NICE to collect its own patient data
pharmafile | November 6, 2008 | News story | Sales and Marketing | NICE
NICE's chairman Prof Sir Michael Rawlins has revealed some details of how it will change to ensure more patients will receive life-extending cancer drugs and other 'end of life' treatments.
On Tuesday the government announced that patients would be allowed to pay private top-up fees for expensive drugs not recommended by NICE. But it is hoped that a less strict appraisal system for 'end of life medicines' will see most available on the NHS, meaning that very few patients will need to consider paying privately.
The Institute will raise the threshold on its QALY cost-effectiveness model, making it easier for these drugs to gain approval, but it has not determined what that new threshold should be, and this will only be decided after a rapid consultation with stakeholders.
But Prof Rawlins has revealed that NICE is to break with tradition and collect its own 'real world' data from patients taking life-prolonging drugs. For the first time NICE will have its own data to assess just how effective the treatments are.
NICE usually only has clinical trial data from manufacturers on which to base its decisions, but Rawlins says this is frequently inadequate for NICE's purposes.
He says that its appraisal committees need their own data to satisfy themselves that the drugs are delivering the benefits claimed by manufacturers.
"We want our appraisal committees to be confident in the benefits and the longevity being claimed," Prof Rawlins told a briefing hosted by public affairs consultancy Hanover.
NICE is aiming to collect data direct from physicians or even patients, and record how long they live while taking the treatment. The Institute will also collect quality of life assessments from patients.
In recent weeks, Prof Rawlins has made it very clear he believes randomised clinical trials have limitations in terms of providing NICE with the data it needs.
It is these limitations that have led NICE to gather its own data.
"The results of clinical trials do not [always] pan out in the real world," he said, and underlined that the 'confined and homogenous nature' of clinical trials did not provide a realistic picture.
Prof Rawlins says this data will be used alongside clinical trial data when NICE updates its appraisals of the products in question.
The system would see NICE collect 'real world' unanonymised data on patients to build up its own database. Prof Rawlins says NICE wants to involve patients in the process by allowing them to contribute quality of life insights via the internet and electronic submissions.
NICE would then anonymise and share the findings with manufacturers.
Rawlins' views on clinical trials data will not be appreciated by UK pharmaceutical companies. Many companies have complained that it is NICE's cost modelling – and not their clinical trials data – which produces an inaccurate picture of a drug's worth.
The 'end of life' medicines' QALY
Asked for his views on where the QALY should be set for these special cases, Prof Rawlins said he didn't have an upper limit in mind, but confirmed that it wouldn't rise as high as £200,000 per QALY, one high estimate suggested.
The highest QALY rating for any NICE approved drug was that for Novartis' leukaemia drug Glivec. It was approved by NICE in 2002 with a cost-per-QALY of £48,000, and Rawlins quotes this as a benchmark.
NICE's recent preliminary appraisal of kidney cancer treatments, including Pfizer's Sutent, found none of them reached the standard £30,000 threshold. The Institute's calculations found the drugs had QALY scores of between £71,000 (Sutent) and £171,000 (Avastin), suggesting that NICE would have to more than double its current threshold in order to recommend any of these drugs.
The government and NICE want to see the new system in place by January, which means the consultation period will have to be shorter than the usual five weeks.
Related Content
NICE recommends migraine treatment for NHS use
The National Institute for Health and Care Excellence (NICE) has shared draft guidance recommending AbbVie’s …
GSK’s Jemperli recommended by NICE for endometrial cancer treatment
GSK has announced that the National Institute for Health and Care Excellence (NICE) has recommended …
NICE recommends SC treatment of AbbVie’s Tepkinly for patients with DLBCL
AbbVie has announced that the National Institute for Health and Care Excellence (NICE) has recommended …
