Background:The advent of biosimilars has heralded a new era for cost effective biologic prescribing in the NHS. As patents expire for originator biologics, less expensive versions are now widely available as biosimilars. Non-medical switches (for reasons unrelated to a patient’s health) ensure prescribing of best value medicines, and cost savings can be redirected to patient care.1This practice resonates with recommendations from Lord Carter’s 2016 report regarding reducing unwarranted variation in the NHS and adopting cost saving opportunities.2In 2018/19, following loss of patent exclusivity for the expensive adalimumab originator biologic, UHCW worked in accordance with national directives to drive forward one of the largest non-medical biosimilar switches.Objectives:This qualitative review aims to explore the success of the adalimumab biosimilar switch and key themes associated with switch backs/refusals across the Rheumatology (R), Gastroenterology (G) and Dermatology (D) specialities at UHCW.Methods:The switch plan occurred between April-December 2019. 403 patients (R;189, G;176, D; 38) were eligible for switch. Patients were informed of the plan in advance via a patient information leaflet/hospital clinic visits. Switch refusals, withheld treatments and cancellations were documented and patients were advised to contact the hospital pharmacy/clinical teams if they encountered any concerns, adverse effects or lack of efficacy post switch. The clinician would then advise on subsequent management.Results:During April-December 2019, 264/403 patients had been successfully switched (R;122, G;109, D;33). 33/403 patients switched back to the originator biologic (R;22, G;10; D;1). Of the 22 rheumatology switch back patients; 6 patients reported injection site pain and variably headache, fatigue, disease relapse, gastrointestinal (GI) upset, erythema; 10=reported lack of efficacy and variably influenza-type symptoms, relapse in associated psoriasis, difficulty in walking/sleeping, hair loss, excessive perspiration, facial cellulitis, foot drop and GI upset; 1=blepharitis;1=latex allergy before injection; 3=later declined switch; 1=damaged two devices and did not wish to continue biosimilar. Of the 10 gastroenterology switch back patients; 1=injection site pain; 2=lack of efficacy; 1=developed needle phobia; 1=latex allergy before injection; 1=switch detrimental to health; 2=unstable disease; 1=insomnia; 1=pregnancy. The 1 dermatology switch back patient reported injection site pain and bleeding.38/403 patients refused the switch and remained on the originator biologic (R;11, G;27, D;0). 29/403 patients had treatment cancellations and were switched to an alternative biologic (R;17, G;9, D;3). 32/403 patients stopped treatment (R;13, G;19, D;0). Treatment was withheld for 7/403 patients (R;4, G;2, D;1).Conclusion:The UHCW adalimumab biosimilar switch plan succeeded in switching a total of 66% of patients; thus an annual cost saving of £73,020. Injection site pain, most likely due to the biosimilar citrate content, and lack of efficacy according to patient perception and subsequent clinical review, were the most predominant causative themes for switch backs. Gastroenterology patients accounted for 71% (27/38) of the total switch refusals. Additional data regarding patient refusals, identifies future opportunities to improve patient counselling and drive further cost savings.References:[1]Azevedo V, et al. Biosimilars: considerations for clinical practice. Considerations in Medicine. 2017;1(1):13–8[2]Lord Carter of Coles. (2016) Operational productivity and performance in English NHS Acute Hospitals: Unwarranted variations [Online]Acknowledgments:Mark Easter, Chief Pharmacist, Hardeep Bagga, Deputy Chief Pharmacist, UHCW Pharmacy Homecare Team, UHCW Specialist Clinical Teams.Disclosure of Interests:None declared
Immediate Type I Hypersensitivity Response Implicated in Worsening Injection Site Reactions to Adalimumab