UK Group Reports on a Successful Switch to Biosimilar Etanercept

Anti—tumor necrosis factor (anti-TNF) medicines are one of the costliest drugs for many health systems, including the United Kingdom, with £780 million (US $947 million) spent across England, and £5.42 million (US $6.58 million) spent in the Berkshire West Clinical Commissioning Group (CCG) in the last 12 months alone. A recent article described how the CCG managed the switch of patients on the originator etanercept (Enbrel) to a biosimilar (Benepali) using a fixed-price model.

The CCG identified 154 patients taking the reference Enbrel eligible for switching. A total of 113 patients (43 with rheumatoid arthritis, 43 with axial spondyloarthritis and 27 with psoriatic arthritis) were switched from originator etanercept to Benepali from August 2016 to March 2017.

Evaluation outcomes included savings in drug acquisition costs, patient-reported side effects, and adverse events. There was no increased incidence of side effects before and after switch. Drug acquisition costs were decreased by £95,000 (US $115,385) with an overall reduction in prescribing costs of £186,000 (US $225,912).

The authors noted that the availability of biosimilar anti-TNF drugs presents a significant opportunity for the National Health Service to achieve substantial savings based on a lower acquisition price of 20% to 50% against the list price of the originator product.

Because etanercept is a self-injectable, it presented different challenges compared to the switching of those on intravenous infliximab, such as home care teams and patient training. In the United Kingdom, etanercept is delivered through home care, using a third-party organization. This added complexity when planning how to switch patients, the authors wrote.

Before the biosimilar, Benepali, became available, a working group consisting of clinicians and stakeholders across the CCG was formed to figure out how to support patients and maximize savings opportunities.

The following clinical standards were created in order to allow switching:

• Standardization of the procurement and formulary process
• Consistency in biologics prescribing processes and safety monitoring
• Standardization of processes in brand name prescribing/dispensing
• Creating defined treatment pathways and protocols
• Ensuring patient outcome measures and data collection processes maintain high quality of care

Besides setting up a biosimilar working group, the other steps taken to implement the program were to do the following:

• Define the treatment pathway
• Run patient-focused initiation
• Run a biosimilar monitoring system
• Measure and monitor the implementation pathway

The implementation was carried out in 2 key phases, with the first part including efforts to educate patients by:

• Sending letters and information sheets about the switch
• Discussing with patients the reasons for the switch and gaining consent
• Organizing educational events after gaining patient consent, with the prescription for Benepali sent to the home care team

The second phase involved the managed switch of the patients within the home care system. Each consented patient was contacted to confirm how much of the originator product they had on hand.

Those patients with lowest amount of drug on hand were prioritized and had their current Enbrel home care prescription cancelled. A new prescription for Benepali was created, with delivery timed according to their supply of Enbrel. Patients had a follow-up appointment in the outpatient clinic 12 weeks after the switch to monitor response effects for the switch.

Prescriptions were flagged to allow for accurate recharging at the CCG fixed-price model. The fixed price model is based around an agreement with the CCG that all brands of a given biologic drug will be recharged at a fixed price for a set period (usually 1 year); the price is approximately 75% of the originator price but is dependent upon the price of the biosimilar upon release.

The aim is to leave a gap of approximately 6% to 10% between the fixed price and the price of biosimilar brand, so that when patients are switched to the less expensive biosimilar, the trust gains 100% of this savings gap.

The CCG benefits when they can realize a 25% saving across the year and ensure that all patients are switched within this time, the authors said.

During the 2016-2017 financial year, the fixed-price rechargeable value was £699,806 (US $849,627) and the procurement cost of Benepali was £593,539 (US $720,610).

The savings through the reduction of drug acquisition costs was £95,017 (US $115,359) during the switch; those savings were used to hire a long-term biosimilar switch pharmacist.

NHS England has a target that at least 80% of existing patients should be switched to the best value biological medicine within 12 months. The authors, who all work for either Berkshire West or the Royal Berkshire NHS Foundation Trust, said knowledge gained from the etanercept switch allowed the trust to achieve over the 80% target switches of another biologic in the first 2 months.

Reference

Chan A, Kitchen J, Scott A, Pollock D, Marshall R, Herdman L. Implementing and delivering a successful biosimilar switch programme—the Berkshire West experience. Future Healthc J. 2019 Jun; 6(2):143-145. doi: 10.7861/futurehosp.6-2-143.