The Challenges of Drug Accessibility
In the U.S., medicines are far more available than in developing countries. However, we still experience access issues due to a variety of factors, including shortages, reimbursement problems and waste, all of which are topics of discussion in this issue.
- By Patrick M. Schmidt
JUST MORE than a decade ago, the Secretary-General of the United Nations reported that over one-third of the world’s population (approximately two billion people) did not have sufficient access to essential medicines. Thankfully, in the U.S., medicines are far more available than in developing countries. However, we still experience access issues due to a variety of factors, including shortages, reimbursement problems and waste, all of which are topics of discussion in this issue.
We begin with an analysis of the current plasma-derived immune globulin (IG) shortage. Beginning last April, many patients across the country began to hear the IG product used to treat their life-threatening illness was limited or stopped altogether. Yet, as we explain in our article “The Current Challenge of Immune Globulin Access” (p.16), official acknowledgment of the shortage and an explanation of its origin didn’t materialize until August, when the U.S. Food and Drug Administration released an explanatory statement. As of this writing, nine of the 16 available IG products are affected by this shortage caused mainly by an ever-increasing demand for the treatment, which continues to grow more than 8 percent a year. Demand is fueled by a number of factors, including an increase in the number of autoimmune, inflammatory, immunodeficiency and other immune-mediated disorders; more aggressive treatment of autoimmune neurologic diseases with high-dose IG; a surge in demand in other countries; and, most recently, an increase in the number of secondary antibody deficiencies and a growing geriatric population with weakened immune systems prone to antibody deficiency disorders. And, while there is no prediction about when the IG shortage will end, the number of plasma collection facilities is on the rise, manufacturers are optimizing IG production capacity, and organizations are suggesting ways manufacturers and healthcare providers can mitigate the current situation.
Even when available, the high cost of IG products often results in reimbursement denial by payers, leaving patients without needed treatment. To help providers who prescribe and administer IG products, our article “A Guide to Immune Globulin Billing and Reimbursement” (p.20) offers a roadmap to avoiding reimbursement pitfalls. Included is information about which diagnoses are reimbursable for treatment, which require pre-authorization, how to effectively bill for treatment and how to file an appeal if denied.
Regrettably, waste is often an unfortunate outcome when medicines expire before they can be used, which is extremely costly to the healthcare profession. As such, it is vitally important medications are properly managed to ensure they don’t become short-dated, which occurs when they near their expiration date and are not yet consigned to a buyer. Our article “Short-Dated Products: Reducing Unsalable Returns and Supply Chain Waste” (p.24) discusses industry safeguards to protect product from becoming short-dated, as well as considerations for handling inventory such as with smart systems on a consignment basis to minimize the risk of short-dated product returns. A consignment strategy can streamline and automate inventory management processes and reduce carrying costs for specialty pharmaceuticals. This approach allows hospitals to store products in their pharmacies and pay for them only when they are used. A revolutionary cost-saving idea!
As always, we hope you enjoy this issue of BioSupply Trends Quarterly, and find it both relevant and helpful to your practice.
Helping Healthcare Care,
Patrick M. Schmidt
Publisher
