LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE

Transcription

1 FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on 02 March 2011 in Room 004, Ground Floor, Pentland House Present: Dr E Brown J Carson Dr J Dear Dr J Forbes Dr S C Hornibrook Professor S Lawrie I Mohammed J Pearson L Shaw T Slaughter Dr D Wilks Dr R Williams In attendance: Z Simpson N Morrison Apologies for absence: Dr H Gillett Dr S Hurding Dr W Jamieson S Kerr L Leitch S McNaughton Consultant Oncologist, Western General Hospital Lead Directorate Pharmacist, Royal Infirmary of Edinburgh Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh Formulary Committee Co-Chair and Reader in Health Economics, University of Edinburgh General Practitioner, Lothian Formulary Committee Co-Chair and Professor and Honorary Consultant Psychiatrist, Royal Edinburgh Hospital (in the chair) Clinical Effectiveness Pharmacist, NHS Fife Formulary Pharmacist, NHS Lothian Lead Directorate Pharmacist, Royal Infirmary of Edinburgh Clinical Effectiveness Pharmacist, North Cumbria Medicines Management Group Consultant in Infectious Diseases, Western General Hospital General Practitioner, Lothian Medicines Management Team Administrator Pre-registration Pharmacist, NHS Lothian Consultant Gastroenterologist, St John s Hospital General Practitioner, NHS Lothian General Practitioner, Lothian Lead Pharmacist, Western General Hospital Formulary Pharmacist, NHS Borders Associate Director, Contracted Community Pharmacy Services & CHP Development, NHS Lothian Welcome The Chair welcomed Niamh Morrison, pre-registration pharmacist, to the meeting, to enable her to gain an insight into the processes involved with the introduction of new medicines in NHS Lothian. Each of the members of the committee introduced themselves in turn Declarations of interest: The Chair reminded members to declare any interests in any of the products to be discussed.

2 Membership It was noted that a Specialist Registrar has expressed an interest through Dr Rutledge to represent Public Health on the committee. It was agreed that this nomination would be followed up. ACTION: JF Minutes 1. Minutes of the previous meeting held on 26 January The minutes of the meeting of 26 January 2011 were approved as an accurate record of that meeting. 2. Matters arising from previous minutes 2.1 dronedarone (Multaq ) A submission for this drug was presented to Formulary Committee in September Following receipt of further information, the drug was approved and added to the Additional List, for Specialist initiation in November The committee were informed that a GP in Lothian has expressed concern over the decision and has made an informal request for Formulary Committee to amend classification of the drug to Specialist Use only, due to safety concerns and the need for monitoring of liver function The committee discussed the request in light of the revised DAD issued by SMC in January 2011 and the current safety concerns The committee noted that it is estimated that only a very small number of patients will require this treatment (approximately 150) and that a number of other drugs prescribed in primary care also require monitoring. It was highlighted that prescribing of the drug is to be initiated by a specialist It was agreed that following discussion of the above points the classification remains unchanged. A reply will be sent to the GP concerned highlighting this, and notifying them that should they wish to formally request a change; an application can be made by completion and submission of a Minor Amendment Request Form. 2.2 capsaicin patch (Qutenza ) The committee were notified that following feedback to SMC regarding the wording of the advice for capsaicin cutaneous patch, for the treatment of neuropathic pain in adults with post herpectic neuralgia; amended advice was circulated and published on the website by SMC on Monday 7 February 2011.

3 3. SMC Recommendations - FAF1s LOTHIAN FORMULARY COMMITTEE 3.1 abatacept (Orencia ) The committee noted and discussed the previously circulated submission, NICE MTA guidance and SMC report. Declarations of interest were included within the submission and were noted by the committee. Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor NICE MTA 195 The appraisal of adalimumab and the review of the appraisals of etanercept, inflixmab, rituximab and abatacept for the treatment of rheumatoid arthritis have resulted in changes in the guidance. Rituximab in combination with methotrexate is still recommended as an option for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor. Additional treatment options are now recommended for these adults if rituximab therapy is contraindicated or withdrawn because of an adverse event, specifically: If rituximab is contraindicated or withdrawn, adalimumab, etanercept, infliximab and abatacept, each in combination with methotrexate, are now recommended as treatment options If rituximab therapy cannot be given because methotrexate is contraindicated or withdrawn because of an adverse event, adalimumab and etanercept, each as monotherapy, are now recommended as treatment options The committee noted the FAF1 submission for the use of abatacept (Orencia ) It was noted that an application has been made for use following a NICE Multiple Technology Appraisal which supersedes SMC advice in August 2007, where it was classified Not Recommended NICE guidance indicates the use of abatacept for patients who cannot receive rituximab due to adverse events or contraindication The committee discussed the enclosed submission and algorithm and noted the drug is proposed for more restricted use than the NICE guidance The algorithm shows abatacept to be last line anti-tnf therapy and is therefore estimated for use in approximately only 24 patients at an annual cost of 288, It was agreed that following the recent approval of certolizumab in January 2011 as formulary first choice, with etanercept and adalimumab as second line agents, the protocol requires amendment by deletion of infliximab from the first box. The committee also highlighted they would like the algorithm to show monitoring steps following the initiation of abatacept It was agreed to add abatacept (Orencia ) to the Additional List, Specialist Use only, subject to the clinical team making an amendment of the local protocol, as above, to ensure consistency with the formulary.

4 3.2 indacaterol (Onbrez Breezhaler ) The committee noted and discussed the previously circulated submission and SMC report. Declarations of interest were included within the submission and were noted by the committee. indacaterol 150 and 300 micrograms inhalation powder hard capsules (Onbrez Breezhaler ) No 619/10 ADVICE: following a full submission indacaterol (Onbrez Breezhaler ) is accepted for use within NHS Scotland. Indication under review: maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). Indacaterol has been found to be statistically superior to placebo and other long-acting bronchodilators in improving lung function (FEV1) after 12 weeks. Another long-acting beta 2 agonist is available at lower cost The committee noted the FAF1 submission for the restricted use of indacaterol (Onbrez Breezhaler ) The clinical team propose to use indacaterol in line with NICE Clinical Guideline 101 as a step up treatment for patients already taking short acting beta agonists (SABA) or short acting muscarinic agonists (SAMA). Long acting beta agonists (LABA) are an alternative to long acting muscarinic agonists (LAMA) for patients unable to tolerate or are not suitable for LAMA The committee raised concerns over the proposed number of patients cited within the submission. The application indicates the number to be treated per annum at around 306. Based on the number of patients with COPD treated in primary care, this was considered to be substantially underestimated Concerns were also highlighted that this agent is not licensed in combination with a corticosteroid therefore when progressing to stage III treatment, a change in agent would be required It was noted that there are 2 long acting agents currently in the formulary that are also licensed as combination products It was agreed to classify indacaterol (Onbrez Breezhaler ) as Not preferred in Lothian as suitable alternatives exist.

5 3.3 rituximab (MabThera ) The committee noted and discussed the previously circulated submission and SMC report. Declarations of interest were included within the submission and by a committee member; these were noted by the committee. rituximab, 100mg and 500mg concentrate for solution for infusion (MabThera ) No 493/08 ADVICE: following a full submission rituximab (MabThera ) is accepted for restricted use within NHS Scotland for the treatment of previously untreated patients with stage III to IV follicular lymphoma in combination with chemotherapy. Rituximab added to a number of different chemotherapy regimens produced statistically significant improvements in the primary study endpoints when compared with the chemotherapy regimens alone. Rituximab is restricted to use only by haematologists or oncologists who have expertise in treating lymphoma. It should be administered in a healthcare environment where full resuscitation facilities are available. SMC issued advice in December 2004 regarding the use of rituximab in combination with cyclophosphamide, vincristine and prednisolone (CVP) chemotherapy for the treatment of previously untreated patients with stage III to IV follicular lymphoma. The current advice extends the range of chemotherapy regimens that can be used in combination with rituximab for this indication The committee noted the FAF1 submission for the restricted use of rituximab (MabThera ) approved for use by SMC in August This submission would extend the chemotherapy regimens that can be used in combination with rituximab for untreated patients with stage III to IV follicular lymphoma Infusion is indicated in secondary care only where full resuscitation facilities are available The new combination R-CHOP proposes to replace R-CVP and therefore there would be no overall increase in patients being treated with rituximab. The only difference between the combinations is the inclusion of doxorubicin in R-CHOP, not included in R-CVP Estimated number of patients per annum is 20, costing around an additional 1361 in Lothian ( 2,000 in SCAN); although it is suspected that this combination is already currently being used by the clinical team and therefore the additional expenditure is already being incurred It was agreed to add rituximab (MabThera ) to the Additional List, for Specialist Use only.

6 3.4 rituximab (MabThera ) The committee noted and discussed the previously circulated submission and SMC report. Declarations of interest were included within the submission and by a committee member, these were noted by the committee. rituximab, 100mg in 10mL, 500mg in 50mLconcentrate for solution for infusion (MabThera ) No 675/11 ADVICE: following a full submission rituximab (MabThera ) is accepted for restricted use within NHS Scotland Indication under review: Rituximab maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. SMC Restriction: for maintenance treatment in follicular lymphoma patients who have responded to induction with rituximab plus chemotherapy. Rituximab significantly increased progression free survival following a response to induction therapy in patients with previously untreated follicular lymphoma compared with observation alone. Longer follow up is required to establish benefit in overall survival The committee noted the FAF1 submission for the restricted use of rituximab (MabThera ) The submission proposes the use of rituximab as maintenance therapy indicated for the treatment of follicular lymphoma patients responding to induction therapy Maintenance therapy involves treatment every 2 months and continues for a period of 2 years. This is a new treatment option which is in accordance with SMC advice It is anticipated that approx 30 patients across SCAN would be eligible for the treatment The cost per annum in Lothian is estimated to range from 200,000 in year 1 to 400,000 in year 2 ( 300,000 to 600,000 in SCAN). Costs are anticipated to double in year 2 and then plateau The committee noted the increase in progression free survival data, however there was no evidence on the long term survival. It was highlighted that this condition generally has a very good prognosis The committee discussed treatment following disease progression and noted that treatment pathways reflecting when to retreat with rituximab are currently being devised with the SCAN haematology group The committee agreed that it would be useful to have a local treatment protocol from the clinical team to identify patient selection It was agreed to add rituximab (MabThera ) to the Additional List, Specialist Use only subject to the approval of a satisfactory protocol.

7 4. SMC latest Not Recommended Medicines (January and February 2011) The committee noted the following medicine not recommended for use by SMC in NHS Scotland: 4.1 golimumab, 50mg, solution for injection in pre-filled pen (auto-injector) or prefilled syringe (Simponi ), Report No. 674/11, is not recommended for use within NHS Scotland alone or in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. 4.2 trastuzumab 150mg powder for concentrate for solution for infusion (Herceptin ), Report No. 623/10, is not recommended for use within NHS Scotland in combination with capecitabine or 5-florouracil and cisplatin for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastrooesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Herceptin is indicated for use only in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay. 4.3 miconazole, 50mg, muco-adhesive buccal tablet (Loramyc ), Report No. 517/08, is not recommended for use within NHS Scotland for the treatment of oropharyngeal candidiasis (OPC) in immunocompromised patients. 4.4 adapalene 0.1% benzoyl peroxide 2.5% gel (Epiduo ), Report No 682/11. is not recommended for use within NHS Scotland for the cutaneous treatment of acne vulgaris when comedones, papules and pustules are present. 4.5 vinflunine ditartrate 25mg/mL concentrate for solution for infusion (Javlor ), Report No 686/11. is not recommended for use within NHS Scotland for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract (TCCU) after failure of a prior platinum-containing regimen. 4.6 Non-submissions ivabradine (Procoralan ) 5mg and 7.5mg film coated tablets, Report No. 689/11 is not recommended for use within NHS Scotland for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease in adults with normal sinus rhythm, in combination with beta-blockers, in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60bpm The committee noted that this drug is not recommended for use within NHS Scotland for the above indication, which is causing difficulties within cardiology. It was agreed by the committee that a letter should be sent to the Clinical Director to highlight that ivabradine for the above indication it is Not Recommended by SMC. ACTION: SL colesevelam 625mg film-coated tablets (Cholestagel ), Report No. 690/11, is not recommended for use within NHS Scotland in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia.

8 fenticonazole 2% vaginal cream and 200mg/600mg vaginal capsules (Ginoxin ), Report No. 691/11, is not recommended for use within NHS Scotland for the treatment of vulvovaginal candidiasis. botulinum toxin type a (Bocouture ), Report No. 695/11, is not recommended for use within NHS Scotland for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at frown, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. 5. Other Medicines Proposed for Use - FAF2s and FAF3s NONE 6. SMC Abbreviated Submissions 6.1 sildenafil citrate 0.8mg/mL solution for injection (Revatio ) (No: 688/11) sildenafil citrate 0.8mg/mL solution for injection (Revatio ) No. 688/11 ADVICE: following an abbreviated submission sildenafil citrate (Revatio ): is accepted for restricted use within NHS Scotland. Indication under review: for the treatment of patients with pulmonary arterial hypertension who are currently prescribed oral sildenafil and who are temporarily unable to take oral medicine, but are otherwise clinically and haemodynamically stable. SMC restriction: restricted to use on the advice of specialists in the Scottish Pulmonary Vascular Unit and from the Scottish Adult Congenital Cardiac Service. Oral sildenafil is indicated for treatment of patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. SMC has previously accepted oral sildenafil in this orphan indication. The intravenous formulation is significantly more expensive than the oral preparation but it is intended only for short-term use (the estimated average duration of intravenous treatment is three days) The committee noted the above abbreviated submission It was noted that the IV preparation is more expensive than the oral product which is supplied by the Scottish Pulmonary Vascular Unit and may therefore be an additional cost for Lothian It was agreed to add sildenafil citrate (Revatio ) to the Additional List, on the advice of a specialist in the Scottish Pulmonary Vascular Unit.

9 6.2 fosaprepitant dimeglumine 150mg powder for solution for infusion (IVEmend ) (No: 678/11) fosaprepitant dimeglumine 150mg powder for solution for infusion (IVEmend ) No. 678/11 ADVICE: following an abbreviated submission fosaprepitant dimeglumine (IVEmend ): is accepted for use within NHS Scotland. Indication under review: Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults. IVEmend 150 mg is given as part of a combination therapy. Fosaprepitant 150mg is not recommended for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults, as SMC has previously not recommended both fosaprepitant iv and aprepitant capsules for this indication The committee noted the above abbreviated submission It was highlighted that the 115mg preparation has now been discontinued in the UK. The 150mg preparation is cost neutral against the 115mg preparation dosing regimen which includes 2 days oral treatment with aprepitant. The 150mg strength does not require additional dosing with oral aprepitant It was agreed to add fosaprepitant dimeglumin 150mg (IVEmend ) to the Additional List, Specialist Use only and update the webtables to reflect the withdrawal of the 115mg from the UK market. 6.3 tacrolimus granules for Oral Suspension (Modigraf ) (No: 657/10) tacrolimus granules for Oral Suspension (Modigraf ) No. 657/10 ADVICE: following an abbreviated submission tacrolimus granules for oral suspension (Modigraf ) are accepted for restricted use within NHS Scotland. Indication under review: Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients. SMC restriction: for use in patients for whom tacrolimus is an appropriate choice of immunosuppressive therapy and where small changes (less than 0.5mg) in dosing increments are required (e.g. in paediatric patients) or seriously ill patients who are unable to swallow tacrolimus capsules. Modigraf granules for oral suspension offer 18% greater bioavailability than immediate release capsules and may have different bioavailability compared to other unlicensed tacrolimus suspensions in use in the past. Careful monitoring and possible dosage changes are needed when introducing treatment with Modigraf. Tacrolimus granules for oral suspension are significantly more expensive than the capsule formulation.

10 6.3.1 The committee noted the above abbreviated submission It was agreed to add tacrolimus (Modigraf ) to the Additional List, for use on the advice of a transplant specialist. 6.4 ethinylestradiol 30microgram and levonorgestrel 150microgram (Rigevidon 30/152 microgram) film-coated tablets (No: 646/10) ethinylestradiol 30microgram and levonorgestrel 150microgram (Rigevidon 30/152 microgram) film-coated tablets No. 646/10 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 The committee noted the above abbreviated submission The committee agreed that following the change to the formulary, information on the new products requires to be widely distributed It was agreed to add Rigevidon to the LJF as first choice. An article to be included in the next issue of the bulletin to highlight the change in the formulary. 6.5 ethinylestradiol 20 microgram / gestodene 75microgram (Millinette 20/75microgram) film-coated tablets ethinylestradiol 30 microgram / gestodene 75microgram (Millinette 30/75microgram) film-coated tablets (No: 644/10) ethinylestradiol 20 microgram / gestodene 75microgram (Millinette 20/75microgram) filmcoated tablets ethinylestradiol 30 microgram / gestodene 75microgram (Millinette 30/75microgram) filmcoated tablets No. 644/10 ADVICE: following an abbreviated submission ethinylestradiol 20microgram/gestodene 75microgram and ethinylestradiol 30microgram/gestodene 75microgram (Millinette ): is accepted for use within NHS Scotland. 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 The committee noted the above abbreviated submission It was agreed to add Millinette 30/75 to the LJF as second choice It was agreed to classify Millinette 20/75 as Not Preferred in Lothian as suitable alternatives exist.

11 6.6 ethinylestradiol 20microgram / desogestrel 150microgram (Gedarel 20/150 microgram) film-coated tablets ethinylestradiol 30microgram / desogestrel 150microgram (Gedarel 30/150 microgram) film-coated tablets (No: 643/10) ethinylestradiol 20microgram / desogestrel 150microgram (Gedarel 20/150 microgram) film-coated tablets ethinylestradiol 30microgram / desogestrel 150microgram (Gedarel 30/150 microgram) film-coated tablets No 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 The committee noted the above abbreviated submission It was agreed to add Gedarel 30/150 to the LJF as second choice It was agreed to classify Gederal 20/150 as Not Preferred in Lothian as suitable alternatives exist. 6.7 ethinylestradiol 30/40microgram/levonorgestrel 50/75/125microgram (TriRegol ) (No: 645/10) ethinylestradiol 30/40microgram/levonorgestrel 50/75/125microgram (TriRegol ) No 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 The committee noted the above abbreviated submission It was agreed to classify TriRegol as Not Preferred in Lothian as suitable alternatives exist.

12 7. Formulary Additions and Amendments 7.1 ADULT Chapter 5 Infections in adults The committee noted and discussed the amendments to Chapter 5 of the formulary Infections in adults It was highlighted that there is currently both LJF guidance mainly used in primary care, and UHD guidance which is more specialised and widely referred to in secondary care The current guidance is in different formats, however, choices and indications are consistent. It was noted that there may be a move to eventually combine the guidance It was noted that this revision is based on advice from the Health Protection Agency and the Scottish Antimicrobial Prescribing Group. The committee agreed that there is a need to maintain local ownership within the formulary The committee agreed with both the new format of the chapter and the changes made. Minor amendments are required to the MRSA section, pages 27 and The committee approved the additions and amendments to Chapter 5 and it was agreed to update the website as soon as possible. 8. NICE/SIGN/NHS QIS Clinical Guidance 8.1 NICE CG 113 Generalised anxiety disorder and panic disorder (with or without agoraphobia in adults) The committee noted and discussed the above NICE Clinical Guideline which is a revision of the guidance published in The guideline was discussed in particular in relation to drug treatment It was agreed that the LJF section has not been recently reviewed, and the revised guidance will require further discussion with the Working Group. 8.2 NICE CG 114 Anaemia management in people with chronic kidney disease The committee noted and discussed the above NICE Clinical Guideline which is a revision of the guidance previously published in The committee noted in particular the guidance on aspirational targets It was agreed that no revision to LJF advice is required. 8.3 NICE STA Aripiprazole for the treatment of schizophrenia in people aged 15 to 17 years The committee noted and discussed the above NICE Single Technology Appraisal It was noted that there is no recommendation of aripiprazole in paediatrics and therefore no change is required to the formulary.

13 8.4 NICE MTA 160 Alendronate, etidronate, risedronate, raloxifene, strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women The committee noted and discussed the above NICE Multiple Technology Appraisal updated final guidance It was noted that following the submission of additional evidence from the manufacturer of strontium ranelate, the recommendations on strontium ranelate remain unchanged from those originally published and therefore no action is required. 8.5 NICE MTA 161 Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women The committee noted and discussed the above NICE Multiple Technology Appraisal It was noted that following the submission of additional evidence from the manufacturer of strontium ranelate the recommendations on strontium ranelate remain unchanged from those originally published and therefore no action is required. 9. Drug Safety Issues MHRA Advice/NPSA Advice 9.1 Drug Safety Update Volume 4, Issue 7, February The committee reviewed the above MHRA Drug Safety updates for February It was agreed that following the current safety concerns associated with dronedarone; the committee will request the Lothian Prescribing Bulletin Editorial Committee consider publication of an article. ACTION: ZS 10 SMC Statement to NHS Boards 10.1 Mesalazine products The committee noted that a number of new branded versions of oral mesalazine are being launched within the UK with variable changes to formulation and licenses Following consultation of the SMC with Formulary Pharmacists in NHS Scotland and the approval of the SMC board, it is noted that SMC will not be reviewing the products and it will remain a local decision on which products will be made available It was agreed that once a range of products are available, discussion and agreement on which will be prescribed within Lothian will be made locally following consultation with the GI Working Group Dovobet Gel for the treatment of scalp psoriasis The committee noted that Dovobet Gel has recently been launched for the topical treatment of scalp psoriasis and is identical in formulation to Xamiol Gel Dovobet also has an additional indication for the treatment of body psoriasis and the committee noted that this is out-with the remit of SMC It was agreed that should dermatology wish to use Dovobet Gel for this indication, they will require to submit a FAF2 application. 11 Antimicrobial Management Team Minutes 11.1 The committee noted the minutes from the Antimicrobial Management Team meeting held on 08-Dec-10.

14 12 For Information Only 12.1 Formulary Committee Reports and Letters The committee noted the following Formulary Committee reports and letters: certolizumab (Cimzia ) riboflavin eptotermin alfa (Osigraft ) sucrose 33% oral solution vitamins A and D capsules vitamin E capsules alemtuzumab (MabCampath ) denosumab (Prolia ) colecalciferol (Dekristol ) ADTC eptotermin alfa application UHD D & T riboflavin application levetiracetam (Keppra ) 13 AOCB 13.1 The committee were informed that the Chief Auditor has been approached by the Chief Executive to initiate an audit into the processes regarding the approval, prescribing and affordability of SMC approved drugs The committee were informed that as the Medicines Review Group has only recently formed and is not yet fully established, a request has been made to delay a full audit until the financial year 2012 to The committee agreed that this would be a major task and expressed concerns that as it currently stands, the committee do not have the resources and skills to make informed decisions regarding the affordability aspect of drugs within Lothian It was highlighted, that a further committee with increased budgetary powers may be required to meet the possibility of increased expectations. 14. Date of Next Meeting 14.1 The committee noted that the next meeting would be held on 20 April 2011, at 2pm in the Room No 004, Pentland House, 47 Robb s Loan, Edinburgh. (The deadline for submission of papers for this meeting is close of play Tuesday 5 April 2011).