Interest in a digital health tool in veterans with epilepsy: results of a phone survey.

Objective: Online tools for managing chronic health conditions are becoming increasingly popular. Perceived benefits include ease of use, low costs, and availability but are contingent on patient engagement, Internet access, and digital literacy. This article describes data collected during the recruitment phase of a study evaluating an online self-management platform for epilepsy in a U.

Health technology assessment and private payers' coverage of personalized medicine.

Purpose: Health technology assessment (HTA) plays an increasing role in translating emerging technologies into clinical practice and policy. Private payers are important users of HTA whose decisions impact adoption and use of new technologies. We examine the current use of HTA by private payers in coverage decisions for personalized medicine, a field that is increasingly impacting oncology practice.

Capacity building for assessing new technologies: approaches to examining personalized medicine in practice.

This article focuses on the overarching question: how can we use existing data to develop the capacity to improve the evidence base on personalized medicine technologies and particularly regarding their utilization and clinical utility? We focus on data from health payers who are key stakeholders in capacity building, as they need data to guide decisions and they develop data as part of operations. Broadly defined, health payers include insurance carriers, third party payers, health-plan sponsors and organized delivery systems. Data from health payers have not yet been widely used to assess personalized medicine.

Health technology assessment and private payers's coverage of personalized medicine.

Objective: Health technology assessment (HTA) plays an increasing role in translating emerging technologies into clinical practice and policy. Private payers are important users of HTA whose decisions impact adoption and use of new technologies. We examine the current use of HTA by private payers in coverage decisions for personalized medicine, a field that is increasingly impacting oncology practice.

Personalized medicine and oncology practice guidelines: a case study of contemporary biomarkers in colorectal cancer.

Predictive and prognostic biomarkers offer a potential means to personalize cancer medicine, although many reach the market-place before they have been validated, and their adoption is often hindered by variable clinical evidence. Because of this variability in supporting evidence, clinical practice guidelines formulated by panels of subspecialty experts may be particularly important in guiding stakeholders' acceptance and use of new personalized medicine biomarker tests and other nascent technologies. This article provides a structured review of the clinical evidence supporting 4 contemporary biomarker tests in colorectal cancer: K-ras and B-raf mutation analyses, mismatch repair protein testing, and the Oncotype DX Colon Cancer Assay.

Coverage policy development for personalized medicine: private payer perspectives on developing policy for the 21-gene assay.

Purpose: Personalized medicine is changing oncology practice and challenging decision making. A key challenge is the limited clinical evidence for many personalized medicine technologies. We describe the strategies private payers employed to develop coverage policy for personalized medicine using the example of the 21-gene assay in breast cancer.

Clinical practice patterns and cost effectiveness of human epidermal growth receptor 2 testing strategies in breast cancer patients.

Background: Testing technologies are increasingly used to target cancer therapies. Human epidermal growth factor receptor 2 (HER2) testing to target trastuzumab for patients with breast cancer provides insights into the evidence needed for emerging testing technologies.

Methods: The authors reviewed literature on HER2 test utilization and cost effectiveness of HER2 testing for patients with breast cancer.

Valuing personalized medicine: willingness to pay for genetic testing for colorectal cancer risk.

Objectives: Personalized medicine using genetic information is increasing in cancer screening and treatment; however, little is known about perceived value of genetic testing for cancer risk in a general population. The objectives of this report are: to identify a general population's willingness to pay for genetic testing that provids colorectal cancer risk information; examine whether screening intentions (likelihood of testing and test choice) change based on risk; and identify providers' beliefs about patients' perceived value.

Methods: A survey of US general (n = 1087) and physician (n = 100) populations using the willingness-to-pay method was carried out.

Trends in colonoscopy for colorectal cancer screening.

Background: A major health priority is to increase colorectal cancer screening, and colonoscopy has become an increasingly important method of screening. The Medicare program began coverage for colonoscopy for average risk individuals in 2001.

Objectives: We sought to examine whether overall colorectal cancer screening increased over time and whether these increases were a result of increased utilization of all methods or a result of greater use of colonoscopy but reduced use of other methods, whether the enactment of Medicare coverage was associated with an increase in colonoscopy among Medicare enrollees, and whether these trends equally affected subpopulations.

Provider practice models for and costs of delivering medication abortion -- evidence from 11 US abortion care settings.

Purpose: Understanding practice models and provider costs for medication abortion (MAB) provision may elucidate ways to facilitate MAB integration into a larger arena of health care services. This study provides descriptive data on the diverse MAB practice models currently being utilized by US health care providers and the costs associated with the components of those models.

Method: Data were gathered from a sample of 11 abortion care settings, using clinic administrative records and patient satisfaction surveys.

Innovation in personalized medicine: BiDil as a case study for integrating clinical and policy developments.

BiDil (hydralazine and isosorbide dinitrate) represents an interesting application of personalized medicine - the first pharmaceutical specifically approved by a regulatory agency, the US FDA, for an indication in a particular population based on race as a surrogate phenotypic marker, without a companion genomic diagnostic directed at measuring drug responsiveness. The focus of this paper is to use BiDil as a case study of a personalized medicine application and evaluate its clinical and policy-relevant characteristics as an illustrative example of the usefulness of the Evaluation Data for Assessing Personalized Medicine Translation (EDAPT) evidence base.

Novel personalized medicine technology: UGT1A1 testing for irinotecan as a case study.

Third Wave's Invader UDP glucuronosyltransferase 1A1 (UGT1A1) Molecular Assay, a genotyping system to predict adverse drug reactions in patients receiving the chemotherapeutic agent irinotecan (Camptosar, Pzifer, NY, USA) for the treatment of metastatic colorectal cancer (mCRC), was recently approved by the US FDA. Clinical application, economic and regulatory data were collected on this test in the Evaluation Data for Assessing Personalized Medicine Translation (EDAPT) evidence base. This descriptive analysis highlight these data and the issues for the translation of this test to practice, including gaps in the evidence base, issues regarding adoption of the test to clinical practice and the potential societal impact of UGT1A1 testing for irinotecan prescribing.

Initial development of an evidence base for personalized medicine's translation to clinical practice and health policy.

A major challenge to adoption of personalized medicine approaches, such as pharmacogenomics, is that data to address many critical questions relevant to clinical application, economics, policy and regulation are typically unavailable or widely dispersed. The evidence base we tentatively call Evaluation Data for Assessing Personalized Medicine Translation (EDAPT) would generate the foundation for a database of information. This article begins with a description of the rationale and conceptual framework for this effort.

Protocols for pediatric poisonings from nontoxic substances: are they valid?

Objectives: Most pediatric poisonings have favorable outcomes and are managed in the home by poison control centers utilizing protocols that deem products or substances as nontoxic. We sought to evaluate the validity of protocols for nontoxics.

Methods: This is retrospective study in which poison control center case records within a statewide poison control center system during calendar year 2001 were searched for products or substances involved in a pediatric poisoning ingestion and identified in the poison control center nontoxic substance or product list.

Regulatory perspectives on pharmacogenomics: a review of the literature on key issues faced by the United States Food and Drug Administration.

Pharmacogenomics (PGx), the use of genetic information to individualize drug therapy, is an immediate and important application of the Human Genome Project. The advent of PGx presents challenges to the U.S.

Patient costs for medication abortion: results from a study of five clinical practices.

Purpose: In 2000, the FDA approved mifepristone as a medication abortion alternative. There is limited understanding of the patient costs associated with use of this method. Our objective was to determine total patient costs for medication abortion.

Measuring the value of pharmacogenomics.

Pharmacogenetics and pharmacogenomics offer the potential of developing DNA-based tests to help maximize drug efficacy and enhance drug safety. Major scientific advances in this field have brought us to the point where such tests are poised to enter more widespread clinical use. However, many questions have been raised about whether such tests will be of significant value, and how to assess this.

A systematic review of cost-effectiveness analyses of pharmacogenomic interventions.

Cost-effectiveness analysis is a widely used tool to assess the value of healthcare interventions. Our objective was to conduct a systematic review of the literature on the cost effectiveness of pharmacogenomic interventions. We found 11 studies that met our inclusion criteria.

Genetic testing and pharmacogenomics: issues for determining the impact to healthcare delivery and costs.

Objectives: To determine the potential impact of genetic testing and pharmacogenomics on healthcare delivery and costs.

Study Design: Literature review.

Methods: We examined 3 examples: (1) BRCA1/2 testing for breast cancer risk, (2) HER2/neu overexpression testing to guide drug treatment in women with breast cancer, and (3) CYP2C9 testing before the use of the anticoagulant warfarin.