Plasma Therapies: From Supply to Dosing and Reimbursement

IN COMING YEARS, the number of chronic to their business. illnesses treated with lifesaving therapies manufactured from human plasma is predicted to grow. This means more patients, physicians and pharmacists will be impacted by the issues surrounding supply and demand, appropriate and adequate dosing, and billing and reimbursement of these therapies, most notably immune globulin (IG) and albumin. In this plasma-themed issue of BioSupply Trends Quarterly, we take a critical look at each of these segments of the plasma market.

In the past, shortages of IG and albumin left physicians and pharmacists hunting for these scarce drugs and often paying exorbitant gray market prices to get them. But, as our article “The Plasma Industry: Investing Today to Ensure IG and Albumin Supply for Tomorrow” explains, the industry is committed to averting future shortages. Manufacturers are addressing the challenge by building additional plasma collection centers and processing capacity to keep ahead of the growing U.S. and worldwide demand for both key products. The article illustrates the big-picture story with charted data that provide a diagram of historical plasma sourcing, plasma fractionation, and intravenous IG (IVIG) and subcutaneous IG (SCIG) and albumin demand.

Patients with genetic and phenotypic primary immunodeficiency disorders (PIDDs) depend on IG to maintain their health and improve their quality of life. In our article “When It Turns Out to Be PIDD: Benefits of Early Diagnosis,” we look at how the rare nature of these disorders tends to delay diagnosis and create roadblocks to treatment. By examining the history of PIDDs, the circumstances in which IVIG or SCIG replacement therapy is indicated, and the appropriate dosing strategies that result both from manufacturer-suggested guidelines and, most importantly, from professional judgment by treating physicians, we can help improve patient outcomes and facilitate access to these life-sustaining proteins.

Behind the clinical picture of PIDDs are the patients and their families, as well as the physicians who treat them. In our story “XLA: A Patient’s Perspective,” we look at the lives of one family that must deal with the daily challenges, heartbreak and loss that come with four children who have X-linked agammaglobulinemia, one of whom succumbed to the disease as an infant. And, in our question-and- answer interview XLA: A Physician’s Perspective, Dr. Hans Ochs, an authority on PIDDs with a special interest in genes linked to XLA, shares how, thanks to the advent of IG, children who are diagnosed and treated early can go on to lead normal and active lives.

Of course, as anyone who has ever been on the prescribing or receiving end of IG knows all too well, maintaining continuity of care is often difficult due to a cumbersome and complex reimbursement model. The fact is, getting reimbursed, especially for IG, can be a challenge, even for the most experienced providers. In our article “Immune Globulin: A Guide to Billing and Reimbursement,” we give physicians and providers a step-by-step guide to getting authorization, submitting a claim and, if necessary, filing an appeal — all essential to avoiding delays, denials and financial hardship.

As always, we hope you find this issue of BioSupply Trends Quarterly educational, insightful and innovative. Looking to the future, we hope to continue to bring you the information and resources that are helpful to you in your practice.