Value of research and value of development in early assessments of new medical technologies.
OBJECTIVE
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.
Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (NKI-AVL), Amsterdam, The Netherlands.
Valesca P
VP
Retèl
Janneke P C
JP
Grutters
Wim H
WH
van Harten
Manuela A
MA
Joore
D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000628:therapy; D017024:Chemotherapy, Adjuvant; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D005260:Female; D006801:Humans; D008390:Markov Chains; D018803:Models, Economic; D009426:Netherlands; D017410:Practice Guidelines as Topic; D019057:Quality-Adjusted Life Years; D012106:Research / Q000191:economics / Q000458:organization & administration*; D013673:Technology Assessment, Biomedical / Q000191:economics* / Q000379:methods*; D059467:Transcriptome
EVPI; EVSI; cost-effectiveness analysis; decision modeling; development; early technology assessment; value of information