London Medicines Evaluation Network (LMEN) / Friday 5thJune 2015
Room 1
50 Eastbourne Terrace, Paddington
2pm-4.30pm
Chair: / Ben Rehman / Secretary / Sheena Vithlani
Attendees:
David Erskine / Director London MI Guys and St Thomas’ NHS Foundation Trust
Kevan Wind / Medicines Procurement Specialist Pharmacist, London and East of England
Sarah Cavanagh / Regional MI Pharmacist East Anglia Medicines information Service
Glenn Harley / Mental Health Lead for Pharmacy and Medicines Use and procurement LPP
Pritiesh Bodalia / Principal Pharmacist - Medicines Management & Clinical Trials, UCLH
Shaista Hussain / Prescriber Support Pharmacist, North and East London CSU
Nick Beavon / Chief Pharmacist NHS Wandsworth CCG
Pauline McCalla / Cancer specialist pharmacist, LPP
Martin Bradley / Lewisham and Greenwich NHS Trust
Draft Minutes
1 / Introductions and apologies
Apologies from: Neeshma Shah, Farrah Khan, Tim Root, Priya Shah, Nicola Carson, Manpreet Randhawa, Paulin McCalla, Philip Aubrey, Rachel Dorsey, Jagait Parmjit, Philip Blatchford, Raju Rahim, Scott Mercer, Rishi Rampersad, Sanjay Patel, Jackie Box, Belinda Krishek, Christine Booth, Tim McCarthy, Sonali Sonecha, Kashyap Thakrar, Yee Ngan Ching, Jerzy Paszkiewicz, Chris Goldsmith.
2 / Minutes of last meeting(BR)
The draft minutes of the February 2015 meeting were confirmed as an accurate reflection of the meeting.
The only actions arising from the last meeting not covered elsewhere on the agendawere followed up or deferred to this meeting.
3 / Activities to promote sharing for the network
Collated information database
At the last LMEN meeting, discussions centered on whether the decision sharing database is suitable for purpose, whether changes are needed and suggestions around how to maximise usefulness. Changes suggested were as follows:
  • The LMEN Decision Sharing Database should include active links to nationally produced drug reviews and local APC/DTC websites, where available.
  • There is no need for the ‘shareable on the LMEN website?’ field and this should be removed.
  • More granularity and clarity is required when describing decisions in the LMEN Decision Sharing Database. Current subcategories are to be changed from:
 Approved
 Approved for shared care
 Approved for transitional care
 Deferred
 Not Approved
to the following subcategories with simple colour coding
 Approved for use in primary and secondary care
 Approved for specialist use only
 Approved for specialist initiation only
 Approved for shared care
 Not approved
 Deferred decision
  • A section for notes should remain though it is not necessary to share place in therapy.
  • Decision data predating NICE TA’s should automatically be removed from view once a NICE TA was published because the NICE TA would supersede local decisions.
  • A modified version of the Data Collection Template devised by SV/BR in Jan 15 may be used to initially collect data for sharing via a nominated contact person for every group (i.e. ideally an APC secretary or Trust Formulary Pharmacist) who would agree to be contactable by other members of the LMEN network.
  1. DE and SV attended the Chief Pharmacists Meeting in March and DE provided feedback. DE fed back that the chief pharmacists were supportive of the LMEN decision sharing database. One comment from the meeting was that the data for sharing be uploaded by formulary pharmacists/APC secretaries.
  2. SV demonstratedthe latest iteration of the LMEN decision sharing database after the above changes were made to it by RR. At the last meeting, some of the pilot data were for drugs that are not in NDO because they are older, unlicensed products or devices. SV confirmed that these can be entered into NDO as inactive monographs which should not interfere with national horizon scanning work. Inactive monographs can still be used by RR for the purposes of the LMEN decision sharing database. The group discussed any further changes required to the database in order to make the around database suitable for purpose and to maximise its usefulness. The following were agreed:
  3. ‘Approved for use with Shared Care’ to be changed to 'Approved with formal SCA in place'
  4. An additional tab/area to be added as a colour coded definitions glossary with examples to define the subcategories used to describe decision data.
  5. Data to be collected from December 2014 to present via the data collection template.
  6. Decision data for sharing (initially) to be initially provided by (or persons nominated by) Nick Beavon for SW London (including Louise Cochlan from Croydon CCG), David Erskine for the SE London, Pritish Bodalia for central and North London, Belinda Krishek for NE London areas and Sheena Vithlani (via Cecilia Tse/Chris Corfield) for NW London.
Reviews
Reviews to be shared by all members of the LMEN regardless of whether the approved template is used or not, though use of the template is encouraged.
Rolling out
Once established in London, rolling out of the Decision sharing database to the East of England was suggested by KW and this was supported by other attendees. A representative from UKMi/LMEN will present the database at the East of England Chief pharmacist meeting in November 2015 – this will be finalized and written as an action at the next LMEN meeting in September/October. The principle of further rolling out of the database will also be discussed at the next meeting.
ACTIONS:
  • SV to upload February 2015 minutes onto the LMEN website area.
  • SV to contact Helen Davis (Director of UKMi centre at Liverpool) to discuss adding inactivated monographs into NDO for our local purposes around decision sharing.
  • SV to liaise with RR with regards tomaking the above changes to the LMEN Decision Sharing Database(a-b) input the relevant data and upload onto the LMEN website area.
  • SV to make the requested change to the LMEN decision sharing database data collection template and circulate to for population with decision data from December 2014 to present (c-d).
  • NB to seek agreement from individual hospital Chief Pharmacists in SW London area who are willing to share decision data with the LMEN group (action rolled over from last meeting).
  • BR to raise the topic of the LMEN Decision Sharing Database at the next Chief Pharmacists Meeting on the 22nd September 2015.

4 / Update on regional MI produced LMEN reviews
SV and SC provided updates on completed LMEN reviews as requested:
Published Reviews
  • Aflibercept (Eylea) is now licensed to treat adultswith vision loss due to Diabetic Macular Oedema (DMO). This LMEN review reports the evidence base and considers its place in therapy. Comments were received from the Moorfields Pathway Development Group and incorporated prior to publication.
  • Since the last LMEN meeting in February 2015, several other reviews have been published on the LMEN website area including two requested by the Moorfields Pathway Development group, a Q&A on biosimilar infliximab and a comparison of insulin devices.
Reviews in progress
  • SV noted that reviews requested at last meeting on Dalbavancin and Apremilast had not been undertaken because Apremilast is being reviewed by NICE and Dalbavancin is not for UK launch.
  • SV updated on collagenase clostridium histolyticum for men with Peyronie’s Disease. A draft has been circulated for comment to LMEN members and to SC for peer review. SC will arrange for a urologists opinion. SV will then ask for the manufacturers comment and local accuracy check.
  • SC updated on Naltrexone with bupropion for obesity. A draft has been circulated for comment to LMEN members and to SC for peer review. Details on launch and price are not yet available but the significant interest from clinicians was acknowledged. Agreed that it would be accuracy checked and published with a view to updating with price and launch information once available.
  • SC updated on a review of Liraglutide for obesity which is ready for comment. However there are no details about UK launch which may not be imminent. Agreed that it was best to hold publication of this review until further information on these became available.
ACTIONS:
  • SV to make amendments to the review on Clostridium Collagenase Histolyticum as suggested by peer reviewer, comments from LMEN group, manufacturer and accuracy check then publish review.
  • SC to arrange for naltrexone/bupropion in obesity to be uploaded and add price later.
  • SC/SV to monitor market progress of liraglutide for obesity in the UK/EU with a view to publication of LMEN review.

5 / Medicines to be reviewed from now on pan-London basis by regional MI teams
The group considered a horizon scanning spreadsheet derived from NDO listing recently launched, approved, positive EU opinion and filed (EU) drugs and discussion whether LMEN reviews should be undertaken this quarter. The group considered further action (s) were necessary for the following:
Agreed for Review:
  • Dulaglutide, abiglutide for type 2 diabetes (Approved)
SV reported no other reviews and not planned for NICE TA as of Jan 2015 – see actions.
  • Insulin glargine products for type 1 and 2 diabetes. Class &safety review (Approved)
Two new glargine products are in the pipeline; insulin glargine biosimilar (Abasria) and Toujeo (300iu/ml) injection both of which are estimated for launch in Q3 of 2015. It was agreed to present this review comparing these two products and insulin glargine asa safety assessment and a Q&A document to be a joint publication by Guys and Northwick Park MI and will include specialist input from Stephen Thomas (Endocrinologist at Guy’s and St Thomas’ Diabetes & Endocrine Unit) prior to publication.
  • Capsaicin patch for peripheral diabetic neuropathy (filed)
This was previously licensed for localised neuropathic pain following varicella zoster infection. Thelicense is now extended to localised neuropathic pain in patients with diabetes. The patch may be used in the same way as the cream as an alternative formulation.
  • Ulipristal (Esmya) for uterine fibroids (positive opinion)
Already approved for the pre-operative treatment of moderate to severe symptoms but duration limited to 3 months. The latest approval allows 1 repeated course of a three-month treatment. SV to update original review.
  • Prucalopride (Resolor) for chronic constipation in laxative resistant men (positive opinion)
Already approved for use in women but license extended to include men. SV to update original review.
  • SGLT-2 inhibitors (e.g. empagliflozin) class review (positive opinions)
AHSN to be contacted to see if they can undertake this review – see actions.
  • Vortioxetine (Serotonin 5HT3 antagonist, 5HT1a agonist) for depression (Approved)
SV reported NICE TA due Sept 15 but unlikely there is non-specialist mental health interest. SV to find out if NC (mental health specialist pharmacist at CNWLH) has reviewed this.
  • Guanfacine for ADHD in adolescents (filed)
SV reported no other reviews and not planned for NICE TA as of Jan 2015. SV to find out if NC (mental health specialist pharmacist at CNWLH) has reviewed this.
ACTIONS:
  • Dulaglutide, abiglutide for type 2 diabetes. DE/Guys MI to check if other work is being done and ifnot,toundertake a two page class review.
  • SV to seek opinion from microbiology specialist pharmacists about whether there is interest in Ceftolozone + Tazobactam, Tedizolid or Oritavancin reviews.
  • SV to discuss safety aspect of insulin glargine review with relevant MI pharmacists at NPH and Guys MI.
  • SC to lead on capsaicin for neuropathic pain review.
  • SV to update the reviews on ulipristal and prucalopride to take into account new data relating to license extensions.
  • AHSN to be contacted by NB to see if they can undertake a class review of SGLT-2 inhibitors (e.g. empagliflozin) class review. BR to draft an email for NB to send to AHSN contact.
  • SV to contact NC to find out if local and mental health specialist reviews are available for sharing for vortioxetine and guanfacine.
Actions specific to new drugs from last meeting
SV to find out more about ketoconazole for Cushing’s disease, Cortiment MMX for UC, Preotact (parathyroid hormone) for hypothyroidism, Abasria (insulin biosimilar). SV to find out more about pitosalient, about other licensed options for sleepiness in PD. SV to liaise with Helen Williams and Sotiris Antoniou for views on Vorapaxar and potential place in therapy to gauge level of potential interest in LMEN review.These actions were addressed as part of the presentation of the horizon scanning spreadsheet.
Further actions specific to new drugs
Idarucizumab: A mAb fragment with high specific binding affinity to dabigatran, intended for use to reverse effects of dabigatran.
Aflibercept (Eylea) license extension to cover myopic CNV
Opicapone for Parkinson’s disease with end of dose fluctuation - a peripherally selective inhibitor of catechol-O-methyltransferase.
ACTIONS:
  • Abasria (biosimilar glargine insulin) – see ‘Agreed for Review’ above.
  • SV to continue to try and liaise with Helen Williams and Sotiris Antoniou for views on Vorapaxar and potential place in therapy to gauge level of potential interest in LMEN review.
  • BR to discuss idarucizumab with antidotes specialist to address need for review
  • BR to liaise with Moorfields Group to address need for review of aflibercept for Myopic CNV
  • DE to ask colleague at Kings to address need for review of Opicapone for Parkinson’s disease.

6 / AOB
DE mentioned that Guys MI have been working on an updated overview of developments in key biosimilars based on NDO and supplemented using other horizon scanning resources. KW also has some work on file relating to Biosimilars. KW noted that it is important to differentiate between pre-launch and post launch actions.
DE mentioned a critical appraisal of the key IMPROVE-IT study of simvastatin + ezetimibe in patients with ACS which looked at cardiovascular outcomes. This may need updating since it has been published in full.
ACTIONS:
  • All biosimilar work will be shared with BR for collation.
  • DE to arrange for update and upload of critical appraisal of fully published IMPROVE-IT study.

6 / Date for next meeting

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