On behalf of the HAEA team, I wish you a joyous holiday season. The positive spirit of our HAEA community prevailed throughout 2021 as we met the challenges posed by the COVID 19 pandemic. We welcomed the first oral preventive therapy and continue laying the groundwork for future treatment innovation. The HAEA family’s willingness to participate in clinical trials and be part of a visible and organized nationwide advocacy movement has resulted in active development of no less than 13 new HAE treatments.

Throughout 2021, the HAEA has focused on providing programs, services, and activities that bring our community together, and protect and expand access to currently approved HAE medicines.

Despite not being able to meet in person for our regular biannual Summit, the first ever HAEA Virtual Summit series was a huge success with active participation by over 1200 HAEA friends. The Series included highly important and topical HAE-related information from expert HAE physicians, insurance company representatives, HAE Youth, the HAE International team, and the FDA. The enthusiasm shown during all four segments of the virtual summit series made it clear that HAEA friends took this year’s hae day :-) slogan, “Take Action for HAE” to heart.

In addition, we saw record breaking participation in HAEA events such as the 2021 Virtual Capitol Hill Campaign, HAEA Meet & Greet Events, 2021 HAE IN-MOTION® Virtual Challenge, Youth Meet and Greets, and Treatment Education Webinars.

Issues surrounding access to and reimbursement for approved HAE medicines received considerable attention throughout the year. We presented an HAEA-initiated study at a national meeting of health insurers showing that the stress associated with delays and denials in access to therapy caused a 70 percent increase in attacks. This study also formed the basis for the US HAEA Insurance Reimbursement Guidebooks that we published to help HAEA friends understand and navigate the complex and often confusing insurance process.

The power of our voice as a united community was on display when a prestigious medical journal published HAEA research that showed the true value of certain HAE medicines. Our research, based on real world information provided by over 800 HAEA friends, convincingly contradicted a poorly designed study (featured in an insurance industry journal) alleging HAE medicines are not cost effective.

Pandemic challenges notwithstanding, our nationwide advocacy movement continues to gain momentum as our community embraces the goals of increasing HAE awareness and education, empowering access to suitable treatment, and fostering groundbreaking research to increase quality of life. Your fellow people with HAE and caregivers at the HAEA are grateful for the opportunity to serve you.

Wishing you a joyous holiday season!

Warmest regards,

Tony Castaldo

US HAEA President & CEO

The HAEA Youth Programs support the youngest members of our community during all stages of their HAE journey. The programs are designed to empower, educate, and inspire youth to lead happy and healthy lives and participate in the management of their HAE.

In addition, we recognize that our HAEA youth are the advocates of the future, and that is why we put great emphasis on building a diverse and dynamic Youth Advocacy Training Program.

In 2022, we will offer learning opportunities focused on topics such as how to:

• raise HAE awareness in the school environment and through social media communications, and
• effectively advocate for the HAEA youth community’s needs by engaging elected representatives.

Your charitable contribution of $20, $50, $100, or hopefully more, will support the HAEA’s Youth Programs and prepare the next generation of advocates.

INSPIRE Donate $100 to the Pam King HAEA Scholarship Program and help a student with HAE attend college. The HAEA provides scholarships of up to $2,500 twice a year.

EMPOWER Donate $50 to support the highly successful Youth Advocacy Program that teaches young people with HAE how to engage with elected representatives and advocate for themselves and the needs of the HAE community.

ENGAGE Donate $20 and we will send copies of the HAEA Children’s Book Series to local school libraries to help raise awareness about HAE.

Your generous tax-deductible contribution is an investment in the many ways we inspire, empower, and engage the next generation of HAEA leaders.

Click HERE to make a difference

Or send a check to: Hereditary Angioedema Association 10560 Main Street Suite PS40 Fairfax City, VA 22030 Please write “families for HAE” in the memo!

Many in the HAEA Community rely on financial assistance to help with copays--the portion of an HAE medicine’s cost that is not covered by insurance. Historically, copays have been counted toward reaching deductible and maximum out-of-pocket (OOP) limits, regardless of the payment sources. Unfortunately, many health plans are now amending their policies to exclude copays from third parties and charitable organizations from applying to deductibles and OOP maximums. HR 5801 will prevent insurers from making this ill-advised change to health insurance policies.

We urge all the HAEA friends to help raise awareness and support for this extremely important legislation by posting your support on social media and sending emails to your Senators and representatives in the House.

We urge all the HAEA friends to share your support for the bill by contacting your representatives here and via social media.

If you would like more information on HR 5801, or if you would like to participate in HAEA’s advocacy efforts, please contact an HAE Advocate, at (866) 798-5598 or info@haea.org.

As the end of the year is upon us, we wanted to review some important reminders. Navigating insurance issues will be a lot easier if you stay organized and are prepared with essential documents. Each medication has specific requirements, so be sure you are familiar with what is needed for your medication and have it readily available.

Prior Authorization (PA) renewals are submitted to insurance companies every 6-12 months as part of getting access to HAE medicines. Mark your calendar in advance of when your next PA is due and check with your physician’s office to make sure they have sufficient information to make a timely submission.

Common Requirements needed for PA renewals include:

• Confirmed diagnosis of HAE, Journal of HAE attacks, past/present therapies
• Lab Work (C1INH antigenic, C1 function, C4) *Please keep a copy of the lab tests results
• Prescriber Information, Statement of Medical Necessity
• Up to date clinical notes from physician and must be seen once a year
• Peer reviewed articles that support your therapy
• Family History of HAE (if any)
• Insurance Information

As a reminder - PSI (Patient Services Inc) and TAF (The Assistance Fund) are Patient Assistance Programs available to help with copays, medication, insurance premiums, travel and more.

PSI (Patient Services Inc) is open and accepting applications currently.

• https://www.patientservicesinc.org/patients/ to Apply Online

TAF (The Assistance Fund) is waitlisted for enrollment

• Tafcares.org to Apply Online

INSURANCE OPEN ENROLLMENT continues to be open for Medicare Prescription Drug Plan and will close on December 7th, and ACA Plans will close on December 15th. If you do not have coverage or are unhappy with your plan, NOW is the time to change.

We wish a joyful holiday season and a Happy New Year!

The HAEA Health Team is always here for you! Please reach out to us at 866-798-5598 for assistance with: 1) insurance issues, 2) finding an HAE expert physician, 3) updating your member information, 4) joining a virtual support group, or 5) an HAE-related question.

The HAEA is pleased to recognize dedicated HAEA Healthcare Hero, Mark Stevens, MD!

“Dr. Stevens is an amazing advocate for his Hereditary Angioedema (HAE) patients. He is kind, understanding, and extremely knowledgeable. He is always up-to-date on the latest research and medications, and doesn’t hesitate to make sure that his patients have the best treatments available for them; even if that means extra paperwork, phone calls, or patient advocacy. He is a phenomenal doctor!” - Dawn

Thank you Dr. Stevens for your dedicated service to the HAE community!

We invite you to download and listen to HAE Speaks, a podcast exclusively created for the HAEA community. The podcast series presents unique stories of individuals affected by HAE with the goal of connecting our community through shared experiences. We invite you to add HAE Speaks to your podcast playlist and listen on all major podcasting platforms!

Episode 20: HAEA year in review. The Hereditary Angioedema Association continues to be the galvanizing force advocating and supporting the HAE community. In this episode, the HAEA staff provides a review of 2021 programs and accomplishments.

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

In this month’s episode of the #BeyondHAE Youth Podcast, we invite you to listen to Jess and Hannah’s story. They describe how meeting someone else their age with HAE changed their outlook on life and helped them to feel validated in their struggles with the rare chronic illness.

The #BeyondHAE Youth Podcast series is a podcast produced BY young people with HAE FOR young people with HAE. Listen to stories from young people affected by HAE as they share the ways that they navigate life with HAE or support a diagnosed family member.

RAPIDe-1 Study

The US HAEA is currently assisting Pharvaris in recruiting people with HAE for the RAPIDe-1 study, a worldwide clinical research study to investigate the safety and effectiveness of an investigational oral drug to relieve the symptoms of Hereditary Angioedema (HAE) attacks. There are currently 5 active sites in the US.

In the RAPIDe-1 study, doctors will be evaluating how effective three different doses of the study medication (PHVS416) are in relieving symptoms associated with HAE attacks. The study drug is in the form of soft capsules taken by mouth.

To qualify, participants must be diagnosed with HAE Type I or II and be between the ages of 18 and 75 years old, with at least 3 attacks in the last four months or 2 attacks in the last two months. The use of an approved on-demand medication to treat acute attacks is permitted.

CSL312 Study

The US HAEA is also assisting CSL Behring in recruiting people with HAE for the CSL 312 Garadacimab study, a worldwide clinical research study to investigate the safety and effectiveness of an investigational subcutaneous medication given once a month to prevent Hereditary Angioedema (HAE) attacks. There are currently 10 active sites in the US.

In this study, doctors will be evaluating Garadacimab, to assess its effectiveness at preventing HAE attacks by comparing it to placebo (inactive drug).

People diagnosed with HAE (at least 12 years of age with Type I or Type II HAE) who participate in this study may receive either Garadacimab or placebo for six months. During that time, using on demand medication to help with acute attacks will be permitted.

Normal C1-Inhibitor Trial

The US HAEA continues to support Takeda’s efforts in recruiting people with HAE with Normal C1-Inhibitor for their clinical trial. Individual sites will comply with state and local guidelines and safety protocols for bringing individuals into clinics. There are currently 14 active sites in the US.

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.

Enlace de la conferencia: https://haea.zoom.us/j/84151428506

Número de teléfono: +1 (646) 558-8656 (Webinar ID: 841 5142 8506)

Get to know other HAEA members from your community! The HAEA Virtual Meet & Greet Events are a perfect way to reach out and get to know others affected by HAE in your area. If you are interested in participating in an HAEA Virtual Meet & Greet, please check out the HAEA Events Calendar or reach out to Mike Mallory at mikemallory@haea.org.

What would you tell someone who is considering attending a future HAEA Meet & Greet?

"The Information gained in these meetings can change your outlook on life." John F.

Tuesday, December 14th, 6:30 ET

• GA and FL

Tuesday, January 25th, 6:30 ET

• https://fundraise.haea.org/January2022

Register today to receive a FREE HAEA swag bag after the event!

For more information, please contact Mike Mallory at mikemallory@haea.org or 513-858-9370.