Advocacy In Action
The Lupus and Allied Diseases Association (LADA) supports initiatives that address barriers to healthcare access in order to ensure individuals receive the most appropriate therapies as directed by their treating healthcare professionals and consistent disease management is preserved.
We strongly support establishing essential patient protections that improve access to vital therapies; in turn reducing the emotional, physical and economic impact of disease, improving outcomes, and allowing individuals to lead more productive lives.
We are actively engaged in advocacy efforts at both the federal and state levels to ensure that the patient voice is present and heard including joining national and state coalitions, submitting comments, and supporting group sign-on letters. We confront healthcare access issues as they arise, often taking the lead to organize efforts; boldly inserting ourselves into the regulatory, legislative, and research communities when necessary to guarantee the patient stakeholder is included at the table.
Lupus Community Advocacy Victory
We are thrilled to share that on December 27, 2020, President Donald J. Trump signed into law a fiscal 2021 spending package that includes $21.5 million in new funding specifically for lupus research and education programs. The package also includes $42.9 billion for biomedical research through the National Institutes of Health (NIH).
The omnibus spending package combines the Fiscal Year 2021 twelve annual appropriations bills into one legislative package to fund the entire government. The legislation includes:
$9.5 million for the National Lupus Patient Registry Program at the Centers for Disease Control and Prevention (CDC), a $1 million increase from 2020 funding;
$10 million for the Lupus Research Program at the Department of Defense;
$42.9 billion for the NIH, which has committed $517 million in the last 5 years to lupus research;
$2 million for the Office of Minority Health’s National Health Education Lupus Program.
We give credit and thanks to The Lupus Foundation of America and the many advocates who were instrumental in establishing the National Lupus Patient Registry at the CDC, and to Congress for continuing to recognize the program’s critical role in learning more about lupus and the millions of Americans affected by the disease. Congress has now provided more than $80.5 million for the Registry since its establishment in 2003.
In addition, the Lupus Research Program at the DoD will now have committed $35 million to lupus research since its establishment by Congress in 2017. The Lupus Research Program funds high-impact research to identify the causes of lupus and accelerate the discovery of additional treatments for the disease.
The Lupus and Allied Diseases Association is proud to have advocated for all of these programs since their inception and we extend sincere appreciation to the countless lupus warriors from across the nation who made their voices heard by contacting their lawmakers. We also recognize and thank both the Lupus Foundation of America and the Lupus Research Alliance for their lupus advocacy initiatives.
In addition, we extend gratitude to Congress for supporting these vital programs and commend the Congressional Lupus Caucus Co-Chairs Rep. William Keating (D-MA), Rep. Peter King (R-NY), and Rep. Eddie Bernice Johnson (D-TX), House Appropriations Champions Nita Lowey (D-NY) and Kay Granger (R-TX) and Senate Appropriations Champions Richard Shelby (R-AL) and Patrick Leahy (D-VT) for their leadership in advancing these efforts.
LADA President & CEO Shares Patient Viewpoint
Lupus and Allied Diseases Association, Inc. (LADA) President & CEO Kathleen Arntsen shared her patient perspective on living with complicated autoimmune conditions including Grave's Disease with the US Food and Drug Administration (FDA) Dermatologic and Opthalmic Drugs Advisory Committee (DODAC) on Friday, December 13, 2019 regarding a new Biologics License Application (BLA) to treat thyroid eye disease (TED).
The proposed treatment, teprotumumab, is a biologic drug, a fully human monoclonal antibody, IGF-1R inhibitor, and the first potential treatment of active thyroid eye disease, a debilitating and life-diminishing disease of unmet need.
The Advisory Committee voted 12-0 in favor of the drug for TED and we are hopeful that the FDA will take the Committee's recommendation and approve the drug to treat TED and help to improve the quality of life for those individuals struggling to manage TED.
Make Your Voices Heard Program
LADA Board Members and patient advocates Sandi Frear and Lisabeth Iglesias accompanied President Arntsen to the FDA Meeting as part of LADA's Make Your Voices Heard Program, an initiative designed to
educate and empower additional individuals with lupus and autoimmune diseases and their loved ones to learn how to effectively raise their voices to advocate on state and federal healthcare access, and regulatory and public policy issues that impact their lives. This program focuses on the importance of becoming actively engaged in the advocacy process to influence positive change through participation.
One of our goals is to educate and empower patient advocates to learn about the regulatory process and witness advisory committee meetings in person in order to gain a better understanding of the drug and device development process.
LADA would like to recognize Amgen and AdvaMed for their support of this important initiative.
A Path to Lupus Advocacy
Brian Vogel’s lupus journey started in the summer of 2008 when at the age of 17 he began experiencing severe joint pain, swelling, and extreme fatigue. The pain was so excruciating he was unable to even get out bed. He and his family were determined to achieve a diagnosis, traveling as far as NYU Langone Medical Center to get a second opinion. The next two years consisted of countless doctor visits, one misdiagnosis, numerous blood tests, and various medications, some of which worked but all of which had side effects. He was finally diagnosed with Systemic Lupus Erythematous in 2011 by a rheumatologist.
Despite his deteriorating health, Brian attended Clarkson University in the fall of 2008, but his lupus flared and he was forced to return home and attend community college for 18 months. Still determined, he returned to Clarkson University in the Fall of 2010 and earned his B.S. degree by the Spring of 2013, majoring in biology and minoring in chemistry. He overcame many complications associated with his lupus, some of which include Idiopathic Thrombocytopenia (or low platelet count), kidney disease, Raynaud’s phenomenon, alopecia, and skin rashes. Neurologically, lupus has affected his mental health as well and he continues to deal with brain fog, depression, and anxiety.
In the summer of 2017, Brian and his Mother, Lori contacted Lupus and Allied Diseases Association and were connected to President & CEO Kathleen Arntsen who listened to his story and helped them to understand lupus better. She also shared resources and invited them to volunteer at the Lupus Charity Golf Classic in August. Brian met other people with lupus at the event and decided that he wanted to get more involved.
In the spring of 2018, Brian and Lori attended the Annual Lupus Awareness Event in Albany, NY at the state capitol as a constituent of LADA. They were able to meet many people with lupus and their loved ones from across the state and share experiences with them. They also shared their story and experiences with various legislators in the New York Senate and Assembly. This was the first time Brian felt that he was able to really express how lupus had affected him and his family. He shared that this was an amazing experience because he felt validated by witnessing how his story resonated with others. Brian and Lori also participated in LADA’s Lupus Education Symposium in Syracuse, NY where he learned about the importance of self advocacy, carepartnering, and clinical trials from experts in the field.
Since then Brian and Lori have continued to attend the Albany Awareness Event, volunteer at the Golf Classic (Brian even has his own team and plays), attend a Lupus Gala in New York City, and in April 2020 they both became LADA Board Members. Brian enjoys being an advocate and part of the solution and is grateful to LADA for welcoming him and his family into the lupus community.
Lupus has affected every aspect of Brian’s life and he feels that it has been a difficult learning experience. It has tested his limits and he has had to learn what works for his body and what does not. He continues to take ten pills daily and self-administer an injection for his lupus every week. He credits the endless support from his incredible family, for helping him to be where he is today by fighting to get him a diagnosis and the best treatment team. He doesn’t know where he would be without them and feels very blessed. We feel very thankful to have Brian and Lori and their wonderful family in the LADA family.
Pictured above left is Brian Vogel (center) receiving his 2019 Golf Classic Sponsor plaque from LADA President Kathleen Arntsen along with his wonderful family and support system, Grandparents Ron and Sue Durgan, friend Scott Marra, and Parents Lori and Joe Vogel. Pictured above right are LADA Advocates Anne Zablotowicz, Lisabeth Iglesias, and Brian Vogel receiving the 2019 NYS Lupus Awareness Resolution from Senator Joseph Griffo along with LADA Advocates Dave Arntsen and Lori Vogel at the New York State Capitol Building in May 2019.
A Rare Gem in the Advocacy Community
Christine Von Raesfeld is a rare gem in the advocacy community and we are honored to have her as a strong patient voice representing LADA and other organizations on important research and advocacy initiatives. She is a visionary leader in bringing a critically needed patient perspective to cutting edge medical innovations. Christine has been involved in patient advocacy since 2015 in the lupus and rare disease communities in the San Francisco Bay area, deciding to expand her efforts to focus on national initiatives earlier this year.
She is a committed to providing support and empathy to people living with chronic and rare diseases by working with patient advocacy organizations, biopharmaceutical industry representatives, and patient stakeholders and their family members. Living with many rare and chronic diseases herself, she believes that in order to foster understanding and empowerment, patients must be treated as people first.
Christine’s drive to make lives better for patients has not gone unnoticed. Earlier this year, she spoke on stage at the Startup Health Festival as an invited guest of Sanguine Biosciences. In 2018, Christine was chosen as a member of the Team of Patient Advisors for PatientsLikeMe, a company working to create digital avatars of patients and ‘healthy’ individuals so that in the future, medication can be first tested on the digital recreations. She was also recognized as a Wego Health 2018 Top 10 Healthcare Collaborators Patient Leader as well as being named one of the Silicon Valley Business Journal's 100 Women of Influence for 2019.
On the community side, Christine currently serves as a Board member of More than Lupus, a ‘start-up’ patient advocacy organization. She also volunteers her time with us at LADA because we are the only patient-led national lupus advocacy organization, as well as representing many other grassroots organizations. She provides an honest patient perspective at conferences assisting companies in advancing their patient-centric initiatives.
Christine’s conference speaking engagements, consulting efforts, and ability to share her personal experiences have allowed her to bring a much needed change to the healthcare industry while bridging the gap between biopharmaceutical and patient stakeholders and we are thrilled to have Christine and her amazing energy, expertise, and spirit as part of the LADA Team.
Here is a video link to her recent Women of Influence Award.
Pictured left is patient advocate Christine Von Raesfeld receiving her Women of Influence Award on May 16, 2019. Pictured above are LADA Board Members Juana and Estela Mata at the LADA / More than Lupus table. Pictured right are Estela and Juana Mata, Christine, LADA President Kathleen Arntsen and LADA Honorary Medical Advisory Board Member Dr. Julia Simard all helping to honor Christine and share in her amazing achievements.
An Outstanding Patient Advocacy Champion
Peter Morley is an extraordinary individual who despite living with lupus, surviving cancer and being disabled, has become one of the strongest patient advocates and healthcare activists in the nation. He has worked with numerous elected officials including U.S. Representative Carolyn Maloney (NY-12), Senate Minority Leader Charles Schumer from NY, and members of the Senate HELP Committee. He has traveled to Washington, D.C., by train on 15 separate occasions and held over 250 meetings so far with Congressional members and their staff to advocate for better healthcare by sharing his own journey and the stories of people from all across the United States.
In December 2016, Peter joined Twitter and created the handle @morethanmySLE to foster awareness of men who have Lupus. His Twitter account gave him major visibility that then led to his working with his own federal Representative, Congresswoman Maloney. He began his advocacy career in May 2017, when he attended our Annual Lupus Awareness Event in the NY State Capitol and met with his state legislators. From that point on he knew that advocacy was his calling. Since then he has increased his voice and scope of advocacy to include fighting to preserve the Affordable Care Act (ACA). He states that no one should ever have to worry about having their healthcare taken away from them simply because they became ill. He is inspired to travel to the nation’s capital, “To fight for each of us with Lupus and for others with chronic illnesses and to ensure that we all have the health coverage we need and deserve.”
Peter recognizes the importance of the ACA in guaranteeing health insurance coverage to those with preexisting conditions, because prior to it being enacted, many people with Lupus could be denied coverage and vital medical care. On February 6, 2019 he had the honor of testifying before the U.S. House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies as a witness to the Impact of the Trump Administration’s Policies and Effect on the Affordable Care Act. We are all extremely proud of Peter and grateful to him for his advocacy and for being our voice on healthcare.
Patient advocate and activist Peter Morley testifying in Washington, DC on February 6, 2019.
LADA President & CEO Shares Perspective
Lupus and Allied Diseases Association President & CEO Kathleen Arntsen shared her patient perspective on non-medical switching in The Alliance for Safe Biologics’ (ASBM) recently launched video featuring physicians and patient advocates discussing the topic.
Kathleen joined ASBM's Chair Dr. Madelaine Feldman; ASBM's Immediate Past Chair, Dr. Harry Gewanter; ASBM's Founding Chair, Dr. Richard Dolinar; and fellow ASBM Steering Committee Member, Andrew Spiegel, Executive Director of the Global Colon Cancer Association (GCCA) to discuss the practice of non-medical switching of biologic medicines by insurers and pharmacy benefit managers (PBMs).
Kathleen discussed the sanctity of the doctor/patient relationship and the importance of not disrupting patient continuity of care.
To learn more and watch the video click here.
Ground Breaking Lupus Initiative
The Lupus and Allied Diseases Association, the Lupus Foundation of America, and the Lupus Research Alliance collaborated on a Lupus Patient-Focused Drug Development (PFDD) Initiative holding the Lupus: Patient Voices Meeting on September 25, 2017. This ground breaking endeavor culminated in a day-long meeting that featured a series of facilitated panel and audience discussions designed to provide the Food and Drug Administration (FDA) and other stakeholders with perspectives from people with lupus.
The Lupus: Patient Voices Report, a comprehensive report composed as a result of the externally-led Lupus Patient-Focused Drug Development (PFDD) Meeting and pre-meeting survey, was released on March 6th. More than 2,100 people with lupus and their representatives contributed information to this report, sharing insights on living with lupus and their experiences with treatments. This report is a major milestone for the lupus community and will be shared directly with the U.S. Food and Drug Administration (FDA) to help advance treatments for lupus. The Lupus: Patient Voices Report and the Lupus PFDD Meeting are the result of a collaboration by the three national lupus organizations and is a parallel effort to the U.S. Food and Drug Administration’s (FDA) Patient-Focused Drug Development Initiative.
2019 NY State Advocacy Victories
We are thrilled to share that both S02849-A / A02969-A limiting non-medical switching practices and S04078 / A03009 synchronizing drugs and standardizing dispensing fees were passed by the NY State Senate and Assembly in June after years of advocacy efforts by LADA and other patient and professional organizations.
We thank the many patient advocates and organizations who supported these important access to care initiatives for making their voices heard in person, by telephone and e-mail and through social media. We also commend the New York state legislature and the bill sponsors for putting New Yorkers first before profits.
S02849-A sponsored by Senator Neil Breslin and A02969-A sponsored by Assemblywoman Crystal Peoples-Stokes is an act to amend the insurance law in relation to prescription drug formulary changes during a contract year which would limit non-medical switching practices. Non-medical or formulary-driven switching is a policy designed by commercial insurance companies and pharmacy benefit managers to limit prescription drug coverage to less expensive medications, resulting in New Yorkers being required to use a different medication than the one initially prescribed or forcing them off their current effective treatments when they are stable. The NY state legislation establishes consumer safeguards to ensure that New Yorkers have access to lifesaving and life-enhancing therapies through consistent coverage, stable formularies, and fair out-of-pocket costs. Bill Memo
S04078 sponsored by Senator Neil Breslin and A03009 sponsored by Assemblyman Dan Quart is legislation that amends the insurance law, in relation to synchronization of multiple prescriptions and dispensing fee standardization and provides coverage for a pharmaceutical claim for less than a 30-day supply for patients enrolling in medication synchronization programs. The legislation facilitates the prescription drug process by allowing medication synchronization and pro-rated co-payment or co-insurance amounts. The medication synchronization model promotes adherence and appropriate medication use and provides both a more coordinated level and more effective delivery of care; resulting in healthier patients and a reduction in overall costs to payers and the health care system.
This bill is voluntary for patients, health care practitioners and pharmacists. Nothing in this bill requires health care practitioners and pharmacists to synchronize the filling of prescriptions. It simply establishes a mechanism for medication synchronization for patients with chronic illness when there is a voluntary agreed upon plan between the patient, the health care provider and the pharmacist. Bill Memo
Unfortunately, Governor Cuomo vetoed the non-medical switching bill but did sign the drug synchronization bill into law.
NY State Step Therapy Regulation
The New York State Step Therapy Reform Bill was signed into law on December 31, 2016 by Governor Andrew Cuomo. We thank the nearly 80 patient advocacy and provider organizations, the NYS Legislature, and the bill sponsors Senator Catharine Young and Assemblyman Matthew Titone for their tremendous support and efforts for nearly seven years. We applaud Governor Cuomo for standing with us by providing strong safeguards that will ensure proper access to treatments for patients when appropriate.
Links to help with questions during the implementation of the law for insurers, consumers and providers are below.
December Press Release
FAQ Guidance for Health Insurers on Law
Q & A on Law
Physician Form Requesting Review
The Step Therapy / First Fail Legislation introduced by Senator Catharine Young (S 3419-C) and Assemblyman Matthew Titone (A 2834-D) passed unanimously in both the Senate and Assembly in June 2016. This bill regulates Step Therapy protocol and provides a clear and concise override process for health care providers to follow. The bill was signed into law On December 31, 2016 by Governor Cuomo. We appreciate the support of the many patient advocacy and professional organizations who advocated tirelessly to get these bills passed.
Click Here for the bill text
NY State Lupus Advocacy Successes
After ten years of passionately advocating for the Lupus Taxpayer Gifts Bill S5489B / A2788B in New York state, it was finally signed into law by Governor Andrew Cuomo on October 1, 2018. The legislation provides for taxpayer gifts for lupus education and prevention and establishes the lupus education and prevention fund and outreach program. This bill will allow New York state taxpayers the option to contribute to the lupus education and prevention fund on their annual tax return beginning in 2019.
Thank you to the Lupus Agencies of New York State and to all of the advocates for making your Voices' Heard on this vital lupus and healthcare access legislation and helping to get each of them passed and signed into law in New York state over the last several years! We commend our Legislative Champions Senator Diane Savino and Senator Kevin Parker and Assemblywoman Crystal Peoples-Stokes for sponsoring our lupus bills and working with us to get them over the finish line.
The Lupus Education and Outreach Bill was signed into law in 2016 and creates an education and outreach program for the autoimmune disease known as lupus; provides for an advisory council consisting of representatives of people with lupus and their families and health care providers who specialize in treating lupus.
Assembly Bill A03072
Senate Bill S05216
The Lupus Awareness License Plate Bill was signed into law in 2017 and relates to authorizing the creation of a lupus awareness license plate
and to creating the lupus research and education fund.
Assembly Bill A08087
Senate Bill S01703
The Power of Advocacy
Kathleen Arntsen, President and CEO of Lupus and Allied Diseases Association, participated in a video project to promote the power of advocacy. The overview listed her as "a powerful national patient advocate from New York living with multiple autoimmune diseases, including lupus. She joins with other patient advocates to make their voices heard in vital patient safety policy discussions."
Kathleen also participated in the 2015-16 Lupus Research Alliance Patient Advocacy Program by sharing her perspectives.
A link to the video interview is below.