Deficiencies in methods used by the UK’s National Institute forHealth and Clinical Excellence (NICE) have compromised publicconfidence and could stop patients in England and Wales benefitingfully from major incremental innovations available elsewhere.
Suchis the warning presented to Parliament by the drug industry. At thestart of the House of Commons health select committee hearings in itssecond inquiry into NICE, the Association of the British PharmaceuticalIndustry (ABPI) said the bar to positive recommendation from NICE wasbeing raised to unrealistic levels, and there was pressure on NICE tomake decisions on the basis of limited clinical or cost-effectivenessdata.
In evidence to the panel, ABPI stressed concern aboutwhat it saw as overreliance on cost and qualify-of-life-adjusted years(QALYs) in making (rather than informing) decisions; expectations ofcertainty in decision-making that could not be achieved, particularlyearly in a product’s lifecycle; issues of quality and consistency inwork commissioned from assessment and/or evidence review groups(AGs/ERGs), including transparency; and an “unnecessarily adversarial”approach to industry within some AGs/ERGs.
ABPI said thisled to a trend to resort to an appeal process that was seriouslyflawed, and had resulted in no significant changes to NICE guidanceover the past two years.
ABPI called for a moreconstructive, less adversarial approach including, from the outset ofeach appraisal, dialogue between manufacturers, NICE and AGs/ERGs onmethods, data quality and sources used.
The Commons inquiryreceived written evidence from 92 individuals and groups includinggovernment, industry groups, manufacturers, the royal colleges, otheracademic bodies and patient associations.
Among the latteris the Alzheimer’s Society, which is shortly to take part in thefirst-ever High Court challenge to a NICE ruling. This seeks tooverturn the current decision that patients in early-stage Alzheimer’sdisease should not have access to the four drugs licensed to treat thecondition: donepezil (Aricept®), rivastigmine (Exelon®), galantamine(Reminyl®) and memantine (Ebixa®).
The society said NICEwas being challenged when its decisions were poor because theseimpacted hugely on people’s lives. A major reason for challenges wasthe fact that decisions gave insufficient weight to evidence frompatients and professionals.
The society said: “NICE failedto consider that evidence from patients and carers might be consideredon its own merits rather than as pointers. The knowledge and experienceof clinicians with expertise in the disease area has also been ignored,resulting in guidance that does not translate easily to clinicalpractice.”
The society said lack of transparency also ledto challenges: during drug appraisal it had been impossible tounderstand how many decisions were reached. The society called for anindependent appeals process, with appellants given more detail on howthe panel reached decisions.
Pfizer, lead claimant in theupcoming judicial review, also provided evidence to the inquiry. Itsaid NICE should revise its appeal process so it considered the meritof the decision as well as the process, and the appeal process shouldbe conducted and chaired by an independent panel.