>>CHICAGO--(BUSINESS WIRE)--March 31, 2003-- Angiomax an Economically Dominant Treatment in PCI At a symposium conducted this weekend concurrent with the American College of Cardiology conference, Dr. David Cohen of the Harvard Clinical Research Institute presented the pre-specified, protocol-directed cost of care analysis of the REPLACE-2 clinical trial.
The REPLACE-2 trial in coronary angioplasty compared The Medicines Company's (Nasdaq:MDCO - News) Angiomax® (bivalirudin) with the prior care standard, heparin given with intravenous platelet inhibitors. Dr. Cohen reported that the analysis of the 4,651 patients treated in the U.S. demonstrated statistically significant cost advantages for Angiomax, driven by savings in drug acquisition costs and reductions in hospital resource consumption related to reduced bleeding and thrombocytopenia.
Significant cost reductions were observed at all three pre-specified time points analyzed by Dr. Cohen, namely:
The coronary angioplasty procedure itself (p-value less than 0.001) The hospital stay after angioplasty (p-value less than 0.001), and The 30-day patient follow-up period (p-value of less than 0.001). These cost reduction data, together with the improved clinical outcomes data previously reported, characterize Angiomax as an economically dominant treatment in PCI, The Medicines Company believes.
According to Dr. Cohen's analysis, Angiomax treatment yielded an average per-patient (as treated) drug acquisition cost savings of $402 compared with the prior standard. In addition, Angiomax treatment reduced costs associated with the complications of angioplasty by $185 per patient.
Complications of angioplasty, including major and minor bleeding, were strong independent drivers of hospital cost as shown in the data table below. The strongest cost driver was the infrequent occurrence of in-hospital Coronary Artery Bypass Graft (CABG) surgery. Repeat angioplasty, major bleeding episodes or a diagnosis of thrombocytopenia were also very costly events to manage, according to Dr. Cohen's analysis. Laboratory diagnosis of myocardial infarction after angioplasty was found to be less expensive than major bleeding episodes and thrombocytopenia. Even minor bleeding episodes, which occurred in more than 25% of patients given heparin with GPIIb/IIIa inhibitors but only 12% of patients given Angiomax, were found to be statistically significant cost drivers.
Independent cost drivers after coronary angioplasty --------------------------------------------------- (Source: Dr. David Cohen, Harvard Clinical Research Institute)
Variable Cost/Event P-value --------------------------------------------------- In-hospital CABG $29,056 less than 0.001 (coronary bypass surgery)
Repeat PCI $8,187 less than 0.001 (second angioplasty)
Major bleed $6,300 less than 0.001 (stroke, transfusion or greater than 15% loss of blood volume)
Thrombocytopenia $5,842 less than 0.001 (low platelet counts)
MI (CKMB greater than 10x) $4,084 less than 0.001
MI (CKMB 5-10x) $2,233 less than 0.001 (various levels of severity of myocardial infarction)
MI (CKMB 3-5x) $1,165 less than 0.001
Minor bleed $396 0.05 (generally bleeding from the access site)
Dave Stack, President and CEO of The Medicines Company noted, "Dr. Cohen's rigorous cost analysis - the largest such PCI economic analysis done to date - is an important validation of our message that using Angiomax lowers the cost incurred by our customers as they provide gold-standard treatment. We expect further studies to validate the cost savings that can be realized as a result of Angiomax ease of use. Following the presentation and publication of the overall REPLACE-2 results, we have increased hospital formulary acceptance of Angiomax and increased our penetration among our target customers." <<
snip
Cheers, Tuck |