Showing papers by "Louis P. Garrison published in 2007"

Cost‐effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2‐positive breast cancer

Abstract: BACKGROUND. Adding trastuzumab to adjuvant chemotherapy provides significant clinical benefit in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. A cost-effectiveness analysis was performed to assess clinical and economic implications of adding trastuzumab to adjuvant chemotherapy, based upon joint analysis of NSABP B-31 and NCCTG N9831 trials. METHODS. A Markov model with 4 health states was used to estimate the cost utility for a 50-year-old woman on the basis of trial results through 4 years and estimates of long-term recurrence and death based on a meta-analysis of trials. From 6 years onward, rates of recurrence and death were assumed to be the same in both trastuzumab and chemotherapy-only arms. Incremental costs were estimated for diagnostic and treatment-related costs. Analyses were from payer and societal perspectives, and these analyses were projected to lifetime and 20-year horizons. RESULTS. Over a lifetime, the projected cost of trastuzumab per quality-adjusted life year (QALY; discount rate 3%) gained was $26,417 (range, $9104-$69,340 under multiway sensitivity analysis). Discounted incremental lifetime cost was $44,923, and projected life expectancy was 3 years longer for patients who received trastuzumab (19.4 years vs 16.4 years). During a 20-year horizon, the projected cost of adding trastuzumab to chemotherapy was $34,201 per QALY gained. Key cost-effectiveness drivers were discount rate, trastuzumab price, and probability of metastasis. The cost-effectiveness result was robust to sensitivity analysis. CONCLUSIONS. Trastuzumab for adjuvant treatment of early stage breast cancer was projected to be cost effective over a lifetime horizon, achieving a cost-effectiveness ratio below that of many widely accepted oncology treatments. Cancer 2007. © 2007 American Cancer Society.

Assessing A Structured, Quantitative Health Outcomes Approach To Drug Risk-Benefit Analysis

Abstract: Regulatory authorities make difficult risk-benefit decisions when approving new drugs. Food and Drug Administration (FDA) advisory committees and reviewers must consider a complex body of evidence, including efficacy and safety results of trials, disease epidemiology, potential side effects, and patients’ needs. However, this menu of information is not usually presented in a consistent and integrated framework. The members of an FDA review panel vote with some unobserved, implicit weighting of the evidence. This paper argues that outcomes research tools for modeling long-term health outcomes, measuring health preferences, and establishing the value of additional information could provide a more structured, transparent, and quantitative process of assessing risk-benefit balance.

The Economics of Personalized Medicine: A Model of Incentives for Value Creation and Capture

Abstract: Personalized medicine is a concept promoted as a new paradigm for health care delivery, with particular emphasis on more tightly linking genomics-based diagnostics and therapeutics. Previous analyses focused on the pharmaceutical market; this analysis also addresses the incentives to develop linked genomics-based diagnostics and the broader public policy implications. Using a standard economic framework of an insurer-payer negotiating reimbursement with manufacturers of an innovative, targeted diagnostic and a companion patented therapeutic, several illustrative hypothetical scenarios are developed. The relative importance of the key economic factors is examined, including whether the reimbursement system is value or cost based, whether the therapeutic is already marketed, the strength of diagnostic intellectual property, and a current year versus longer time frame. The results suggest that health systems reforms that promote value-based, flexible reimbursement for innovative, patent-protected diagnostic and therapeutic products are critical to create stronger economic incentives for the development of personalized medicine.

A comparison of medical resource use for 4 chemotherapy regimens as first-line treatment for metastatic colorectal cancer (MCRC): XELOX vs. FOLFOX4 {+/-} bevacizumab (A)

Abstract: 4098 Background: A recent randomized phase III trial with a 2x2 factorial design compared 4 chemotherapy regimens as first-line treatment for MCRC: oral capecitabine + i.v. oxaliplatin q3w (XELOX); 5-FU/LV + i.v. oxaliplatin (FOLFOX4); XELOX+A; and FOLFOX4+A. The XELOX regimens were found to be non-inferior to FOLFOX4 in terms of progression-free survival (the primary endpoint), and the A regimens were superior to the placebo arms. The attractiveness of these regimens to providers, patients, and payers will also depend on the medical resources involved. The purpose of this analysis was to compare the expected resource use across the 4 groups. Methods: A resource use model was constructed based on trial data and projections from trial protocols. Both medical resources and patient time were considered. The medical resources included visits for chemotherapy administration, central venous access (CVA), treatment of adverse events (AEs), and hospital use for common treatment-related AEs. Patient time for chemo...