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OVERVIEW

While there are now more than a dozen disease-modifying therapies (DMTs) for patients with multiple sclerosis (MS) available, the cost of DMTs continues to grow, potentially impeding access to care. Generic and biosimilar DMTs have the potential to substantially reduce drug-related expenses and promote adherence to therapy for patients living with MS. Currently, there is only 1 generic DMT, generic glatiramer acetate (GA). The structural complexity of GA has resulted in misconceptions regarding the bioequivalence between the generic and innovator molecule and precludes the use of the cost-saving generic therapy in clinical practice. Specialty and managed care pharmacists have unique roles as pharmacotherapy experts, key formulary decision makers and, in many cases, healthcare providers who have direct contact with patients with MS. This archived webcast will provide pharmacists with the information necessary to enhance their role in the management of patients with MS, particularly with assessing the appropriate utilization of generic agents.

GOAL

The goal of this educational activity is to provide an in-depth understanding of generic and biosimilar DMTs so that specialty and managed care pharmacists can implement strategies to improve access to DMTs for their patients with MS and reduce healthcare costs.

TARGET AUDIENCE

This educational initiative is intended for specialty and managed care pharmacists, as well as other pharmacists interested in the management of MS 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. At the conclusion of this activity, the participant should be able to:

• ASSESS the potential of generic and biosimilar DMTs to reduce the financial burden associated with MS.
• COMPARE the FDA approval process for generic, non-biological complex drugs and biosimilar agents as it relates to MS DMTs.
• EVALUATE data regarding therapeutic equivalence of approved and investigational generic and biosimilar DMTs.
• IMPLEMENT pharmacist-driven strategies to improving access to MS DMTs and reduce healthcare costs.

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 application-based activity will provide a statement for 1.5 contact hours of credit (1.5 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: 0064-0000-17-210-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 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

Published: August 31, 2017
Expires: August 31, 2018

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

Kavita V. Nair, PhD (Chair)
Professor
Center for Pharmaceutical Outcomes Research
Skaggs School of Pharmacy and Pharmaceutical Sciences
University of Colorado Anschutz Medical Campus
Aurora, Colorado
Dr Nair reports receiving grants/research support from Biogen, Genentech Inc, Gilead Sciences Inc, and Novartis AG.

Daniel Kantor, MD, FAAN
Kantor Neurology
President Emeritus
Florida Society of Neurology
Coconut Creek, Florida
Dr Kantor reports serving as a consultant for Bayer, Biogen, EMD Serono Inc, Genzyme, Novartis AG, Sandoz Inc, and Teva; and serving on a speakers' bureau for Avanir Pharmaceuticals Inc, Biogen, EMD Sorono Inc, Gezyme, Novartis AG, and Otsuka..

OFF-LABEL PRODUCT DISCUSSION

In accordance with ACPE Criteria for Quality, the participant is advised that discussions in this CPE activity do not include reference(s) to unlabeled, unapproved, or investigational uses of therapeutic agents, or biomedical devices.

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 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 archived webcast with synced slides and audio, 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

• Preassessment

• Activity Overview and Goals
  Kavita V. Nair, PhD
     
• Overview of DMTs
  Daniel Kantor, MD, FAAN
     
• Considerations for FDA Approval of MS Generics and Biosimilars
  Kavita V. Nair, PhD
     
• Approved Generic DMTs: GA
  Daniel Kantor, MD, FAAN, and Kavita V. Nair, PhD
     
• Investigational Generic and Biosimilar DMTs in MS
  Daniel Kantor, MD, FAAN
     
• Pharmacist-Driven Strategies to Overcome Barriers to DMT Access
  Kavita V. Nair, PhD
     
• Discussion of Clinical Pearls and Conclusions
  Daniel Kantor, MD, FAAN, and Kavita V. Nair, PhD
     
• Postassessment

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.