Evidence map›Paper›PMID 19204417›Full record

ArticlePublic health genomics2009

Pharmacogenomics, evidence, and the role of payers.

P A Deverka

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Public health genomics, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02625155 (Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens), which is not on this map. Cited by 27 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02625155 phase4unknown statusnot on this mapstarted 2015, after this paper: background citation

Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens: SPHERE

TypeinterventionalSponsorInSource DiagnosticsRan2015Enrolled14,000ConditionsTarget Drug-related Adverse EventsArmsUrine diagnostic testing as SOC, drug regimen changes per SOC, Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
  6. Article
  7. Preemptive pharmacogenetic testing: exploring the knowledge and perspectives of US payers.Genetics in medicine : official journal of the American College of Medical Genetics · 2019
    Article
  8. Review
  9. Article
  10. Economic evaluation of personalized medicine: a call for real-world data.The European journal of health economics : HEPAC : health economics in prevention and care · 2017
    Article
  11. Payer decision making for next-generation sequencing-based genetic tests: insights from cell-free DNA prenatal screening.Genetics in medicine : official journal of the American College of Medical Genetics · 2017
    Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Clinical integration of next generation sequencing: coverage and reimbursement challenges.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2014
    Article
  18. Article
  19. Article
  20. Insurance coverage policies for personalized medicine.Journal of personalized medicine · 2012
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author.

P A DeverkaDivision of Pharmacotherapy, UNC Institute for Pharmacogenomics and Individualized Therapy, University of North Carolina, Chapel Hill, NC 27599-7360, USA. pat_deverka@unc.edu

Funding

POPULATION GENETICS AND DRUG METABOLISMU01GM063340 · NIGMS · WASHINGTON UNIVERSITY · PI MCLEOD, HOWARD L · 2001 to 2009
$17.4M
NIGMS NIH HHS U01 GM063340NIGMS NIH HHS U01 GM63340
6 · The paper itself

Abstract

Initial enthusiasm for the potential of pharmacogenomics (PGx) to transform medical practice has been tempered by the reality that the process of biomarker discovery, validation, and clinical qualification has been disappointingly slow, with a limited number of PGx tests entering the marketplace since the initial publication of the human genome sequence. Reasons for the delays include the complexity of the underlying science as well as clinical, economic, and organizational barriers to the effective delivery of personalized health care. Nevertheless, payers are interested in using PGx services to ensure that drug use is safer and more effective, particularly in the settings of medications that are widely used, have significant risks of serious adverse events, have poor or highly variable drug response, or are very expensive. However, public and private payers have specific evidence requirements for new health care technologies that must be met prior to obtaining favorable coverage and reimbursement status. These evaluation criteria are frequently more rigorous than the current level of evidence required for regulatory approval of new PGx tests or PGx-related drug labeling. To support payer decision-making, researchers will need to measure the impact of PGx testing on clinical and economic outcomes and demonstrate the net benefit of PGx testing as compared to usual care. By linking payer information needs with the current PGx research agenda, there is the opportunity to develop the data required for informed decision-making. This strategy will increase the likelihood that PGx services will be both reimbursed and used appropriately in clinical practice.

Indexed as

Evidence-Based MedicineHumansInsurance, Health, ReimbursementPharmacogeneticsTechnology Assessment, Biomedical

Identifiers

PMID19204417
PMCPMC2836944

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.