FOR IMMEDIATE RELEASE: May 3, 2012

Contact: Richard Pezzillo (202)-675-6984 r.pezzillo@hemophiliafed.org

Link to PDF of HFA Celebrates Hepatitis Awareness Month

Washington, D.C. – In 2001, the Centers for Disease Control (CDC) and Prevention designated the month of May as Hepatitis Awareness Month to bring awareness and attention to those living with viral hepatitis.

In the 1980s and 1990s, thousands of people with hemophilia contracted HIV and Hepatitis C (HCV) from the contaminated blood supply transmitted by clotting factor products. According to CDC Universal Data Collection (UDC), of the 18,300 patients with bleeding disorders (hemophilia and von Willebrand) currently receiving care at specialized comprehensive care Hemophilia Treatment Centers (HTCs), approximately 6,950 have tested positive for Hepatitis C. This chronic condition causes liver damage, liver failure, and has become the leading cause of death among adults with hemophilia.

“National Hepatitis Awareness Month helps to bring public awareness about viral hepatitis and encourages the development of improved prevention, education, and treatment,” said Kimberly Haugstad, Executive Director of HFA.  “We are committed to addressing the evolving needs of the bleeding disorders community to create a better quality of life for all persons with bleeding disorders.”

“The current Hepatitis C treatments are difficult and often times ineffective,” said Chad Blair, a young man with hemophilia and Hepatitis C. “We need to put pressure on our legislators to allow the development of new treatments.”

HFA encourages member organizations and patients affected by a bleeding disorders to spread the word about Hepatitis Awareness Month by posting messages on Facebook, Twitter, giving presentations in schools, and sharing information with their family and friends.

About Viral Hepatitis*

Hepatitis A

Hepatitis A is an acute liver disease caused by the Hepatitis A virus (HAV), lasting from a few weeks to several months. It does not lead to chronic infection.

Transmission: Ingestion of fecal matter, even in microscopic amounts, from close person-to-person contact or ingestion of contaminated food or drinks.

Vaccination: Hepatitis A vaccination is recommended for all children starting at age 1 year, travelers to certain countries, and others at risk.

Hepatitis B

Hepatitis B is a liver disease caused by the Hepatitis B virus (HBV). It ranges in severity from a mild illness, lasting a few weeks (acute), to a serious long-term (chronic) illness that can lead to liver disease or liver cancer.

Transmission: Contact with infectious blood, semen, and other body fluids from having sex with an infected person, sharing contaminated needles to inject drugs, or from an infected mother to her newborn.

Vaccination: Hepatitis B vaccination is recommended for all infants, older children and adolescents who were not vaccinated previously, and adults at risk for HBV infection.

Hepatitis C

Hepatitis C is a liver disease caused by the Hepatitis C virus (HCV). HCV infection sometimes results in an acute illness, but most often becomes a chronic condition that can lead to cirrhosis of the liver and liver cancer.

Transmission: Contact with the blood of an infected person, primarily through sharing contaminated needles to inject drugs.

Vaccination: There is no vaccine for Hepatitis C.

Information source: Center for Disease Control and Prevention. For more information please visit www.cdc.gov.

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The Hemophilia Federation of America is a national 501(c) (3) organization consisting of more than 30 member organizations and numerous individual members who offer assistance and grassroots advocacy on behalf of the bleeding disorders community.   Incorporated in 1994, the HFA provides programs and services to improve the quality of life for persons with hemophilia, von Willebrand disease (VWD) and other rare bleeding disorders.

For more information, visit our website at www.hemophiliafed.org or call 1-800-230-9797.

A federal judge has denied the request of a group of community pharmacists to immediately stop the acquisition of Medco Health Solutions by Express Scripts, Inc. The judge will next decide whether to throw out the lawsuit.

The pharmaceutical benefits management companies Express Scripts and Medco merged on April 2, after the Federal Trade Commission announced it would not block the deal. The companies had announced their plans in July 2011.

Community pharmacists — represented by the National Association of Chain Drug Stores, the National Community Pharmacists Association and nine community pharmacies — filed suit in March against the $29 billion deal in U.S. District Court for the Western District of Pennsylvania. The groups said that neighborhood pharmacies and consumers would be at a disadvantage if the two companies were allowed to join forces, which could lead to reduced competition. They asked the court to block the deal while the lawsuit is pending.

On Wednesday, Federal District Court Judge Cathy Bissoon said that the pharmacists “have not met their burden to establish the likelihood of immediate, irreparable harm” that would require the court to issue a preliminary injunction. Furthermore, she wrote that “the fears expressed by plaintiffs already have been realized.” The two companies have already shared proprietary information with each other and most of Medco’s senior staff have left. If she granted the pharmacists’ request to keep the two companies separate, the result for Medco even back in early April would have been “a headless organization that would likely be unable to survive on its own, much less compete against” Express Scripts.

The company has asked that the pharmacists’ case be dismissed, a motion that Bissoon is currently considering.

The pharmacists said in a joint statement on Thursday that “we presented a compelling argument for the court to suspend the combination of Express Scripts and Medco until the merits of our complaint could be considered in full. It is important to note that the judge has not yet ruled on the merits of the case or the motion to dismiss, so the case is continuing.”

PBMs act as middlemen who negotiate with drugmakers for the lowest possible prices on behalf of insurance plans, passing those savings on to the plans and others. The drug benefit managers also run their own mail-order and specialty pharmacies. This deal creates the biggest PBM in the country.

The community pharmacy companies are backed by consumer groups such as the Consumer Federation of America, National Consumers League, National Legislative Association on Prescription Drug Prices and the Public Interest Research Group. The consumer advocates wrote in a brief to the court that they are “concerned with the abusive, anti-consumer conduct” of the PBMs.

The FTC investigated the deal for eight months before the panel decided that it would not take action to block it. The retail pharmacists hope that their lawsuit against the combined company will give them one more chance to thwart the deal.

Friends and supporters,

We should all be enormously encouraged by the increasing cascade of promising results from investigational HCV drug trials.  A couple of years ago, greatly improved therapy was a dream.  Now, some investigational drug combinations show good cure rates with low side effects and greatly reduced treatment timeframes.  Pharmaceuticals are engaged in a race to test and document such combinations.  Many expect that hard work and market incentives are likely to result in prescription-availability of much better therapies in the next three years.  But we, people with bleeding disorders, do have specific needs, and specific reasons to push for the fastest possible access to promising investigational therapies.

● In the first place, we are medically different from the average HCV community as a whole.  We are more susceptible to side effects affecting hemostasis (clotting ability), plus, we’ve all had HCV for a very long time, often starting early in childhood.  Because we’re different, some clinical trial data for people with bleeding disorders and HCV would help inform therapeutic decisions immediately after new drugs are approved.
In this regard, one pharmaceutical firm has agreed to provide “People with Bleeding Disorders and HCV”  with timely notice on clinical trials for their particularly promising drug.  We will circulate all notices to our mailing list and to the national bleeding disorder organizations, with the hope that trial participation from the bleeding disorders community may provide our treaters with information on community-specific side effects/efficacy when therapies first become available for prescription.

Better notification of upcoming clinical trials may be helpful for individuals who are eligible, but who have found trials to be fully subscribed by the time they hear of them.  However, this notification activity will probably not be helpful to those with advanced disease because often they do not meet trial eligibility requirements.

● In the second place, a substantial percentage of our adult population (25% according to one recent paper*) has advanced liver disease.  These people need therapy the most, but they are the worst candidates for current standard therapy, and they are frequently excluded from trials because of the severity of their condition.  Under normal procedures this group (or whatever percentage of them survives) will see no relief till much better new drugs are fully approved.  In circumstances such as ours, FDA has told us** that they will encourage pharmaceuticals to provide special relief  via curative protocols***.

We are in communication with several pharmaceutical firms about curative protocols.  We think that we would be a little more effective with pharmaceutical firms and with FDA if we could state that we have a list of individuals (perhaps several dozen) who are endangered by advanced HCV disease and poor medical options, and would be willing to consider a curative protocol.  Please get back to us if you would like to be added to this list.  The list will never be released, but we will send you an email if a pharmaceutical firm offers a curative protocol … so that you can contact them.  Provide your name, address, and email.  Kindly note that this list is designed to include only people with bleeding disorders who are both:
- at substantial health risk without therapy within the next few years, and,
- poor candidates for existing approved therapies.

● Finally we’d like to mention a more long term effort.  Pharmaceutical innovators tell of substantial disincentives and weak incentives to pursue curative protocols.  We hope to discuss this with FDA and prescription drug policy groups.

Mark Antell and Paul Brayshaw for
People with Bleeding Disorders and HCV
access.hcv.therapy@google.com

Anna, a resident of New Jersey and former board member of HFA,  was one of the first to help drive awareness, educate and help correctly diagnose, manage, and treat women with bleeding disorders. She will be deeply missed.

Further information will be posted as it becomes publically available.

Shelly Mattson and Anna DeSimone, in 2006.

FOR IMMEDIATE RELEASE: April 12, 2012

Contact: Richard Pezzillo (202)-675-6984 r.pezzillo@hemophiliafed.org

Link to PDF of World Hemophilia Day 

Washington, DC– Today, Tuesday, April 17, tens of thousands of families across our nation and around the world are celebrating World Hemophilia Day to raise awareness of bleeding disorders.

“World Hemophilia Day brings public awareness about bleeding disorders and encourages the development of improved treatment,” said Kimberly Haugstad, Executive Director of Hemophilia Federation of America (HFA).  “Worldwide, 1 in 1,000 women and men have a bleeding disorder and 75% of them still receive inadequate or no treatment at all.  Today is about shining a light on a disorder too few understand, and too many are affected by. HFA stands with thousands of families around the world today in calling for better treatments and quality of life for those affected by bleeding disorders.”

World Hemophilia Day 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 the health of families.

Comprehensive care is particularly important to treating the physical, emotional, psychological, social, and educational needs of people with hemophilia and other bleeding disorders.

An estimated 3 – 5 million Americans have a bleeding disorder, including about 20,000 with hemophilia –- affecting all ethnic and economic groups.

*Photos and personal stories available and we can assist in setting up interviews.

**World Hemophilia Awareness Video: http://hemophiliafed.org/2012/04/10/world-hemophilia-day/

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.  Individuals with bleeding disorders lead productive lives with regular and ongoing access to needed treatments, therapies and when specialized medical professionals are available.

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.

About Hemophilia

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, the 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.

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Hemophilia Federation of America is a national 501(c) (3) organization consisting of more than 30 member organizations and numerous individual members who offer assistance and grassroots advocacy education on behalf of the bleeding disorders community. Incorporated in 1994, the (delete) HFA provides programs and services to improve the quality of life for persons with hemophilia, von Willebrand disease (VWD) and other rare bleeding disorders.

For more information, visit our website at www.hemophiliafed.org or call 1-800-230-9797.

]]> http://hemophiliafed.org/2012/04/17/press-release-families-throughout-the-u-s-celebrate-world-hemophilia-day/feed/ 0 http://hemophiliafed.org/2012/04/12/press-release-hfa-elects-new-executive-board-during-symposium/?utm_source=rss&utm_medium=rss&utm_campaign=press-release-hfa-elects-new-executive-board-during-symposium http://hemophiliafed.org/2012/04/12/press-release-hfa-elects-new-executive-board-during-symposium/#comments Thu, 12 Apr 2012 15:47:21 +0000 rpezzillo http://hemophiliafed.org/?p=13263 Read More »]]> HFA Elects New Executive Board During Symposium

FOR IMMEDIATE RELEASE: April 12, 2012

Contact: Richard Pezzillo (202)-675-6984 r.pezzillo@hemophiliafed.org

Link to PDF of HFA Elects New Executive Board

Washington, D.C. – During their recent annual Symposium in Santa Clara, California, the Hemophilia Federation of America’s (HFA) Board of Directors named Matthew T. Compton as the new board president of the national grassroots community based organization. Matthew is an active national leader in the bleeding disorder community and was elected after serving the organization as Vice President since 2009.

“I am honored to be elected as HFA President and look forward to working together with our member organization’s, to create a better quality of life for all persons with bleeding disorders,” said Compton.

Also elected at the meeting include: 1^st Vice President, Tracy Cleghorn, member of the Virginia Hemophilia Foundation; 2^nd Vice President, Ryan Crowe, member of the Texas Central Hemophilia Association; Treasurer, Carlos Ruiz, independent member from Georgia; Secretary, Lori Long, member from Sangre de Oro Hemophilia Foundation of New Mexico; Members at Large, Matthew Igelman, member of the Hemophilia Foundation of North Carolina and Steve Tejiram, member of the Hemophilia Association of Florida.

HFA also recognized the following board members who transitioned off the board for their commitment, hard work, and service:

Paul Brayshaw, President from 2009-2012, Hemophilia Association of the Capital Area

Chad Stevens, President from 2007-2009, Snake River Hemophilia and Bleeding Disorders Association

Brian Compton, Lone Star Hemophilia Chapter

Dan Tinklenberg, Hemophilia Foundation of Minnesota/Dakotas

Lesa Kaercher, Bleeding Disorders Association of the Southern Tier

Sandra Lilly, Oklahoma Hemophilia Foundation

James Dawdy, Hemophilia Foundation of Oregon

Stanford Murry, Tennessee Hemophilia and Bleeding Disorder Foundation

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Hemophilia Federation of America is a national 501(c) (3) organization consisting of more than 30 member organizations and numerous individual members who offer assistance and grassroots advocacy education on behalf of the bleeding disorders community. Incorporated in 1994, the (delete) HFA provides programs and services to improve the quality of life for persons with hemophilia, von Willebrand disease (VWD) and other rare bleeding disorders.

For more information, visit our website at www.hemophiliafed.org or call 1-800-230-9797.

HFA Begins Accepting Applications for Items Program 

Items Program Reimburses for Medically Necessary Items

FOR IMMEDIATE RELEASE  April 3, 2012

Washington, D.C. – Today, Hemophilia Federation of America’s (HFA) Helping Hands Emergency Assistance Program began taking applicants for the Bleeding Disorder Items Program — a program that Patient Services, Inc. (PSI) previously managed.

Since July 2003, PSI has operated the Bleeding Disorders Items Program, which is designed to reimburse patients with bleeding disorders for durable medical equipment and items including:

• Protective Gear
• Braces and Supports
• Walking Supports
• Heating/Cooling Items
• *Over the Counter Items
• *Nutritional Drinks

*Requires physician statement of medical necessity

PSI has transitioned the Items Program to HFA because the program no longer fits with their list of provided services.  PSI will work with HFA to ensure the program continues to run smoothly.  The Bleeding Disorder Items Program is made possible through donations from CVS Caremark, Specialty Therapeutic Care, and the University of California, San Francisco Adult Hemophilia Treatment Center.

If you are need of item assistance, please contact HFA at 1-800-230-9797 or fill out an online application here: http://hemophiliafed.org/what-we-do/programs-and-services/items-program/

About Hemophilia Federation of America

Hemophilia Federation of America is a national 501(c) (3) organization consisting of more than 30 member organizations and numerous individual members who offer assistance and grassroots advocacy education on behalf of the bleeding disorders community. Incorporated in 1994, the (delete) HFA provides programs and services to improve the quality of life for persons with hemophilia, von Willebrand disease (VWD) and other rare bleeding disorders.

About HFA’s Helping Hands Emergency Assistance Program

HFA’s Helping Hands Emergency Assistance Program is designed to establish a rapid, non-invasive source of relief for emergency situations or urgent needs to those persons who are affected by bleeding disorders.  Each year, HFA aids hundreds of families with emergency/urgent funding to assist in crisis situations such as housing, transportation, and utility bills.

About Patient Services, Inc.

PSI (www.patientservicesinc.org) is the “ground breaking” 501(c)(3) non-profit, charitable organization of its kind.  Founded in 1989 by Dana Kuhn, Ph.D., the Midlothian, Virginia based company has helped people who live with specific chronic illnesses or conditions locate suitable health insurance coverage and access ways to satisfy expensive co-payments.  PSI provides assistance with the cost of health insurance premiums associated with COBRAs, State High Risk Pools, Open enrollment, Guaranteed Issue policies, HIPAA conversion policies; and prescriptions co-payments associated with private insurance as well as with Medicare Parts B and D.

Contact: Richard Pezzillo (202)-675-6984 r.pezzillo@hemophiliafed.org

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Providing Less Volume to Infuse

ADVATE is now available with a 2 mL diluent (sterile water for infusion) volume for dosage strengths ranging from 250 IU to 1700 IU. This represents a reduction in diluent volume from 5 mL to 2 mL.  The new 2 mL diluent is another benefit offered by ADVATE for infusing smaller volumes.  ADVATE is now also approved for prophylaxis in both adults and children (0 – 16 years old).¹

ADVATE is a medicine used to replace clotting factor VIII that is missing in people with hemophilia A (also called “classic” hemophilia). ADVATE is used to prevent and control bleeding in people with hemophilia A. Your healthcare provider may give you ADVATE when you have surgery.

ADVATE is not used to treat von Willebrand Disease.

You should not use ADVATE if you are allergic to mice or hamsters or any ingredients in ADVATE.

Having seven potencies available with 2 mL diluent volume and three additional potencies available with 5 mL diluent volume, ADVATE offers a broad selection of doses and offers the opportunity for a single-vial option.¹

“Baxter is committed to people with hemophilia and their families across all life stages, from first diagnosis through adulthood,” said Ashish Sagrolikar, vice president, sales & marketing, Hemophilia Therapies, Baxter Healthcare Corporation. “We developed the 2 mL diluent vials in response to the community’s desire for a decreased volume to infuse.”

New color-coded packaging

ADVATE with a 2 mL diluent vial will be available in nominal dosage strengths of 250 IU, 500 IU, 1000 IU & 1500 IU, and in intermediate dosage strengths of 375 IU, 750 IU & 1700 IU.  The color of the unit carton and the label on the 2 mL diluent vials will be purple.

ADVATE with a 5 mL diluent vial will be available in nominal dosage strengths of 2000 IU & 3000 IU and in the intermediate dosage strength 2500 IU. The color of the unit carton for the 5 mL diluent configuration will remain yellow/orange.

All dosage strengths of ADVATE come with the BAXJECT II mixing device. Each unit carton of ADVATE with a 2 mL diluent vial also will include a 25-gauge (Terumo microbore) butterfly infusion set to help accommodate the smaller infusion volume.

You should be trained on how to do infusions by your hemophilia treatment center or your healthcare provider. A dose of ADVATE should be administered over a period of ≤ 5 minutes, up to a maximum infusion rate of 10 mL/min, regardless of the diluent volume.

Clinical Study

Baxter performed an open-label, multi-center, randomized, crossover study to compare the pharmacokinetics of ADVATE reconstituted in 2 mL vs. 5 mL diluent in previously treated adult and adolescent patients with severe hemophilia A. The study demonstrated that the same dose of ADVATE reconstituted in either diluent volume resulted in similar factor eight (VIII) levels in the body.

Please see below for Detailed Important Risk Information for ADVATE and the attached ADVATE full Prescribing Information.

For more information, visit advate.com or call 888-4-ADVATE.

DETAILED IMPORTANT RISK INFORMATION FOR ADVATE

You should not use ADVATE if you are allergic to mice or hamsters or any ingredients in ADVATE.

You should tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines and dietary supplements, have any allergies, including allergies to mice or hamsters, are nursing, are pregnant, or have been told that you have inhibitors to factor VIII.

You can have an allergic reaction to ADVATE. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting.

Your body may form inhibitors to factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, it may stop ADVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

Side effects that have been reported with ADVATE include: cough, sore throat, unusual taste, abdominal pain, diarrhea, nausea/vomiting, headache, fever, dizziness, hot flashes, chills, sweating, joint swelling/ aching, itching, hematoma, swelling of legs, runny nose/congestion, and rash.

Call your healthcare provider right away about any side effects that bother you or if your bleeding does not stop after taking ADVATE.

Please visit advate.com for full ADVATE Prescribing Information.

1. ADVATE prescribing information. Westlake Village, CA: Baxter Healthcare Corporation; December, 2011.

Baxter, Advate and Baxject are registered trademarks of Baxter International Inc. All other products or trademarks appearing herein are the property of their respective owners.

HFA Celebrates 2^nd Anniversary of Affordable Care Act

FOR IMMEDIATE RELEASE March 23rd, 2012

Washington, D.C. – Today marks the two-year anniversary of the passage of the Affordable Care Act, landmark legislation to reform our health care system in ways that lower costs and expand access to insurance coverage.  The law is already making a difference for families across the country by drastically improving access to higher quality care, addressing rising health care costs, and protecting consumers.  According to the Department of Health and Human Services (HHS), more than 5.1 million seniors and people with disabilities on Medicare saved billions on prescription drugs, thanks to the Affordable Care Act.

“HFA has consistently advocated for the needs of individuals with bleeding disorders,” said Kimberly Haugstad, Executive Director of HFA.  “Going forward, HFA will continue to highlight the benefits of the healthcare reform legislation and the need for effective implementation.”

Patients in the bleeding disorder community have seen the impact of this legislation on their personal lives. For example, the health care reform act allowed Alex, who has hemophilia from Oregon, from hitting a fourth lifetime cap, and allowed him more time to find a job with benefits after college.  The legislation has also allowed, Jenni from Tennessee, to no longer worry about her husband and son — who have von Willebrand diesase — from reaching their lifetime cap.

The Affordable Care Act has afforded our community with new rights and benefits. Like in Alex’s situation, parents have been able to keep their children on their family policy until the age of 26 or until they receive coverage through an employer.  Small businesses have received tax credits to help provide financial resources to cover the cost of health insurance premiums.  Insurance companies can no longer discriminate against children with pre- existing conditions and rescind a policy if you get sick.  Patients no longer have to pay deductibles or other costs sharing fees for preventative doctor visits and child immunizations.

Insurance companies can no longer place lifetime limits on plans and are restricted on the annual dollar limits that may place on a plan, with the eventual elimination of annual limits in 2014.  However, it is still unclear how the federal government will provide administrative and financial resources to states by 2014 when all individuals are mandated to have health insurance.

Contact: Richard Pezzillo (202)-675-6984 r.pezzillo@hemophiliafed.org

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Hemophilia Federation of America is a national 501(c) (3) organization consisting of more than 30 member organizations and numerous individual members who offer assistance and grassroots advocacy education on behalf of the bleeding disorders community. Incorporated in 1994, the (delete) HFA provides programs and services to improve the quality of life for persons with hemophilia, von Willebrand disease (VWD) and other rare bleeding disorders. For more information, visit our website at www.hemophiliafed.org or call 1-800-230-9797.