CME: Biosimilars in the treatment of malignancies and supportive care
ACCREDITATION EXPIRED: May 13, 2023
Activity Description / Statement of Need:
In this online, self-learning activity:
Biosimilar drugs are products meant to be similar in quality, safety, and efficacy to an already licensed reference biotherapeutic product. Whereas generics are virtually identical replicas of conventional medications, biosimilars are not the same as the original product – a practically unavoidable outcome because of the considerably large molecular structure that biologics mimic. The literature suggests that learning activities focused on the evolving landscape of biosimilars, which are germane to the therapeutic area because of their potential role in cost containment. Both the FDA and medical literature independently affirm the need for clinician education on biosimilars, including: Comparative efficacy; adverse event rates and management (potential concerns have included immunogenicity); regulatory guidance on interchangeability and substitution – including prescribers retaining some degree of ability to intervene in a product’s substitution at the dispensing stage; and cost considerations.
Given the rapid expansion of these product types and the presence of gaps in the area of hematologic malignancies and oncologic and supportive care therapies, this activity has been designed to bring HCPs’ knowledge of biosimilar products in those areas up to date and to improve their competence and performance in employing them in practice.
Target Audience:
The following healthcare professionals: Hematologist-oncologists and medical oncologists; physician assistants, nurse practitioners, and pharmacists who practice in oncology; and any other healthcare professionals with an interest in or who clinically encounter patients with hematologic malignancy or oncologic disease states who may receive treatment with biosimilars.
Commercial Support Disclosure: This program is supported by educational grants from AMGEN and Coherus.
This activity is free of charge.
Release Date: May 13, 2021 -- Expiration Date: May 13, 2023
Faculty: Elizabeta Popa, MD
Agenda
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Introduction, disclosures |
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A primer on biopharmaceuticals vs. reference medications [Learning Objective No.1] • Characteristic differences in reference medications vs. biologics: molecular-level differences, composition, method of preparation • Definitions: biologic, biosimilar, and interchangeability The regulatory landscape [Learning Objective No. 1] • FDA regulation, action, and draft guidance • State laws Cost considerations [Learning Objective No. 2] |
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The present landscape of treatments for malignancies and related, supportive care [Learning Objectives No. 3] • Biosimilar agents approved for the following conditions and related literature review: malignancies and supportive care (e.g., colony stimulating factors, hematopoietic agents) • Efficacy • Safety • Immunogenicity • Patient education: how to discuss biosimilar concepts and options with patients • Patient case(s) |
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Barriers to adoption a strengthened patient-HCP relationship to avoid the nocebo effect [Learning Objective No. 4] • Contributing factors to barriers, including the “nocebo effect” • Strategies to avoid / ameliorate the nocebo effect when converting to biosimilars • Share decision-making • Clearly informing patients about the reasons for the switch • Providing ‘soft skills’ staff training to address patient concerns • Openly discussing possible nocebo effects • Comprehensive patient education and support, including: • Face-to-face discussions • Provision of patient information sheets on biosimilar switch • Access to a helpline number • Regular clinical reviews |
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• Future considerations • Summary, conclusion, and recap |
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Learning Objectives
By the end of the session the participant will be able to:
- List the differences between biosimilars and reference medications with respect to what the regulatory steps are for their approval in the U.S.
- Recall ways in which biosimilars may reduce healthcare costs in the treatment of malignancies and supportive care.
- Describe the evidence, including real world data, behind the substitution of a biosimilar medication for its reference medication in malignancies and supportive care, and apply that information to patient case(s).
- Describe barriers to the adoption of biosimilars for malignancies and supportive care and how they may be addressed by employing shared decision making with patients.
Accreditation
ACCME Activity #201748770
ACCREDITATION FOR THIS COURSE HAS EXPIRED. YOU MAY VIEW THE PROGRAM, BUT CME / CE IS NO LONGER AVAILABLE AND NO CERTIFICATE WILL BE ISSUED.
Faculty Disclosure and Resolution of COI
As a provider of continuing medical education, it is the policy of ScientiaCME to ensure balance, independence, objectivity, and scientific rigor in all of its educational activities. In accordance with this policy, faculty and educational planners must disclose any significant relationships with commercial interests whose products or devices may be mentioned in faculty presentations, and any relationships with the commercial supporter of the activity. The intent of this disclosure is to provide the intended audience with information on which they can make their own judgments. Additionally, in the event a conflict of interest (COI) does exist, it is the policy of ScientiaCME to ensure that the COI is resolved in order to ensure the integrity of the CME activity. For this CME activity, any COI has been resolved thru content review ScientiaCME.
Faculty Disclosure: Elizabeta Cristina Popa, MD, Associate Professor of Clinical Medicine, Weill Cornell Medical College, has no relevant financial disclosures.
Disclosures of Educational Planners: Charles Turck, PharmD, BCPS, BCCCP, President of ScientiaCME, has no relevant financial disclosures.
Commercial Support Disclosure: This program is supported by educational grants from AMGEN and Coherus.
Instructions
- Read the learning objectives above
- Take the Pre-Test (optional). Completion of the pre-test will help us evaluate the knowledge gained by participating in this CME activity.
- View the online activity. You may view this is in more than one session, and may pause or repeat any portion of the presentation if you need to.
- Minimum participation threshold: Take the post-test. A score of 70% or higher is required to pass and proceed to the activity evaluation.
- Complete the activity evaluation and CME registration. A CE certificate will be emailed to you immediately.
System Requirements
Windows 7 or above
Internet Explorer 8
*Adobe Acrobat Reader
Mac OS 10.2.8
Safari or Chrome or Firefox
*Adobe Acrobat Reader
Internet Explorer is not supported on the Macintosh
*Required to view Printable PDF Version
Please take a few minutes to participate in the optional pre-test. It will help us measure the knowledge gained by participating in this activity.
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