The Inflation Reduction Act (IRA) signed into law by President Biden in August 2022 included more than $891 billion in climate spending, tax credits, and other legislative reforms, many of which will directly impact patient access and affordability.

The health care provisions of the IRA mainly apply to Medicare patients, though a few impact the commercial insurance market as well.

These provisions include:

• A monthly out-of-pocket cap for insulin
• An annual cap on spending for all Medicare beneficiaries
• Granting the Secretary of Health and Human Services (HHS) the authority to negotiate drug prices for a select group of medications
• An annual cap on premium increases for Medicare Part D
• Penalties assessed in drug prices are increased above the annual inflation rate

With provisions impacting people with chronic disease, the Global Healthy Living Foundation (GHLF) sought to learn more about what our patient community knows about the IRA.

Of the 673 respondents:

• About half (42 percent) had heard of the IRA
• 45 percent had not
• 13 percent were unsure

Of those who had heard, the overwhelming majority (91 percent) had heard about it on the news.

The poll then asked respondents about what they’ve heard about how the IRA affects health care. Fifteen percent had not heard of how the IRA affects health care; others were able to select all that apply:

• 71% heard of the monthly out-of-pocket cap for insulin
• 63% heard of the increased ability to negotiate Medicare drug prices for certain medications
• 44% heard of the limits on out-of-pocket spending for people on Medicare
• 29% heard of the penalties for drug manufacturers if they raise drug prices faster than inflation
• 9% heard of the extensions for people who get premium tax credits for the Affordable Care Act through the individual marketplace

Here’s what you need to know about these provisions and when they will take effect.

Spending Caps

The IRA implemented two major spending caps: one is a monthly cap on out-of-pocket costs for insulin, and the other is an annual spending cap.

Insulin prices were capped at $35 per month for all Medicare beneficiaries — effective January 1, 2023, for people enrolled in Medicare Part D and effective July 1, 2023 for Medicare Part B and Medicare Advantage plans.

Notably, earlier this year, the three insulin manufacturers Eli Lilly, Novo Nordisk, and Sanofi announced they would cap insulin prices for all patients, regardless of insurance status, to $35 per month. The new manufacturer policy will make it easier to follow one set of rules than to have multiple pricing structures for the different types of health plans.

“The action taken by the three biopharmaceutical companies is important as they put the patient’s well-being before profits,” says Robert Popovian, PharmD, MS, Chief Science Policy Officer, at GHLF. “The IRA will codify their actions into law, which will help patients now and in perpetuity.”

For the annual cost cap, the IRA has implemented a ceiling for out-of-pocket spending for Medicare Part D at $2,000. The policy ensures that starting in 2025, patients on Medicare will never have to shell out more than $2,000 annually for their health care costs. This significantly reduces the financial burden for patients, especially considering that 2019 data suggests that nearly 1.5 million Part D participants surpassed the annual catastrophic coverage threshold of $5,100 in total out-of-pocket expenses.

Drug Price Negotiation and Innovation

For the first time, the IRA allowed the federal government to negotiate drug prices for Medicare for some of the most expensive drugs on the market for a set number of years.

The provision mandates that the secretary negotiates Medicare drug prices for a select list of high-priced, single-source drugs that have been available on the market for a set number of years.

The Centers for Medicare and Medicaid Services recently announced the 10 drugs that will be part of Medicare’s first round of drug price negotiation. The complete list includes:

• Eliquis, for preventing strokes and blood clots
• Jardiance, for diabetes and heart failure
• Xarelto, for preventing strokes and blood clots
• Januvia, for diabetes
• Farxiga, for chronic kidney disease
• Entresto, for heart failure
• Enbrel, for arthritis and other autoimmune conditions
• Imbruvica, for blood cancers
• Stelara, for Crohn’s disease and other autoimmune conditions
• Fiasp and NovoLog insulin products, for diabetes

According to HHS, these drugs accounted for 20 percent or $50.5 billion of total Medicare Part D gross covered prescription drug costs between June 1, 2022, and May 31, 2023.

Patients will not feel the impact just yet. CMS is slated to publish the prices for these selected drugs on September 1, 2024, with the new negotiated prices becoming active on January 1, 2026.

Moving forward, manufacturers must also pay rebates to Medicare if they raise their prices above the inflation rate.

The IRA also provided a three-year extension for people who receive premium tax credits for the Affordable Care Act (ACA) through the individual marketplace, thus reducing the price of health care for millions of patients nationwide.

Navigating the Uncertainties of New Drug Price Controls and Their Potential Impact on Autoimmune Patients

Recognizing the significant impact on those with autoimmune diseases, we reached out to our CreakyJoints community on social media. We wanted to hear directly from you: What questions and concerns do you have regarding the IRA and these drug pricing negotiations?

A common question among your patient peers: “Is there a list of the next wave of drugs to be included? And if so, are any of these drugs on the next list designed to treat inflammatory arthritis?”

While we don’t know yet which drugs are next on the list, we do know that over the next two years another 30 medications (15 per year) will be selected for negotiated prices, beginning in 2027 and 2028, and up to 20 more drugs for each year after that.

IRA has the potential to drastically reduce drug prices for some of the most common and most expensive drugs on the market and hopefully lead to savings for patients. While cost reduction is a key goal, according to government agencies (e.g., Congressional Budget Office), there will be a reduction in the number of new innovative biopharmaceuticals introduced in the market in the next few years. In addition, IRA does not guarantee that any savings will reach patients directly at the point of sale at the pharmacy counter.

Finally, due to changes in Medicare Part D benefit design, seniors will have potential degradation in benefits as they will face increased administrative burden in accessing life-saving medicines. As IRA gets a foothold, patients who previously waited five years for a new treatment must now wait 10, which could impact their quality of life.

“Like any legislation, there are benefits and risks for patients,” says Popovian, noting that seniors will gain some financial protection, with caps on insulin prices and no out-of-pocket costs for vaccines. “Unfortunately, the risks involved with IRA cannot be ignored — the federal government and private sector analysis are unequivocal that the number of innovative medicines coming to the market will be curtailed in a meaningful way, putting at risk the possibility of finding cures for various diseases.”

In addition, IRA doesn’t help patients with out-of-pocket spending at the pharmacy counter. “The federal government failed to allow seniors to benefit directly from multibillion dollar concessions siphoned by the pharmacy benefit management companies from the biopharmaceutical companies,” explains Popovian. “Unlike other segments of the health care system, patients do not benefit from the prices negotiated on their behalf by their insurers or pharmacy benefit managers (PBMs). IRA could have solved that problem but did not.”

Become a 50-State Network Advocate

Joining the 50-State Network takes just a few minutes, and then you will be plugged into a nation-wide and state-by-state community of other like-minded people who are living with chronic conditions (or love someone who is). Together, we share our strength, experience, wants and needs as a patient community so that we can raise our voices with our healthcare decision-makers. Sign up today.

Living with a chronic illness is a multifaceted challenge that extends beyond managing symptoms and treatment. It often involves building up enough resilience to handle the stress of navigating the health insurance system.

From understanding the intricate details of coverage to dealing with roadblocks like prior authorizations and denials, managing health insurance can be a full-time job.

In a recent #CreakyChats discussion, we explored various facets of health insurance with our members. Topics ranged from the emotional toll of insurance-related stress to strategies for overcoming insurance hurdles like prior authorization and denials. We also discussed how to talk about insurance with health care providers and how to raise awareness about these challenges to improve health care access.

The insights gleaned from our #CreakyChats discussion underscore the vital roles that a supportive network, proactive communication, and self-advocacy play in managing health challenges. We hope these shared experiences and strategies not only inspire you but also help you feel less isolated in your journey.

The Fight for Medication Access

Access to medication is a critical issue that many people don’t anticipate until they’re diagnosed with a chronic illness. And often, the struggle doesn’t end with a diagnosis; it continues as they try to get the treatment they need.

“I never knew access to medications would be an issue until I was 35 years old and diagnosed with my first chronic illness. It only got worse from there! The insurance companies continued to fight against 75 percent of the meds my providers felt would benefit me the most.” — JP S.

“The what if really gets you. What if I don’t get my medication on time? What if they decide I need something else? What if my doctor doesn’t respond? It can be stressful because so much is out of your control.” — Eddie A.

“It drains so much of my mental energy. I feel frustrated, angry, and often, left in tears. The unnecessary stress exhausts me to the point I withdraw from being around my loved ones and want to be left alone. I just don’t want anyone to see me in this state of mind.” — JP S.

Building Your Support Network

Support is essential when navigating the confusing world of chronic illness and health care. The emotional and informational support from a community can make all the difference.

“Get people in your corner. Doctors, friends, family, internet friends. Whoever you have to help you — you don’t have to be the only one fighting and there are people out there who can help.” — @maddieles

Working With Your Doctors

The best way to avoid frustrations and roadblocks is to be proactive. Know what steps you need to take and how long they might take so that you’re not left in the lurch.

“My rheumatologist or other doctors usually bring it up and try to help with getting the prior authorization going and if not, I bring it up and ask about a timeframe and what I need to do. I leave the appointment with a plan.” — Shelley F.

“I have learned that asking the right questions is THE most important thing. Each person in the cog thinks you know what they do. I also have to start with the simplest solution to the problem and work outward to the most complicated. That saves a lot of time.” — @UnexpctdAdvocate

Hurry Up and Wait: Patience Is Key

Navigating the health care system often feels like a lesson in patience, as waiting — whether on the phone for insurance authorization or for a doctor’s reply — becomes an inevitable part of the journey.

“I try to take notes of everything I’m told. A couple of years ago I had to stay on the phone about three hours being on hold and transferred. I was not hanging up without an answer. You have to be prepared to hurry up and wait.” — Eddie A.

“Adjusting my expectation to just planning to be on hold for hours has helped lower the frustration some.” — Elisa C.

Be Your Own Advocate

Managing chronic illness involves more than merely adhering to medical advice; it also calls for active self-advocacy in your health care journey.

“We have to be our own advocate. Besides, every doctor’s office has different processes. It’s better to be informed.” — Jae W.

“We are our own best health advocates. We have to be, no one else is going to fight for us. It’s just so exhausting, enraging. That time, effort, and energy never gets made up though… The fight and the diseases all get intermingled, it can be overwhelming.” — @jessupatlarge

“Use your voice in as many ways as possible. Social media. Speaking to people at insurance and pharmacy. But politicians need to be made aware. This won’t change unless companies are forced to. It shouldn’t be this difficult.” — Eddie A.

Join Our Monthly #CreakyChats

Our monthly, patient-driven Twitter discussion, #CreakyChats, explores topics that are important to the chronic disease community. During a one-hour moderated chat, we provide a space for people to discuss pressing issues facing the arthritis/chronic disease community. You don’t need to be a Twitter pro to join.  

During #CreakyChats we encourage everyone to share their strengths, challenges, and experiences — that is how we can help and support people as they navigate life with chronic disease.  

“I could have had my grandparents a lot longer than I did had they been treated properly for their conditions,” says Ashley Krivohlavek, whose mother is more than one-half Cherokee, making Ashley a quarter Cherokee.  

Skipping through memories of her maternal grandparents on the reservation in Salina, Oklahoma, Ashley inevitably recalls being around 3 years old and sitting beside her grandmother in a medical clinic waiting room for what seemed like endless hours. Back then, there were no scheduled appointment slots; it was strictly a first-come, first-served system. If you arrived after 9 am, you were too late to be seen that day.  

“She didn’t know how to drive,” Ashley says, describing her grandma. “She was blind from glaucoma by that point, so she never needed to learn. I think she only made it to eighth grade before she had to take care of her family — her brothers and sisters — from her mom’s illness.” 

When asked about any strengths or benefits of living remotely, at first Ashley found it challenging to think beyond the hardships so etched into her memories and stories told to her by her family members. “Family is at the center of everything,” she shared. “I think living on the reservation and being close to people that are the same as you, and are going through the same struggles as you, are of benefit because you can help each other out.” 

Differences in Treatment Across Generations

Ashley’s maternal grandfather was diagnosed with rheumatoid arthritis, but he never received proper treatment, she explains. “He only had his joints drained of synovial fluid,” she recalls. “He walked with a cane and was disabled.”    

Now 39, Ashley lives with psoriatic arthritis (PsA), Raynaud’s, and polycystic ovary syndrome (PCOS). She can’t help but contrast her own treatment experience in Tulsa, Oklahoma, with the lack of treatment her grandparents received on the reservation. She attributes the dramatic difference to the extensive resources available to her in a larger city.    

“When I go to see my GP, at the Creek Nation, it’s in a larger metropolitan area,” Ashley explains. “It’s in Tulsa, Oklahoma, versus Salina, Oklahoma, which is a blip on the map — you blink and you miss it. That right there is a problem. I get treated differently just because I’m in a metropolitan area. I’m really thankful that I’ve got this person as my doctor, but again, they move around a lot. You never know if you’re going to be able to keep that physician long-term.” 

Underrepresentation in the Medical Field

Native Americans and Alaskan Natives make up only 0.4 percent of the physician workforce, making it unlikely for a physician to be paired with a patient of the same background. 

A 2022 study published in JAMA highlighted the representation of American Indian and Alaska Native individuals in medical training. Compared to their white peers, American Indian and Alaska Native individuals had 63 percent lower odds of applying to medical school. However, research shows that having shared identity in race and ethnicity between patient and physician can lead to increased rates of patient satisfaction and improved communication between physicians and patients.

Ashley speaks to the variability in health care providers on reservations. “A lot of doctors from other countries do their practice hours on the reservation. You never have a regular general physician (GP); you see whoever’s there and it switches all the time,” she says. “You just get who you get.” 

Remembering the Past to Change the Future

It’s critical to remember and talk about the past. “Even though you will think the Trail of Tears was in the middle of the 1800s, those impacts are still lasting,” she says. “They’re still there. A wave reverberates through the generations.” The Trail of Tears was when the Cherokee Nation was forced to move from their homes in the southeastern United States to Oklahoma in 1838-1839, because of a law signed by President Andrew Jackson called the Indian Removal Act of 1830.

Health care is not always the first priority when you’re just trying to work and survive the day and start all over tomorrow, she cautions. She fears it may not be a priority to some until it’s an emergency.  

“So a lot of it is just cyclical,” she elaborates. “They can’t get great jobs because they live on a reservation and it’s difficult to get off the reservation because of communication barriers and transportation barriers. So, if you’re just stuck, health care is the least of your worries.” 

Looking at the past and current limitations, Ashley buckets ways to improve health outcomes on the reservation into the following: 

• Consistent standard of care across reservations 
• Nutrition and exercise education and access
• Patient counseling on medical treatment 

Consistent standard of care across reservations

Inconsistent health care can make chronic illness management particularly difficult for certain populations, Ashley points out, using her aunt’s diabetes experience as an example. Over the years, her aunt’s diabetes management plan has varied based on the treating physician, making it hard to stabilize her blood sugar.

This challenge is exacerbated by the limited food options on the reservation, which often consist of shelf-stable items high in preservatives and sugars — key contributors to inflammation and diabetes. Interestingly, diabetes was a rare condition among Native peoples until the 1940s. The introduction of these commodity foods led to a surge in obesity and diabetes cases. While more nutritious options have become increasingly available, not everyone has the luxury of choosing fresh produce over canned goods.

However, initiatives like the Food Distribution Program on Indian Reservations (FDPIR) Self-Determination Demonstration Project offer some hope. This program allows tribes to supplement USDA-approved foods with tribally sourced items, expanding food choices for tribal members.

Nutrition and exercise education and access

Access to fresh food and proper nutrition is a critical issue for many Native American reservations, many of which are located in food deserts where healthy, affordable options are limited. Offering in-person visits to these reservations a couple of days a week for free nutrition and exercise classes could be a significant step in improving health outcomes, says Ashley. Given that internet access can be sparse on some reservations, relying solely on online resources may not be effective for everyone. In-person educational sessions would help bridge this gap and could provide tailored guidance on how to maintain a balanced diet and an active lifestyle with the resources available.  

Patient counseling on medical treatment 

 Offering counseling as people are prescribed medications could also help individuals make lifestyle changes in regard to nutrition and exercise. Ashley recalls a family member with diabetes being handed pills to take without any counseling on lifestyle choices. The quality of health care varies greatly across centers, so another patient might receive more guidance and support than another, so there needs to be a standard of care.  

Advocating for Change in Health Care Inequities

Ashley holds the distinction of being the first college graduate on her mom’s side of the family — a significant achievement considering her mother has seven siblings and Ashley herself has numerous cousins.

This educational journey has given Ashley a unique perspective on health care. Although she hasn’t personally experienced the same healthcare challenges that many in her community face, witnessing these struggles has had a profound impact on her. This motivates her to use her voice and position to advocate for better health care for all.

Putting her passion into action, Ashley serves as an ArthritisPower Patient Governor with the Global Healthy Living Foundation. Through this role, she channels her experiences and insights into tangible efforts to improve health care access and quality.

“As someone with certain privileges, I don’t claim to understand everyone’s struggles,” Ashley acknowledges. “But I have immense pride in my family’s resilience, and I recognize that taking on healthcare inequities is a substantial responsibility—one I’m enthusiastic about tackling. Being able to effect positive change, especially in honor of my grandparents, means the world to me.”

Can you relate to Ashley’s story? Do you have ideas on how to address health care inequities within the Native community? We would love to hear from you. Email: sfritz@ghlf.org.

Lung disease, rheumatoid arthritis, inflammatory bowel disease, and chronic bacterial infections are diverse conditions that often require frequent monitoring of C-reactive protein (CRP), a protein that rises in the bloodstream during periods of high inflammation. Measuring CRP is valuable for assessing disease activity, predicting flares, and evaluating treatment response. Currently, the most common method of measuring CRP levels is through blood tests, which necessitate visits to health care facilities or clinics. However, excitingly, new technology is on the horizon to change that. 

Recently published research suggests that individuals with inflammatory conditions may soon be able to monitor their CRP levels at home, thanks to the development of wearable sensors capable of detecting CRP in sweat. 

Researchers have been diligently working on creating these wearable sensors that can detect CRP in sweat, and enable individuals to track their inflammation levels without the need for frequent blood tests. This advancement opens up new possibilities for patients with inflammatory conditions, providing a less invasive and more user-friendly approach to manage and monitor their health. 

Some patients may choose to wear these sensors continuously, receiving alerts when potential issues arise — similar to how individuals with diabetes use continuous glucose monitors (CGMs) to monitor their blood sugar levels. (It’s worth noting that while current CGMs use a small needle to measure glucose beneath the skin, ongoing developments in glucose-measuring sweat sensors are also underway.) 

Promising Advances in Sweat-Based CRP Detection  

One such notable advancement in this field, published in Nature Biomedical Engineering, originates from the California Institute of Technology. A group of researchers, led by Jiaobing Tu, has developed a wireless sensor capable of measuring CRP levels using small amounts of sweat. Their primary focus was on creating a sensor to monitor CRP in individuals with chronic obstructive pulmonary disease (COPD). Such monitoring can be valuable in tracking disease progression and determining whether a flare-up is caused by a bacterial infection, necessitating antibiotic treatment. 

Tu and colleagues designed a wireless sensor that effectively measures CRP levels in tiny amounts of sweat, which are secreted throughout the day. Importantly, heavy perspiration is not required for the sensor’s accurate functioning. “The wearable sensor performs autonomous sweat extraction, collection, biomarker analysis, are wireless data transmission on-demand across daily human activities in individuals who are sedentary,” explained researchers.  

To ensure accuracy, the researchers also compared CRP levels measured by the sweat sensors with CRP blood test results. They found “a strong correlation between CRP levels in sweat and serum.” 

Moving Toward Commercialization: Addressing Unmet Needs  

While further research is needed to validate and bring this product to the market, researchers believe that the reported wearable technology holds promising potential to offer personalized, quantitative information about inflammation. It could potentially address the unmet needs of patients with inflammatory diseases and their caregivers. 

At the same time, other scientists are working on developing similar technology tailored for people with inflammatory bowel disease (IBD). Several studies have already validated a sweat-sensing device that measures CRP and other inflammatory markers, bringing it closer to becoming available in the market. 

What You Should Know  

While advancements in wearable sensors for detecting CRP levels in sweat show promise for the future, the current standard for CRP testing still involves blood tests. Your doctor may order a CRP test based on your specific condition, whether it’s to monitor your progress, evaluate treatment effectiveness, aid in diagnosing inflammatory and autoimmune diseases, or assess remission status as part of a comprehensive test panel.  

It is important to consult with your doctor to determine the most appropriate tests for your individual needs. 

Be a More Proactive Patient with ArthritisPower

ArthritisPower is a patient-led, patient-centered research registry for joint, bone, and inflammatory skin conditions. You can participate in voluntary research studies about your health conditions and use the app to track your symptoms, disease activity, and medications — and share with your doctor. Learn more and sign up here.

A recent study by the Global Healthy Living Foundation (GHLF) shows that contrary to what insurers and pharmacy benefit managers (PBMs) say, protecting patient assistance programs by restricting accumulator and maximizer programs has not made health insurance more expensive.

Accumulator and maximizer programs can make it much harder for patients to afford their medicines. They prevent financial assistance from counting toward a patient’s deductible and their maximum out-of-pocket payments (set yearly health care cost). The result: patients don’t get all the financial help they need and have to pay more out of pocket. Insurance companies and pharmacy benefit managers use these programs to shift the burden of medication costs onto individual patients — PBMs and insurers pocket such assistance intended for patients as profit.

• Accumulators stop assistance from counting toward a patient’s deductible and out-of-pocket maximums.
• Maximizers set out-of-pocket maximums equal to the maximum value of assistance, usually spread evenly throughout the year. Maximizers also stop assistance from counting toward a patient’s deductible and out-of-pocket maximum.

JP Summers, a rheumatoid arthritis and migraine patient, and Patient Advocate and Community Outreach Manager at GHLF, says “When I finally found a specialty treatment that worked, it was expensive, and I relied on a patient assistance program (PAP) to afford the medication that finally helped me feel better,” she shares. “But after using a PAP-funded card, the funds weren’t applied to my deductible. Instead, my monthly co-pay jumped from $40 to around $350. I had to make hard choices about which medications I could take home.”

PAPs help patients afford costly medications that might be beyond their reach due to their health plan’s design and out-of-pocket payment rules. However, individuals or families might not realize that their plan includes an accumulator or maximizer program. Such schemes can lead to unexpected costs when they find out they still owe money for their prescriptions, even after using the funds provided by the PAPs.

So, patients like Summers might find themselves choosing between necessary medicines and daily needs. “To me, this was basically like a car payment,” she says. “With chronic illness, it’s an ongoing thing — it’s not like getting the flu or breaking an ankle. We had budgeted for the $40 monthly, because that’s what I was used to paying for.”

To further illustrate this, GHLF has developed a free interactive tool demonstrating that state laws banning accumulator and maximizer clauses in health insurance policies have not increased the cost of health insurance.

So far, 19 states have passed laws protecting patient assistance programs (PAPs) by requiring that the financial assistance given to patients count toward the share of health care costs they must pay — co-pays, co-insurance, deductibles, and out-of-pocket maximums.

“Our analysis, which this year includes data from 13 states in 2022 and 19 states in 2023, shows no significant change to premiums, nor is the rate of health insurance premiums rising in states with protective, patient-centered legislation,” says Dr. Robert Popovian, PharmD, MS, Chief Science Policy Officer at the GHLF.

The GHLF tool makes it easy to see health insurance cost changes by state since 2014 and compare it to how health care premium costs have changed in states that have or have not protected patient assistance programs. Such data can provide valuable information for legislators, policymakers, and interested parties who value objective and transparent data to advocate for similar legislation in all states and at the national level.

“It’s not reasonable that patients are paying more than their fair share. We encourage legislators and other advocates who develop state and federal health policy to use our tool to fight for patient-protective laws nationwide,” says Dr. Robert Popovian, PharmD, MS, Chief Science Policy Officer at the GHLF.

And what can people living with chronic illness do? Find out if you’re affected by these programs by asking your employer’s health benefits manager about your coverage options, specifically:

• I’ve heard about programs called accumulator adjusters that might stop my prescription assistance from counting toward my deductible. Are these programs going to be part of our plan next year?
• Do you offer any low-deductible or co-pay only plans that could better match my healthcare needs? If those aren’t available, what support can you provide to help me afford my medicine, given the financial strain accumulators and maximizers could create?

Glossary of Terms

Understanding health care terms can be confusing. Here’s a list of handy definitions to help clear things up and empower you to advocate for your own health care needs.

• Accumulator: a rule in some health insurance plans stating that the money you get from patient assistance programs doesn’t count toward your yearly deductible or your maximum out-of-pocket costs.
• Co-insurance: a part of the cost (or percentage of the total bill) for health care services or prescriptions that a person with health insurance must pay after they’ve met their deductible and until they reach their out-of-pocket maximum.
• Co-pay: a fixed amount of money that someone with health insurance pays each time they get certain health services or prescriptions. Sometimes, co-pays don’t count toward your yearly deductible. Instead, you must keep paying these co-pays until you have reached your out-of-pocket maximum for health care costs.
• Deductible: a set amount of money that an insured person or policy holder pays for their medical care in a year. Once you pay this amount, the insurance company starts to help pay for a portion of your health care. The insurance company will pay for some health care, like preventative care, even before the deductible is met.
• Health insurance premium: This is the money you pay to buy a health insurance policy for you and your family (like your spouse and children). You usually pay this cost every year, broken down into 12 monthly payments.
• Maximizer: a clause in a health insurance policy that sets your out-of-pocket costs equal to the maximum value of a patient assistance program. These costs are typically spread out over a year but don’t count toward your annual deductible and maximum out-of-pocket obligations.
• Out-of-pocket maximum: the most money you have to pay for covered health care services in a plan year. After you spend this amount on deductibles, copayments, and co-insurance, your health plan pays 100 percent of the costs of covered benefits.
• Patient assistance programs: programs that provide financial assistance (discounts or subsidies) to people who cannot afford the cost of the prescription medicine(s) the company produces. These programs are offered by pharmacy organizations, non-profit foundations, state governments, and pharmaceutical companies. When sponsored by a company, the assistance is only for the drugs produced by that company.
• Pharmacy benefit managers (PBMs): companies that negotiate what insurance companies will pay pharmacies and pharmaceutical companies for drugs, including discounts and rebates. PBMs often are also responsible for establishing formularies (list of which drugs insurance will or will not cover) and processing and paying bills for prescription drugs. PBMs also own specialty pharmacies that dispense medicines.
• Policies: the written agreements that detail what amounts or portions of medical or pharmacy costs will be paid by the insured (buyer of the policy) and the insurance (seller of the policy) toward specific medical expenses.

Become a 50-State Network Advocate

Joining the 50-State Network takes just a few minutes, and then you will be plugged into a nation-wide and state-by-state community of other like-minded people who are living with chronic conditions (or love someone who is). Together, we share our strength, experience, wants and needs as a patient community so that we can raise our voices with our healthcare decision-makers. Sign up today.

Editor’s note: LGBT stands for lesbian, gay, bisexual, and transgender. Throughout this article, you’ll also see common variants of this acronym referenced in research and expert interviews, including LGBTQ (which includes queer or questioning persons) and LGBTQIA (which includes intersex and asexual persons). As an editorial team, we use the full acronym and the plus sign when referring to the LGBTQIA+ community, which symbolizes the large diversity of other identities that can’t yet be fully described with letters and words. 

In every field of medicine, including arthritis, it’s increasingly clear how important it is to recognize disparities in the care of LGBTQIA+ patients.  

In 2022, 7.1 percent of Americans identified as lesbian, gay, bisexual, transgender, or something other than heterosexual — double the percentage from 2012, per Gallup data. What’s more, about 21 percent of Gen Z Americans who have reached adulthood (those born between 1997 and 2003) identify as LGBT, nearly double the proportion of millennials who do. The gap is even more striking when compared to older generations.  

However, these patients don’t always receive the same level of care as others, even though they have unique needs — including when it comes to pain management.   

The Challenges LGBTQIA+ Individuals Face

The LGBTQ+ population experiences unique needs regarding chronic pain management compared to the general population, note the authors of a November 2021 review in the Journal of Pain Research.  

Here are three key facts from that review to consider: 

• Sexual minority adults experience functional limitations more frequently due to pain and are more likely to experience pain from multiple sites compared to heterosexual adults (for instance, back pain, shoulder/neck pain, migraine, and arthritis are more common in this population)
• There’s a well-established link between depression and pain. These conditions are strongly linked to each other and lead to worse outcomes when patients suffer from both — and sexual minority adults experience higher levels of depressive symptoms and disorders than heterosexual adults.
• A larger portion of LGBTQ+ individuals lack access to health insurance and live in poverty than is the case in the general population. LGBTQ+ individuals are more likely to delay medical care or forgo it entirely. Reasons for avoiding health care include discrimination from health care providers and even denial of care.

When it comes to arthritis specifically, the prevalence is 5.6 percentage points higher among gay/lesbian adults than among straight adults (26.7 percent vs 21.1 percent), per a 2015 study published in the journal Preventing Chronic Disease.  

What’s more, over 30 percent of transgender individuals reported at least one negative experience related to being transgender, like being refused treatment, being harassed or assaulted, or receiving incompetent care, per The Report of the 2015 U.S. Transgender Survey. 

This can be compounded if you’re part of a sexual minority group and also a person of color.  

“When we look at the LGBTQIA+ community, they have multiple challenges — not only with race and ethnicity, but also of course sexual orientation,” says Sheila Thorne, President and CEO of Multicultural Healthcare Marketing Group. “For instance, Black, Latino, Asian, and Native American LGBTQIA+ people have a very different experience than those who are white LGBTQIA+.” 

What Health Care Providers Can Do

Before these barriers to care can be eliminated, it’s key for providers to acknowledge the unique challenges and health problems of the LGBTQIA+ community. This will enable them to better treat chronic pain and improve the quality of life for these patients.  

“Provider education and dedication to improving cultural competency are measures that the medical community can take to help this population gain confidence in utilizing health care,” note the authors of the Journal of Pain Research review. “Additionally, improving access to health insurance remains a necessary step.”  

There are several steps that can be taken to ensure this from the health care provider perspective, says Amber Dixon, the CEO of Elderly Guides, an organization that provides resources for coping with age-related issues. Those steps include:  

• Improving cultural competency. Health care professionals should receive ongoing training to understand the unique experiences and health needs of LGBTQIA+ individuals, including those with arthritis and chronic pain.
• Creating inclusive environments. Health care facilities should adopt inclusive policies, anti-discrimination guidelines, and use gender-neutral language to ensure a welcoming and safe environment for LGBTQIA+ patients.
• Addressing mental health. Providers need to understand the increased risk of mental health issues in the LGBTQIA+ community and provide appropriate support and referrals as needed, especially when dealing with chronic conditions like arthritis.
• Foster collaboration. Health care providers should collaborate with LGBTQIA+ advocacy organizations to better understand the needs of the community, share resources, and promote access to care. 

“You really have to surround the community and saturate it with a message,” says Thorne. “The resources are there — including governmental resources and using social media carefully. These are the best ways to reach populations with messages that will educate, empower, motivate, and activate people to take charge and take control of their health.”  

How You Can Advocate for Yourself

Although many responsibilities fall into the hands of health care providers and the larger health care system, there are also ways you can advocate for yourself in the doctor’s office if you are an LGBTQIA+ individual. 

The first step is connecting with a caring doctor — and making corrections and asking questions as needed, per Cedars-Sinai. This may involve telling your doctor if you are being misgendered or dead-named (when a transgender person is called by their birth name even after they have changed their name as part of their gender transition).  

You should also speak up if you’re not being offered preventive health screenings appropriate for your sex designated at birth or for your risk factors based on your sexual practices.  

Ask questions about why your provider enquires about particular practices, habits, or bodily functions if you don’t understand the reasoning. That clarification can improve your relationship with your doctor and help you determine if you’re getting caring, adequate care — and enable you to understand your symptoms and treatment options better.  

If your physician doesn’t provide judgment-free care or isn’t culturally competent, look for a new provider. You may ask community members of friends for referrals to LGBTQIA+-friendly providers or search online using keywords like “inclusive,” “LGBTQIA+-friendly,” and “gender-affirming care.”  

The LGBTQ+ Healthcare Directory, which was created by the Gay and Lesbian Medical Association in partnership with Cigna and the Tegan and Sara Foundation, is a free and searchable database of health care professionals who are knowledgeable and sensitive to the unique health needs of LGBTQ+ people in the United States and Canada. You can use the platform to search specific types of providers in your area. 

Meanwhile, the National LGBT Health Education Center offers resources for both health care providers and patients on improving access to care for LGBTQI+ individuals, including webinars on topics like Long COVID and LGBTQIA+ Mental Health and Primary Care for Transgender and Gender Diverse Patients. 

Health care disparities in the LGBTQIA+ community won’t be cured overnight, but bit by bit, many organizations and health care providers are working toward providing better care for this population.  

“This is a journey — it’s not a 90-day wonder,” says Thorne. “You really have to be committed to making sure that your efforts are sustainable, measurable, and replicable. It has to be focused on where the population is, what the resources are to access care, and hopefully galvanize the community around health issues that will enable them to live a quality life, especially if there’s no cure for their condition.”  

Asthma Podcast: LGBTQ+ Patients

In this edition of The Asthma Podcast, we dive into the stories of LGBTQ+ asthma patients within the theme of “Love Should Take Your Breath Away, Not Asthma,” exploring how LGBTQ+ individuals navigate their identities, relationships, and asthma all at the same time. Listen now.

Living with ankylosing spondylitis (AS), psoriatic arthritis (PsA), rheumatoid arthritis (RA), or any chronic illness can be challenging when it comes to reaching low disease activity. But the good news is that there are treatments available to help manage your symptoms and improve your quality of life. 

Working closely with your doctor is crucial to finding the right treatment plan that fits your unique needs and goals. This may involve setting attainable goals like attending an upcoming event, going on a planned vacation, returning to work, or simply being able to perform daily activities without the burden of chronic pain. Together, you and your doctor can work towards achieving these goals and improving your quality of life. 

To help guide your conversations with your doctor, we suggest using a shared-decision making tool as a starting point for productive discussions about achieving optimal disease control. While the term “optimal disease control” may not be part of your regular vocabulary, it simply refers to the process of reducing symptoms and improving your overall quality of life. 

Remember, your doctor is there to support you and work with you to find the best treatment options available. Don’t hesitate to discuss any concerns or questions you may have, and together, you can create a personalized treatment plan that works best for you. 

Step 1: Define Your Treatment Goals and Lifestyle Considerations

The first step is to think about what goals you want to achieve with your treatment — and then prioritize them so you can communicate them clearly with your doctor.  

Keep in mind that it’s okay to modify your goals along the way, depending on how your disease progresses, whether you have any co-occurring conditions, and changes in your short- and long-term lifestyle goals. By integrating both medical and personal objectives, you can work with your doctor to develop a more comprehensive treatment plan that better supports your overall well-being. 

Some common medical goals include: 

• Reducing pain and stiffness
• Improving joint function and mobility
• Preventing joint damage
• Achieving remission or low disease activity
• Minimizing side effects from treatment

Lifestyle goals and considerations include: 

• Maintaining or improving physical fitness and activity levels
• Managing work and daily responsibilities
• Balancing personal and social life, including hobbies and relationships
• Prioritizing mental health and well-being, including managing stress and anxiety
• Addressing dietary and nutritional needs
• Ensuring quality sleep and rest
• Planning for future health care needs, such as surgery or specialized care

Step 2: Share Your Priorities and Preferences

Clearly communicate your medical and lifestyle goals, as well as any concerns or challenges you’re facing. This helps your doctor tailor treatment recommendations that align with your personal needs and objectives. 

For example, consider the way the medication is administered. Is it given as a pill versus injection versus infusion? Which one feels most comfortable for you and fits best with your lifestyle and priorities. For example, if you have a busy schedule or travel frequently, taking a pill may be more convenient for you than having to schedule regular injections or infusions.  

Step 3: Discuss Treatment Options

There are many different medications and treatment approaches available. Some examples include: 

• Nonsteroidal anti-inflammatory drugs (NSAIDs) 
• Glucocorticoids (steroids) 
• Disease-modifying antirheumatic drugs (DMARDs)  
• Conventional synthetic DMARDs 
• Methotrexate 
• Biologic DMARDs  
• TNFi biologics  
• IL-6 
• Targeted Synthetic DMARDs 
• Janus kinase inhibitors (JAKi) 
• Biosimilars 
• Physical therapy and exercise 
• Lifestyle modifications 
• Surgery in severe cases 

Discuss the benefits and risks of each option and help you choose the best treatment plan for you. It’s important to ask questions, express any concerns you may have, and seek clarification on aspects that directly affect your daily life or long-term plans. 

Step 4: Monitor Your Progress

Regular monitoring of disease activity is important to ensure that your treatment plan is working effectively. Depending on your condition and individual patient factors, your rheumatologist may use various disease activity measures to assess disease activity. Being aware of these and discussing with your physician is important 

• Ankylosing Spondylitis Disease Activity Score (ASDAS): A composite measure that assesses disease activity in ankylosing spondylitis based on spinal pain, patient global assessment, peripheral joint involvement, and CRP levels. 
• Clinical Disease Activity Index (CDAI): A composite measure that assesses joint tenderness and swelling, patient and physician global assessments, and CRP levels. 
• Disease Activity Score (DAS): Another composite measure that assesses joint tenderness and swelling, patient global assessment, and CRP levels or erythrocyte sedimentation rate (ESR). 
• Health Assessment Questionnaire (HAQ): A measure that assesses the impact of rheumatic disease on a patient’s ability to perform daily activities. 
• Patient-Reported Outcomes Measurement Information System (PROMIS): A set of questionnaires that assess different aspects of patient-reported outcomes, such as pain, fatigue, and physical function. 
• Routine Assessment of Patient Index Data (RAPID): A composite measure that assesses disease activity based on 5 domains: physical function, pain, patient global assessment, swollen joint count, and CRP levels. 
• Simplified Disease Activity Index (SDAI): A composite measure that assesses joint tenderness and swelling, patient and physician global assessments, CRP levels, and tender joint count. 

Step 5: Adjust Treatment as Needed

It is not uncommon that your current treatment plan might not be meeting your goals or is causing side effects that are impacting your quality of life. If this is happening to you, it may be time to discuss adjusting your plan with your doctor. This can involve trying a different medication or combination of medications, or even evaluating your lifestyle habits. Eating nutritious foods, getting regular exercise, and reducing stress can help manage arthritis symptoms and improve the effectiveness of medication.  

Step 6: Have Patience with the Journey

It’s completely understandable to feel fearful, sad, and anxious about adjusting your treatment plan. Making changes to your treatment can be a difficult and emotional process, especially when you’re dealing with a condition like AS, PsA, or RA. However, it’s important to remember that your journey to finding the right treatment is not always a linear one. Sometimes, it takes a few tries to find what works best for you.  

It’s also important to remember that this is not a failure on your part. What works for one person may not work for another. Your doctor is your partner in this journey and is there to help guide you toward the treatment plan that works best for you, your symptoms, and your lifestyle goals.   

Step 7: Be Open About Complementary Treatment

It’s understandable and normal that you are using or may be looking for additional ways to manage your symptoms. It’s important to be open and honest with your doctor, who can help you make informed decisions that are right for you.

Step 8: Don’t Settle for Subpar Treatment

Finally, it is important to advocate for yourself and not settle for subpar treatment. If you feel that your treatment plan is not adequately managing your symptoms or achieving your goals, bring up your concerns, ask questions, and even reference a drug you saw advertised somewhere.  

 If you think your doctor isn’t fully understanding your concerns or motivations for seeking a change in treatment, that’s a different story — it might be time to seek a second opinion from a different provider. Check out these signs that you’re seeing the right rheumatologist for your health needs.  

Check Out Remission Possible

Our Remission Possible podcast is dedicated to guiding and supporting you on your mission to take back your life and control symptoms. In each episode, we’ll share inspiring stories from patients who are succeeding in their mission and discuss how patients and doctors can work together to better understand the optimal course of treatment for different chronic conditions while keeping personal goals and lifestyle choices in mind. Listen now.  

This article was made possible with support from AbbVie. 

Join us as we explore the meaning of remission in rheumatic disease through the experiences of our patient community and insights from rheumatologists. We’ll uncover diverse perspectives on remission and learn how patients and doctors navigate the journey together toward improved health. 

Themes on Remission

Through our discussions, several themes emerged, revealing different meanings attached to the concept of remission: 

• Remission is subjective, varying for each individual. 
• Treatment decisions should be a collaborative process between patients and their doctors. 
• Open communication with your doctor about what remission means to you is crucial. 

Patient Perspectives on Remission

Our vibrant community members, who live with rheumatic diseases ranging from ankylosing spondylitis to psoriatic arthritis to rheumatoid arthritis, shared their personal understandings of remission.  

Here’s what they had to say:  

• “For me, it means that my sed rate is normal and I have little to no swelling or pain on a daily basis.” — Liz R., rheumatoid arthritis 
• “I feel like only partial remission is possible for me. I understand remission to be long term (like 3+ months) with low or no disease activity. — Tara B., ankylosing spondylitis 
• “It’s a dream. I’ve never experienced it.” — @Dedradavis, psoriatic arthritis 
• “To me, remission means no inflammation, pain or symptoms. It means I look and feel seemingly healthy.” — @Gracefully_jen, rheumatoid arthritis  
• “Not having to worry if today’s activity will have me in bed the next day or days.” — Jill M., rheumatoid arthritis 
• “I don’t think AS goes into remission…I just have good and bad days.” — Alex K, ankylosing spondylitis  
• “Well first off, it took me some time to accept that, for RA at least, it’s drug-induced remission. I feel like drug free remission is what remission means to me. Otherwise even if I am symptom free, the medication I am taking is still affecting my immune system, weakening its ability and ultimately affecting my overall health. I’m still hoping and praying for a cure but for now I am truly grateful that there is treatment, and for the most part, it is working for me.” — @Averycrampton, rheumatoid arthritis 
• “Remission to me is reduction in pain. Less pain medication. No damage progression. Able to not be reliant on biologics. I’m there. It took a while.” — Katie P., ankylosing spondylitis 
• “Remission for me stands when I am free of all symptoms for at least two months. We will then discuss end of treatment.” — @Mindfuljourneys, dermatomyositis  
• “For me remission means I can go about my normal daily life with no pain, mobility issues, or fatigue. Being in a flare up is so hard, I’m greatly appreciative that I am on a treatment that works for me. Sending strength to those who are currently in a flare.” — @Pollyspocketvintage_ , rheumatoid arthritis 
• “Remission is low or no disease activity measures, an improvement in pain, a sense of feeling better, and improved quality of life.” — @David J., ankylosing spondylitis 
• “I compare symptoms to boiling over on a stove. When docs/family/people see the pot spilling over they have an understanding and help treat you. Once the pot is down to a rapid boil and not spilling, they call it remission. Still boiling though. I’ve never been taken off the heat.” — @Jeanne.w.s, ankylosing spondylitis 
• “Thriving every day!” — @Iam_catinamorrison, rheumatoid arthritis, fibromyalgia 
• “I had a little time where I felt ‘normal.’ I remember walking up and down stairs holding things. It’s back with a vengeance now though.” — @Pommy38, rheumatoid arthritis, fibromyalgia 
• “Remission would mean a significant reduction in pain and a significant improvement in function.” — Steph K., ankylosing spondylitis   
• “I would love to see true remission, but as long as I have symptoms, without organ damage, I call it quiescence, not remission.” — @Thebumblebeehive, systemic lupus and rheumatoid arthritis 
• “Not having disease activity.” — @Kristina.kostuk, RA and OA 
• “In the 30 years since diagnosis, I have managed my disease but have never had remission.” — Melody P., rheumatoid arthritis 
• “That I could have a day’s activity longer than 10-3:30.” — Anne M., rheumatoid arthritis, osteoporosis, CRPS in knees, Graves’ disease 

Rheumatologists’ Insights on Remission

Liana Fraenkel, MD, MPH, Professor of Rheumatology at Yale School of Medicine and Section Chief of Rheumatology at Berkshire Medical Center, explains that remission means “feeling as if you don’t have the disease anymore. No more swollen joints, and you can finally feel normal again.” 

To achieve this goal, rheumatologists employ a strategy known as treat-to-target. This approach, as Dr. Fraenkel explains, aims to minimize disease activity and symptoms, providing the best chance of reaching a state of remission or inactive disease. 

Additionally, rheumatologist Grace C. Wright, MD, PhD, underscores the importance of understanding the broader impact of the disease on patients’ lives. “I always tell my patients to give me an idea of the experience that they’re living, not just the data points that we check off when we do our disease activity assessments.”  

Does Remission Mean Stopping Your Medication?

Not necessarily. “Remission doesn’t mean you’re off your medication though. In rheumatology, it is expected that the patient will continue to be on a DMARD (disease-modifying anti-rheumatic drug),” says Dr. Fraenkel, who likes to see patients in low disease activity or remission for several to many months before tapering off DMARDs.  

If a patient wants to taper off supplemental medications, such as an NSAID (non-steroidal anti-inflammatory drug), they should discuss this option with their doctor. Tapering off a medication is considered if the patient wants to do so but can maintain the lowest risk of flaring. 

Perhaps most importantly, says Dr. Fraenkel, is to make it a “shared decision-making process.”  

Remission holds various meanings for individuals living with RA, influenced by personal experiences and treatment outcomes. Effective communication between patients and their health care providers is essential to align expectations and optimize treatment decisions. 

Remember, remission may look different for each person, and achieving a state of reduced symptoms and improved quality of life remains the primary goal. 

Check Out Remission Possible

Our Remission Possible podcast is dedicated to guiding and supporting you on your mission to take back your life and control symptoms. In each episode, we’ll share inspiring stories from patients who are succeeding in their mission and discuss how patients and doctors can work together to better understand the optimal course of treatment for different chronic conditions while keeping personal goals and lifestyle choices in mind. Listen now.  

This article was made possible with support from AbbVie. 

A wide array of products containing cannabidiol (CBD) have flooded the market in recent years, yet whether most are being sold legally is a bit unclear. While many states have passed laws that make it possible to sell cannabis products (including for medical use), the U.S. Food and Drug Administration (FDA) hasn’t actually approved any CBD drug products other than Epidiolex, a prescription-only drug used to treat seizures.

Although most CBD creams, pills, and tinctures sold in stores and online don’t quite qualify as “drugs” per the FDA’s official definition, the agency says that they aren’t exactly “supplements,” either. This applies even if they are THC-free (tetrahydrocannabinol is the psychoactive component of cannabis) or derived from hemp. As a result, they’re not being properly vetted under any current FDA pathway. The solution: Create a brand-new one.

Typically, manufactures seeking to bring a new drug to market must go through a very specific process to demonstrate its safety and effectiveness. On the other hand, dietary supplements are not subject to this level of scrutiny. The FDA lacks the authority to approve supplements or their labeling before they are sold. Instead, the agency simply reviews product labels, occasionally inspects manufacturing facilities, and assesses adverse event reports. If necessary, the FDA takes action to improve the product or take it off the market.

In January 2023, the FDA announced that it had formed a “high-level internal working group” to explore how to best evaluate CBD products. They concluded that neither the drug approval process nor the supplement regulations were suitable. The FDA determined the need to establish a new regulatory pathway that balances the public’s desire for CBD access with necessary oversight to manage risks. Simultaneously, the FDA rejected three petitions seeking to market CBD as dietary supplements.

According to Dr. Janet Woodcock, Principal Deputy Commissioner of the FDA, the working group she chairs has thoroughly examined various studies and scientific literature related to CBD-based drug Epidiolex. They also reviewed information from public dockets and studies conducted or commissioned by the agency. “Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives,” said Woodcock in a statement. “For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.”

While many people assume that CBD products without THC are completely harmless, the FDA highlights some potential risks. CBD has the potential to cause liver injury, interact with alcohol or medications, and may lead to drowsiness, digestive issues, or irritability/agitation.

What is particularly concerning is the lack of sufficient research on CBD. The FDA states that it is still unknown whether long-term daily use of CBD could result in any problems. Additionally, the impact of CBD on the developing brain, especially in children, and its potential effects on human fertility are yet to be determined, although animal studies suggest possible impairments.

To address these concerns, the FDA will be working with Congress to develop the new regulatory pathway. Meanwhile, the agency remains committed to taking action against CBD and other cannabis-derived products when necessary to protect the public. They will monitor the marketplace diligently, identify products posing risks, and act within their authorities.

What You Should Know

When it comes to CBD products, it’s important to have some key information in mind. Firstly, it’s worth noting that most CBD products have not undergone sufficient evaluation by the FDA, which means their safety and effectiveness remain uncertain.

Additionally, it’s crucial to be aware that CBD carries the potential to cause issues like liver damage or interactions with other medications. It is highly recommended to consult with your doctor before considering the use of CBD products to ensure your safety and well-being.

Be a More Proactive Patient with ArthritisPower

ArthritisPower is a patient-led, patient-centered research registry for joint, bone, and inflammatory skin conditions. You can participate in voluntary research studies about your health conditions and use the app to track your symptoms, disease activity, and medications — and share with your doctor. Learn more and sign up here.

Last December, more than 80 percent of U.S. hospital beds were occupied, and COVID wasn’t the only reason. The flu and respiratory syncytial virus (RSV) also caused a surge in hospitalizations. While we have vaccines to help protect against COVID and the flu, there’s no vaccine for RSV yet.

But that could change soon. An advisory panel to the FDA voted in favor of approving two different RSV vaccines. One is made by Pfizer and the other is made by GSK.

However, this doesn’t mean that the FDA has approved the vaccines yet. The agency still needs to vote on it, but they usually follow the advice of the Advisory Committee.

What Is RSV?

RSV is a virus that’s pretty common in the U.S. during the fall and winter. It usually just gives you cold-like symptoms that will go away on their own after a week or two, so you might have had it before without even knowing.

But here’s the thing: RSV can be more serious in some people, especially babies who are six months old or younger. If babies get RSV, they might have trouble breathing and need to go to the hospital.

Adults who are 65 years old or older also have a higher chance of getting serious complications from RSV, including pneumonia (lung infection) or bronchiolitis, which is inflammation of the small airways in the lungs. These complications can impair breathing and, in some cases, prove fatal.

Every year, more than 60,000 older adults are hospitalized because of RSV and about 6,000 of them die from the infection.

How Well Do the New RSV Vaccines Work?

The new vaccines are made to protect older adults from getting sick from RSV. There are also vaccines being tested for infants, but they’re not ready for the FDA to evaluate yet.

The FDA Advisory Committee checked if the new Pfizer and GSK vaccines work and if they’re safe. They voted seven to four on the Pfizer vaccine’s effectiveness and 12 to 0 on the GSK vaccine’s effectiveness. They based their decision on scientific evidence presented by both manufacturers.

Pfizer did a study with their RSV vaccine candidate, and it showed that the vaccine was about 67 percent effective at preventing people from getting two or more symptoms of “RSV-associated lower respiratory tract illness.” It was also 86 percent effective at preventing three or more symptoms.

GSK showed data from a phase 3 clinical trial in The New England Journal of Medicine. The study found that the vaccine was about 83 percent effective against RSV-lower respiratory tract disease, and 94 percent effective at preventing severe RSV.

If approved, an RSV vaccine could save thousands of lives every year. “If 8,000 older adults die from RSV each year in the U.S., a vaccine that’s 80 percent effective could save 6,400 lives,” said Dean L. Winslow, MD, a professor of medicine in the division of infectious diseases and geographic medicine at Stanford University, in an interview with Verywell Health.

What Are the Downsides?

The FDA Committee voted 7 to 5 on the safety of the Pfizer vaccine and 10 to 2 on the safety of the GSK vaccine.

The biggest safety concerns raised was about the risk of Guillain-Barre syndrome, a rare but serious nervous system disorder. In the GSK trial, one participant developed this disorder, and in the Pfizer trial, two people had it. This might not seem like a lot, but typically, Guillain-Barre only impacts up to 3 out of 100,000 people age 60 and older.

When Will the FDA Decide About RSV Vaccines?

The FDA is expected to decide whether or not to approve these RSV vaccines this May.

The Advisory Committee has already suggested that if the Pfizer vaccine is approved, the manufacturer should conduct a post-marketing safety study to further investigate the potential risk of Guillain-Barre syndrome. That means they’ll continue studying its safety even after its potentially approved.

What This Means for You

Respiratory viruses like RSV can pose a risk to your health, but there are steps you can take to lower your risk. One important measure is to wash your hands frequently, as this can help reduce the spread of germs. Additionally, it is wise to avoid close contact with people who are sick, as this can help prevent the transmission of respiratory viruses.

If you are in crowded areas, you may want to consider wearing a mask as an additional precaution. This can help protect you from inhaling airborne particles that may contain viruses like RSV. By taking these precautions, you can help reduce your risk of getting sick from respiratory viruses.

It is important to stay tuned for updates on this decision, as it could affect the availability of certain treatments or medications. Keeping informed about developments like this can help you make informed decisions about your health and well-being.

Be a More Proactive Patient with ArthritisPower

ArthritisPower is a patient-led, patient-centered research registry for joint, bone, and inflammatory skin conditions. You can participate in voluntary research studies about your health conditions and use the app to track your symptoms, disease activity, and medications — and share with your doctor. Learn more and sign up here.