Approaching the Process of Operationalizing Biosimilars in Cancer Care

The first step toward operationalizing the uptake of biosimilars is having a program-level discussion that not only describes what biosimilars are, but also assesses how they impact the bottom line and could get incorporated into treatment plans.

The first step toward operationalizing the uptake of biosimilars is having a program-level discussion that not only describes what biosimilars are, but also assesses how they impact the bottom line and could get incorporated into treatment plans, according to Sandeep Parsad, PharmD, MBA, BCOP, assistant director of pharmacy at Hematology/Oncology & Investigational Drug Services and director of the PGY2 Oncology Pharmacy Residency Program at the University of Chicago Medicine, during a session at Community Oncology Alliance Virtual 2021 Conference 2021.

However, conducting this extensive conversation as a program has gotten easier over time as biosimilars have become more widely adopted. Yet, the discussion still requires a purposeful approach that incorporates the perspectives of all involved in the treatment process, Parsad explained.

This program-level discussion includes meeting with both physicians and nursing staff to discuss the current regulatory requirements for biosimilars and provide data regarding how biosimilars compare to their reference product. During this discussion, it is beneficial to provide information regarding how, in order to be approved for use in clinical practice, biosimilars need to meet the same high standard of safety and quality as other drugs on the market.

However, biosimilars are also not interchangeable with their reference product, which highlights the reason why many physicians expect and request that they are always informed if a therapy is switched to a biosimilar.

“But I feel that it goes [sic] fairly smoothly once there’s this really open dialogue. The harder part was not the acceptance of a biosimilar as something we could use, but more so operationalizing it. The conversation then really focuses on how to approach this with patients,” Parsad said during the session.

Parsad explained that it is necessary to assess during this conversation whether it would be beneficial to switch from a branded product to a biosimilar for patients who are newly starting therapy or whether it is better to transition existing patients to a biosimilar following initial therapy with a branded product. However, this latter option raises the question of patient consent, which brings forth new questions to consider.

“Do we need to reconsent those patients who have already been on a branded product and are moving over? By and large, I feel that’s been the harder issue, at least for us, and I will say, also from comments I’ve received from other colleagues, it’s that transition for patients who have been potentially for months or years on a branded product that we now need to switch over,” Parsad said during the session.

Parsad noted that at her organization, these questions have brought up other issues that have required additional discussions among both physicians and nurses within a provider group.

“If your patient is stable, is it appropriate to rock the boat and switch to a biosimilar or not? And that conversation got even more deep [sic], in my opinion, with questions about if a patient has metastatic disease, or is progressing, perhaps we’ll start with them first,” Parsad said during the session. “That we had to really work through.”

Once deciding as an organization that the data and literature provided enough evidence to pursue using biosimilars and move further on in the decision process, the next issue to face more broadly is the need for real-world evidence, Parsad explained.

“The first hump was just going from branded product to the biosimilar, but now with multiple biosimilars being available within the same drug class, if you will, what do you do then?” Parsad said during the session. “We are seeing payers that are switching their biosimilars every 3 months, so you could be faced with questioning whether a patient can move from A to B to C, and we just don’t have that [sic] data.”

Parsad also noted that informatics play a key role in the process of operationalizing biosimilars as well. When assessing pathways and treatment plans, establishing how to build in a system within a computerized physician order entry that allows providers to switch from biosimilar to biosimilar may be necessary as well.

In terms of the timeframe for these different steps, Parsad explained that her organization took approximately 3 months to have the initial program-wide discussion.

“It was meeting at a program level by level, making sure that we had buy-in, making sure that this was not an edict, and this was a true conversation,” Parsad said during the session. “Then the question of patient education, was that driven by the physician, was that driven by nursing, is it multi-modality, and how do we do that.”

However, now that her organization is firmly established as one that uses biosimilars, Parsad noted that as new biosimilars come in, the turnaround has vastly quickened.

“I will say that turnaround is about a month,” Parsad said. “Really, the timing is informatics-based. I mean, that is not a quick and easy turnaround time.”

REFERENCE

Parsad S, Broun ER, Oskouei S, Oubre K. Biosimilars in Cancer Care: Challenges & Opportunities; April 9, 2021. Presented at: Community Oncology Alliance Virtual 2021 Conference; Accessed April 9, 2021.