The authors conclude that "HTA organizations should provider greater transparency" including "explicit recognition and rationale for differential approaches." In overview, the authors summarize a wide range of case studies of genomic test technology assessments by different bodies. Then, the authors summarize ten points, essentially a mix of problems-seen and recommendations for moving forward.
The article Garfield et al. is online here. It isn't open access; it's $35, or a journal subscription is $332, or a membership in ISPOR including the journal is $150. There are also three supplemental pages online, however. A one page summary is open access, here. A Q&A interview with Garfield is online, here. The home page for the committee (ISPOR's diagnostics assessment committee) is online, here.
The first author, Susan Garfield, is Principal at the global consultancy EY (formerly Ernst & Young), here. I also cited her work on pharma strategy a few months ago on this blog (here). Thanks to Prof. Kathryn Phillips of UCSF for pointing the new ISPOR article out. Philips heads the Center for Translational and Policy Research on Personalized Medicine.
Also this fall, Deverka and colleagues produced a position paper on genomics clinical utility, based on interviews and analysis with a large group of consensus-driven stakeholders, here. Deverka and colleagues provide ten action points to guide better production of clinical utility evaluations.
And also this fall, another recent consensus review article on "clinical utilities in molecular pathology testing procedures" by a collective group of authors at AMP, see Loren Joseph et al., J Molec Dx, here. Joseph, who is at Harvard/Beth Israel, also published a single-author article on clinical utility of cancer profiling in Exp Rev Molec Dx, here.
Abstracts posted below, after the break.
See also a 2016 review of these topics by Sey et al. in Exp Rev Drug Met & Toxicol, here. For a 2015 open-access review in EPMA journal by Akhmetov & Bubnov, here. For an earlier, 2014 review by Parkinson et al. in Clinical Cancer Research, see here.
Value Health. 2016 Jul-Aug;19(5):577-87. doi: 10.1016/j.jval.2016.02.012. Epub 2016 May 11.
Health Technology Assessment for Molecular Diagnostics: Practices, Challenges, and Recommendations from the Medical Devices and Diagnostics Special Interest Group.
Garfield S1, Polisena J2, S Spinner D3, Postulka A4, Y Lu C5, Tiwana SK6, Faulkner E7, Poulios N8, Zah V9, Longacre M10.
Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
diagnostics; health technology assessment
_____ JOSEPH (GROUP)