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
  • Within the last years, many new standard half-life (SHL) and extended half-life (EHL) rFVIII products have entered the market; this includes some products from both that have experienced molecular alterations to change their PK characteristics, potentially resulting in less frequent prophylactic infusions. With large product variability between and within patients, PK parameters of these rFVIII products should not be compared across studies due to different patient populations, assays and statistical analyses used in those clinical trials.
    In order to keep the variability between products and their PK parameters constant, EMA, FDA and ISTH recommend studying new rFVIII products with a similar existing product within the same individual, leveraging the patient as their own control. The resulting data can then be used to calculate ratios of PK parameters such as half-life, AUC and clearance to provide a valid comparison across different rFVIII products. This information can lead to a better understanding of the potential benefits and limitations of new SHL and EHL 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.