LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE

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1 FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on 26 th February 2014 from 2.00pm 4.30pm in Room 004, Ground Floor, Pentland House Present: Dr E Brown K Davidson V Hailey Dr SC Hornibrook Dr S Hurding Dr W Jamieson L Leitch I Mohammed L Shaw T Slaughter G Todd Dr R Williams In attendance: Angela Boys Z Krajčovič Consultant Oncologist, Western General Hospital Formulary Pharmacist, NHS Lothian Lead Directorate Pharmacist, Royal Hospital for Sick Children General Practitioner, Lothian General Practitioner, NHS Lothian General Practitioner, Lothian (in the chair) Formulary Pharmacist, NHS Borders Clinical Effectiveness Pharmacist, NHS Fife Lead Directorate Pharmacist, Royal Infirmary of Edinburgh Clinical Effectiveness Pharmacist, North Cumbria Medicines Management Group Lead Pharmacist, Royal Edinburgh Hospital and Roodlands Hospital General Practitioner, Lothian Community Pharmacist Apologies for absence: Dr J Dear Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh A Gilchrist Lead Pharmacist, Medicines Management Team Dr H Gillett Consultant Gastroenterologist, St John s Hospital S Kerr Lead Pharmacist, Western General Hospital Dr J Smith Health Economist, Western General Hospital Dr D Wilks Consultant in Infectious Diseases, Western General Hospital Welcome: The Chair welcomed Ms Angela Boys, Community Pharmacist as an observer at the meeting. Members introduced themselves in turn. Declarations of interest: The Chair reminded members to declare any interests in any of the products to be discussed. Membership: The committee contacted the Public Health department and asked them to identify a suitable candidate who would become a Formulary Committee member. It was noted that Public Health have decided not to have a representative on the committee as a regular member however they would be keen to attend the meeting when their contribution is required.

2 The department of psychiatry have not yet identified a suitable representative for the committee. The committee discussed a request from Professor David Webb to consider inviting Dr Emma Morrison, Trainee Clinical Pharmacologist to become a member of the Formulary Committee. It was noted that Dr Morrison has expressed her interest in joining the committee and attended the meeting in January 2014 as an observer. It was agreed to send a proposal of inviting Dr Morrison to join the committee to the ADTC for approval. 1. Minutes of the previous meeting held on 22 nd January The minutes of the meeting of 22 nd January 2014 were approved as an accurate record of that meeting. 2. Matters arising from previous minutes 2.1 Blood glucose monitoring Formulary Committee approved the changes made to Section Diagnostic and monitoring agent for diabetes mellitus in December It was agreed to amend the choices box for section (a) insulin-treated diabetes to be the same as under section (b) patients with uncomplicated type 2 diabetes who require blood glucose monitoring The committee subsequently received correspondence from the clinical team expressing some concern regarding this decision. The team asked whether the first choice for insulin-treated diabetes monitoring could be amended to say as advised by specialist diabetes team, as was proposed in the initial submission The reasoning behind this request is that the clinical team felt that the requirements for meters in this sub group were variable due to disease and patient characteristics and it was difficult to recommend one meter that would cover all the different requirements. Other factors such as district nurse training would also affect the choice of the meter The committee acknowledged the points well made in the correspondence but remained concerned about the potential for confusion in prescribing and would prefer to have clear first and second choice glucose meters identified. It was agreed to include a prescribing note for circumstances when other meters were recommended by a specialist team, there must be clear documentation as to the reasons for this recommendation It was agreed to discuss the suggested changes with the Blood Glucose Meter Working Group and make the appropriate amendments to the formulary section. 3. SMC Recommendations 3.1 bortezomib (Velcade ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interests were included with the application.

3 bortezomib 3.5mg powder for solution for injection (Velcade ) No. 927/13 ADVICE: following a full submission: bortezomib (Velcade ) is accepted for restricted use within NHS Scotland. Indication under review: In combination with dexamethasone, or with dexamethasone and thalidomide, for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. SMC restriction: use as triple therapy in combination with dexamethasone and thalidomide. Bortezomib, used in combination with dexamethasone and thalidomide for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation improved response rates compared with a dual combination regimen The committee noted the FAF1 submission for the use of bortezomib (Velcade ) in combination with dexamethasone, or with dexamethasone and thalidomide, for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation It was noted that a local Lothian protocol has been developed and provided with the application. Prescribing will take place in secondary care only The committee noted that this medicine is already being used for a different indication It was noted that there is an open recruitment to a myeloma X1 trial. Only patients not suitable for randomisation into this trial will be treated with bortezomib as part of triple therapy with dexamethasone and cyclophosphamide. It was noted that currently these patients would be treated with cylosphospamide, thalidomide and dexamethasone The evidence is based on a phase III randomised, open-label, controlled study which showed that patients response was higher in the bortezomib, thalidomide and dexamethasone group. It was noted that there is some evidence of an improved safety profile if bortezomib is administered subcutaneously rather than intravenously The committee noted that the costs included in the financial information section of the application are for the combination therapy. This part of the application should have included costs of bortezomib alone. It was therefore agreed to ask the applicants to confirm the costs of bortezomib. Applicants have submitted a breakdown of these costs in the appendix which was noted by the committee The committee agreed to Include bortezomib (Velcade ) on the Additional List, for Specialist Use only, for the indication in question. ACTION: WJ/KD 3.2 eltrombopag (Revolade ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interests were included with the application.

4 eltrombopag, 25mg, 50mg, 75mg film-coated tablets (Revolade ) No. 919/13 ADVICE: following a full submission: eltrombopag (Revolade ) is accepted for use within NHS Scotland. Indication under review: In adult patients with chronic hepatitis C virus infection, for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy. Two double-blind, randomised, controlled studies in patients with chronic hepatitis C virus infection and thrombocytopenia demonstrated significantly higher sustained viral response rates in patients who continued treatment with eltrombopag during interferonbased antiviral therapy than in those patients whose eltrombopag treatment was discontinued on initiation of antiviral therapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of eltrombopag. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower The committee noted the FAF1 submission for the use of eltrombopag (Revolade ) in adult patients with chronic hepatitis C virus infection, for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferonbased therapy It was noted that eltrombopag will be used in patients with low platelet count that makes them ineligible for hepatitis C treatment or limits their ability to maintain optimal interferon based therapy It was noted that this is the only available medicine for patients with hepatitis C infection and thrombocytopenia It was noted that a local Lothian protocol has not been submitted and that prescribing will take place in secondary care The committee thought that a treatment protocol was essential to ensure that this product is used strictly within its license. It was noted that the drugs used for genotype 1 HCV are different from the ones used in the licensing studies and therefore it is important to have a clear protocol including the criteria for starting, stopping and monitoring treatment. It was agreed to go back to applicants and ask them to produce a treatment protocol The committee noted that PAS is available for the use of eltrombopag (Revolade ) The committee agreed to Include eltrombopag (Revolade ) on the Additional List, for Specialist Use only, for the indication in question. It was also agreed to ask the applicants to produce a treatment protocol. ACTION: WJ/KD 3.3 vemurafenib (Zelboraf ) The committee noted and discussed the previously circulated submission and SMC report. No declarations of interests were included with the application.

5 vemurafenib 240mg film-coated tablet (Zelboraf ) No. 792/12 ADVICE: following a resubmission: vemurafenib (Zelboraf ) is accepted for restricted use within NHS Scotland. Indication review: as monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. SMC restriction: for use in the first-line treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. Vemurafenib significantly increases overall survival and progression-free survival compared with a current standard chemotherapy for patients with previously untreated unresectable stage IIIC or stage IV melanoma with V600 BRAF mutation. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of vemurafenib. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower The committee noted the FAF1 submission for the use of vemurafenib (Zelboraf ) as monotherapy for the treatment of adult patients with BRAF V600 mutationpositive unresectable or metastatic melanoma It was noted that a local Lothian protocol has been developed and provided with the application. All prescribing will take place in melanoma oncology outpatient clinic It was noted that vemurafenib will be offered as standard first-line treatment for patients with metastatic BRAF V600 mutant melanoma It was noted that vemurafenib would replace dacarbazine chemotherapy The committee noted that vemurafenib significantly increased overall survival and progression-free survival in comparison with the dacarbazine chemotherapy. It was noted that in the pivotal study, 38% of patients treated with vemurafenib had a dose interruption or modification due to the adverse events It was estimated that patients will receive approximately 7 months of treatment however for a small group of patients the treatment might be extended if the benefit is ongoing The committee noted that PAS is available for the use of vemurafenib (Zelboraf ) The committee agreed to Include vemurafenib (Zelboraf ) on the Additional List, for Specialist Use only, for the indication in question. ACTION: WJ/KD

6 3.4 afatinib (Giotrif ) The committee noted and discussed the previously circulated correspondence and SMC report. afatinib 20mg, 30mg, 40mg, 50mg film-coated tablets (Giotrif ) No. 920/13 ADVICE: following a full submission: afatinib (Giotrif ) is accepted for use within NHS Scotland. Indication under review: As monotherapy, for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). In two phase III studies, in patients with EGFR mutation positive adenocarcinoma of the lung, afatinib was significantly superior to the chemotherapy regimen comparators for the primary endpoint of progression free survival. Overall survival data are immature. A mixed treatment comparison provides indirect comparative data versus other tyrosine kinase inhibitors. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of afatinib. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower The committee noted and discussed the feedback received from the clinical team regarding the use of afatinib (Giotrif ) as monotherapy, for the treatment of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s) The committee agreed to Not include afatinib (Giotrif ) on the LJF because the NHS Lothian decision is that the medicine does not represent sufficient added benefit to other comparator medicines to treat the condition in question. The current LJF choice is erlotinib. ACTION: WJ/KD 4. SMC latest Not Recommended Medicines (January February 2014) The committee noted the following medicine not recommended for use by SMC in NHS Scotland: 4.1 alogliptin (Vipidia ), Report No. 937/14, is not recommended for use within NHS Scotland for the treatment of adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. 4.2 colestilan (BindRen ), Report No. 939/14, is not recommended for use within NHS Scotland for the treatment of hyperphosphataemia in adult patients with chronic kidney disease (CKD) stage 5 receiving haemodialysis or peritoneal dialysis.

7 4.3 insulin degludec (Tresiba ), Report No. 956/13, is not recommended for use within NHS Scotland for the treatment of diabetes mellitus in adults. 4.4 NON-SUBMISSIONS lomitapide (Lojuxta ), Report No. 956/14, is not recommended for use within NHS Scotland as adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). saxagliptin (Onglyza ), Report No. 958/14, is not recommended for use within NHS Scotland as monotherapy in adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. 5. Other Medicines Proposed for Use 5.1 bendamustine (Levact ) (in combination with rituximab) The committee noted the FAF3 submission for the off-label use of bendamustine (Levact ) (in combination with rituximab) for relapsed chronic lymphocytic leukaemia (CLL) One declaration of interest (personal non-specific) was included with the application and noted by the committee It was noted that a local Lothian protocol has been developed and submitted with the application. Prescribing will take place in the secondary care The clinical team has submitted a treatment algorithm and they aim to use this preparation as a second- to fourth-line treatment The evidence on comparative efficacy shows that the rituximab and bendamustine combination therapy has the highest overall response rates and amongst the longest progression-free survival rates of any treatment in the relapsed CLL setting for patients who are not suitable for fludarabine containing treatment The committee noted that the costs included in the application are for the combination therapy and that applicants have submitted a breakdown of these costs, including the costs of bendamustine alone, in the appendix. It was agreed to ask the clinical team to confirm the costs for bendamustine alone The committee agreed to add bendamustine (Levact ) (in combination with rituximab) to the Additional List for Specialist Use only, categorised RED under the ADTC policy for unlicensed and off label medicines. ACTION: WJ/KD 5.2 ertapenem (Invanz ) The committee noted the FAF3 submission for the off-label use of ertapenem (Invanz ) for multi-resistant infections treatment in Outpatient Parenteral Antimicrobial Treatment (OPAT) clinic No declarations of interests were included with the application It was noted that ertapenem will be used to facilitate outpatient intravenous treatment to treat infections of multiresistant organism where there is either no suitable alternative or the oral route is not appropriate.

8 5.2.4 It was noted that a local Lothian protocol has been developed but not submitted with the application. Prescribing will take place in secondary care in the OPAT clinic It was noted that patients might receive the first dose of ertapenem in the inpatient ward and then be transferred to OPAT clinic It was noted that the ertapenem has a safety profile similar to or better than other β-lactams A question was asked about the availability of data on the safety and efficacy of the OPAT service, although it was noted that this was out-with the remit of the committee. The committee noted that audit data for the OPAT service is regularly collected and the Antimicrobial Management Team provides regular updates to the ADTC The committee agreed to add ertapenem (Invanz ) 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 Alert Antibiotic Policy should be updated. 5.3 piperacillin plus tazobactam ACTION: WJ/KD The committee noted the FAF3 submission for the use of piperacillin plus tazobactam for the treatment of neonates with suspected or confirmed late onset blood stream infection (LOI) defined as infection arising greater than 72 hours after birth in infants currently on the neonatal unit at the Royal Infirmary of Edinburgh It was noted that this preparation is not licensed for under 2 year olds No declarations of interests were included with the application It was noted that a local Lothian protocol has been developed and the use of piperacillin plus tazobactam is part of the Royal Infirmary of Edinburgh Neonatal unit Antibiotic Clinical Guideline The committee noted that piperacillin plus tazobactam will be used as a first-line therapy in conjunction with vancomycin It was noted that piperacillin plus tazobactam has a more favourable toxicity profile and fewer undesirable features when used concomitantly with vancomycin compared to gentamicin It was noted that piperacillin plus tazobactam is a broad spectrum antibiotic and there are concerns about risks associated with the use of these agents The committee agreed to add piperacillin plus tazobactam to the LJF as a first-line treatment, for Specialist Use only, categorised RED under the ADTC policy for unlicensed and off label medicines. ACTION: WJ/KD

9 6. SMC Abbreviated Submissions 6.1 darunavir (Prezista ) darunavir 400mg, 800mg film-coated tablets and oral suspension 100mg/mL (Prezista ) No. 948/14 ADVICE: following an abbreviated submission: darunavir (Prezista ) is accepted for restricted use within NHS Scotland. Indication under review: darunavir co-administered with low dose ritonavir in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in paediatric patients 12 to 17 years of age and at least 40kg body weight who are: antiretroviral therapy (ART) naïve; or, ARTexperienced with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/ml and CD4+ cell count 100 cells/mm3. SMC restriction: in patients <18 years, to be prescribed under the supervision of specialists in paediatric HIV. The Scottish Medicines Consortium has previously accepted darunavir for use in this indication in adults and in highly pre-treated children and adolescents, from the age of 6 years and at least 20kg body weight, who have failed on more than one regimen containing a protease inhibitor. Darunavir is listed in the British National Formulary for Children in combination with other antiretroviral drugs, for HIV infection resistant to other protease inhibitors in children previously treated with antiretrovirals The committee agreed to Include darunavir (Prezista ) on the Additional List, for Specialist Use only, for the indication in question. 6.2 levonorgestrel (Upostelle ) levonorgestrel 1500microgram tablet (Upostelle ) No. 938/14 ADVICE: following an abbreviated submission: levonorgestrel (Upostelle ) is accepted for use within NHS Scotland. Indication under review: emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. When the use of emergency contraception is indicated this is a slightly cheaper alternative to an existing preparation It was noted that an updated policy statement regarding brand prescribing and hormonal contraceptives was to be presented at ADTC The committee agreed to Include levonorgestrel (Upostelle ) on the LJF for the indication in question. The choice of product will be reviewed with the Working Group.

10 6.3 solifenacin and tamsulosin (Vesomni ) solifenacin succinate plus tamsulosin hydrochloride 6mg / 0.4mg modified release tablet (Vesomni ) No. 945/14 ADVICE: following an abbreviated submission: solifenacin succinate plus tamsulosin hydrochloride 6mg / 0.4mg modified release tablet (Vesomni ) is accepted for use within NHS Scotland. Indication under review: for the treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia in men who are not adequately responding to treatment with monotherapy. In patients for whom concomitant use of solifenacin succinate and tamsulosin hydrochloride is appropriate, Vesomni allows administration of a single tablet at a lower cost compared to the individual components administered separately It was noted that solifenacin is currently included on the LJF for symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as occur in patients with overactive bladder syndrome. Tamsulosin is currently included on LJF for symptoms of benign prostatic hyperplasia (BPH) The committee agreed to Not include solifenacin and tamsulosin (Vesomni ) on the LJF because the NHS Lothian decision is that the medicine does not represent sufficient added benefit to other comparator medicines to treat the condition in question. The current LJF choices are oxybutynin or solifenacin and tamsulosin. 6.4 timolol gel eye drops (Tiopex ) timolol, 1mg/g eye gel for single-dose container (Tiopex ) No. 941/14 ADVICE: following an abbreviated submission: timolol gel eye drops (Tiopex ) is accepted for restricted use within NHS Scotland. Indication under review: reduction of the elevated intraocular pressure in patients with: - ocular hypertension, - chronic open angle glaucoma. SMC restriction: to use in patients who have proven sensitivity to preservatives. The cost of this once daily preservative-free formulation is significantly cheaper than the twice daily preservative-free preparation and may for some patients offer advantages in the lower concentration and reduced applications. Preserved timolol eye drops are included in the drug tariff and are significantly cheaper than preservative-free preparations It was noted that this preparation will replace the current preservative-free unit doses for long term treatment of glaucoma.

11 6.4.2 The committee agreed to Include timolol gel eye drops (Tiopex ) on the LJF as a prescribing note for the indication in question. 6.5 zonisamide (Zonegran ) zonisamide 25mg, 50mg and 100mg capsules (Zonegran ) No. 949/14 ADVICE: following an abbreviated submission: zonisamide (Zonegran ) is accepted for restricted use within NHS Scotland. Indication under review: as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescents, and children aged 6 years and above. SMC restriction: on advice from specialists (paediatric neurologists or paediatricians with an expertise in epilepsy). The Scottish Medicines Consortium has previously accepted zonisamide for restricted use in adult patients with partial seizures, with or without secondary generalisation. It was restricted to initiation by physicians with appropriate experience in the treatment of epilepsy and should be used principally in patients who have not benefited from treatment with an older anti-convulsant drug such as carbamazepine or sodium valproate, or for whom these drugs are unsuitable because of contra-indications, interaction or poor tolerance The committee agreed to Include zonisamide (Zonegran ) on the Additional List, for Specialist Initiation, for the indication in question. 7. Non-submissions to Formulary Committee (December day target) 7.1 trastuzumab (Herceptin ), SMC No 928/ It was noted that the clinical team are preparing a FAF1 submission Not included on the LJF, pending protocol. 8. Formulary Additions and Amendments 8.1 Formulary Additions ADULT Section Antimigraine drugs It was noted that additional amendments made by the Working Group have been presented at the meeting and discussed by the committee It was agreed to include a reference to the Refhelp section on Headache in the introductory notes The committee approved this formulary section subject to amendments. The LJF website will be updated.

12 8.2 Formulary amendment request forms Topical NSAIDs The committee noted the amendment request form to add a prescribing note into section 10.3, Topical NSAIDs for the knee or hand osteoarthritis, specifying that prescribers should choose the most cost-effective licensed product and that currently it is piroxicam gel 0.5% No declarations of interests were included with the application The committee were reluctant to specify a product under this section due to the frequently changing prices. It was also difficult to assess cost-effectiveness of different products due to a lack of head to head data. However it was agreed to add a note encouraging prescribers to prescribe economical licensed products The committee agreed to amend the LJF section 10.3, Topical NSAIDs. 9. NICE/SIGN/NHS QIS Clinical Guidance January 9.1 CG 175 Prostate cancer: diagnosis and treatment The committee noted and discussed the above NICE clinical guideline. 9.2 CG 176 Head injury The committee noted and discussed the above NICE clinical guideline. 9.3 STA 303 Teriflunomide for treating relapsing-remitting multiple sclerosis The committee noted and discussed the above NICE single technology appraisal. February: SIGN Guidelines 9.4 SIGN 137 Management of lung cancer The committee noted and discussed the above SIGN guideline. 10. Drug Safety Issues MHRA Advice December January MHRA Drug Safety Update, Volume 7, Issue 6, January The committee noted the drug safety update December letters for healthcare professionals on the safety of medicines: Iclusig (ponatinib) Efient (prasugrel) Temodal (temozolomide) Xeloda (capecitabine) Arzerra (ofatumumab) Inrelex (mecasermin) ngsandmessagesformedicines/con The committee noted the updated information.

13 10.3 January letters for healthcare professionals on the safety of medicines: Erbitux (cetuzimab) Abraxane (paclitaxel) Erivedge (vismodegib) Combined hormonal contraceptives COSOPT (dorzolomide hydrochloride/timolol maleate) preservative-free eye drops Rienso (ferumoxytol) ngsandmessagesformedicines/con The committee noted the updated information. 11. Unlicensed and Off-Label Medicines listed on LJF 11.1 Following discussions at NHS Lothian ADTC regarding GMC recommendations for unlicensed medicines, ADTC had requested a review of LJF in terms of recommendations of unlicensed medicines as first or second choices. A paper had been submitted to the February ADTC meeting. The paper noted that in the vast majority of recommendations, unlicensed medicines were only recommended where there was no licensed alternative Formulary Committee discussed the paper and agreed with the recommendation that where not already done, unlicensed medicines in the LJF will be annotated to indicate their status to prescribers. An explanatory text will be included in the introduction of LJF highlighting implications and responsibilities of the prescriber The Formulary Committee members acknowledged the good work invested in this by the Medicines Management Team The next stage is to look at recommendations of off label medicines as first or second choices in LJF. It is planned to submit this to ADTC in June NHSL Policy and Procedures for the use of Unlicensed Medicines 12.1 The committee noted the draft revision of this policy and procedures The committee members were asked to review this policy and procedures and send any comments to the by 17 March For Information Only 13.1 Formulary Committee Reports and Letters The committee noted the following Formulary Committee reports and letters: axitinib (Inlyta ) tocilizumab (RoActemra ) caffeine citrate (Peyona ) saxagliptin (Onglyza ) eltrombopag (Revolade ) mannitol (Bronchitol ) vemurafenib (Zelboraf )

14 vildagliptin (Galvus ) Aquacel Ribbon 1cm x 45cm Glutafin pizza bases 13.2 Antimicrobial Management Team (AMT) Minutes The committee noted the following AMT minutes. 23 rd October th November AOCB None. 15. Date of Next Meeting The committee noted that the next meeting would be held on Wednesday 9 th April 2014, at 2pm. (The deadline for submission of papers for this meeting is close of play Tuesday 25 th March 2014.) Apologies: Dr Walter Jamieson