S Claiborne Johnston1. 1. Department of Neurology, University of California, San Francisco, CA 94143-0114, USA. clay.johnston@ucsfmedctr.org
Abstract
BACKGROUND: The societal costs and health benefits of tissue plasminogen activator (tPA) for ischemic stroke can be modeled and extended to the US population. Similarly, the societal impact of new thrombolytics with improved efficacy or safety or extending eligibility can also be modeled. METHODS: We previously modeled the impact of tPA on societal costs and health in the United States. Pertinent publications on utilization, societal cost, and health impact were identified by systematic review, updated to include studies describing the impact of extending the tPA time window. Information on utilization of tPA was integrated with published per-use data on costs and health impact (converted to 2004 dollars) to generate annual projections for the US population. Model inputs were modified to reflect various characteristics of new thrombolytics. RESULTS: At its current price, tPA saves $6074 and adds 0.75 quality-adjusted life year (QALY) per use. If tPA were priced at $50,000/QALY, a standard benchmark for cost-effectiveness, it would cost $45,800 per dose and would be expected to generate $458 million in revenue annually for its manufacturer. Thrombolytics for stroke that extended the time window or improved efficacy could generate greater revenue if priced at an accepted level of cost-effectiveness. Given current clinical development costs, development of candidate drugs with 2.8% to 5.7% probability of ultimate FDA approval would be justified. CONCLUSIONS: tPA produces substantial health and economic benefits in the United States. Better thrombolytics for stroke could have substantial impact on society, and potential returns to developers would appear to justify greater investment in new candidates.
BACKGROUND: The societal costs and health benefits of tissue plasminogen activator (tPA) for ischemic stroke can be modeled and extended to the US population. Similarly, the societal impact of new thrombolytics with improved efficacy or safety or extending eligibility can also be modeled. METHODS: We previously modeled the impact of tPA on societal costs and health in the United States. Pertinent publications on utilization, societal cost, and health impact were identified by systematic review, updated to include studies describing the impact of extending the tPA time window. Information on utilization of tPA was integrated with published per-use data on costs and health impact (converted to 2004 dollars) to generate annual projections for the US population. Model inputs were modified to reflect various characteristics of new thrombolytics. RESULTS: At its current price, tPA saves $6074 and adds 0.75 quality-adjusted life year (QALY) per use. If tPA were priced at $50,000/QALY, a standard benchmark for cost-effectiveness, it would cost $45,800 per dose and would be expected to generate $458 million in revenue annually for its manufacturer. Thrombolytics for stroke that extended the time window or improved efficacy could generate greater revenue if priced at an accepted level of cost-effectiveness. Given current clinical development costs, development of candidate drugs with 2.8% to 5.7% probability of ultimate FDA approval would be justified. CONCLUSIONS:tPA produces substantial health and economic benefits in the United States. Better thrombolytics for stroke could have substantial impact on society, and potential returns to developers would appear to justify greater investment in new candidates.
Authors: Peter Sandercock; Eivind Berge; Martin Dennis; John Forbes; Peter Hand; Joseph Kwan; Steff Lewis; Richard Lindley; Aileen Neilson; Joanna Wardlaw Journal: Stroke Date: 2004-04-22 Impact factor: 7.914
Authors: S C Fagan; L B Morgenstern; A Petitta; R E Ward; B C Tilley; J R Marler; S R Levine; J P Broderick; T G Kwiatkowski; M Frankel; T G Brott; M D Walker Journal: Neurology Date: 1998-04 Impact factor: 9.910
Authors: Mathew J Reeves; Shalini Arora; Joseph P Broderick; Michael Frankel; John P Heinrich; Susan Hickenbottom; Herbert Karp; Kenneth A LaBresh; Ann Malarcher; G Mensah; Charles J Moomaw; Lee Schwamm; Paul Weiss Journal: Stroke Date: 2005-05-12 Impact factor: 7.914
Authors: Werner Hacke; Markku Kaste; Erich Bluhmki; Miroslav Brozman; Antoni Dávalos; Donata Guidetti; Vincent Larrue; Kennedy R Lees; Zakaria Medeghri; Thomas Machnig; Dietmar Schneider; Rüdiger von Kummer; Nils Wahlgren; Danilo Toni Journal: N Engl J Med Date: 2008-09-25 Impact factor: 91.245