Immunoglobulin Therapies in the US: How they are used, a Roundtable Report

To set the table for the discussion, Maik Klasen, Ph.D., presented information on Ig therapies and their use in a variety of clinical indications, which has been studied by global health care strategy and marketing consultancy firm Adivo Associates for more than 20 years. Following the presentation, Hogan Lovells partner Stuart Langbein moderated a discussion on access to, and use of, Ig therapies, and took questions from a live audience.

The following key takeaways emerged from Dr. Klasen’s presentation and the subsequent roundtable conversation among clinicians:

• Ig is used to treat immune deficiencies and other conditions that involve the immune system.

• The majority of Ig therapy use (approximately 65%) is as treatment for U.S. Food and Drug Administration (FDA) approved indications, and the rest is as treatment for other conditions that are supported by scientific or practice-based evidence.

• Use of Ig therapies has increased as a result of patients on therapy living longer, improved diagnosis rates, wider use in oncology-related secondary immunodeficiencies, and expanding scientific knowledge of Ig benefits for patients.

• Access challenges can result in patients missing or delaying Ig treatment, which can have severe and immediate consequences on patient health.

• Switching patients between Ig therapies is not simple, as some patients do not tolerate certain products but do tolerate others.

• Ig therapies provide significant benefits to patient health, outcomes, and quality of life, and for many patients, are the only treatment option.

• Clinicians recognize that Ig availability is dependent on plasma donations from healthy volunteers and believe that increasing plasma collection is a safer and more promising approach to address access challenges compared to restricting Ig use.

You can view the full report here.

Dr. Klasen was joined for the roundtable discussion by a panel of leading clinical experts in the U.S. who use Ig to treat patients:

• Antoine Azar, M.D., of Johns Hopkins University
• Syed S. Mustafa, M.D., of Rochester Regional Health and the University of Rochester;
• Christina Price, M.D., of Yale School of Medicine; and
• Gil Wolfe, M.D., FAAN, of University at Buffalo Jacobs School of Medicine and Biomedical Sciences, SUNY.

Authored by Stuart Langbein and Boyd Jackson