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Attention Pharmacists and Pharmacy Techs: Click to access CPE Monitor and latest CE information More Information

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This activity will cover key topics of interest to stakeholders who set practice policy and will be called upon to evaluate and make decisions on issues pertaining to biosimilars.

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Managed Care Biosimilars Update: 2017 Policy Initiatives and Formulary Impact

Activity Downloads

To Participate

To participate in this continuing education activity:

  1. Review the activity description and objectives.
  2. View the activity.
  3. Complete the online post-test and activity evaluation.

NOTE: If you attended the live CE webinars titled "Managed Care Biosimilars Update: 2017 Policy Initiatives and Formulary Impact" that were held on February 8, 15, 16, 2017, AND received CE credit (i.e. a pharmacist CE statement with ACPE Universal Activity Number 0221-0000-17-036-L04-P), you are NOT eligible to also receive CE credit for this home-study activity.

Description

New developments in biosimilars pose ongoing challenges for prescribers and pharmacists responsible for developing related formulary strategies and require that they stay abreast of updates to FDA guidance documents, new biosimilar approvals, data from post-approval studies, decisions regarding naming for biosimilars in the US, and state legislation related to interchangeability/substitution.

This activity will cover key topics of interest to pharmacists, payers, P&T committees, and other stakeholders who set practice policy and will be called upon to evaluate and make decisions on issues pertaining to biosimilars—especially in the second phase of the biosimilars era as the market continues to mature and expand in the U.S.

Learning Objectives

The target audience for this activity is pharmacists. Upon completion of this activity, participants will be able to:

  • Summarize the current status of biosimilar development in the United States, including the FDA approval pathway, FDA guidance documents, and the approval status and pipeline for biosimilars
  • Describe the use of extrapolation/interchangeability in the FDA approval process for biosimilars and their indications, and how this may impact formulary diagnostic criteria and tier placement
  • Recognize how conflicts between state legislative initiatives and FDA guidance may impact managed care policy
  • Identify economic and formulary implications surrounding uptake and use of biosimilar agents in clinical practice
  • List the clinical, legal, and operational implications that institutions must consider when preparing to add biosimilars to formularies

Faculty

Steven G. Avey, MS, RPh, FAMCP
Vice President, Medimpact Direct Specialty Clinical Programs
Medimpact Healthcare Systems, Inc.
San Diego, California

Steven Lucio, PharmD, BCPS
AVP, Clinical Solutions and Pharmacy Program Development
Vizient
Irving, Texas

Accreditation

Release Date: 2-8-2017
Expiration Date: 3-16-2018

Pharmacists

ACPE LogoProCE, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number 0221-0000-17-036-H04-P has been assigned to this home-study knowledge-based activity (initial release date 2-8-2017). This activity is approved for 1.0 contact hour (0.1 CEU) in states that recognize ACPE providers. The activity is provided at no cost to participants. Statements of completion will be issued online at www.ProCE.com upon completion of the evaluation and post-test with a score of 70% or higher. Proof of completion will be posted in NABP CPE Monitor profiles. No partial credit will be given.

Disclosure

It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants any significant financial interest or affiliation with companies that manufacture or market products discussed in this activity. Steven Avey and Steven Lucio have no relevant commercial or financial relationships to disclose.

Please note: The information and views presented in this activity are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include the use of drugs and/or devices for unlabeled indications, which should be considered experimental. Participants are advised to consult manufacturer product information and the professional literature, and use professional judgment in applying the presented information in patient-care activities.

Funding

This activity is supported by an educational grant from Sandoz, a Novartis company.

The material presented in this CE activity does not reflect the views of ProCE, Inc. or the commercial sponsor. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

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