IG: The Challenge, the Promise, the Future

THERE ARE NO shortages of challenges and opportunities in the world of healthcare. From new technologies in flu vaccine to exciting advances in cancer treatment and the extraordinary strides with plasma therapies, the future is indeed promising. But with these promises come challenges, and in the world of immune globulin (IG), the demonstrated potential of these miraculous proteins to save and sustain lives is often thwarted by the complex and intertwined encumbrances that continually create barriers to access.

This third plasma-themed issue of BioSupply Trends Quarterly takes a close, magnifying glass look at IG — from the onand off-label diseases it treats, to dosing strategies and a complex reimbursement model that, coupled with the high cost of this fragile lifesaving therapy, has created what many are calling a perfect storm.

In our feature Immune Globulin Therapy: The Investigational Frontier, it is gratifying to see that IG is showing promise in the treatment of more diseases than ever, despite having FDA on-label approval for only five. And while the number of off-label diseases IG is used to treat may exceed 60, according to the Medscape reference website, the majority of these are relatively new to the IG treatment frontier. The promise of this new landscape is hindered only by the challenges in supply and access. Our feature Immune Globulin Reimbursement explores the healthcare crisis that a complex reimbursement model has been instrumental in creating. Navigating this regulatory maze is all the more difficult because of the numerous obstacles and continually changing healthcare landscape. Healthcare providers and their patients are repeatedly challenged to not only find a therapy for what are usually rare and often misunderstood diseases, but then to manage therapy access and cost. The good news is that there are individuals and groups now collaborating to propose universally accepted criteria and standardization of processes to help prescribing physicians maintain continuity of care when treating patients with IG.

Another standardization challenge clinicians face with IG therapy is the lack of dosing guidelines. Dosing strategies are often unique to individual patients. Our feature Individual IG Dosing Strategies examines ongoing research and studies that could result in establishing national guidelines for IG dosing in the U.S. The impact of evidence-based guidelines would be the development of treatment protocols that result in a higher quality of life for a large portion of primary immune deficiency disease (PIDD) patients, among other IG patient populations.

Access is at the center of the mission of this issue’s featured leader, Nebraska State Senator Abbie Cornett, a PIDD patient, and also chair and president of The Alliance for Biotherapeutics of which she is a founding member. The Alliance works on behalf of patient groups and providers to help ensure that all individuals in need receive access to and adequate reimbursement for lifesaving biotherapeutics. Given the dynamic nature of the industry and its complex challenges, her leadership and commitment to working with all stakeholders is appreciated by those who share this vision.

As we bring in a new year, we look forward to new strides in both the development of and access to these miraculous proteins that are both lifesaving and life-enhancing to the patients we serve. We hope you enjoy this issue of BioSupply Trends Quarterly, and find it both relevant and helpful to your practice.