ImmunoScience

Stuart Bradford/The New York Times

September 9, 2019

Intravenous ImmunoGlobulin Shortage Impacts Patients Nationwide

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A national shortage of some brands of Intravenous Immunoglobulin, a life-improving and sometimes life-saving treatment of antibodies, is impacting patients in places from Boston to Virginia.

Immunoglobulins are another term for antibodies, a class of proteins that attach to and tag pathogens in the body.

“IVIG is a biologic drug made from the blood of healthy people and delivered into the blood of sick people. It is made up of specific components of the blood, called immunoglobulins,” said Prof. Cynthia Leifer, microbiology and immunology.

While patients struggle to get the treatment they need, the FDA is working with pharmaceutical companies to increase supply and clinicians and advocates are working to develop short term solutions to the crisis.

According to Leifer, for patients with autoimmune diseases, IVIG therapy helps eliminate self reacting antibodies, those that are not programmed correctly and attack the host body. Currently, one of the autoimmune diseases IVIG is used to treat is myasthenia gravis.

“The immune system generates immunoglobulins against muscle cells that prevent them from receiving signals from neurons. This results in paralysis,” Leifer said.

One patient with myasthenia gravis, Melissa Miedema, described her symptoms as feeling like

“an overwhelming need to lay down. You just feel like your body is jello.”

Miedema is a resident of Middletown, New York, and was treated at the Orange Regional Medical Center, where she also worked as a nurse.

After her first myasthenic crisis in April, she was prescribed Gammagard, an IVIG product made by Takeda. She said she “felt better than [she] had in years”, but that improvement did not last. After she missed a dose due to the IVIG shortage, she has been hospitalized for multiple life-threatening myasthenic crises.

While treatment with other brands of IVIG and plasmapheresis (manual blood filtering) mitigated her symptoms, she was still unable to work.

Miedema lost her job as an ICU nurse, was denied short term disability and is now not receiving any IVIG or plasmapheresis unless her life is in danger.

In an email to The Sun, she wrote, “I checked the [insurance] marketplace and I have to pay $5,000 to $7,000 out of pocket plus copays. How is that possible? I have no income.”

According to Prof. Colleen Carey, policy analysis and management, people like Miedema are the reason why health economists have argued for the decoupling of employment and health insurance.

“Individuals who are too sick to work need coverage the most. Relying on employment to provide that coverage is really limiting,” Carey said.

Patient advocates, pharmaceutical companies and medical providers all suggest different reasons for the shortage and support a range of different solutions, including collecting more plasma to increase the supply of drugs.

According to patient advocates like Michelle Vogel, vice president of patient advocacy and provider relations for CSI pharmacies, one short-term solution that some providers have taken is switching from IVIG brands in shortage to brands with a larger supply.

Dana Lynch, a representative from CSL Behring, which manufactures IVIG brands Privigen and Hizentra, confirmed this statement.

“CSL Behring has had no manufacturing issues or supply disruptions related to Hizentra or Privigen and expects to supply the market significantly to help meet growing demand; however, we cannot fill the entire gap created by shortages of other manufacturers’ products,” Lynch said.

John Boyle, president of the Immune Deficiency Foundation, supports the short-term solution of brand switching, but with reservations. According to Boyle, switching Ig products for non-medical reasons can cause untoward side effects.

Carey believes that more flexible pricing would help companies invest in expanding the supply of IVIG to meet demand even though it may complicate the affordability of the medications during a shortage.