NICE accountability for reasonableness: a qualitative study of its appraisal of treatments for attention-deficit/hyperactivity disorder (ADHD)

Abstract

The appraisal process adhered to predefined timelines, which were sensibly adapted by NICE to changes in the environment. A4R criteria most pertinent to the case study were 'publicity' and 'relevance'. The 'publicity' condition was greatly fulfilled, except for commercial-in-confidence data and economic model. 'Relevance' requires appraisals to reflect concerns for fairness and to be evidence-based; in that respect, principles and realization of the assessment deserve further scrutiny. Questions also remain regarding the 'appeal' and 'enforcement' conditions under A4R.

The use of cost-effectiveness by the National Institute for Health and Clinical Excellence (NICE): no(t yet an) exemplar of a deliberative process

“…98;63 see http://www.nice.org.uk/) focused on the processes adopted by NICE. The case study, which was largely in agreement with the positive findings of the WHO review,4 confirmed the high (albeit not perfect) level of transparency, predictability, and the participatory nature of the NICE approach 81. However, the analysis also indicated a need for further in-depth inquiry.…”

“…Official statements by NICE have remained vague 88 89. Appraisal committee meeting minutes are hardly informative,81 83 despite reasonable expectations created by NICE’s own process description, claiming, “the minutes provide an accurate record of its proceedings and discussions and also inform the public of the matters discussed at the meeting” 87…”

“…Although understandable from a pragmatic perspective, these limitations are not adequately compensated for by opportunities for (invited) consultees and commentators to provide inputs during the appraisal process. Only relatively short windows of opportunity are provided, with a massive amount of data to be reviewed under limited transparency 81 83 87…”

Recent amendments to NICE’s value-based assessment of health technologies: implicitly inequitable?

“…A notable strength of NICE's amended methods and processes is their relative transparency. NICE supports many of the principles of the 'accountability for reasonableness' framework, and each recent amendment has been subject to scrutiny through a public consultation process [12][13][14][15].…”

Cost-utility analysis of methylphenidate and amphetamine/dexamphetamine in adults with attention-deficit hyperactivity disorder

“…Adults with ADHD not only suffer from inattentiveness, hyperactivity and impulsivity, but also are prone to deficiencies in cognitive self‐regulatory processes such as memory impairment, reduced planning and problem solving capabilities . In addition, uncontrolled ADHD can lead to absenteeism, presenteeism, frequent job changes and poor health‐related quality of life (HRQoL) …”