Bayer Hematology Medical Affairs Department is interested in receiving and reviewing Grant Applications to support appropriate programs as described below.

Therapeutic Areas/Disease States:

Hemophilia

Intended Audience:

• Physicians (Hematologists / Hemophilia Specialists)
• Nurses
• Pharmacists
• Other Hemophilia Treatment Center Team Members
• Patients / Caregivers
• Managed Care

Bayer Hematology Rationale for Educational Support:

Areas of interest based on referenced literature:

• Pharmacokinetics of FVIII
• Emerging therapies for hemophilia A
• Recombinant FVIII foundational treatments for hemophilia A
• Extended Half-Life FVIII replacement therapy products
• Monitoring of Extended Half-Life FVIII Products

Accredited Proposal Requirements:

The proposal must be compliant with standards and guidelines for commercial support (e.g., ACCME).

The proposal should include:

• Needs assessment
• Educational design and rationale for selection
• Learning Objectives
• Proposed Faculty
• Participant Recruitment Plan
• Outcomes Strategy/plan
• Definition of Successful Program
• Detailed Budget (must use the template available on the website)

Provider Justification:

1. Copy of most recent accreditation letter and status
2. Samples of other programs in similar therapeutic areas [O]

Process

Applications/proposals which are submitted and determined to be complete are reviewed monthly.

Acceptance of a Bayer educational grant indicates that you will:

• Reconcile grant funding within 60 days of completion of the educational program
• Permit a Bayer Medical Affairs representative to audit live programs of at least $5000 (Bayer Compliance staff may also audit live programs and/or review the use of the grant)
• Share activity data and outcomes metrics within 30 days of their availability

Literature/Data Referenced

1. Bullinger M, Globe D, Wasserman J, Young NL, von Mackensen S. Challenges of Patient-Reported Outcome Assessment in Hemophilia Care-a State of the Art Review. Value Health. 2009; 12:809-820.
2. DiMichele DM, Hoots WK, Pipe SW, Rivard GE, Santagostino E. International workshop on immune tolerance induction: consensus recommendations. Haemophilia. 2007 Jul;13 Suppl 1:1-22.
3. Geraghty S, Dunkley T, Harrington C, et al. Practice patterns in haemophilia A therapy– global progress towards optimal care. Haemophilia. 2006;12:75-81.
4. Hacker MR, Geraghty S, Manco-Johnson M. Barriers to compliance with prophylaxis therapy in haemophilia.Haemophilia. 2001;7:392-396.
5. Konkle BA, Kessler C, Aledort L, et al. Emerging clinical concerns in the ageing haemophilia patients. Haemophilia. 2009;15:1127-1209.
6. Manco-Johnson MJ, Abshire T, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357:535- 544.
7. National Hemophilia Foundation. MASAC recommendations concerning prophylaxis. MASAC Document #179. Accessed at: . http://www.hemophilia.org/NHFWeb/Resource/ StaticPages/menu0/menu5/menu57/masac.179.pdf. January 2012.
8. Shapiro A. Why is primary prophylaxis underutilized in the United States? Haemophilia.2003;9:670-672.
9. Scharrer I, Bray GL, Neutzling O. Incidence of inhibitors in haemophilia A patients- a review of recent studies of recombinant and plasma-derived factor VIII concentrates. Haemophilia. 1999;5:145-154.
10. Scharrer I, Bray GL, Neutzling O. Incidence of inhibitors in haemophilia A patients- a review of recent studies of recombinant and plasma-derived factor VIII concentrates. Haemophilia. 1999;5:145-154.
11. Scharrer I, Ehrlich HJ. Lack of evidence for increased inhibitor incidence in patients switched from plasma-derrived to recombinant factor VIII, Haemophilia. 2001;7:346-348.
12. Thornburg CD, Pipe SW. Adherence to prophylactic infusions of factor VIII or factor IX for haemophilia. Haemophilia. 2006;12:198-199.