Regulatory Focus™ > News Articles > Study: Some Drugs Waiting up to Nine Years for NICE Approval

Study: Some Drugs Waiting up to Nine Years for NICE Approval

Posted 16 May 2012 | By Alexander Gaffney, RAC 

A study looking at the UK's National Institute for Health and Clinical Excellence (NICE), a healthcare rationing body in charge of reimbursement decisions in the UK, has found the body to take five years on average to clear a drug for use and reimbursement, with some drugs taking as long as nine years to be cleared.

The Telegraph notes, "the process often takes much longer as in some cases NICE does not begin its assessment until a treatment has been on the market for more than a year."

Drugs in the UK are first assessed for safety and effectiveness by the Medicines and Healthcare products Regulatory Agency (MHRA), after which they are assessed under a health technology assessment (HTA) framework put together by NICE to see if the drugs represent a fair value to UK consumers.

The study, conducted by the UK's Office for Health Economics, covered all drugs studied by NICE since 2000, notes The Telegraph.

Many of the delays in approval are the result of a bifurcated approval path that sees some drugs assessed in conjunction with other drugs, notes The Telegraph.

Drugs intended to be used independently of other medications are assessed by themselves, and are approved within a year on average. However, drugs intended to be taken as part of a multi-drug regimen are subject to more rigorous testing, known as Multiple Technology Appraisal (MTA), and these reviews take substantially longer to complete on average.

NICE disputes the findings of the report, explaining some of the drugs included in the study began their assessment before NICE was established in 1999, which skewed the statistics against the agency.

"We aim to achieve this within six months for the vast majority of our single technology appraisals," said NICE in a statement. "Over the years, this time has decreased dramatically, with an average time frame currently standing at around four months."

Added NICE: "There are many elements to the appraisal process that we cannot control, all of which can lengthen the time it takes to publish guidance, particularly late notification of changes to regulatory approval timescales. Appeals and other legal challenges may be lodged; pharmaceutical companies might submit patient access schemes part-way through an appraisal; further research might be requested. 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."

Read more:

The Telegraph - Patients 'waiting up to nine years' for NICE to approve drugs

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