Med Decis Making - Assessing personalized medicines in Australia: a national framework for reviewing codependent technologies.

Tópicos

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Resumo

CKGROUND: Since the mapping of the human genome in 2003, the development of biomarker targeted therapy and clinical adoption of "personalized medicine" has accelerated. Models for insurance subsidy of biomarker/test/drug packages ("codependent technologies" or technologies that work better together) are not well developed. Our aim was to create a framework to assess the safety, effectiveness, and cost-effectiveness of these technologies for a national coverage or reimbursement decision.METHODS: We extracted information from assessments of recent Australian reimbursement applications that concerned genetic tests and treatments to identify items and evidence gaps considered important to the decision-making process. Relevant international regulatory and reimbursement guidance documents were also reviewed. Items addressing causality theory were included to help explain the relationship between biomarker and treatment. The framework was reviewed by policy makers and technical experts, prior to a public consultation process.RESULTS: The framework consists of 5 components--context, clinical benefit, evidence translation, cost-effectiveness, and financial impact--and a checklist of 79 items. To determine whether the biomarker test, the drug, both, or neither should be subsidized, we considered it crucial to identify whether the biomarker is a treatment effect modifier or a prognostic factor. To aid in this determination, the framework explicitly allows the linkage of different types of evidence to examine whether targeting the biomarker varies the likely clinical benefit of the drug, and if so, to what extent.CONCLUSIONS: The first national framework to assess personalized medicine for coverage or reimbursement decisions has been developed and introduced and may be a suitable model for other health systems.

Resumo Limpo

ckground sinc map human genom develop biomark target therapi clinic adopt person medicin acceler model insur subsidi biomarkertestdrug packag codepend technolog technolog work better togeth well develop aim creat framework assess safeti effect costeffect technolog nation coverag reimburs decisionmethod extract inform assess recent australian reimburs applic concern genet test treatment identifi item evid gap consid import decisionmak process relev intern regulatori reimburs guidanc document also review item address causal theori includ help explain relationship biomark treatment framework review polici maker technic expert prior public consult processresult framework consist componentscontext clinic benefit evid translat costeffect financi impactand checklist item determin whether biomark test drug neither subsid consid crucial identifi whether biomark treatment effect modifi prognost factor aid determin framework explicit allow linkag differ type evid examin whether target biomark vari like clinic benefit drug extentconclus first nation framework assess person medicin coverag reimburs decis develop introduc may suitabl model health system

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