Economic and Cost-Effectiveness Considerations for Pharmacogenetics Tests: An Integral Part of Translational Research and Innovation Uptake in Personalized Medicine

Paci, Daniele; Ibarreta, Dolores

doi:10.2174/187569209790112355

Cited by 25 publications

(15 citation statements)

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“…Adjustments involve a process of trial and error to reach the desired effect for each individual patient. With a personalized approach to prescribing, physicians could test patients' genetic characteristics in advance and use that information to select medications and set dosage amounts [14].…”

Section: Personalized Medicine Basicsmentioning

confidence: 99%

Overcoming regulatory and economic challenges facing pharmacogenomics

Cohen¹

2012

New Biotechnology

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Section: Personalized Medicine Basicsmentioning

confidence: 99%

Overcoming regulatory and economic challenges facing pharmacogenomics

Cohen¹

2012

New Biotechnology

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“…39 Since economic and cost-effectiveness considerations play an important role in the translational research (from basic discoveries to normative science) and in public health decision-making, 40 it might be desirable for economic analysis to be applied to the study of data protection in biobanks.…”

Section: The Lack Of Economic Evaluationmentioning

confidence: 99%

Data Protection and Sample Management in Biobanking - A legal dichotomy

Bäumen

Paci

Ibarreta

2010

Life Sci Soc Policy

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Biobanking in Europe has made major steps towards harmonization and shared standards for the collection and processing of data and samples stored in biobanks. Still, biobanks and researchers face substantial legal difficulties in the field of data protection and sample management. Data protection law was harmonized almost 15 years ago while rights in samples fall under the competence of the Member States of the EU. Despite the Data Protection Directive the field of data protection shows a substantial degree of deviation as public health was excluded from the harmonization. Biobanks seem to have substantially fewer difficulties to cope with in terms of the legal requirements in the field of sample management. This paper discusses the legal framework, experiences of different biobanks in Europe and potential ways forward. It also highlights the need for a health economic analysis of the costs and benefits of privacy protection in Europe. At the moment, policymakers seem to build their decisions on an insufficient evidence base which underestimates the potential value of biobanks for European public health. Within the past few years little progress has been achieved with regards to the development of a unified legal framework in Europe, The diversity in the legal system is also reflected in the different approaches of ethics committees towards biobanking. To secure the responsible and effective use of data and samples, more efforts are needed to come up with pathways for a solution.

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“…Economic considerations are key in the development of health technologies, especially in times of scarce resources. Despite these efforts, there is still a lack of cost-effectiveness evidence to support the uptake of companion diagnostics in medical practice [2]. There are a number of companion diagnostics required or recommended by the US FDA in different disease areas, and many more are in different stages of development, constituting an increasingly growing market [3].…”

Section: Introductionmentioning

confidence: 99%