DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of the meeting held on Tuesday, 9 th August 2011

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1 DERBYSHIRE JOINT AREA PRESCRIBING COMMITTEE (JAPC) Minutes of the meeting held on Tuesday, 9 th August 2011 Summary Points Guidelines ratified Treatment guideline for glaucoma Oral Nutrition Supplements Shared care updates Liraglutide and Exenatide Bicalutamide Memantine Traffic lights Drug Dabigatran Coagucheck testing strips Paliperidone long acting injection Retigabine Lacosamide Memantine Liraglutide Exenatide Tafluprost preservative free eye drops Decision RED BROWN RED RED GREEN (after specialist initiation) AMBER GREEN if undertaken specialist training AMBER for non-trained clinicians GREEN if undertaken specialist training AMBER for non-trained clinicians GREEN (after specialist initiation) after preservative free beta-blockers 1

2 Present: Derbyshire County PCT Dr J Bell Dr C Emslie Dr D Fitzsimons Mr S Hulme Dr A Mott Mrs S Qureshi Assistant Director of Public Health (Chair) GP NE Derbyshire GP Derbyshire Dales Assistant Director of Medicines Management GP Amber Valley NICE Liaison and Audit Pharmacist Derbyshire Community Health Services Trust Mr M Steward Head of Pharmacy - DCHS Derby City PCT Mr S Dhadli Mrs L Hunter Assistant Director of Medicines Management Assistant Director of Finance Derby Hospitals NHS Foundation Trust Mr T Gray Dr J Leung Chief Pharmacist Chair Drugs and Therapeutic Committee Derbyshire Healthcare Services Trust Dr P Brownsett Consultant Psychiatrist Chesterfield Royal Hospital NHS Foundation Trust Mr M Shepherd Chief Pharmacist In Attendance: Mr A Thorpe Derby City PCT (Minutes) Ms J Booth Derbyshire Community Health Services (for agenda item 5 a) 1. APOLOGIES Mr D Anderton, Dr R Elkheir, Mr D McLean, Mrs L Hunter, Dr A Morkane, Dr A Tooley and Mrs S Sims 2. DECLARATIONS OF INTEREST No declarations of interest were made. There were no items of any other business. 2

3 It was agreed that the RA Biologics Algorithm update agenda item be deferred. 3. MINUTES OF JAPC MEETING The minutes of the meeting held on 12 th July 2011 were agreed as a true and accurate record after the following amendments: 4: Exenatide/Liraglutide Shared Care amend to read: Mr Dhadli reported that he had taken the exenatide and liraglutide shared care guideline to the Royal Derby Hospital shared care guideline group. The group had not supported a shared care approach because there was no special monitoring or follow up and proposed that this should be green specialist initiation only. Dr Mott commented that the issue was that exenatide could not be classified as green until all GPs had been trained to initiate it. There was an issue with the ongoing monitoring of patients which did not merit shared care. Mr McLean stated that it was accepted that the training was underway but was keen to have green specialist initiation for the surgeries where the training had been delivered. He stated also that there was a referral mechanism for GLP1 agonist trained GP in exenatide/liraglutide use to cascade to those non-glp1 agonist trained GP within the same practice and for those surgeries with no trained clinician to refer back to the Trust for initiation and then ongoing prescribing under the Derbyshire diabetes guidelines. Mr Dhadli reported that there were 17 practices in Derby which had at least one trained person, but 15 practices had not. The training concerned the administration of the injections by the patients. 5 (a) Denosumab - In light of the new NICE technology appraisal for denosumab Dr Summers wanted to withdraw his original business case that had been in circulation. 6 Tapentadol amend to read Mr Dhadli presented an assessment prepared by Mr Burrill of tapentadol (immediate-release and prolongedrelease tablets) a new preparation used for the treatment of moderate to severe acute pain and severe chronic pain normally managed with opioid analgesics. The SMC had reviewed the use of the prolonged-release preparation for severe chronic pain to replace oxycodone CR and transdermal fentanyl patches. A review of evidence highlighted deficiencies in the analysis with no direct comparison with transdermal fentanyl in the trial and patients not being allowed break through doses of the relevant drug which is considered normal practice. A further flaw being the use of limited paracetamol dosing (1g day) allowed only during the titration phase. This is a black triangle drug with no long term safety data and therefore classified as BROWN. 4. MATTERS ARISING a. Exenatide/Liraglutide Shared Care Mr Dhadli reported that Dr Garry Tan had carried out the training in Derby City and Erewash. The training in the north of the County is to be organised by Chesterfield Royal Hospital and Jane Hannah would arrange for Derbyshire Dales and Swadlincote. A date for training was awaited for Amber Valley. Mr Dhadli added that only 34 out of 136 practices across Derbyshire had 3

4 undertaken the training and this low uptake had been raised with Dr Tan. Scoping of online training is being looked at with the help of the drug companies and this would take some time to organise. In order to increase the number of trained clinicians Mr Hulme commented that it was intended that each practice would send a representative to the training which would then be cascaded back to their surgery. There would need to be an assurance plan and timetable for training in place in order to highlight any gaps. The distance learning should be able to address these gaps. Dr Mott commented that the Clinical Commissioning Groups would also need to be involved with issues about the training. Agreed: To leave the training to be rolled out and bring back to JAPC if necessary 5. NEW DRUG ASSESSMENTS a. Paliperidone palmitate injection Mr Dhadli reported that paliperidone was a prolonged release suspension for injection and was indicated for the maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. It was being promoted on the grounds that it did not need to be refrigerated and could be administered monthly without initial oral supplementation. Two non-inferiority studies were used by the SMC in their appraisal of the drug: (1) A 53 week non-inferiority study had failed to demonstrate that paliperidone was non inferior to risperidone and (2) a 13 week trial had showed paliperidone LAI was non-inferior to risperidone LAI. Mr Dhadli advised that costings were based on early discharge from secondary care and there were issues about long-term safety and efficacy compared to other anti-psychotics. The JAPC was advised that the Derbyshire Healthcare Foundation Trust Drugs and Therapeutic Committee had also not supported the use of paliperidone palmitate at their meeting held in June 2011 given that the economic analysis did not support early patient discharge and long term safety is not established. Agreed: paliperidone classified as a RED drug b. Coagucheck Mr Dhadli advised that coagucheck was a near patient/self testing piece of kit using strips to measure INR in patients taking oral anticoagulants. The current spend was 9,600 for the City and 20,700 for the County. NICE has stipulated that self-monitoring for patients with AF who required long-term anticoagulation should be considered in accordance with patient preference and that the stated criteria were met. There was robust evidence for coagucheck which demonstrated good accuracy of testing compared to conventional INR testing. There was discussion about the costs of the strips compared to INR testing in secondary care laboratories and a possible equity issue associated with the fact that the strips for coagucheck are allowed on the NHS whereas the coagucheck meters are purchased at a considerable cost to the patient. Agreed: coagucheck classified as a BROWN drug 4

5 6. CLINICAL GUIDELINES a. Glaucoma Mr Gray presented an update of the existing treatment guidance for glaucoma which complemented the NICE guidance and gave advice on the treatments which could be recommended for use. Tafluprost had been added as a preservative free prostaglandin analogue which was considered a second line preservative free choice after beta-blockers. JAPC noted that, although twice the cost of equivalent beta blocker therapy, the dosing meant that this was cost neutral. Dr Leung commented that it would also offer cost savings due to a reduction in operations and complications for older patients. Agreed: the treatment guideline for glaucoma was ratified and tafluprost classified as GREEN (after specialist initiation) as second line preservative free eye drops after preservative free beta-blockers b. Oral Nutrition Supplements Mr Hulme advised that the updated guideline for oral nutrition in adults now includes Complan Shake as the first prescribed option for primary care to consider after the fortification of food and patients purchasing over-thecounter products. Increased use of Complan Shakes would reduce primary care spend on Oral Nutrition Supplements (ONS). It was noted that this was an updated version of a paper which had previously been considered by JAPC. A possible conflict of interest was highlighted to JAPC that the author of the updated guideline was employed by Royal Derby Hospital and that the PCTs used a rebate from NUTRICIA who manufactured fortisip. Mr Hulme explained that the author had not been involved with the choice of products and had not written the guideline in isolation. Agreed: the updated guideline was ratified c. Dabigatran for the prevention of stroke in patients with AF Mr Dhadli presented the EM PCTs policy for dabigatran which was an oral anti-thrombotic and highlighted the considerable financial risk for the prescribing budget if used instead of warfarin. A NICE TAG on dabigatran is due to be published in December EMSCG have developed a commissioning policy for use by PCTs to help them commission an interim policy between the launch date of the drug and the expected publication of the TAG. Dr Bell commented that the cost of dabigatran in the policy was less than originally expected and this would considerably change the cost effectiveness of the drug. Dr Leung highlighted safety and efficacy concerns associated with dabigatran and possible side effects and risks of bleeding. Mr Dhadli advised that the proposal for the licensing of dabigatran had changed the licensed dosage for the over 80 years age group and recommended the lower dose, although the evidence base for superiority over warfarin was for the higher 150 mg dose. An article from PULSE in July 2011 stated that for the 110mg dose the cost per QALY was estimated to be 97,000 which was not cost effective. The main RE-LY study which backed 5

6 up the evidence for the non-inferiority with warfarin referred to a large category of patients who were excluded from the trials. Mr Gray stated that the East Midlands Cardiac and Stroke Network had expressed concern that they were not fully engaged with the discussions about dabigatran. There would also be cost implications associated with the need to maintain the existing infrastructure for the patients who were well established on warfarin and INR testing. Mr Hulme commented that this would need to be properly commissioned and the time interval before the publication of the NICE guidance gave sufficient time to put a plan in place. Agreed: dabigatran to remain as RED and further work to be undertaken on the commissioning and cost implications 7. ITEM FROM DERBYSHIRE COMMUNITY HEALTH SERVICES Cellulitis Ms Booth presented the primary care cellulitis pathway which provided a guide to the treatment of class II cellulitis in the community setting with I.V antibiotics. This could be administered on a once daily basis by the Rapid Response Nursing Team in the Chesterfield area with the aim of reducing the cost of patients admitted to hospital with cellulitis. Discussion ensued during which the amount and duration of the dosage was queried. The fact that the drugs are unfamiliar to GPs and the risk of increased antigen resistance and C.Diff were also highlighted. Mr Shepherd reported teicoplanin resistance could be an issue. Details of the costs were needed including the effect of reduced hospital admissions and it would be advantageous to discuss with the anti-microbial pharmacists the presentation of a possible business case. Dr Mott advised that links should be made with the Chesterfield Clinical Commissioning Group as it was important that GPs were on board and they would be able to assist in the development of the proposal with Ms Booth. Agreed: Liaise with Mr Dhadli on the pathway and check the EPACT data to ascertain how much prescribing was been done at present. : Ms J Booth JB 8. SHARED CARE a. ADHD Dr Brownsett stated that it was unclear what consultation on the shared care agreement for ADHD in children had taken place and the document which had been produced was an old version with track changes and incorrect Trust names. There would also be some amendments to reflect the changes in service providers and the fact that community paediatrics was now part of Derbyshire Healthcare rather than the PCT. Agreed: clarify who had been consulted with and produce the appropriately changed document : Mr D McLean DMcL b. Exenatide and Liraglutide Dr Leung presented the shared care agreement and advised that this had now been updated to include details for the prescribing of liraglutide. Mr 6

7 Dhadli pointed out that the procedures section to the stopping of exenatide if pancreatitis was suspected should also include liraglutide. Agreed: JAPC ratified the exenatide and liraglutide shared care agreement with the agreed change. Agreed: traffic light classification for exenatide and liraglutide agreed as GREEN if undertaken specialist training/amber for non-trained clinicians c. Lacosamide Mr McLean had written to indicate that the DHFT Shared Care Sub-Group had recommended that a shared care guideline was not required for lacosamide and that it be re-classified as green specialist initiation. Agreed: lacosamide SCA to be removed from the website Agreed: lacosamide classified as GREEN (specialist initiation) d. Bicalutamide This shared care agreement was to be reviewed. Agreed: JAPC ratified the bicalutamide SCA with the inclusion of a review date : Mr D McLean e. Memantine This was a new proposal which reflected the changes recommended in the NICE TAG 217 issued in March 2011 and is for specialist initiation of up to a four month trial strictly for moderate Alzheimer s disease. Mr Dhadli explained that the costs of implementing shared care would be 17,165 for the Derby City and 65,560 for the county and monies for this had been allocated by the City RIC and County ROC. It was highlighted that it should be made clear at the top of the SCA that the indication for use is for dementia of Alzheimer s type classified as moderate to severe. Agreed: JAPC ratified the memantine SCA Agreed: memantine classified as AMBER 9. NICE GUIDANCE a. TAG Erlotinib monotherapy for maintenance treatment of nonsmall-cell lung cancer Specialist use for information b. TAG Bortezomib and thalidomide for the first-line treatment of multiple myeloma Specialist use for information. c. TAG Dexamethasone intravitreal implant for the treatment of macular oedema secondary to retinal vein occlusion Specialist use for information. d. TAG Bivalirudin for the treatment of ST- segment-elevation 7

8 myocardial infarction Specialist use for information. e. TAG Agomelatine for the treatment of major depressive episodes This was a terminated appraisal. f. TAG Retigabine for the adjunctive treatment of partial onset seizures in epilepsy Retigabine could be used as an option for the adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and older with epilepsy when other previous treatments had not provided an adequate response or were not tolerated. Mr Dhadli stated that the cost compared equally with other more expensive anti-epileptic treatments and should be initiated only by clinicians who had previous experience in the treatment of elipepsy. Agreed: retigabine classified as RED g. CG 125 Peritoneal Dialysis No medicines-related implications were noted. 10. JAPC BULLETIN The JAPC bulletin was ratified after the removal of the section on liraglutide and exenatide from the key messages section and from the traffic light classifications. 11. GUIDELINE GROUP a Medicines Management Guideline Group The minutes of the meeting held on 15 th July 2011 were noted for information. Mr Dhadli stated that the Guideline Group met monthly to review the website and shared care and also referred to the minor amendments made to guidelines and treatments. Dr Mott queried how the changes made by the Guideline Group were communicated to GPs and Mr Dhadli stated that these were included on the website. It was agreed that a summary of key decisions made by the Guideline Group would be useful for JAPC. Mr Hulme queried whether formularies should be included as part of the discussions about the terms of reference of the JAPC together which was also an opportunity to look at the membership of the Guidelines Group. : Mr Dhadli to produce summary for JAPC SD 12. TRAFFIC LIGHTS ANY CHANGES? Paliperidone long acting injection RED Coagucheck testing strips BROWN Tafluprost unit dose eye drops GREEN (after specialist initiation) Dabigatran RED Memantine AMBER Liraglutide - GREEN if undertaken specialist training 8

9 AMBER for non-trained clinicians Exenatide - GREEN if undertaken specialist training AMBER for non-trained clinicians Lacosamide - GREEN (after specialist initiation) Retigabine - RED 13. MINUTES OF OTHER PRESCRIBING GROUPS - FOR INFORMATION STAMP 14/6/11 Royal Derby Hospital Drugs and Therapeutic Committee 23/6/ DATE AND TIME OF NEXT MEETING Tuesday, 13 th September 2011, Parkhouse Room, Coney Green, Clay Cross at 1.30pm. N.B. Papers to Slakahan Dhadli by 20 th August 2011 please 9

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