Biologic medicines have become increasingly important for the medical care of patients, with 22% of drugs approved by the US Food and Drug Administration (FDA) between 2010 and 2015 classified as biologics. Biologic agents have been linked with 28% of prescription spending despite contributing to less than 1% of all prescriptions in the United States.1 Therefore, an important need to reduce medication costs in an attempt to manage healthcare resources has come to the forefront. The education of healthcare providers including physicians and nurse is crucial to assisting patients in the shared decision process when integrating biosimilars into clinical practice.
This educational initiative is directed toward hematologists/oncologists, critical care specialists, primary care physicians, nurse navigators, clinical trial coordinators and nurse educators dealing with oncology patients.
Upon completion of the activity, participants should be able to:
- Summarize the basic steps involved in the approval of biosimilars.
- Describe when biosimilar indications may be extrapolated.
- Illustrate steps that clinicians can take to better inform and include patients in the shared decision-making process surrounding the potential use of biosimilars.
- Discuss the role of nurses and patient navigation in the implementation of biosimilars.
|Gary H. Lyman, MD, MPH, FASCO, FACP, FRCP Professor of Medicine, Public Health and Pharmacy University of Washington Senior Lead, Healthcare Quality and Policy Hutchinson Institute for Cancer Outcomes Research Fred Hutchinson Cancer Research Center Seattle, Washington||Consultant Chairperson Research Grant||Agendia, Amgen, Genomic Health, Halozyme, Mylan, Partners Healthcare, Pfizer, Samsung Bioepis, Spectrum Task Force on Biosimilars in Oncology, American Society of Clinical Oncology Amgen Inc.|
|Dorothy Caputo, MA, BSN, RN – CE Director of Accreditations||N/A||Nothing to disclose|
|AKH, Inc., Center of Excellence Media LLC and CME University Planners and Reviewers||N/A||Nothing to disclose|
Method of Participation
In order to receive credit, participants should read the entire monograph, complete and submit an evaluation and score at least 70% on the self-assessment test. AKH Inc. allows for one (1) re-test at no additional charge; additional re-tests must be purchased again at the full cost. Certificates will be available in the transcripts upon successful completion of the self-assessment test. If you have questions about this CME/CE activity, please contact AKH Inc. at [email protected].
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AKH Inc., Advancing Knowledge in Healthcare and CE University. AKH Inc., Advancing Knowledge in Healthcare is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
AKH Inc., Advancing Knowledge in Healthcare designates this enduring activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
NCCPA accepts AMA PRA Category 1 Credit™ from organizations accredited by ACCME.
AKH, Inc., Advancing Knowledge in Healthcare is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.
This activity is awarded 0.5 Contact Hours.
This activity is jointly-provided by AKH Inc., Advancing Knowledge in Healthcare and CE University.
There is no commercial support for this activity
It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The author must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are resolved by AKH prior to accreditation of the activity and may include any of or combination of the following: attestation to non-commercial content; notification of independent and certified CME/CE expectations; referral to National Author Initiative training; restriction of topic area or content; restriction to discussion of science only; amendment of content to eliminate discussion of device or technique; use of other author for discussion of recommendations; independent review against criteria ensuring evidence support recommendation; moderator review; and peer review.
Disclosure of Unlabeled Use and Investigational Product
This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant’s misunderstanding of the content.