ETANERCEPT BIOSIMILAR SWITCH: CAN IT BE SUCCESSFUL WITHOUT CLINIC REVIEW?
Muhammad Khurram Nisar
Luton and Dunstable University Hospital, Rheumatology, Luton, United Kingdom
Background: Since the introduction of anti-TNF biosimilars in routine clinical practice, there has been a drive to implement the switch program for all biosimilars at the point of availability. Etanercept biosimilar (SB4) was granted marketing authorisation by the EMA in January 2016. Our Trust was one of the leading centres to switch all patients within one year of the drug’s availability. The aim of the non-medical switch was to obtain significant savings for the NHS whilst achieving similar clinical outcomes.
Objectives: We report patient experience after a year of completing the switch program.
Methods: A list of all patients prescribed etanercept was extracted through our database. The original strategy included a ‘switch’ letter sent to all patients including SB4 information sheet. Patients were given the opportunity to contact nurse helpline for information or if disease control worsened/adverse effects developed. We reviewed all relevant records and collected data on any adverse events and disease outcome on either side of the switch.
Results: 84 patients were prescribed reference etanercept. 41 (49%) had RA, 17 (20%) had PsA, 18 (21%) had AS and remaining eight had JIA. One person declined the transfer to the biosimilar and one patient with JIA was on 37.5mg weekly dose which was unavailable. 82 agreed to the switch that was completed by March 2017. Median age of switchers was 59.6 (range 14-74 years). 25 (30%) were men and remaining 59 (75%) were women.
76 patients remain on SB4 biosimilar a year after switch. Seven patients described concerns within the first five months of switching. One was found to have concurrent severe Vit D deficiency which upon correcting allowed him to continue with the biosimilar. Six patients had side effects with corresponding worsening of respective disease activity scores. Four returned to the originator with resolution of adverse effects and disease control was regained. Two continued to have uncontrolled disease and were moved to alternative mode of action.
Conclusion: Overall patient experience following etanercept biosimilar switch has been positive. 90% continue with SB4 originator a year later with no adverse outcomes. All were happy to switch after receiving a letter and having the opportunity to contact if necessary. This made the process quite smooth, easy to administer and avoided costs associated with face-to-face review. Substantial annual cost savings of nearly £100,000 were achieved once the switch process completed. Only six patients (7%) encountered adverse effects, two of whom had uncontrolled diease despite switching back to the originator. We support the routine switching from originator to biosimilar etanercept in view of good patient experience and disease outcomes. This can be achieved with minimal contact in a cost-efficient manner.
Patient characteristics of switch related adverse events
DAS2.0 (Apr 18)
DAS 2.4 (Feb 18)
BASDAI 1.6Spinal VAS 0
BASDAI 4Spinal VAS 4
Sev Vit D def treated
BASDAI 3.2Spinal VAS 1SB4 continued
BASDAI 3Spinal VAS 3
BASDAI 4Spinal VAS 4
BASDAI 3Spinal VAS 0 (Aug 17)
TJ 0, SJ 0
TJ 3, SJ 3
TJ 0, SJ 0 (Sep 18)
DAS 5.3 (Aug 18)
DAS 5.2 (Jun 18)
Disclosure of Interests: Muhammad Khurram Nisar Grant/research support from: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Novartis, Celgene, Mallinckrodt, UCB and Lilly, Consultant for: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Novartis, Celgene, Mallinckrodt, UCB and Lilly, Speakers bureau: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Novartis, Celgene, Mallinckrodt, UCB and Lilly
Citation: Ann Rheum Dis, volume 78, supplement 2, year 2019, page A1380
Session: Public health, health services research, and health economics