Rapid adoption of FDA-approved biosimilars is feasible, measurable, and scalable—and pharmacists should lead the charge, according to data presented at the virtual 2021 American Society of Clinical Oncology Quality Care Symposium.
Results of a pharmacy-driven intervention showed a statistically significant increase in biosimilar adoption over a 1-year period. In addition, the pharmacy-based substitution approach was found to be “far more efficient and effective” than a physician-driven substitution process, the investigators reported.
“A pharmacy-based substitution approach allows providers to focus on front-end patient care instead of the back-end medication substitution process,” said lead study investigator David Michael Waterhouse, MD, MPH, Co-Chair, Clinical Research, Oncology Hematology Care/US Oncology Network, Cincinnati, OH. “More importantly, after standardized training, with all providers signing an acknowledgment form on automatic biosimilar substitutions, daily provider and clinic interruptions were avoided when needing approvals.”
Biosimilars are clinically equivalent and highly similar to FDA-approved biologic drugs yet cost significantly less, which is beneficial to patients who are often burdened with a large portion of cancer drug costs. Effective conversion to biosimilar products is thus vitally important to total cost-of-care savings, and can be achieved without negatively affecting patient outcomes, Dr Waterhouse explained.
“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 continued. “Right now, it’s estimated that cost-savings could be somewhere between 21% and 24% based on ASP [Average Sales Price] data from 2020 as reported by CMS [Centers for Medicare & Medicaid Services].”
Study Design
For this intervention, Dr Waterhouse and colleagues first established a baseline by measuring the percentage of patients who were currently receiving brand-name drugs versus those who were receiving biosimilar products. The investigators then compared the amount of reference product that was infused with the biosimilar and created a complementary report to track 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 into the pharmacy review team hands. After obtaining consent from the physicians for the biosimilar policies and standard operating procedures, the investigators measured pre- and postintervention classifications.
Conversion to Biosimilars “Near-Complete”
As Dr Waterhouse reported, the quality improvement initiative for rituximab (Rituxan), trastuzumab (Herceptin), and bevacizumab (Avastin) was implemented on September 1, 2020, but was not initially mandated for a fourth biosimilar—pegfilgrastim (Neulasta).
“This allowed us to compare the pharmacy-driven auto substitution based on education to a physician-driven process,” he explained.
When the rate of biosimilar adoption prior to September 1, 2020, was compared with the rate of adoption after that date, a very significant difference was observed. In fact, the pharmacy-driven conversion to biosimilars was “near-complete,” said Dr Waterhouse. Conversion rates based upon billed biosimilar units improved from 11.7% (baseline) to 90.2% for rituximab, 8.4% to 87.4% for trastuzumab, and 0% to 90.0% for bevacizumab.
Conversely, pegfilgrastim, which had no initial pharmacy intervention and was still reliant on physician-driven conversion, showed virtually no change in adoption after September 1, 2020. After the pharmacy-driven process was enacted in May 2021, however, “bioconversion has happened rapidly for Neulasta,” he said.
“If you wait for the physician to do it, it isn’t going to happen,” Dr Waterhouse concluded. “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.”
