The National Institute for Health and Clinical Excellence (NICE) is aggressively firing back at a study released which claimed the health technology assessment (HTA) body was taking an average of five years to approve new drug products for reimbursement.
The study, published 15 March in The Daily Mail, also said some drugs took up to nine years to get approved, with NICE not even starting to assess many drugs until a year after they have been approved by the Medicines and Healthcare product Regulatory Agency (MHRA).
Not true, says NICE, who called The Daily Mail piece "inaccurate and misleading."
Specifically, the report omits several important pieces of information, says Andrew Dillon, chief executive of NICE.
"The report includes in its average figures some drugs that received their licenses many years before NICE was established," explained Dillon. "NICE has since been asked to appraise such drugs, but their inclusion in this report has skewed the average length of time elapsed from marketing authorization to published NICE guidance quite considerably."
NICE is also subject to "many elements [of] the appraisal process that [it] cannot control," adds Dillon. These elements include "particularly late notification of changes to regulatory approval timescales," appeals, legal challenges and requests for further research from industry.
"We recognize that all these factors are a legitimate part of the appraisal process, but we don't think they are a fair reflection of the time that NICE takes to appraise a drug," concluded Dillon.
NICE also enlisted the authors of the original report, Phil O'Neill, Nancy Devlin and Ruth Puig-Peiro of the Office for Health Economics (OHE), who said The Daily Mail's interpretation of their work was "misleading and inaccurate in several key respects."
In addition to backing up some of Dillon's main contention, the report also notes NICE is not the sole arbiter of comparative effectiveness.
"The figures cannot be interpreted as a failure by NICE, because NICE does not have a remit to appraise all medicines when they are launched," said the OHE authors. "Instead, the medicines which NICE considers are chosen by the Department of Health via a 'topic selection process' - not by NICE."
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Regulatory Focus - Study: Some Drugs Waiting up to Nine Years for NICE Approval