LOTHIAN FORMULARY COMMITTEE FORMULARY COMMITTEE

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1 FORMULARY COMMITTEE Minutes of the Formulary Committee meeting held on 25 th January 2012 in Board Room, Royal Victoria Hospital Present: Dr E Brown Consultant Oncologist, Western General Hospital J Carson Lead Directorate Pharmacist, Royal Infirmary of Edinburgh Dr J Forbes Formulary Committee Co-Chair and Reader in Health Economics, University of Edinburgh Dr H Gillett Consultant Gastroenterologist, St John s Hospital Dr S Hurding General Practitioner, NHS Lothian S Kerr Lead Pharmacist, Western General Hospital Professor S Lawrie Formulary Committee Co-Chair and Professor and Honorary Consultant Psychiatrist, Royal Edinburgh Hospital (in the chair) L Leitch Formulary Pharmacist, NHS Borders I Mohammed Clinical Effectiveness Pharmacist, NHS Fife J Pearson Formulary Pharmacist, NHS Lothian L Shaw Lead Directorate Pharmacist, Royal Infirmary of Edinburgh Z Stofankova G Todd Lead Pharmacist, Royal Edinburgh Hospital and Roodlands Hospital Apologies for absence: Dr P Conaglen Specialist Registrar in Public Health Dr J Dear Consultant Clinical Pharmacologist, Royal Infirmary of Edinburgh Dr SC Hornibrook General Practitioner, Lothian T Slaughter Clinical Effectiveness Pharmacist, North Cumbria Medicines Management Group Dr W Jamieson General Practitioner, Lothian Dr R Williams General Practitioner, Lothian Dr D Wilks Consultant in Infectious Diseases, Western General Hospital Declarations of interest: The Chair reminded members to declare any interests in any of the products to be discussed. Minutes 1. Minutes of the previous meeting held on 14 th December The minutes of the meeting of 14 th December 2011 require amendment to section 3.2. The point should have read as committee agreed that they would support the submission of SCP to GPPC. ACTION: ZS

2 2. Matters arising from previous minutes 2.1 golimumab (Simponi ) A submission for this drug for the treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy was presented to Formulary Committee on 9 th November It was agreed golimumab is not preferred as suitable alternatives are available The committee received an appeal to the decision and discussed the correspondence in response to this request The correspondence confirmed that needle phobia of approximately 25% mentioned in the original FAF1 was an overestimate and that needle phobia rate of 5% is more realistic. The patient selection criteria in this letter are different to the original FAF It was proposed to use golimumab in place of infliximab in AS patients who develop an ADR to adalimumab (5%), and who in turn have a history of iritis (20-25%; etanercept not used in this group), or who have needle phobia (5%). Based on AS patients starting a TNF inhibitor per annum in Lothian, this works out as 1-2 patients per year The correspondence also confirmed that the annual drug costs of golimumab would be significantly lower than of infliximab The committee noted that there will be an additional group of patients who are secondary non-responders to adalimumab who should switch to an alternative monoclonal antibody infliximab or golimumab. However it is difficult to estimate the numbers of those patients. It could be potentially 5-10 patients per annum The committee agreed to add golimumab (Simponi ) to the Additional List for Specialist Use only. ACTION:JP/SL

3 3. SMC Recommendations - FAF1s 3.1 tapentadol prolonged-release tablets (Palexia ) The committee noted and discussed the previously circulated submission and SMC report. Three declarations of interest (personal, non-specific and specific, and non-personal, non-specific) were included with the submission and noted by the committee. tapentadol, 50, 100, 150, 200 and 250mg prolonged-release tablets (Palexia ) No. 654/10 ADVICE: following a resubmission: tapentadol prolonged-release tablets (Palexia ) is accepted for restricted use within NHS Scotland. Indication under review: the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics. SMC restriction: patients in whom morphine sulphate modified release has failed to provide adequate pain control or is not tolerated. Results of a meta-analysis of three, 12-week studies suggest that tapentadol prolonged release has improved gastrointestinal tolerability and similar efficacy compared to another long-acting opioid included as an active control. The manufacturer s submission related only to the use of tapentadol prolonged release in severe chronic pain. SMC has not yet received a submission for tapentadol immediate release tablets for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics. Tapentadol immediate release tablets are not recommended for use in NHS Scotland The committee noted the FAF1 submission for the use of tapentadol prolongedrelease tablets (Palexia ) for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics It was noted that the above group of patients is currently treated with oral morphine. Oxycodone is used in patients in whom morphine is not tolerated or is ineffective The committee noted that tapentadol would replace oxycodone It was noted that the evidence is based on three randomised, double-blind, active and placebo-controlled, phase III studies: two in patients with osteoarthritis of the knee and one in patients with low back pain The committee discussed the studies and noted that there are weaknesses with the quality of the clinical data, in particular classifying those patients that discontinued treatment as non-responders The design of studies did not allow for the use of breakthrough doses of the relevant drug during periods of dose titration or maintenance therapy. Very limited doses of paracetamol (1g daily) were allowed during the titration phase The meta-analysis indicated that tapentadol SR had better gastrointestinal tolerability than oxycodone MR.

4 3.1.9 It was agreed to add tapentadol prolonged-release tablets (Palexia ) to LJF as second choice drug after morphine for severe chronic pain. Note that the immediate release tapentadol tablets are not approved for use. 3.2 paliperidone palmitate (Xeplion ) The committee noted and discussed the previously circulated submission and SMC report. One declaration of interest (personal, non-specific) was included with the submission and noted by the committee. A committee member noted a personal, non-specific interest. paliperidone palmitate 50mg, 75mg, 100mg and 150mg prolonged release suspension for injection (Xeplion ) No. 713/11 ADVICE: following a resubmission: paliperidone palmitate (Xeplion ) is accepted for use within NHS Scotland. Indication under review: maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, it may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed. Paliperidone prolonged release suspension for injection was non-inferior to another atypical antipsychotic depot injection in terms of control of schizophrenia symptoms over a 3-month period and was more effective than placebo in preventing relapse of schizophrenia The committee noted the FAF1 submission for the use of paliperidone palmitate (Xeplion ) as maintenance treatment of schizophrenia in adult patients stabilised with oral paliperidone or oral risperidone It was noted that the paliperidone palmitate would be used as an alternative to risperidone LAI in new patients The committee noted that in comparing to risperidone there is an advantage in dosing schedule of paliperidone palmitate, as it is given monthly rather than fortnightly, and there is no requirement for initial oral antipsychotic supplementation It was also noted that paliperidone palmitate doesn t require reconstitution and can be stored at room temperature which may lead to reduced wastage The committee noted that paliperidone palmitate could be appropriate for Shared Care Protocol (SCP). The initiation of a depot antipsychotic should be on a consultant psychiatrist s advice only, however maintenance treatment with depots takes place in both secondary and primary care The economic evidence proved paliperidone palmitate to be more cost effective than risperidone based on the assumption that paliperidone palmitate would shorten the length of stay in hospital by one third The committee noted that there was no suggestion in the FAF1 that existing patients on risperidone LAI would be switched to paliperidone, but that paliperidone would be used for new patients. The advantages in switching can be seen, but that would remain a clinical decision.

5 3.2.9 The committee agreed to add paliperidone palmitate (Xeplion ) to the LJF as second choice drug. 3.3 retigabine (Trobalt ) The committee noted and discussed the previously circulated submission and SMC report. Two declarations of interest (personal, non-specific and nonpersonal, non-specific) were included with the submission and noted by the committee. retigabine, 50mg, 100mg, 200mg, 300mg and 400mg film-coated tablets (Trobalt ) No. 712/11 ADVICE: following a full submission: retigabine (Trobalt ) is accepted for restricted use within NHS Scotland. Indication under review: Adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy. SMC restriction: patients with refractory epilepsy. Treatment should be initiated only by physicians who have appropriate experience in the treatment of epilepsy. In two placebo-controlled studies in patients with refractory epilepsy retigabine was superior to placebo in terms of the proportion of patients experiencing 50% reduction in partial seizure frequency per 28 days. An indirect comparison indicates that retigabine has similar efficacy to two other antiepileptic drugs used as adjunctive therapy The committee noted the FAF1 submission for the use of retigabine (Trobalt ) as adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy It was noted that retigabine would be used for the treatment of refractory patients who have failed on other drugs and are not suitable for epilepsy surgery. The prescribing will take place in primary care on specialist advice It was noted from the clinical trials that 5% of retigabine-treated patients experienced adverse reactions related to voiding dysfunction, including urinary retention. Therefore retigabine must be used with caution in patients at risk of urinary retention Further clarification on costs and patient numbers were requested by the committee which was provided by the applicants prior to the meeting The committee discussed the received correspondence and noted that approximately 20% of patients with epilepsy would require add on therapy. However due to the high volume of patient characteristics affecting the choice of add on therapy it is hard to predict what drugs will retigabine replace Based on the additional information provided, the estimated total net drug cost for the treatment of 30 patients would be approximately 5,521 per annum The committee agreed to add retigabine (Trobalt ) to the Additional List. The usage of this drug will be monitored via Medicines Utilisation and Review Group (MURG).

6 3.4 boceprevir (Victrelis ) The committee noted and discussed the previously circulated submission and SMC report. One declaration of interest (personal, non-specific) was included with the submission and noted by the committee. boceprevir 200mg capsule (Victrelis ) Treatment naïve patients No. 723/11 ADVICE: following a full submission: boceprevir (Victrelis ) is accepted for use within NHS Scotland. Indication under review: Treatment of chronic hepatitis C (HCV) genotype 1 infection, in combination with peginterferon and ribavirin, in adult patients with compensated liver disease who are previously untreated The committee noted the FAF1 submission for the use of boceprevir (Victrelis ) for the treatment of chronic hepatitis C (HCV) genotype 1 infection, in combination with peginterferon and ribavirin, in adult patients with compensated liver disease who are previously untreated The committee expressed concern about the large tablet burden needing to be taken by each patient per day It was noted that the patient selection criteria section in the submitted FAF1 states that the genotype one patients who are deemed suitable for treatment will be offered either boceprevir or telaprevir. However the application doesn t specify who would be selected for what drug It was noted that the trials excluded patients who were co-infected with HBV or HIV Therefore it was noted that more information is required on patient selection criteria and that the committee would like to see an algorithm for this section The committee were unable to make decision at this stage. It was agreed to go back to the applicants and ask them to provide further information as detailed above.

7 3.5 telaprevir (Incivo ) The committee noted and discussed the previously circulated submission and SMC report. One declaration of interest (personal, non-specific) was included with the submission and noted by the committee. A committee member noted a personal, non-specific interest. telaprevir 375mg film-coated tablets (Incivo ) No. 743/11 ADVICE: following a full submission: telaprevir (Incivo ) is accepted for use within NHS Scotland. Indication under review: in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis) who are treatment-naïve. In the pivotal phase III randomised study, addition of telaprevir to current standard therapy in treatment-naïve patients with genotype 1 chronic hepatitis C virus, significantly increased the proportion of patients who achieved a sustained virologic response, even in patients treated for a shorter overall duration using response-guided therapy The committee noted the FAF1 submission for the use of telaprevir (Incivo ) in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis) who are treatment-naïve The committee noted that in compare to boceprevir the daily tablet burden is slightly lower It was noted that the trials excluded patients who were co-infected with HBV or HIV The committee noted that like in the previously discussed application for boceprevir it is unclear what patients would be selected for use of telaprevir. Therefore more information is required on patient selection criteria Additional information will also be requested to clarify if peginterferon and ribavirin will be given for 24 or 48 weeks and if anaemia is routinely treated with epo The committee were unable to make decision at this stage. It was agreed to go back to the applicants and ask them to provide further information as detailed above.

8 3.6 boceprevir (Victrelis ) The committee noted and discussed the previously circulated submission and SMC report. One declaration of interest (personal, specific) was included with the submission and noted by the committee. boceprevir 200mg capsule (Victrelis ) Treatment experienced patients No. 722/11 ADVICE: following a full submission: boceprevir (Victrelis ) is accepted for use within NHS Scotland. Indication under review: treatment of chronic hepatitis C (HCV) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who have failed previous therapy The committee noted the FAF1 submission for the use of boceprevir (Victrelis ) for the treatment of chronic hepatitis C (HCV) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who have failed previous therapy It was noted that the evidence is based on one pivotal phase III, multi-centre, randomised, double-blind, placebo-controlled study tested on 403 patients. Patients with HIV were excluded from the study The committee noted that the study has proved that there was a significantly higher incidence of anaemia in the groups receiving boceprevir It was noted that there are no current UK guidelines to follow and that the local Lothian protocol has also not been developed It was noted that the trials excluded patients who were co-infected with HBV or HIV It was noted that the patient selection criteria section in the submitted FAF1 doesn t include specific information on individual patient characteristic and therefore it was unclear to the committee to whom will be offered boceprevir or telaprevir. Further clarification on this section is required The committee were unable to make decision at this stage. It was agreed to go back to the applicants and ask them to provide further information as detailed above.

9 3.7 telaprevir (Incivo ) The committee noted and discussed the previously circulated submission and SMC report. One declaration of interest (personal, specific) was included with the submission and noted by the committee. A committee member noted a personal, non-specific interest. telaprevir, 375mg, film-coated tablets (Incivo ) No. 742/11 ADVICE: following a full submission: telaprevir (Incivo ) is accepted for use within NHS Scotland. Indication under review: in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis) who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders. In the pivotal phase III randomised study, the addition of telaprevir to current standard therapy in patients with genotype 1 chronic hepatitis C virus, who had failed previous therapy, significantly increased the proportion of patients who achieved a sustained virologic response The committee noted the FAF1 submission for the use of telaprevir (Incivo ) in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis) who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders It was noted that the evidence is based on one pivotal phase III, randomised, double-blind placebo controlled study. Patients with HBV or HIV were excluded from the study It was noted that the patient selection criteria section in the submitted FAF1 doesn t include specific information on individual patient characteristic and therefore it was unclear to the committee to what patients will telaprevir be offered. Further clarification on this section is required The committee were unable to make decision at this stage. It was agreed to go back to the applicants and ask them to provide further information as detailed above.

10 3.8 linagliptin (Trajenta ) No declarations of interest were included with the application. linagliptin, 5mg film-coated tablet (Trajenta ) No. 746/11 ADVICE: following a full submission: linagliptin (Trajenta ) is accepted for restricted use within NHS Scotland. Indication under review: The treatment of type 2 diabetes mellitus to improve glycaemic control in adults: As monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contra-indicated due to renal impairment As combination therapy in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control SMC restriction: in combination therapy with metformin when diet and exercise plus metformin alone does not provide adequate glycaemic control in patients for whom the addition of a sulphonylurea is inappropriate. In two randomised double-blind, controlled studies, linagliptin in combination with metformin was found to be non-inferior to a sulphonylurea plus metformin, and superior to placebo plus metformin in controlling glycaemia, measured by the change in glycosylated haemoglobin (HbA1c). Linagliptin was associated with similar rates of hypoglycaemia and changes in weight when compared with placebo. Linagliptin is one of a number of medicines in this class, some of which are available at a lower acquisition cost. SMC cannot recommend the use of linagliptin as monotherapy or in combination with metformin and a sulphonylurea as the company s submission related only to its use in combination with metformin The committee noted the correspondence received in relation to this drug where the clinical team have decided to not use linagliptin in practice. They agree that that it has no further clinical advantage to the drugs which are already in use The committee agreed linagliptin (Trajenta ) is not preferred as suitable alternatives are available. 4. SMC latest Not Recommended Medicines (December 2011) The committee noted the following medicine not recommended for use by SMC in NHS Scotland:

11 4.1 entecavir (Baraclude ), Report No. 747/11, is not recommended for use within NHS Scotland for the treatment of chronic hepatitis B virus (HBV) infection in adults with decompensated liver disease. 4.2 ranozaline (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 antagonists). 4.3 NON-SUBMISSIONS dexamethasone (Ozurdex ), Report No. 751/11, is not recommended for use within NHS Scotland for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis. 5. Other Medicines Proposed for Use - FAF2s and FAF3s 5.1 levobupivacaine, sodium chloride, ketorolac and adrenaline The committee noted the FAF3 submission for the use of levobupivacaine, sodium chloride, ketorolac and adrenaline as analgesia for all patients undergoing total knee replacement unless contraindication to any of the medicine used in the mixture No declarations of interest were included with the submission The committee noted that this mixture has been used at the Royal Infirmary of Edinburgh for the last six years. It replaced the use of PCA morphine post surgery and reduced the PCA related side-effects. Patients are usually managed with oral analgesia. It was noted that the patients are mobilising earlier post surgery which caused reduction in length of patient s stay in the hospital It was noted that the mixture will only be used in orthopaedic theatres It was noted that currently 400 patients are treated with this mixture by two orthopaedic surgeons as part of the enhanced recovery programme It was noted that the evidence is based on three studies, but none of them is using the same combination of medicines as submitted by applicants The committee s main concerns were around safety of patients. It was noted that the members of the committee would like to see audit information relating to reduced hospital stay, confirmation that PCA analgesia is not used and reassurance regarding mixing procedures The committee were unable to make decision at this stage. It was agreed to go back to the applicants and ask them to provide further information as detailed above % sodium bicarbonate The committee noted the FAF3 submission for the use of 8.4% sodium bicarbonate as rapid top-up of epidural for emergency Caesarean Section No declarations of interest were included with the submission.

12 5.2.3 It was noted that there are currently 600 patients per year requiring emergency Caesarean Section where delivery is required in less then 30 minutes from decision The committee noted that the only other existing top-up is with 0.5% levobupivacaine which is too slow for emergency use or 2% lidocaine with 1:200,000 adrenaline It was noted that the evidence is based on three studies which have shown a faster onset of epidural block. There were no significant safety issues in maternal or neonatal outcomes The committee noted that there is an existing local Lothian protocol, although it will need to be updated should this drug be approved The committee agreed to add 8.4% sodium bicarbonate to the Additional List for Specialist Use only, categorised RED. 6. SMC Abbreviated Submissions (December 2011) 6.1 fentanyl (Instanyl ) fentanyl 50, 100, 200 microgram single dose nasal spray (Instanyl ) No. 750/11 ADVICE: following an abbreviated submission: fentanyl (Instanyl ) is accepted for restricted use within NHS Scotland. Indication under review: for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. SMC restriction: to patients who are unsuitable for other short-acting oral opioids (e.g. oral morphine) as an alternative to other buccal and sublingual fentanyl preparations. It should be noted that the doses of fentanyl nasal spray are significantly lower than doses of fentanyl given by other routes of administration for this indication. In a pharmacokinetic study in healthy volunteers, this single dose fentanyl nasal spray presentation was shown to be bioequivalent to the multi-dose nasal spray presentation and is available at equivalent cost per dose The committee received communication from Palliative Care team related to this drug and has agreed to classify fentanyl (Instanyl ) not preferred as suitable alternatives are available. ACTION: JP

13 7. Formulary Additions and Amendments ADULT 7.1 Chapter 1 - Gastrointestinal It was noted that all dosing data currently marked in tablets will be changed to milligrams to ensure the consistence of data in the document The committee noted and approved the amendments to this section. ACTION: JP 7.2 Section 4.10 Smoking Cessation The committee noted and approved the amendments to this section. ACTION: JP 7.3 Chapter 5 - Infections The committee agreed that the paediatric section will be also updated. Due to the similarity of information the paediatric chapter would not need to be brought to the formulary committee for approval The committee noted and approved the amendments to the paediatric and adult section. ACTION: JP 8. NICE/SIGN/NHS QIS Clinical Guidance 8.1 CG 134 Anaphylaxis The committee noted and discussed the above NICE clinical guideline. 8.2 TA 238 Arthritis (juvenile idiopathic, systemic) - tocilizumab The committee noted and discussed the above NICE technology appraisal guideline. 8.3 TA 239 Brest cancer (metastatic) - fulvestrant The committee noted and discussed the above NICE technology appraisal guideline. 8.4 TA 240 Colorectal cancer (metastatic) - panitumumab The committee noted and discussed the above NICE technology appraisal guideline. 9. Drug Safety Issues MHRA Advice 9.1 MHRA Drug Safety Update, Volume 5, Issue 5, Dec The committee noted the drug safety update It was noted that an article will be included in the Lothian Prescribing Bulletin, Issue European Medicines Agency starts review of aliskiren-containing medicines following termination of ALTITUDE study The committee noted the drug safety update.

14 9.2.2 It was noted that an article will be included in the Lothian Prescribing Bulletin, Issue Strattera (atomoxetine) - risk of increased blood pressure and heart rate The committee noted the drug safety update. 9.4 Cipralex (escitalopram) - association with dose-dependent QT interval prolongation The committee noted the drug safety update. 9.5 Motilium and generic products (domperidone) The committee noted the drug safety update. 9.6 Seroquel (quietapine) - Information on weight gain, hyperglycaemia, and metabolic risk The committee noted the drug safety update. 10. Antimicrobial Management Team Minutes The committee noted the following AMT minutes for information: 12 th October For Information Only 11.1 Formulary Committee Reports and Letters The committee noted the following Formulary Committee reports and letters: bortezomib (Velcade ) ranibizumab (Lucentis ) dalteparin (Fragmin ) dabigatran etexilate (Pradaxa ) tinzaparin sodium (Innohep ) FOLFIRINOX combination chemotherapy (folic acid, 5-Fluorouracil irinotecan, oxaliplatin) 12. AOCB None. 13. Date of Next Meeting 13.1 The committee noted that the next meeting would be held on Wednesday 7 th March 2012, at 2pm in Room 004, Pentland House, 47 Robb s Load, Edinburgh. (The deadline for submission of papers for this meeting is close of play Tuesday 21 st February 2012.) Apologies: Sheena Kerr