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P527 Infliximab biosimilar switching program overseen by specialist pharmacist saves money, realises investment and optimises therapy

St. Clair Jones A.*1, Smith M.2

1Brighton and Sussex University Hospitals NHS Trust, Department of Pharmacy, Brighton, United Kingdom 2Brighton and Sussex University Hospitals NHS Trust, Department of Gastroenterology, Brighton, United Kingdom

Background

The parity of efficacy and safety of the biosimilar infliximab (IFX) has been demonstrated with data on switching still emerging.

Specialist gastroenterology pharmacists are ideally placed to manage medicines optimisation and therapeutic drug monitoring (TDM) [1], overseeing the switch, realising considerable cost savings and income through negotiations with commissioners.

Methods

A payment per switched patient was negotiated with commissioners for reinvestment into the inflammatory bowel disease (IBD) service. Information was sent to each patient offering counseling with the pharmacist. Over 8 weeks all patients were switched from Remicade® to Remsima®, IFX trough levels and antibodies, C-reactive protein (CRP), Harvey Bradshaw (HB) or simple clinical colitis activity score (SCCAI) and faecal calprotectin (FCLP) were recorded prior to the infusion of the first dose of biosimilar. 6 month later HB or SCCAI, CRP and FCLP were remeasured and compared.

The pharmacist reviewed all results and managed any therapy changes, if necessary with multidisciplinary team (MDT) review. Savings were recorded.

Results

A payment of £1250/patient was negotiated to fund the switch. 71 (60 CD, 11 UC)patients were switched realising an income of £88,750 used to fund a specialist IBD nurse.

No patient requested an additional appointment due to the pharmacist conducting counselling during infusion clinics prior to the switch. 17 patients stopped IFX, 7 due to antibodies and 2 due to loss of response (LOR) and need for surgery, 8 patients were changed to alternatives by MDT review.

54 patients continued on IFX infusions without experiencing LOR in the following 6 months. Savings on drugs was £224,000 and overall £300,000.

Table 1. Financial impact

Number of patients (N=71)Yearly cost vs Remicade®Yearly cost vs Remsima®
Patients changed to Remsima®54−£223,970£0
Patients treatment stopped9−£80,490−£43,160
Patients changed to adalimumab4−£1,980+£14,620
Patients changed to golimumab3−£4,855+£7,590
Patients changed to vedolizumab1+£2,760+£6,910
Patients with dose reduced6−£15,230−£8,165
Patients with dose increased8+£20,310+£10,887
Charges for IFX and FCLP/savings OPA tests71/28+£4290+£4290
Total costs−£299,170−£7,030

TDM results were analysed by the pharmacist who initiated 14 dose adjustments preventing 28 clinic appointments.

CRP and IBD scores were reviewed at each infusion. A minority of patients submitted FCLP pre and post preventing meaningful anlysis.

Table 2. Patients clinical parameter pre and post switch

Crohn's disease (N=60)Ulcerative colitis (N=11)
No. (%) of pts with IBD score changes of ≤128 (52%)6 (60%)
No. (%) of pts with IBD score reduction ≥211 (20%)1 (10%)
No. (%) of pts with IBD score raise ≥214 (26%)3 (30%)
No. (%) of pts with IFX antibodies5 (8%)2 (18%)
No. (%) of pts IFX levles below ≤1.915 (25%)2 (18%)
No. (%) of pts IFX levels ≥8.15 (8%)4 (36%)
No. (%) of pts with CRP change of ≤5 pre switch43 (71%)9 (81%)
No. (%) of pts with CRP ≤5 post switch44 (73%)9 (81%)
FCLP sumitted pre/post / pre&post38 (63%)/12 (20%) / 8 (14%)6 (55%)/2 (18%) / 1 (9%)

Conclusion

Switching to biosimilar IFX is safe.

Active management of treatment around the switch by the Specialist IBD pharmacist saves money, realises investment into the service, optimises therapy in a timely manner and reduces outpatient appointments.

IBD pharmacists are failiar with TDM, management of IBD patients and able to negotiate with commissioners directly.

References:

[1] A St. Clair Jones, M Smith, (2015), Embedding pharmaceutical care into the multidisciplinary team, Ecco 2015 Abstract P306, https://www.ecco-ibd.eu/index.php/publications/congress-abstract-s/abstracts-2015/item/p306-embedding-pharmaceutical-care-into-the-multidisciplinary-team.html, 2016-01-01