In: Michael Kattan (ed.):
Encyclopedia of Medical Decision-Making.
Thousand Oaks, CA: Sage, 2009.
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Expensive Drugs for Rare Disorders: To Treat or Not to Treat? The Case of Enzyme Replacement Therapy for Mucopolysaccharidosis VI.
Current Medical Research and Opinion (CMRO), 25 (5), 2009: 1285-1293.
Although enzyme replacement therapy (ERT) for mucopolysaccharidosis (MPS) VI received marketing authorization in the European Union in January 2006, patients’ access to this therapy varies geographically due to differences between national reimbursement schemes for orphan drugs. Some inclusion and exclusion criteria for treatment of MPS VI patients with ERT appear arbitrary and may contribute to the exclusion from treatment of patients who could benefit in the long term. Reimbursement schemes which rely on proof of short-term treatment effectiveness may discriminate against slowly progressive patients, as health gain can often not be confirmed over a short period of time in these patients. Conventional cost effectiveness analysis remains silent on crucial issues related to budgetary impact, i.e. opportunity cost from a system perspective, and fair access to treatment.
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Der Effizienz auf der Spur. [In Search of Efficiency.]
Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen [German Journal for Evidence and Quality in Health Care] 103 (2), 2009: 117-125.
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The use of cost-effectiveness by the National Institute for Health and Clinical Excellence: No(t yet an) exemplar of a deliberative process.
Journal of Medical Ethics 34 (7), 2008: 534-539.
Paper selected "Editor's Choice" of the month.
Seeking to combine legitimacy and pragmatism, and realizing that utilitarianism'has next to nothing to offer in eradicating health inequalities', NICE put aside questions of whether matters of content can be resolved solely with a reference to 'due process' and explicitly subscribed to the principles of accountability for reasonableness. The paper reveals that NICE has not yet met its stated objective to fulfill the conditions of accountability for reasonableness.
The luck of being late: Should international health care policy makers follow the NICE model?
E-Bulletin of the Journal of Medical Economics, 1, 2008: 1-2.
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Has NICE got it right? An international perspective.
Current Medical Research and Opinion 24 (4), 2008: 951-966.
A previous critical analysis of NICE Technology Appraisal No. 98 revealed a number of issues which must cast doubt on the robustness of the NICE approach. In this paper, potential underlying problems will be explored, followed by a discussion of lessons for international health care policy makers. The paper is intended to be an invitation to further debate and inquiry.
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Is NICE infallible? A qualitative study of its assessment of treatments for attention-deficit/hyperactivity disorder (ADHD).
Current Medical Research and Opinion, 24 (2), February 2008: 515-535 (with supplementary data appendix).
The National Institute for Health and Clinical Excellence is widely regarded as a role model for the implementation of Health Technology Assessments (HTAs) including economic evaluation. Somewhat unexpectedly, the present analysis does not confirm the robustness of the NICE approach when addressing complex clinical decision problems.
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Health Technology Assessments
by the National Institute for Health and Clinical Excellence:
A Qualitative Study.
New York, NY: Springer, 2007.
(Monograph, 245 pages).
"In recent years there has been a proliferation of health technology assessment (HTA) initiatives internationally. The National Institute for Health and Clinical Excellence (NICE) in England and Wales stands prominently among these initiatives. The current study reviews the NICE appraisal process, confirms the transparent, inclusive and participatory nature of the appraisal, but identifies a number of inconsistencies in the assessment itself and problems in the way the evidence was presented. Having identified these shortcomings, the study at hand offers significant lessons for policy makers, not only in England and Wales, but in other settings as well."
Panos Kanavos, London School of Economics.
"While the focus of this monograph is the NICE ADHD analysis and appraisal process, the careful step-by-step critique might be used as a guide for future appraisal processes, not just for NICE, but for all health care policy analysts as well."
Peter Jensen, Columbia University, New York, NY.
"This is a remarkable piece of work which is indicative of a scholar who is totally on top of his subject area and capable of expressing his ideas in lucid prose. ... It is timely to puncture the self-congratulatory culture which is developing amongst health economic evaluators. ... A particular strength of the monograph is the evaluation of the process using Daniels and Sabin’s “accountability for reasonableness” (A4R) framework and especially as this is advocated by NICE. It is a shame that NICE did not perform better. ... The scope of the author’s analysis in the final chapter is impressive. … The issues raised are those which will determine the future of the evaluation process both at the level of application and the conceptual framework."
Jeff Richardson, Monash University, Melbourne, Vic.
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Impact of Attention-Deficit/Hyperactivity Disorder (ADHD) on Prescription Drug Spending for Children and Adolescents: Increasing Relevance of Health Economic Evidence.
Child and Adolesent Psychiatry and Mental Health, 1: 13 (November 15, 2007) 1-17.
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Aktuelle Daten zur medizinischen Versorgung von Kindern und Jugendlichen mit ADHS in Deutschland: Administrative Prävalenz, beteiligte Arztgruppen und Arzneimitteltherapie.
psychoneuro 33 (10), October 2007: 412-415.
Based on the Nordbaden project, key information is summarized on administrative prevalence, physicians involved in care, and drug treatment of attention-deficit/hyperactivity disorder (ADHD) in Germany. Part of a special issue of psychoneuro on ADHD.
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Who cares for patients with attention-deficit/hyperactivity disorder (ADHD)?
European Child & Adolescent Psychiatry, 16 (7), October 2007, 430-438.
This is the first full publication based on the Nordbaden project for health care utilization research. Insights are presented on the age and gender specific administrative prevalence of ADHD in Germany and on physician involvement in health care provision for these patients.
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Long-acting medications for the hyperkinetic disorders: a note on cost-effectiveness.
European Child & Adolescent Psychiatry, 16 (7), October 2007, 421-429.
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Evidence submitted to the United Kingdom Parliament, House of Commons, Health Select Committee Inquiry on NICE, March 2007
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Treatment for ADHD: Is more complex treatment cost-effective for more complex cases?
Health Services Research, 42 (1), February 2007, 165-182.
Analyses of costs and effectiveness of treatment for ADHD must consider the role of therapeutic objectives and comorbidities. From a United States payers' perspective, high-quality medication management appears cost-effective at all levels of willingness to pay. For some comorbid conditions, however. pychosocial interventions (alone or in combination with medication) may become cost-effective choices at higher levels of willingness to pay, too.
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NICE accountability for reasonableness: a qualitative study of its appraisal of treatments for attention-deficit/hyperactivity disorder (ADHD).
Current Medical Research and Opinion, 23 (1), January 2007, 207-222.
A preliminary analysis of the NICE technology appraisal based on a qualitative case study. While the process adhered to predefined timelines and appeared highly (albeit not perfectly) transparent, questions remained regarding fulfillment of the conditions of relevance, appeal, and enforcement under "accountability for reasonableness".
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Cost-Effectiveness of ADHD Treatments: Findings From the Multimodal Treatment Study of Children With ADHD.
American Journal of Psychiatry, 162 (9), September 2005, 1628-1636
Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. This paper presents the first economic analysis of clinically proven ADHD treatment strategies based upon the MTA study, the largest clinical trial conducted in this field to date. Findings were first presented at the IACAPAP World Congress in Berlin, August 2004, and at the Annual Meeting of the German Association of Child and Adolescent Psychiatrists and Psychologists (BKJPP), held in Gelsenkirchen, Germany, November 2004. See also here.
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Drug Utilization and Pharmaceutical Cost-Containment in Germany: Perspectives One Year after Enactment of the GMG.
Medizinische Klinik 100 (6), June 2005, 314-324.
After three decades of health care cost containment in Germany, enactment of the most recent reform (GMG) marks a watershed: apparently, the potential has been largely exhausted for further savings in pharmaceutical spending. Yet the new drugs segment maintains its role as a growth driver, owing to the continuing shift from older to new, and frequently more expensive, products. It is argued that formal health economic evaluations would be required to better differentiate pharma-ceutical products based on their incremental value or "cost-effectiveness ratio". Further tightening of pharmaceutical component management in Germany may well result in increasing underuse of effective products ("static" inefficiency) as well as in ("second order") dynamic inefficiencies.
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Affordability of Increasing Health Care Expenditures in Germany: A Macroeconomic Analysis.
Gesundheitsoekonomie & Qualitaetsmanagement 10 (3), June 2005: 178-187.
Future health spending in Germany may rise at a faster rate than the economy as a whole, expressed by increase in gross domestic product (GDP). Abstracting from distributional issues, we analyze how "affordability" depends on real economic growth. Result: At real annual per-capita GDP growth rates exceeding one percent, we find "affordability" at the macroeconomic level for at least another 50 years. We conclude that willingness-to-pay, not ability-to-pay, will be decisive for future growth of health care spending in Germany. Assuming moderate economic growth, crucial factors determining health care spending will include societal and individual preferences, distributional issues, and the value of medical care.
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