The rapid adoption of FDA-approved biosimilars is feasible, measurable, and scalable, and pharmacists should lead the charge, according to a pharmacy-driven intervention presented by David Michael Waterhouse, MD, MPH, Co-Director, Clinical Research, Oncology Hematology Care, US Oncology Network, Cincinnati, OH. Dr Waterhouse described this intervention at the 2021 ASCO Quality Care Symposium.
The results of this pharmacy-driven intervention study showed a statistically significant increase in the adoption of biosimilars over a 1-year period, with dramatic improvements in the rates of conversion to biosimilars.1 In addition, the pharmacy-based substitution approach was far more efficient and effective than a physician-driven substitution, Dr Waterhouse reported.
“If you wait for the physician to do it, it isn’t going to happen,” Dr Waterhouse emphasized. “On the other hand, if you let a well-directed, pharmacy-driven process accomplish your biosimilar adoption, you have the chance to be very successful.”
“A pharmacy-based substitution approach allows providers to focus on front-end patient care instead of the back-end medication substitution process,” explained Dr Waterhouse. “More important, after standardized training, with all providers signing an acknowledgment form on automatic biosimilar substitutions, daily provider and clinic interruptions were avoided when needing approvals,” he added.
Although biosimilars are clinically equivalent and highly similar to biologic drugs, they cost less than the reference drug, which is especially important to patients with cancer, for whom the costs of medications could reach hundreds of thousands of dollars annually.
Effective conversion to biosimilar drugs is vitally important to the total cost-of-care savings and can be achieved without negatively affecting patient outcomes, Dr Waterhouse suggested.
“By utilizing biosimilars, we’re not only finding financial savings for our patients, but for the practice and for those who are funding the healthcare,” he pointed out. “Right now, it’s estimated that cost-savings could be somewhere between 21% and 24%, based on ASP [average sales price] data from 2020.”
In their study, Dr Waterhouse and colleagues first established a baseline by comparing the percentage of patients who were currently receiving brand-name drugs versus those who were receiving biosimilar drugs. They then compared the amount of reference drug that was infused with the biosimilar and created a complementary report to track the billed units per month, to facilitate auditing and ensure accuracy.
With the help of an e-learning system developed by the US Oncology Network, they implemented mandatory biosimilar education of physicians, advanced practice providers, pharmacists, nurses, financial navigators, and prior authorization team members. Patient education was verified using established teaching visits by tracking documentation in the electronic health record.
Dr Waterhouse and colleagues instituted workflow changes that would alleviate the burden of a patient-by-patient decision for the providers and turn it over to the pharmacy review team. After obtaining consent from the physicians for the biosimilar policies and standard operating procedures, the investigators measured the pre- and postintervention classifications.
The quality improvement initiative for biosimilars to rituximab, trastuzumab, and bevacizumab was implemented on September 1, 2020, but was not initially mandated for biosimilars to pegfilgrastim.
“This allowed us to compare the pharmacy-driven auto substitution based on education to a physician-driven process,” Dr Waterhouse explained.
When the rate of biosimilar adoption before September 1, 2020, was compared with the rate of adoption in early 2021, a very significant difference was observed. In fact, the pharmacy-driven conversion to biosimilars was “near complete,” said Dr Waterhouse.
The conversion rates that were based on billed biosimilar units improved from 11.7% at baseline to 90.2% for rituximab, from 8.4% to 87.4% for trastuzumab, and from 0% to 90% for bevacizumab.
Conversely, pegfilgrastim, which had no initial pharmacy intervention and was still reliant on physician-driven conversion, showed virtually no change in adoption to the biosimilar. After the pharmacy-driven process was enacted in May 2021, “bioconversion has happened rapidly for Neulasta,” Dr Waterhouse concluded.
- Waterhouse DM, Burdette C, Davies D, et al. Scaled integration of FDA approved biosimilars: closing the knowledge and adoption gaps. J Clin Oncol. 2021;39(28_suppl):15.