Study Address Financial, Clinical, Operational Concerns About Biosimilars

Biologics are the most expensive drug category in the United States. A recent study, published in the Journal of Managed Care and Specialty Pharmacy, investigated how American health systems are reacting to the introduction of biosimilars into the marketplace, and described real-world implementation strategies.

To maximize the potential impact of biosimilars, health care providers, payers, and biosimilar manufacturers must understand where and how biosimilars bring the most value to patients. In order to gain insight from health system experiences with the first infliximab biosimilar (Inflectra) approved in the US, a questionnaire was distributed to pharmacy representatives from health systems during March and April 2017. Responses were collected from 57 health systems across the country, and revealed that the key barriers and challenges faced with biosimilar uptake include payers and reimbursement, interchangeability, provider preference, and cost.

Financial Concerns

All health systems that responded to the questionnaire had used the reference infliximab product within their respective organizations. When asked about potential cost savings with the infliximab biosimilar:

• 76% of respondents perceived that there was a cost savings opportunity compared with the reference product

• 28% were concerned about payers or reimbursement
• 10% were concerned about cost
• One-third said that they had conversations with payers to understand their viewpoints on biosimilars

Clinical concerns

After financial barriers for payers and reimbursement, interchangeability and switching patient therapy were identified by 20% of respondents as the next greatest barrier to infliximab biosimilar uptake. Provider and patient preferences were identified by the study as the third greatest barrier (14%), with immunogenicity and clinical safety highlighted as well (6%).

Operational concerns

The study explained that health systems work to streamline and standardize inventory, so if a decision is made to keep a biosimilar and reference product on hand, additional steps may be required to ensure appropriate management of the products. In fact, a small percentage (2%) of questionnaire respondents mentioned stocking multiple products as another barrier for infliximab biosimilar use.

The potential cost-savings from biosimilars has been estimated to be $44.2 billion over a 10-year timeframe, according to the study. Yet concerns must be overcome to truly realize the benefits. With increasing pressure to reduce the overall cost of health care, biosimilars have the potential to intensify competition in the biologics space. According to the study, ideally the biosimilar movement will affect healthcare much like the introduction of generic drugs did years ago: by increasing competition, driving down costs, and maintaining optimal patient outcomes.