From: mchalert-bounces@list.ncemch.org on behalf of MCH Alert [mchalert@ncemch.org] Sent: Friday, February 16, 2007 7:21 AM To: MCHAlert@list.ncemch.org Subject: MCH Alert ************************************************************ MCH Alert Tomorrow's Policy Today ************************************************************ Maternal and Child Health Library This and past issues of the MCH Alert are available at http://www.mchlibrary.info/alert/archives.html. February 16, 2007 1. Curriculum Focuses On Ensuring Access To Oral Health Services For Young Children with Special Health Care Needs 2. Report Examines State Children's Health Insurance Program Trends, Experiences, and Issues Within and Across States 3. Paper Suggests Priority Areas for Increased Federal Funding to Support Children 4. Report Explores Recent Changes Affecting Maternal Mortality Data 5. Authors Assess Economic Returns of Clinical Trials Performed Under FDA's Pediatric Exclusivity Program ************************************************************ 1. CURRICULUM FOCUSES ON ENSURING ACCESS TO ORAL HEALTH SERVICES FOR YOUNG CHILDREN WITH SPECIAL HEALTH CARE NEEDS Special Care: An Oral Health Professional’s Guide to Serving Young Children with Special Health Care Needs, is a Web-based continuing education (CE) course that provides oral health professionals (dentists, dental hygienists, and dental assistants) with information to ensure that young children with special health care needs have access to health-promotion and disease-prevention services that address their unique oral health needs in a comprehensive, family-centered, and community-based manner. The Web-based curriculum was prepared by the National Maternal and Child Oral Health Resource Center at Georgetown University and designed by the Center for Advanced Distance Education at the University of Illinois at Chicago with support from the Maternal and Child Health Bureau. Topics include (1) an overview of children with special health care needs and oral health, (2) the provision of optimal oral health care, (3) oral health supervision, (4) oral disease prevention, and (5) behavior management. Four CE credits through the Indian Health Service or through the American Dental Hygienists’ Association will be awarded upon successful completion of the course. The course is free of charge and is available at http://www.mchoralhealth.org/SpecialCare. ************************************************************ 2. REPORT EXAMINES STATE CHILDREN'S HEALTH INSURANCE PROGRAM TRENDS, EXPERIENCES, AND ISSUES WITHIN AND ACROSS STATES Children's Health Insurance: State Experiences in Implementing SCHIP and Considerations for Reauthorization addresses trends in the enrollment and current composition of the State Children's Health Insurance Program (SCHIP) across states, states' spending experiences under SCHIP, and considerations for SCHIP reauthorization. The report presents testimony of the U.S. Government Accountability Office before the U.S. Senate Committee on Finance and is based on prior work, analysis of the Current Population Survey conducted by the U.S. Census Bureau (2003-2005), information from states' annual SCHIP reports (2002-2005), and SCHIP enrollment and expenditure data from the Center for Medicare and Medicaid Services. Contents include background information on SCHIP allotments to states, design choices, and coverage of adults. Figures provide data on SCHIP enrollment, the percentage of children who are uninsured, state SCHIP design choices, SCHIP eligibility for children and adolescents ages 6-18, and types of cost-sharing under SCHIP. Tables provide information on the basis of coverage for states with separate child health programs, premium-assistance programs in nine states, states covering adults in SCHIP, selected SCHIP program characteristics of shortfall and non-shortfall states, and SCHIP enrollment in states using SCHIP funds to cover adults. The full report, including the scope and methodology, is available at http://www.gao.gov/cgi-bin/getrpt?GAO-07-447T. Report highlights are available at http://www.gao.gov/highlights/d07447thigh.pdf. ************************************************************ 3. PAPER SUGGESTS PRIORITY AREAS FOR INCREASED FEDERAL FUNDING TO SUPPORT CHILDREN Cost-Effective Investments in Children examines options for investing additional resources in children as part of an overall federal-deficit-reduction plan. The paper, one in a series of papers on budget choices published by the Budgeting for National Priorities project at the Brookings Institution, is based on a review of benefit-cost evidence. The author identifies four areas of investment in children where there is sufficient evidence of positive outcomes and sound benefit-cost ratios to merit expanded federal funding. These areas include (1) high-quality early childhood education programs for children ages 3 and 4, (2) nurse home-visiting programs to promote prenatal care and the healthy development of infants and toddlers, (3) school reform with an emphasis on programs in high-poverty elementary schools that improve the acquisition of basic skills for all students, and (4) programs that reduce the incidence of adolescent pregnancy. For each of the four areas, the paper reviews the social science evidence regarding program effectiveness -- particularly cost effectiveness -- and outlines a specific proposal with a budgetary estimate. Summary tables and conclusions are also presented. The paper is available at http://www.brookings.edu/views/papers/200701isaacs.pdf. ************************************************************ 4. REPORT EXPLORES RECENT CHANGES AFFECTING MATERNAL MORTALITY DATA "In the NVSS [National Vital Statistics System], maternal deaths increased with the introduction of the ICD [International Classification of Disorders]-10 and when the separate pregnancy status question switched from being supplemental information available from some state certificates to an item expected to be included on all state certificates," state the authors of Maternal Mortality and Related Concepts. In the NVSS, deaths of pregnant or recently pregnant women are identified according to the information reported on the women's death certificates. As alternative data sources have been developed and research groups have focused on maternal mortality in greater detail, there has been interest in improving the information available from the death certificate. A growing number of states have made efforts to improve vital-statistics-data quality by including a separate question on recent pregnancy history on death certificates. The report summarizes processing of maternal mortality in the NVSS, describes recent changes affecting NVSS data, and discusses the impact of these changes on statistics on deaths of pregnant and recently pregnant women. The data presented in the report, published by the National Center for Health Statistics, is based on information from death certificates filed in the 50 states and the District of Columbia that are subsequently compiled into national data, also known as the NVSS. States were divided according to whether the state death certificate included any form of a separate pregnancy question. The authors found that * Maternal mortality fluctuates from year to year but was 12.1 deaths per 100,000 live births in 2003. * The implementation of the ICD-10 in 1999 resulted in about a 13% increase in the number of deaths identified as maternal deaths between 1998 and 1999. * The rate increased again between 2002 and 2003 after a separate pregnancy question became a standard item on the U.S. Standard Certificate of Death. The authors conclude that "because most states have yet to adopt the standard format of the separate pregnancy question, it is likely that maternal and late maternal death rates in all states will continue to be subject to increases because of the adoption of questions rather than actual increases in maternal mortality." Hoyert DL. 2007. Maternal mortality and related concepts. Vital Health Statistics 3(33). Available at http://www.cdc.gov/nchs/data/series/sr_03/sr03_033.pdf. Readers: More information is available from the MCH Library's organizations resource list, Maternal Morbidity and Mortality, at http://www.mchlibrary.info/action.lasso?-database=Organizations&-layout=Web&-response=/databases/OrgLists/orgs_matmort.html&-MaxRecords=all&-DoScript=auto_search_matmort&-search. ************************************************************ 5. AUTHORS ASSESS ECONOMIC RETURNS OF CLINICAL TRIALS PERFORMED UNDER FDA'S PEDIATRIC EXCLUSIVITY PROGRAM "The Pediatric Exclusivity Program has been a success from the perspective of conducting trials for labeling in children," state the authors of an article published in the February 7, 2007, issue of JAMA, the Journal of the American Medical Association. Historically, only 25% of approved drugs marketed in the United States have sufficient pediatric data to support approval of product labeling by the U.S. Food and Drug Administration (FDA) for dosing, safety, or efficacy in children. In 1997, Congress passed the U.S. FDA Modernization Act. Section 505A of this act, known as the Pediatric Exclusivity Provision, was designed to give a financial incentive of 6 months of patent extension or marketing rights to pharmaceutical companies that conduct studies requested by the FDA. The Best Pharmaceuticals Act of 2002 extended the economic incentives provided by pediatric exclusivity. This program has resulted in a substantial increase in pediatric drug research. Nevertheless, critics of the program contend that it has provided a "windfall" to the prescription drug industry. Several revised components of the Pediatric Exclusivity Program legislation have thus been proposed. These include disbanding the program altogether, varying the length of marketing protection based on annual sales, and reducing marketing protection from 6 to 3 months. The study described in this article sought to determine whether incentives provided by the law are disproportionate to the cost of the studies they affect. The authors identified clinical trials performed for pediatric exclusivity for which data were submitted between 2002 and 2004. During this period, data from 59 drugs were submitted to FDA. Among these, 9 drugs that were granted pediatric exclusivity were selected for the study, one in each of the following categories: (1) allergy/immunology, (2) cancer, (3) central nervous system, (4) cardiovascular, (5) psychiatry, (6) endocrine, (7) gastrointestinal, (8) infectious disease, and (9) other. For each, the authors estimated the net economic return to industry from participation in the exclusivity program and calculated the resulting net return-to-cost ratio. The authors found that * The median estimated cost of conducting each trial was $12.34 million. The median cost for a single-dose pharmacokinetic study was $894,941, for a multidose pharmacokinetic study was $2,297,250, and for an efficacy study was $6,464,921. * Median cash inflows were $140,447,244 assuming 6 months of exclusivity, and decreased proportionately when the exclusivity period was reduced to 3 months. * Median cash outflows were $10,362,062. * Assuming 6 months of exclusivity, the median net economic benefit was $134,265,456. Assuming 3 months of exclusivity, the median net benefit was reduced to $64,041,833. * A very high rate of return was realized by blockbuster drugs (those with yearly U.S. sales exceeding $1 billion); however, a much lower rate of return was realized by most products in the overall 2002-2004 cohort. The authors conclude that "from the policy perspective, our study shows that the Pediatric Exclusivity Program overcompensates blockbuster products for performing trials in children, while other products have more modest returns on investments under this program." They continue, "Further understanding and modeling are necessary to ascertain what constitutes adequate economic return to manufacturers for their risk. Clearly, however, the greatest return of the exclusivity program is the benefits derived in obtaining new information relevant and applicable toward the care of children, and this benefit should not be compromised." Li JS, Eisenstein EL, Grabowski HG, et al. 2007. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA, the Journal of the American Medical Association 297(5):480-488. Abstract available at http://jama.ama-assn.org/cgi/content/abstract/297/5/480. ************************************************************ To subscribe to MCH Alert, send an e-mail message to MCHAlert-request@list.ncemch.org with SUBSCRIBE in the subject line. You do not need to enter any text in the body of the message. To unsubscribe from MCH Alert, send an e-mail message to MCHAlert-request@list.ncemch.org with UNSUBSCRIBE in the subject line. You do not need to enter any text in the body of the message. ************************************************************ MCH Alert © 1998-2007 by National Center for Education in Maternal and Child Health and Georgetown University. MCH Alert is produced by Maternal and Child Health Library at the National Center for Education in Maternal and Child Health under its cooperative agreement (U02MC00001) with the Maternal and Child Health Bureau, Health Resources and Services Administration, U.S. Department of Health and Human Services. 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