Statement of Need

In order to prevent and treat bleeding in patients with hemophilia A, the activity of the replaced clotting factor VIII must reach or exceed a target level over a period of time. Pharmacokinetic (PK) measures are therefore used to determine the dosing regimen of the different factor VIII replacement products. Recently, extended half-life recombinant factor VIII products with improved PK profiles have been approved and these reduce treatment burden and improve treatment adherence.

In this CME Outfitters live and on-demand webcast, renowned hematologists will discuss the clinical significance of the results of the head-to-head comparison study of PK profiles of extended half-life factor VIII products including the application of population PK models and shared decision-making to provide personalized hemophilia A therapy.

Learning Objectives

At the end of this CE activity, participants should be able to:

• Summarize the comparative PK data and the clinical significance of popPK studies on factor VIII replacement therapies.
• Apply popPK models to determine individualized dosing regiments for patients with hemophilia A.
• Integrate approaches for SDM to develop patient-centered, PK-based treatment plans for patients with hemophilia A.

The following learning objectives pertain only to those requesting CNE or CPE credit:

• Summarize the comparative PK data and the clinical significance of popPK studies on factor VIII replacement therapies.
• Explain popPK models that can determine individualized dosing regimens for patients with hemophilia A.
• Describe approaches for SDM to develop patient-centered, PK-based treatment plans for patients with hemophilia A.

Financial Support

Supported by an educational grant from Bayer HealthCare Pharmaceuticals Inc.

Target Audience

Hematologists, physician assistants, nurse practitioners, nurses, and clinical pharmacists.

Credit Information

CME Credit (Physicians):
CME Outfitters, LLC, is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CME Outfitters, LLC, designates this live activity for a maximum of 1.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CNE Credit (Nurses):
Provider approved by the California Board of Registered Nursing, Provider Number CEP 15510, for 1.5 contact hours.

Note to Nurse Practitioners: Nurse Practitioners can apply for AMA PRA Category 1 Credit™through the American Academy of Nurse Practitioners (AANP). AANP will accept AMA PRA Category 1 Credit™ from organizations accredited by the Accreditation Council for Continuing Medical Education. Nurse practitioners can also apply for credit through their state boards.

CPE Credit (Pharmacists):
CME Outfitters, LLC, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. 1.5 contact hours (0.15 CEUs) Universal Activity Number:
Live: 0376-0000-20-002-L01-P
Enduring: 0376-0000-20-002-H01-P

Type: Knowledge-based

ABIM MOC Credit:
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.5 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Learning Formats
Live activity
Enduring material

MIPS Improvement Activity: This activity counts towards MIPS Improvement Activity requirements under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Clinicians should submit their improvement activities by attestation via the CMS Quality Payment Program website.

Note to Physician Assistants: AAPA accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credit^TM from organizations accredited by the Accreditation Council for Continuing Medical Education.

Royal College MOC:
Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners in the Royal College MOC Program may record completion of accredited activities registered under the ACCME's "CME in Support of MOC" program in Section 3 of the Royal College's MOC Program.

Post-tests, credit request forms, and activity evaluations must be completed online (requires free account activation), and participants can print their certificate or statement of credit immediately (75% pass rate required). This website supports all browsers except Internet Explorer for Mac. For complete technical requirements and privacy policy, visit https://www.cmeoutfitters.com/privacy-and-confidentiality-policy

Disclosure Declaration

It is the policy of CME Outfitters, LLC, to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CE activities. Faculty must disclose to the participants any relationships with commercial companies whose products or devices may be mentioned in faculty presentations, or with the commercial supporter of this CE activity. CME Outfitters, LLC, has evaluated, identified, and attempted to resolve any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that these relationships will have a negative impact on the presentations.

Dr. Iorio’s reports his institution, McMaster University, has received project-based funding via research or service agreements from Bayer Inc.; Novo Nordisk; Octapharma; Pfizer Inc.; F. Hoffmann-La Roche Ltd; and Takeda Pharmaceutical Company Limited.

Evan Luberger (planning committee) has no disclosures to report.

Kavitha Ramanchandran, PhD (planning committee) has no disclosures to report. 

Jan Perez (planning committee) has no disclosures to report.

Sharon Tordoff (planning committee) has no disclosures to report.

Disclosures were obtained from the CME Outfitters, LLC staff: No disclosures to report.

Faculty of this CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational uses (any uses not approved by the FDA) of products or devices.

Questions about this activity? Call us at 877.CME.PROS(877.263.7767).