Biosimilars in the Era of Value-Based Care: Pharmacist-Driven Strategies for Implementing Patient-Centered Management

Biosimilars in the Era of Value-Based Care:
Pharmacist-Driven Strategies for Implementing Patient-Centered Management

Provided by The University of Tennessee College of Pharmacy, in cooperation with ASiM.
Supported by an educational grant from Pfizer Inc.

Published:

October 31, 2018

Expires:

October 31, 2019

OVERVIEW

Biosimilar drugs offer the potential to foster significant improvements in patient management by substantially reducing healthcare costs and increasing patient access to potentially life-saving therapies. However, their use remains clouded by clinician uncertainty regarding their efficacy, safety, and how they appropriately fit into clinical practice, precluding patients from reaping these benefits. 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 archived webcast activity, the following topics will be reviewed: key differences between biosimilars, generics, and reference biologics; US Food and Drug Administration (FDA) regulatory requirements for their approval and interchangeability; their importance as a key component of value-based care; and, pharmacist-led strategies to overcome administrative and educational barriers to biosimilar implementation.

GOAL

The goal of this educational activity is to understand the unique considerations in treating patients with biosimilars as part of the provision of value-based care, as well as to develop pharmacist-driven strategies for optimizing the use of biosimilars in clinical practice.

TARGET AUDIENCE

This activity is primarily intended for pharmacists from all practice settings (eg, specialty, managed care, community/retail, health-systems, and other settings). 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. At the conclusion of this activity, the participant should be able to:

  • DIFFERENTIATE biosimilars and the regulatory processes involved in biosimilar approval from their reference products and from generics of small molecule drugs.
  • EVALUATE biosimilars as a key component of the value-based care paradigm, as well as their role in current practice models.
  • DEVELOP strategies for patient and healthcare provider education on the potential advantages of biosimilars.
  • DESIGN strategies, including appropriate documentation and coding, to facilitate reimbursement of biosimilars.

ACCREDITATION STATEMENT

The University of Tennessee College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education to provide continuing education for pharmacists. 

CONTINUING EDUCATION INFORMATION

acpeSuccessful completion of this application-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: 0064-0000-18-206-H04-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: Application

Media: Internet

Fee Information: There is no fee for this educational activity.

Estimated time to complete activity: 90 minutes

HOW TO EARN CREDIT

Participants must complete the activity as described above in the Credit Designation Statement. 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 (Course Director)
Clinical Coordinator
Hematology/Oncology Department of Pharmacy 
University of Arizona Cancer Center 
Tucson, Arizona
Ali McBride, PharmD, MS, BCOP, reports serving on an advisory board 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 Coherus Biosciences and Stemline Therapeutics 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, sponsor, faculty member, or other individual wanting to file a grievance with respect to any aspect of an activity sponsored or cosponsored by The University of Tennessee College of Pharmacy may contact the Associate Dean for Continuing Education in writing at gfarr@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 Powerpoint, Flash Player & HTML5

ACTIVITY

The following is an archived webcast activity designed to help you gauge your basic knowledge of the topic and then direct you to areas you may need to focus on. It consists of 3 sections: an unaccredited pre-test, an interactive case study, and a CPE post-test, and evaluation. All 3 sections must be completed to receive CPE credit. A statement of credit will be available online immediately following successful completion of the activity.

TABLE OF CONTENTS

Activity Overview and Goals
Ali McBride, PharmD, MS, BCOP

The Future of Value-Based Care: An Introduction to Biosimilars
John Valgus, PharmD, MHA, BCOP

Question and Answer Session Part 1 
Faculty Panel

Practice Implications of Biosimilars: Perspectives for Pharmacists
Ali McBride, PharmD, MS, BCOP

Clinical Pearls for Reimbursement and Coverage of Biosimilars 
Ali McBride, PharmD, MS, BCOP

Question and Answer Session Part 2 
Faculty Panel

Conclusions
Ali McBride, PharmD, MS, BCOP

What you are about to see is a previously recorded webcast. Please note that only "home study" credit will be awarded for participating in this archived presentation. No "live" credits are available.

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