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NICE’s Selective Application of Differential Discounting: Ambiguous, Inconsistent and Unjustified 1,* James F O’Mahony, MA & Mike Paulden, MSc, MA 2,* * Both authors contributed equally to this work 1. Department of Health Policy and Management, Trinity College Dublin, Dublin, Ireland 2. Toronto Health Economics and Technology Assessment (THETA) Collaborative, University of Toronto, Toronto, Canada [email protected], [email protected] Abstract 2. Why is this a Problem? The National Institute for Health and Care Excellence (NICE) recently recommended differential NICE’s amendment presents a number of problems, the first of which is that the amendment discounting of costs and health effects in the economic appraisal of healthcare interventions in itself is ambiguously stated. However, the biggest problem with NICE’s guidelines relates to the certain circumstances. The recommendation was published in an amendment to NICE’s guide selective use of differential discounting only in certain cases. Other problems relate to NICE’s to the methods of technology appraisal. The amendment states that differential discounting choice of discount rates and their attempts to justify the amendment. These problems are should be applied where “treatment effects are both substantial in restoring health and described in more detail below. sustained over a very long period (normally at least 30 years)”. Renewed interest in differential discounting from NICE is welcome; however, the recommendation’s selective application of 2.1 Problems of Ambiguity differential discounting raises a number of concerns. The stated criteria for applying The language used in NICE’s amendment is ambiguous, making it unclear exactly which differential discounting are ambiguous. The rationale for the selective application of interventions qualify for differential discounting and whether differential discounting should be differential discounting has not been articulated by NICE and is questionable. The selective used in the base-case or merely in sensitivity analyses. application of differential discounting leads to several inconsistencies, the most concerning of which is the lower valuation of health gains for those with less than 30 years remaining life 2.2 Problems of Inconsistency expectancy, which can be interpreted as age discrimination. Furthermore, the discount rates Since differential discounting can yield more favourable cost-effectiveness ratios, but NICE’s chosen by NICE do not appear to be informed by recent advances in the theoretical amendment does not apply universally, this means the guidelines confer an advantage in understanding of differential discounting. NICE’s apparent motivation for recommending terms of cost-effectiveness that is enjoyed by only some interventions. Furthermore, as there differential discounting was to ensure a favourable cost-effectiveness ratio for a paediatric is no apparent reason to apply differential discounting selectively, there then seem to be a oncology drug. While flexibility may be appropriate to allow some interventions that exceed number of inconsistencies between eligible and ineligible interventions. Examples of apparent conventional cost-effectiveness thresholds to be adopted, the selective adjustment of inconsistencies are shown in Box B. Special consideration is given to the potential for age appraisal methods is problematic and without justification. discrimination in Box C. 1. What did NICE do? 2.3 Discount Rates not Justified by Recent Research or Public Consultation NICE usually applies equal discounting of costs and health effects at an annual discount rate of The discount rates adopted by NICE do not accord with the findings of important recent 3.5%. However, in July 2011 NICE amended their guidelines to recommend that differential research on differential discounting. As such, they are without a sound methodological discounting of 3.5% for costs and 1.5% for health effects be applied in special circumstances justification. NICE did consult their Citizen’s Council regarding differential discounting, but it is [1]. The guideline requires differential discounting be applied in cases in which “treatment doubtful if this consultation offers any legitimacy to the amendment. Both these issues are effects are both substantial in restoring health and sustained over a very long period (normally considered in Box D. at least 30 years)”. Importantly, this means not all interventions will be eligible for differential discounting, only those matching the criteria. Box B: Examples of Inconsistencies Prevention vs Cure Box A: What is Differential Discounting? NICE’s amendment stipulates that differential discounting be applied to interventions for “restoring health”, which presumably precludes preventative interventions. This leads to Economic evaluations typically value future costs and health effects less relative to those an apparent inconsistency whereby prevention is assessed on a less favourable basis occurring in the present. This is called discounting and is applied in economic evaluations than cure. of healthcare interventions such as cost-effectiveness analysis (CEA). Discounting is important, as cost-effectiveness ratios can be very sensitive to discounting Cure vs Maintenance Therapy The criterion in NICE’s amendment that health gains be “sustained” could be interpreted Usually, discounting is applied equally to costs and effects. However, differential as precluding interventions that required a maintained course of treatment rather than discounting is the practice of applying relatively less discounting to health effects than to offering a cure with a single course of treatment. If so, this would disadvantage costs. Typically this results in more favourable cost-effectiveness ratios than when equal maintained interventions such as anti-retroviral therapy relative to once-off cures. discounting is applied, especially in cases in which costs are upfront but benefits occur later, as in the case of prevention. This has implications for resource allocation as, in The Many vs the Few principle, interventions with more favourable cost-effectiveness ratios are more likely to The amendment’s requirement that benefits be “substantial” could be interpreted as be approved for use. precluding those treatments that provide only a modest health gain per patient. This again leads to apparently inconsistent treatment of interventions that have similar Differential discounting is applied in very few countries worldwide. Typically those aggregate health gains, depending on whether they are realised through modest gains countries that apply differential discounting apply it universally to all interventions. for many patients or large gains for a few patients. 1 4. Why does this Matter? Box C: Age Discrimination By apparently attempting to avoid a political controversy over an expensive drug, NICE Possibly the most important example of inconstancy stemming from NICE’s amendment adjusted their appraisal methods in an arbitrary way, which creates the potential for relates to age discrimination. The restriction to interventions with effects lasting 30 years unjustified differences in how different interventions are appraised. These differences or more precludes interventions for those with a remaining life expectancy less than 30 potentially lead to unjustified differences in cost-effectiveness and, by extension, unjustified years from the benefits of differential discounting. Since those with shorter remaining life differences in coverage decisions. In doing so, NICE has compromised their objectivity and expectancy are often, although not always, older people, the amendment leaves NICE undermined their scientific credibility. open to criticism of age discrimination. The charge of age discrimination is one that NICE has faced before regarding the use of quality-adjusted life-years (QALYs) as a metric of health gain [2]. These accusations have Box E: Stop Press! April 2013 Change to Discounting Guidance by NICE previously been soundly refuted, as NICE’s use of the QALY values health gain equally in Since the acceptance of this poster NICE have made a further amendment to their individuals of any age [3]. However, this defence does not apply to NICE’s selective use of discounting guidance. In April 2013 NICE published a complete revision to their methods differential discounting. of technology appraisal [7]. The recommendation for differential discounting in special circumstances has been removed, which is welcome. However, in its place, the new guidance now states that equal discounting at 1.5% for both costs and health effects should be applied in special circumstances very similar to those in the 2011 amendment, 3. So why did NICE do this? whereas the standard reference case discount rate of 3.5% remains for other interventions. NICE apparently adopted selective differential discounting to achieve a more favourable costeffectiveness ratio for mifamurtide, an expensive drug used to treat bone cancer in children and young adults. The drug’s high price meant it had a poor cost-effectiveness ratio and so While the new guidance avoids some specific problems related to differential should have been rejected by NICE. However, such a rejection would clearly be politically discounting, the selective use of lower discount rates remains a problem, as the unpopular. It appears that NICE selectively changed their methods guidance to achieve a more inconsistencies between otherwise similar interventions remain. We urge NICE to favourable ratio so the drug could be approved and thus avoid controversy. reconsider the use of selective discounting. References Box D: Ignoring Evidence and Manufacturing Legitimacy 1. National Institute for Health and Clinical Excellence (NICE). Discounting of Health Benefits in Special Circumstances; Available from: http://www.nice.org.uk/media/955/4F/ Clarification_to_section_5.6_of_the_Guide_to_Methods_of_Technology_Appraisals.pdf. [Accessed June 19th, 2012]. The discount rates chosen by NICE do not reflect recent research on what the appropriate differential between discount rates might be [4,5]. This research has shown that given the decision rules employed by NICE, any discounting differential should be 2. Harris J. QALYfying the value of life. J Med Ethics 1987;13(3):117-23. linked to the rate of growth in the cost-effectiveness threshold. However, NICE ignored 3. Paulden M, Culyer AJ. Does cost-effectiveness analysis discriminate against patients with short life expectancy? Matters of logic and matters of context. Theta Collaborative Working Paper Series. Toronto: University of Toronto; 2010. this methodological literature and recommended apparently arbitrary rates. 4. Claxton K, Paulden M, Gravelle H, Brouwer W, Culyer AJ. Discounting and decision making in the economic evaluation of health care technologies. Health Econ 2011;20(1):2-15. NICE referred the issue of discounting to its Citizen’s Council of lay people [6]. They asked the council to consider the issue of differential discounting in the context of a 5. Paulden M, Claxton K. Budget allocation and the revealed social rate of time preference for health. Health Econ 2011;21(5):612-8. hypothetical childhood cancer drug; an example that shared a marked similarity to mifamurtide. While the Citizen’s Council endorsed the application of differential 6. National Institute for Health and Clinical Excellence (NICE). NICE Citizens Council meeting: How should NICE assess future costs and health benefits; Available from: http:// www.nice.org.uk/media/06B/B8/Citizens_Council_report_on_Discounting.pdf. [Accessed October 17th, 2012]. discounting, the consultation arguably unhelpfully conflated issues of greater willingness to pay for interventions for children and for severe diseases with questions of discounting. As such, it is not clear if the consultation adds any legitimacy to NICE’s 7. National Institute for Health and Care Excellence (NICE). Guide to the methods of technology appraisal 2013; Available from: http://publications.nice.org.uk/pmg9 [Accessed May 13th 2013]. amendment. 2