US Hereditary Angioedema Association


IN THIS ISSUE
2023 hae day :-) Major Medical Journal Publishes HAEA-led Study on Negative Impact of Insurance Denials Support Groups HAEA Community Blog	HAE Speaks Podcast Clinical Trial Updates HAEA Events Calendar Social Media Snapshots

Congress Joins in Celebrating hae day :-) 2023

In a speech appearing in the Congressional Record, Congressman Gerry Connolly of Virginia called on his peers to continue to improve coverage and access, and lowering out-of-pocket costs for people with HAE. The Congressman stressed the dangers people with HAE face due to arbitrary barriers to accessing care and therapies.

You can read the Congressional Record article with Congressman Connolly's remarks here.

The overwhelming participation in this year’s hae day :-) campaign reflects our community’s strong and growing commitment to the cause of continuously improving quality of life for people with HAE. Your impressive engagement in hae day :-) activities and contribution of meaningful photos resulted in record-breaking levels of raising HAE awareness.

Check out all the photos on our hae day :-) photo wall here!

Major Medical Journal Publishes HAEA-led Study on Negative Impact of Insurance Denials

In 2022, the US HAEA funded a series of four focus groups in partnership with the University of Michigan to examine the impact of insurance delays and denials on the health and well-being of patients with HAE. This research aimed to show that although modern therapies have dramatically increased quality of life, insurance changes, delays, and denials are becoming more common.

20 participants were recruited to complete a pre-work survey, and 19 of the participants continued on to take part in focus groups addressing the impact of insurance challenges on the use of healthcare services, work/school attendance, impact on family life and anxiety.

We are pleased to report that a manuscript of this research has been accepted for publication in The Journal of Allergy and Clinical Immunology: In Practice. You can access the publication free of charge by visiting this link.

Here is the AAAAI Press Release:

https://www.aaaai.org/About/News/News/2023/insurance

It is only with the continued support of the HAE Community that the HAEA can provide relevant and timely research initiatives, and we thank you for your support!

HAE Heroes Connecting: June Topic - Self-Care in the Great Outdoors

Outdoor activities can boost our physical and emotional wellness! In this month’s HAE Heroes Connecting virtual support groups we will share ideas for self-care activities that take place outside, and explore ways to stay safe during our fun in the sun.

You can find the dates and times of the upcoming HAE Heroes Connecting virtual support groups in the HAEA Events Calendar section below.

The HAE Heroes Connecting virtual support groups are held once a month through Zoom. Join us next month when we talk about the community events as reunions for our HAE family!

These group meetings offer opportunities for members of the HAE community to share their experiences and provide support to 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.

You’ve completed your diagnostic journey and have been diagnosed with Hereditary Angioedema (HAE). Your doctor has prescribed a treatment protocol and you discover that your healthcare insurance will not cover the cost of the medicine. Now what?

This month’s HAEA Community Blog Article gives tips on how you can navigate your HAE and insurance journey.

Access the HAEA Community Blog today and read You, Your Medications, and Your Healthcare Insurance, written by Anita Wilkerson, an Individual with HAE, by clicking 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!

Podcasts

HAE Speaks Podcast

HAE Speaks Podcast - Episode 37: In this episode of the HAE Speaks podcast Missy talks with Bobbi and Mike about their journey of living with HAE and also the transition of becoming caregivers for their children diagnosed with HAE.

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.

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, June 29, 2023 - 7:00 PM ET

HAEA Treatment Education Series Webinar: A view of ORLADEYO (berotralstat) through people’s real-life experiences (VIRTUAL)

Date: Thursday, June 29, 2023
Time: 7:00 PM ET / 4:00 PM PT
Speakers: Frank Lichtenberger, MD and BioCryst Director of Patient Access, Amara Stuckert, PACS
Sponsored by: BioCryst
Link Webinar: https://haea.zoom.us/j/84888003930
Phone: +1 646 558 8656 (Webinar ID: 848 8800 3930)

Upcoming HAE Heroes Connecting Support Groups:

Thursday, June 15th, 2023 - 11:00 AM ET
Tuesday, June 20th, 2023 - 10:00 PM ET
Wednesday, July 5th, 2023 - 7:30 PM ET

If you want to join a virtual support group, please contact an HAE advocate at health@haea.org.

Tuesday, June 13th, 2023 - 6:30 PM ET

HAEA Round Table: Women and HAE (VIRTUAL)

Location: Virtual
Watch on the US HAEA official Facebook page here!

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.