Too Far Off-Label ?
The FDA approved a total of 69 indications , compared with 113 indications in the NCCN recommendations .
Budget Buster
Hurry Up and Wait
Data Stream
Too Far Off-Label ?
The National Comprehensive Cancer Network ( NCCN ) issues guidelines for cancer treatment that often involve the offlabel use of drugs or combinations not yet approved by the U . S . Food and Drug Administration ( FDA ). According to an observational study published in The BMJ , the organization may be playing fast and loose with its recommendations .
Researchers compared indications listed by the FDA with recommendations in NCCN guidelines for a total of 47 drugs approved by the FDA between 2011 and 2015 .
The FDA approved a total of 69 indications , compared with 113 indications in the NCCN recommendations .
Budget Buster
Providing Americans under age 65 with health insurance will cost the U . S . government more than $ 700 billion in subsidies in 2018 , according to a report from the Congressional Budget Office . This amount covers people who receive health insurance through their jobs or through government-sponsored programs .
This includes :
$
705 billion
$ 55 billion on non-group coverage
$ 82 billion on Medicare
$ 272 billion in tax write-offs for employers offering coverage
120
$ 296 billion on Medicaid and the Children ’ s Health Insurance Program
100
80
39 %
additional NCCN recommendations
After accounting for the approximately $ 20 billion the government will collect in taxes and penalties related to coverage , this totals $ 685 billion . This amount is only expected to increase in coming years , owing in part to rising insurance premiums and the repeal of the Affordable Care Act ’ s individual mandate .
Source : Bloomberg , May 23 , 2018 ; Con gressional Budget Office , “ Federal Subsidies for Health Insurance Coverage for People Under Age 65 : 2018 to 2028 .”
Number of indications
60
Hurry Up and Wait
40
20
0 FDA Indications
NCCN Indications
Sixty-nine overlapped with FDA indications , but 44 ( 39 %) were additional recommendations – most of which were based on non-randomized , early-stage trials .
Source : Wagner J , Marquart J , Ruby J , et al . Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration : retrospective observational study . BMJ . 2018 ; 360 : k668 .
Results from phase III oncology trials can take nearly a year to reach the public , and these delays could have deleterious effects on both patient care and scientific research , according to a study published in JAMA Oncology .
The investigators measured delays as the time between a trial sponsor having access to study results ( and issuing press releases announcing the complete analysis ) and when the medical community had access to them .
Between 2011 and 2016 , all but 1 of the 100 press releases analyzed had an associated peerreviewed publication , posting to ClinicalTrials . gov , or both . But , the median time to reporting was 300 days ( range = 263-348 days ).
Trial sponsors were more eager to quickly publicize positive study findings than negative findings : 272 days versus 407 days ( p < 0.001 ).
“ Addressing delays at every step toward publication should be the goal ,” the authors concluded .
Source : Qunaj L , Jain RH , Atoria CL , et al . Delays in the publication of important clinical trial findings in oncology . JAMA Oncol . 2018 April 12 . [ Epub ahead of print ]
12 ASH Clinical News July 2018 Bonus Mid-Year Edition