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Uncategorized

Open Enrollment is NOW

Do you feel like you are paying too much for healthcare services and prescription drugs under your current health insurance plan? Does your insurer require you to try and fail at less costly therapies before allowing the treatment your doctor has prescribed? Is the medication your doctor prescribed denied by because it isn’t listed on your plan’s formulary?

Now may be the most important time of the year if you are dissatisfied with your health insurance coverage. We are currently in the middle of Open Enrollment season for Medicare and the Affordable Care Act (ACA) Marketplace plans. For those insured under employer plans, the end of the year is also a time when new or updated plans are often offered, allowing employees to make changes to their benefits plans.

The following are important deadlines to keep in mind for applying for or making changes to insurance coverage for 2022:

  • Medicare Open Enrollment ends December 7.
  • ACA Open Enrollment ends January 15 (coverage starts February 1).
    • Deadline for ACA coverage to start on January 1 is December 15.
  • For employer plans, check with your human resources manager.

CSI Pharmacy is here to help you navigate the system. We are experts at understanding the fine print in health insurance policies. We can help you review your options and find the plan that best meets your healthcare needs as well as your budget.

For those who are having trouble paying for healthcare coverage, here are some options that can help:

Medicare Assistance Programs – If you are unable to afford Medicare premiums, several types of State Medicare Savings Programs are available to help you pay your Medicare premiums. In some cases, they may also pay deductibles, coinsurance, copayments, and prescription drug coverage costs. Each of the programs has different eligibility criteria. There are even programs that allow individuals who delayed enrollment into either Medicare Part A or Part B to enroll outside regular enrollment periods. In some cases, qualifying for these programs automatically qualifies you to get Extra Help to pay for Medicare drug coverage.

To see if you qualify for these programs and to apply, contact your State Medicaid Program or Department of Social Services. You can also call 1-800-MEDICARE (1-800-633-4227) to get the phone number for your state’s Medicaid office.

Extra Help – If you meet certain income and resource limits, you may qualify for Extra Help in paying for your Medicare prescription drug plan premiums, deductibles, and copays. Depending on your income and state of residence, you may pay less or nothing for premiums and deductibles, and copays are capped at an affordable rate.

For additional information and to see if you qualify, see the Extra Help webpage at Medicare.gov. In some cases, you may automatically qualify if you qualify for the Medicare Savings Programs above. If you don’t automatically qualify, there is a link on the Extra Help page where you can apply.

Medicaid is a joint federal/state program that helps with medical costs for those with limited income and resources. Each state has different eligibility requirements and application processes. You can now apply for Medicaid either through the ACA Marketplace or directly with your state Medicaid agency. See this website for more information and to see if you qualify. You can also call 1-800-MEDICARE (1-800-633-4227) to get the phone number for your state’s Medicaid office.

PACE – Program of All-Inclusive Care for the Elderly (PACE) is a comprehensive healthcare program through Medicare and Medicaid that helps individuals remain in the community rather than going to a nursing home or other extended care facility. The program provides a team of healthcare professionals who work with you and your family to coordinate your care. It covers all the services this team decides you need, including drugs, provider visits, transportation, home care, hospital care, and nursing home stays when needed.

You never pay a deductible or copay for any drug or service provided. If you are covered by Medicaid, long-term care is also fully covered. If you have Medicare but not Medicaid, there is a monthly premium for long-term care and Medicare drug coverage (Part D). Enrolling in PACE, however, means you are required to use a PACE-preferred physician and the other providers associated with the plan.

PACE is only available in some states and only in some areas. To qualify, you must:

  • Be 55 or older
  • Live in the service area of a PACE organization
  • Need nursing home-level care (as certified by your state)
  • Be able to live safely in the community with help from PACE

To find out if you qualify and if there is a PACE program in your area, search for PACE plans in your state, or call 1-800-MEDICARE (1-800-633-4227) to get the phone number for your state’s Medicaid office.

Veterans Benefits – If you qualify for health benefits from the Department of Veterans Affairs (VA), you can receive both Medicare and VA benefits, but they don’t work together. Medicare doesn’t pay for any care provided at a VA facility, which is the only place VA benefits are offered. Many veterans use their VA benefits to get services not covered by Medicare, such as prescription drugs. For more about eligibility and benefits, call the VA Health Administration Center at 1-800-733-8387 or 1-877-222-8387.

ACA Marketplace – Uninsured individuals and families who do not qualify for the government-funded programs above can still get coverage, often at a discount, through the ACA Health Insurance Marketplace, also known as the Exchange. ACA plans are offered through private insurers participating in the Exchange. They all provide the same essential health benefits, and you cannot be denied based on pre-existing conditions. You can review plans and apply for coverage at Healthcare.gov. In completing the application, you can also see if you qualify for free or low-cost coverage through Medicaid, or for savings on a Marketplace plan.

Marketplace plans and insurers change every year. This year premium subsidies enacted under the COVID-related American Rescue Plan Act (ARPA) last year are still in effect for 2022. This means many Americans will qualify for lower premiums. The number of insurance companies participating has also increased, so there are more options to choose from. If you currently have a Marketplace plan, you may want to consider exploring these options to see if you can find a more affordable rate rather than allowing you current plan to auto-reenroll.

If you make changes to your health insurance coverage, be sure to notify your healthcare providers and your pharmacist so the transition to the new plan is smooth.

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IG Therapy

Does IG Contain COVID Antibodies?

Many who depend on immune globulin therapy to treat their autoimmune or primary immune deficiency disease wonder about the presence of antibodies against COVID-19 in the IG products they use. If so, they want to know if it’s possible that these antibodies might protect them against this deadly infection.

To find out, we contacted one of the manufacturers we work with: Octapharma, which produces Octagam, Panzyga, and Cutaquig.

The company ran a study in which they tested their IVIG and SCIG products derived from donated plasm they collected in the United States to see if they contained antibodies to SARS-CoV-2, the virus that causes COVID-19. The testing was done from the end of 2020 through June 2021 and tested to see if these antibodies could react to and neutralize the virus.

They found that their IG products do indeed contain antibodies to SARS-CoV-2, and they do have the ability to neutralize the virus. They also found that concentrations of these antibodies increased over the time of the study, probably as a result of increasing numbers of donors who had been infected or vaccinated before donating their plasma.

According to the company spokesperson, “The increasing levels of SARS-CoV-2 antibodies in Octapharma IVIG and SCIG products indicate that a certain level of protection could be possible against COVID-19 in patients…who are receiving standard IG therapy.”

Given these results, it’s likely that other brands of IG also contain some level of COVID antibodies as well. In fact, a similar study conducted by Takeda evaluated SARS-CoV-2 antibodies in their product, Gammagard Liquid, and found similar results.

Researchers from both studies expect COVID antibodies to continue to increase in the plasma supply as more donors are exposed to or vaccinated against the SARS-CoV-2 virus. They went on to predict that, given the six-month lead time from plasma collection to release of the IG product, IG users can expect a similar level of antibodies as that found in convalescent plasma (that is, plasma donated by individuals who have recently recovered from COVID) by summer 2021.

We want to stress, however, that it is impossible to know at what levels SARS-CoV-2 antibodies may be present in any given dose of IG. It is also unclear exactly how high plasma antibody levels would need to be in order to provide COVID protection to primary immune deficient or autoimmune patients through IG therapy.

Therefore, immune globulin therapy should not be considered a source of protection against COVID infection. According to the CDC, vaccination against SARS-CoV-2 remains the best way to avoid severe disease and hospitalization.

Read the report of Octapharma’s study here.

Read the report of Takeda’s study here.

Categories
Health Information

Wellness is Within Your Control

Lisa was in her mid-twenties when she suddenly came down with asthma. She had never had allergies or wheezing as a child—the time when this sort of disease usually strikes people. But now she was desperately sick, struggling for breath on a daily basis, often needing to go to the emergency room for intravenous medication that would open her lungs and allow her to breathe again.

Her doctors told her this condition was chronic, that she would have to take medication for the rest of her life, and she’d have to be careful about all the things that could trigger an asthma attack. There may even be things that she would never be able to do again. Dancing, for example.

Like many people who are diagnosed with a chronic medical condition, Lisa was devastated. She became depressed, gained weight, and developed other health problems, all of which left her feeling out of control and helpless. 

One day, however, she learned about a class at the children’s hospital for people newly diagnosed with asthma. She decided to go. Even though it was aimed at kids and their parents, that class changed her life.

She learned what was happening to her body when she was having an asthma attack and what she could do about it. She learned about changes she could make to her home to reduce things like dust and mold and feathers that triggered wheezing. Most importantly, she came away from that session feeling empowered. She wasn’t as helpless as she thought.

That class set Lisa on a path toward wellness. She studied everything she could find about self-care and holistic options for treating chronic conditions. She changed her diet, started exercising more, saw a therapist, started meditating, and spent time in nature. Lisa was determined to prove those doctors wrong.

It took several years and a combination of mainstream medicine and wellness practices, but it happened. Lisa gradually decreased the amount of medication she was taking, and one day she realized that it had been years since she’d had an asthma attack. She could even forget about that inhaler that she always carried with her like a lucky rabbit’s foot “just in case.”

While not everyone who lives with a chronic condition can completely leave it behind in this way, most health problems can be improved by actively taking charge of the things in your life you do have control over. Here are some important areas to address:

Take care of your body

This includes getting enough sleep, eating a healthy diet, and getting enough exercise. In fact, paying attention to these practices puts you way ahead of the curve for all healthy living habits. All three help you think more clearly, lower your stress, improve your mood, and feel less fatigued. They can also help you control your weight, which can reduce your risk from other health conditions, such as diabetes and heart disease. And they all have a positive impact on your immune system and can reduce inflammation.

And while you’re doing good things for your body, don’t forget the things you shouldn’t do that are toxic to your health. Smoking, for example. Quitting is the single most important thing you can do to get your health on sound footing. Taking it easy when it comes to using alcohol and caffeine is also a good idea.

Mind your mental, emotional, and spiritual health

You are more than your physical body. Paying attention to how you are feeling, your mental space, and your spiritual wellbeing can have important influences on your physical health. You may be surprised to see how effective it can be when you take steps to control excessive stress, toxic thoughts, and harmful emotions like anger and anxiety.

There are so many ways to do this: See a therapist or talk to a friend. Start a meditation, mindfulness, or yoga practice. Keep a journal. Pray. Cultivate gratitude and find joy in all that is around you. Take a walk in the woods. Be creative. Cuddle with your furry friends. Make time on a regular basis to do what makes you feel good and helps you connect with the Divine.

Don’t forget your peeps!

Research shows that a strong social support system is extremely important for staying physically and mentally healthy. Having positive interactions with the people in your life makes you more resilient to stress, decreases the impact of post-traumatic stress disorder (PTSD), reduces the impact of disease, and helps you live longer. Studies also show a positive impact on mental health, immune function, cardiac health, and more. And having the support of friends and family enhances your ability to go along with good health habits, such as eating a nutritious diet, exercising, and smoking cessation.

It’s not just being on the receiving end of support that has an impact. Helping others helps you, too. Lending a hand has been shown to lower stress, disability, and mortality in the giver as well as the receiver.

But beware: poor social support can have a negative impact on health. If interactions with the people in your network cause conflict, criticism, and excessive demands, that’s a cause for concern. You may want to distance yourself, choosing instead to interact with the positive people in your life.

Categories
Patient communities

Finding Hope through Community

Larry Leisher had no idea what inclusion body myositis (IBM) was when he was diagnosed with this slowly progressive muscle disease 16 years ago. He’d been having trouble going up and down the stairs for a while before that. His legs were looking very thin, and he was falling too often for it to be normal. When the diagnosis came, it threw Larry and his wife JoAnn for a loop.

“The biggest problem was not having any idea where it came from or how it started,” Larry says. “I’d never really been a sick person, so to have this come upon me the way it did was really devastating for both JoAnn and me.”

The Leishers are not alone in feeling confused and overwhelmed. Being diagnosed with a rare, chronic condition, especially one like IBM that has no treatments, can be one of the most difficult and stressful life experiences, for both the patient and her or his partner. Suddenly, a spouse becomes a caregiver and the life they thought they were living has been upended. Plans for the future, work and social life, and relationships all have to be retooled to include medical interventions and disability. None of that is easy.

About a year into his diagnosis, Larry ran across an article in the local paper written by Lee Thames, the first person Larry ever heard of who had IBM. So he called him.

“Lee and I got together and decided to start a support group,” Larry says. “At first it was just he and I. Our first meeting was in February of 2007, and it’s been going ever since.”

Getting together with other people who also live with myositis can be a life saver. It’s a way to learn more about this condition that most people have never heard of before. And because no one else in your life really knows what you’re going through, sharing the story of your journey with someone else who understands the challenges of living with this life-changing disease can lighten the load, whether you’re the patient or the caregiver.

Over the years, the myositis support group Larry helped to start in Jacksonville has grown to include 20-25 people, both patients and their caregivers. Eventually they connected with The Myositis Association (TMA) and became an official part of the organization’s national network of support groups.

Before the pandemic ended in-person meetings, they would try to get together quarterly. Larry arranged for speakers to come in and talk with the group about different aspects of their disease. 

“A support group is a good thing to have,” Larry says. “It gives hope to those who have none. It gives people a chance to talk with others who have the same difficulties. We talk about things that get us through the day, things that you can’t just turn on the computer and find.”

But it’s not just about the meetings. Larry works hard to make sure members of his group are taken care of. He calls everyone every few weeks, just to check in. And pre-pandemic, he and another member, Jim Farrlley, would also get in the car and drive as far as 70 miles to visit members who were no longer able to make it to meetings.

These efforts have paid off. Before the pandemic, the group was so connected that, even after their loved one passed away, a couple of caregivers still attended in-person meetings. And more than one member continued with the group even after their doctor decided they didn’t have myositis after all. 

Like everything in our lives over the last year or so, however, the social distancing has made it difficult for members to be there for each other. While many events have moved online through video meeting apps like Zoom, that hasn’t been an option for the Jacksonville group. Too many of the members are unfamiliar and uncomfortable with this technology, and some don’t have access to a computer.

So Larry has been on the phone a lot. He calls members weekly or biweekly, just to let them know they’re still part of a supportive community that cares about them and to keep them abreast of what’s going on at TMA and in the myositis research world.

“It’s been hard since we can’t get out to visit people,” Larry says. “So I just try to keep the conversations going. A lot of people are disappointed because we’re no longer getting together. Things are getting more and more difficult for folks…problems at home and such.”

More than anything, Larry has an unwavering positive attitude. He is committed to his mission of passing on hope to folks who may be feeling even more lost and alone than in normal times.

Recently, for example, a report on arimoclomol, a new medication being tested for IBM, showed the drug had failed to meet research expectations in clinical trials. It was devastating news for IBM patients who had pinned all their hopes on this, the only drug anywhere close to being a possible therapy for their disease.

“I contacted our members who have IBM and let them know about the results,” Larry says. “But I also let them know that, although it failed, this was not a time to give up. We still have to have hope. We still have to support the research and TMA.”

In the end, this optimistic attitude and sharing it with others keeps him going too. He refuses to let this disease take him down.

“I don’t want to lose the group,” Larry says. “Even if it’s shrinking in size, I still feel that, between our group and TMA, there’s a lot of hope that can be passed around.”

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Health Information Patient communities

COVID Vaccine and Our Patient Communities

Across the country we are starting to see the light at the end of the tunnel as the rollout of COVID-19 vaccines has begun. For many of our patients with primary immunodeficiency diseases or autoimmune conditions, however, getting vaccinated is not a straightforward decision. They have lots of questions and must weigh carefully a number of considerations.

Immunologist and rheumatologist Dr. Terry Harville has some concerns, too. “There are questions in my mind that haven’t been fully answered,” he says about the new vaccines that have recently been granted emergency use authorization by the Food and Drug Administration (FDA). “And I’m worried that there will be unintended consequences.”

The fact that we have only two months’ worth of safety data from the clinical trials testing these new vaccines from Pfizer/BioNTech and Moderna leaves many medical professionals worried about longer-term effects. Others are unsure about how the vaccines will react in patients with rare autoimmune and primary immunodeficiency diseases, because testing did not include people who live with these conditions.

Despite these concerns, Dr. Harville—along with most other healthcare practitioners—stresses that most people should still get the vaccine. Because when hundreds of thousands of people get COVID and one or two percent of them die, the statistics overwhelmingly support COVID-19 vaccination.

Dr. Harville, who is a professor of medicine at the University of Arkansas for Medical Sciences and an expert in primary immunodeficiency disorders, offers some guidelines for those who are trying to make a decision about the vaccine and might be at greater risk for complications from it.

If you have a primary immunodeficiency (PI) disease, you probably already know that you need to be careful about taking immunizations, especially if they are made with live virus. The COVID-19 vaccines that are currently being administered, however, are not made with live virus. They are created from a man-made part of the virus’s genetic code called mRNA. This means they are safer for those who are unable to take live virus vaccines.

With a few exceptions, Dr. Harville says, “It is the general consensus that we don’t see any reason to not vaccinate those with primary immune deficiency diseases.”

One exception is interferonopathies, IDs associated with dysfunction in components of the immune system called interferons. Another exception is CTLA4 deficiency. These are conditions in which patients tend to develop autoimmune disorders. Dr. Harville recommends that individuals with these types of ID should probably not get the currently available COVID vaccines. While there is no data to support this at this time, there is concern among immunologists that vaccination in this group of patients may trigger an overly aggressive immune response that would be harmful. As more data becomes available, better recommendations will be forthcoming.

If you use immune globulin therapy, there appears to be no reason you shouldn’t get the vaccine. In fact, even if you get the disease, you may actually be better off than others.

“What’s interesting is,” Dr. Harville says, “if you look at SARS-CoV-2 infection in patients with antibody deficiencies—whether that’s X-linked agammaglobulinemia (XLA) or common variable immunodeficiency (CVID)—when these patients are receiving appropriate immunoglobulin (IG) replacement therapy, they tend to have milder disease.”

Intravenous immunoglobulin (IVIG) has even been used, in some cases, to treat COVID-19 infection. While clinical trials to prove effectiveness are still ongoing, some physicians believe IVIG does decrease the risk of severe complications. IG manufactured from the plasma of people who have recovered from COVID-19 infection is also being tested as a treatment.

If you have had a severe reaction to immunizations in the past, this may be a reason to opt out of getting the COVID vaccine. This includes those who have a primary immunodeficiency disorder and developed the infection after receiving a vaccine. It also includes autoimmune disease patients who have experienced a severe flare of their symptoms after a vaccination.

In the 1976, there was a rise in cases of the autoimmune condition known as Guillain-Barré syndrome (GBS) that was thought to be triggered by the swine flu vaccine given that year. This was an inactivated virus vaccine, not the type of mRNA vaccine we now have with COVID. Nevertheless, if you’ve had GBS in the past, be sure to let your healthcare provider know this, as it may be a consideration for whether or not you should get the COVID vaccine.

During the COVID vaccine clinical trials, a very small number of participants who received the Pfizer vaccine developed a severe, life-threatening allergic reaction. Since then, others have also had what is called an anaphylactic response soon after getting vaccinated. If you have ever experienced shortness of breath, tightening in the throat, swollen lips or face, or other severe allergic symptoms, you should probably not get this vaccine in particular. (Other vaccines using whole virus are currently in development and will likely be safer.) Anyone who does get a COVID vaccine should be observed for at least 15 minutes and be sure the healthcare personnel administering it have emergency equipment needed to respond to anaphylaxis.

Regardless of your disease, everyone can reduce their own risk. Dr. Harville stresses that, even if you get vaccinated, it’s still important to wear a mask, wash your hands, and maintain physical distance from others.

“Ultimately whether you take or do not take the vaccine is an individual patient decision,” Dr. Harville says. “This should be made after weighing all the risks and benefits and based on a discussion with your physician.”

We highly recommend that you learn more about the risks and benefits of COVID-19 vaccination as it relates to your particular situation. The Centers for Disease Control and Prevention (CDC) offers these guidelines for COVID-19 vaccination for those with underlying medical conditions. In addition, a number of disease organizations offer educational programming about the impact of the virus and the vaccine on specific disease conditions.

Please also see disease-specific statements about COVID-19 vaccines from these patient organizations:

Guillain-Barré syndrome – GBS|CIDP Foundation

Immune Deficiency Foundation

Myasthenia Gravis Foundation of America

The Myositis Association

Myositis Support and Understanding

Platelet Disorder Support Association

Categories
Advocacy IG Therapy Patient stories

IG Shortage is Coming

Walter “Kip” Caro started noticing tingling, numbness, and pain in his feet back in 2007. Gradually these symptoms progressed up his legs and into his body to the point where he had to be hospitalized because his torso was affected and he couldn’t breathe. It took three years for doctors to diagnose him with chronic inflammatory demyelinating polyneuropathy (CIDP). In that time, Kip suffered permanent nerve damage in his
feet.

For the last 11 years, however, Kip has been treated with intravenous immune globulin (IVIG), which has worked like a charm. He never has to worry about his symptoms, unless he can’t get his treatments every three weeks. If he doesn’t, as happened last June when there was a shortage and his infusion center couldn’t get immune globulin (IG) products from their distributor, his disease starts to relapse.

“It was scary,” he says of this experience.

“Over the years, we’ve met people said they could make a change to their treatment schedule, and their symptoms would not be affected,” says Kip’s wife Bonnie Joslin. “But we’ve learned, for Kip, his body just can’t do that.”

Kip feels lucky that Bonnie is such an advocate for him. By the time his infusion center called and told him they weren’t able to get his medication, Bonnie had already been reading about other patients’ experiences
online. She reached out Facebook and was put in touch with CSI Pharmacy, which was able to get Kip hooked up
with home infusions within a week.

“He was already starting to relapse,” Bonnie says. “But CSI pushed it through, and Natalie Edwards in the insurance department worked to get approval. I know it wasn’t easy, but it was like a miracle
happened.”

By early 2021, however, nearly all IG manufacturers expect to see shortages again. This time it’s because pandemic shutdowns earlier in the spring have decreased plasma donations. Plasma is the raw material from which IG and other protein therapies are made. The manufacturing process takes seven to nine months to create IG from donated plasma, so unlike last year’s shortage, this time we know it’s coming and can be prepared.

When IG products are in short supply, rationing does happen. Certain sites of care may stop treating outpatients. If they do treat outpatients, they may limit treatment to primary immune deficiency, Kawasaki disease, and transplant patients.”

That’s because supplies of IG are not universally distributed. Hospitals and infusion centers have contracts with
certain manufacturers or distributors, so they can only get specific brands. Last year, patients like Kip who were served by these sites of care sometimes found their treatments delayed or dropped completely.

Specialty pharmacies like CSI Pharmacy that offer home infusion services, however, have access to more brands
of IVIG as well as subcutaneous immune globulin (SCIG). In 2019, CSI Pharmacy was able to work with patients, their healthcare providers, and their insurance plans to allow them to continue IG treatment in the home.

At times this meant switching to a different brand of IVIG when certain brands were not available. Some patients even switched to subcutaneous (meaning under the skin) infusion after being on the intravenous (IV) form.

While changing to a different product can be scary for patients who have confidence in a brand of IG that is working well for them, please be assured that  a switch can be relatively comfortable if you
work closely with your doctor and pharmacist. The pharmacist can find a brand that is close in formulation to your current brand, for example. If side effects become a problem, the infusion rate can be reduced
and pre-medications prescribed. 

If you depend on IG therapy, now is the time to prepare. We suggest you have a conversation with your provider and current site of care. 

  • Ask your provider what other brands are good options if your brand is in short supply, and ask your care site if they are able to obtain one of these brands if needed.
  • Ask the site of care if they will prioritize patients if there is a shortage. Will it be based on disease, IgG levels, and/or rationing product by the number of grams or frequency?
  • Ask how the site of care handled past shortages.

If it turns out that your site of care does not prioritize patients with your disease or they are unable to obtain your brand of IG, you may want to consider how important is it to you that you continue IG therapy. (Some patients feel comfortable skipping their treatment for a month or two if it means they don’t have to make changes.)

If you’re like Kip, however, and can’t function without regular IG infusions, you’ll need to think about what options are available to enable you to access this treatment. Are you willing to switch brands? Are you willing to move to home infusion? Are you willing to switch to SCIG?

If home infusion becomes your alternative, we urge patients to make that move now. Specialty
pharmacies are more flexible and were less affected during the last shortage, but that may not be the case this time. 

If you are a patient of a specialty pharmacy when this crisis hits, you may be able to get access to IG since they do not ration based on disease and have access to more brands. However, we do not know how the shortage will affect sites of care. 

At CSI, we want to see all patients have access to all brands in their preferred site of care. But we just don’t know what the impact is going to be. We expect this shortage will be across all manufacturers. Patients should understand that this is not going to be a perfect scenario. You may still run into hurdles like access to your preferred brand.

CSI Pharmacy’s patient advocates are available to discuss your options related to IG therapy, regardless of whether or not you are our patient. If we can’t service your needs, we will gladly help you find other resources. No patient should suffer alone.

Categories
Health Information IG Therapy Patient communities

Choices: IVIG versus SCIG

Many patients with autoimmune disorders and primary immune deficiency diseases depend on regular infusions of immune globulin (IG) to keep them healthy. For most of the nearly four decades since immune globulin therapies have been available, patients have had only one viable option for how this treatment was given. It was only available as an intravenous (IV) infusion.

Since 2006, however, when the first IG product was approved for subcutaneous (SC) administration, patients have had a choice about how they received their treatments. Both products are considered equivalent in terms of efficacy, but there are lots of other factors that may make one preferable over the other. Providers usually have their own sense about how IG should be administered, but we asked IG users for their thoughts on the pros and cons of each option.

Convenience is the biggest factor in which route patients prefer. Ironically, both IV and SC users think their choice is most convenient.

Rebecca, for example, has been getting IVIG for 12 years after being diagnosed with common variable immunodeficiency (CVID). She speaks for many when she says, “I like that I only sacrifice one day every three weeks for treatment.”

The convenience of once-a-month infusions with IVIG comes at the expense of independence, though. IVIG poses higher risks, because it goes directly into the vein rather than under the skin. So it must be given under a nurse’s supervision, whether that is in the hospital, an infusion center, or at home. This means it also has to take place on a schedule that may not always be convenient.

Those who use SCIG usually take their infusions once a week rather than once every three to four weeks or so. Still they prefer the control they have over when they infuse, because they do it themselves. As Brandina, who has myasthenia gravis, says, “I love that I can administer it myself. The treatment days are flexible, and I can take the medication with me, so I don’t have to plan my vacation around treatments.”

Infusing once a week is also inconvenient for some SCIG users, but for most this is a minor drawback. As Jen, who has specific antibody deficiency, says, “I absolutely love SCIG. There are so many more pros that I could list and only this one con.”

Getting infusions at home, whether it is IV or SC, is also a convenience. This has become especially important since the COVID-19 pandemic has made it less desirable to go to a healthcare clinic. Brynne, whose six-year-old daughter uses IVIG for juvenile dermatomyositis (JDM), was grateful when her overnight hospital infusions were changed to in-home infusions because of coronavirus restrictions.

Making the most of infusion time is something IVIG users have worked into their lives. Sitting in an infusion center or even hanging out at home with a nurse for six to eight hours or more can be a huge inconvenience, but it doesn’t have to be wasted time. Dana, who has dermatomyositis, likes IVIG, because it forces her to take time for herself and relax. And Robin, who has CVID, uses the time to crochet.

Mary, whose husband has myasthenia gravis (MG), prefers to get his IVIG at the hospital infusion center for other self-care reasons. “He loves the heated, vibrating recliner,” she says. “And they provide snacks and lunch.”

Adverse effects can be more of a problem with IVIG. In fact, this is often the reason patients switch to SCIG, which has far fewer reactions. Symptoms can range from fatigue, fever, flushing, chills, and ‘‘flu-like’’ symptoms to more life-threatening reactions like anaphylaxis (severe allergic reaction) and blood clots.

The most frequent side effect is headache, which can last several days and be more severe than a migraine. Some, like Lola, who has Sjögren’s syndrome, even get aseptic meningitis (inflammation of the membrane covering the brain) after infusions. This causes debilitating headaches, dizziness, and other symptoms.

Scar tissue and knots of fluid under the skin from subcutaneous infusions was a drawback for those using SCIG. These knots usually disappear within a few hours, though, and any redness or swelling at the injection site usually decreases over time.

Pain from being stuck with needles is not an insignificant side effect, regardless of whether it’s IV or SC. Whether it’s having to stick oneself multiple times or whether it’s having difficult-to-access veins, nobody likes to feel like a pincushion.

This can be especially challenging for children. Nancy’s nine-year-old daughter has JDM and receives IVIG at a pediatric infusion center. She says having ultrasound to find and insert the IV needle makes a world of difference for her daughter. Being spoiled by the nurses also takes some of the sting out of the whole ordeal.

Fluctuations in therapeutic effect is another reason many people switch to SCIG. An IG dose is mostly metabolized by the body over about 22 days, whether it’s given IV or SC. With IV infusion the dose reaches its peak immediately and dissipates over the next three to four weeks. This means that some patients will feel their symptoms returning as IG levels in the blood go down.

“As I got closer to my next treatment date, I would start to feel the effects of needing my next treatment,” says Karon, who has MG. “After I received it, I could tell I had just received a boost and had more energy.”

Giving IG under the skin makes the blood levels rise more slowly. And because SCIG is given more frequently—usually weekly—IG levels in the bloodstream fluctuate far less, so patients don’t feel that fatigue and other symptoms returning.

Whatever you decide about IG therapy, Lea, who has used IVIG for 22 years to treat CVID, offers this important advice: “You have to listen to your body and watch how it reacts to everything and try things until they work for you.”

For those who would like to learn more about IVIG or SCIG, please contact the CSI Pharmacy advocacy team at [email protected].

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Health Information

Clinical Trials for Rare Diseases

The idea of clinical trials is much in the news these days as medical researchers work hard to identify new treatments and vaccines for COVID-19. A clinical trial is a formal research study that, among other things, tests new therapies to see how well they work and if they are safe to use in humans. It’s an essential step in the Food and Drug Administration’s (FDA) process for approving new therapies.

For those who live with rare diseases, though, clinical drug trials have a more direct impact on their day-to-day lives. Many rare disease patients have few or no options when it comes to effective treatment of their symptoms. Even when medications with confirmed effectiveness are prescribed, they often are used without FDA approval (a practice known as off-label use), which sometimes makes it difficult to get insurance to cover the cost.

Getting new medications to market requires extensive testing in order to attain FDA approval. These studies need to have a sizable number of participants in order to show accurate results. That’s not a problem for common diseases like heart disease and cancer. But with so few people with diseases like myositis, myasthenia gravis, or pemphigus, it can be difficult to get enough qualified participants to show clear results.

That’s why many of the patient organizations that we work with encourage their members to consider taking part in a clinical trial if at all possible. This can be a big decision, one that you should discuss with family members and your doctor to be sure they are comfortable with your participation and the role they may need to play in the process. But it’s a great way feel like you are contributing to a cure.

Clinical trials are not limited to testing medications, but here we focus on clinical trials testing safety and effectiveness of new drugs. We’ve outlined answers to some common questions that can help you understand the general process of participation in such trials. Specific questions about a particular trial can be answered by the study coordinator of that trial.

How does a clinical trial work? Each clinical trial follows a strict set of rules outlining who can participate, what processes will be done, how participants are protected against risks, how long the trial is expected to last, and more. This protocol is designed to clearly answer specific research questions about the treatment. These protocols are outlined for all medications being tested in the US on the NIH website ClinicalTrials.gov. Here you can search for a trial based on disease, drug, location, or other criteria. Each trial also has contact information for additional information.

What is informed consent? All research participants have the right to know exactly what they are getting into. Informed consent is the process of providing you with essential information about the study before you decide to take part. Members of the research team will provide written and verbal explanation of the details of the study, including its purpose, how long it’s expected to last, tests or procedures that will be done as part of the research, and who to contact for further information. All known risks and potential benefits are also explained and included in the document. Before you decide to sign this document (which means you agree to participate) you should ask questions and be sure you understand everything included in it. It’s important to note that taking part in a clinical trial is voluntary, and you can leave the study at any time. 

Why do some patients not receive the treatment? Clinical trial protocols often involve comparing outcomes of patients who receive the new drug or treatment with those who are given a placebo (a non-active substitute). Most times neither the researcher nor the participant knows whether the drug or a placebo is being given. Participants are usually randomly assigned to the treatment or the placebo group. In this way, researchers can clearly see that the medication was responsible for the effect and not some other cause, such as participants getting better on their own.

What are “phases” of clinical trials? New medications and other treatments take place using a step-by-step process that begins in the laboratory (preclinical phases) then moves on to testing in humans. Each of these phases seeks answers to different questions.

These are the questions posed during each of the phases:

  • Phase 1 – Different doses of the drug are tested for the first time in a small group of healthy people—usually less than 100.
    • What are the side effects?
    • Is this drug safe to continue testing?
  • Phase 2 – The drug is tested in a larger group of people who have the disease—ideally a few hundred (but usually fewer in rare diseases).
    • What are the side effects in this population?
    • Does the drug work as treatment for this specific disease?
  • Phase 3 – The drug is tested in a much larger group of people who have the disease—ideally several hundred to several thousand.
    • What are the side effects?
    • How well does the drug work to treat the disease?
    • How much of the drug should people take?
    • How does the drug compare to currently available treatments?
  • Phase 4 – This phase happens after the drug is approved by the FDA and is being used by patients.
    • What are the long-term effects of the drug?
    • What is the best way to use this drug as treatment?
    • Are there other risks to using this drug?
    • Are there other benefits not previously identified?

How safe are these experiments? While all medical interventions carry some amount of risk, those who participate in clinical trials are not “guinea pigs.” The FDA requires researchers to include in their protocols certain measures to ensure the study is ethical, that the rights and welfare of participants are protected, and that the risks are reasonable when compared to potential benefits. And all research organizations require any protocol that involves human subjects to be reviewed, monitored, and approved by an independent Institutional Review Board (IRB) of scientists and ethicists.

You can learn more about clinical trials at the National Institutes of Health (NIH) website.

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Advocacy Patient stories

Disability Benefits in Danger

Andrea Williams had a panic attack when she opened her mail earlier this year. Her hands were shaking even before she tore into the envelope from the Social Security Administration (SSA). The letter inside informed her that, according to SSA, she was no longer disabled and would no longer receive disability benefits, including Social Security Disability Income (SSDI) and Medicare.

Andrea is one of thousands of American citizens who are unable to work because of severe, chronic health problems who can expect to receive these notices in the coming year. This is because SSA wants to cut $2.6 billion dollars from SSDI and its sister program Supplemental Security Income (SSI) by changing the rules they use to terminate people like Andrea, who have depended on the disability safety net for years.

Six years ago, Andrea was diagnosed with a rare, debilitating disease of the muscles called myositis. She had trouble lifting her head, she couldn’t pick up her newborn baby, she couldn’t climb stairs, she couldn’t even lift her arms enough to wash her hair. For months she went back and forth to the doctor saying, “I feel like I’m dying.” It wasn’t until she was referred to a specialist and ended up in the hospital for a week that she was finally diagnosed.

Myositis causes chronic pain, disabling weakness, and extreme fatigue. Treatment has helped Andrea, but she has lost too much muscle tissue that she will never regain. She can’t stand for any length of time, she drops things, and the brain fog from her medications makes it difficult for her to think. Her doctor told her she would never work again. When she applied for SSDI benefits in 2016, her application was accepted on the first try, which almost never happens.

“I’m scared to death,” she says. “My biggest fear is not having the medications, and I already can’t afford the doctors.”

An “Explanation of Determination” letter like the one Andrea received is a notice an SSDI or SSI recipient gets when they have been identified by SSA for “Continuing Disability Review” (CDR). This is the agency’s review process to see if beneficiaries are still medically eligible for the program. After this review, if SSA believes the person no longer meets their criteria for disability, their benefits are terminated.

A medical CDR is done at least once every three years, unless the SSA expects your medical condition to improve sooner. Those who have a medical condition that is not expected to improve undergo a CDR every seven years.

A rules change that took effect earlier this year, however, dramatically increases how often a person must undergo a CDR review. This change adds a new category for those whose condition is “likely to improve.” Hundreds of thousands of people now in less frequent CDR categories will be moved into this new category to be reviewed every two years.

This new rules change is especially disturbing because it targets people like Andrea who have chronic conditions that flare up unpredictably. Those who are approaching retirement age and those with mental illness are some of the other people this rules change aims to remove from benefits.

If you get one of these letters, the first thing you need to do is notify Social Security that you want to appeal this decision. To appeal, you need to submit a Request for Reconsideration form within 60 days of receiving the notice of denial of benefits. If you want to continue receiving benefits while your case is being decided, you will need to submit this form withing 10 days of the denial, and you need to specifically ask that benefits continue. Be aware, however, that if your case is unsuccessful, SSA can require you to return the overpaid benefits.

Andrea has followed this advice and is awaiting a response from SSA. She is hopeful that, with the support of her doctors and her patient advocate, her appeal will be granted and she will once again be able to sleep at night.  

For others like her, Andrea offers this advice:

“You have to reach out and get some help from someone like a patient advocate,” she says. “You have to have your medicine. You have to see your doctors. You can’t take no for an answer.”

CSI Pharmacy has patient advocates who can help you navigate this and other health care access challenges. We offer this service regardless of whether you are a CSI Pharmacy patient.

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Advocacy CSI Pharmacy stories

CSI Pharmacy’s Plasma Donor Superhero

Maddie was in high school when she developed juvenile dermatomyositis, a rare autoimmune disease of the muscles that made her so weak she couldn’t walk. Bill developed myasthenia gravis, another autoimmune neuromuscular disease, after having anesthesia for bypass surgery. Amanda and her daughter have immune deficiency diseases that make them susceptible to all kinds of infections. Immune globulin (IG) has been a life-saving therapy for all of these individuals.

IG is one of a number of treatments that can only be made from donated human plasma. This year, as a result of coronavirus restrictions, plasma therapeutics companies have experienced a significant drop in donations, which will limit supplies of plasma products such as IG by the end of the year. For patients, this is their worst fear. It means they may not be able to get the medications that allow them to live a normal life.

When Justin McNeill learned that plasma donations were down by as much as 40%, he thought of patients like Maddie, Bill, Amanda, and her daughter. Much of CSI Pharmacy’s business involves providing home infusion services for those who depend on IG therapy. As a delivery technician for CSI Pharmacy, it’s Justin’s job to pack up shipments of immune globulin and the supplies needed to administer it and make sure it all gets to the patient’s home in time for their infusion. 

In the spring, CSI Pharmacy joined the Immunoglobulin National Society in an effort to raise awareness about plasma donation and to inspire more healthy donors to contribute. As part of that effort, the company initiated an internal contest to encourage employees to become plasma donors. Justin was among the first to respond.

“We were told that with all the coronavirus restrictions, people aren’t donating plasma as much,” Justin says. “That means patients aren’t going to be able to get the medicine they need. I figured I’m able to give, so there’s no reason not to.”

Justin started donating in May and has given twice a week ever since—the maximum weekly donations allowed. To date, he has donated plasma 24 times. And even though he works full time and goes to school in the evenings, showing up at the BPL Plasma donation center is part of his weekly routine. He plans to keep on giving as long as they’ll let him.

Justin may have run away with this contest, but he’s not the only CSI Pharmacy employee to participate in the plasma donor drive. Eleven other members of the staff have also donated at least twice. (Regulations require two donations before the plasma can be used to make plasma protein therapies like IG.)

The rules governing who can qualify as a plasma donor are very strict. Justin, who is 24 years old and healthy, had no problem qualifying. When several other employees attempted to donate, however, they were turned away because they have chronic health conditions or other restrictions. This only made Justin more committed to continue donating.

“I knew a lot of the people here in the office couldn’t donate because of various health issues or medications, so I said, why not me?”

“Justin is very modest,” says James Sheets, CEO of CSI Pharmacy. “I know he doesn’t like to call attention to himself. But for us he is a superhero. We are pleased that our employees take this so seriously and are willing to donate plasma. And we’re extremely proud of Justin for his ongoing commitment to making plasma donation a part of his life.”

For Justin, it’s all about Maddie, Bill, Amanda and her daughter, and others for whom he packs up the products and supplies for their home infusions. He urges anyone who qualifies to consider becoming a plasma donor.

“We’re probably about to get hit with a really bad shortage of IG products,” he says. “Our patients need this medicine that’s made from human plasma. We’ve got a lot of people who are really sick and really need this medicine. Even donating just twice will help save lives. You can make a big difference.”

As the winner of CSI Pharmacy’s Plasma Donation Incentive Program, Justin McNeill was presented with a trophy and a monetary gift during a ceremony in September.

Find a plasma donation center near you.