Bayer: Science For A Better Life

United States of America

HEME CFG - 1

Therapeutic Areas/Disease States:  Hemophilia

Budget: $125,000 or less

Intended Audience:

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

Bayer Hematology Rationale for Educational Support:

Areas of interest based on referenced literature:

  • Pharmacokinetic studies using patient cross-over designs to compare rFVIII products

Accredited Proposal Requirements:

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

All supporting documents should be in PDF format and 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

Provider Justification:

1. Copy of most recent accreditation letter and status

2. Samples of other programs in similar therapeutic areas

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.