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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 [email protected].

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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 immediately contacted Michelle Vogel, who administers a Facebook page for people who depend on IG therapy. Michelle, who also serves as vice president for patient advocacy at CSI Pharmacy, was able to get Kip hooked up with home infusions within a week.

“He was already starting to relapse,” Bonnie says. “But Michelle 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 will happen, Michelle says. “When the market tightens and we have shortages, what tends to happen is that certain sites of care like hospitals may stop treating outpatients. If they do treat outpatients, they will 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. 

“We want to see all patients have access to all brands in their preferred site of care,” Michelle says. “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.

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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].