3 submission for the use of propranolol for the treatment of childhood haemangioma causing functional problems or disfigurement No declarations of interests were included with the application It was noted that the local Lothian protocol has been developed and approved by the Paediatric Drug and Therapeutic Committee. The applicants have submitted the protocol with the application The committee noted that propranolol has already been used in this indication via the non-formulary route It was noted that propranolol is proposed to be used as first line treatment. On rare occasions it may be necessary to also use prednisolone It was noted that prescribing will take place in secondary care only with monthly outpatient reviews. Likely duration treatment is 3-6 months depending upon assessed response at combined follow up clinic The committee noted that the evidence is based on one small study comparing propranolol with placebo. There are also various unpublished clinical studies comparing this drug with placebo and steroids. However the outcome of these trials is still awaited It was noted that the clinical team at the Royal Hospital for Sick Children closely monitors all patients on propranolol and collects all information and evidence. There are currently over 40 patients who have been treated successfully with minimal side effects. There were only two cases of re-growth once the treatment has been stopped The committee agreed to add propranolol to the Additional List, for Specialist Use only, categorised RED under the ADTC policy for unlicensed and off label medicines. It was noted that the committee members would like to see the outcome from the trials once they are published ACTION: JF/JP

8 6. SMC Abbreviated Submissions LOTHIAN FORMULARY COMMITTEE 6.1 budesonide (Budenofalk ) budesonide 9mg gastro-resistant granules (Budenofalk ) No. 831/12 ADVICE: following an abbreviated submission: budesonide 9mg gastro-resistant granules (Budenofalk ) is accepted for use within NHS Scotland. Indication under review: induction of remission in patients with active collagenous colitis. Budesonide gastro-resistant granules provides a once daily alternative to budesonide gastro-resistant 3mg capsules (which are given three times daily) at no additional cost. The granules may have advantages for patients who have difficulty swallowing It was noted that there was also a full submission issued by SMC for this drug at the same time as the abbreviated submission. Therefore the clinical team have been asked to submit the FAF1 application for both pieces of SMC advice at the same time The committee agreed to Not Include budesonide (Budenofalk ) on the LJF, pending protocol. 6.2 colecalciferol (Desunin 800 IU ) colecalciferol 800 international units (equivalent to 20 micrograms vitamin D 3 ) tablets (Desunin 800 IU ) No. 840/13 ADVICE: following an abbreviated submission: colecalciferol tablets (Desunin 800 IU ) is accepted for use within NHS Scotland. Indication under review: prevention and treatment of vitamin D deficiency in adults and adolescents. In addition to specific osteoporosis treatment of patients who are at risk of vitamin D deficiency, supplemental calcium should be considered. The therapeutic use and safety profile of colecalciferol as a treatment for vitamin D deficiency and as an adjunctive treatment in osteoporosis is well established. There are no comparative data for colecalciferol (Desunin ). It is the same cost as another vitamin D preparation The committee agreed to Include colecalciferol (Desunin 800 IU ) on the LJF for the indication in question.

9 6.3 etanercept (Enbrel ) LOTHIAN FORMULARY COMMITTEE etanercept 10mg and 25mg powder and solvent for solution for injection for paediatric use, 25mg and 50mg solution for injection in pre-filled syringe, 50mg solution for injection in pre-filled pen (Enbrel ) No. 842/13 ADVICE: following an abbreviated submission: etanercept (Enbrel ) is accepted for restricted use within NHS Scotland. Indication under review: for the treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate; psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate; enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. SMC restriction: use within specialist rheumatology services (including those working within the network for paediatric rheumatology). Etanercept has previously been accepted by the SMC for the treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Etanercept is listed in the British National Formulary for Children as one of a number of treatment options for juvenile idiopathic arthritis including the above subtypes The committee agreed to Include etanercept (Enbrel ) on the Additional List, Specialist Use only, for the indication in question.

10 6.4 linagliptin + metformin (Jentadueto ) linagliptin 2.5mg plus metformin 850mg and linagliptin 2.5mg plus metformin 1000mg film-coated tablets (Jentadueto ) No. 841/13 ADVICE: following an abbreviated submission: linagliptin plus metformin tablets (Jentadueto ) is accepted for restricted use within NHS Scotland. Indication under review: Treatment of adult patients with type 2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin. in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. SMC restriction: to use in patients for whom a combination of linagliptin and metformin is an appropriate choice of therapy and these fixed-doses are considered appropriate The committee agreed to Not include linagliptin + metformin (Jentadueto ) on the LJF because NHS Lothian decision is that the medicine does not represent sufficient added benefit to other comparator medicines to treat the condition in question which are already available in the formulary. Sitagliptin remains the LJF choice. 6.5 palonosetron (Aloxi ) palonosetron 500microgram soft capsules (Aloxi ) No. 838/13 ADVICE: following an abbreviated submission: palonosetron soft capsules (Aloxi ) is accepted for use within NHS Scotland. Indication under review: prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. At recommended licensed doses the soft capsule formulation has been shown to be clinically non-inferior to the intravenous formulation and is cost neutral. SMC has previously accepted palonosetron intravenous injection for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy The committee agreed to Include palonosetron (Aloxi ) on the Additional List for the indication in question.

11 7. Non-submissions to Formulary Committee (November day target) In line with the SGHD/CMO(2012)1 letter that applications should be made to FC within 90 days of SMC issue advice, the committee noted and discussed the following non-submissions: aminolaevulinic acid (Ameluz ), SMC No 811/ Not included on the LJF because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine. 7.2 perampanel (Fycompa ), SMC No 819/ Not included on the LJF because clinicians have not responded to an invitation to apply for formulary inclusion for this medicine. 8. Formulary Additions and Amendments 8.1 Formulary Additions ADULT Chapter 8 Malignant disease and immunosupression It was noted that the amendments to this formulary section have been prepared by the Formulary Working Group and subsequently reviewed and agreed by the Cancer Therapeutic Committee The committee noted and approved the amendments to this section. 8.2 Formulary amendment request forms Carbo-Dome - Coal Tar Solution 10% Cream The committee noted the amendment request form to remove Carbo-Dome for the treatment of psoriasis from the LJF, preparations for psoriasis section due to the discontinuation of the preparation No declarations of interests were included with the application It was noted that the clinical team proposed a clear wording for the formulary section listing Psoriderm cream as a first choice, Exorex lotion as a second choice and Coal Tar Solution as a third choice product for the mild to moderate psoriasis. Coal Tar (Crude) has been suggested in three different strength for the treatment of moderate psoriasis It was agreed that there should be only first and second choice for the treatment of mild to moderate psoriasis and that the proposed third line treatment will be listed under prescribing notes The committee agreed to amend the section of the LJF tacrolimus ointment 0.1% and 0.03% (Protopic ) The committee noted the FAF1 for the use of tacrolimus ointment 0.1% and 0.03% (Protopic ) Two declarations of interest (personal specific and personal non-specific) were included with the application and noted by the committee.

12 It was noted that the members were uncertain of what they were being asked to agree The committee agreed to go back to the applicants and ask them to clarify the aim of the application. ACTION: JF/JP 9. NICE/SIGN/NHS QIS Clinical Guidance December CG 154 Ectopic pregnancy and miscarriage The committee noted and discussed the above NICE clinical guideline It was noted that the Obstetrics Department is reviewing their treatment policy to reflect changes in line with the NICE guideline. 9.2 TA 268 Melanoma (stage III or IV) - ipilimumab The committee noted and discussed the above NICE single technology appraisal guideline. 9.3 TA 269 Melanoma (BRAF V600 mutation positive, unresectable metastatic) - vemurafenib The committee noted and discussed the above NICE single technology appraisal guideline. 9.4 TA 270 Leukaemia (acute myeloid) decitabine (terminated appraisal) The committee noted and discussed the above NICE technology appraisal guideline. 10. Drug Safety Issues MHRA Advice December MHRA Drug Safety Update, Volume 6, Issue 5, December hive/index.htm The committee noted the drug safety update Letters for healthcare professionals on the safety of medicines: Sprayable Evicel fibrin sealant Lapatinib (Tyverb) Lenalidomide (Revlimid) gsandmessagesformedicines/monthlylistsofinformationforhealthcareprofessionals onthesafetyofmedicines/con The committee noted the updated information It was agreed to highlight the information regarding lenalidomide to the Haematology/Oncology Department in order to update the monitoring section in their treatment protocols if required. January Report on levothyroxine tablet products: A review of the clinical and quality considerations

13 gsandmessagesformedicines/con The committee noted the information provided in the report It was agreed to discuss this issue with the endocrinology and identify any action required for implementing the recommendations into practice. 11. Antimicrobial Management Team Minutes The committee noted the following AMT minutes for information: 24 th October For Information Only 12.1 Formulary Committee Reports and Letters The committee noted the following Formulary Committee reports and letters: fesoterodine (Toviaz ) tenofovir (Viread ) moxifloxacin (Avelox ) cabergoline (Dostinex ) nepafenac (Nevanac ) aclidinium (Eklira Genuair ) 12.2 Formulary Committee Attendance in The members of the committee have noted their attendance in Members were reminded that further to the FC Constitution they are required to attend a minimum of 50% of the meetings each year. Those who do not attend sufficient amount of meetings will be asked to review their commitment and attend more frequently or to resign. 13. AOCB 13.1 Declarations of interests The members of the committee noted that there has been discussions regarding participation in meeting were interests in the business being discussed are declared. ADTC are to review the current policy and make any necessary changes Formulary Committee will implement any changes that are required following this Formulary Committee Membership It was noted that J Bradie has decided to step down as a member of the committee and is currently helping to secure a nursing representative who could take her place on the committee It was noted that the interest for this position is high and when a potential candidate is identified he or she would be formally invited by ADTC to join Formulary Committee.

14 14. Date of Next Meeting 14.1 The committee noted that the next meeting would be held on Wednesday 6 th March 2013, at 2pm. (The deadline for submission of papers for this meeting is close of play Tuesday 19 th February 2013.) Apologies: Sheena Kerr