US Hereditary Angioedema Association


IN THIS ISSUE
Advocacy Corner HAEA Study on Insurance Denials HAE Speaks Podcast BeyondHAE Podcast Support Groups	HAEA Community Blog: HAE At A Young Age Clinical Trial Updates HAEA Events Calendar Social Media Snapshots

Join the HAEA Grassroots Advocacy Network!

There is nothing more important to the future health of our community than protecting full access to HAE therapies, financial support for treatment, and funding for HAE research. We are, however, facing ever-increasing challenges that could threaten the progress that all of us worked so hard to accomplish in gaining access to and reimbursement for multiple therapies. Maintaining and even improving the availability of HAE medicines will only happen through continued fierce and well-organized grassroots advocacy.

We invite you to join the fight and become part of the HAEA Grassroots Advocacy Network!

The HAEA Grassroots Advocacy Network brings together HAE advocates who are passionate about safeguarding the health and well-being of people with HAE. Grassroots advocacy opens the door for communicating the HAE message and educating your elected officials on the federal and state levels.

Members will:

Receive updates on policies affecting the HAE community that include
- Legislation affecting the HAE community,
- Advocacy alerts and newsletters,
Participate in online and in-person training on how to be an effective advocate, and
Become a part of a larger community.

Members will support the HAE community by:

Advocating for uninterrupted access to HAE treatment
- Conducting outreach with elected officials in Washington DC as well as in your local state
Providing testimony and writing letters or emails to elected Representatives
- Sending Letters of Support – we will provide letters (that you can customize) that will be sent to members of Congress through our electronic system Voter Voice, and
- Organizing and participating in local awareness events.

The youngest members of our community are also strongly encouraged to be part of the HAEA Grassroots Advocacy Network by joining our Youth Advocacy Network.

The Youth Advocacy Network is a branch of the HAEA’s Grassroots Advocacy Network that offers specialized youth-focused training and advocacy opportunities for teens and young adults. The Youth Advocacy Network amplifies our collective voices by rallying young people between the ages of 12 and 25 to become active players in communicating the needs of the HAE community to elected representatives.

Program Goals:

Educate youth and young adults about the importance of playing an active role in advocacy and HAE legislative programs
Empower young people to become HAE advocates to ensure they have a growing impact on public policy affecting the HAE community
Inspire the next generation of HAE community leaders
Represent each US state with HAEA Youth Advocacy Network members

Are you ready to learn more about advocacy, and move forward policies that benefit the HAE community?

For more information about the program, please contact Mike Mallory at mikemallory@haea.org.

Ready to join? Become a member of the HAEA Grassroots Advocacy Network here!

HAEA Sponsored Study Reveals Harmful Impact of Insurance Denials for HAE Medicines

Members of our community who face insurance company decisions to delay or initially deny coverage for a prescribed HAE medicine are forced to somehow cope with a wide range of devastating consequences. The HAEA commissioned a study to highlight the disturbing and costly effect of delays and denials as part of our continuing campaign to reduce delays and denials by demonstrating the holistic value of HAE medicines.

In our study:

70% of participants reported an increased frequency of attacks resulting from insurance delays
More than 50% missed work/school days because of increased attacks,
90% reported greater anxiety,
25% of respondents reported an increase in costly urgent care or emergency department visits,
Almost all participants reported that insurance-related problems had a negative impact on

health,
family, and
work/school life.

The full article published in the prestigious Journal of Allergy and Clinical Immunology in Practice can be accessed for free by clicking on this link.

Podcasts

HAE Speaks Podcast

HAE Speaks Podcast - Episode 38: In this episode of HAE Speaks podcast learn more about hosting an HAE DIY event. Missy speaks with Mike about DIY events and the many HAEA resources available to assist you with planning your event. Also, listen in as Missy sits down with Lora and participants at the Lyndon Memorial Walk, a DIY HAE awareness event.

Listen Now!

Do you have a topic, question, or idea that you would like us to cover? Send your suggestion to Mike Mallory at mikemallory@haea.org.

#BeyondHAE Youth Podcast

Youth Podcast series

The #BeyondHAE Digging Deeper Interview series continues this month with our guest, Nathan, who chats with HAEA Youth Leadership Council Member Noah about what it's been like for him growing up with HAE. Nathan joined us from his study abroad program in Switzerland where he is attending college. Nathan discusses what it's been like studying abroad with HAE and what he did to prepare for his time away from home. If you're thinking about traveling internationally or applying for a study abroad program, you won't want to miss this episode! This is Nathan's story.

Listen to the Podcast here!

HAE Speaks and #BeyondHAE are available to download on Apple Podcasts, Spotify, or wherever you get your latest podcasts!

HAEA CARE GROUPS (Community, Acceptance, Respect, Empathy)

Over the last six years the HAE Heroes Connecting virtual support groups have provided opportunities for our HAEA community members to connect and guide each other. As we continue to explore new ways to uplift each other and practice self-care, we are excited to share that the HAE Heroes Connecting groups will now be called the HAEA CARE GROUPS (Community, Acceptance, Respect, Empathy). We look forward to the continued empowerment of our HAE family to be a resilient community with acceptance, respect, and empathy for the experiences of us all.

July is National Family Reunion Month so the theme of our support group meetings is celebrating the community of our HAE family! Many members of our community will be getting together for our National Patient Summit, and we can’t wait to be reunited with those who will be attending.

We will continue to meet at the following times:
1st Wednesday of the month 7:30 PM ET / 4:30 PM PT
2nd Thursday of the month 11:00 AM ET / 8:00 AM PT
3rd Tuesday of the month 10:00 PM ET / 7:00 PM PT

You can find the dates and times of the upcoming HAEA CARE GROUPS in the HAEA Events Calendar section below.

The HAEA CARE GROUPS are held virtually once a month through Zoom. Join us next month when we talk about Relaxation 101: How do we find new ways to relax?

These virtual group meetings offer opportunities for our community to share experiences and support others. Interested in joining one of these monthly support groups? Contact the HAEA Health Team for more information by calling 866-798-5598 or emailing an advocate at health@haea.org.

Being newly diagnosed with HAE can bring about extreme challenges and uncertainty, especially when you’re the first individual in your family to receive a diagnosis.

This month’s HAEA Community Blog article focuses on HAEA Social Media Intern, Wessam, as he describes his journey to an HAE diagnosis as a young child, the challenges he has faced along the way, and how getting involved with advocacy has changed his perspective on his diagnosis.

Access the HAEA Community Blog today and read HAE at a Young Age, by clicking on the link HERE!

Would you like to share a unique story or opinion about your HAE? The HAEA Community Blog is the perfect venue to share your personal story with other members of the HAE community. You can share your story HERE!

Clinical Trial Updates

What is a Clinical Trial?

Clinical trials are research studies conducted to evaluate whether a medicine to treat HAE is safe and effective in humans. Clinical trials are a critical part of drug development and are required before a treatment can be approved by the Federal Drug Administration (FDA) and become available by prescription.

What are the benefits of participating in a Clinical Trial?

Clinical trials can offer an open-label extension, which means free access to HAE medicines being studied until they are approved and commercially available. Participation in a clinical trial also provides regular touchpoints with an HAE physician throughout the trial period, and allows you to have a more active role in your health care.

Following is a list of clinical trials currently underway. If you are interested in receiving more information on clinical trials, or are interested in participating in any of the trials listed below, please reach out to the HAEA Research Team at research@haea.org.

The ALPHA-STAR Trial

The US HAEA is currently assisting Astria Pharmaceuticals in recruiting people for the ALPHA-STAR trial, a Phase 1 study evaluating a new medicine (STAR-0215) for long acting prevention of HAE attacks. STAR-0215 is delivered subcutaneously once every 3 months or in some cases even less frequently. This trial is not placebo controlled, so each participant will receive the trial medication.

You may qualify for the ALPHA-STAR study if you are 18 years of age or older and diagnosed with HAE Type I or II, have had at least 4 attacks in the past year and are not on preventative therapy. Individuals currently on preventative therapy and interested in participating should consult with their physician to discuss the risks and benefits before discontinuing medication.

The OASIS-HAE Plus Study

The US HAEA is currently assisting IONIS in recruiting people with HAE for the OASIS-HAE Plus study.

The OASIS-HAE Plus study is an open-label extension study without placebo, evaluating the safety and effectiveness of an investigational subcutaneous preventive medicine called donidalorsen, which is given either once every 4 or 8 weeks. This investigational drug uses a technology called antisense, which targets the kallikrein generating system using messenger RNA to suppress the protein that produces kallikrein.

To qualify for the OASIS-HAE Plus study, participants must be 12 years of age or older with a documented diagnosis of HAE. This study will help researchers learn if the study drug is safe and effective for people with HAE when given over a long-term period. Participants in the OASIS-HAE Plus study are either switching over from a different prophylaxis therapy, or continuing on from another donidalorsen study.

HAERMONY₁ Study

The US HAEA is currently assisting BioMarin in recruiting people with HAE for the HAERMONY1 study, an investigational gene therapy called BMN 331 to improve HAE symptoms in adults 18 years of age and older diagnosed with HAE due to C1-INH deficiency.

To qualify for the HAERMONY₁ study, participants must be 18 years of age or older; diagnosed with HAE due to C1-INH deficiency; have 6 months of a continuous prophylaxis or on-demand treatment regimen (prior to study enrollment); and a documented attack frequency of at least 1 attack per month on average.
*Additional study requirements apply.

For those who qualify, participation lasts about 5 years after receiving the study drug. There are weekly and monthly visits during the first year. After the first year, the visits occur every three or every six months.

If you have HAE Type I, Type II, or HAE with Normal C1-Inhibitor and are interested in learning about new clinical studies to prevent attacks, please contact an HAE advocate at 866-798-5598 to see if there will be an active clinical trial site in your area.

HAEA Events Calendar

Thursday, July 27, 2023 - 7:00 PM ET / 4:00 PM PT

HAEA Treatment Education Series Webinar: This is My Takhzyro Experience- Imagine Yours(VIRTUAL)

Speakers: Dr. Daniel Soteres, MD and Pam C. (Person living with HAE)
Sponsored by: Takeda
Link Webinar: https://haea.zoom.us/j/82021050074
Phone: +1 305 224 1968 (Webinar ID: 820 2105 0074)

Upcoming HAEA CARE GROUPS:

Thursday, July 13th, 2023 - 11:00 AM ET / 8:00 AM PT
Tuesday, July 18th, 2023 - 10:00 PM ET / 7:00 PM PT
Wednesday, August 2nd, 2023 - 7:30 PM ET / 4:30 PM PT

If you are interested in joining a virtual support group, please reach out to an advocate by calling 866-798-5598 or emailing health@haea.org.

Social Media Snapshots

Don’t miss the latest HAEA news and announcements, connect with us on social media!

Update your HAEA membership information HERE!


10560 Main Street, Suite PS40 Fairfax City, VA 22030		CONTACT AN HAE ADVOCATE: (877) 839-4232
DONATE		JOIN HAEA
The HAEA is an advocacy and research organization committed to actively engaging our community in a wide variety of grassroots activities that promote HAE education and awareness. We provide personalized services to address the unique needs of people with HAE and their families, which includes helping them secure access to and reimbursement for modern HAE medicines. Our great success in supporting clinical research has resulted in a variety of FDA-approved therapeutic options. We work closely with expert physicians to continuously upgrade our community’s quality of life through improving diagnosis and knowledge of the condition, and encourage an individualized approach to selecting an optimal treatment. The HAEA is product and company neutral and continues to enthusiastically support drug discovery research aimed at the next generation of HAE therapies. Copyright © (2023) US Hereditary Angioedema Association All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means, mechanical, electronic, photocopying, recording, or otherwise without the prior written permission of the US Hereditary Angioedema Association. For information, send an email to info@haea.org.