September 27, 2022

Education and Access Play Key Role for Improving Well-being for Women Living with Autoimmune Diseases

By Monica Lefton, Communications Manager.

The incidence of autoimmune diseases and conditions in the United States is rising, and women are disproportionately affected. Eighty percent of autoimmune patients are women, although gender ratios differ among individual diseases. While the causes of many autoimmune diseases remain unknown, sex and hormonal activity play an important role in their onset, symptom manifestation, severity, and treatment outcomes.

On August 4, 2022, SWHR convened an interdisciplinary group of policy experts, researchers, clinicians, and patient advocates for a one-day roundtable meeting to discuss policy needs and opportunities as they relate to women’s autoimmune and immune-mediated diseases and conditions across the lifespan. The roundtable participants highlighted gaps and opportunities in education and policy to improve autoimmune care.

What Makes an Autoimmune Disease

Autoimmune diseases include more than 80 chronic and often disabling diseases that develop when the immune system mistakenly attacks the body’s own healthy organs, tissues, and cells.

The exact number of individuals in the United States affected by autoimmune diseases is unknown, with estimates ranging from 10 million individuals to more than 24 million and as many as 50 million. Olivia Casey, Senior Director of Programs at the Autoimmune Association, noted that gaps in research, disagreements on a single definition of autoimmune disease, and a lack of a comprehensive registry make determining the number of individuals living with autoimmune diseases in the United States near impossible. As she explained, “It’s hard to categorize what we can’t define.”

Moreover, added Casey, current autoimmune disease estimates don’t include up to 23 million people now living with long COVID (lingering COVID symptoms at least four weeks after infection, according to the Centers for Disease Control), which some experts think may be an autoimmune-related disorder.

While a historical lack of research makes it difficult to answer why women are affected more often by autoimmune diseases, research shows a woman’s environment, including including hormone levels in drinking water and her microbiome may play a role, said Betty Diamond, MD, Director of the Institute of Molecular Medicine at Northwell Health’s Feinstein Institute for Medical Research.

Living with an Autoimmune Disease

Most autoimmune diseases cannot be cured, but finding a diagnosis and effective treatment quickly can improve both health outcomes and quality of life. But, with disease symptoms not always well understood, the burden of autoimmune education and seeking appropriate medical care is often left to patients. Presha Kardile started to have unexplained health issues in the mid 2010s but didn’t receive a lupus diagnosis until 2021. Looking back, she wishes there was more information about how autoimmune disease symptoms appear across different skin types and ages. DeAnna Clark, who was diagnosed with multiple sclerosis (MS) in August 2016, also described the seemingly long time it took her to be diagnosed—a process that was exacerbated due to the two-hour travel time between her home and her doctor in St. Louis, MO. Given her experience, Clark is passionate about finding a way to advocate for and support those in the waiting process. Other diagnosis challenges Clark described included much of the early disease education falling to her and her husband and unreliable internet. Unreliable or unavailable Internet access can strip one of the ability to rely on telehealth services, a common reality for those living in rural or economically disadvantaged areas.

Every autoimmune story is different, so personalized care for autoimmune disease is particularly crucial. Autoimmune providers should strive for a holistic approach to care and disease management, Working Group members said, prescribing medications and treatment solutions based on an individual’s unique experiences and circumstances — and avoiding a one-size-fits-all approach. Together with treating the person and not the disease, mental health support must also be integrated into the autoimmune care plan, the Working Group agreed. Because many autoimmune and immune-mediated diseases are systemic in the body, they increase the risk of anxiety and depression, including frequently in individuals with psoriatic diseases, noted Sarah Buchanan, Director of Federal Government Relations and Health Policy at the National Psoriasis Foundation.

To assist individuals in navigating their diagnosis, support groups — for patients and caregivers — can have profound, positive effects. After Clark became active in the National MS Society, she found the courage to speak about her story, ask for help, and even request benefits at work under the Americans with Disabilities Act (ADA). The National MS Society, National Psoriasis Foundation, Autoimmune Association, Crohn’s & Colitis Foundation, and Global Autoimmune Institute are some of the organizations that offer groups to support patients and caregivers.

Both Clark and Kardile expressed wanting more time with their providers. Clark recommends individuals schedule several follow-up appointments after they receive a diagnosis, so they have plenty of time to ask questions after processing the news. Had Kardile had more time, she would have asked her doctors to speak in more realistic terms about living with an autoimmune disease and how lupus could affect all aspects of her life, from her workplace to her reproductive health. “There’s going to be no ‘before lupus’ anymore for me. Every aspect of my life going forward will include lupus,” she said.

Because autoimmune diseases require long-term care management, fulfilling the role of caregiver for someone with an autoimmune condition can feel all-consuming at times. Kardile has full-time caregivers in her parents and Clark in her husband and daughter (who lives an hour away from Clark but still helps care for her mother regularly), but in seeing these caregiving responsibilities firsthand, they —along with other members of the Working Group—repeatedly called for improved caregiving rights, including through additional caregiving support groups, caregiving funding, and the caregiver tax credit.

Working Around an Autoimmune Disease

Living with an autoimmune disease can feel like a full-time job, on top of other responsibilities. Having flexible workplace policies (e.g., work from home options, flexible hours, care accommodation, scheduled breaks) can make a world of difference, Clark and Kardile agreed. Clark is a teacher and was given an extra assistant to help with certain tasks like trips to the copy room; saving energy by delegating some tasks has been critical to her continued success at work.

Education and awareness are key to improving the workplace environment. Clark frequently speaks with her co-workers about autoimmune diseases and even coordinated a conference call between her doctor and employer to answer questions about certain accommodations. Kardile approaches work accommodations as an ongoing conversation with her team, updating them as her needs evolve.

“Employers may not be able to fully comprehend your needs when you have an autoimmune disease, as the symptoms tend to be invisible or are not always present outwardly, as it is in the case of physical disabilities. So, it is incredibly important to reach out to your employer and explain your needs, as there is an overall lack of education and awareness regarding autoimmune diseases.,” Kardile said

Opportunities to Improve Autoimmune Research

The opportunities in autoimmune and immune-mediated disease research are expansive. Some areas identified by the Working Group include research on the increasing incidence of autoimmune diseases, sex bias in autoimmune diseases, and gene drivers of autoimmune diseases.

Improved data collection — namely the development of common data elements — is a key to such research, Working Group members agreed. This, along with using the same terminology to describe autoimmune phenotypes and characteristics, was discussed as a fundamental first step to advance research on and between underlying disease pathways. While a significant undertaking, the federal government could support and advance this, said Caren Heller, MD, MBA, Chief Scientific Officer at the Crohn’s & Colitis Foundation. Similar requests for common data elements have been advanced within the National Institutes of Health’s (NIH) National Institute of Neurological Disorders and Stroke (NINDS), said Nicole Boschi, PhD,  Director of Regulatory Affairs at the National MS Society. Improved data collection would help researchers understand nuances as well as connections between autoimmune cases, such as whether the prevalence of mental health conditions within these communities are at all associated with the biological mechanisms of autoimmune diseases, Sonia Manocha, MD, with the Rheumatology Division at the Allegheny Health Network, added.

Collected data, though, must reflect patient populations, so ensuring diversity in autoimmune research clinical trials is another important step. “Clinical trials need to be specific in their efforts to reach diverse populations in regard to race, ethnicity, and gender in order to be able to treat autoimmune diseases fully,” said Quardricos Driskell, Vice President of Public Policy and Government Affairs at the Autoimmune Association. Policies and position papers, such as S.2706 DIVERSE Trials Act and H.R.6584 DEPICT Act, and analyses, such as the National Academies of Sciences, Engineering, and Medicine (NASEM) Assessment of NIH Research on Autoimmune Diseases, identify important factors for improving study diversification, but research teams must take the steps to implement these guidelines in their work themselves. Ensuring diversity in clinical trials also requires addressing potential or existing mistrust; offering appropriate compensation for participation; providing transportation assistance; and reaching target communities with information, communicating the importance of trial involvement, and building trust for participation.

Access to Autoimmune Disease Care

Broader education and awareness of autoimmune diseases across all groups—from policymakers and employers to health professionals and community groups—will accelerate diagnosis and improve autoimmune care, Working Group members agreed. Both clinicians and individuals living with autoimmune diseases in the Working Group mentioned the difficulty of coordinating autoimmune care coverage and noted it should not rest solely on the individual to manage. Wider management support would particularly benefit women, who often have the majority of health care responsibilities on their shoulders, Anna Hyde, Vice President of Advocacy and Access at the Arthritis Foundation, noted.

Patient navigators within the health system also play an important role, Hyde said. Patient navigators can help manage health care coverage and thereby reduce some of the burden individuals living with autoimmune diseases face.

Many individuals with autoimmune conditions also face challenges due to utilization management (UM), sometimes called utilization review, which is defined as “the evaluation of the medical necessity, appropriateness, and efficiency of the use of health care services, procedures, and facilities under the provisions of the applicable health benefits plan.” Two main types of UM include prior authorization (PA) and mandated step therapy (sometimes called “fail first”). Read more about UM, PA, and mandated step therapy in this SWHR fact sheet: Utilization Management Policies and Autoimmune Diseases: A Women’s Health Issue. Inappropriate management of UM policies may result in delayed care, which can have negative, long-lasting impacts on health. For example, individuals who already underwent mandated step therapy to gain access to a certain drug under one plan may be asked to redo step therapy when switching insurance plans or pharmacies; others may be asked to undergo PA each year to maintain access to their autoimmune drugs, explained Dr. Manocha. One study showed patients with psoriasis using step therapy had lower odds of treatment effectiveness, mainly due to lower odds of adhering to treatment, Hyde noted, so as UM practice grows in frequency, providers must implement reasonable guardrails to protect individuals.

Drug costs also present a frequent challenge for many individuals with autoimmune conditions. A recent National Pharmaceutical Council report shows that “low-wage employees are less likely to use autoimmune medicines than employees who earn more despite a higher prevalence of autoimmune conditions in low-wage employees,” and those with a lower income are 14% less likely to be using a specialty medication for autoimmune disease management. In a survey conducted by Hyde’s team at the Arthritis Foundation, 37% of respondents reported issues with out-of-pocket costs when managing their autoimmune conditions. Specialty treatments like physical therapy and acupuncture (that may be beneficial to individuals living with an autoimmune disease) often have high copays and can become cost restrictive, Kardile noted from personal experience.

Working group members also indicated that the recent Supreme Court ruling Dobbs v. Jackson Women’s Health Organization has presented additional access challenges for women with autoimmune diseases, especially for those who have already had challenges with diagnosis time and accessing the right treatment option. Individuals have reported losing access to autoimmune treatments because certain drugs have components that can induce an abortion. Dr. Diamond and others noted concern for how the ruling may dictate the management of health risks in women with autoimmune disease if they become pregnant, particularly if the woman is on certain treatments when she becomes pregnant or if pregnancy termination to save a woman’s life is required. Many autoimmune diseases present higher risks for pregnant women, whether because the disease itself presents pregnancy complications or because the medications used to manage the disease may impact a developing fetus. As a result of the challenges rheumatoid arthritis patients are facing, groups including the American College of Rheumatology and the Arthritis Foundation have expressed concern on the potential unintended consequences of this ruling.

Preparing for Tomorrow

Living with an autoimmune disease requires constant management, from the workplace and home to the doctor’s office. But, as Clark and Kardile show, individuals with autoimmune diseases can find empowerment and learn to live for the moment, even as they navigate long-term care solutions. Support for these individuals cannot wait and requires that all stakeholders “do something to help people now before we think about the long term,” Kardile said. Support can and should come from all corners of the health ecosystem for individuals living with autoimmune diseases and conditions.

SWHR will continue promoting awareness and science-based policies that expand access to coverage, improve workplace experience, account for caregiving needs, and advocate for improved health equity and outcomes for women living with autoimmune conditions and diseases.

SWHR’s Autoimmune Program is supported by an educational sponsorship from Horizon Therapeutics. SWHR maintains editorial control and independence over educational content.