LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE

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1 FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on 15 December 2010 in Room 004, Ground Floor, Pentland House Present: Dr E Brown J Carson Dr J Forbes Dr H Gillett Dr S C Hornibrook Dr S Hurding Professor S Lawrie I Mohammed J Pearson L Shaw T Slaughter Dr D Wilks In attendance: Z Simpson Apologies for absence: Dr J Dear Dr W Jamieson S Kerr L Leitch S McNaughton Dr R Williams Consultant Oncologist, Western General Hospital Lead Directorate Pharmacist, Royal Infirmary of Edinburgh Formulary Committee Co-Chair and Reader in Health Economics, University of Edinburgh Consultant Gastroenterologist, St John s Hospital General Practitioner, Lothian General Practitioner, NHS 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 Medicines Management Team Administrator Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh General Practitioner, Lothian Lead Pharmacist, Western General Hospital Formulary Pharmacist, NHS Borders Associate Director, Contracted Community Pharmacy Services & CHP Development, NHS Lothian General Practitioner, Lothian Declarations of interest: The Chair reminded members to declare any interests in any of the products to be discussed. Membership The committee noted the resignation submitted from Lee McGuiness, Chief Nurse, General Surgery, Royal Infirmary of Edinburgh from Formulary Committee. A nomination from the department has been made, which will be considered; however the committee noted that members are invited to join based on experience and expertise. Members were also reminded that a replacement for Dr Philip Rutledge has not yet been identified. The Chair of the committee requested that all members give consideration to possible nominations for these vacancies.

2 Minutes LOTHIAN FORMULARY COMMITTEE 1. Minutes of the previous meeting held on 10 November An amendment to the previous minutes of 10 November 2010 is required. The classification for Section 2.1, dronedarone (Multaq ) currently reads Add to the Additional List, for Specialist Use only. This drug should be classified as Add to the Additional List, Specialist initiation. 1.2 It was agreed to amend the minute and webtables. An updated version of the report and letter will also be circulated. ACTION: ZS 2. Matters arising from previous minutes 2.1 e-ljf Vision (update) An update of the 3 phases for implementation of e-ljf Vision was provided to the committee. The target completion dates of end January 2011 for Formulary headings and mid February 2011 for e-ljf headings were noted. 2.2 amifampridine Following correspondence from Formulary Committee on 10 November 2010 regarding this SMC not recommended drug for the treatment of Lambert-Eaton Myasthenic Syndrome; the clinical team had queried if it would be acceptable practice to continue using the older unlicensed product, 3,4 DAP West Midlands Specialised Commissioning Office has released a report regarding the position of the use of the licensed product amifampridine, stating that funding for this drug will not be supported. It is understood that SMC are also considering issuing a statement The considerable cost differential was noted, 1,200 for the older unlicensed medicine and 44,000 for the new licensed product. Given these factors, ADTC are considering the release of a similar position statement for the continued use of the unlicensed preparation for existing patients who are clinically stable The committee agreed to write to ADTC in support of the principle to issue a statement for continued use of 3,4 DAP in clinically stable patients. All new patients are to follow the process for individual patient treatment requests. ACTION: SL 2.3 febuxostat (Adenuric ) The submission for febuxostat was reviewed at Formulary Committee on 10 November At that time, a decision was deferred and a letter written to the clinical team requesting further information on liver and renal function testing, clarification of patient selection and prescribing in relation to allopurinol. A response was received and circulated to the committee The correspondence confirmed that baseline monitoring of both liver and renal function would be carried out. Phase III trials observed mild abnormalities of LFTs in 3.5% of patients and therefore periodic testing of liver and renal function would be carried out, based on clinical judgement It was noted that the response received did not include a protocol for patient selection and prescribing in relation to allopurinol. The clinical team did however confirm that febuxostat would be restricted for use in line with SMC and British Society of Rheumatology guidance; increasing the dose by 100mg increments

3 (adjusted if required for renal function) until the therapeutic target of 900mg is reached. If there is an inadequate response, febuxostat would be indicated It was agreed to add febuxostat (Adenuric ) to the formulary as second choice. A prescribing note is required to clarify prescribing in relation to allopurinol and contraindications of its use in patients with ischemic heart disease. 3. SMC Recommendations - FAF1s 3.1 certolizumab, (Cimzia ) 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. certolizumab pegol (Cimzia ) No 590/09 ADVICE: following a resubmission Certolizumab pegol (Cimzia ) is accepted for restricted 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 antirheumatic 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 The committee noted the FAF1 submission for the restricted use of certolizumab pegol (Cimzia ) The clinical team proposed that certolizumab should be added as first choice anti- TNF for rheumatoid arthritis, replacing etanercept, with the other agents, etanercept, adalimumab and infliximab, to be available as second line choices Concerns were raised over the omission of a protocol within the submission, and a lack of clarity about the relative place of the various agents in prescribing It was noted that certolizumab would be used in 138 patients per annum, and by replacing etanercept this could generate savings of 55,001 in year 1 to 230,460 in year 2 +. The accuracy of costs could not be fully appreciated without further information on the length of time patients are likely to remain on this treatment.

4 3.1.6 The committee noted that studies showed a fast and effective response to the treatment; however discussions took place on the lack of comparative safety evidence and concerns over an increased risk of infections The committee highlighted concerns over the number of drugs available for secondline choice and agreed that the clinical team should establish a single anti-tnf second-line agent It was agreed to defer classification. Rheumatology are to be contacted to request a protocol for prescribing and a decision to be made regarding a single anti-tnf second-line agent of choice. ACTION: SL 4. SMC latest Not Recommended Medicines (November 2010) The committee noted the following medicine not recommended for use by SMC in NHS Scotland: 4.1 dexamethasone, 700 microgram intravitreal implant (Ozurdex ), Report No. 652/10, is not recommended for use within NHS Scotland for the treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). 4.2 prucalopride, 1mg and 2mg tablet (Resolor ), Report No. 653/10, is not recommended for use within NHS Scotland for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief It was agreed that further communication to GPs is required, to increase awareness that this drug is not recommended by SMC. An article in the Lothian Prescribing Bulletin will be used to highlight this. 4.3 ranolzine, 375mg, 500mg and 750mg prolonged-release tablets (Ranexa ), Report No. 565/09, is not recommended for use within NHS Scotland as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta blockers and/or calcium channel antagonists). 4.4 gefitinib, 250mg film-coated tablets (Iressa ), Report No. is not recommended for use within NHS Scotland for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK). 4.5 Non-submissions diclofenac, (Mobigel Spray ) 4% spray gel, Report No. 667/10 is not recommended for use within NHS Scotland for the local symptomatic relief of mild to moderate pain and inflammation following acute blunt trauma of small and medium-sized joints and periarticular structures. fondaparinux sodium (Arixtra ) 1.5mg/0.3mL solution for injection pre-filled syringe, Report No. 668/10, is not recommended for use within NHS Scotland for the treatment of acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.

5 denosumab (Prolia ) 60mg solution for injection in pre-filled syringe, Report No. 670/10, is not recommended for use within NHS Scotland for bone loss associated with hormone ablation in men with prostrate cancer at increased risk of fractures. 5. Other Medicines Proposed for Use - FAF2s and FAF3s 5.1 sodium hyaluronate 1.2% (OVD ophthalmic viscosurgical device) No interests were included within the submission The committee noted the FAF2 submission for the use of sodium hyaluronate (OVD ) for injection into the eye to create a deep anterior chamber during cataract surgery and protect the corneal epithelium during the various stages of the ophthalmic operation The request proposes to switch brands to a new OVD. The committee noted that the old and new preparations are produced differently but with no noted significant differences The submission proposes that by switching to the new product, savings of around 7400 to 8325 would be made. It was not known if these costs include VAT, however if this is the case, with the forthcoming VAT increase, a saving of around 9,000 would be generated It was noted that this medicine is for one-off use during surgery and therefore there are no concerns to be considered regarding the switch of drugs It was agreed to add sodium hyaluronate 1.2% to the Additional List, for Specialist Use only. 5.2 chlordiazepoxide (Librium ) and baclofen (Lioresal ) No interests were included within the submission The committee noted the FAF3 submission for the off-label use of chlordiazepoxide (Librium ) adjunct to bacolfen in gamma-butyrolactone (GBL) withdrawal and baclofen (Lioresal ) adjunct to high-dose chlordiazepoxide in gamma-butyrolactone (GBL) withdrawal, to prevent relapse in formerly GBL-dependent patients The committee noted that the application had the full support of Dr Robby Steel, Consultant Psychiatrist, Royal Infirmary of Edinburgh The proposal is to use both drugs for planned in-patient treatment for individuals that have developed severe physical dependence to GBL and wish to discontinue use It was highlighted that baclofen is currently used (unlicensed) to prevent relapse in alcohol dependent patients It was noted that the drugs would be used for approximately 12 patients per annum costing for chlordiazepoxide and for baclofen. For the first 24 hours one nurse would be required, the cost of which is not known Concerns were raised over the availability of chlordiazepoxide at acute sites should patients require transfer. It was agreed that the equivalent dose of diazepam should be recorded in the event that chlorodiazepoxide is not available It was agreed to add chlordiazepoxide (Librium ) and baclofen (Lioresal ) to the Additional List, categorised RED under the ADTC Policy for the use of unlicensed (and off-label use) Medicines in NHS Lothian. Specialist Use only. Equivalent dose of diazepam to be included.

6 6. SMC Abbreviated Submissions LOTHIAN FORMULARY COMMITTEE 6.1 etonogestrel implant 68mg (Nexplanon ) (No: 655/10) etonogestrel implant 68mg (Nexplanon ) No. 655/10 ADVICE: following an abbreviated submission etonogestrel implant 68mg (Nexplanon ): is accepted for use within NHS Scotland. Licensed Indication under review: in patients for whom a long-acting etonogestrel implant is an appropriate choice of contraception. Nexplanon provides an alternative to the existing preparation at no additional cost. This formulation of etonogestrel implant is X-ray opaque, allowing verification of presence and location of implant The committee noted the above abbreviated submission It was agreed to add to the formulary and for the LJF section to be amended to reflect the change in name from Implanon to Nexplanon 6.2 atazanavir 150, 200 and 300mg capsules (Reyataz ) (No: 656/10) atazanavir 150, 200 and 300mg capsules (Reyataz ) No. 656/10 ADVICE: following an abbreviated submission atazanavir 150, 200 and 300mg capsules (Reyataz ): is accepted for use within NHS Scotland. Licensed Indication under review: co-administered with low dose ritonavir is indicated for the treatment of paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products. Data available in children 6 to less than 18 years are very limited. Available data may suggest that atazanavir in combination with ritonavir may not be effective in treatment experienced children even with very few (<3) protease inhibitor mutations. The choice of atazanavir in treatment experienced paediatric patients should be based on individual viral resistance testing and the patient s treatment history. The Scottish Medicines Consortium has previously accepted this product for use in HIV infection in adults. Atazanavir is listed in the British National Formulary for Children for the treatment of HIV The committee noted the above abbreviated submission It was agreed to add atazanavir to the Additional List, for Specialist Use only.

7 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. Licensed 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 tacroliumus 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 The committee noted the above abbreviated submission It was noted that SMC licensed this drug for a greater number of indications than anticipated and the manufacturer is only able to meet supply demand in paediatric patients under 5 years The clinical team are currently continuing to make their own preparation, and have been contacted regarding their preference for classification It was agreed to defer classification, pending further information from the clinical team. 7. Formulary Additions and Amendments 7.1 Formulary Minor Amendment Request Form Versiva XC No interests were declared The committee noted the Formulary Minor Amendment Request for the use of Versiva XC in moderate to high exudating, sloughy or granulating wounds to replace the use of a combination of Aquacel and Allevyn (adhesive or nonadhesive) The minor amendment request form proposes for Versiva XC to be used instead of Aquacel and Allevyn in combination for wounds requiring both dressings It was noted that this could generate considerable savings of up to 50% on the costs of the combination of the 2 dressings, however actual costs cannot be

8 predicted, as it is not known what proportion of current prescribing will be replaced with Versiva XC It was highlighted that Tissue Viability nurses will need to provide education to practice/community nurses in the use of this combination product It was agreed to add Versiva XC to the formulary as a prescribing note, to be first choice in place of Aquacel and Allevyn when used in combination. Wound section to be updated. 8. NICE/SIGN/NHS QIS Clinical Guidance 8.1 NICE STA 208 Trastuzumab for the treatment of HER2-positive metastatic gastric cancer The committee noted and discussed the above NICE Single Technology Appraisal for information This STA is contrary to SMC advice in August 2010 which indicates trastuzumab to be not recommended for use with NHS Scotland The committee noted that there is an intention to resubmit to SMC. 8.2 NICE MTA 209 Imatanib for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours The committee noted and discussed the above NICE Multiple Technology Appraisal which is a part review of technology appraisal It was noted that there is no effect on the formulary The committee agreed to write to oncology as a reminder that the higher doses of 600mg or 800mg are not recommended for use. ACTION: SL 8.3 SIGN 121 Diagnosis and management of psoriasis and psoriatic arthritis in adults The committee noted and discussed the above SIGN guideline It was highlighted that the use of a combined potent corticosteroid plus calcipotriol ointment is currently in the LJF as Specialist Use only. It was noted that dermatology are reviewing its use in primary care The SIGN guideline includes the use of tazarotene gel, not currently included within the LJF Currently the LJF recommends short contact dithranol with a 60 minute contact time; however the SIGN guideline suggests 30 minute exposure. 9. Drug Safety Issues MHRA Advice/NPSA Advice 9.1 Drug Safety Update Volume 4, Issue 4, November 2010 The committee noted and reviewed the above MHRA Drug Safety update. 9.2 memantine oral solution: administration errors The committee noted cases of administration errors following the introduction of a new pump device in April Healthcare professionals should be aware that there are differences in doses and dose schedules between the pump device and dropper device for memantine.

9 9.3 ullipristal: pregnancy register The committee noted and discussed advice circulated by HRA Pharma It was noted that ellaone may fail to prevent pregnancy and as a result the European Health Authorities have requested that a pregnancy register is established Healthcare professionals are requested to report details of any patients exposed to ellaone, at any time during pregnancy, on the pregnancy registry website. 9.4 isotretinoin and severe skin reactions The committee noted and discussed new safety information for isotretinoin It was noted that severe skin reactions have been reported in association with the use of isotretinoin. 10 For Information Only 10.1 Formulary Committee Reports and Letters The committee noted the following Formulary Committee reports and letters: amifampridine (Firdapse ) febuxostat (Adenuric ) sitagliptin (Januvia ) palivizumab (Synagis ) calcium carbonate and colecalciferol (Calcichew D3 Caplets ) colistimethate sodium (Promixin ) dronedarone (Multaq ) Palliative Care Guideline 11 AOCB The Chair of the Committee thanked all members for their valued contribution during Date of Next Meeting 12.1 The committee noted that the next meeting would be held on 26 January 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 11 January 2011).

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