medwireNews: Many treatment guidelines by the US National Comprehensive Cancer Network (NCCN) include additional recommendations beyond those indicated in the US FDA approvals, and these “often” rely on low levels of evidence, say researchers.
“Given that NCCN endorsement is linked to reimbursement by many commercial insurers and the [Centers for Medicare and Medicaid Services], our results suggest that payers may be covering cancer drugs with varying and scientifically less robust justification,” they write.
Vinay Prasad, from the Oregon Health & Science University in Portland, USA, and team conducted a review of all drugs approved by the FDA during 2011–2015 for hematologic or solid cancers in adults, and compared these with the NCCN recommendations for the same drugs.
During this period, 47 drugs were approved by the FDA for 69 indications, while the NCCN endorsed these agents for 113 indications. Sixty-one percent of the NCCN recommendations overlapped with the FDA decisions; the remaining 39% were additional recommendations, most commonly expanding treatment to a different malignancy (32%) and removing the need for a prior therapy (29%).
Seeking to assess the evidence supporting these additional endorsements, Prasad et al found that just 23% were cited as being based on results from randomized controlled trials, with only 16% based on phase III trial findings. And there was no evidence cited for just over a third (36%) of the additional recommendations.
The researchers admit that they “did not search for independent evidence to support recommendations beyond the references provided by the NCCN,” but add: “If there is additional evidence in support of these recommendations the NCCN should improve its process and cite all evidence used.”
They also conducted a follow-up at about 21 months from the original analysis of all FDA labels for the drugs included in their study, finding that just six (14%) of the NCCN’s additional recommendations subsequently received FDA approval.
Prasad and colleagues write in The BMJ that “[w]hen it comes to costly cancer drugs with serious toxicities, it is important to recognize that merely because some drugs were later validated does not mean that off-label recommendations for all drugs is, on average, a good thing. It remains an open question.”
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