Abstract published: August 2021
Development of a standardised approach for evaluating and assimilating biosimilars should improve efficiency of their integration into existing workflows. A comprehensive cancer centre shares some practical considerations to serve as a guide to other institutions as they navigate the biosimilars landscape and support the transition to biosimilars in practice.
Biosimilars – biological products that are highly similar to reference products with no clinically meaningful differences – were allowed to enter the US market following ratification of the Biologics Price Competition and Innovation Act. Access to these potentially cheaper drugs was anticipated to reduce total pharmaceutical expenditures in the USA ranging between $24 and $150 billion within a 10-year period, with a corresponding reduction in total spending on biologics of approximately 3%. However, biosimilars still comprise less than one third of the total biologics use.
For cancer patients, providers seem more amenable to use biosimilars in the settings of palliation and supportive care than for curative purposes. Barriers to more widespread use of oncology biosimilars may include prescribers’ concerns over safety and efficacy, pricing and contract issues, and laws and regulations for substitution and interchangeability. These barriers may be effectively overcome by better prescriber education on switching studies, clear FDA guidance on substitution, and reform of formulary policies. And from a practical standpoint, willingness to provide temporal and financial investment to operationalize transition to biosimilars is required.
For the above reasons, a comprehensive cancer centre in Houston, TX reports the strategies, challenges, and lessons learned when they elected to move forward with biosimilars.
The first biosimilar evaluated for formulary addition at the cancer centre was the hematopoietic growth factor filgrastim-sndz. After a failed preliminary assessment, subsequent payer policy change and greater opportunities for cost savings, coinciding with publication of post-marketing safety data, led to re-evaluation and full implementation of the biosimilar alongside formulary deletion of the reference biologic. Formulary review for this process included the following steps – first, cost, coverage, and access were evaluated, followed by formulary preparation for use of the biosimilar with engagement of requesting physician, pharmacy, and therapeutics (P&T) committee, and purchasing personnel.
These experiences allowed the cancer centre to transition to biosimilar implementation within an effective timeline.
Trastuzumab is the gold standard of treatment for HER2-expressing cancers, although it is associated with an iThere are many barriers to the increased use of oncology biosimilars in treatment: concerns over safety and efficacy, pricing and contract issues, and laws and regulations for substitution and interchangeability. Improved prescriber education on switching studies, clear FDA guidance on substitution, and reform of formulary policies may help to overcome these barriers and start the transition to biosimilar implementation.