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IG Therapy Infusion

What to Know About Subcutaneous Immunoglobulin (SCIg)

Subcutaneous immunoglobulin (SCIg) therapy is a medical treatment used to manage rare and chronic primary immune deficiencies, certain autoimmune conditions, and some neurological disorders. SCIg provides patients with a vital source of antibodies to enhance their immune system’s ability to fight infections and maintain overall health. This article will explore the benefits of SCIg, uses, and administration process of SCIg to help patients, caregivers, and healthcare professionals understand its role in treating these conditions. 

 

What is Subcutaneous Immunoglobulin (SCIg)? 

SCIg is a form of immunoglobulin therapy in which purified antibodies are injected under the skin (subcutaneously) rather than into a vein. Immunoglobulins are essential proteins that help fight infections caused by bacteria and viruses. When the body can’t produce enough antibodies on its own, SCIg therapy provides them as replacement therapy to improve immune function. By delivering the necessary antibodies, SCIg helps patients fight infections more effectively and supports overall immune health. 

Administration of SCIg Treatments 

SCIg is administered through a subcutaneous injection, meaning immunoglobulin is injected beneath the skin rather than directly into a vein. These injections are typically given in the fatty tissue of the abdomen, thigh, or upper arm. After receiving proper training from an experienced infusion nurse, many patients are able to administer SCIg at home on their own. Each infusion typically requires 3-4 needles, depending on the dosage. Subcutaneous infusions can be scheduled in smaller doses a few times a week, or larger doses once a week or every other week, depending on the patient’s specific treatment plan. 

 

Diseases Treated with SCIg Therapy 

SCIg infusion is a potential treatment option for patients with immunodeficiencies, autoimmune diseases, and neurological conditions that affect the immune system, including: 

  • Primary Immunodeficiencies (PID) 
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 

 

Benefits of SCIg Therapy 

SCIg therapy offers a range of benefits for patients with rare and chronic health conditions, including: 

  • Immune Globulin Replacement: SCIg replaces the missing or dysfunctional antibodies in patients who have an immune deficiency. The goal of SCIg is to reduce the frequency, severity, and potential complications of repeated infections. 
  • Convenient Self Administration at Home: With proper training from an infusion nurse, many patients can conveniently administer SCIg therapy at home, reducing the need for frequent nurse visits. 
  • Minimal Side Effects: SCIg therapy usually causes fewer side effects that affect the whole body as compared to IVIg therapy. This can make it a comfortable option for long-term treatments. 
  • Improved Quality of Life: SCIg may allow patients to experience fewer infections, better immune health, and increased energy levels to improve their overall quality of life. 

 

SCIg Therapy Side Effects 

As with any medical treatment, SCIg treatments may come with some mild side effects. Common side effects include temporary pain, redness, or swelling at the injection site. Some patients may experience mild headaches or fatigue as well. Less common symptoms include fever or chills. It’s important to consult with a healthcare provider about any side effects or concerns to make sure they are managed with proper care. 

 

In-Home SCIg Therapy with CSI Pharmacy 

At CSI Pharmacy, we specialize in IVIg and SCIg infusion therapies for patients with immunodeficiencies, autoimmune, and other rare or chronic conditions. Our nationwide team of nurses is committed to delivering expert, compassionate care in the comfort of your home. Alongside our dedicated pharmacy, insurance & reimbursement, and intake teams, we ensure that you have the support you need every step of the way. If you’re looking for an IVIg or SCIg partner, let us help make the process seamless and stress-free. 

Categories
IG Therapy

What to Know About Intravenous Immunoglobulin (IVIg)

Intravenous Immunoglobulin (IVIg) therapy is a medical treatment used to manage a range of rare primary immune deficiencies, autoimmune conditions, and some neurological disorders. IVIg is made from pooled human plasma and contains antibodies that are vital for the immune system’s proper function. Review this guide on IVIg for a better understanding of how it works, the diseases it is used to treat, and more. 

 

How Does IVIg Work? 

IVIg therapy involves infusing immunoglobulins directly into the bloodstream. Immunoglobulins, also known as antibodies, are proteins that play a crucial role in defending the body against infections. When administered through an intravenous (IV) infusion, these antibodies help boost the immune system’s ability to fight off diseases and infections in patients who have an immune deficiency. 

Administration of IVIg Treatments 

IVIg therapy is generally administered by a medical professional in the comfort of the patient’s home or at a healthcare clinic/hospital. The infusion process generally takes a few hours, with the exact duration depending on the dosage and the patient’s specific condition. The frequency of treatments may vary, with some individuals receiving IVIg therapy once a month, while others may require more frequent infusions. 

 

Diseases Treated with IVIg Therapy 

IVIg therapy is a potential treatment option for patients with a variety of immunodeficiencies, autoimmune diseases, and neurological disorders that affect the immune system. Some of these conditions include: 

  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) 
  • Common Variable Immunodeficiency (CVID) 
  • Multifocal Motor Neuropathy (MMN) 
  • Multiple Sclerosis (MS) 
  • Myasthenia Gravis 
  • Myositis 
  • Pemphigus & Pemphigoid 

Benefits of IVIg Therapy 

IVIg therapy offers several benefits for individuals with chronic and rare medical conditions. Some key benefits of IVIg include: 

  1. Immune Globulin Replacement: IVIg replaces the missing or dysfunctional antibodies in patients who have an immune deficiency. The goal is to reduce the frequency, severity, and potential complications of repeated infections. 
  2. Immune Modulation: IVIg treatments may help reduce the body’s over-reactive response in autoimmune conditions and improve symptoms like pain, muscle weakness, and nerve damage. 
  3. Improved Quality of Life: By reducing the frequency and severity of symptoms, IVIg can significantly improve the quality of life for many individuals. 

 

IVIg Therapy Side Effects 

Like any medical treatment, IVIg treatments can cause side effects. However, they are generally mild and temporary. Common side effects include headache, fever, chills, fatigue, and nausea. In rare instances, individuals may experience allergic reactions, kidney problems, or blood clotting. It is important to discuss any concerns with your healthcare provider prior to starting treatments. Your infusion therapy provider should monitor your condition during and after treatments and manage any side effects that arise. 

 

In-Home IVIg Therapy with CSI Pharmacy 

In-home IVIg therapy provides patients with the convenience and comfort of receiving their infusions at home while maintaining the highest standards of care. CSI Pharmacy offers personalized, compassionate therapy, administered by skilled medical professionals to provide a safe and effective treatment experience in the comfort of your own home. Reach out to CSI Pharmacy today to learn more about how they can support your healthcare needs with in-home IVIg therapy. 

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IG Therapy

What to Look for in an IVIg and SCIg Therapy Provider

Choosing the right IVIg (Intravenous Immunoglobulin) or SCIg (Subcutaneous Immunoglobulin) therapy provider is crucial to ensure that you receive quality care and the best possible outcomes. If you or a loved one is considering IVIg or SCIg therapy, it’s important to find a trusted, reliable provider. In this guide, we’ll walk you through the key factors to consider when choosing an IVIg or SCIg therapy provider.

What Are IVIg and SCIg Therapies?

IVIg and SCIg therapies are complex treatments for patients with immune deficiencies and various autoimmune disorders. These infusion therapies utilize the administration of immunoglobulin (antibodies) to help strengthen the immune system to manage and treat chronic conditions.
Conditions treated with IVIg and SCIg:

  • Primary Immunodeficiencies
  • Myasthenia Gravis
  • Myositis
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
  • Guillain-Barre Syndrome
  • Multiple Sclerosis

What to Consider When Choosing an Infusion Therapy Provider

Expertise in Immunoglobulin Therapies

When undergoing IVIg or SCIg treatment, it is important that your provider has specialized knowledge and experience in administering these therapies. Ensure your provider employs registered nurses and board-certified pharmacists who are experienced in managing immunoglobulin therapies for your condition. A great way to verify a provider’s expertise is by checking their IgNS (Immunoglobulin National Society) credentials. IgNS certification verifies that providers have undergone comprehensive training and demonstrated clinical competence in immunoglobulin therapy.

Personalized Treatment Plans

Every patient’s needs are unique, especially when it comes to immunoglobulin therapy. The dosage and frequency of treatments vary based on the condition and medical history. Make sure your provider offers personalized treatment plans, tailored to your individual needs, including customized dosing and ongoing assessments to monitor the success of the treatment to make adjustments when needed.

Comfort and Convenience

Since IVIg and SCIg treatments often require regular treatment sessions, sometimes taking place over several hours or multiple days, it’s important to prioritize comfort and convenience. Many patients benefit from home infusion services, where treatments are administered in the comfort of their own home. If in-home care is not an option for you, check if your provider offers flexible clinic or hospital settings that work with your schedule.

Safety Protocols and Monitoring

Safety is of utmost importance for the administration of immunoglobulin therapies. IVIg and SCIg treatments can cause side effects, so your provider must have safety protocols in place. Ensure your nurse monitors your response to the therapy and takes action if necessary. Your provider should regularly assess your progress through clinical assessments to ensure that your body is responding well to the treatment.

Insurance Coverage and Cost

Immunoglobulin therapy can be expensive, and the financial responsibility can vary depending on your insurance plan. Before choosing a provider, make sure you understand their insurance policies and payment options. Verify whether they accept your insurance and if they are in-network. Look for a provider who offers transparent pricing, including any out-of-pocket costs, copays, and potential financial assistance programs.

Patient Reviews and Reputation

One of the most effective ways to evaluate a potential IVIg or SCIg provider is by looking at patient reviews and feedback. Hearing about other patients’ experiences can provide valuable insights into the quality of care and overall patient satisfaction. Look for a provider with a strong reputation for compassionate care, clear communication, and positive treatment outcomes.

IVIg and SCIg Treatments with CSI Pharmacy

At CSI Pharmacy, we understand the importance of specialized, personalized care for patients receiving IVIg and SCIg therapies. We offer in-home infusion therapy and specialty pharmacy services with rare and chronic conditions. Our team of experienced, certified professionals are committed to patient comfort, safety, and support, ensuring patients receive the best possible care. Start your journey with the individualized care you deserve!

Categories
IG Therapy

Understanding IVIg vs SCIg Infusions

Immunoglobulin therapy, also known as Ig therapy, has become an effective treatment for a variety of autoimmune and immune deficiency conditions. Whether you are considering treatment options for yourself or a loved one, understanding the different types of immunoglobulin therapies, IVIg (Intravenous Immunoglobulin) and SCIg (Subcutaneous Immunoglobulin), is important for making an informed decision. We’ll explain the differences between IVIg and SCIg and highlight important points to think about.

What is Immunoglobulin (Ig) Therapy?

Immunoglobulins are proteins that naturally occur in your immune system and are found in donated human plasma. These proteins are antibodies that play a vital role in defending the body against harmful pathogens (germs), such as bacteria and viruses.

Ig therapy involves infusions of healthy immunoglobulins to treat conditions such as primary immunodeficiency, autoimmune diseases, and some neurological disorders.
In some patients, the immune system doesn’t produce enough immunoglobulins (immune deficiency) so the Ig therapy replaces what is missing in the body. At higher doses for auto-immune conditions, Ig therapy helps to regulate the immune system.
Treatment goals may include reducing infections for immune deficiency, and for autoimmune conditions, decreasing the disease symptoms and stopping the disease from getting worse.

Getting to Know IVIg (Intravenous Immunoglobulin)

IVIg is one of the most common forms of Ig therapy. During an IVIg infusion treatment, immunoglobulins are injected directly into the bloodstream through an intravenous (IV) infusion. IVIg infusions are administered by a trained infusion nurse every 3-4 weeks in the comfort of your home or a clinic setting. IVIg infusions can take anywhere from a few hours to several hours, depending on the dose and the patient’s needs.

Getting to Know SCIg (Subcutaneous Immunoglobulin)

SCIg infusion therapy is another type of Ig therapy that’s administered into the fatty tissue under the skin (subcutaneously). SCIg can be administered at home by the patient themselves, after receiving proper training from an experienced infusion nurse. SCIg requires a few needles for each infusion (typically 3-4 needles) and has more frequent administration compared to IVIg. The subcutaneous infusions can be done in smaller doses a few days a week or larger doses once weekly or every other week.

Comparing IVIg & SCIg Infusions

IVIg and SCIg infusions are both potential treatment options for patients with immunodeficiencies, autoimmune diseases, and neurological conditions including:

    • Primary Immunodeficiencies (PID)

    • Myasthenia Gravis (MG)

    • Dermatomyositis

    • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

    • Multifocal Motor Neuropathy (MMN)

The main differences between these two administration methods of Immunoglobulin are shown in the table below.

Factors to Consider

IVIg Infusion

SCIg Infusion

Administration

Intravenous (IV), given by a trained infusion nurse Subcutaneous (under the skin), self-administered after required training

Frequency of Treatment

Every 3-4 weeks Daily, weekly, or every other week

Infusion Location

Can be administered by a home infusion nurse or in a clinic setting Can be done at home via self-administration after proper training

Needle Sticks

1 needle stick per treatment Multiple needle sticks needed depending on the dose

IVIg vs SCIg: Which Option is Right for You?

Choosing between IVIg and SCIg depends on several factors, including your specific medical condition, treatment goals, lifestyle, and the recommendations of your healthcare team. Both are effective options for treating a variety of autoimmune and immune deficiency conditions. Consult with your healthcare provider to determine which treatment method is best fit for your needs and treatment goals.

IVIg & SCIg Home Infusion Therapy with CSI Pharmacy

At CSI Pharmacy, we specialize in IVIg and SCIg infusion therapies for patients with immunodeficiencies, autoimmune, and other rare or chronic conditions. Our nationwide team of nurses is committed to delivering expert, compassionate care in the comfort of your home. Alongside our dedicated pharmacy, insurance & reimbursement, and intake teams, we ensure that you have the support you need every step of the way. If you’re looking for an IVIg or SCIg partner, let us help make the process seamless and stress-free.

Categories
Advocacy IG Therapy

Peace of Mind with PNS

Recently, we received word of a voluntary recall of a particular brand of immune globulin (IG). The manufacturer requested pharmacies to return all units of two specific lot numbers of the product because of reports of allergic-type reactions in patients who had been infused with these specific lots.

The hives, swelling, and skin redness that patients experienced quickly resolved when they were treated with antihistamines (Benadryl, for example), steroids, and Tylenol. Still, the manufacturer wanted to be sure others were not unduly affected by these uncomfortable symptoms caused by their intravenous IG infusions.

While news of a recall may alarm some patients, making them question the safety of their therapy, veteran IG users know that the rare recall of medications is usually not a cause for concern. In fact, the idea that the manufacturer is vigilant enough about their products to take this step voluntarily makes them feel more confident in their treatments.

Product recall or withdrawal is a common practice in industries across the country, including pharmaceuticals and medical devices. A product recall or withdrawal has several different levels; the highest is a Patient Level Recall, which is a request or warning to stop using a product. This directive can come from the Food and Drug Administration (FDA), which oversees drug safety. More often, however, the request comes voluntarily from the manufacturer, usually in response to some safety concern they’ve noticed.

“We get recall notices from both the FDA and manufacturers,” says Jack Lemley, Pharm.D., Chief Pharmacy Officer at CSI Pharmacy. “Any time we receive a recall alert, we review our electronic inventory to determine if we have ever purchased the affected lot numbers. If we have, we then check to see if any of it is still in stock and remove it.”

Still, there are times when a recalled product may be dispensed before pharmacists are aware of the recall. At CSI Pharmacy, if such a product has been shipped to a patient, pharmacists contact the person immediately and advise not to infuse the therapy, if appropriate to the level of the recall. If the patient has already infused the product, pharmacists will evaluate them for any adverse reactions. Patients are urged to notify their healthcare provider(s) of any potential adverse effects for their IG therapy, even if there is no known recall.

As a partner in their own healthcare, we strongly encourage patients to keep their own records. This should include the manufacturer of the product, the lot number (found on the side of the bottle or container), and the way it was administered (IV or subcutaneous). CSI Pharmacy provides patients with an infusion log used to record this information.

Patients can be proactive in finding out about IG product “events,” as recalls and withdrawals are called, by registering for the Patient Notification System (PNS). Through this free, confidential early warning system, patients can be made aware of a recall before they infuse or inject their therapy.

The PNS was developed by producers and distributors of plasma products and is led by the Plasma Protein Therapeutics Association (PPTA) in response to consumer requests. It provides registrants with automatic updates about plasma product withdrawals and recalls from all participating manufacturers.

To access the Patient Notification System, call 1-888-UPDATE-U (1-888-873-2838) or register online at www.patientnotificationsystem.org. You can choose the products with which you would like to receive notifications, as well as the method of notification: via telephone, fax, e-mail, or overnight letter. You will also receive a first-class letter by the US Postal Service when there are notifications.

While pharmacists do everything possible to ensure the safety of patients, there’s always a chance that a product may slip through. The Patient Notification System in one more way you can team up with your pharmacists to ensure your health and peace of mind.

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Health Information IG Therapy

When Your IG Therapy Makes You Feel Worse

As with most medications, immune globulin (IG) therapy can cause side effects. If your IG infusion leaves you with these uncomfortable symptoms, the good news is most of the time there are things you, your nurse, or the prescriber can do to make side effects less likely and relieve them if they happen.

Infusion reactions are most common if you use intravenous immune globulin (IVIG) rather than the subcutaneous form (SCIG). IG infusion nurses and pharmacists are usually very familiar with the types of reactions that can occur during or after your infusion, and they know how to respond to them. Rest assured that your nurse will be with you throughout your infusion to monitor for any reactions and respond to them.

Premedication can be one way to avoid reactions from occuring. Along with IG infusions, prescribers often prescribe over-the-counter pain medications, such as acetaminophen (Tylenol) or ibuprofen (Advil), and an antihistamine such as diphenhydramine (Benadryl).

Drinking lots of fluids (several liters a day) before, during, and after the infusion will also help. Be sure to hydrate with water not soda, coffee, milk, or other beverages.

Common Symptoms

Headache is one of the most common side effects with IVIG therapy, but usually this is mild. It’s why the nurse will start out running the infusion slowly and increase the rate gradually over the first hour or so. If a headache develops, the nurse will likely run the infusion more slowly to see if this will relieve the pain. Drinking more fluids may also help. If the infusion needs to run so slowly that it will take all day to infuse, it may need to be divided into smaller doses and given over several days.

Other milder symptoms may also occur—with or without a headache—including chills, fever, flushing, dizziness, muscle aches, joint pain, fatigue, nausea and/or vomiting, and rash. If these symptoms are significant, your prescriber may decide to try a different brand of IG. Each brand is slightly different in composition, and some people do better with one brand over another. Your nurse will consult with the pharmacist and/or your prescriber to decide how to best manage your symptoms.

For subcutaneous infusions (SCIG), pain, redness, and swelling at the needle site may also occur. Be sure to let your nurse know if you notice this and if it gets worse during the infusion. One possible solution may be to change or reposition the infusion needle.

If you use SCIG, you may notice lumps under your skin at the infusion site. This is expected and happens because the fluid you are infusing takes some time to be absorbed into your body. If these areas become uncomfortable, you can apply a warm cloth or compress to the area. If they last for more than a day or are painful, call your nurse or pharmacist.

More Serious Adverse Reactions

While headache is a common reaction with IG infusions, it usually goes away during or soon after the infusion, especially if treated with pain medication and hydration.

If your headache continues for days, is especially severe, or you have a stiff neck, drowsiness, high fever, sensitivity to light, eye pain, or severe nausea or vomiting, this is a cause for alarm. These may be signs of a rare reaction called aseptic meningitis (swelling of the brain not caused by infection). You should call your prescriber and the pharmacy and get medical help right away. 

Another rare but serious situation is an allergic reaction (anaphylaxis). This usually happens during the infusion while the nurse is with you. If you get your infusions at home, your shipment from the pharmacy will also include medications the nurse can use to treat this reaction. 

You may notice symptoms of an allergic reaction after the infusion is completed and the nurse has left. Such symptoms may include rash, itching or swelling (especially of the face, tongue, or throat), severe dizziness, or trouble breathing. If these occur, call 911 and get medical attention as fast as possible.

IG may also raise your blood pressure. Your nurse will check this frequently during your infusion. If you have had high blood pressure in the past or are currently being treated for it, please make sure that the prescriber, nurse, and pharmacist are aware. If you check your own pressure, be sure to notify the prescriber if it increases in the days following your infusion.

Other Possible Concerns

IG is made from human blood plasma, so it can rarely cause blood clots. This is more likely in older adults or those who previously have had blood clots, heart problems, or blood circulation problems. Blood clots are also more likely if you have been on bedrest for a long time, are using birth control pills or hormone replacement therapy, or if you have a central intravenous (IV) catheter in place.

Call your prescriber and pharmacist immediately if you have chest pain, trouble breathing, chest tightness, or rapid heartbeats. Other signs of a blood clot can be numbness or weakness, swelling and warmth, or discoloration in an arm or leg.

You should also let your prescriber and pharmacist know right away if you notice that your gums or nose start bleeding, you bruise more easily, it takes a long time to stop a cut from bleeding, you have a fainting spell, you feel like your heart is racing or skipping beats, or you feel unusually tired. These are signs of other cardiovascular problems that may need to be treated.

Sometimes IG can harm your kidneys, especially if you have kidney disease or use certain medicines. Signs of kidney problems include swelling, especially in the legs and hands, rapid weight gain, and little or no urination. Call your prescriber and pharmacy right away if you notice any of these symptoms.

Less of a Concern

Because IG is made with donated human plasma, some people worry about getting a disease from it. The risk of getting an infection from your treatment, however, is almost nonexistent. Modern methods used to purify IG destroy bacteria, hepatitis viruses, and other infectious germs. No one can predict every new infection that may develop, though. This is one of the reasons the pharmacy keeps careful records of the specific IG product you receive.

It’s also important that you keep track of when you get your infusions, the brand, product number, lot number, and any reactions you have around the time of the infusion. This will help you determine which products worked best and can help the pharmacist figure out if you are having side effects related to a specific brand.

Please Ask Questions

Never be afraid to ask questions about any symptom or reaction you have during or after your treatment. Your infusion nurse, pharmacist, and prescriber can all help you understand any reactions you may experience and how to treat them.

Please remember: Every patient is unique in the way they respond to any treatment. Do not hesitate to let your nurse or pharmacist know if you start to notice uncomfortable side effects. Lastly, if you ever experience unusual symptoms that cause you concern, be sure to contact your prescriber immediately.   

Categories
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
IG Therapy

FDA Approves First Proven Treatment for Dermatomyositis

Until recently, those who live with dermatomyositis (DM), have relied on off-label medications to treat this rare autoimmune disease of the muscles. On July 16, however, the Food and Drug Administration (FDA) approved an intravenous immune globulin (IVIG) therapy called Octagam10% for use by adults with DM.

“This is fantastic news for the myositis community,” says Dr. Rohit Aggarwal. “Octagam is the first proven FDA approved treatment for a myositis indication. We’ve had drugs in the past, but this is the first one that has the kind of scientific evidence—a Phase 3 clinical trial that is randomized, double blind, and placebo controlled—that is required for FDA approval.”

Dr. Aggarwal, an internationally recognized myositis expert, was the principal investigator for the Phase 3 clinical trial called ProDERM that demonstrated that Octagam 10% caused significant improvement in DM skin and muscle symptoms as well as other disease criteria.

Immune globulin is a concentrated solution of antibodies derived from donated human plasma. While immune globulin has been used to treat a variety of autoimmune diseases for more than 30 years, it’s use in myositis has been “off-label.” In fact, with a few grandfathered-in exceptions, all treatments for myositis diseases are used without an FDA labeled indication (approval) for this condition.

For a rare disease like myositis, however, it’s often difficult to convince a pharmaceutical company to invest in the research necessary to attain FDA approval. Fortunately, Octapharma, a privately owned pharma company based in Switzerland, chose to take that leap with Octagam.

“We are very responsive to patient and clinician requests,” says Eric Pluckhorn, US director of sales for Octapharma. “This now gives us an entree into the autoimmune market that up until now we really have not had for the Octagam brand.”

Several years ago when the company started this project, DM represented a huge unmet need. At the time, Dr. Aggarwal and his colleagues had recently developed response criteria that would provide the kind of measurable data needed to clearly demonstrate the drug’s benefit for patients. The success of the trial is good news for both DM patients and the providers who care for them.

For patients, off-label use often makes accessing the medication a challenge. IVIG is very effective, but it’s also very expensive. Health insurance companies, in an effort to cut costs, often don’t want to pay for such costly treatments. So they create roadblocks for patients, such as requiring them to first try a number of other treatments without success before they allow IVIG. This practice is called “step therapy.” If the drug is prescribed off-label, many companies simply refuse to pay for it.

Practitioners are also enthusiastic. Empirically,we always knew IVIG works,” Dr. Aggarwal says, “but we were hesitant to give it, partly because of not having Phase 3 clinical trial-level of evidence and partly due to the insurance issues. Now we have an approved drug that we can give to the patients, and insurance companies can no longer deny it because it’s off-label.”

Perhaps more importantly, Dr. Aggarwal suggests this approval sets a precedent for future drug development in myositis.

“Once you have a drug approved through the FDA based on a rigorous process and a valid set of criteria, other drug companies will look at that as a pathway for novel drug clinical trials in myositis,” he says. “The ProDERM study sets a precedence for future drug approval in myositis.”

Within the next five to ten years, Dr. Aggarwal predicts there will be a number of novel therapies approved for myositis diseases, including not only dermatomyositis, but also polymyositis and necrotizing myopathy.

To address the other side of the access equation—that is, the expense—Octapharma plans to offer financial assistance to help cover the cost of the treatment. Eligible patients with commercial health insurance will have access to the company’s Copay Assistance Program that will cover out-of-pocket costs, such as coinsurance, copay expenses, and deductibles, up to $2,500 per year. This assistance is provided without regard for ability to pay. (By law in the US, the company is not able to offer this coverage to those who have government plans such as Medicare, Medicaid, or Tricare.) Patients who don’t have insurance or have lost their insurance may also get assistance through a compassionate use program.

“The FDA approval of Octagam 10% as a safe, tolerable and efficacious treatment for dermatomyositis in adults is exciting news for patients who previously relied on unapproved treatments,” said Octapharma USA President Flemming Nielsen. “Octapharma is committed to providing life-saving and life-enhancing therapies for patients with rare diseases. We look forward to partnering with patient organizations and the medical community to develop educational and other support programs that will serve dermatomyositis patients.”

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Advocacy IG Therapy

Don’t Take No for an Answer

Karen has struggled for many years with intense pain and muscle weakness, symptoms of chronic inflammatory demyelinating polyneuropathy (CIDP). This rare nerve disease causes gradually increasing loss of sensation, numbness and tingling, intense pain, and weakness in the extremities. For the last two years, though, Karen has been doing well with monthly infusions of intravenous immune globulin (IVIG) therapy.

Now, however, Karen is terrified that this life-saving treatment will be yanked away from her, not by her doctors, but by her health insurance company.

Karen receives IVIG infusions at home through an independent specialty pharmacy. But after every monthly treatment, she receives a letter from her insurance company’s pharmacy benefits manager (PBM) telling her that her plan requires that she obtain this medication from their preferred specialty pharmacy.

“We’ve just been living with this every month,” Karen’s husband David says. “It’s so nerve racking. We’re always afraid that they will deny coverage and we will get a bill for thousands of dollars.”

This scenario is happening more often lately, according to James Sheets, CEO of CSI Pharmacy, a small, independent specialty pharmacy that caters to patients who use IVIG. Between five and ten percent of new referrals to his pharmacy are rejected by the patient’s insurance plan because of preferred pharmacy limitations.

“The thing is, this is not always true,” James says. “Even when the claim is denied, we have to do some investigating to see what the truth really is. Often, we are, in fact, able to provide services to these patients.”

So far, Karen is still able to get her treatments through her pharmacy of choice. But last month the PBM, a middleman in servicing pharmacy benefits for health insurance companies, stepped up the pressure. In a letter she received, they stated that there was a nationwide shortage of IVIG and again stated Karen was required to switch to their preferred pharmacy.

Someone from the preferred pharmacy even followed up with a phone call out of the blue, insisting that her health plan would not pay for the treatment if she didn’t get her medication through their company, a large, nationwide chain that is financially linked to both the insurance company and the PBM.

“IVIG is extremely expensive,” Karen says. “There’s no way we can pay for it ourselves. They’ve been writing these letters and now they’re calling me. I’m terrified! These people have no concern for my diagnosis or my medical care.”

While plasma donations decreased last year as a result of pandemic restrictions and many expect some immune globulin (IG) products to be in short supply, an IG shortage has not yet materialized. In fact, the only agency authorized to make a declaration of a drug shortage is the Food and Drug Administration (FDA), and to date no such declaration has been issued for immune globulin.

“It’s just wrong that there is an IG shortage,” James says. “Even if there were, the pharmacy in question would not be the only place that has availability of IG products. In fact, patients at small pharmacies like CSI Pharmacy would be more likely to be protected than those at a large national chain pharmacy.”

For patients like Karen who might be feeling more pressure to change to a new pharmacy for specialty medications like IVIG, James has a few suggestions. For starters, if you are already receiving services that you are happy with, don’t automatically agree to change.

“Be an advocate for yourself,” James says. “Tell your plan, look, I have been stable with my current pharmacy. I’m happy with the services they provide. I have a good relationship with my infusion nurse. I do not want all that change, and I would like to opt out and continue to use my current provider.”

It’s also a good idea to call your specialty pharmacy’s patient advocate and let them know what’s going on with the insurance company. You have a relationship with the people at your pharmacy, and they can do the necessary investigating to see if anything has changed with your coverage.

As Karen and David found out when they called their specialty pharmacy, the insurer was continuing to cover the cost of Karen’s infusions, despite the threatening letters they were sending to her. And her pharmacy had no intention of billing her for anything more than her copay.

If you have Medicare and your IVIG is covered under the Medicare Part D drug plan, you are protected against this practice. Language in the Medicare legislation specifies that patients can choose to get their medications from “any willing provider.” So by law, insurers are not allowed to force patients to a certain pharmacy.

“I believe that patients deserve to have the power to make their own health care decisions,” James says. “That’s when the best care takes place. I hate to see patients being forced, against their will, to use specific pharmacies simply as a business decision. The problem with that is there’s no incentive for the big chain pharmacies to do a great job, because when patients don’t have a choice, they never have to make patients happy in order to keep their business.”

CSI Pharmacy would like to know if this sort of pressure to change pharmacies is happening to others. If you’ve received communication from your insurance plan or their pharmacy benefits manager urging you to move your care to their preferred specialty pharmacy, please drop us a note at advocacy@csipharmacy.com.

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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.