Biosimilar Adoption Policy Proves Successful After 8 Years in a UK Tertiary Hospital

After a 6-year follow-up period, a UK tertiary hospital saw greater biosimilar adoption than the English average after implementing a new policy that encouraged patients to switch from a reference biologic to a biosimilar version.

The retrospective study, published in the British Journal of Clinical Pharmacology, intended to evaluate the effectiveness of biosimilar adoption within a UK tertiary hospital and provide insights into the impact of biosimilar adoption on cost savings, patient outcomes, and the overall efficiency of healthcare delivery within the hospital setting. Additionally, the study sought to contribute to the existing knowledge base on biosimilar adoption strategies and their implications for health systems and patient care.

National Health Service England mandates that English hospitals prescribe the “best-value biologic” to treatment-naïve patients within 3 months of biosimilar availability as well as at least 80% of existing patients within 12 months. To achieve the latter, patients on treatment with an originator must transition to a biosimilar option.

Although biosimilar use is variable between nations, England and Scotland are among those that prioritize rapid adoption of best-value biologics. Additionally, regulatory authorities in the United Kingdom and European Union have declared all biosimilars as interchangeable with their reference agents. However, some patients and health care professionals remain concerned about the safety and efficacy of biosimilars, suggesting that providers need systems implemented to respond to patient requests to remain on the originator or revert to it if patients experience loss of efficacy or experience adverse reactions.

The University College London Hospitals (UCLH) Foundation Trust established a Biosimilar Steering Group (BSG), a multidisciplinary subcommittee of the hospital Drugs and Therapeutics Committee, to facilitate biosimilar introductions. The group would review all requests for an originator biologic and manage a hospital-based registry of patient data to inform future policies. The study period lasted 74 months (January 2016 to March 2022).

Results showed that UCLH consistently surpassed the English average in biosimilar adoption rates, except for a slight lag in the initial 3 months of adalimumab adoption. In 2021/2022, UCLH used a higher proportion of biosimilars than the average in each of the 7 National Health Service regions, resulting in a cost efficiency of approximately £382,494 ($486,220). A service evaluation revealed that 67% of the 147 applications submitted to BSG were for reverting to the original biologic. The study identified several subgroups related to the evaluation of biosimilar adoption and patient outcomes, showing concerns resolved in a majority of cases, and BSG's estimated running costs were £61,649 ($78,367) over 6 years.

The real marginal cost, however, was £0, as the work was carried out within existing job plans without additional funding.

Subgroup 1 involved patients who reverted to their original biologic after switching to a biosimilar. Subgroup 2 included patients who had concerns related to their biologic treatment that spontaneously resolved, leading to decisions that were not actioned by the clinical team. Subgroup 3 comprised of those who had concerns related to the loss of efficacy within a short period of switching to a biosimilar. Patients in subgroup 4 primarily had concerns related to the loss of efficacy following the switch to a biosimilar, leading to recommendations for a switch to a different drug rather than reverting to the originator.

In Subgroup 1, BSG closely monitored 70 patients who reverted to their original biologic, and within 3 to 12 months, concerns were successfully resolved in 87% of cases, specifically addressing tolerability (85%) and efficacy (90%). This resulted in a prolonged continuation of treatment.

Subgroup 2 involved BSG approving 5 cases where the clinical team did not take action, as the reasons for reverting spontaneously resolved.

In Subgroup 3, BSG addressed concerns of loss of efficacy (93%) after switching to a biosimilar, recommending continued treatment for an extended period. In 93% of cases, the primary concerns were resolved by the next clinic review, typically occurring within 6 to 12 months.

Subgroup 4 focused on concerns of loss of efficacy (83%) following a biosimilar switch, accompanied by evidence of secondary failure. BSG recommended a switch to a different drug rather than reverting to the originator, and this advice was adhered to in all cases.

The study's limitations include its single-hospital focus, retrospective data analysis, lack of a control group, and absence of assessment of patient-reported outcomes and broader systemic implications. These limitations should be considered when interpreting the findings, despite the valuable insights provided into the effectiveness of biosimilar adoption within a hospital setting and its potential benefits for patients and health care systems.

Good governance played a crucial role in enhancing biosimilar adoption, aligning with experiences in Sweden. The study emphasized the importance of a national strategy and the need for alignment between local and national efforts. The BSG registry revealed that most patients reverting to their original drug perceived benefits, suggesting observed loss of efficacy post-switch was likely switch-related. Hospitals were recommended to establish BSG-like panels for biosimilar-related requests, supporting the acceptance of individual patient requests to revert to the original biologic based on high resolution rates.

Reference

Barron A, Chung J, Ferner RE, et al. Effectiveness of biosimilar adoption within a UK tertiary hospital: 6-year follow-up. Br J Clin Pharmacol. 2023;89(10):2944-2949. doi:10.1111/bcp.15859