Minutes August 19 th 2014, 12:30-2:30 pm Pharmacy Dept. CMFT Present: Elizabeth Arkell (EA), Associate Director of Pharmacy, UHSM Foundation Trust Jennifer Bartlett (JB) Senior Medicines Management Pharmacist South Manchester CCG Dr Peter Budden (PB) GP and prescribing lead, Salford CCG (Chair) Makrand Goré (MG) Medicines Management Pharmacist, Bolton CCG Elizabeth Craig (EC) Medicines Information Pharmacist, PAHT Andrew Martin (AM) Strategic Medicines Optimisation Pharmacist, GM CSU. Bhavana Reddy (BR) Head of Prescribing Support, RDTC (Professional Secretary) Apologies received: KP, AS and JL. D OR. Declarations of Interest No declarations of interest in relation to the agenda were raised. 1) Minutes of the meeting on 22 nd July 2014. The minutes were accepted as a true and accurate record. ACTION RDTC to publish as final. 2) Matters arising It was noted that the melatonin recommendation was still outstanding. An updated SCP had not been received by either GMMMG subgroup although it was thought that one was available. It was therefore agreed that the NTS recommendation on melatonin should be sent to GMMMG for approval. ACTION: BR to take to GMMMG for final sign off 2b) Treclin for acne The group discussed the draft recommendation and suggested a minor update; to swap around the final two paragraphs. The recommendation was then approved as final. ACTION: BR to update as above and then take to GMMMG for final sign off 2c) Cystistat The group discussed the draft recommendation. The recommendation was then approved as final with no further changes. It was agreed that the issue around evaluation of medical devices should be brought up with GMMMG as some members felt that due to the lack of clinical evidence, medical devices are an effective use of resources issue and as such should be referred to them. It was suggested that if devices were to remain with NTS then a pragmatic try it and see audit approach may need to be taken as the same criteria used to evaluate drugs could not be used. ACTION: BR to take Cystistat to GMMMG for final sign off AM to draft paper for GMMMG on evaluation of medical devices 1
3) Alprostadil cream for ED. The group discussed the data for alprostadil cream for erectile dysfunction. The following points were noted: Alprostadil cream is licensed for the treatment of men 18 years of age with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance ED usually responds well to a combination of lifestyle measures (such as weight loss, smoking cessation and reducing alcohol consumption) and drug treatment. Oral PDE-5 inhibitors are recommended as the first-line therapy for ED, regardless of suspected cause. A low dose should be tried initially, titrating up if ineffective. The Department of Health (DoH) advises that one treatment a week will be appropriate for most patients treated for erectile dysfunction. A man with ED should receive eight doses of an oral PDE-5 inhibitor at a maximum dose with sexual stimulation before being classified as a non-responder. Second-line therapy would be intracavernous injection, intraurethral alprostadil based on patient choice and convenience of administration. If drug treatment is unsuccessful, vacuum constriction devices may be considered Two randomised phase II, double-blind, placebo-controlled studies, and an open-label phase III study including a total of 3,300 subjects have assessed the efficacy of alprostadil topical cream as treatment for erectile dysfunction. Localised penile irritation, including burning, pain and erythema, are the most commonly reported adverse reactions, there are generally transient and mild to moderate in severity. Adverse reactions (e.g. vaginal burning) may also occur in partners of patients using topical alprostadil, so use of latex condoms is advised and must be ensured for sexual intercourse with women who are of childbearing potential, pregnant or lactating. There are no published trials comparing topical alprostadil to the oral, intracavernosal, or intraurethral route. For male ED patients that use alprostadil via the transcavernosal or intraurethral delivery route, topical alprostadil cream offers the convenience of local application from a convenient to use unit dose dispenser rather than potentially inconvenient, painful and cumbersome injections or intraurethral insertions. Currently there are on-going long-term supply issues in the UK with Caverject Dualchamber and Caverject vials expected to last until 2016 The New Therapies Subgroup of the GMMMG considered the use alprostadil (Vitaros ) cream for the treatment of erectile dysfunction in adult men. The group recommends alprostadil cream for the above indication as a second line treatment option alongside intracavernous or intraurethral alprostadil injection. Alprostadil cream is more expensive than using intracavernosal alprostadil but is cheaper than intraurethral alprostadil and oral tadalafil once-daily tablets. However alprostadil cream is single dose; therefore it may reduce the need for follow-up visits for patient training on the use of preparation and dose titration as can currently occur with alprostadil administered by the intracavernosal, or intraurethral route. According to set criteria alprostadil cream was deemed to be a low priority for funding ACTION: BR to draft recommendation as above 2
4) Avanafil for ED The group considered the new Phosphodiesterase type 5 inhibitor avanafil (Spedra ) which is licensed for the treatment of erectile dysfunction in adult men. The group noted the following points: Avanafil would only be suitable for prescribing within the NHS under the restrictions ( SLS ) imposed by the department of health. Oral PDE-5 inhibitors are recommended as the first-line therapy for ED, regardless of suspected cause. Currently available PDE-5 inhibitors for ED include sildenafil, tadalafil and vardenafil In clinical trials, the proportion of attempts resulting in successful intercourse increased by 28% - 44% with avanafil treatment compared with 14% for placebo. Similar results were observed for the proportion of attempts resulting in successful vaginal penetration, and in the change from baseline in IIEF erectile function score. Adverse effects were generally consistent with the known pharmacology of PDE-5 inhibitors, with similar contraindications and prescribing cautions. Treatment with avanafil at any dose is significantly more expensive than treatment with generic sildenafil, which has now been removed from the list of medicines that may be prescribed only where they meet SLS requirements. Avanafil has a slightly quicker onset of action than other available PDE-5 inhibitors, with a similar duration of action as sildenafil and vardenafil. Although there are no published data directly comparing avanafil to other established PDE-5 inhibitors, none of the available evidence suggests that avanafil offers a substantial advantage over the other PDE 5 inhibitors. Avanafil at equivalent doses is currently cheaper than vardenafil and tadalafil. The New Therapies Subgroup of the GMMMG considered the use of avanafil (Spedra ) for the treatment of erectile dysfunction in adult men. The group recommends that avanafil may be considered as an option for those patients who have no response to generic sildenafil and meet the SLS requirements. There is no convincing evidence that any one PDE-5 inhibitor is safer or more effective than any other, therefore generic sildenafil would remain the first line choice. Avanafil is currently cheaper than both vardenafil and tadalafil. According to set criteria avanafil was deemed to be a low priority for funding ACTION: BR to draft recommendation as above 5) Apixaban for VTE treatment and secondary prevention The group discussed the data for use of apixaban for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Venous thromboembolism refers to any condition in which a blood clot forms in a vein, and encompasses both DVT and PE. The treatment goal is to prevent clot growth, prevent formation of new clots, and prevent long-term complications. Current NICE approved treatment options include the use of a LMWH + warfarin or rivaroxaban. Dabigatran is also licensed for this indication. The following points were noted: A large randomised double-blind double-dummy trial found apixaban to be non-inferior to enoxaparin + warfarin over six months treatment. 3
Major and clinically relevant bleeding was less common with apixaban treatment than warfarin, as was the number of total bleeds. There was no difference in the total number of adverse events, or serious adverse events However, several factors may have decreased the power of the trial to detect any true difference between groups, and biased the result in favour of non-inferiority; extensive pretreatment with parenteral anticoagulants in both groups, failure to reach the pre-specified number of outcome events, and restricting the primary efficacy analysis to the intention-to-treat population. A one year extension trial found apixaban 2.5 mg and 5.0 mg to be superior to placebo for prevention of recurrent VTE, with no increase in major bleeding Apixaban will compete with the other oral anticoagulants, which are already licensed in this indication. Apixaban and rivaroxaban have the advantage of not requiring parenteral anticoagulation at the start of therapy, whereas dabigatran and vitamin K antagonists do. Following 6 months treatment for VTE with apixaban or other anticoagulant, the recommended dose for secondary prevention is 2.5 mg twice daily in the SPC. The dose reduction to 2.5 mg BD after 6 months is supported by the AMPLIFY-EXT trial, which found no difference in the safety or efficacy profiles between the two apixaban groups. Apixaban costs substantially more than warfarin, and is comparable to dabigatran and rivaroxaban. All three of the newer oral anticoagulants appear to have similar efficacy and safety profiles in this indication. However, no direct comparisons are available and caution must be used due to differences in the pivotal trials. The New Therapies Subgroup of the GMMMG considered the use of apixaban for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adults. The group does not recommend the routine use of apixaban for the above indication; however it may be suitable for use in patients who are not suitable for LMWH plus warfarin or for rivaroxaban. The group was concerned about the validity of the clinical trial data. Several factors (extensive pre-treatment with parenteral anticoagulants in both groups, failure to reach the pre-specified number of outcome events and restricting the primary efficacy analysis to the intention to treat population) may have decreased the power of the trial to detect any true differences between the groups biasing the result in favour of non-inferiority. According to set criteria apixaban for the above indication was deemed to be a low priority for funding 6) Re-review of old NTS recommendation: Lubiprostone The group agreed that as NICE guidance was now available the NTS recommendation should become superseded by NICE. ACTION: BR to update recommendation as above and then re-publish on website. 7) Current work plans & new submissions received since June & Horizon Scanning The group reviewed the work plan and monthly horizon scanning document. It was noted that IDegLira had changed its name in the marketing authorisation to Xultophy. It was agreed that this would need updating on the website. It was noted that a request had been received to add denosumab for men to the work plan. The group also agreed to add the following drugs for discussion at the September meeting. Olodaterol for COPD Umeclidinium for COPD 4
Umeclidinium/vilanterol for COPD. ACTION: BR to update work plan and the IDegLira recommendation and add the above drugs to the September agenda 8) Updates from other groups. Formulary Subgroup The formulary subgroup did not have a meeting in August therefore no update could be given. GMMMG The next GMMMG meeting is next week. It was however noted that a meeting between chairs and secretaries for the GMMMG groups had been arranged to workout remits now there were three subgroups. Interface Subgroup The group was updated on the second interface subgroup meeting and noted that a process for review of the RAG list and associated SCPs had been agreed. 8) AOB No business was raised. 9) Date of Next Meeting: September 16 th 2014, 12.30-2.30pm, CMFT 5