Results from three separate European health economic analyses of the TRITON-TIMI 38 study showed that treatment with Efient(R) (prasugrel) compared with clopidogrel (Plavix(R)) reduced medical costs by lowering rehospitalisation rates and the need for repeat percutaneous coronary interventions (PCI), including stenting. The analyses, conducted in Germany, France and the UK, showed prasugrel to be a cost-effective treatment option for patients with acute coronary syndrome (ACS) undergoing PCI. These data were presented today at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 12th Annual European Congress in Paris.
The analyses showed that treatment with prasugrel compared with branded clopidogrel lowered medical costs due to the demonstrated reduction in the risk of thrombotic cardiovascular events following an initial PCI, including events during the initial hospitalisation as well as recurrent heart attacks, rehospitalisations and repeat stenting procedures, across several patient groups studied. The greater efficacy of prasugrel in TRITON-TIMI 38 resulted in reductions in the use of expensive healthcare resources such as intensive care unit expenses, rehospitalisations and stenting procedure costs.(1, 2, 3)
"These health economic analyses are important because the results provide the healthcare community with new data to help evaluate prasugrel as an appropriate and cost-effective antiplatelet therapy for patients with acute coronary syndrome undergoing angioplasty," said Joerg Rustige, M.D., Medical Director Cardiovascular, Europe, Eli Lilly and Company. "We believe there is a need to provide innovative medications that improve patient outcomes and do not contribute to increased healthcare costs for patients and the healthcare system."
"ACS is a life-threatening condition that is associated with a significant emotional and economic burden to patients," said Thomas Portz, Ph.D., Head of Public Affairs, Daiichi Sankyo Europe, GmbH. "It is essential that effective new antiplatelet therapies with minimal drug budget impact to the healthcare system are available for ACS-PCI patients."
German Analysis
An analysis of the TRITON-TIMI 38 health economic sub-study performed using German healthcare costs showed medical expenses over the 14.5-month trial period were lower with prasugrel compared with branded clopidogrel by euro 20 per patient in the population of patients who had no history of transient ischemic attack/stroke, weight>=60kg and were <75 years-old due to fewer rehospitalisations for PCI. At the end of the 14.5-month follow-up period, treatment with prasugrel was estimated to reduce costs associated with rehospitalisations for heart attack, stroke or revascularisation by euro 140 per patient, while increasing bleeding-related costs by euro 25 per patient.
Analyses of key sub-populations revealed that prasugrel was an economically dominant strategy compared with generic clopidogrel for patients with diabetes, STEMI and NSTEMI ACS and an index procedure involving PCI with a bare metal stent. "Dominant" is a health economics term used when clinical data in a standard cost-effectiveness analysis showed that a drug both reduced overall costs and provided better efficacy.
Results of the German analysis also showed that prasugrel was a cost-effective treatment option both early and late compared with generic clopidogrel at a cost of euro 1.80 per day across patient sub-populations. Treatment with prasugrel yielded an incremental net cost with prasugrel of euro 285 per patient over the 14.5 months of the study. The results also showed an incremental cost-effectiveness ratio (ICER) of euro 2,213 per life-year gained.
This sub-analysis of TRITON-TIMI 38 included 6,705 patients from eight countries, including Australia, Canada, France, Germany, Italy, Spain, the UK and the United States. Medical costs, including drug expenses, were estimated based on the German healthcare system. Costs for study drugs were estimated using public price per tablet (prasugrel = euro 2.94 per day; clopidogrel = euro 2.68 per day). The cost-effectiveness analysis compared prasugrel against both branded and generic clopidogrel. Life expectancy was estimated based on in-trial cardiovascular and bleeding events, using statistical models developed from a similar population from the Saskatchewan Health Database. Costs incurred in additional years of life were not included in the base case. Elizabeth M. Mahoney, Sc.D., Director, Health Economics and Technology Assessment, St. Luke's Mid America Heart Institute, Kansas City, MO, and colleagues, performed the analysis.
French Analysis
A separate total budget impact analysis done in France showed that compared with branded clopidogrel, prasugrel reduced total medical costs including medical and pharmacy costs, over approximately one year, in part by reducing recurrent hospital stays for repeat angioplasty procedures such as stenting. These results showed potential savings of euro 176 per patient over the 380-day trial period, or euro 0.46 daily per patient, in the population of patients who had no history of transient ischemic attack/stroke, weight>=60kg and were <75 years-old due to fewer rehospitalisations for PCI.
Over a one-year time horizon, in the recommended 10 mg dose group, the total budget impact for all patients for recurrent hospital stays was euro 4,354,983.17 for prasugrel and euro 4,827,315.74 for clopidogrel, a savings of euro 472,332.57. Results of this budget impact model showed that the prevention of recurrent events requiring rehospitalisation with prasugrel generated savings that could offset price differences with clopidogrel.
The French sub-analysis was based on index and recurrent hospital stays related to cardiovascular and bleeding causes from a health economic sub-analysis of 6,705 patients from eight countries, including Australia, Canada, France, Germany, Italy, Spain, the UK and the US, from the TRITON-TIMI 38 study with a mean 380 days of follow-up. A specific diagnosis-related group (DRG) was identified for each hospital stay based on French data. Karine Chevreul, M.D., Henri Mondor Hospital, URC Health Economics, Creteil, Paris, and colleagues performed this analysis.
UK Analysis
A third UK-based health economic analysis based on TRITON-TIMI 38 data showed that compared with branded clopidogrel, prasugrel was a cost-effective treatment option in ACS-PCI patients across patient sub-populations. Results of the analysis showed that over a lifetime horizon, treatment with prasugrel was associated with life expectancy gains of 0.06 years and 0.05 additional quality-adjusted life-year (QALY), due primarily to a reduced rate of MI, and incremental costs of 169 pounds Sterling per patient. A statistical analysis showed a 72 percent chance of prasugrel being cost-effective compared with branded clopidogrel at a willingness-to-pay of 20,000 pounds per QALY. A QALY takes into account both the quantity and quality of life generated by healthcare interventions.
This economic model was based on individual patient data from TRITON-TIMI 38 over 12 months. Hospital admission costs were derived from a sub-analysis of 6,705 patients from eight countries, including Australia, Canada, France, Germany, Italy, Spain, the UK and the US. Patient outcomes were classified into UK DRGs. Cost of study drugs were estimated using public price per tablet (prasugrel at 1.70 pounds per day and clopidogrel at 1.26 pounds per day). Life expectancy was estimated based on in-trial cardiovascular and bleeding events, using a statistical model derived from a systematic literature review. The analysis adopted a lifetime horizon, assuming a maximum of 40 years survival. Andrew Davies, M.D., Oxford Outcomes, Oxford, England, and colleagues, performed this analysis.
About Prasugrel
Daiichi Sankyo Company, Limited, and Eli Lilly and Company co-developed prasugrel, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd. Prasugrel helps keep blood platelets from clumping together and developing a blockage in an artery. The European Commission granted marketing authorisation for prasugrel for the prevention of atherothrombotic events in patients with ACS undergoing PCI.
Important Safety Information about Prasugrel
In the EU prasugrel label, the risk of non-coronary artery bypass graft (non-CABG) major bleeding, including fatal bleeding, was higher with prasugrel (2.2 percent incidence) compared with clopidogrel (1.7 percent incidence). Compared with the overall study population, a higher risk of serious bleeding among prasugrel patients was most evident in three distinct patient populations that are readily identifiable: patients who weighed less than 60 kg (132 lbs), patients who were 75 years of age or older and patients who have had a prior transient ischemic attack (TIA) or stroke. Patients who weighed less than 60 kg, or were 75 years of age or older had increased exposure with prasugrel. In the EU prasugrel label, a 5 mg maintenance dose is recommended for patients who weigh less than 60 kg. Prasugrel is generally not recommended for use in patients 75 years or older; if treatment is deemed necessary in this age group, a 5 mg maintenance dose should be prescribed. Patients with prior TIA or stroke should not be treated with prasugrel.(4)
The EU prasugrel label includes a contraindication for patients with a history of TIA or stroke, as well as a warning for patients who weighed less than 60 kg (132 lbs) and patients who are 75 years of age or older. For the patients in TRITON-TIMI 38 without these risk factors, the efficacy of prasugrel compared with clopidogrel on the primary composite endpoint of CVD, nonfatal MI, or nonfatal stroke was 8.3 percent vs. 11.0 percent, respectively, and consistent with the significant efficacy benefit observed with prasugrel in the overall study population. In these same patients, the risk of serious bleeding was reduced but still higher with prasugrel compared with clopidogrel (2.0 percent vs. 1.5 percent, respectively).
An analysis weighing the risk of major bleeding and the reduction in heart attacks found an overall benefit favouring prasugrel compared with clopidogrel. For every 1,000 patients treated with prasugrel as compared with clopidogrel, there were 22 fewer patients with heart attacks and five more with non-CABG-related major bleeding events.
About Acute Coronary Syndrome
Acute coronary syndrome includes heart attacks and unstable angina (chest pain). Coronary heart disease, which can result in ACS, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(5) In addition, ACS affects nearly 1.5 million people in the United States annually.(6) Heart attack is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits. In some cases the plaque can rupture, resulting in a blood clot, which may partially or totally block the blood supply to portions of the heart, resulting in ACS. Many ACS patients undergo PCI to re-open the artery, which usually includes a stent placement.
About Daiichi Sankyo Company, Limited
A global pharmaceutical innovator, Daiichi Sankyo Co., Ltd., was established in 2005 through the merger of two leading Japanese pharmaceutical companies. This integration created a more robust organisation that allows for continuous development of novel drugs that enrich the quality of life for patients around the world. Areas of primary focus for Daiichi Sankyo research and development are thrombotic disorders, malignant neoplasm, diabetes mellitus, and autoimmune disorders. Equally important to the company are hypertension, hyperlipidemia or atherosclerosis and bacterial infections. For more information, visit www.daiichisankyo.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
This press release contains certain forward-looking statements about the potential of the investigational compound prasugrel (CS-747, LY640315) and reflects Daiichi Sankyo's and Lilly's current beliefs. However, as with any pharmaceutical compound under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the compound will receive regulatory approval, that the regulatory approval will be for the indication(s) anticipated by the companies, or that later studies and patient experience will be consistent with study findings to date. There is also no guarantee that the compound will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission and Daiichi Sankyo's filings with the Tokyo Stock Exchange. Daiichi Sankyo and Lilly undertake no duty to update forward-looking statements.
Efient(R) is a registered trademark of Eli Lilly and Company.
Plavix(R) is a registered trademark of Sanofi-Aventis Corp.
P-LLY
(1) Bruggenjurgen B, Lindgren P, Ehlken B, et al. 2007. Long-term cost-effectiveness of clopidogrel in patients with acute coronary syndrome without ST-segment elevation in Germany. Eur J Health Econ 8: 51-57.
(2) Mahoney EM, Mehta S, Yuan Y, et al. 2006. Long-term cost-effectiveness of early and sustained clopidogrel therapy for up to 1 year in patients undergoing percutaneous coronary intervention after presenting with acute coronary syndromes without ST-segment elevation. Am Heart J 151: 219-27.
(3) McCollam P, Etemad L. 2005. Cost of care for new-onset acute coronary syndrome patients who undergo coronary revascularization. J of Invasive Cardiology 17: 307-11.
(4) European Summary of Product Characteristics.
(5) British Heart Foundation Health Promotion Research Group. European Cardiovascular Disease Statistics 2008, http://www.ehnheart.org/files/statistics%202008%20web-161229A.pdf, Accessed October 15, 2009.
(6) American Heart Association. Heart Disease and Stroke Statistics - 2008 Update. Dallas, TX. American Heart Association. (Pg. 14)
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ots Originaltext: Eli Lilly and Company Im Internet recherchierbar: http://www.presseportal.de
Contact: Derin Denham (Outside of US) of Eli Lilly and Company, +1-317-277-6749 (office), +1-317-370-1435 (cell), or Tammy Hull (US) of Eli Lilly and Company, +1-317-651-9116 (office), +1-317-614-5132 (cell); Dr. Michaela Paudler-Debus of Daiichi Sankyo Europe GmbH, +49(0)89-78-08-685 (office), +49(0)172-845-8974 (cell), or Shigemichi Kondo of Daiichi Sankyo (Tokyo), +81-3-6225-1126 (office)
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