Hemophilia HCP Areas of Interest- Cycle C

Hemophilia HCP Areas of Interest- Cycle C
Biogen Idec| Medical Affairs| Grants Office
Cycle C: Please reference the following cycle code on your grant application/proposal: HEMHCP C-2014
Open Date: June 2, 2014
Close Date: September 19, 2014
Activity Start Date: Cycle C-2014 is for grants with start dates on or after November 30, 2014
Submission Deadline: 5:00pm Friday, September 19, 2014
Contact
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Name:
Title:
Phone:
Email:
Dorian Readnour
Director
617-914-1299
[email protected]
EDUCATIONAL GAP
Hemophilia A and B are rare bleeding disorders caused by a lack of clotting factor VIII (hemophilia A) or a lack of clotting
factor IX (hemophilia B) in circulation. Insufficient levels of clotting factor can make it difficult or impossible for blood to
clot. People with hemophilia A or B do not bleed harder or faster than a person without hemophilia A or B—they bleed
longer.
Hemophilia A and B are genetic conditions; they are lifelong and present from birth. Both forms of hemophilia are
inherited disorders that affect mostly males. However, in about 30% of cases, there is no family history of hemophilia
and the condition is likely the result of a spontaneous mutation of a gene. 1 The genetic mutation negatively affects the
clotting factor, either in quantity or quality. 1 Approximately 1 in 5,000 males are born with hemophilia A, and
approximately 1 in 25,000 males are born with hemophilia B.1
Hemophilia A and B are classified into 3 categories: mild, moderate, and severe. Each category is determined by the
specific level of clotting factor VIII/factor IX a person has in circulation. 1, 2
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People with mild hemophilia A/B have >5% to <40% of normal clotting factor in circulation
People with moderate hemophilia A/B have 1% to 5% of normal clotting factor in circulation
People with severe hemophilia A/B have <1% of normal clotting factor in circulation
In addition to bleeding following an injury, people with severe hemophilia A/B may have frequent spontaneous bleeding
episodes, often into their joints and muscles, which can cause long‐term damage. 1, 3
In a recent independent study 4 of practicing hematologists and nurses in the US who manage patients with Hemophilia
it was discovered that:
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Almost half of hematologists (47%) would not change the clotting factor regimen for a patient with
hemophilia B who is experiencing weekly joint bleeding episodes.
Almost a quarter (23%) did not select "decreased frequency of clinically apparent soft tissue damage
compared with an on demand regimen" as a clinical benefit of primary prophylaxis.
For a non‐adherence, physically active teen with severe hemophilia A who has experienced bilateral ankle
pain for several years, 39% of hematologists did not select "symptomatic joint pain in ankles, signifying
progressive degenerative changes" and 23% did not select “data showing the superiority of prophylaxis for
preventing joint damage, compared with an enhanced episodic regimen” when asked “Which of the
following factors will most influence your selection of clotting factor concentrate replacement at this
juncture?” For a patient with severe hemophilia B experiencing knee bleeds every 2‐3 weeks while on an on‐
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demand regimen, 47% of hematologists did not select "increasing frequency of bleeding episodes (once
every week)" as a prompt to change regimens.
Most hematologists do not include annualized bleed rates at each visit (61%) or clinical scales i.e. QOL, ADL
assessment (59%) for assessing efficacy of on‐demand regimens for patients repeated bleeding episodes in 1
or more joints.
Less than half of hematologists were very familiar with albumin‐fused recombinant clotting factors,
PEGylated recombinant clotting factors, Fc fusion recombinant clotting factors, tissue factor pathway
inhibitor (TFPI) antagonists, single chain recombinant FVIII, and gene therapy.
When asked which approaches they would include to facilitate adherence with a 4‐year‐old patient with
severe hemophilia, 32% of hematology nurses did not include "nursing education in the hemophilia clinic on
infusion technique".
Over three‐quarters of hematology nurses consider "patient/parental lack of adherence to prescribed
prophylaxis regimens" to be a very significant barrier to the optimal management of patients with
hemophilia.
ELIGIBILITY CRITERIA FOR PROPOSALS
The Biogen Idec Grants Office is seeking proposals that are aimed at addressing the independently identified educational
needs of the hemophilia healthcare professional (HCP) community, referenced above and summarized as follows:
All HCPs:
1. The various treatment regimens (prophylaxis vs. on demand) and their correlation with clinical outcomes
such as frequent bleeding episodes or annualized bleed rates and tools for measuring joint damage
progression.
2. The importance of joint pain as a sign of progressive degenerative joint changes.
3. The latest trial data on emerging therapies.
Nurse specific:
1. Tools and techniques to educate patients on the risks and benefits of hemophilia treatments.
2. Best practices for achieving or improving patient adherence to prescribed treatment regimens (coaching,
peer‐to‐peer, mentoring).
3. Communication tactics in educating patients, caregivers and/or HCP peers on the basics of treatment; how
they work in the body and ways to assess their effectiveness including monitoring options.
The Biogen Idec Grants Office supports independently developed educational programming designed to address
knowledge and performance practice gaps (levels 3‐64) of the healthcare professional community, ultimately directed at
enhancing patient care and community health. Special consideration will be given to multi‐component initiatives that
offer scientifically rigorous formats, unique delivery methods, and incorporate adult learning principles (for example,
interactive interventions that reinforce the relevance of the presented content to real‐world practice through case
scenarios).
2015 NATIONAL/REGIONAL CONGRESSES
We acknowledge the value physicians, nurses, and other healthcare professionals place on professional meetings, as
they provide them with the opportunity to stay up to date on advancements in clinical practice, specifically within their
specialty. Therefore, we are seeking requests to fund live activities (face‐to‐face meetings) at major national/regional
conferences and congresses related to hemophilia, such as ASH (American Society of Hematology), HTRS (Hemostasis
and Thrombosis Research Society), ISTH (International Society on Thrombosis and Haemostasis), and others.
As noted above, preference is given to multi‐component initiatives (for example, live activity with enduring spin‐off).
NOTE
Consistent with Biogen Idec policy and our commitment to conduct business ethically, all proposals for continuing
medical education programs and initiatives must comply with ACCME criteria and Standards for Commercial Support™
as well as the AMA, PhRMA Code, FDA, and OIG guidance’s.
In addition:
 Proposals must be fair, balanced, and scientifically sound;
 Data must be objectively selected;
 Content must be independently developed;
 Biogen Idec will not provide input relating to content, presenters, moderators, or program format; and
 Biogen Idec will not support proposals that are linked to prescribing, purchasing, formulary status, or
reimbursement activities.
References:
Roberts HR, Key NS, Escobar MA. Chapter 124. Hemophilia A and Hemophilia B. In: Prchal JT, Kaushansky K, Lichtman MA, Kipps TJ, Seligsohn U, eds. Williams Hematology. 8th
ed. New York: McGraw‐Hill; 2010. http://www.accessmedicine.com/content.aspx?aID=6117504. Accessed May 11, 2012.
2. White GC, Rosendaal F, Aledort LM, et al; on behalf of the Factor VIII and Factor IX Subcommittee. Definitions in hemophilia: Recommendation of the Scientific Subcommittee
on factor VIII and factor IX of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Thromb Haemost. 2001;85:560.
3. Berntorp E. Joint outcomes in patients with haemophilia: the importance of adherence to preventive regimens. Haemophilia. 2009;15:1219‐1227.
4. Source: CE Outcomes Needs Assessment Data. Collected February 2013.
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