The Medicines Company Presents Seven Hospital Data Analyses at Leading Health Economics and Outcomes Research Conferences
The Medicines Company (NASDAQ:MDCO) today announced that seven abstract poster presentations are being delivered by the Company and its research collaborators at this week’s International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 19th Annual International Meeting in Montreal, Canada, and at the American Heart Association Quality of Care and Outcome Research (AHA QCOR) Scientific Sessions 2014 in Baltimore, MD. The abstracts involve analyses within all three areas of hospital focus for The Medicines Company: serious infectious disease care, acute cardiovascular care, and surgery and perioperative care.
Stephanie Plent, MD, Executive Vice President and Chief Value Officer for The Medicines Company stated, “The analyses we are presenting this week are planned to provide a basis for our hospital customers to measure the impact of introducing new solutions to their practice. This in turn serves a key part of MDCO’s purpose, which is to contribute to the economics of healthcare."
SERIOUS INFECTIOUS DISEASE CARE
Three ISPOR posters in the serious infectious disease care area review involve analysis of the Acute Bacterial Skin and Skin Structure Infections (ABSSSI) hospital market:
Severity and Costs of ABSSSI by Treatment Setting: An Application of the Eron Classification to a Real-world Database
MDCO health economic researchers applied an algorithm for treatment of ABSSSI known as Eron/CREST to real-world cost data from US hospitals from the Premier hospital database (which contains one in every six discharges from US hospitals). The Eron classification algorithm includes recommendations about whether to hospitalize a patient or treat in an outpatient setting on the basis of disease severity and comorbidities and – if hospitalized – when to discharge the patient. It classifies patients from ABSSSI Class I (least severe) to ABSSSI Class IV (life threatening). The analysis showed that substantial proportions of patients in Class II (57.85%) and III (22.65%) were not hospitalized, possibly reflecting a trend toward treatment of moderate ABSSSI patients in the ambulatory setting.
Utilization, Costs and Reimbursement of Inpatient and Ambulatory Treatment of ABSSSI Among the Medicare Fee-for-service Population; and Utilization, Costs and Reimbursement of Inpatient Treatment of ABSSSI Among the Medicare Fee-for-service Population
Two additional ISPOR poster abstracts examined utilization, costs and reimbursement of inpatient and ambulatory treatment of ABSSSI among the Medicare fee-for service populations, with costs derived from the Premier hospital database. Data presented in the posters show a median length of stay of three to four days for ABSSSI patients. Since seven to ten days of IV reference therapy vancomycin is required, an average three to seven days of antibiotic treatment is left for outpatient therapy. Despite discharging the patients before the end of therapy, one analysis showed 52% of admissions for the most common ABSSSI diagnosis were projected to result in financial losses to the hospital; net reimbursement was positive for hospitals when the patient length of stay was less than three days, but negative when more than three days.
ACUTE CARDIOVASCULAR CARE
ISPOR: Estimating the Impact of Combining Cangrelor and Bivalirudin to a US Hospital Performing PCI Procedures
This poster abstract described decision analysis modelling to cost data from the Premier hospital database. The decision analytic model, based on current PCI clinical practice, was developed to estimate the impact of using heparin + provisional glycoprotein IIb/IIIa inhibitor (GPI) + clopidogrel (base case) vs. bivalirudin + cangrelor + bailout GPI (scenario case).
AHA QCOR: CHAMPION PHOENIX Study Economic Results: Direct Hospitalization Costs of Patients Receiving Clopidogrel or Cangrelor During Percutaneous Coronary Intervention
Results of a pre-specified economic sub-study of the randomized Phase III CHAMPION PHOENIX trial were presented at the AHA QCOR Scientific Sessions. Actual hospital billing records from 1,117 patients enrolled in the US were collected, certified, and analyzed using standard economic data quality methods.
SURGERY AND PERIOPERATIVE CARE
ISPOR: Cardiovascular Surgery Pathway Microsimulation Framework to Study the Health Economics of Clevidipine
This poster abstract described a decision-analytic microsimulation framework that provides a basis for assessing economic properties of clevidipine use in cardiac surgery.
ISPOR: An Analysis of Hospital Consumer Assessment of Healthcare Providers and Services (HCAHPS) Scoring and the Impact of the Pain Management Dimension on Hospital Performance
This study evaluated current Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) pain measures across facilities, and analyzed the potential benefit to overall HCAHPS scores by improving pain management in an inpatient setting.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on 3,000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
About Angiomax® (bivalirudin) for Injection
In the United States, bivalirudin is marketed under the trade name Angiomax and is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
Please see full prescribing information for Angiomax, available at http://www.angiomax.com.
Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an immediately bioavailable and quickly reversible intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing PCI.
The cangrelor NDA filing was based on the results of a development program which included the data from four randomized, double-blind clinical trials conducted in 25,567 patients with coronary artery disease (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE). The PHOENIX study provided the primary evidence of efficacy for the proposed PCI indication for cangrelor.
About Cleviprex® (clevidipine) Injectable Emulsion
Cleviprex® (clevidipine) is an intravenous dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. In June 2011, the U.S. Food and Drug Administration (FDA) approved the current formulation, which triples the maximum allowable infusion time per vial, commonly referred to in hospitals as "hang time," to 12 hours compared to the original 4-hour hang time vial approved by the FDA in 2008.
Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs or egg products; defective lipid metabolism; and severe aortic stenosis.
Cleviprex is intended for intravenous use. Use aseptic technique and discard any unused product within 12 hours of stopper puncture. Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.
Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal.
Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped.
Most common adverse reactions are ( > 2%) headache, nausea, and vomiting.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "plans," "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on May 12, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
Neera Dahiya Ravindran, MD, +1-973-290-6044
Vice President, Investor Relations & Strategic Planning