Q&A Regarding IVIG Shortage
A nationwide shortage of a potentially life-saving treatment, IVIG (intravenous immunoglobulin), has been an increasing concern throughout 2019. The shortage started to become more evident in late 2018 and has continued to impact patient populations across the country. IVIG is often used by the rare neuroimmune disorder community as an acute treatment therapy, as well as an ongoing method of treatment for disorders in which recurrence of inflammatory attacks is a likely concern. SRNA has received many questions from community members about this shortage. These questions have come from various members representing each of the disorders, and especially from those who’ve been turned away from their appointments or told they must change their ongoing treatment for MOG antibody disease (MOGAD) because IVIG isn’t available. We asked members of our Medical and Scientific Council for their input and perspective of this ongoing concern as it relates to our community.
Why is there a shortage of IVIG? Is it only due to production concerns? Is it a high-demand product? Does a lack of or shortage in blood or plasma donations have anything to do with the shortage?
There is more demand for immunoglobulin products than there is an available supply. IVIG is used to treat many conditions across multiple specialties (e.g., rheumatology, immunology, hematology/oncology, pediatrics, neurology). The product starts with the donation of plasma but then goes through a complicated, long manufacturing process that ultimately leads to IVIG or other immunoglobulin products. Most of the manufacturers of the product are reporting a shortage, but this varies by region and medical institution. One neurologist in SRNA’s network was told by his pharmacy that one of the main manufacturing companies cut their manufacturing in order to produce other products. He has not, however, been able to verify this via official reports. Donation of plasma may help the problem, but it will take time before an increase in donations leads to an increase in the supply, and the facilities that do the manufacturing must be available. The problem is primarily a manufacturing issue and not because of a lack of donations, although donations of blood and plasma are always needed.
How long is this expected to impact the SRNA community?
The shortage is expected to last well into 2020. Many areas and hospitals are still able to get some IVIG and have developed protocols about which patients receive the treatment. Diagnoses for which there is robust evidence supporting its benefits and diagnoses for which there are no other treatment options are getting priority (e.g., Kawasaki Disease). The shortage is concerning as we look towards 2020 when we anticipate an increase in cases of acute flaccid myelitis (AFM). IVIG has antibodies that may have an effect on limiting inflammation or neutralization or replication of enteroviruses and is widely used in treating AFM. It is also used as a maintenance treatment in MOGAD where it has shown to be well-tolerated and in one study, reduced the median annualized relapse rate (AAR). As it has not been approved for MOG-Ab positive patients, it has become difficult to continue these patients on IVIG. As with all typical acute treatments for the rare neuroimmune disorders, because placebo-controlled trials are difficult to perform, particularly on acute treatment therapies, there are no placebo-controlled data confirming the efficacy of IVIG in this population, but it remains a commonly used treatment option for consideration.
What implications does it have for those who rely on IVIG as continuous therapy for their rare neuroimmune disorder (e.g. MOGAD)? What consequences does it have for those newly diagnosed and needing it as an acute treatment (applicable to all of the rare neuroimmune disorders including AFM, TM, etc.)?
Medical professionals are continuing to use IVIG for acute treatments. Many hospitals and physicians have developed protocols for the use of IVIG and established which patients and disorders are given priority for receiving it as an acute treatment. For patients that are receiving this for long-term treatments, we are attempting to get them on a product with a reliable supply (e.g., private infusion clinics, in-home nursing, etc.). If that is not an option (typically insurance-limited), we are forced to look at other treatment options, such as immunosuppressant drugs (e.g., Rituximab, Mycophenolate mofetil, or azathioprine).
How are providers deciding which patients receive IVIG?
Hospital systems may set up a multi-disciplinary group in order to discuss which patients need IVIG as a life-saving drug. These include children with immunodeficiencies, cancers, Kawasaki disease and a few other rare disorders. Children who present with acute, life-threatening disorders such as Guillain-Barré, encephalitis, myelitis, etc., are given IVIG when appropriate (for example, when plasmapheresis is not feasible). Physicians and hospitals are also working to assess patients who may need it urgently versus those who could potentially use other therapies, or safely have a change in dosage.
Some families are being turned away from their infusion appointments because their hospital doesn’t have IVIG – what are they to do in these situations? Should they look elsewhere for the same product or do they need to consider other options?
It is recommended that they look into other supply companies or home infusion companies. There are several home infusion and supply companies (varies by region) that have reported they are not currently in shortage of IVIG products. Some physicians have been able to switch patients receiving repeated IVIG infusions onto home infusions. Insurance approval for this may be a limiting factor in some cases.
Are there institutions that aren’t impacted by the shortage because they have enough of a supply?
Again this, varies by region and changes frequently. The manufacturers supply the entire country and when there is a shortage, it affects the entire supply line. We are not aware of exactly how many suppliers/manufacturers of IVIG there currently are in the U.S./North America. FDA published an article in August, 2019, which noted eight manufacturers of IG products.
Can someone with a rare neuroimmune disorder donate blood and/or plasma? Should they if there isn’t another medical reason for them not to do so?
SRNA is working on finding additional answers from those working specifically in hematology. It is recommended that anyone with a rare neuroimmune disorder discuss blood or plasma donations with their various physicians and come to an individual, medically appropriate conclusion as to whether blood and/or plasma donations is safe for them.
What can a community member or patient using IVIG do to impact change in this area?
It is the general medical community’s understanding that it is a manufacturing and demand issue, not an issue related to donations. We recommend speaking with your specific medical facility to find out about their supply and with your physician to discuss your individual treatment options. It may also be of benefit to bring awareness to this issue by writing your state and federal legislators. As stated previously, the problem is primarily a manufacturing issue and not because of a lack of donations, although donations of blood and plasma are always needed.
If you have additional questions, or if you’ve been personally or professionally impacted by the shortage, we’d like to hear from you about your experience. Please email us at [email protected] at any time.