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Addressing and Understanding Challenges Linked With Adopting Biosimilars Into Practice


December 08, 2020

In a session at ASHP Midyear 2020, Osama Abdelghany, PharmD, MHA, BCOP Yale New Haven Hospital, and David L Crosby, PharmD, BCOP, BCPS, Dartmouth-Hitchcock Health, provide a variety of clinical, operational, and payer coverage considerations for the successful adoption of biosimilars, and highlight some of the challenges faced during this process.

Dr Crosby kicked off the session discussing both the opportunity and impact of biosimilars. He explained that there is growing competition among biosimilars as years pass. More specifically, he broke down six challenges that are often faced when attempting to adopt biosimilars. They are:

  • Provider comfort/experience;
  • Patient education;
  • 3rd Party Payers;
  • Financial impact on patients and organization;
  • Clinical considerations; and
  • Impact to operations.

In the next portion of the session, Dr Abdelghany broke down clinical and formulary considerations. He explained that there are three approaches to the formulary review process. They are:

  • Individual drug reviews;
  • Class review; and
  • Global umbrella review.

He noted that in the formulary management for biosimilars, both the review process and the clinical message are critical elements. Additionally, he said that a biosimilar will undergo review for formulary addition through the System Pharmacy and Therapeutics Committee (SP&T).

According to Dr Abdelghany, when a biosimilar is added, the “formulary will consider available comparative clinical study data, clinical immunogenicity data, cost, ease of use, and product characteristics.”

“When multiple biosimilars for a single reference product require simultaneous review, the evaluation can be conducted as a Class Review,” he said. “If available data within a Class Review support therapeutic equivalence, future biosimilars within the reviewed class need not proceed to SP&T for review.”

As he continued to discuss formulary considerations, he noted that these formulary decisions will be based on cost and operational considerations. Further, he said the pharmacy will need to communicate with key stakeholders before a formulary switch is made.

For clinical considerations, Dr Abdelghany broke down indications and efficacy data. He noted that through extrapolation, it is possible for a biosimilar to gain approval for all indications held by the reference product and eliminates the need for redundant clinical trials. Further, he said that the FDA looks for adequate and sufficient scientific data that justifies the extrapolating data.

Dr Abdelghany then explained that it is important to follow some basic guiding principles for product selection. He said that the top guideline is “cost, cost, and cost.” He said it is important to look at the enhanced value of these products such as:

  • Payers’ coverage;
  • Patient assistance program;
  • Clinical data; and
  • Supply chain.

“Product selection is only the beginning,” he said.

After the product is selected, there are still critical conversion decisions that have to be made. According to the session, new versus existing patients have to be considered. They highlighted that there are positive conversion drivers. Policies and procedures should be created to facilitate seamless conversion.

“At the initiation of a new regimen of biologic, chemotherapy, or oral-oncolytic therapy, the attending physician will discuss the risks of the proposed therapy with the patient or his/her surrogate decision-maker. Consent with drugs name(s) using brand name or generic/biosimilar equivalent are acceptable,” they said.

“Pharmacists may replace a medication order in an active treatment plan due to an approved health system formulary change, drug shortage, or commercial formulation change if within same therapeutic entity. Pharmacists may sign a previously signed order, as long as the order is the same dose, route of administration, and administration duration.”

Additional considerations include determining the true cost of the drug and remembering the cost of conversion. More tips givens were to consider the site of care and value-based model, ensure patient assistance programs are of equal status or better, and to capitalize on increased market competition.

For payer-specific considerations, it was recommended to search the coverage offered by local payers and know how a practice should manage denials and restrictions set forth by a payer. Additionally, they noted that payers are linked with a dynamic environment. Meaning, a pharmacy may have to be prepared to carry different products and payer polices are continually changing and need to be monitored. The major note highlighted was when working with payers, organizations must be innovative in order to negotiate strategies to address payer restrictions and plan for alternative sites of care.

Finally, attendees were given an operational consideration checklist. The checklist includes the following:

  • Communication/Education;
  • Electronic Medical Record Integration;
  • Prior authorization review;
  • Pharmacy procurement/dispensing;
  • Integrated Delivery Networks;
  • Regular review of adjustments/denials; and
  • Monitor integration success.

It was stressed that communication will continue to be needed among key stakeholders. In a graph that was placed as a circle, they said that all parties work together throughout this process. Additionally, the importance again of communicating conversion decisions was made.

Overall, the speakers left the with the following takeaways:

  • “Formulary and drug use policy guidelines are necessary for successful adoption of biosimilars in practice;
  • Complete financial analysis should extend beyond cost and must include considerations for payers’ preferences and restrictions; and
  • Comprehensive operational checklist can be utilized to ensure safe and seamless conversion to formulary agent(s).”

Julie Gould

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