Our mission since 1952 has been to provide information, education, advocacy and direct assistance to persons with hemophilia and a related bleeding disorder, and to encourage and support scientific research to improve medical treatments and to seek cures for those conditions.
We serve persons within the 14 southeastern counties of New York State (New York City, Long Island, Dutchess, Orange, Putnam, Rockland, Sullivan, Ulster and Westchester.
The Association is an organization of and for persons with bleeding disorders and their families helping each other. Be a Part of Our Community .... Read more
REQUEST FOR PROPOSALS FOR STRATEGIC AND BUSINESS PLANNING CONSULTANT SERVICES
The Hemophilia Association of New York & Biogen Idec Hemophilia
Cordially Invites You to Attend an Educational Program FeaturingLee Hall,Community Relations Manager Topic:Understanding the Value of Genotyping For more information click here
PSI PROGRAMS ASSISTANCE FOR BLEEDING DISORDERS
In the PSI spring newsletter Dr. Dana Kuhn, PSI President, mentioned that for the past three years, PSI has been researching, surveying, and working collaboratively with pharmaceutical companies to ascertain the need for copayment assistance among the bleeding disorders community. The justification for many of the oncology and lysosomal storage conditions clearly support the need for copayment assistance as many patients have high deductibles, coinsurance, and copayments. If this were true for these conditions, why wouldn’t it be true for the bleeding disorders community? Our surveys revealed that the bleeding disorders community was having challenges affording their deductibles, coinsurances, and premiums. Thus, PSI convinced a number of companies to develop programs with us to confirm the need. Our current copayment assistance programs have proven to be successful and we continue to accept new applications. If eligible for one of the programs outlined below, financial support may be provided for up to 12 months!
by Mandy Herbert
Director of Marketing and Public Relations
Hemophilia Insurance Financial Assistance Program
Key Benefit: Helps patients in need with their out-of-pocket expenses for Baxter hemophilia products. To apply for assistance, visit www.patientservicesinc.org.
Patients are eligible to apply for the program if:
• They meet specific financial criteria for enrollment
• They have mild, moderate, or severe Hemophilia A or have an inhibitor
• They currently have private health insurance
Who is not eligible to apply?
• Residents of Massachusetts are prohibited by law and are not eligible to apply for the program.
• Presently, patients on public insurance including, but not limited to, Medicare, Medicaid, TriCare, DOD, and PCIP, are not eligible to apply.
Bayer copay/coinsurance Assistance Pilot Program
Key Benefit: Funds provided by PSI can (only) be used towards a patient’s copay/coinsurance expenses for Bayer’s product. If eligible, financial assistance may be provided for up to 12 months or as long as funding is available.
This program is available to patients who meet the program criteria including the requirements outlined below.
• They have Hemophilia A
• They meet specific financial criteria for enrollment
• Currently have private health insurance
For inquiries regarding the Bayer Copay/Coinsurance Assistance Pilot Program, please contact Bayer’s Factor Solutions at 1-800-288-8374.
As we transition into 2014, PSI is actively pursuing the expansion of copayment assistance for the bleeding disorders community (public and privately insured patients). We encourage all pharmaceutical companies to develop a copayment assistance program with PSI to assist patients in affording their out-of-pocket expenses for bleeding disorders products. In addition to the copayment programs noted above, PSI also offers premium assistance to patients who have insurance and are diagnosed with moderate to severe Hemophilia, vWD, or an Inhibitor. Each premium assistance program currently offered is outlined below.
Inhibitors in Bleeding Premium Assistance
Key Benefits: If approved for assistance can receive up to $11,000 in premium assistance. Assistance is provided for 2 years. Can apply online via the PSI website.
A person is eligible to apply if they meet the specific program criteria for enrollment outlined below:
• Moderate or severe
• Public or private insurance
• Federal Poverty Level is set at 400%
Bleeding Disorders Premium Assistance (Hemophilia and vWD)
Key Benefits: If approved for assistance can receive up to $11,000 in premium assistance. Assistance is provided for 3 years. Can apply online via the PSI website.
A person is eligible to apply if they meet the specific program criteria for enrollment outlined below:
The majority of manufacturers offer factor assist programs that can hold you over for a specific period of time during an insurance change, or to try their product to see if it works for you. Factor assist programs can be a lifeline for families in the middle of a strict immune tolerance regimen. In addition to factor assist programs, some manufacturers are now providing financial assistance to cover co-pays, out of pockets (OOP), and in some cases premium assistance. Each program has its’ own set of criteria that can be somewhat confusing, so we urge you to visit their websites or call the numbers listed. In this edition of Insurance Corner, we have compiled as much data allowed to keep you up to date on what’s available.
The CARE Program, short for Coverage, Assistance, Resources, Education, sponsors the Bleeding Disorders Legal Information Hotline created and operated by the Lone Star Chapter of NHF.
The CARE and NAVA programs are in addition to their Hemophilia Insurance Financial Assistance Program that provides patients with private health insurance assistance with out of pocket expenses for Baxter products. This program is administered by PSI.
The AlphaNine SD Savings Card Program is designed to help patients taking AlphaNine® SD with their out-of-pocket prescription costs. The program covers up to $500 per month for a total savings of up to $6000 per year. Eligibility rules apply, so please go to www.alphaninecard.com or call 1-855-355-2574 to receive more information and to apply for a card.
Bayer has an umbrella program called Factor Solutions for patients using their factor product.
They provide support with Insurance questions, such as:
• Understanding your plan
• Identifying resources to help with co-pay or OOP expenses
• Dependents’ coverage and,
• How you might get factor when insurance coverage is lost
Factor Assistance Program provides information about maintaining access to treatment if you experience a lapse in insurance coverage.
• PAP-short term assistance program for uninsured patients or who lack third-party coverage
• GAP-short term assistance program for patients who experience a lapse in their private insurance plan coverage
Co-Pay Assistance Program is need based
• Uses a sliding scale based on income
• Eligible members may receive up to $6,000.00 per year
NovoNordisk has an extensive patient assistance program called SevenSECURE® that offers a wide range of support, and is administered by Rx Crossroads. There are specific criteria and considerations for all of the above support programs. You must create an account on the Changing Possibilities site for complete access to the SevenSECURE® program.
Medical Expense Reimbursement
• Dental work and cleaning
• Compression devices
• Physical Therapy• Outpatient medical evaluation and treatment
• Up to three (3) months of non-factor related prescription drug assistance
• Physical activity reimbursement (i.e. Classes, health club membership, fitness equipment)
• Travel reimbursement for medical appointments
• Financial assistance to attend educational meetings
• Appeal denials
• Track caps
• Coverage assistance
• Premium assistance* (administered by PSI)
• Assistance with mobility device expenses not covered by insurance
• Scholarships: Professor Ulla Hedner Scholarship up to $7,000.00 for HS senior, college or vocational students
Gilead Submits Fixed-dose Combination Ledipasvir/Sofosbuvir HCV Tablet for FDA Approval
A new drug application has been submitted to the FDA by Gilead Sciences for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (90 mg) and the nucleotide analog polymerase inhibitor sofosbuvir (400 mg) for treating chronic hepatitis C genotype 1 infections in adults.
“Today’s filing brings us one step closer to our goal of offering all patients with hepatitis C a simple, safe and highly effective all-oral treatment regimen,” Norbert Bischofberger, PhD, Gilead Sciences executive vice president of research and development and chief scientific officer, said in a statement. “Based on the data from the Phase 3 ION studies, the [ledispasvir/sofosbuvir] LDV/SOF combination may have the potential to cure HCV in genotype 1 patients in as little as 8 weeks and without the need for interferon injections or ribavirin [RBV].”
Earlier, the FDA gave LDV/SOF breakthrough therapy designation.
In its statement, Gilead said the new drug application is based on a trio of Phase 3 studies in which nearly 2,000 genotype 1 HCV patients were randomly assigned to the fixed-dose combination, with or without RBV, for durations of eight, 12 or 24 weeks.
New York State Bleeding Disorders Coalition Albany Days March 23-24, 2014
March 23-24 at the Hotel Albany
REGISTRATION OPEN NOW!
A chance to make a difference in New York!
Every year members of the NYSBDC from across the state join in Albany to meet legislators and advocate for better health care for people with Hemophilia, Von Willebrands, and other bleeding disorders.
Be a part of the team this year! Meals and rooms are provided. Help with travelis available. We provide training on the issues for this year, and work together tomeet with legislators/staff and make our case.
Sign up today!
Issues for 2014:
- Step Therapy: insurance companies require people using many different medicines to try cheaper versions of the medicine first, but this can also delay the person from getting the right treatment when they need it.
- Child Health Plus: follow up on the 2013 CHP bill.
In 2013 the Coalition helped pass a law to give children on CHP clotting factor at home.
People like you made that possible. Join us this year and make a difference!
Hey Greater-NYC Bleeding Disorders Community:
By now, you've probably heard something about my comedic web series on hemophilia called Stop The Bleeding!(if not - where ya been? - and also, catch up!: http://stbhemo.com).
On Monday, March 3rd we will be shooting an episode that calls forA LOT of Extras, and I'd like to invite the community to participate. For more information click here!!!
New York Stock Exchange Closing Bell
On January 21st, we rang the New York Stock Exchange closing bell.
We give thanks to Annemarie, Kristin, Alex and Eugene of the NYSE,
also thanks to Tom and Thom for making this proud moment happened.
We also give thanks to all
(Tyshawn, Sally, Katherine, Victoria, Aureo, Alejandro and Linda)
who were able to attend in spite the snow storm.
If you missed it, you can watch the video below:
New York Stock Exchange Closing Bell
We have been cordially invited to Ring the New York Stock Exchange Closing Bell on Tuesday, January 21st at 4 p.m.
You can see it live at: at the CNBC channel or go to https://nyse.nyx.com/the-bell/todays-bells-live
Big Apple Circus
We had our Big Apple Circus event at Lincoln Center, on January 3rd, (due to the weather some people made it, some didn't) but the circus' customer service was nice enough to accommodate the people that didn't make by exchanging the tickets to a later day, January 11th.
Thanks to all the people that were able to make it, and hope you enjoyed it!!!
New York Wins From ACA
A new report from personal finance website WalletHub puts New York at the top of states benefiting the most from the Affordable Care Act. New York showed the biggest drop in individual insurance premiums of all states—40% on average—and the highest number of preliminary applications on a public exchange. New York also saves 21 cents for every dollar in new federal Medicaid spending, ac-cording to the report, because increased federal funding will cover some of the services the state had previously offered. "New York is one of those states that already had an improved health care sys-tem, so they're now getting a large influx of federal funding without having to spend a lot more in additional funds," said John Kiernan, a senior analyst with WalletHub and an author of the report.
The state Department of Health received $13 million from CMS for fiscal 2013 as a performance bonus for increasing enrollment of eligible children in Medicaid and CHIP. This was the second year in a row the state received a bonus for increasing enrollment above a baseline figure. But New York missed an enrollment target, known as Tier 2, for both years that would have rewarded expanding enrollment by more than 10%. About 278,000 children in New York do not have insurance, according to the Kaiser Family Foundation; 90.4% of eligible children are enrolled in CHIP.
We work 24/7, 365 days, all year round to provide direct assistance to persons with hemophilia or a bleeding disorder and to fund medical research to find a cure. We depend on voluntary contributions to provide this services.
Recombinant Factor IX Fc Fusion Protein Cuts Injection Frequency
Last Updated: December 04, 2013.
For patients with severe hemophilia B, a recombinant factor IX Fc fusion protein with prolonged half-life can safely reduce the frequency of injections, according to a study published online Dec. 4 in the New England Journal of Medicine.
WEDNESDAY, Dec. 4, 2013 (HealthDay News) -- For patients with severe hemophilia B, a recombinant factor IX Fc fusion protein (rFIXFc) with prolonged half-life can safely reduce the frequency of injections, according to a study published online Dec. 4 in the New England Journal of Medicine.
Jerry S. Powell, M.D., from the University of California at Davis, and colleagues examined the safety, efficacy, and pharmacokinetics of rFIXFc in 123 previously treated male patients (age 12 years and older) with severe hemophilia B. Participants were included in four treatment groups: group 1 received weekly dose-adjusted prophylaxis; group 2 received interval-adjusted prophylaxis; group 3 received treatment as needed for bleeding episodes; and group 4 received perioperative treatment.
The researchers found that rFIXFc exhibited a significantly prolonged terminal half-life. In groups 1, 2, and 3 the median annualized bleeding rates were 3.0, 1.4, and 17.7, respectively. During the last three months of the study, 53.8 percent of group 2 participants had dosing intervals of 14 days or more. Most bleeding episodes (90.4 percent) in groups 1, 2, and 3 resolved after one injection. During all major surgeries, hemostasis was rated as excellent or good. No participants receiving rFIXFc had inhibitors; 73.9 percent of participants in groups 1, 2, and 3 had at least one adverse event and 10.9 percent had serious adverse events.
"Prophylactic rFIXFc, administered every one to two weeks, resulted in low annualized bleeding rates in patients with hemophilia B," the authors write.
Several authors are employed by Biogen Idec, which funded the study. One author disclosed working as a drug-development consultant in private practice.
ASSEMBLY MEMBER MICAH KELLNER’S BILL TO COVER HEMOPHILIA OUTPATIENT TREATMENT UNDER CHILD HEALTH PLUS IS SIGNED INTO LAW BY GOVERNOR CUOMO
Kellner Law Ensures That Young New Yorkers with Hemophilia & Other Clotting Protein Deficiencies Will Have Outpatient Services Covered Under State’s ‘Child Health Plus’ Program
Legislation authored by Assembly Member Micah Z. Kellner that provides outpatient coverage under the State’s Child Health Plus program to New Yorkers with hemophilia and other clotting protein deficiencies was signed into law yesterday by Governor Andrew Cuomo. The law will take effect on April 1st, 2014.
Assembly Member Kellner said, “It’s a great day for young New Yorkers with hemophilia and other blood clotting deficiencies, who will soon be eligible for coverage of their conditions under the State’s Child Health Plus program thanks to this new law. This is a long-overdue measure to close the gap in coverage for these New Yorkers that occurred when the legislation creating Child Health Plus was first drafted 22 years ago.
“I am grateful to Governor Cuomo for signing this important measure; to my colleagues in the Assembly who voted unanimously for it; to Senate sponsor Joseph Robach for leading a bipartisan majority in passing this bill through the State Senate; and to the advocates, patients, and families who’ve worked so long and hard to secure its enactment into law.”
Thomas Wilmarth, Chair of the New York State Bleeding Disorders Coalition, said, “This bill will allow children with bleeding disorders who are on Child Health Plus to have equal and fair access to the same standard model of care that those on Medicaid and private insurance currently have. No longer will we have families keeping themselves in Medicaid or spending themselves down into Medicaid to ensure that their child has access to life saving medication. This is both good for the State and for the health of children with bleeding disorders. The New York State Bleeding Disorders Coalition would like to thank our bill sponsors, Assemblyman Micah Kellner and Senator Joseph Robach, for their leadership in getting this bill introduced, and all of the co-sponsors and legislators who supported and guided us through the process.”
BACKGROUND: The legislation (A. 962A/S. 02186-A), which passed the Assembly and the State Senate earlier this year, amends Subdivision 7 of section 2510 of New York State public health law to ensure that persons with hemophilia and other clotting protein deficiencies who are otherwise eligible for the Child Health Plus program shall have access to reimbursement for outpatient blood clotting factor concentrates and other necessary treatments and services.
Hemophilia is a rare hereditary bleeding disorder affecting approximately 2,000 New Yorkers, resulting from a deficiency in blood proteins known as clotting factors. Without an adequate supply of clotting factors, individuals can experience prolonged bleeding following routine medical and dental procedures, trauma, and a range of physical activities. Additionally, individuals with hemophilia often experience spontaneous internal bleeding that can cause severe
joint damage, chronic pain, and even death.
Prior to the 1970’s, individuals with hemophilia rarely lived beyond middle age. Early treatment generally entailed transfusions of whole blood and plasma at hospitals. These treatments proved arduous, time-consuming and only minimally effective. The advent of commercially prepared blood treatment allowed for home infusion and improved the efficacy and convenience of treatment for persons with hemophilia and other clotting protein deficiencies.
In addition to hemophilia, disorders resulting from blood protein deficiencies include Von Willebrand Disease (VWD), the most common bleeding disorder, affecting approximately two million Americans. Individuals with the severest form of VWD rely on clotting factor treatments similar to those used by individuals with hemophilia.
Clotting factor products produced today (derived from plasma or recombinant technology) are very safe and highly effective medications. Access to therapies has vastly improved both the health outcomes and quality of life for the majority of patients and their families. Many patients today rely on a prophylactic regimen to prevent bleeding episodes. This preventative regimen, along with the coordinated care provided by hemophilia treatment centers, has significantly reduced visits to emergency rooms, hospitalizations and joint damage. Further, the ability to manage hemophilia and other bleeding disorders outside of the hospital setting has improved attendance for school-aged children, decreased absenteeism from work for adult patients and caregivers, vastly improved the ability of affected persons to join the work force, and minimized life disruptions for the entire family.
Until now, New York State’s Child Health Plus program presently has not covered clotting factor therapies prescribed for use at home by individuals with hemophilia and other clotting protein deficiencies. The new law authored by Assembly Kellner will bring New York State into line with other statewide children’s health programs; until now, New York has been the only state whose children’s health program did not provide coverage for outpatient clotting factor products used by individuals eligible for a statewide children’s health program.
It is with great sadness that we note the passing of Margaret “Peggy” Bosch, RN. Peggy was the “Super-star” Pediatric Nurse of the Long Island Jewish HTC for over 30 years. Retiring from nursing about 3 years ago she left a lasting impression on those whose lives she touched. Our sympathies go out to her family and friends.
Disclaimer: Topics and contents of discussion – health related or not – is presented for informational purposes only. The Hemophilia Association of New York (HANY) does not engage in the practice of medicine, nor recommend specific treatments or drugs. You are urged to consult your physician or local treatment center before pursuing any course of treatment. HANY does not engage in the practice of law. Specific legal issues should be discussed with a qualified attorney.
Please request that Gov Cuomo sign A0962a and S2186 into law. This will then allow children with bleeding disorders who have Child Health Plus Insurance (CHIP) to have their out patient factor covered under Child Health Plus Insurance.
Please click on the link: www.governor.ny.gov/contact/GovernorContactForm.php
Health Insurance Marketplace
To take advantage of the new, online Health Insurance Marketplace, millions of Americans need to know about it and sign up. Starting in October 2013, Americans who don’t have insurance can choose from quality, affordable health insurance plans in the marketplace for coverage that begins in 2014.
In all states, there will be people trained and certified to help you understand your health coverage options and enroll in a plan. They will be known by different names, depending on who provides the service and where they are located. Using the “Find Local Help” tool, you can find information about assisters like Navigators, application assisters, certified application counselors, and government agencies.
Consumers can also find help at local community health centers and libraries. The Marketplace consumer call center is open 24 hours a day, 7 days a week at 1-800-318-2596 (hearing impaired callers using TTY/TDD can dial 1-855-889-4325), with translation services available in 150 languages. Visit HealthCare.gov or CuidadodeSalud.gov to learn more or participate in a live chat with a trained customer service representative.
Enrollment in the Health Insurance Marketplace continues for six months. Consumers can apply and choose a plan until the end of March, with coverage beginning as early as January 1, 2014.
Persistent Pain: Considerations for the Hemophilia Community Thursday, October 17th, 2013 7:00 PM – 9:00 PM
Dinner and Presentation
HANY’s Office 131 West 33rd Street, Suite 11D (Between 6th and 7th Ave)
Please RSVP with Annie by Tuesday, October 15th @ firstname.lastname@example.org 212-682-5510
TOPICS AND CONTENTS OF DISCUSSION – HEALTH RELATED OR NOT – IS PRESENTED FOR INFORMATIONAL PURPOSES ONLY. THE HEMOPHILIA ASSOCIATION OF NEW YORK (HANY) DOES NOT ENGAGE IN THE PRACTICE OF MEDICINE, NOR RECOMMEND SPECIFIC TREATMENTS OR DRUGS. YOU ARE URGED TO CONSULT YOUR PHYSICIAN OR LOCAL TREATMENT CENTER BEFORE PURSUING ANY COURSE OF TREATMENT. HANY DOES NOT ENGAGE IN THE PRACTICE OF LAW. SPECIFIC LEGAL ISSUES SHOULD BE DISCUSSED WITH A QUALIFIED ATTORNEY.
Parental Disclosure of Hemophilia Carrier Status to Daughters
My name is Katharine Bisordi and I am currently a genetic counseling student at the University of Maryland. I would like to invite you to participate in my graduate thesis research project.
The study I am conducting is investigating the factors that influence parents’ decision to disclose certain or potential carrier status to daughters in families with hemophilia. Though the literature does contain some information about attitudes towards carrier testing, the factors that influence parental disclosure of carrier status to their daughters remain to be described in detail. Further investigation of these factors would not only fill a void in the literature, but also aid genetic counselors and health practitioners in future counseling of these families.
The online survey should take approximately 15-20 minutes to complete. When the survey has been completed, you will be able to submit it online. The survey will remain open until October 31, 2013.
Thank you for taking the time to complete the survey and aid in my graduate research project. Your participation is very highly valued and appreciated, and also necessary for the collection of data and completion of this study. Please feel free to contact me with any questions you may have.
Sincerely, Katharine Bisordi, BS, MS Candidate for Master’s in Genetic Counseling University of Maryland School of Medicine Katharine.Bisordi@som.umaryland.edu
Disclaimer: This material is provided for informational purposes only. The Hemophilia Association of New York (HANY) does not engage in the practice of medicine, nor recommend specific treatments or drugs. You are urged to consult your physician or local treatment center before pursuing any course of treatment. HANY does not engage in the practice of law. Specific legal issues should be discussed with a qualified attorney.
Click hereto see Stop the Bleeding, episodes 4 & 5
On episode 4, Spencer steals an idea from LeBron James of the Miami Heat and forces the gang to help him find a celebrity face for hemophilia. Are sparks flying between two officemates? Will Spencer find his face? Will Benny choke on what is essentially air? All this and more on Episode 4 of Stop the Bleeding!
On episode 5, Spencer fights for attention in Las Vegas while the team vacations! A mystery tip leads Spencer to Los Angeles where he meets major league All-Star Pitcher CJ Wilson of the Anaheim Angels, who has some key advice! Will Spencer listen? Will Franklin get the girl? Will Benny get any of it?? All this and more on Episode 5 of Stop the Bleeding!
Hello Blood Brothers! Join HFA this August with two national online events:
Blood Brotherhood Online Forum Live Chat
Join other adult men from around the country in a live online chat on Tuesday, August 13th at 8:00pm Eastern/ 7:00pm Central/ 6:00pm Mountain/ 5:00pm Pacific, on the Blood Brotherhood Online Forum. Connect and learn from others on a variety of topics in real time!
Adult men (age 18+) with bleeding disorders only, please
Blood Brotherhood Webinar
HFA's Blood Brotherhood invites adult men with bleeding disorders and their partners/spouses to join this informative session on legal planning for the future. Topics will include healthcare directives, medical and general powers of attorney, special needs trusts for persons with disabilities, and laws surrounding medical records and information.
“Planning for the Road Ahead: Tools and Rules for Your Legal Ride Through Life”
STAGED READING OF DELETED SCENES The event on June 10th was to benefit of our Patient Services Fund which subsidizes medical care costs and assistance with insurance premiums for persons with bleeding disorders.
Thanks to all the cast & to everyone who were able to join us!!!!
* $100 VIP tickets Pre-show champagne toast Premium seating Autographed copy poster (featuring playwright Ryan Gielen & actors Patrick James Lynch & Anthony Rapp)
Robert Champagne (President, CJ Wilson's Children's Charities) and Patrick James Lynch sent the following message to the teens in our community:
We want to see how you are going to make a difference in your community this summer. Send us a video about how you plan to use your personal skill set to positively influence your community over the summer, and share it with all your friends and family! The videos with the top-three view counts at the end of the contest will win an iPad & a Throw Strikes Package courtesy of CJWCC.
Enter by MAY 31st to be considered for the prizes!! Please share this with anyone you think may be interested!
Watch the video below:
You are invited to an education and discussion group at:
The New York Comprehensive Center forHemophilia and Coagulation Disorders at New York Presbyterian Hospital-Weill Cornell Medical Center
“All You Have Ever Wanted to Know about the Genetics of Hemophilia and other Bleeding Disorders: An Education and Discussion Group”
. The Science
. Family Planning Options
. Answers to Your Questions
Guest Speaker: Connie Gibb, MS, Genetic Counselor
Wednesday, May 15, 2013
New York Presbyterian Hospital
525 East 68th Street
New York, NY 10065
RSVP: Jacqueline Lefkowitz, PhD, LCSW
Pizza and light refreshments will be served.
Green Light on Patient Enrollment for Investigational Drug GreenGene
April 22, 2013, Green Cross Corporation announces the initiation of an international Phase III clinical trial to determine the safety, efficacy, and pharmacokinetics of their investigational drug GreenGene. GreenGene is a recombinant Factor VIII product for the treatment of severe Hemophilia A, which utilizes a dual clearance solvent/detergent treatment and nano-filtration process to minimize the possibility of pathogen contamination. For more information click here!!!
World Hemophilia Day
The World Federation of Hemophilia (WFH) and the global community have worked together, for the past 50 years, to improve care and treatment for inherited bleeding disorders. World Hemophilia Day 2013 will take on a special significance as we mark '50 Years of Advancing Treatment for All'.
However, most people with hemophilia or other bleeding disorders still do not receive adequate diagnosis, treatment, and management for their condition. It is important that we reflect on where we have been, where we want to go, and that together, we can Close the Gap.
Join together on April 17 to mark World Hemophilia Day. Connect with the global online community, on the WFH’s Facebook page, and share your hopes and wishes for the next 50 years.
Together, we will Close the Gap.
We encourage you to click on this link and use thePOSTERto help support your World Hemophilia Day activities
For more information, contact Sarah Ford, WFH communications manager, at email@example.com.
Ryan White was diagnosed with AIDS at age 13. He became a national poster child for HIV/AIDS in the USA. He and his mother Jeanne White Ginder fought for his right to attend school, gaining international attention as a voice of reason about HIV/AIDS.
At the age of 18, Ryan White died on April 8, 1990, just months before Congress passed the AIDS bill that bears his name – the Ryan White CARE Act. The legislation has been reauthorized four times since – in 1996, 2000, 2006, and 2009 – and is now called the Ryan White HIV/AIDS Program.
Source: Health Resources and Services Administration
REQUEST FOR HANY SCHOLARSHIP APPLICATION IS CLOSED.
Evaluating Child Bruising, Bleeding: New Guidelines
Mar 25, 2013
Although bruising or bleeding in a child can raise suspicions of abuse, treating physicians must be careful in assessing whether the injuries might result from accidental trauma or bleeding disorders, according to guidelines published March 25 in a clinical report in Pediatrics.
The American Academy of Pediatrics Section on Hematology/Oncology and Committee on Child Abuse and Neglect compiled the report. Committee members James D. Anderst, MD, and Shannon L. Carpenter, MD, both from the University of Missouri-Kansas City School of Medicine, and Thomas C. Abshire, MD, from the Medical College of Wisconsin, Milwaukee, were lead writers.
Physicians may suspect abuse when children present with bruising or bleeding, which often includes cutaneous bruises and intracranial hemorrhage (ICH). However, other conditions also could cause bruising or bleeding, the committee writes.
"When bleeding or bruising is suspicious for child abuse, careful consideration of medical and other causes is warranted," they write. Inappropriate diagnosis of abuse could result in removal of a child from the home or prosecution of an innocent person, while attributing an abusive injury to a medical condition or accidental injury could place a child at future risk for abuse or death.
Extensive laboratory testing may be warranted, combined with comprehensive medical history-taking and physical examination. However, if findings during an examination reveal likely abuse, the lab testing is unnecessary.
"For instance, a child with a patterned slap mark who describes being hit with an open hand does not require a laboratory evaluation for a bleeding disorder," the committee writes.
In bruising cases, an evaluation should focus on the reason given for the bruising, the nature and location of the bruising, and the mobility and developmental status of the child. Unless an obvious trauma event explains a case, "ICH in a nonmobile child is highly concerning for child abuse," they write.
The clinical report contains 6 guidelines for assessing children who have bruising or bleeding suspicious for abuse:
Take a complete medical and family history and perform a thorough physical examination.
Consider the possibility of a medical condition as the cause.
Tailor any laboratory test to the individual child.
Note that laboratory testing suggesting a bleeding disorder does not eliminate abuse as a potential cause.
Delay screening for children with ICH until transfused blood clotting elements are eliminated.
Closely collaborate with a pediatric hematologist to ensure effectiveness of evaluation and testing methods.
The committee also compiled a technical report that provides details on medical conditions that predispose children to bruising and bleeding, including ICH, hemophilia, heritable disorders, and congenital platelet abnormalities, for which evaluation for coagulopathies might be required.
Ironically, the committee writes, "Because of the chronic nature of their disease, children with bleeding disorders may be at higher risk of abuse." Modification of large databases to include such factors as bruising location or location and character of ICH would help in distinguishing cases, they write. "In the absence of such data, physicians must use existing data, including epidemiologic and clinical factors, in their decision-making process."
Medscape Medical News
For more than 55 years, MedicAlert has provided live 24/7 emergency medical information and identification services for members and their families, and reuniting families and caregivers during wandering incidents or medical emergencies. MedicAlert is always there for you and your loved ones.
MedicAlert relays critical information to emergency responders about your important health concerns such as a bleeding disorder and other medical conditions, to ensure your safety and peace of mind. Learn more about the importance of medical IDs, go to www.medicalert.org.
Albany Days - March 10/11, 2013
“Spring Forward” to new accomplishments!
This is your opportunity for you to learn about key legislative issues affecting the bleeding disorders community. It’s a chance for you to tell your stories to your elected representatives and staff members, helping them understand your needs and concerns.
GOAL:Pass S.2186/A.962, adding coverage of Outpatient
Factor to New York Child Health Plus.
Sunday, March 10:
1:00 PM – PROGRAM REGISTRATION BEGINS
1:00 PM – Welcoming Session
2:00 PM – “Advocates In Action” training for all with an Issue Review
& Meeting Practice
4:00 PM – Break & Hotel Registration
5:00 PM – DINNER
- Welcoming Remarks from the NYSBDC Chair
- Pulse On The Road.
8:00 PM – Meeting Schedule final check-in and Networking Time
Monday, March 11:
7:00 AM - BREAKFAST
8:00 AM – Last minute reminders
8:15 AM - Walk to legislative Office Building
8:30 AM - 4:00 PM Legislator Visits
●LEGISLATOR MEETINGS: Monday starting 8:30 am. See your local leader for times/rooms. Please turn in your Meeting Notes before leaving Albany.
● HOTEL: Official Check in time starts at 4:00 pm. Your room charge has been covered by your association, chapter, or center. You are responsible for any additional charges to the room. Parking is provided by the hotel.
● MEALS: Dinner Sunday, and Breakfast Monday will be provided.
● TRAVEL: A portion of your travel costs may be reimbursed; see your local leader for details. If you drive, leave your car at the hotel until you’re ready to depart Albany.
If you have questions or need help with something LOOK FOR THE SPECIAL NAME TAGS!
CDC Hosts FB Chat for Women This Week
Women in the bleeding disorders community are invited to attend the
US Centers for Disease Control and Prevention (CDC)
"Blood Disorders & the 3 P’s
(Preconception, Pregnancy, and the Postpartum Period):
The chat will be led by Dr. Althea Grant, Chief of Epidemiology and Surveillance Branch, Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, and other bleeding disorders experts.
HIV May Raise Risk of Heart Attack
Study found 48 percent higher chance of heart trouble
MONDAY, March 4 (HealthDay News) -- People living with HIV may face a greater chance of suffering a heart attack, a new study indicates.
Researchers looked at data on more than 82,000 U.S. veterans, and found that there were 871 heart attacks in this group over a median follow-up of 5.9 years. The investigators also found that HIV-positive people had a "consistently and significantly higher" risk of heart attack across three decades of their lives.
Among the veterans, heart attack events per 1,000 people per year were: at ages 40 to 49, 2.0 for those with HIV and 1.5 for those who did not have HIV; at ages 50 to 59, 3.9 for those with HIV versus 2.2 for those without HIV; at ages 60 to 69, 5.0 for those with HIV versus 3.3 for those without HIV.
After accounting for other risk factors, the researchers calculated that people with HIV have an overall 48 percent increased risk of heart attack.
The study was published online March 4 in the journal JAMA Internal Medicine.
The findings may not be applicable to women because the patients included in the study were overwhelmingly male, study author Dr. Matthew Freiberg, from the University of Pittsburgh School of Medicine, and colleagues noted in a journal news release.
The success of antiretroviral therapy means that HIV-infected people are living longer, and are now at greater risk for heart disease, the authors added.
While the study found an association between HIV and increased risk of heart attack in the veterans, it did not prove a cause-and-effect relationship.
However, the findings show "a clear and consistent excess risk" of heart attack in HIV-positive people across a range of age groups, Patrick Mallon, from the University College Dublin in Ireland, wrote in an accompanying commentary. He added that further research is needed to learn more about the causes of this increased risk and how to reduce it.
The New York State Bleeding Disorders Coalition is a partnership of not-for-profit organizations dedicated to public advocacy on behalf of people affected by bleeding disorders in New York state.
Their facebook page is another way to share information and build support for our advocacy among community members and others - especially if they don't regularly use the website. Aside from Coalition work, I think partners can use it to share their work, especially upcominglocal advocacy and education programs.
Community Leaders, HFA encourages you to distribute the following message to your networks. People with Bleeding Disorders, their families, our care providers, friends and neighbors. This is an important message.
Attention: This petition is an active ACTION that each of us can support! It will only take a few minutes of time.
We all know someone in the bleeding disorders community who lives with HCV. Please watch https://vimeo.com/36791500 for a video testimony of some of our own amazing community members and friends impacted by HCV.
DEERFIELD, Ill., January 24, 2013 - Baxter International Inc. (NYSE:BAX) announced today that it has agreed to acquire the investigational hemophilia compound OBI-1 and related assets from Inspiration BioPharmaceuticals, Inc. as well as certain other OBI-1 related assets, including manufacturing operations, from Ipsen Pharma S.A.S. in conjunction with Inspiration's ongoing bankruptcy proceedings. The transaction is subject to bankruptcy court and regulatory approvals.
OBI-1 is a recombinant porcine factor VIII (rpFVIII) being investigated for the treatment of bleeding in people with acquired hemophilia A and congenital hemophilia A patients with inhibitors. Acquired hemophilia A is a rare, potentially life-threatening bleeding disorder, which, unlike congenital hemophilia, typically affects older adults and occurs equally in both males and females.
"OBI-1 has the potential to address existing unmet needs of hemophilia patients and is a strong strategic fit with Baxter's current hemophilia portfolio," said Bruce Ewenstein, M.D., Ph.D., vice president of clinical affairs in Baxter's BioScience business.
Under the terms of the agreement, Baxter will make an upfront payment of $50 million for the OBI-1 assets, including the manufacturing operations. In the future, Baxter may make payments of up to $20 million in total based on regulatory approval of the acquired hemophilia A indication in the United States and first additional country. Additional amounts may be paid upon approval of additional indications, through net sales payments, and as sales milestones when sales exceed $100 million.
OBI-1 is currently in Phase III clinical studies in individuals with acquired hemophilia A and those with congenital hemophilia A who have developed inhibitors against human FVIII. OBI-1 received orphan drug designation in the United States and Europe, and was recently granted fast track designation for acquired hemophilia A by the United States Food and Drug Administration (FDA).
About Acquired Hemophilia A Acquired hemophilia A is a very rare (estimated annual incidence of 1.5 cases per million lives) and potentially life-threatening acute bleeding disorder caused by the development of autoantibodies (inhibitors) against coagulation FVIII. In acquired hemophilia A, individuals typically experience soft tissue or post-procedural bleeding, in contrast to bleeding into joints, which is more typical in congenital hemophilia.
About Baxter in Hemophilia Baxter has more than 60 years experience in hemophilia and has introduced a number of therapeutic firsts for hemophilia patients. Baxter has the broadest portfolio of hemophilia treatments in the industry and is able to meet individual therapy choices, providing a range of options at each treatment stage. The company's work is focused on optimizing hemophilia care and improving the lives of people living with hemophilia A and B worldwide.
About Baxter International Inc. Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning an agreement made by the company to acquire certain assets from Inspiration BioPharmaceuticals, Inc. and Ipsen Pharma S.A.S., including expectations regarding upfront and other future payments. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the ability of the parties to obtain bankruptcy court approval and other required regulatory approvals and to otherwise satisfy other closing conditions; continued strength in the company's financial position, including cash flows; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on its website. Baxter does not undertake to update its forward-looking statements.
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Secretary Kathleen Sebelius announced $1.5 billion in new Exchange Establishment Grants to California, Delaware, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, New York, North Carolina, Oregon, and Vermont to ensure these states have the resources necessary to build a marketplace that meets the needs of their residents. View the full release here
A drug developer has initiated enrollment for a phase 3 trial for a hemophilia therapeutic that could reduce the frequency that people with the rare blood disorder need to take medication. The move is part of a larger trend of biotechnology companies in this area that focus on reducing injections from daily to weekly.
CSL Behring, a King of Prussia, Pennsylvania-based company in suburban Philadelphia, specializes in developing plasma protein biotherapeutics. The pediatric phase 3 study, which starts in the Czech Republic, will evaluate the safety, efficacy and pharmacokinetics (or how the body absorbs and distributes the drug) for recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) in previously treated children to aid with blood clotting.
The drug is part of a program at CSL to develop therapeutics to control and prevent bleeding in surgery, and in patients with factor IX deficiency, a rare blood disorder caused by a genetic mutation that interferes with the ability of the patient’s blood to clot.
A report by Datamonitor published earlier this month pointed to two emerging trends in the hemophilia market: developing long-acting recombinant factor IX therapeutics and making these drugs more affordable.
HHS awards $1.5 billion to support states building
Health Insurance Marketplaces
Health and Human Services (HHS) Secretary Kathleen Sebelius today announced $1.5 billion in new Exchange Establishment Grants to California, Delaware, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, New York, North Carolina, Oregon, and Vermont to ensure these states have the resources necessary to build a marketplace that meets the needs of their residents.
“These states are working to implement the health care law and we continue to support them as they build new affordable insurance marketplaces,” Secretary Sebelius said. “Starting in 2014, Americans in all states will have access to quality, affordable health insurance and these grants are helping to make that a reality.”
Because of the Affordable Care Act, consumers and small businesses will have access to marketplaces starting in 2014. The marketplaces are one-stop shops that will provide access to quality, affordable private health insurance choices similar to those offered to members of Congress. Consumers in every state will be able to buy insurance from qualified health plans directly through these marketplaces and may be eligible for tax credits to help pay for their health insurance. These marketplaces promote competition among insurance providers and offer consumers more choices.
Delaware, Iowa, Michiga, Minnesota, North Carolina, and Vermont received awards today for Level One Exchange Establishment Grants, which are one-year grants states will use to build marketplaces. California, Kenucky, Massachusetts, New York and Oregon received Level Two Exchange Establishment Grants today. Level Two grants are multi-year awards to states to further develop their marketplaces.
A total of 49 states, the District of Columbia, and four territories have received grants to plan their marketplaces, and 34 states and the District of Columbia have received grants to build their marketplaces. To ensure states have the support and time they need to build a marketplace, states may apply for grants through the end of 2014 and may use funds through their start-up year.
HFA will be providing scholarships to first time attendees who need financial assistance. They are committed to this effort… and provide well over 100 scholarships every year. Sign up – is now! It is a great national meeting! HFA may offer scholarships for a family of up to 4 for every Member Organization working on the funding to do that, would you be interested?
Apply for an intership through the Bayer Hemophilia Leadership Development Program today!
Making a change in the world begins by making a difference in the community. Apply todayfor the Bayer Hemophilia Leadership Development Program (BHLDP) and begin to learn how to be the change YOU want to see!
The Bayer Hemophilia Leadership Development Program was created by Bayer together with hemophilia advocacy organizations, healthcare professional thought-leaders, and other community advocates to help prepare future leaders in the hemophilia community. For years, Bayer has offered motivated, young individuals with a tie to hemophilia an eight-week, paid internship. The BHLDP program also includes an opportunity to spend time working at a hemophilia organization where interns can put their leadership and business skills to work for the hemophilia community.
Bayer is looking for students enrolled full-time in college who are touched by hemophilia and have a strong interest in and commitment to becoming a future leader in the hemophilia community. Interns will travel to Bayer's U.S. headquarters in New Jersey, where they will spend eight-weeks participating in activities that aim to help them grow personally and professionally.
Applications are due no later than Friday, February 8, 2013 at 11:59 p.m. ET.
New York, NY– Today, hundreds of thousands of people in our nation and around the world observe World AIDS Day to raise awareness about HIV and AIDS.
World Aids Day was established in 1988 by the World Health Organization (WHO) to ensure renewed and continual attention to the threat posed by HIV and AIDS. The Center for Disease and Control (CDC) estimates that over 1 million people in the United States are currently living with the HIV infection.
The Hemophilia Association of New York, Inc. observes and acknowledges this day to honor all the hemophilia community members who contracted HIV and Hepatitis C after injecting contaminated anti-hemophilic clotting factor prior to 1985. Approximately 10,000 people with hemophilia contracted HIV and Hepatitis C during this time; more than 8,000 have died.
“In honor of our fallen community members and those who still struggle with co-morbidities from contaminated products, we offer gratitude for your heroic diligence and sacrifice in ensuring a relatively safe blood supply for all,” said Linda Mugford, Executive Director. “This annual event focuses attention on the importance of comprehensive health care. Such care is at the heart of major changes currently happening to our health care system, and can positively impact families.”
Comprehensive care is vital and essential to treating the physical, emotional, psychological, social, and educational needs of people with hemophilia and other bleeding disorders.
About Bleeding Disorders
Bleeding disorders are a group of conditions in which there is a problem with the body’s blood clotting process. These disorders can lead to heavy and prolonged bleeding, either spontaneously or after an injury.
An estimated 3 to 5 million Americans have a bleeding disorder, including about 20,000 with hemophilia. Worldwide, one in 1,000 women and men have a bleeding disorder. However, 75% still receive very inadequate treatment or no treatment at all. Bleeding disorders can affect all ethnic and economic groups.
Hemophilia and von Willebrand Disease (vWD) are two of the most common types of bleeding disorders and are lifelong, genetic illnesses in which one of the proteins needed to form blood clots is missing or reduced.
Hemophilia is a sex-linked, hereditary blood clotting disorder. The underlying cause is missing or deficient protein -- known as factor -- that is needed for blood to clot. The bleeding can occur spontaneously and/or after injury. Bleeding episodes may be external or internal into joints, muscles, the abdominal cavity, brain, and other organs. Untreated bleeds can lead to crippling deformities of the joints or life threatening bleeds within the body.
Currently, there is no cure, and medication needed to treat the disorder typically costs $60,000 to $300,000 annually per person.
About von Willebrand
Von Willebrand Disease (vWD) is an inherited bleeding disorder with similarities to hemophilia. vWD is caused by a decreased or defective function of a protein called von Willebrand factor, which is necessary for normal blood clotting and affects men and women.
The Hemophilia Association of New York, Inc.
serves persons with bleeding disorders
in the 14 downstate counties of NY
Obama administration moves forward to implement health
care law, ban discrimination against people with pre-existing conditions
The Obama administration moved forward today to implement provisions in the health care law that would make it illegal for insurance companies to discriminate against people with pre-existing conditions. The provisions of the Affordable Care Act also would make it easier for consumers to compare health plans and employers to promote and encourage employee wellness.
“The Affordable Care Act is building a health insurance market that works for consumers,” said Health and Human Services Secretary Kathleen Sebelius. “Thanks to the health care law, no one will be discriminated against because of a pre-existing condition.”
“The Affordable Care Act recognizes that well-run, equitable workplace wellness programs allow workers to access services that can help them and their families lead healthier lives,” said Secretary of Labor Hilda L. Solis. “Employers, too, can benefit from reduced costs associated with a healthier workforce.”
The Obama administration issued:
♦ A proposed rule that, beginning in 2014, prohibits health insurance companies from discriminating against individuals because of a pre-existing or chronic condition. Under the rule, insurance companies would be allowed to vary premiums within limits, only based on age, tobacco use, family size, and geography. Health insurance companies would be prohibited from denying coverage to any American because of a pre-existing condition or from charging higher premiums to certain enrollees because of their current or past health problems, gender, occupation, and small employer size or industry. The rule would ensure that people for whom coverage would otherwise be unaffordable, and young adults, have access to a catastrophic coverage plan in the individual market.
♦ A proposed rule outlining policies and standards for coverage of essential health benefits, while giving states more flexibility to implement the Affordable Care Act. Essential health benefits are a core set of benefits that would give consumers a consistent way to compare health plans in the individual and small group markets. A companion letter on the flexibility in implementing the essential health benefits in Medicaid was also sent to states.
♦ A proposed rule implementing and expanding employment-based wellness programs to promote health and help control health care spending, while ensuring that individuals are protected from unfair underwriting practices that could otherwise reduce benefits based on health status.
Medicaid patients in New York state don’t have to use mail order to purchase the most expensive prescriptions under an agreement reached Friday in an Albany court. Judge Roger D. McDonough got the state Department of Health to agree to stop letting managed care plans refuse to pay for prescriptions filled locally.
The Pharmacists Society of the State of New York and several pharmacies went to court, saying managed care plans were breaking state law by forcing patients to order drugs by mail instead of getting them from a local pharmacy.
Hundreds of millions of dollars are involved, said Craig M. Burridge, executive director of PSSNY. Managed care plans have created a list of more than 400 of the most expensive prescription medicines and blocked local pharmacies from providing them.
It creates no savings for the state, Burridge said, because local pharmacies are required to meet or beat the prices of mail-order pharmacies. More, the mail-order pharmacies are all outside of New York. Unlike PSSNY’s 3,800 members and the thousands of assistants and others with whom they work, those filling mail-order prescriptions don’t pay taxes to New York, he said. Burridge said the number of pharmacies in the state has dropped by hundreds in recent years. Blocking those that remain from providing the most expensive medicines to Medicaid patients will make it harder for those that remain to survive, he said.
Linda Clark, an attorney for Hiscock & Barclay who represented PSSNY in front of McDonough, said requiring patients to receive prescriptions by mail threatens their health. She told of a patient who needs to take drugs to prevent his body from rejecting a transplanted liver. He needs to take the drugs at specific times, but has no idea when the Postal Service or UPS will show up with his medicine, she said.
Those living in large apartment buildings sometimes find their prescriptions left in a hallway near a wall of mail slots. Or worse: “Leaving a $10,000 hepatitis drug on the stoop outside in the summer might not be a good idea,” she said.
Further, Clark argued, state law forbids requiring patients to get prescriptions by mail. She said the law is clear for those with private insurance as well as for those on Medicaid. “You can’t be forced into mandatory mail order,” she said.
She said Medicaid patients who have received letters telling them they had to use mail order can now go to their own pharmacy. If there is a problem, she said they should call the state Department of Health. And, she said, they can call the PSSNY which is gathering information on the issue.
The matter will be heard again by McDonough at a show-cause hearing in December, according to court documents.
The state Department of Health did not return a phone call seeking comment.
Published: Friday, October 05, 2012
By Charles McChesney, The Post-Standard
NYFAHC is 20 years old this year!
Twenty years ago, NYFAHC was formed as a statewide coalition to provide a unique, powerful and influential voice for health insurance consumers that focuses especially on people with higher than average health care needs.
NYFAHC's work has amplified and leveraged the voices of member organizations that represent consumers with chronic illnesses and disabilities, and shown the power of collective action to make health insurancework better for the people who need it the most.
We’ve had a considerable number of successes since we came together in 1992:
Defeated proposals to charge higher premiums to subscribers with serious illnesses and disabilities.
Eliminated some forms of insurance discrimination (Community Rating Law).
Ensured doctor choice for those who need it (Point of Service Law).
Protected access to specialists (Managed Care Bill of Rights).
Won coverage of clinical trials, promising experimental treatments, and uses of off-label drugs (External Review Law).
Urged creation of the health insurance marketplace (Exchange Executive Order).
Today, we are a founding member and play a leading role in broader coalitions focusing on improving insurance coverage.
Patrick Lynch is a very talented young man who also is a member of our Community. HANY fully supports this project and looks forward to the premier. Please click on this link and share this announcement with all who may be interested.
My name is Patrick James Lynch. I'm an actor, writer, producer, and hemophiliac. For the past year, I've been developing STOP THE BLEEDING! a comedic web series about a screwball hemophiliac and his dysfunctional non-profit organization. I've teamed up with director/producer Ryan Gielen of Believe Limited and the people of Baxter Pharmaceutical, and we're set to shoot the series in September! Episodes will spoof off of topics relevant to our community (i.e., prophylaxis, fitness, & pain management), and will be produced in conjunction with additional videos that deepen the conversation on these topics.
One of our episodes features a number of extras portraying people with or connected to hemophilia. I thought it would be fun if some of these extras were actual members of the community! These individuals would be filmed for the appropriate scene, and some may be selected for interviews to be shown in our supplemental videos!
It'll be shooting on Saturday, September 29th. Location and time TBD (3 hours). While we cannot pay participants, we are offering a $25 Amazon or iTunes gift card as well as catering services. Anyone else that may be interested in coming to this should contact me ASAP!
A recent case reminds us of the importance of paying premiums on time. Premium bills state a “due date” for the receipt of payment. Don’t count on the so-called “grace period”. You should make every attempt to send that payment before the date indicated, since a delay in delivery or posting could lead to cancellation of your all-important health coverage.
Most insurers limit the number of times that cancelled “direct payer” policies can be “reinstated”. And, even if you are reinstated, the insurer may not honor claims that occurred during the periods of suspension.
FDA Rescinds Exclusivity for Octapharma’s Wilate
Last month, the US Food and Drug Administration (FDA) rescinded the seven-year orphan drug exclusivity for Octapharma’s Wilate®, an injectable human plasma-derived von Willebrand factor (VWF)/factor VIII (FVIII) concentrate for the treatment of spontaneous and trauma-induced bleeding episodes in patients with all types of von Willebrand disease (VWD). Wilate is also indicated for the treatment of patients with mild or moderate VWD in whom the use of desmopressin (a synthetic version of the hormone vasopressin) is ineffective or contraindicated.
Wilate was initially granted orphan drug status by the FDA in December 2009.
The re-evaluation was initiated by a citizen petition filed by CSL Behring in March 2011, asking the FDA to do three things: revoke Wilate’s orphan drug designation, revoke its seven-year period of orphan drug exclusivity, and deny its "hypothetical claims of superiority" in terms of its safety profile. The FDA concluded that the available data don’t "support a conclusion that Wilate has been demonstrated ‘to provide a significant therapeutic advantage over and above that provided’ by Humate-P®." CSL Behring’s Humate-P is a human plasma-derived FVIII/VWF product used in the treatment and prevention of bleeds in patients with hemophilia and VWD.
Retroactive to December 2009 when Wilate was approved, it will lose seven years of exclusivity, but retain its orphan drug status. Further, although the FDA determined that Wilate was "chemically the same type drug" for the same orphan designation as Humate-P, it determined that Octapharma had a legitimate claim for superior safety. Wilate involves two viral inactivation processes, whereas Humate-P involves one.
The FDA’s Office of Orphan Products Development grants orphan drug status to unique drugs or biologics to treat rare diseases, those affecting fewer than 200,000 people. Approved products go through an expedited review process, ensuring that therapies become available earlier to patients with rare life-threatening diseases who need effective treatments.
Source: drugs.com, August 10, 2012
Dads in Action Webinar Series
The Hemophilia Federation of America is hosting a webinar for Dads. Maintaining strong, healthy joints is extremely important for children with bleeding disorders. Join the webinar to learn age-specific strategies for improving overall joint health, what to do following a bleed or injury to support the joint until it's fully healed, and tips that will help you create a plan that includes activities your child enjoys and that fits into your lifestyle. All parents are welcome.
We know living with bleeding disorders is a challenge. That's why we created the Fall Family Retreat! Open to families and adults with bleeding disorders, the Retreat is an informativeand fun 3 day retreat in New York's scenic Adirondack Mountains.
The Family Retreat is FREE and includes:
- Separate adult and youth activities.
- Hands on information programs.
- The chance to make new friends who share your challenges!
Camp Aldersgate features comfortable heated and furnished cabinson over 100 acres of land bordering two lakes.
Space is limited, so apply early! A $50 deposit is asked to reserveyour place and will be returned to you when you arrive. Gas money is provided if you need. The deposit can be waived for those who qualify.