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NOTE for further information about Journals Production please consult our FAQs at http://journals.cambridge.org/production_faqs Author queries: Q1: The distinction between surnames can be ambiguous, therefore to ensure accurate tagging for indexing purposes online (eg for PubMed entries), please check that the highlighted surnames have been correctly identified, that all names are in the correct order and spelt correctly. Typesetter queries: Non-printed material: Calibrating QALYs to Respect1 Equality of Persons2 D O N A L D F R A N K L I N Q1 3 UK Department of Health4 University College London5 Comparative valuation of different policy interventions often requires interpersonal6 comparability of benefit. In the field of health economics, the metric commonly used7 for such comparison, quality adjusted life years (QALYs) gained, has been criticized8 for failing to respect the equality of all persons' intrinsic worth, including particularly9 those with disabilities. A methodology is proposed that interprets 'full quality of life'10 as the best health prospect that is achievable for the particular individual within11 the relevant budget constraint. This calibration is challenging both conceptually and12 operationally as it shifts dramatically when technology or budget developments alter13 what can be achieved for incapacitated individuals. The proposal nevertheless ensures14 that the maximal achievable satisfaction of one person's preferences can carry no more15 intrinsic value than that of another. This approach, which can be applied to other domains16 of social valuation, thus prevents implicit discrimination against the elderly and those17 with irremediable incapacities.18 INTRODUCTION19 Current practice in health economics in measuring intervention effec-20 tiveness compromises equality by using an absolute standard of full21 health to which many cannot aspire. The challenge, set out in section I,22 is to define an alternative metric that is flexible enough that it can23 be used to compare treatment outcomes across individuals with very24 different capacities to benefit. Section II proposes a solution involving25 calibration of gains to individuals' own maximal potential health26 prospect. In section III, the adequacy of the QALY under the proposed27 calibration to its role in social decision-making is assessed, in particular28 the requirement of homogeneity of intrinsic social value. Section IV29 considers the practical implications and applicability of this approach30 to the assessment of health treatments in a way that respects equality.31 I. THE EQUITY CHALLENGE32 There is widespread consensus in the practice of health economics that33 allocative decisions can usefully be supported by cost-utility analysis,34 and that the quality adjusted life year (QALY) is an appropriate unit35 of health-related utility. To the extent that it represents an accurate36 measure of social value, the QALY enables fair comparison of the37 effectiveness of different interventions in a range of contexts, including38 the promotion of health, the prevention of illness and accident, the39 c© Cambridge University Press 2016 Utilitas Vol. 00, No. 0, May 2016 doi:10.1017/S0953820816000194 2 Donald Franklin cure and the palliation of ill-health. Its use acknowledges that health40 benefits can involve either extending life expectancy or enhancing41 quality of life or both, and that beneficiaries rationally trade these42 different aspects of health benefit.43 In this methodology, the concept of quality of life is implicitly defined44 by the method used to elicit substitution rates between quality of life45 and its duration. The QALY gain or loss from an intervention for a46 representative patient is estimated through two distinct steps:47 i. Health Prospect Description. The patient's health prospect in the48 absence of intervention is described, where a health prospect is49 the array of prospective health states with their probabilities of50 occurrence, and health states are characterized using a standard51 tool, such as the EuroQoL-5D. The EuroQoL-5D describes52 health states using five dimensions of health related quality53 of life: Mobility, Self-care capability, Ability to carry out usual54 activities, Pain/discomfort, Anxiety/depression. A health state is55 described by assessing whether it involves 'no', 'mild/moderate'56 or 'severe/extreme' problems on each of the five dimensions. (See57 <www.euroqol.org/>). Similarly, the patient's health prospect58 with the intervention is described. An intervention's effect is to59 move the patient from one health prospect to another.60 ii. Health State Scoring. Each relevant health state is given a61 Health Related Quality of Life (HRQoL) score relative to full62 health, where full health is assigned a value of 1, and states63 equivalent to being dead are assigned a score of 0.64 Taking account of duration and probability of each state in the array65 of states in the health prospects faced by an individual respectively66 with and without the intervention, the number of QALYs promised by67 an intervention can be derived. (Thus, a sure life extension of one year68 in full health generates 1 QALY, as does a certainty of raising someone69 in a health state with HRQoL = 0.5 to full health for two years.)70 The assignment of different health states to HRQoL levels, step ii,71 is generally derived from a representative sample of members of the72 general public. It is here that the challenge to equality of human worth73 arises.74 To assign a HRQoL to a specific health state, the sample of the general75 public is asked to respond as if they were in that state either to the76 question77 What risk of death they would accept to achieve full health (this78 being the Standard Gamble, SG, elicitation technique)79 or to the question80 Calibrating QALYs to Respect Equality 3 What proportion of their imagined expected life-term (usually81 standardized for the exercise at ten years) would they forego in order82 to achieve full health (this being the Time Trade Off, TTO, elicitation83 technique).84 The problem lies with the implicit interpretation of 'full health'.85 With a sample drawn from the general public, 'full health' is likely86 to be interpreted as full psychophysical function. This is problematic87 when applied to interventions that might benefit those with permanent88 irremediable disabilities. So measured, the maximum possible health89 gains for such patients, from interventions that necessarily only90 partially mitigate disability or that extend life without addressing91 disability, will fall short of what can be gained by those without92 disability. Their health is capped at a level that will receive a HRQoL93 score of less than 1; for thus are such disabled states scored by the94 general public. Hence life extensions or best-possible cures for illnesses95 for the disabled will be assigned fewer QALYs and thus less social value96 than corresponding gains for the able-bodied.97 The practice of health economics often appears to assume that in98 the QALY we have a measure of a social good – health gain – that is99 clearly of uniform intrinsic social value. (Intrinsic in contradistinction100 to any extrinsic value that the health of an individual may bear, positive101 or negative, for example in enhancing tax receipts, or in mitigating102 inequality.) However, as currently calculated, the QALY is akin to a103 physical measure of health gain; to turn it into one appropriate for104 social valuation requires consideration of what contribution different105 health improvements make to what is of intrinsic social value. This106 issue is considered further in section III; it plausibly makes reference107 to individuals' own rational aspirations for their lives (their welfare).108 If that is right, use of average valuation is problematic.109 The problem lies in the transfer of the valuation of a gain elicited from110 one population group (the representative sample) to other groups (the111 individual patients who will be the beneficiaries of the intervention).112 Whilst benefit transfer, a common and very useful technique113 in normative economics, inevitably ignores much heterogeneity,114 systematic bias should be avoided. Transferring valuations from a115 representative cross-section of the population for use in valuing benefits116 for an irremediably disabled sub-section, involves systematic bias.117 That use of standardized valuations to assess interventions for the118 permanently disabled in health technology appraisal is problematic has119 been widely recognized. And this critique has been used to discredit120 cost-utility appraisals. An article in The Lancet put it thus:121 The QALY outcome measure has problems. Even if a life-year in which a person122 has impaired mobility is worse than a healthy life-year, someone adapted to123 4 Donald Franklin wheelchair use might reasonably value an additional life-year in a wheelchair124 as much as a non-disabled person would value an additional life-year without125 disability. Allocators have struggled with this issue.1126 Within the health economics literature, the problem has generated a127 strand of analysis and various proposals. No such proposal has yet128 found its way into general practice of health technology appraisal,129 which therefore remains vulnerable to the claim of systematic bias130 against the disabled.131 The most straightforward proposal was offered by Eric Nord with132 colleagues:133 [F]or states of chronic illness or disability that are preferred to death, all saved134 life years count as one.2135 To resolve the issue, we have suggested that all life years gained by disabled136 people should count as 1 . . . 3137 This proposal, which is termed by its authors the 'equal value of138 life approach' (EVL), is however only a partial solution, as it does not139 address the valuation of an intervention somewhat to raise the quality140 but not to extend the years of someone with a permanent disability.141 Once we decide to accord equal value to the life of the disabled, it142 becomes appropriate to assign full value to the maximal functional143 state of someone with a permanent disability and to value functional144 recovery to that state following an illness as full recovery.145 Hence, to make the use of a QALY metric acceptable, an alternative146 understanding of Health Related Quality of Life is required, one147 that does not implicitly rate the lives of those with less than perfect148 psychophysical functional ability as inferior.149 The challenge is complicated by the fact that those with disabilities150 are often stuck in health states from which others can gain from151 treatments; indeed, it is for the appraisal of such treatments that the152 HRQoL and QALY methodology is designed. Further, even those with153 disabilities that are currently untreatable could gain from conceivable154 treatments. From this perspective the apparent full recovery for the155 permanently disabled is not after all a truly full recovery.156 1 Govind Persad, Alan Wertheimer and Ezekiel J Emanuel, 'Principles for Allocation of Scarce Medical Interventions', The Lancet, vol. 373, issue 9661, 31 January 2009, pp. 423–31, at 427 2 E. Nord, J. L. Pinto, J. Richardson, P. Menzel and P. Ubel, 'Incorporating Concerns for Fairness in Numerical Valuation Of Health Programmes', Health Economics 8 (1999), pp. 25–39, at 36. 3 E. Nord, P. Menzel and J. Richardson, 'The Value Of Life: Individual Preferences and Social Choice: A Comment to Magnus Johannesson', Health Economics 12 (2003), pp. 873–7, at 873. Calibrating QALYs to Respect Equality 5 This creates a dilemma in assignment of states to HRQoL: to respect157 equality, we must accord all lives full worth; yet to motivate cure for158 those with temporary disability, and to motivate the search for cure for159 those with apparently permanent disability, we must recognize that160 some health states are less good than others.161 ∗ ∗ ∗162 Before developing a technical solution to this problem in section II – one163 which admittedly involves a degree of conceptual acrobatics – we should164 address three alternative approaches that might be thought to dissolve165 the problem: Dworkin's proposal to select the basket of health treat-166 ments through a hypothetical health insurance optimization; use of167 equity weights to increase the valuation of treatments that benefit the168 disabled; and adversion to elicited societal preferences regarding valu-169 ation of interventions benefiting the disabled. Consider each in turn.170 Suppose that health treatment appraisal is conceived from the171 perspective of a healthy individual maximizing her potential welfare172 in the face of a set of risks, and wishes to select the optimum basket173 of health services so to do. Use of an absolute scale of psychophysical174 function to appraise different treatments is in such a case appropriate175 as no interpersonal comparisons are involved. Compare for example176 a treatment that would give fourteen healthy years following a heart177 attack and another treatment that would yield fifteen traumatic years178 under treatment for cancer.4 If the risk of heart attack and the risk179 of cancer are similar, and the pain and suffering attending the cancer180 cure are unpleasant enough, it would be rational for someone to choose181 to include the heart treatment rather than the cancer treatment in182 the portfolio of treatments (assuming that she cannot afford both).183 There is no required judgement of the relative value of the life184 years of two different persons, respectively with cancer and heart185 disease: for the comparison here is of the possible outcomes for one186 individual.187 In his 'Justice in the Distribution of Health Care', Ronald Dworkin188 proposes the use of a thought experiment of this kind, in which a189 society with an equitable distribution of resources chooses what basket190 of health care services it should fund, as a guide to the basket of services191 that should now be funded publicly (or mandated for social insurance192 funding). He argues that193 [W]e should aim to make collective, social decisions about the quantity and194 distribution of health care so as to match, as closely as possible, the decisions195 4 I am grateful to Richard Cookson for the challenge presented by this example, which is picked up again at the end of section III. 6 Donald Franklin that people in the community would make for themselves, one by one, in the196 appropriate circumstances, if they were looking from youth down the course of197 their lives and trying to decide what risks were worth running in return for198 not running other kinds of risks.5199 Dworkin stipulates that for the experiment to work in guiding200 community choices, you must201 [I]magine that no one in your community – including insurance companies – has202 any information available about the antecedent probability of any particular203 person contracting any particular disease or infirmity that he or she does204 not evidently already have. No one would be in a position to say, of himself205 or anyone else, that that person is more or less likely to contract sickle-cell206 anemia, or diabetes, or to be the victim of violence in the street, than any other207 person.6208 It might be argued that the selection of treatments within a budget209 constraint so as to maximizemaximize expected QALYs calibrated210 relative to full psychophysical function is precisely what one would211 expect of someone ignorant of their particular set of health needs.212 Dworkin argues that nothing that that hypothetical society would do,213 'by way of health care arrangements, is open to objection on grounds214 of justice' and 'what they would do through independent decisions can215 serve as a guide to what we should do, in whatever way we can, to216 improve justice in our own circumstances'.7217 However, Dworkin himself excludes from the ignorance stipulation218 to which his hypothetical purchaser of health insurance is subject only219 risk of 'disease or infirmity that he or she does not evidently already220 have'. Hence, in drawing lessons from the hypothetical choices, we will221 still have to confront the challenge of designing a basket of services222 that would fit the choices of those with existing permanent disabilities223 as well as those who have none.224 Dworkin does not spell out the rationale for thus suggesting that225 the disabled should choose with knowledge of their disability, but226 presumably it is that those who are actually disabled could otherwise227 deny the relevance of the thought experiment: they are not in a position228 to choose a basket of services that would have mitigated the risk of or229 the consequences of the disability from which they suffer, so it is unjust230 to insist that they respect the decisions that they might have made had231 they been in such a circumstance. If the community is to act on their232 behalf it must recognize that their conception of full health differs from233 that of others.234 5 Ronald Dworkin, 'Justice in the Distribution of Health Care', McGill Law Journal 38.4 (1993), pp. 883–98, at 888. 6 Dworkin, 'Justice in the Distribution of Health Care', p. 889. 7 Dworkin, 'Justice in the Distribution of Health Care', p. 890. Calibrating QALYs to Respect Equality 7 Another response to the challenge is to stick with psychophysical235 function as the interpretation of 'full health' but to attach additional236 value to treatments that benefit those who are disadvantaged through237 disability.238 Use of such weights would be appropriate were the problem one of a239 failure to move towards equality of outcome.240 For egalitarian reasons it may be appropriate to compromise total241 health gain in order to achieve a fairer distribution of health. But that242 egalitarian question cannot even be posed without a prior assessment243 of what health gain has and could be achieved for different individuals244 using interpersonally comparable units. Calibration of health states245 to respect equality of human worth is required to generate units246 of uniform intrinsic social value. Hence, the problem is a failure247 appropriately to calibrate health gain in a way that respects the equal248 value of lives lived with disability.249 A third possible route to addressing the challenge is to advert to250 elicited societal preferences, using such preferences to overlay QALY251 measurement with societal valuation of QALY gains in different252 circumstances. Peter Ubel and colleagues attempt to address the253 confrontation between the standard approach to QALY measurement254 (described above) with 'a preference . . . for avoiding discrimination255 against people who have limited treatment potential' as follows:256 For example, suppose the public thinks that saving the lives of people with257 paraplegia is equally as important as saving the lives of people who can be258 returned to full health . . . . saving the life of either group of patients [would259 then] bring 1 QALY per patient [per year of life extension]. However, this260 rescaling would also force us to conclude that people with paraplegia have the261 same quality of life as people without paraplegia and that curing paraplegia262 would not improve HRQoL. (No HRQoL is gained by 'improving' patients from263 an HRQoL of 1.0 to an HRQoL of 1.0.)264 Here is the attempted solution:265 Suppose the societal value of program A [which cures 100 people of a life266 threatening illness returning them to full health] is given an arbitrary value267 of 1.0 [per patient]. Now suppose people think that program B, which saves268 the lives of 100 people [who remain] with paraplegia, should receive the same269 priority for funding as program A . . . Now suppose the same people think that270 curing 600 patients of paraplegia (program C) is equally as important as saving271 100 otherwise healthy people's lives (program A). Program C therefore has . . .272 a societal value of 0.16 [per patient] . . . .273 What is the benefit of separating societal value from HRQoL measurement? . . .274 the HRQoL brought by programs B and C (in conventional CEA [Cost275 Effectiveness Analysis]) must sum to the number of QALYs brought by program276 A (1 QALY [per person year]). However, . . . the societal value of programs B and277 C add to 1.16 . . . . We can now say that saving the lives of people with paraplegia278 8 Donald Franklin is equally as valuable as saving other people's lives while still acknowledging279 that it is beneficial to cure people of paraplegia.8280 The problem with this proposal is that it creates a paradox, which281 the authors half-acknowledge:282 Some may worry that the societal value approach to QALYs is inconsistent283 because it allows the value of programs like B and C to sum to a value >1.284 However, if society places the same value on saving the life of a paraplegic285 and saving the life of a non-paraplegic and if society also values the cure of286 paraplegia, then our suggestion is consistent with societal values.287 The defence does not answer the worry that the advocated approach288 is inconsistent. Consider how it would value a programme D, one that289 was able to save the lives of those with paraplegia threatened by some290 fatal illness and cure their paraplegia at the same time. Programme291 D = B + C in its effect, so should be valued at 1.16 per life year –292 apparently making the programme more valuable than programme A293 (which saved the lives of non-paraplegics), notwithstanding that both294 programmes A and D leave their beneficiaries, who would all otherwise295 die, with exactly the same HRQoL.296 If the Ubel et al. scheme is inconsistent, then that it reflects society's297 values merely shows society's values also to be inconsistent. Nord et al.298 suggest that 'we may be forced to accept [such] inconsistencies rather299 than impose a framework that clearly violates social preferences'.9300 However, it is better to strive for an interpretation of citizens' expressed301 preferences that is both consistent and free of ethical errors.302 The paradox is dissolved by systematically distinguishing between303 those whose incapacity is irremediable and those whose condition304 is curable, in other words by calibrating health assessment to305 beneficiaries' varying capacity to benefit.306 II. CALIBRATING TO BEST ATTAINABLE HEALTH STATE307 This section develops 'A Proposal to Solve the Comparability Problem in308 Cost-Utility Analysis', by Bleichrodt, Herro and Pinto. They recognize309 that valuation of health states should vary systematically with the310 'attainable health state' of each individual:311 The optimal solution . . . is to determine for each individual his set of attainable312 health states and to elicit his health utility function, scaled such that the utility313 of death is equal to zero and the utility of his best attainable health state is314 equal to one. This scaling ensures that a year in the best attainable health315 8 Peter A. Ubel, E. Nord, M. Gold, P. Menzel, J. L. Prades and J. Richardson, 'Improving Value Measurement in Cost-Effectiveness Analysis', Med Care 38 (2000), pp. 892–901. 9 Nord et al., 'The Value of Life', p. 875. Calibrating QALYs to Respect Equality 9 state gets the same weight across individuals and avoids the possibility of316 discrimination due to differences in capacity to benefit.10317 But there is work to be done. First: how do we conceptualize this318 scaling in the presence of uncertainty regarding attainable health319 state? Second, what is attainable depends not only on technology but320 also on budget. Third, taking this approach to avoid discrimination of321 the disabled seems paradoxically to inhibit us from attributing a value322 to possible mitigations of incapacity. And finally, what if those whose323 prospects are very bleak – is individual scaling still appropriate?324 My proposal involves four steps to address these issues:325 (1) calibration to best health prospect (rather than health state),326 (2) respecting the budget constraint of the particular budget holder327 when assessing best health prospect,328 (3) recalibration when changes in technology or budget expand (or329 constrict) the prospects achievable,330 (4) exempting from calibration to best health prospect lives of little331 quality and all consideration of duration.332 (1) Calibrating to personal best health prospect333 When estimating the value of health interventions that shift334 individuals from one prospect to another, calibration to best attainable335 health permits sensitivity to the varying capacity to benefit of different336 individuals. However, as treatment decisions are essentially forward-337 looking, and as health outcomes are probabilistic, it is important that338 calibration is to a best attainable health prospect rather than a best339 attainable health state (a departure from the Bleichrodt et al. proposal).340 We adopt:341 Principle One: calibration to personal best attainable health prospect. In the342 assignment of cardinal values to individuals' health prospects (Health Related343 Quality of Life HRQoLhp) for each relevant future period for the purpose of344 comparative appraisal of possible interventions, where a prospect is an array345 of possible health states hs each associated with a probability phs such that346 phs =1:347 • the value zero is assigned to the health state of being dead,348 • the value 1 is assigned to the best health prospect achievable by that349 person for that period, where health prospects are ordered according350 to the individuals' own rational preferences,351 • intermediate values are assigned to a health prospect hp for a period,352 according to individuals' rational indifference between hp and a353 10 H. Bleichrodt, C. Herrero and J. L. Pinto, 'A Proposal to Solve the Comparability Problem in Cost-Utility Analysis', Journal of Health Economics 21 (2002), pp. 397–403, at 398. 10 Donald Franklin prospect involving a probability HRQoLhp of best attainable health354 prospect and a probability (1HRQoLhp) of death,355 • HRQoLhp is then a coefficient applicable to the duration of the356 affected temporal parts of individuals' health prospects with/without357 an intervention, thus generating a QALY gain or loss attributable to358 the intervention, e.g. a 0.5 gain in HRQoLhp for a period of a year359 would represent a 1⁄2 QALY gain.360 Hence, for somebody with both a remediable and an irremediable361 condition, a best attainable health prospect for that person is defined362 to remedy the remediable but to include the irremediable condition.363 Consider first appraisal of a screening programme to mitigate the364 risk of a life-threatening condition. To avoid discrimination against365 people with disabilities, the assessment of quality of life used in366 calculating incremental QALYs conferred by the screening programme367 must be calibrated to the best health prospect that is available to368 each person affected. The years that are in jeopardy from the life-369 threatening disease are full value years even if they will be enjoyed370 by someone whose maximum gain cannot include sight, no technology371 being available that can restore sight.372 Now, consider the position of a person whose blindness is curable.373 Attainment of sight is attainable for this person, so we should assess374 her options against this standard. Her blindness is not part of her375 endowment but a condition for which she seeks treatment, and hence376 we should calibrate other prospects against a health opportunity set377 that includes a chance of full sight.378 Suppose this second blind person suffers from cataracts that can379 be removed, but the operation has not yet occurred. Suppose she is380 also at risk of developing a life-threatening condition. Is screening her381 to mitigate this risk as valuable as screening a sighted person? Yes,382 but it is less cost-effective, for two procedures are required to achieve383 the same outcome (sight with mitigated risk). The fact that a given384 health prospect for some people involves more cost than for others is385 incontrovertible and should properly inform appraisal.386 (2) Respecting the budget constraint387 Suppose the same scenario arises with a blind person whose blindness388 is technically curable but for whom the budget is not available to cure389 her: perhaps the cure for this person's type of blindness falls above the390 cost-effectiveness threshold consistent with the budget constraint.391 If the budget constraint is binding, it is just as real a constraint as the392 technological limit. Hence, this person's life years with blindness should393 be attributed intrinsic social value equal to the person whose blindness394 is technically incurable. So, in our example, it should be considered as395 Calibrating QALYs to Respect Equality 11 cost-effective to screen her for a life-threatening condition as to screen396 a sighted person.397 Hence, we must accept:398 Principle Two: maximal individual health prospect is defined with399 reference to any binding budget constraint. In the assessment of the400 maximum health prospect achievable by an individual, the maximum401 is defined not only by technological limits but also by the budget402 constraint, assuming that the budget constraint is truly binding.403 Note that the principle that individuals' best attainable health404 prospects are determined by taking account of the budget constraint405 applies only if the budget constraint is actually binding. If there is406 resource allocated to some other activity which can be reallocated into407 health, then that assumption does not hold, and the allocation between408 that other good and health must be set using some metric of value that409 encompasses both health and whatever good is realized by the other410 budget.411 If a thousand pounds becomes available to the health budget, it412 should be used to fund those interventions that would maximize the413 calibrated QALYs gained. Amongst interventions that only improve414 quality of life without affecting longevity, the best intervention for an415 individual is the one that minimizes the HRQoL that that individual416 would then have reason to assign to their current health prospect.417 Budgetary resources should be displaced from elsewhere just in case418 the social value that they are realizing in that alternative use falls419 short of the social value of the QALYs that would be created by their420 best health use.421 Whose budget constraint should be applied? Budgets are particular422 to budget holders, and budgets are governed by decision-making423 individuals and protocols. The best attainable health prospect for a424 beneficiary will therefore vary with the resources available to the425 decision maker for that use.426 Compare, for example, the relative valuation of different427 interventions carried out by an aid agency to the valuation carried428 out by officers of the impecunious health system that the aid agency429 wishes to support. The latter is forced to take as fixed incapacities that430 from the perspective of a wealthier donor are properly seen as ailments431 requiring cure.432 This gives us:433 Principle Three: The budget constraint that defines beneficiary's best434 attainable health prospect is that of the current decision-maker.435 Therefore, each funder of health care allocating its budget so as to436 maximize health gain must regard any unaffordable improvement of437 12 Donald Franklin health condition as an incurable condition not detracting from the438 value of the lives afflicted.439 Decision-making in a publicly funded health service, however, is440 complex: budgets are distributed across many different levels, and the441 hardness of these budget constraints is often not clear. This may require442 a decision-maker locally to countenance two conflicting perspectives:443 on the one hand prioritizing locally on the assumption that the budget444 is fixed, on the other making the case for budget expansion from an445 understanding of what health gains could be achieved were the budget446 restraint relaxed.447 (3) Recalibration to best health prospect when changes in technology448 or budget expand (or constrict) the prospects achievable449 Suppose a technology emerges that would allow a particular form of450 blindness to be corrected cost-effectively, the attainable quality of life451 of those suffering from that form of blindness shifts upwards, and452 it is correct to attribute value to the improvement of their lives to453 that higher level. Potential gains of quality of life are thenceforward454 reckoned as a proportion of the attainable quality of life including the455 innovation.456 Yet if the new technology is assessed to be cost-ineffective, the current457 lives of that group continue to be viewed (e.g. in assessing other458 interventions from which they might benefit) as of full quality.459 The appearance of paradox arises because we fail readily to grasp460 the radical shift in the status of the persons affected that occurs if the461 innovation is accepted – from one of disability-demanding-respect to462 one of affliction-demanding-treatment. A member of such a group is463 now unable to realize her potential without intervention, because her464 potential in life has expanded. Existing treatments become inadequate465 to her need.466 We may wish to say that the innovation of an affordable cure was467 there all the time – awaiting discovery, and we merely underestimated468 the potential quality of life of those afflicted by the condition. With469 adoption of the innovation, it turns out that that was the true maximum470 prospective quality of life. Such an account would explain why we471 attribute value to the discovery itself.472 A similar shift occurs when a budget expansion renders an existing473 treatment affordable – or, in reverse, if a budget contraction forces474 out of the basket of interventions an existing marginally cost-effective475 treatment.476 (4) from calibration to best health prospect lives of little quality and477 all consideration of duration478 Calibrating QALYs to Respect Equality 13 Two objections to the proposal to calibrate quality of life to maximum479 potential function should now be addressed:480 • The implications become counter-intuitive when applied to those with481 very low potential quality of life.482 • The proposal responds to alleged discrimination against the disabled.483 But the QALY approach to measuring benefit is open to a similar484 objection on behalf of those who have less than average life485 expectancy.486 We will consider each issue in turn.487 Suppose someone is in a permanent vegetative state and the488 possibility emerges to restore to them some minimum level of brain489 function still short of consciousness. To the extent that that represents490 the maximum function that can be attained for such a person, it might491 seem to follow from the equality of persons that such an intervention492 should be reckoned as if it were conferring full quality of life.493 To avoid this outcome, we could stipulate a minimum level of mental494 function as delimiting the ambit of the principle of equality. Social value495 might be thought to inhere in the existence or the doings of ethical496 persons, and there is philosophical space to deny ethical personhood to497 those lacking basic mental function. Whilst there may be separate and498 powerful ethical reasons to attribute value to the lives of the comatose,499 the demented and to tiny infants in most contexts, conditionality upon500 personhood shields from absurdity the proposal to calibrate maximum501 HRQoL level to the individual's best attainable health prospect when502 appraising interventions.503 Conditionality upon personhood is in turn supported by a minimal504 substantive understanding of what gives life its equal potential value.505 To avoid conditioning valuation upon one particular theory of life's506 value, calibration for equality aims to value improved psychophysical507 function according to the importance that individuals themselves would508 attribute to it. (Calibrating against an average citizens' assessment, by509 contrast, would implicitly ignore the potential of someone with some510 disability to find a distinctive yet equally valuable use for the time511 that they have available to them.) There is nevertheless a minimum512 level of functioning beneath which neither experiences nor activities of513 value are conceivable. The permanently comatose are capable of neither514 experiences nor activities of intrinsic value.515 A more demanding minimum is set by Nord et al. in qualifying the516 Equal Value of Life proposal mentioned in section I: 'To resolve the517 issue, we have suggested that all life years gained by disabled people518 should count as 1 as long as the health state in question is preferred to519 14 Donald Franklin being dead by those concerned.'11 In some communities where a suicide520 wish is reckoned reasonable (rather than the product of a distress that521 observers may hope will prove temporary), intervention to prevent it is522 not thought appropriate. It is no doubt with such situations in mind that523 Nord et al. proposed the limitation to their EVL rule. The important524 point here however is that some lower limit is plausibly consistent with525 the principle of equality.526 In section III, intuitions regarding our proposal at this difficult527 borderline are tested against an example.528 Regarding the second issue, are we bound by the principle of equality529 also to calibrate potential gain in years of life to the maximum potential530 years of life available to each person?531 Though such calibration would be technically feasible, the results532 would be strikingly counterintuitive.533 Suppose of two patients facing a small risk of death, small enough534 that this is not a risk from which rescue is demanded (given that rescue535 creates its own ethical demands), the life expectancy of one of the536 patients is dramatically shorter: she has only a day or two to live before537 she will die from a pre-existing condition. It is apparent that an inter-538 vention to reduce the small risk of immediate death is more valuable539 for the person with greater life expectancy. And the reason is this: the540 capacity for experiences and activities of value is broadly proportionate541 to time; the doctrine of equality thus lacks plausibility over this dimen-542 sion. Whether there is strict proportionality between time granted and543 value of life is less obvious, as we will discuss in the next section.544 III. THE ROLE OF QALYS IN SOCIAL DECISION-MAKING545 QALYs play a particular role in social decision-making: they represent546 units of impact that bear constant intrinsic social value, such that547 when appraising different options, an option yielding twice as many548 QALYs will yield twice as much intrinsic social value. In this section I549 first focus upon the theoretical requirements for value-homogeneity of550 the QALY metric. I then test the proposal against intuitions regarding551 minimal quality of life and the displacement of treatments delivering552 higher relative quality of life.553 As Sen points out, to allow interpersonal comparisons of levels and554 of increments, achievement of social value must be susceptible to555 measurement for each individual on a ratio scale, and the origin of556 the scale must be non-arbitrary.12557 11 Nord et al., 'The Value of Life', p. 873. 12 A. Sen, 'Interpersonal Comparisons of Welfare', essay 12 in Choice, Welfare and Measurement (Cambridge, MA, 1982), see particularly sec. 4, 'Comparability Types: Formal Structures'. Calibrating QALYs to Respect Equality 15 Sen suggests a possible zero: 'The interpretation [of 'the "origin"558 of a person's welfare function'] may be to identify a distinguished559 point below which misery dominates . . . '. He notes however that 'other560 interpretations are possible'. It is natural to identify this 'origin' with561 the zero point on the HRQoL scale described in section I. This zero is562 commonly associated with 'death' rather than with 'misery', but death563 is actually inappropriate as an interpretation, being an event rather564 than a state, and irreversible. Sen's 'misery' suggestion may be more565 helpful, understood, under the SG methodology, as a level of pain or566 other affliction such that there is no risk of death a person would be567 unwilling to accept to recover from a prospect in which that state is568 endured indefinitely.569 In order to discharge a commitment to the equality of human worth,570 the intrinsic social value attributed to any individual's welfare should571 also be scaled to a common maximum value for any given duration. (Re-572 garding a maximum, Sen refers briefly to the possibility of prohibiting a573 set of welfare functions for interpersonal comparisons 'that "blows up"574 the welfare function of one person arbitrarily keeping those of others575 unchanged'.) This ceiling on the intrinsic social value of individual576 welfare can be identified with the ceiling on the HRQoL scale, HRQoL577 = 1, attributable to any individual's best attainable life prospect.578 It might be objected that even a person enjoying their best attainable579 health prospect may yet lack adequate resources to flourish. Neverthe-580 less, we can call in aid the point established in section II that calibration581 to maximum potential is relative to what is achievable by the budget-582 holder conducting an appraisal, and is thus subject to the resources at583 their disposal. For the allocator of healthcare resources, the allocation584 of other resources is taken as a given, so for that budget holder there585 is an equivalence between HRQoL and Quality of Life tout court.586 Indeed, this approach is not limited to healthcare decision-making.587 The methodology outlined in sections I and II makes no essential588 reference to health: for decision-makers with other interventions in589 their portfolio, health states, health prospects and attainable health590 states can be displaced by more general concepts of welfare. Individuals'591 conceptions of what lends value to their lives, whether health or592 education or other goods, are incorporated into the methodology for593 assigning quality of life levels to different life states and life prospects594 relative to best attainable life prospect.595 Sen, in his championing of an ethically broad-based measure of596 success in social policy, focuses upon 'individual capabilities to do things597 that a person has reason to value'.13 At least without fitting to it the598 13 A. Sen, Development as Freedom (Oxford, 1999), p. 56. 16 Donald Franklin formal restrictions suggested above, the capability approach is open to599 an elitist interpretation, one that values the societal sum of capability600 calculated employing absolute measures of functioning. To insist on a601 maximum level of capability that is attainable is to deny the validity602 of perfectionist accounts of human worth. Notwithstanding that we603 may be confident that Jack will flourish less than Jill upon any and604 every objective scale, we take it as axiomatic that the social value605 of enabling Jack to flourish as much as he possibly can for a year606 is of no less value than doing the same for Jill. This is interestingly607 consistent with Jack actually wasting what opportunity he is given.608 The principle of equality applies in prospect not in retrospect – but the609 decision contexts with which we are dealing do not require retrospective610 comparison.14611 This proposal is not to be understood as a compromise to meet612 egalitarian or fairness concerns, for we lack an alternative ethically613 tolerable metric of interpersonal value comparison. Rather it is614 intrinsic to our understanding of value that the social value of any615 individual's life prospect is of no more value, year for year, than any616 other's. To respect this intuition regarding valuation we therefore insist617 on calibrating welfare against a scale that not only has a significant zero618 but also has a significant maximum, set at the individual's maximum619 achievable and affordable welfare prospect.620 The social value of welfare must be measured in units that have a621 time dimension as well as a magnitude at a time. Elsewhere I have622 argued that a year's gain in life expectancy (a statistical life year) is623 an attractive interpersonally comparable measure of roughly constant624 intrinsic social value, notwithstanding that the lives vary in longevity.15625 But to use the QALY as a measure of homogeneous intrinsic social value626 is to assign equal value to each of a person's prospective life years at best627 attainable health, as well as equal value to the life years of different628 people.629 Assessing aggregate value by integrating over duration is630 inconsistent with John Broome's contention that time is not separable631 in the social value function.16 However, separability of times, like632 separability of persons (for which Broome argues), is a simplification633 that may be adequate to certain decision contexts, though not to634 others. Broome is correct that it is not adequate to a context in635 which decisions are being taken that might affect the age structure636 of a whole community. For other questions, perhaps dealing with637 14 Donald Franklin, Groups in Conflict: Equality versus Community (Cardiff, 2008), see particularly ch. 1: 'The Doctrine of Equal Human Worth', pp. 20-9. 15 Donald Franklin, 'Valuing the Time of Your Life' (under review). 16 John Broome, Weighing Lives (Oxford, 2004), ch. 7. Calibrating QALYs to Respect Equality 17 sustaining communal institutions such as the family, separation of638 persons will also be inadequate. Nevertheless, for social decision-639 making in the contexts here under consideration (the allocation of640 healthcare resources, and similar goods and services affecting the641 quality of the lives of existing groups), a reasonable simplification is642 to extend equal concern to each period of a person's life.643 Let us now test this proposal against challenging scenarios involving644 lives whose maximum health prospect even with best treatment is of645 low quality, and whose treatment will displace that of individuals with646 better prospects.647 Imagine a condition that leaves its sufferers fully conscious, but in648 a very poor physical condition. Suppose that this condition is rated649 as preferable to being dead (or that the choice of being dead in this650 community is not available). Now a treatment becomes available that651 would improve quality of life to a very small, but real, degree, but652 only at such an expense that it would only be reckoned affordable653 if the improvement were calibrated in the way discussed such that654 the improved state is deemed full health for this group (HRQoL = 1).655 To fund such treatment might displace treatments from others whose656 quality of life would be much higher subsequent to treatment at only657 slightly higher cost per year of benefit. Can funding the treatment658 nonetheless be justified?659 For example, suppose the condition leaves sufferers in almost660 constant severe pain – but with regular remissions of average661 duration of fifteen minutes per day. Suppose the proposed treatment662 could increase the period of remission to one hour. Suppose that663 a conventional assignment of HRQoL levels to these two health664 prospects – respectively without and with the treatment to extend665 remission periods – would generate assignments of 0.025 and 0.1666 (assuming for simplicity proportionality of life value with time in667 remission). That is to say that a representative sample of the general668 public would be willing to take a 97.5 per cent risk of death to avoid the669 untreated prospect if the alternative were full psychophysical health,670 and that they would be willing to take a 90 per cent risk of death to671 avoid even the with-treatment prospect (to use the Standard Gamble672 interpretation of the assignment of health prospects to HRQoL levels673 described in section I).674 Four years with this condition would conventionally generate only675 one tenth of a QALY (0.025 × 4 = 0.1), and the treatment would raise the676 tally to 0.4 QALY (0.1 × 4 = 0.4) – a gain of 0.3 QALY. With calibration,677 however, we would scale to the maximum achievable quality of life for678 this group – which is the prospect with the treatment. To those with679 this condition, suppose we elicit a willingness to take a risk of death of680 18 Donald Franklin 75 per cent to get the benefit of the treatment and to avoid the prospect681 of remissions remaining at only fifteen minutes per day. From which682 we infer that, from the perspective of this group, the treatment raises683 HRQoL from 0.25 to 1, generating 3⁄4 QALY each year, three QALYs684 over four years.685 Under the calibration-for-equality proposal, therefore, this treatment686 would be judged affordable in preference to one of equal per capita687 cost that generated an expected additional thirty-five months in full688 psychophysical health to some other group, e.g. through mitigation of689 a lethal heart condition.690 Is it reasonable to attribute such a high value to a treatment that691 leaves sufferers in such a miserable condition?692 Note first, remembering Dworkin's insurance proposal, that if the693 chronic pain condition is merely one to which the general population694 is at risk, alongside the risk of heart disease, and the choice is which695 treatment to fund, then calibration is not appropriate. In that case,696 each member of the population is trading between risks of different697 outcomes, and each would rationally maximize uncalibrated QALYs in698 so doing.699 Rather, we are envisaging that known sufferers of the chronic pain700 condition (like those who are blind from birth in the earlier examples)701 are members of the population for whom the basket of services is being702 chosen. (Whether this is appropriate for a particular condition may703 depend upon the age of incidence – a issue touched upon in section IV.)704 Their perspective with the condition is the one that is pertinent to the705 community's choice of service basket: there is no legitimate argument706 based upon what choices they would have made from a full health707 perspective had they been merely at risk of the condition that they708 now irremediably have. They cannot be bound by such hypothetical709 choices.710 As this is a question of interpersonal comparisons rather than711 of risk optimization for a single set of people, the group with this712 condition can invoke the equal value of human life in defending713 their claim to have the health gain on offer recalibrated to their714 maximum health prospect. If the intuition of equality is challenged715 by this example – attributing as it does equal value to a year with716 chronic severe pain only remitted for an hour a day and that of a717 year with no disability – the burden of proof is on those who would718 salvage some coherent account of a commitment to the equality of719 human life. Alternatively, the objector would have to abandon that720 principle, and then presumably countenance differentiation of the721 intrinsic value of life across all dimensions of function (intelligence,722 strength of interpersonal relationships, happiness of disposition inter723 alia).724 Calibrating QALYs to Respect Equality 19 It is clear that the proposed calibration of comparative health725 impact on different people conflicts with our unreflective judgement726 of comparative value of different health states – as these will727 unreflectively be based on an intrapersonal comparison.728 For example, recall from section I that in the discussion of the729 Dworkin insurance model we considered treatments respectively for730 heart and for cancer patients, the heart treatment yielding fourteen731 untroubled years, the cancer treatment delivering fifteen years marred732 by significant pain and disability. We saw that so long as we are733 ignorant as to which group cancer risks apply, and to which group734 heart risks apply, then appraisal is for the general population. In735 which case, interpersonal comparisons of value are not involved736 and calibration for equality is not required, so the heart treatment737 can be selected for the basket of treatments. If, however, the two738 groups are distinct, calibration for equality requires us to view the739 best health prospect for each group to be of equal intrinsic value740 year by year, and the cancer treatment must be selected (at least741 if they involve equal total cost per person). This outcome may742 seem counterintuitive, perhaps because we slide between the two743 cases.744 To press the point, suppose there are two separate groups of745 individuals, A and B, who are at equal risk of contracting respectively746 condition A and condition B, and all who contract these conditions747 would die with no treatment. (Again, it is important that these are two748 separate groups; if all were at risk of either disease, then intrapersonal749 comparative valuation would yield answers without the need for750 calibration.) Suppose for those who contract condition A treatment A1,751 which gives health state hs1 for one year, is preferred to treatment752 A2, which gives health state hs2 for three years, given the difficulties753 implicit in the latter state. The only available treatment for condition754 B is treatment B, which gives health state hs1, for two years. Given755 that hsB is the maximal health state for condition B sufferers, it must756 be assigned a HRQoL score of 1. If resource is available only to treat757 those at risk of condition A or those at risk of condition B, but not758 both, and treatment costs and other relevant impacts are the same,759 treatment A2 would be socially preferred to treatment B, as it yields760 three years to every beneficiary whereas treatment B yields only two761 years. As A1 yields only one year, were it taken to displace treatment762 A2 from the social reckoning (given that it is preferred by A), treatment763 B would be chosen. Yet, the potential for three years of life for group A764 is what is normative for the social decision-maker comparing the two765 treatments, notwithstanding that the outturn (given that group A will766 actually opt for treatment A1) will be fewer years in the same health-767 state than would have been achieved for group B. Whilst longevity768 20 Donald Franklin may be sacrificed for quality of life by individuals in group A with769 respect to their own lives, social cost-benefit analysis is constrained770 not to make such sacrifices interpersonally. Where there are different771 population groups for whom outcomes are being compared, calibration772 to maximum health prospect is required.773 Perhaps this corollary of the principle of equality remains774 counterintuitive. The analogy with dexterity or height or intelligence775 or pulchritude or happiness of disposition may help to render this776 approach natural. These attributes are generally valued as goods in777 contexts in which we assess how much human beings can contribute to778 others' lives (for example in recruitment for employment or selecting779 members for a sports team or a musical ensemble), or when seeking780 to avoid hazards that might jeopardize our capabilities in these781 dimensions, or in the exceptional cases where a deficit can be remedied782 (by a growth hormone, or by therapy of some sort, or by surgery). But for783 the most part, we accept that we are endowed with different levels of784 these attributes, and that that is our lot, without these differences785 rendering us less or more valuable intrinsically as human beings.786 Hence, when assessing relative effectiveness of health interventions,787 these differences are irrelevant. Irremediable health conditions should788 be treated likewise.789 IV. IMPLICATIONS FOR THE PRACTICE OF790 HEALTH ECONOMICS791 What difference should this proposal make in the practice of health792 economics?793 Calibration to maximum health prospect ought in principle to have794 wide application: given the high incidence of multiple morbidity,795 treatments will often benefit large numbers of individuals with796 a range of other pre-existing conditions or disabilities; without797 calibration, the benefit of treatments for such individuals would be798 reckoned to fall short of benefits to otherwise healthy and able-bodied799 individuals.800 In practice, however, health economics valuations are usually801 valuations of treatments, and appraisals of treatments generally802 assume that the target group is homogeneous. If a treatment is803 approved, it will be approved for a population, and ethical and legal804 norms governing the clinical context will prevent any discrimination805 against the disabled in authorizing or funding the treatment, whilst806 clinicians determining to whom to apply these treatments are sheltered807 from the direct application of cost-utility analysis. (Co-morbidities are808 taken into account but only to the extent that they raise risk of adverse809 outcomes or reduce likelihood of recovery.)810 Calibrating QALYs to Respect Equality 21 Calibration to maximum health prospect as here proposed is811 therefore achieved simply by not making any explicit adjustments for812 individuals with co-morbidities or disabilities notwithstanding their813 lower achievable health prospect. For example, where a treatment814 offers a full cure for a disease, it is normally implicitly assumed that815 all individuals who benefit from the treatment will be returned to full816 health, notwithstanding that some individuals who benefit from the817 treatment will have other conditions or disabilities that affect their818 health (so that 'full health' is effectively understood as 'maximum819 health prospect').820 Hence, our proposal can be seen primarily as a principled justification821 of current practice. It implies that it would not only be a breach of822 clinical ethics to discriminate against the irremediably blind person823 in authorizing a risk-mitigating treatment, it would also be a mistake824 from a cost-effectiveness perspective, even if it were only marginally825 cost-effective.826 The implications of the methodology are less straightforward for827 treatments whose principal beneficiaries are those who have fallen828 victim to a progressive disease that limits maximal psychophysical829 function, and for the elderly. The measured QALY impact, and hence the830 assessed value for money, of interventions to slow illness progression is831 systematically reduced if potential health gain is assessed relative to a832 general population conception of full health, as is standard practice.833 Whether this is discriminatory depends upon the perspective834 employed: whether we seek to maximize outcomes for the currently-835 healthy at-risk population (as in a Dworkin insurance model) or836 whether those currently suffering from such conditions should be837 considered part of the population for whom the basket of services838 covered by health services is being chosen.839 For example, suppose we do take the view that it is the valuation840 of diabetics rather than those merely at risk of diabetes that should841 be authoritative in assessing an intervention to reduce risk of adverse842 sequelae. In that case, the importance of avoiding a particular adverse843 outcome – like blindness – is assessed for its estimated particular844 impact proportioned to the realistic health aspirations of those with845 diabetes (rather than relative to some standard characterization of full846 health). Standard assignments of HRQoL level to health prospect, i.e.847 those based upon responses from surveys where respondents assume848 no fixed limit to achievable psychophysical function,17 would have849 17 E.g. P. Dolan, C. Gudex, P. Kind and A. Williams, 'A Social Tariff for EuroQoL: Results from a UK General Population Survey', University of York: Centre for Health Economics, 1995, Discussion Paper 138. 22 Donald Franklin to be recalibrated for application to a population with maximum850 health prospect involving irremediable disability. Thus if a treatment is851 under consideration for a population whose maximum health prospect852 would be assigned a HRQoL level of m for those without irremediable853 disability, then all other prospects with a standard assignment of l, less854 than m, should be scaled up to l/m. (For example, a prospect standardly855 assigned a level of 0.2 would be rated at 0.5 for a population whose856 maximum possible health prospect would be rated for the population857 without irremediable disability at only 0.4.)858 The same dilemma regarding perspective arises with much more859 general application in considering treatments that particularly benefit860 the elderly. Health economics valuations of treatments are sometimes861 reduced on account of the lower average self-reported health-related862 quality of life scores of the elderly, notwithstanding that these lower863 scores are unavoidable. (This discount is applied to the fewer life years864 that are inevitably attributable to treatments benefiting older people.)865 The methodology proposed could be used to avoid such diminished866 valuation of additional years and increased health relative to maximum867 health prospect for the elderly as for all those with incapacities868 unrelated to the condition targeted by the intervention being appraised.869 Whether it is appropriate thus to calibrate elder life years to870 best attainable health prospect depends upon whether we can adopt871 the Dworkin insurance model for this group. To do so would allow872 consideration of disabilities associated with age to be weighed by each873 potential beneficiary of health services 'looking from youth down the874 course of their lives and trying to decide what risks were worth running875 in return for not running other kinds of risks'.876 It is at least arguable that older citizens would hope that their877 diminished average level of health would not be allowed to compromise878 valuation of the prospective health treatments from which they might879 benefit, and that they might deny the relevance of the insurance880 argument. Evidently the timing of the selection of treatments for the881 insurance basket relative to the life course of members of society, and882 the temporal scope of decision, are relevant when determining which883 infirmities are to be considered known. Perhaps the constituency whose884 welfare is at issue should be defined by a planning horizon for the885 decisions to be made. If any who might benefit are currently suffering,886 then their perspective, alongside those merely at risk, would at least887 be relevant.888 It is a subtle point in political economy and in social contract theory889 requiring debate and further work whether the participants in the890 contract are to be considered all to be in their youth as Dworkin891 seems to suggest; or whether we envisage some broader constituency,892 and if so how to integrate competing perspectives regarding the same893 Calibrating QALYs to Respect Equality 23 intervention. However, what is clear, or so I have argued, is that894 respecting equality of human worth requires calibration of welfare895 impacts for all those for whom social decisions are being taken to their896 best attainable welfare prospect however limited that may be; to do897 otherwise is to denigrate their intrinsic life-value.18898 donald.franklin@dh.gsi.gov.uk899 18 I am grateful to the following for perceptive comments: Eric Nord, Tongtong Qian, the Editor and an anonymous reviewer for Utilitas, members respectively of the Golders Green Kreis, of the Health Economics Study Group of the United Kingdom, and of the London Economics Journal Club of the UK Department of Health. Views expressed are not necessarily those of the Department of Health.