June 15, 2013 | Expiration date:
June 15, 2014
Estimated time to complete activity:
Type of Activity:
Knowledge | Medium:
This activity is supported by an educational grant from ViroPharma Incorporated.
Medical directors, pharmacy directors, specialty pharmacists, and other managed care professionals who oversee the care of patients with hereditary angioedema.
Statement of Educational Need
Characterized by recurrent episodes of extravascular fluid accumulation and swelling of the extremities, abdomen, or larynx, hereditary angioedema (HAE) is a rare autosomal dominant disorder resulting from C1 inhibitor deficiency. While laryngeal involvement is less common, findings indicate that over 50% of affected patients experience at least 1 episode during their lifetime, potentially resulting in asphyxiation and death. HAE is a chronic disease that typically presents early in life. However, because the condition is uncommon and symptoms closely resemble other ailments (eg, allergic reactions, gastrointestinal tract obstructions), diagnostic delays may exceed 10 years.
Appropriate disease management may minimize morbidity and mortality, reduce emergency department visits, improve quality of life, and enable patients to work. Management generally encompasses treatment of acute episodes and prophylactic therapy to prevent exacerbations and reduce the frequency and severity of recurrent attacks. One major managed care issue related to treatment of HAE is third-party reimbursement for the newer, disease-specific therapies. Many of these newer agents have not yet been added to formularies, and as such, claims are automatically rejected, or are associated with high copays. As a result, patients may be treated with older, less expensive therapies (eg, androgens), and beyond their associated adverse effects, these agents are not optimally effective in preventing breakthrough attacks. To provide greater access to newer therapies, it is vital to develop an infrastructure that provides patients with copay assistance.
This activity provides an overview of the clinical presentation and diagnostic criteria of HAE, and examines the managed care implications of HAE, including direct and indirect costs, resource utilization, and reimbursement issues. The discussion also centers on conventionally used versus recently approved medications, and addresses selection of candidates who qualify for Cinryze therapy.
Upon completion of the educational activity, the participant should be able to:
Review the clinical presentation of HAE and review diagnostic criteria
Compare and contrast conventionally used versus recently approved medications, and discuss the safety, efficacy, and place in therapy of each
Select candidates who qualify for Cinryze therapy and discuss appropriate training techniques
Examine managed care implications of HAE, including direct and indirect costs, resource utilization, and reimbursement issues
This activity is free of charge for physician participants requesting AMA PRA Category 1 Credit™.
The activity is free for participants submitting evaluation forms and posttests online for pharmacy credit. For participants submitting their posttests/evaluation forms and requests for credit via fax or mail, there is a nominal fee of $10.00.
According to the disclosure policies of the Physicians’ Education Resource, LLC (PER), and Pharmacy Times Office of Continuing Professional Education, all persons who are in a position to control content are required to disclose any relevant financial relationships with commercial interests. If a conflict is identified, it is the responsibility of the PER and Pharmacy Times Office of Continuing Professional Education to initiate a mechanism to resolve the conflict(s). The existence of these relationships is not viewed as implying bias or decreasing the value of the activity. All educational materials are reviewed for fair balance, scientific objectivity of studies reported, and levels of evidence.
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Physicians’ Education Resource and the Pharmacy Times Office of Continuing Professional Education. Physicians’ Education Resource is accredited by the ACCME to provide continuing medical education for physicians.
Physicians’ Education Resource designates this enduring material for a maximum of 2.5 AMA PRA Category 1
Credits™. Physicians should claim only the credit commensurate with the extent of their participation
in the activity.
Pharmacy Times Office of Continuing Professional Education is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity is approved for 2.5 contact hours (.25 CEUs) under the ACPE universal activity number 0290-9999-13-136-H01-P. The activity is available for CE credit through June 15, 2014.
Participants must read each article in this supplement, complete the posttest achieving a passing score of 70% or higher, and complete an evaluation and request for credit. Detailed instructions on obtaining a CME certificate (physicians) or statement of credit (pharmacists) are included on the evaluation/posttest page contained in this supplement.
Off-Label Disclosure and Disclaimer
The contents of this CME/CE supplement may include information regarding the use of products that may be inconsistent with or outside the approved labeling for these products in the United States. Physicians and pharmacists should note that the use of these products outside current approved labeling is considered experimental and are advised to consult prescribing information for these products.
For additional information about approved uses, including approved indications, contraindications, and warnings, participants are advised to consult prescribing information for all products discussed. The information provided in this CME/CE activity is for continuing medical and pharmacy education purposes only and is not meant to substitute for the independent medical or pharmacy judgment of a physician or pharmacist relative to diagnostic, treatment, or management options for a specific patient’s medical condition.
The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of The American Journal of Managed Care, Physicians’ Education Resource®, LLC, the Pharmacy Times Office of Continuing Professional Education, or any of the companies that provided commercial support for this CME/CE activity.
William J. Cardarelli, PharmD
Director of Pharmacy Revenue and Supply
Harvard Vanguard Medical Associates
William R. Lumry, MD
Clinical Professor of Internal Medicine/Allergy
University of Texas Southwestern Medical School
Medical Director, AARA Research Center
Contributing Editorial Support
Roderick A. Smith, MS
Medical-Science Communications Expert
These faculty have disclosed the following relevant commercial financial relationships or affiliations in the past 12 months.
William J. Cardarelli, PharmD, has no relevant financial relationships with commercial interests to disclose.
William R. Lumry, MD
Consultant: Biocryst, CSL Behring, Shire Human Genetic Therapies, ViroPharma Incorporated
Grants: CSL Behring, Dyax, Shire Human Genetic Therapies, ViroPharma Incorporated
Speakers’ Bureau: CSL Behring, Dyax, Shire Human Genetic Therapies, ViroPharma Incorporated
Roderick A. Smith, MS, has no relevant financial relationships with commercial interests to disclose.
The American Journal of Managed Care
Publishing Staff—Jeff D. Prescott, PharmD, RPh; Kara Guarini, MS; and Ida Delmendo have no relevant financial relationships with commercial interests to disclose.
PER and Pharmacy Times Office of Continuing Professional Education
Planning Staff—Judy V. Lum, MPA; and Elena Beyzarov, PharmD, and Ann C. Lichti, CCMEP, have no relevant financial relationships with commercial interests to disclose.
Signed disclosures are on file at the office of The American Journal of Managed Care
, Plainsboro, New Jersey.
Opinions expressed by authors, contributors, and advertisers are their own and not necessarily those of Clinical Care Targeted Communications, LLC, d/b/a Managed Care & Healthcare Communications, LLC, the editorial staff, or any member of the editorial advisory board. Clinical Care Targeted Communications, LLC, d/b/a Managed Care & Healthcare Communications, LLC, is not responsible for accuracy of dosages given in articles printed herein. The appearance of advertisements in this publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality, or safety. Clinical Care Targeted Communications, LLC, d/b/a Managed Care & Healthcare Communications, LLC, disclaims responsibility for any injury to persons or property resulting from any ideas or products referred to in the articles or advertisements.
Publisher’s Note: The opinions expressed in this supplement are those of the authors, presenters, and/or panelists and are not attributable to the sponsor or the publisher, editor, or editorial board of The American Journal of Managed Care. Clinical judgment must guide each professional in weighing the benefits of treatment against the risk of toxicity. Dosages, indications, and methods of use for products referred to in this supplement are not necessarily the same as indicated in the package insert for the product and may reflect the clinical experience of the authors, presenters, and/or panelists or may be derived from the professional literature or other clinical sources. Consult complete prescribing information before administering.
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