Does NICE apply the rule of rescue in its approach to highly specialised technologies?

Abstract

The National Institute for Health and Care Excellence (NICE), the UK’s main healthcare priority-setting body, recently reaffirmed a longstanding claim that in recommending technologies to the National Health Service it cannot apply the ‘rule of rescue’. This paper explores this claim by identifying key characteristics of the rule and establishing to what extent these are also features of NICE’s approach to evaluating ultra-orphan drugs through its highly specialised technologies (HST) programme. It argues that although NICE in all likelihood does not act because of the rule in prioritising these drugs, its actions in relation to HSTs are nevertheless in accordance with the rule and are not explained by the full articulation of any alternative set of rationales. That is, though NICE implies that its approach to HSTs is not motivated by the rule of rescue, it is not explicit about what else might justify this approach given NICE’s general concern with overall population need and value for money. As such, given NICE’s reliance on notions of procedural justice and its commitment to making the reasons for its priority-setting decisions public, the paper concludes that NICE’s claim to reject the rule is unhelpful and that NICE does not currently meet its own definition of a fair and transparent decision-maker.

Revision of Ireland’s Cost-Effectiveness Threshold: New State-Industry Drug Pricing Deal Should Adequately Reflect Opportunity Costs

“…The UK uses a threshold range rather than a point threshold, leaving five explicitly stated but unquantified additional criteria that can influence the probability of approval [13]. Additional formalised exceptions to the standard UK threshold include the End of Life criteria; the two iterations of the Cancer Drugs Fund; non-standard discounting guidelines; and the Highly Specialised Technologies criteria [13][14][15][16][17]. Notably, all these exceptions have attracted pointed criticism from health economists and others [15][16][17][18][19].…”

“…Additional formalised exceptions to the standard UK threshold include the End of Life criteria; the two iterations of the Cancer Drugs Fund; non-standard discounting guidelines; and the Highly Specialised Technologies criteria [13][14][15][16][17]. Notably, all these exceptions have attracted pointed criticism from health economists and others [15][16][17][18][19]. Other examples of departures from point thresholds include various forms of severity weighting in the Netherlands, Sweden and Norway [20][21][22].…”

Revision of Ireland’s Cost-Effectiveness Threshold: New State-Industry Drug Pricing Deal Should Adequately Reflect Opportunity Costs

“…The UK uses a threshold range rather than a point threshold, leaving five explicitly stated but unquantified additional criteria that can influence the probability of approval [10]. Additional formalised exceptions to the standard UK threshold include the End of Life criteria; the two iterations of the Cancer Drugs Fund; non-standard discounting guidelines; and, the Highly Specialised Technologies criteria [10][11][12][13][14]. Notably, all these exceptions have attracted pointed criticism from health economists [12][13][14][15].…”

“…Additional formalised exceptions to the standard UK threshold include the End of Life criteria; the two iterations of the Cancer Drugs Fund; non-standard discounting guidelines; and, the Highly Specialised Technologies criteria [10][11][12][13][14]. Notably, all these exceptions have attracted pointed criticism from health economists [12][13][14][15]. Other examples of departures from point thresholds include various forms of severity weighting in the Netherlands, Sweden and Norway [16][17][18].…”

Resource allocation in the Covid-19 health crisis: are Covid-19 preventive measures consistent with the Rule of Rescue?

“… 1 A more comprehensive account of proposed definitions of the Rule of Rescue is provided by Charlton ( 2021 ). …”