Cobra SMC2669 — инструкция

East Region Formulary East Region Formulary Committee Minutes Date: 23 July 2025 Time: 2.00pm – 4:20pm Location: MS Teams Present:

Ruth Cameron Advanced Clinical Nurse Specialist - Urology, NHS Fife Carla Capaldi Senior Practice Pharmacist, NHS Fife Dr Konstantinos Dabos Consultant, GI, NHS Lothian Dr Joan Egerton GP, NHS Fife Dr David Griffith Consultant – Microbiologist, NHS Fife Ryan Headspeath Senior Clinical Pharmacist, Dermatology and Shared Care, NHS Fife Dr Elliot Longworth GP, NHS Borders Lesley Macher Lead Pharmacist - Medicines Governance and Guidance, NHS Lothian Iain Macintyre Consultant – Renal (Co-Chair), NHS Lothian – in the Chair Diane Murray Formulary Pharmacist, NHS Lothian Fraser Notman Senior Pharmacist – Medicines Management, NHS Fife Dr Monica Szabo Consultant Oncologist, NHS Lothian Sarah Tait Lead Advanced Practitioner, NHS Borders In attendance:

Helen Crozier, Medicines Advice and Guidance Team Co-Ordinator, NHS Lothian (minutes) Noreen Mohammed, Senior Practice Pharmacist, NHS Fife Mandy Wilson, Advanced Cancer Care Pharmacist – Haematology, NHS Lothian Apologies:

Jane Browning, Associate Director of Pharmacy, NHS Lothian Malcolm Clubb, Director of Pharmacy (Co-Chair), NHS Borders Dr Grace Ding, Consultant Oncologist, NHS Lothian Dr Tariq Farrah, Consultant - Renal, NHS Lothian Carol Holmes, Pharmacist - Primary Care, NHS Lothian Dr Paul Neary, Consultant – Cardiology, NHS Borders Cathryn Park, Deputy Director of Pharmacy, NHS Borders Dr Jo Rose, GP, NHS Lothian 1 Welcome and Apologies The Chair welcomed those present to the East Region Formulary Committee (ERFC). ERFC noted that the meeting is being recorded Leaving – Carla Capaldi.

The Chair and committee members acknowledged that Carla Capaldi will be leaving the committee temporarily and look forward to her return. 1.2 Matters arising None noted. ERFC Minutes 23 July 2025 Page 1 of 13

Стр. 1

2 Governance 2.1 East Region Formulary Committee (ERFC) meeting minutes 28 May 2025 The minutes of the previous meeting were approved as an accurate record with no changes to note. 2.2 East Region Working Group (ERWG) meeting minutes 02 July 2025 The minutes of the ERWG meeting on 02 July 2025 were noted for information.

2.3 East Region Formulary (ERF) sections/amendments for review 2.3.1 ERF Adult – Lidocaine plasters & topical Capsaicin The committee noted the review of current formulary guidance taking into consideration recommendations for Lidocaine patches in the following guidance - “ Items of Low and Limited Clinical Value - Medicines - achieving value and sustainability in prescribing: guidance - gov.scot ”. The committee discussed the amendment and noted comments from NHS Borders around plans for non- formulary requests for indications beyond the national guidance. There was a brief discussion regarding additional guidance for the individual Boards to provide where required.

The committee noted changes to reflect that there is currently no licensed Capsaicin cream available. It was agreed to redraft the pathways to signpost to local Board guidance for use in adults beyond national guidance, and share it around committee members to approve virtually. Members discussed work taking place in other Boards to review prescribing of Lidocaine patches. The ERFC agreed to share the amendment with further changes for approval before the formulary website will be updated. ACTION:

Diane Murray, Formulary Pharmacist, NHS Lothian/NHS Lothian Admin Team 2.3.2 ERF Child - Lidocaine plasters & topical Capsaicin It was noted that use of lidocaine patches in children was not covered in the Scottish Government guidance. It was agreed to edit the wording in line where relevant and approve it virtually. The committee noted changes to reflect that there is currently no licensed Capsaicin cream available The ERFC agreed to share the amendment with further changes for approval before the formulary website will be updated. ACTION:

Diane Murray, Formulary Pharmacist, NHS Lothian/NHS Lothian Admin Team 2.4 Stop & Assess Pre-ERFC Panel SBAR The paper was verbally summarised, and committee members were invited to share their feedback on the proposed disbandment of the Stop and Assess Pre-ERFC Panel, as well as its potential impact on ERFC moving forward. There were concerns regarding the quality of some of the completed submission forms. It was suggested that further education is needed to support applicants in presenting their cases more effectively, helping to avoid challenges during the meeting and subsequent delays.

The committee acknowledged that members already undertake comprehensive reviews; however, more in-depth scrutiny and fact-finding may be necessary. As a result, additional time may be required for submissions to the ERFC. For example, draft pathways could be shared with applicants in advance of the meeting to allow for review and feedback. ERFC Minutes 23 July 2025 2 of 13

Стр. 2

These comments will be fed back. The ERFC agreed to the disbandment of the Stop & Assess Pre-ERFC Panel. ACTION: NHS Lothian Admin Team 3 New Medicines 3.1 Formulary Application Forms (FAF) 3.1.1 FAF1 Sodium Thiosulphate: Pedmarqsi ( SMC2730 ) The ERFC noted and discussed the previously circulated FAF1 submission. No declarations of interest were received. Named CD support was received from all three Boards and from Tayside for their RHCYP patients. Indication: For the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to The finance budget template was included with the FAF.

The ERFC reviewed the submission, noting that the patient numbers detailed in the application mirror the predicted estimates from the SMC, however there is potentially an underestimate of patients. The ERFC agreed that Sodium Thiosulphate: Pedmarqsi (SMC2730) is appropriate for inclusion in the Formulary Decision section of the ERF, with Specialist Use Only formulary flagging. The ERFC agreed to classify FAF1 Sodium Thiosulphate: Pedmarqsi (SMC2730) as Routinely available in line with national guidance. Included on the ERF for Specialist Use Only. The formulary website will be updated. ACTION: NHS Lothian Admin Team 3.1.2 FAF1 Elranatamab:

Elrexfio ( SMC2669 ) The ERFC noted and discussed the previously circulated FAF1 submission. No declarations of interest were received. Named CD support was received from all three Boards. Indication: As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. The clinical management guideline, local treatment protocol, and finance budget template were included with the FAF.

The ERFC reviewed the submission, with supporting evidence provided by the MagnetisMM-3 study. The committee discussed Clinical Director approval, specifically concerning NHS Fife. It was noted for future reference that whilst oncology applications for the East Region are approved through SCAN, separate Clinical Director sign-off is required for non-malignant haematology applications in each respective Board. ERFC Minutes 23 July 2025 3 of 13

Стр. 3

The ERFC requested named CD sign off from NHS Fife. The applicants are requested to respond with information on the recommended action by 02 September 2025. ACTION: Fraser Notman, Senior Pharmacist – Medicines Management, NHS Fife/NHS Lothian Admin Team The ERFC agreed that Elranatamab: Elrexfio (SMC2669) is appropriate for inclusion in the Formulary Decision section of the ERF, with Specialist Use Only formulary flagging subject to confirmation of NHS Fife CD support. The ERFC agreed to classify FAF1 Elranatamab: Elrexfio (SMC2669) as Routinely available in line with national guidance. Included on the ERF for Specialist Use Only. The formulary website will be updated. ACTION:

NHS Lothian Admin Team 3.1.3 FAF1 Linzagolix: Yselty ( SMC2631 ) The ERFC noted and discussed the previously circulated FAF1 submission. No declarations of interest were received. Named CD support was received from all three Boards. Indication: The treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. SMC restriction : for use in patients when conventional first-line treatments (such as tranexamic acid, hormonal contraceptives and intrauterine devices) have failed or are considered unsuitable. The finance budget template was included with the FAF.

The ERFC reviewed the submission, with evidence to support the use of Linzagolix for this indication from the PRIMROSE 1 and PRIMROSE 2 studies. The ERFC agreed to classify FAF1 Linzagolix: Yselty (SMC2631) as Routinely available in line with national guidance. Included on the ERF for Specialist Initiation. The formulary website will be updated. ACTION: NHS Lothian Admin Team 3.1.4 FAF1 Elafibranor: Iqirvo ( SMC2714 ) The ERFC noted and discussed the previously circulated FAF1 submission. No declarations of interest were received. Named CD support was received from all three Boards. Indication:

For the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. The local clinical management guideline and finance budget template were included with the FAF. The ERFC noted the early submission of the application allowing extra time to gather information to support formulary decision making. The ERFC reviewed the submission and noted all three Boards intend to use off-label Bezafibrate prior to Elafibranor, with plans to submit a FAF3 for Bezafibrate in due course. ERFC Minutes 23 July 2025 4 of 13

Стр. 4