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Implementing Biosimilars in the Oncology Setting: Pharmacist-Driven Strategies for Optimizing Patient-Centered Management
Provided by The University of Tennessee College of Pharmacy, in cooperation with ASiM.
Supported by an educational grant from Pfizer Inc.
OVERVIEW
Biosimilar drugs offer the potential to foster significant improvements in oncology patient management by reducing healthcare costs and increasing patient access to treatment and supportive care. However, their use remains clouded by considerable uncertainty regarding how they fit appropriately into oncology practice. While mimicking the concept of generic small-molecule drugs and their branded agents, the association between biosimilars and their reference biological products is more complex, requiring unique considerations for development and regulatory approval. In this activity, we will review the following: key differences between biosimilars, generics, and reference biologics; US Food and Drug Administration regulatory requirements for their approval and interchangeability; considerations and implications for cancer treatment and supportive care; and pharmacist-led strategies to overcome administrative and educational barriers to biosimilar implementation.
GOAL
The goal of this educational activity is to provide an in-depth understanding of biosimilars in cancer treatment and supportive care, including their evaluation, regulation, and real-world use, as well as to discuss pharmacist-driven strategies to facilitate and optimize the use of oncology biosimilars in clinical practice.
TARGET AUDIENCE
This activity is primarily intended for oncology pharmacists as well as other pharmacists (eg, specialty, managed care, community/retail, health-systems pharmacists) involved in the management of oncology patients. No prerequisites required.
LEARNING OBJECTIVES
The University of Tennessee College of Pharmacy takes responsibility for the content, quality, and scientific integrity of this CPE activity. Upon the conclusion of this activity, the participant should be able to:
- SUMMARIZE how the FDA uses a "totality of evidence" strategy to evaluate biosimilar compounds.
- REVIEW current and emerging efficacy and safety data for biosimilar agents for the treatment of cancer.
- SUMMARIZE current safety and efficacy data with supportive care biosimilars.
- DISCUSS key clinical considerations associated with the use of biosimilars in the treatment of cancer.
- REVIEW biosimilar implementation pathways in clinical practice.
CREDIT DESIGNATION STATEMENT
The University of Tennessee College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Successful completion of this knowledge-based activity will provide a statement for 1.5 contact hours of credit (0.15 CEUs) and will be available at the completion of the activity. Successfully completing the activity and receiving credit includes: 1) attending the session; 2) watching, listening to, and participating in the educational activity; 3) completing the self-assessment instrument with a score of at least 70%. UAN: 0064-9999-19-202-H01-P. CE credit will be submitted to the NABP CPE Monitor within 30 days. It is recommended that you check your NABP CPE Monitor e-profile database 30 days after the completion of any CE activity to ensure that your credits are posted.
NABP e-PROFILE ID NUMBER: Pharmacists or pharmacy technicians with questions regarding their NABP e-Profile or CPE Monitor should refer to the FAQ section on the NABP website: https://nabp.pharmacy/cpe-monitor-service/cpe-monitor-faqs/.
To receive credit for your participation in this activity, all pharmacists must include their CORRECT NABP e-Profile ID number, along with their month and date of birth. If incorrect information is provided, this will result in "rejected" status from the CPE Monitor. It is the responsibility of the participant to notify The University of Tennessee (within the 60 day submission timeframe) of their corrected information. Otherwise, the completed CE will not be accepted by the CPE Monitor.
Please allow up to 30 days for your credit to appear on CPE-Monitor.
Type of Activity: Knowledge
Media: Internet
Fee Information: There is no fee for this educational activity.
Estimated time to complete activity: 90 minutes
Published
December 12, 2019
Expires
September 12, 2020
HOW TO EARN CREDIT
Participants must complete the activity as described above in the Continuing Education Information section. To answer the questions, click on your selected choice for each answer then proceed to the next question. We recommend that you print a copy of your answers before you submit them to us. Once completed, click on Submit Post-test at the bottom of the page. Your post-test will automatically be graded. If you successfully complete the post-test (score of 70% or higher), your statement of CE credit will be made available immediately. Click on View Certificate and print the CE statement for your records. If you receive a score lower than 70%, you will receive a message notifying you that you did not pass the post-test. You will have 2 opportunities to pass the post-test.
FULL DISCLOSURE POLICY AFFECTING CPE ACTIVITIES
As an accredited provider by the Accreditation Council for Pharmacy Education (ACPE), it is the policy of The University of Tennessee College of Pharmacy to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer(s) of any commercial product(s) discussed in an educational presentation. The Course Director and Participating Faculty reported the following:
PARTICIPATING FACULTY
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP (Course Director)
Clinical Coordinator
Hematology/Oncology Department of Pharmacy
University of Arizona Cancer Center
Tucson, Arizona
Ali McBride, PharmD, MS, BCOP, reports serving as a consultant for Sandoz.
John Valgus, PharmD, MHA, BCOP
Assistant Professor of Clinical Education
UNC Eshelman School of Pharmacy
UNC School of Medicine
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina
John Valgus, PharmD, MHA, BCOP, reports serving as a consultant for Genentech, Inc.
OFF-LABEL PRODUCT DISCUSSION
In accordance with ACPE Criteria for Quality, the audience is advised that authors in this CPE activity may include reference(s) to unlabeled, unapproved, or investigational uses of therapeutic agents or biomedical devices. The authors will inform the reader of when they discuss or reference an unapproved, unlabeled, or investigational use of therapeutic agent or biomedical device.
DISCLAIMER STATEMENT
The opinions and recommendations expressed by faculty and other experts whose input is included in this activity are their own. This activity is produced for educational purposes only. Use of The University of Tennessee College of Pharmacy name implies review of educational format, design, and approach. Please review the complete prescribing information of specific drugs or combinations of drugs, including indications, contraindications, warnings, and adverse effects, before administering pharmacologic therapy to patients.
Grievance Policy
A participant, provider, faculty member, or other individual wanting to file a grievance with respect to any aspect of an activity provided or coprovided by The University of Tennessee College of Pharmacy may contact the Director of Continuing Professional Development in writing at jwheeler@utasip.com. The grievance will be reviewed and a response will be returned within 45 days of receiving the written statement. If not satisfied, an appeal to the Dean of the College of Pharmacy can be made for a second level review.
REQUIRED COMPUTER HARDWARE/SOFTWARE
Please ensure the computer you plan to use meets the following minimum requirements:
- Operating System: Windows 98 or higher & Macintosh 2.2 or higher
- Internet Browser (Mac &/Windows): Internet Explorer 6.0 or higher, Google Chrome, Safari 5.0.6 or higher, Firefox 3.0.3 or higher & Opera 5 or higher
- Broadband Internet connection: Cable, High-speed DSL & any other medium that is internet accessible.
- Peripherals: Computer speakers or headphones
- Monitor Screen Resolution: 320 x 480 or higher
- Media Viewing Requirements: Adobe Reader, Microsoft Power Point, Flash Player & HTML5
AGENDA
Activity Overview and Goals
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP
The Future of Value-Based Care: An Introduction to Biosimilars
John Valgus, PharmD, MHA, BCOP
FDA Guidance and Abbreviated Approval Pathway for Biosimilars
John Valgus, PharmD, MHA, BCOP
Practice Implications of Biosimilars: Perspectives for Oncology Pharmacists
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP
Question and Answer Session Part 1
Faculty Panel
Pharmacist-Led Strategies for Optimizing Biosimilar Use in Oncology Care
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP, and John Valgus, PharmD, MHA, BCOP
Question and Answer Session Part 2
Faculty Panel
Conclusions and Postassessment
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP
What you are about to see is a previously recorded live webcast. Please note that only "home study" credit will be awarded for participating in this archived presentation. No "live" credits are available.
