Value of research and value of development in early assessments of new medical technologies

Valesca P. Retèl, Janneke P.C. Grutters, Wim H. van Harten, Manuela A. Joore

    Research output: Contribution to journalArticleAcademicpeer-review

    7 Citations (Scopus)
    30 Downloads (Pure)

    Abstract

    Objectives: In early stages of development of new medical technologies, there are conceptually separate but related societal decisions to be made concerning adoption, further development (i.e., technical improvement), and research (i.e., clinical trials) of new technologies. This article presents a framework to simultaneously support these three decisions from a societal perspective. The framework is applied to the 70-gene signature, a gene-expression profile for breast cancer, deciding which patients should receive adjuvant systemic therapy after surgery. The “original” signature performed on fresh frozen tissue (70G-FFT) could be further developed to a paraffin-based signature (70G-PAR) to reduce test failures.

    Methods: A Markov decision model comparing the “current” guideline Adjuvant Online (AO), 70G-FFT, and 70G-PAR was used to simulate 20-year costs and outcomes in a hypothetical cohort in The Netherlands. The 70G-PAR strategy was based on projected data from a comparable technology. Incremental net monetary benefits were calculated to support the adoption decision. Expected net benefit of development for the population and expected net benefit of sampling were calculated to support the development and research decision.

    Results: The 70G-PAR had the highest net monetary benefit, followed by the 70G-FFT. The population expected net benefit of development amounted to €91 million over 20 years (assuming €250 development costs per patient receiving the test). The expected net benefit of sampling amounted to €61 million for the optimal trial (n = 4000).

    Conclusions: We presented a framework to simultaneously support adoption, development, and research decisions in early stages of medical technology development. In this case, the results indicate that there is value in both further development of 70G-FFT into 70G-PAR and further research.
    Original languageEnglish
    Pages (from-to)720-728
    Number of pages9
    JournalValue in health
    Volume16
    Issue number5
    DOIs
    Publication statusPublished - 2013

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    Technology
    Research
    Costs and Cost Analysis
    Transcriptome
    Netherlands
    Paraffin
    Population
    Clinical Trials
    Guidelines
    Breast Neoplasms
    Genes
    Therapeutics
    Industrial Development

    Keywords

    • IR-87628
    • METIS-298493

    Cite this

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    title = "Value of research and value of development in early assessments of new medical technologies",
    abstract = "Objectives: In early stages of development of new medical technologies, there are conceptually separate but related societal decisions to be made concerning adoption, further development (i.e., technical improvement), and research (i.e., clinical trials) of new technologies. This article presents a framework to simultaneously support these three decisions from a societal perspective. The framework is applied to the 70-gene signature, a gene-expression profile for breast cancer, deciding which patients should receive adjuvant systemic therapy after surgery. The “original” signature performed on fresh frozen tissue (70G-FFT) could be further developed to a paraffin-based signature (70G-PAR) to reduce test failures.Methods: A Markov decision model comparing the “current” guideline Adjuvant Online (AO), 70G-FFT, and 70G-PAR was used to simulate 20-year costs and outcomes in a hypothetical cohort in The Netherlands. The 70G-PAR strategy was based on projected data from a comparable technology. Incremental net monetary benefits were calculated to support the adoption decision. Expected net benefit of development for the population and expected net benefit of sampling were calculated to support the development and research decision.Results: The 70G-PAR had the highest net monetary benefit, followed by the 70G-FFT. The population expected net benefit of development amounted to €91 million over 20 years (assuming €250 development costs per patient receiving the test). The expected net benefit of sampling amounted to €61 million for the optimal trial (n = 4000).Conclusions: We presented a framework to simultaneously support adoption, development, and research decisions in early stages of medical technology development. In this case, the results indicate that there is value in both further development of 70G-FFT into 70G-PAR and further research.",
    keywords = "IR-87628, METIS-298493",
    author = "Ret{\`e}l, {Valesca P.} and Grutters, {Janneke P.C.} and {van Harten}, {Wim H.} and Joore, {Manuela A.}",
    year = "2013",
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    Value of research and value of development in early assessments of new medical technologies. / Retèl, Valesca P.; Grutters, Janneke P.C.; van Harten, Wim H.; Joore, Manuela A.

    In: Value in health, Vol. 16, No. 5, 2013, p. 720-728.

    Research output: Contribution to journalArticleAcademicpeer-review

    TY - JOUR

    T1 - Value of research and value of development in early assessments of new medical technologies

    AU - Retèl, Valesca P.

    AU - Grutters, Janneke P.C.

    AU - van Harten, Wim H.

    AU - Joore, Manuela A.

    PY - 2013

    Y1 - 2013

    N2 - Objectives: In early stages of development of new medical technologies, there are conceptually separate but related societal decisions to be made concerning adoption, further development (i.e., technical improvement), and research (i.e., clinical trials) of new technologies. This article presents a framework to simultaneously support these three decisions from a societal perspective. The framework is applied to the 70-gene signature, a gene-expression profile for breast cancer, deciding which patients should receive adjuvant systemic therapy after surgery. The “original” signature performed on fresh frozen tissue (70G-FFT) could be further developed to a paraffin-based signature (70G-PAR) to reduce test failures.Methods: A Markov decision model comparing the “current” guideline Adjuvant Online (AO), 70G-FFT, and 70G-PAR was used to simulate 20-year costs and outcomes in a hypothetical cohort in The Netherlands. The 70G-PAR strategy was based on projected data from a comparable technology. Incremental net monetary benefits were calculated to support the adoption decision. Expected net benefit of development for the population and expected net benefit of sampling were calculated to support the development and research decision.Results: The 70G-PAR had the highest net monetary benefit, followed by the 70G-FFT. The population expected net benefit of development amounted to €91 million over 20 years (assuming €250 development costs per patient receiving the test). The expected net benefit of sampling amounted to €61 million for the optimal trial (n = 4000).Conclusions: We presented a framework to simultaneously support adoption, development, and research decisions in early stages of medical technology development. In this case, the results indicate that there is value in both further development of 70G-FFT into 70G-PAR and further research.

    AB - Objectives: In early stages of development of new medical technologies, there are conceptually separate but related societal decisions to be made concerning adoption, further development (i.e., technical improvement), and research (i.e., clinical trials) of new technologies. This article presents a framework to simultaneously support these three decisions from a societal perspective. The framework is applied to the 70-gene signature, a gene-expression profile for breast cancer, deciding which patients should receive adjuvant systemic therapy after surgery. The “original” signature performed on fresh frozen tissue (70G-FFT) could be further developed to a paraffin-based signature (70G-PAR) to reduce test failures.Methods: A Markov decision model comparing the “current” guideline Adjuvant Online (AO), 70G-FFT, and 70G-PAR was used to simulate 20-year costs and outcomes in a hypothetical cohort in The Netherlands. The 70G-PAR strategy was based on projected data from a comparable technology. Incremental net monetary benefits were calculated to support the adoption decision. Expected net benefit of development for the population and expected net benefit of sampling were calculated to support the development and research decision.Results: The 70G-PAR had the highest net monetary benefit, followed by the 70G-FFT. The population expected net benefit of development amounted to €91 million over 20 years (assuming €250 development costs per patient receiving the test). The expected net benefit of sampling amounted to €61 million for the optimal trial (n = 4000).Conclusions: We presented a framework to simultaneously support adoption, development, and research decisions in early stages of medical technology development. In this case, the results indicate that there is value in both further development of 70G-FFT into 70G-PAR and further research.

    KW - IR-87628

    KW - METIS-298493

    U2 - 10.1016/j.jval.2013.04.013

    DO - 10.1016/j.jval.2013.04.013

    M3 - Article

    VL - 16

    SP - 720

    EP - 728

    JO - Value in health

    JF - Value in health

    SN - 1098-3015

    IS - 5

    ER -