Study of Acetadote Injection as a cost-saving treatment for acetaminophen poisoning published

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that an independently conducted study of Acetadote (acetylcysteine) Injection, or intravenous N-acetylcysteine, as a cost-saving treatment for acetaminophen poisoning was published in Volume 12, Number 4 of the peer-reviewed Journal of Medical Economics, distributed in December. The study concludes that Acetadote is a less costly treatment regimen than oral N-acetylcysteine in all evaluated scenarios.

The cost differential between the use of oral N-acetylcysteine and Acetadote was shown to range between $881 and $2,259 depending on the time elapsed since ingestion and the decision to manage patients in the intensive care unit (ICU) or the general ward.

"The results of this analysis provide a strong economic argument for treatment of acetaminophen poisoning with Acetadote for substantial cost savings to the healthcare system," said Dr. Albert Marchetti, President and Medical Director of the Medical Education and Research Alliance of America, Adjunct Professor at the University of Medicine and Dentistry of New Jersey, and lead author of the publication. "Using real world data to model best- and worst-case scenarios, Acetadote was shown to be the less costly option in all cases."

A principal difference between oral N-acetylcysteine and Acetadote administration is the time required to complete recommended treatment. Under approved therapeutic protocols, the oral product requires 72 hours to administer compared to 21 hours for Acetadote. Consequently, the use of Acetadote results in shorter hospital stays, which is the primary reason for the substantial cost disparity between the two treatments.

To provide assistance in evaluating potential savings for individual hospitals or other facilities, Cumberland Pharmaceuticals offers an online tool to help medical professionals compare Acetadote and oral treatment using their own data. This economic modeling tool, which may also be downloaded, can be found at www.acetadote.net.

"We have believed for some time now that using Acetadote to treat acetaminophen poisoning offers not only a clinical benefit for patients and their caregivers, but a financial benefit for hospitals as well," said A.J. Kazimi, Chief Executive Officer at Cumberland Pharmaceuticals. "This analysis concludes that for healthcare systems there is a significant difference in the cost of treatment in favor of cost savings with Acetadote."

Summary Results

The study found that the estimated total cost associated with oral treatment is $5,817 if a patient presents within 10 hours of ingestion and is treated in the ICU; $3,850 if managed in the ward. By comparison, Acetadote is estimated to cost $3,765 for a similar scenario in the ICU and $2,768 in the ward.

For patients who present from 10 to 24 hours after ingestion, the costs are higher but the differential is slightly diminished. For these patients oral treatment has a total estimated cost of $6,200 in the ICU or $4,233 if managed in the ward. In the same scenario Acetadote is estimated to cost $4,293 in the ICU or $3,296 in the ward.

Scenario ORAL PRODUCT ACETADOTE Differential ICU Ward ICU Ward ICU Ward Patient presents <10 hours after ingestion Base Case $5,817 $3,850 $3,765 $2,768 $2,052 35% $1,083 28% Best Case $5,590 $3,624 $3,527 $2,530 $2,063 37% $1,094 30% Worst Case $6,470 $4,503 $4,211 $3,214 $2,259 35% $1,290 29% Patient presents 10-24 hours after ingestion Base Case $6,200 $4,233 $4,293 $3,296 $1,906 31% $937 22% Best Case $5,579 $4,006 $3,645 $2,647 $1,934 35% $1,359 34% Worst Case $6,783 $5,053 $5,169 $4,172 $1,614 24% $881 17%

Background

The American Association of Poison Control Centers reports that acetaminophen overdose is the most commonly reported poisoning in the United States and has the highest rate of mortality, with more than 100,000 exposures and 300 deaths reported annually. It has replaced viral hepatitis as the most common cause of acute hepatic decompensation and is the second most common cause of hepatic failure requiring transplantation. However, in cases where patients present within 16 hours of ingestion and treatment is administered quickly, catastrophic outcomes are uncommon. Thus, rapid diagnosis and treatment are the keys to patient safety, short hospital stays, and cost management.

The goal of this analysis was to quantify and compare full treatment costs from the provider perspective to manage acute acetaminophen poisoning with either oral N-acetylcysteine or Acetadote in a standard treatment regimen. Clinical data were abstracted from authoritative peer-reviewed publications. Financial data were obtained from a combination of published sources, consultation with respected physicians, and direction from the Contracting and Analysis Department of University Hospital at the University of Medicine and Dentistry of New Jersey. Additionally, a wide-ranging list of consumed resources and related expenses was found in a recently published financial analysis of a patient who suffered various consequences of acetaminophen poisoning. High and low ranges for costs and probabilities were used to compare a base-case scenario with best-case and worst-case scenarios.