Wednesday, March 7, 2018

BMJ Publishes Article Criticizing Level of Evidence in NCCN Drug Recommendations

BMJ has published a six page article by OHSU authors Wagner et al. that reviews and critiques the level of evidence used to issue NCCN drug recommendations, in comparison to the level of evidence used in FDA labeling.
  • The 2018 BMJ article, by Wagner et al, is online here.
  • The authors conclude, "The strength of the evidence cited by the NCCN supporting [non FDA labeled] recommendations is weak. Our findings raise concern that the NCCN justifies the coverage of costly, toxic cancer drugs based on weak evidence."
  • The authors note that 6 of 44 NCCN recommendations progressed to FDA-labeled approval during the writing of the publication.
    • Opinion piece in BMJ by senior author Vinay Prasad is here.
      • See a like minded summary here.
    • Trade press at Medscape here
    • Trade press at CNN here.
  • The last time this topic received a major airing was in 2009.
    • Annals of Internal Medicine review by Abernethy et al. here.
      • 2012 Deck by Abernethy at NAS, here.
    • Additional 2009 piece in JNCI by Twombly, here.
    • 2009 in NYTimes, here.
  • A 2016 article in JAMA Oncology looked at financial conflicts among NCCN reviewers, Mitchell et al., here.
  • Medicare regulations for the admission or exclusion of cancer compendia
    • At 42 CFR 414.930, here.
    • Rulemaking, November 27, 2007 (72 FR 66303ff) here.
    • Revisions, November 25, 2009 (74 FR 61901ff) here.
  • Medicare webpage for anticancer compendia here (numerous links).
    • 2006 MedCAC on anti-cancer regimen compendia here.



In 2014, Wang et al. used a similar approach to critique the level of evidence used by FDA authors for inclusion of pharmacogenetic labeling in drug labels; here.

In his OpEd, Prasad notes the project took 1000 hours of manual review of PDFs, and that review at BMJ was onerous, the project in total close to 24 months to publication.