New Value Assessment Framework Needed for Biosimilars, White Paper Argues

As US healthcare increasingly moves toward value-based payment approaches, biosimilars, which reduce costs while maintaining treatment quality, can be an important driver of value. However, according to a newly published white paper, a new framework for assessing the value of biosimilars is warranted.

In response to rising healthcare costs, a variety of value assessment frameworks have been developed, including the American Society of Clinical Oncology Value Framework, the Memorial Sloan Kettering Cancer Center’s DrugAbacus, the National Comprehensive Cancer Network’s Evidence Blocks, and the Avalere—Faster Cures Patient-Perspective Value Framework, along with reviews undertaken by the Institute for Clinical and Economic Review (ICER).

However, the white paper, authored by Xcenda for the Biosimilars Forum, argues that no current value assessment framework is fully suited to assessing the value of biosimilar medicines; several of the above frameworks focus on oncology drugs alone, ICER’s focus on quality-adjusted life years (QALYs) has been questioned for its appropriateness, and each framework is oriented to the perspective of a particular stakeholder.

Read more about ICER assessments.

Currently, no framework incorporates all elements for valuing biosimilars, write the authors, adding that that patient-reported outcomes may “provide an anchor for presentation of value in cost savings to the patient in the form of [out-of-pocket] costs, increased choice of treatments, or access to the biologic class, or to treatments previously out of reach due to costs.”

In a statement on the paper, Juliana M. Reed, president of the Biosimilars Forum, said, “Biosimilars hold great promise to help control rising healthcare costs in the United States, but we need to fully recognize their value in order to realize these benefits. A more comprehensive value assessment framework can provide a much-needed lens to help stakeholders across the medical community better understand the dynamic nature of the biosimilars market.”

Specifically, the paper identifies 5 elements that will be important to consider in developing value assessments of biosimilars:

Lower drug acquisition costs. Because biosimilars are priced below their reference products, they could also drive reference products’ prices lower, and lower prices for therapies may contribute to increased patient access. However, without strategic policy efforts, US patients may not feel the benefit of lower co-pays for biosimilars. Furthermore, rebating practices may discourage health plans for adopting biosimilars.

Improved adherence. Poor adherence, associated with high costs or other factors, results in suboptimal outcomes, whereas improved adherence may lead to lower overall healthcare costs.

Earlier treatment. Patients who have early access to effective therapies such as biologics may avoid complications and morbidity, thereby reducing their healthcare resource utilization.

Patient experience. Improving access and decreasing the financial burden of care may have a positive impact on patient outcomes.

Development and innovation. Greater use of biosimilars may provide an opportunity to increase access to innovative therapies.

Kristen Migliaccio-Walle of Xcenda, one of the paper’s authors, said that these elements will help to capture perspectives not present in existing frameworks. In doing so, she said, “We can increase awareness of the true value of biosimilars and improve overall patient health.”