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Addressing Oncologists' Gaps in the Use of Biosimilar Products
Chad Williamson, MBA, MS; Leanne Berger, BS, Thomas P. Sullivan, BS; Jeffrey Crawford, MD; and Gary H. Lyman, MD, MPH, FASCO, FRCP
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Addressing Oncologists' Gaps in the Use of Biosimilar Products

Chad Williamson, MBA, MS; Leanne Berger, BS, Thomas P. Sullivan, BS; Jeffrey Crawford, MD; and Gary H. Lyman, MD, MPH, FASCO, FRCP
The availability of biosimilar products may improve access to healthcare by increasing the number of therapeutic options available at potentially lower costs. As of April 2019, 18 such biological products had been approved by the FDA, including 4 biosimilars for trastuzumab, 3 each for infliximab and adalimumab, 2 each for pegfilgrastim and filgrastim, and 1 each for rituximab, epoetin alfa, bevacizumab, and etanercept. The pace of approvals has accelerated, from the first indication for a filgrastim biosimilar in 2015 to 3 approvals in 2016, 5 in 2017, and 9 through early 2019, 7 of which were announced in the 2018 calendar year. 
Introduction

The availability of biosimilar products may improve access to healthcare by increasing the number of therapeutic options available at potentially lower costs.1 As of April 2019, 18 such biological products had been approved by the FDA, including 4 biosimilars for trastuzumab, 3 each for infliximab and adalimumab, 2 each for pegfilgrastim and filgrastim, and 1 each for rituximab, epoetin alfa, bevacizumab, and etanercept. The pace of approvals has accelerated, from the first indication for a filgrastim biosimilar in 2015 to 3 approvals in 2016, 5 in 2017, and 9 through early 2019, 7 of which were announced in the 2018 calendar year. 

According to a current market forecast, global sales of biosimilars will exceed $19 billion by 2023, up from just $2.5 billion in 2017, driven by their cost-effectiveness and the patent expiration of a number of biologics.2 These products present substantial opportunities for cost savings, with one recent modeling analysis indicating an estimated 5-year US cost savings of $256 million for use of biosimilar filgrastims in patients with cancer requiring myelosuppressive chemotherapy.

Physicians, pharmacists, and other healthcare providers are likely the most important stakeholders for biosimilar acceptance4 and are expected to play a key role in their uptake.5 In practice, however, there are few clinical practice guidelines to direct the use of biosimilars, and their introduction has been met with optimism and skepticism as clinicians ponder the efficacy, safety, and interchangeability of these products compared with their biologic originator drugs. 

Clinicians appeared wary of prescribing biosimilars, according to the results of a 2018 survey from PricewaterhouseCoopers’ Health Research Institute: 55% reported being unfamiliar with biosimilars and 35% reported never prescribing biosimilars.6 In an earlier survey, Molinari and colleagues found that physicians, particularly those in the United States, lacked technical knowledge and understanding of the effects of biologics and biosimilars sharing the same nonproprietary name.7 Another survey found that 30% of physicians would not prescribe a biosimilar to a treatment-naïve patient, assuming similar efficacy and safety, and given their current state of knowledge.5 Barriers to prescribing among reluctant hematologists and oncologists include mistrust, issues with manufacture, and insufficient data.8 

There is a growing consensus that educating healthcare providers on biosimilars may improve understanding of the products and instill confidence in their use.4,9 The American Society of Clinical Oncology (ASCO) said in a 2018 statement that continuous provider education on biosimilars is “critical to inform, promote, and use biosimilar products in a medically appropriate and cost-effective way to treat cancer.”10 Examples of such efforts, according to ASCO, may include webcasts, online practice guidelines, social media updates, and educational sessions at scientific meetings. 

Aim

Continuing medical education (CME) has been shown to improve clinician performance and patient health, with more positive outcomes seen in programs that include features such as interactivity or multiple methods of education.11 Accordingly, we developed and deployed live and online expert-led, interactive CME-certified activities with the goal of better preparing medical oncologists, hematologists, nurses, pharmacists, and other clinicians to incorporate biosimilars into the treatment paradigm for patients with cancer. We hypothesized that these activities would help improve the ability of clinicians to assess the risks and benefits of biosimilars and to mitigate barriers to their adoption in clinical practice. 

Methods

We developed a CME-certified educational initiative, “From Biologics to Biosimilars in Oncology Practice: A New Source of Value,” intended for medical oncologists, hematologists, nurses, pharmacists, and other clinicians involved in the care of patients with cancer. The program consisted of a live series of meetings and an online course based on the same educational content. Three live meetings were held in conjunction with ASCO state/regional meetings that took place between September 15, 2017, and July 13, 2018. The online course was available for CME credit between December 22, 2017, and December 22, 2018. The program was reviewed and accredited by the Accreditation Council for Continuing Medical Education but was not reviewed by an institutional review board. 

The format for both the live and online activities consisted of a slide-based lecture with interactive multiple-choice questions developed in collaboration with a steering committee including Gary H. Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center, Seattle, Washington, and first author of the aforementioned ASCO biosimilars statement10; and Jeffrey Crawford, MD, of Duke Cancer Institute, Durham, North Carolina. The online activity was also presented by Drs. Lyman and Crawford. The live meetings, which took place in Harrisburg, Pennsylvania; Newark, Delaware; and Miami, Florida; were presented by Gary I. Cohen, MD, of Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland. 

The activities were developed within the framework of Moore’s conceptual model for planning and assessing continuous learning for physicians.12 Specifically, the activity addressed Moore’s levels 1 (participant demographics), 2 (participant’s assessments of educational activities), 3 (knowledge acquisition and attitude change), 4 (competence), and 5 (performance). 

A standardized evaluation tool was used to characterize participant demographics, satisfaction, perception of bias, perception of enhanced clinical effectiveness, and overall assessment of activity format and any educational materials provided. Assessment also included attitude, confidence, practice, and barrier questions (open-ended, multiple choice, or Likert scale). Barriers to the use of biosimilars in managing patients with cancer were rated by participants using a Likert scale of 1 (not a barrier) to 5 (extreme barrier). We considered major barriers to be the proportion of learners choosing 4 or 5 on the scale. 

To measure change from baseline to postactivity knowledge, multiple-choice questions were developed and posed to participants at the live event through interactive web-based polling technology for the online course. To measure the impact of the education, each question was posed twice: once before exposure to the education and once immediately after exposure. Live activity participants were invited to complete an electronic follow-up survey including the same questions, at 6 to 8 weeks after the event, in order to measure knowledge retention over time. Each of the questions corresponded to 1 learning objective in order to measure change in (1) understanding of the biosimilar approval process, (2) awareness of currently approved biosimilars, and (3) familiarity with the evidence supporting approval of a trastuzumab biosimilar. For the live activity, these questions were incorporated into the content, while for the online activity, they were administered as standard online pre-and postactivity surveys. 

Statistical Analysis

Data management, extraction, and statistical analyses were performed using Educational Trak (Educational Measures, 2003, Centennial, Colorado). Because all questions were not answered by every attendee before and after the activity and upon follow-up, the preactivity, postactivity, and follow-up data were compared as independent samples (t test). Significant differences between the responses to the pretest and posttest and follow-up were assessed at P <.05. 

Effect-size calculations using Cohen’s d were performed to measure the magnitude of the difference in scores between pretest responders (ie, naïve to the education) and posttest responders (ie received the education). Results are expressed as the percentage of nonoverlap between those 2 measures, with higher percentages (eg, increasing proportion of correct answers in the posttest group) reflecting more effective education. A measure of patient impact was also calculated by extrapolating these results to the broader pool of participants for the live and online activities. Effect size was calculated on randomly selected unmatched responses from 30 participants for the regional meetings on randomly selected matched responses from 50 participants for the web course. 

Results

Demographics 

A total of 9599 individuals participated in the activities, including 114 at the regional meetings and 9485 in the web course. Attendees at the live meetings were predominantly physicians (MD/ DO, 66%; 14%, NP/PA; 12%, RN/BSN; 9%, pharmacist), while the web course participants were predominantly nurses (RN/BSN, 58%; MD/DO, 17%; 17%, pharmacist; 6%, NP/PA; 2%, other). 

Physicians attending the live meetings were predominately oncologists (76%) and hematologists (11%), have been in practice more than 10 years, and see more than 25 patients with cancer per month. Web course participants reported their specialty as hematology/ oncology (10%), primary care (45%), surgery (27%) and other (19%); have been in practice more than 10 years (57%); and see at least 1 patient with cancer per month (69%). 

Impact on Knowledge, Competence, and Attitudes 

Following completion of the activity, significantly more participants understood the level of evidence needed for biosimilars to be approved by the FDA (Table 1), representing 68% and 66% absolute increases among live meeting and web course attendees, respectively. The 10% of regional meeting attendees prior to the activity who understood that for FDA approval, a biosimilar must demonstrate no clinically meaningful differences with the reference biologic in terms of safety, purity, and potency, indicates the level of unfamiliarity with the biosimilar process among community oncologists. 

In the pretest, participants were most likely to underestimate the number of FDA-approved biosimilars when asked to specify a range (Table 2). The number of participants correctly selecting 6 to 15 approved products (as of November 2018) increased 36% in the live meetings and 56% in the web course (P <.05) for both comparisons). 

 
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