In vitro diagnostics (IVD), which involves testing blood or other sample types taken from a patient, has long been a critical part of medicine and an indispensable tool in diagnosing and monitoring diseases, predicting patient prognosis and monitoring therapy. In the last decade, however, the value of IVD has steadily gained recognition among the medical community and, perhaps most importantly, among health-system payers and administrators, because of its potential to save money and lives through earlier diagnosis of medical conditions. The main reason for this is a greater focus on the optimal utilization of laboratory tests, which then drive earlier diagnosis and interventions, saving lives and potentially billions of dollars in health-care-related expenses.
A classic economic study found that while IVD-related expenses only account for 2 percent of total health care costs, 75 percent of medical decisions are made based, in great part, on this information. While it may be difficult to pinpoint exact numbers, and huge geographical and cultural differences certainly exist, it is unquestionable that in any health care system worldwide, the true value of IVD testing greatly outweighs its costs.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
Given this evident value, it is about time healthcare administrators acknowledge this tremendous value and stop looking at the laboratory as a cost center. They should instead consider it a major partner and center of opportunity that brings millions of dollars in savings to their institutions.
One perfect example is acute kidney injury (AKI), a highly prevalent and underdiagnosed condition that some estimates claim is associated with approximately $16 billion in excess annual health care costs in the U.S. alone. The reason for this tragic and expensive reality is that AKI diagnosis previously relied on creatinine and urine output, and by the time the disease was recognized it was often too late for any intervention to improve patient outcomes.
This grave situation has significantly improved since the discovery of the cell cycle arrest biomarkers TIMP-2 and IGFBP-7, released by kidney cells under stress conditions. These biomarkers identify patients at high risk for developing AKI in the 12-24 hours following testing. This is early enough for treating physicians to implement crucial nephroprotective measures, such as adjusting pain medications and antibiotics, optimizing fluid balance and avoiding imaging studies with contrast. Studies have shown that when patients are identified as high risk for AKI using these biomarkers, and protective measures are implemented early, the incidence of kidney damage decreases by approximately 30 percent.
While large populational studies are not yet available to assess the nationwide economic impact of the tremendous benefits of IVD for clinicians and patients, one can make a rough estimate. Based on $16 billion annually spent in the U.S. due to AKI, these biomarkers alone mean an opportunity to save upwards of $5 billion per year – certainly not a number to ignore in our current health economic reality.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
A second excellent example of the value that IVD can bring to health care systems is a newly discovered biomarker called bioAdrenomedullin (bioADM), which identifies residual congestion in patients with acute decompensated heart failure (ADHF). This disease is another major public health and economic burden both in the industrialized and developing worlds, primarily due to the repeated re-hospitalizations these patients typically undergo in the course of their disease (averaging 6-8 events per year). These re-hospitalizations occur primarily because doctors today don’t have a tool to identify patients with residual, extra-vascular congestion after they have been treated and their intra-vascular congestion improved, as identified with IVD markers BNP and NTproBNP.
Thanks to bioADM’s ability to identify residual congestion, doctors will soon be able to pinpoint those ADHF patients not yet ready to be discharged, ensuring that they receive optimal in-hospital diuretic and supportive therapy, decreasing mortality and morbidity for these patients. Once again, IVD is bringing novel solutions to clinical challenges that have persistently frustrated clinicians and harmed patients for decades, while at the same time bringing major savings opportunities to healthcare payers.
It is clear that the healthcare industry needs to cut costs where it matters the most and focus on optimal utilization of those resources that have both the lowest economic impact and the highest clinical benefit. The laboratory fills these needs perfectly. With increased focus on improving the quality, efficacy, and cost-effectiveness of lab tests, the IVD industry can drive great value for patients and the economics of the healthcare system. In this way, IVDs have played – and will continue to play – a critical role in improving health care.
Photo: MilosJokic, Getty Images
