Immunoglobulin availability: New battlefronts, continuing advocacy

By: John G. Boyle, President & CEO

Each day, members of the Immune Deficiency Foundation (IDF) team hear new stories from families affected by primary immunodeficiency diseases (PI) about their challenges in accessing immunoglobulin (Ig) products. Many are a variation on the theme that we’ve been hearing all year. Some, however, show that the challenges are ever-changing.

As I wrote earlier this year, the issues with the plasma supply chain are global ones. Supply and demand levels for Ig are perilously close and any wiggle room that used to exist within the market has now seemingly evaporated. As this is ultimately an issue of increasing demand, there are no quick or easy fixes.

Ripple effects in the supply chain

Early on, many of the challenges seemed to be centered on subcutaneous Ig (SCIG) products and their availability through specialty pharmacies. For the last two months, though, we have been hearing more and more about intravenous Ig (IVIG) products and their availability within hospitals.

This was not a surprise to many: if the SCIG market is tight, then the expectation is that new patients are more likely to be put on IVIG, thus putting more strain on that market. Many have compared this shifting of pressures to a balloon: squeeze one end and the other expands. Squeeze the other? The air then shifts to the opposite side.

But while there are indications that the challenges in the SCIG market may be plateauing, the increasing number of IVIG stories coming out of hospital-based pharmacies is alarming.

Hospitals and their use of Ig: Big questions and concerns

In the last two weeks, the number of reports to IDF of hospital-based problems has increased dramatically in frequency and intensity. Of particular concern to us are the reports where a hospital-wide communication is sent out and one of the solutions is to reduce all Ig dosing by a fixed percentage.

I’m not a physician, but I can say that this seems like a phenomenally bad idea. In fact, it sounds like bad medicine.

Both IVIG and SCIG have a number of “on-label” uses. Antibody replacement for people with specific forms of PI are among them. But the problem is that IVIG and SCIG are also used for a large number of “off-label” uses.

One would expect hospitals and other centralized care systems to be decent stewards of such a precious resource, but some of the reports that we have received (some that are explicitly confidential) paint a troubling picture of many hospitals seemingly being caught off guard by the issues within the Ig market. It also reveals how little planning or forethought many hospitals seem to have undergone in terms of how Ig is stewarded and used.

Simply put, it’s unclear as to how hospitals are handling their on-label vs. off-label use of Ig. People who require Ig as an antibody replacement therapy essentially have no other options in terms of maintaining their health. Are people with PI being told that they have to go without their Ig or have to accept a reduced dose because hospitals have managed their Ig resources poorly? It’s hard to say at this point. But when we hear about hospitals saying that they’re running low on Ig, we say: it’s time to prioritize. Our community can’t go without Ig.

Ongoing communication and advocacy

In the month of June, I was in communication with Dr. Peter Marks, the head of CBER at the FDA, about this issue on two different occasions. There continues to be information sharing between IDF and CBER on a regular basis. In addition, we continue to aggressively and frequently communicate the patient perspective to the PPTA (Plasma Protein Therapeutics Association), its member companies, and other members of the plasma supply chain to reinforce the acute needs of people with PI and the pitfalls of non-medical switching.

In short, we’re doing what we can to ensure that we can seek solutions by gathering thought leaders on a national and international level and engaging them in constructive conversations about what can be done to stabilize and improve the supply and conditions for our patient community. This includes exploring territory that’s new for us in terms of better understanding what’s happening within hospitals and helping hospital and health system leaders to better understand our community’s needs and find ways to make it through this next wave of challenges.

What you can do

If you are told that your Ig product is not available, get ready to ask questions. Who are the parties normally involved in securing Ig? What are the exact causes for the change in availability? Is this a contracting issue? Can they help you find Ig through another source? If the answers you receive are vague, go one level higher. Many people are operating off of second-hand information and don’t know the actual reasons. While you’re asking these questions, make sure that you are writing down the answers.

Once you have that written-down information, please let us know through Ask IDF. It is imperative that we know exactly what you are experiencing and hearing. IDF can’t affect the contracting and distribution challenges that may be behind your particular situation, but the information that you share with us will help guide our advocacy efforts and help us keep all other stakeholders up-to-date about the changing battlefronts. 

The main thing that you can do is to be a squeaky wheel. If you’ve been prescribed Ig for an antibody deficiency, you need that Ig to stay healthy. If someone tells you that they don’t have the power to get you what you need, tell them to put you in touch with someone who can. There is Ig out there, so if one pharmacy can’t get it, another one likely can. In consultation with your care team you may ultimately decide to make some changes to ensure that you get the amount of Ig that’s needed to keep you healthy, but the most important thing is that you can’t go without.

Final note: The world still needs more plasma

While you fight your battles, IDF continues to expand efforts to encourage plasma donation rates and highlight donors for the heroes they truly are to our community. I would ask all people affected by PI, including families and loved ones, to share this issue with friends, co-workers, and others in your social circle to drive home the importance of increased plasma donation. Every little bit of education and awareness helps, and we all need to do our part at all levels of this issue to make a difference. To learn more about plasma donation, go to: plasmahero.org.

We’re working toward solutions and answers, and we will update you as we know more and continue this fight for people whose lives depend on these products.

Immunoglobulin (Ig) products are lifesaving, lifelong treatments for people with PI, specifically those who are antibody deficient. For information about Ig products, go to www.primaryimmune.org/ig.

This content should not be used as a substitute for professional medical advice. In all cases, patients and caregivers should consult their healthcare providers. Each patient’s condition and treatment is unique. The benefits and risks of any treatment should be discussed with the patient’s provider.