Transforming the cost-effectiveness threshold into a ‘value threshold’ Initial findings from a simulation model Mike Paulden and Christopher McCabe Problem • The conventional cost-effectiveness (CE) threshold represents “an estimate of health forgone as other [services] are displaced to accommodate the additional costs of new technologies” (Claxton et al. 2013) • Plotted as a straight line on the CE plane (Drummond et al. 2005) • Numerous limitations and assumptions: • Assumes constant marginal returns and divisibility of technologies • No account for aspects of ‘value’ beyond those considered by the QALY • Impact of imperfect information is not explicitly considered, nor the possibility that new interventions represent net disinvestments • No account for multiple decision makers with conflicting objectives • Recently, NICE has applied ‘modifiers’ to its baseline threshold to account for aspects of ‘value’ beyond the QALY (NICE 2009, 2014) • Resulted in inconsistencies in NICE’s methodology (Paulden et al. 2014) Objective • Our objective is to transform the conventional CE threshold into a ‘value threshold’ of greater use to decision makers • In doing so we aim to address the limitations previously described • As a first step we have developed a simulation model in order to understand how a ‘value threshold’ may differ from a CE threshold • Of key interest are the implications of: i. Relaxing conventional assumptions such as constant marginal returns to scale and perfect divisibility of technologies ii. Incorporating imperfect information and ‘value’ considerations within a complex health system with multiple decision makers iii. Extending the threshold so that it may be used for net disinvestments Model schematic Pool of initial technologies The cost and effectiveness of each technology is drawn from a distribution Each technology is randomly assigned a ‘value’ attribute and a specific health production function ‘shape’ (applies only if marginal returns are diminishing) Model schematic Pool of initial technologies The cost and effectiveness of each technology is drawn from a distribution Each technology is randomly assigned a ‘value’ attribute and a specific health production function ‘shape’ (applies only if marginal returns are diminishing) Divisibility of technologies Technologies in the pool are either all divisible or all indivisible Marginal returns to scale Technologies in the pool either all have constant marginal returns to scale or all have diminishing marginal returns to scale Model schematic Pool of initial technologies The cost and effectiveness of each technology is drawn from a distribution Each technology is randomly assigned a ‘value’ attribute and a specific health production function ‘shape’ (applies only if marginal returns are diminishing) Initial budget Upon the establishment of the health system, an initial budget is assigned for purchasing technologies from the pool Divisibility of technologies Technologies in the pool are either all divisible or all indivisible Marginal returns to scale Technologies in the pool either all have constant marginal returns to scale or all have diminishing marginal returns to scale Model schematic Pool of initial technologies The cost and effectiveness of each technology is drawn from a distribution Each technology is randomly assigned a ‘value’ attribute and a specific health production function ‘shape’ (applies only if marginal returns are diminishing) 1. The initial allocator purchases technologies from the pool until the initial budget is exhausted Initial budget Upon the establishment of the health system, an initial budget is assigned for purchasing technologies from the pool Divisibility of technologies Technologies in the pool are either all divisible or all indivisible Marginal returns to scale Technologies in the pool either all have constant marginal returns to scale or all have diminishing marginal returns to scale Imperfect information Each decision maker has one of four levels of information regarding the effectiveness of technologies: none, poor, good, or perfect Other value considerations Each decision maker assigns one of four possible weights to ‘value’ considerations beyond the QALY: none, small, medium, or large Initial allocator Model schematic Pool of initial technologies The cost and effectiveness of each technology is drawn from a distribution Each technology is randomly assigned a ‘value’ attribute and a specific health production function ‘shape’ (applies only if marginal returns are diminishing) 1. The initial allocator purchases technologies from the pool until the initial budget is exhausted Initial budget Upon the establishment of the health system, an initial budget is assigned for purchasing technologies from the pool Divisibility of technologies Technologies in the pool are either all divisible or all indivisible Imperfect information Each decision maker has one of four levels of information regarding the effectiveness of technologies: none, poor, good, or perfect Initial allocator Marginal returns to scale Technologies in the pool either all have constant marginal returns to scale or all have diminishing marginal returns to scale Other value considerations Each decision maker assigns one of four possible weights to ‘value’ considerations beyond the QALY: none, small, medium, or large New intervention Each new intervention represents either a net investment or net disinvestment Net investments impose costs on the health system, requiring that resources be released from other technologies Net disinvestments release resources, allowing these to be spend on other technologies from the pool Model schematic Pool of initial technologies The cost and effectiveness of each technology is drawn from a distribution Each technology is randomly assigned a ‘value’ attribute and a specific health production function ‘shape’ (applies only if marginal returns are diminishing) 1. The initial allocator purchases technologies from the pool until the initial budget is exhausted Divisibility of technologies Technologies in the pool are either all divisible or all indivisible Imperfect information Each decision maker has one of four levels of information regarding the effectiveness of technologies: none, poor, good, or perfect Initial allocator Marginal returns to scale Technologies in the pool either all have constant marginal returns to scale or all have diminishing marginal returns to scale Other value considerations Each decision maker assigns one of four possible weights to ‘value’ considerations beyond the QALY: none, small, medium, or large Agent New intervention Each new intervention represents either a net investment or net disinvestment Net investments impose costs on the health system, requiring that resources be released from other technologies Net disinvestments release resources, allowing these to be spend on other technologies from the pool 2. The agent recommends the new intervention if its expected value exceeds the agent’s value threshold Value threshold Used by the agent to determine whether or not to recommend the new intervention Initial budget Upon the establishment of the health system, an initial budget is assigned for purchasing technologies from the pool Model schematic Pool of initial technologies The cost and effectiveness of each technology is drawn from a distribution Each technology is randomly assigned a ‘value’ attribute and a specific health production function ‘shape’ (applies only if marginal returns are diminishing) 1. The initial allocator purchases technologies from the pool until the initial budget is exhausted Divisibility of technologies Technologies in the pool are either all divisible or all indivisible Imperfect information Each decision maker has one of four levels of information regarding the effectiveness of technologies: none, poor, good, or perfect Initial allocator Marginal returns to scale Technologies in the pool either all have constant marginal returns to scale or all have diminishing marginal returns to scale Other value considerations Each decision maker assigns one of four possible weights to ‘value’ considerations beyond the QALY: none, small, medium, or large Reallocator Agent New intervention Each new intervention represents either a net investment or net disinvestment Net investments impose costs on the health system, requiring that resources be released from other technologies Net disinvestments release resources, allowing these to be spend on other technologies from the pool 2. The agent recommends the new intervention if its expected value exceeds the agent’s value threshold Value threshold Used by the agent to determine whether or not to recommend the new intervention Initial budget Upon the establishment of the health system, an initial budget is assigned for purchasing technologies from the pool Model schematic Pool of initial technologies The cost and effectiveness of each technology is drawn from a distribution Each technology is randomly assigned a ‘value’ attribute and a specific health production function ‘shape’ (applies only if marginal returns are diminishing) 1. The initial allocator purchases technologies from the pool until the initial budget is exhausted Divisibility of technologies Technologies in the pool are either all divisible or all indivisible Imperfect information Each decision maker has one of four levels of information regarding the effectiveness of technologies: none, poor, good, or perfect Initial allocator Marginal returns to scale Technologies in the pool either all have constant marginal returns to scale or all have diminishing marginal returns to scale Other value considerations Each decision maker assigns one of four possible weights to ‘value’ considerations beyond the QALY: none, small, medium, or large Reallocator Agent 3. If the agent recommends a net investment, the reallocator must contract adopted NE/NW technologies and/or expand non-exhausted SE/SW technologies. Alternatively, if the agent recommends a net disinvestment, the reallocator may expand non-exhausted NE technologies and/or contract adopted SW technologies Initial budget Upon the establishment of the health system, an initial budget is assigned for purchasing technologies from the pool New intervention Each new intervention represents either a net investment or net disinvestment Net investments impose costs on the health system, requiring that resources be released from other technologies Net disinvestments release resources, allowing these to be spend on other technologies from the pool 2. The agent recommends the new intervention if its expected value exceeds the agent’s value threshold Value threshold Used by the agent to determine whether or not to recommend the new intervention Model schematic Pool of initial technologies The cost and effectiveness of each technology is drawn from a distribution Each technology is randomly assigned a ‘value’ attribute and a specific health production function ‘shape’ (applies only if marginal returns are diminishing) 1. The initial allocator purchases technologies from the pool until the initial budget is exhausted Divisibility of technologies Technologies in the pool are either all divisible or all indivisible Imperfect information Each decision maker has one of four levels of information regarding the effectiveness of technologies: none, poor, good, or perfect Initial allocator Marginal returns to scale Technologies in the pool either all have constant marginal returns to scale or all have diminishing marginal returns to scale Other value considerations Each decision maker assigns one of four possible weights to ‘value’ considerations beyond the QALY: none, small, medium, or large Reallocator Agent 3. If the agent recommends a net investment, the reallocator must contract adopted NE/NW technologies and/or expand non-exhausted SE/SW technologies. Alternatively, if the agent recommends a net disinvestment, the reallocator may expand non-exhausted NE technologies and/or contract adopted SW technologies New intervention Each new intervention represents either a net investment or net disinvestment Net investments impose costs on the health system, requiring that resources be released from other technologies Net disinvestments release resources, allowing these to be spend on other technologies from the pool 2. The agent recommends the new intervention if its expected value exceeds the agent’s value threshold Value threshold Used by the agent to determine whether or not to recommend the new intervention Initial budget Upon the establishment of the health system, an initial budget is assigned for purchasing technologies from the pool Agent’s authority Agent may have mandate to consider reallocation and/or an alternative to the intervention Model schematic Pool of initial technologies The cost and effectiveness of each technology is drawn from a distribution Each technology is randomly assigned a ‘value’ attribute and a specific health production function ‘shape’ (applies only if marginal returns are diminishing) 1. The initial allocator purchases technologies from the pool until the initial budget is exhausted Divisibility of technologies Technologies in the pool are either all divisible or all indivisible Imperfect information Each decision maker has one of four levels of information regarding the effectiveness of technologies: none, poor, good, or perfect Initial allocator Marginal returns to scale Technologies in the pool either all have constant marginal returns to scale or all have diminishing marginal returns to scale Other value considerations Each decision maker assigns one of four possible weights to ‘value’ considerations beyond the QALY: none, small, medium, or large Reallocator Agent 3. If the agent recommends a net investment, the reallocator must contract adopted NE/NW technologies and/or expand non-exhausted SE/SW technologies. Alternatively, if the agent recommends a net disinvestment, the reallocator may expand non-exhausted NE technologies and/or contract adopted SW technologies Initial budget Upon the establishment of the health system, an initial budget is assigned for purchasing technologies from the pool 4. Prior to making its recommendation, the agent places its own valuations on both the new intervention and the reallocator’s preferred reallocation. If the agent has the authority to mandate a reallocation and/or propose an alternative to the new intervention then it also places a valuation upon this. The optimal value threshold is that which ensures that a new intervention is only recommended if doing so maximizes the expected value to the agent New intervention Each new intervention represents either a net investment or net disinvestment Net investments impose costs on the health system, requiring that resources be released from other technologies Net disinvestments release resources, allowing these to be spend on other technologies from the pool 2. The agent recommends the new intervention if its expected value exceeds the agent’s value threshold Value threshold Used by the agent to determine whether or not to recommend the new intervention Agent’s authority Agent may have mandate to consider reallocation and/or an alternative to the intervention Conventional Assumptions $50m Higher budget Expenditure on new technology $40m $30m Lower budget Threshold 'kinks' $20m $10m $0m -$10m All decision makers have perfect information -$20m All decision makers place no weight on other ‘value’ considerations Lower budget -$30m -$40m Technologies are divisible Technologies exhibit constant returns to scale Higher budget -$50m -2,000 -1,000 Agent cannot reallocate 0 1,000 2,000 Value of new technology (QALY equivalents) Diminishing Returns to Scale $50m Higher budget Expenditure on new technology $40m $30m Lower budget $20m $10m $0m -$10m All decision makers have perfect information -$20m All decision makers place no weight on other ‘value’ considerations Lower budget -$30m -$40m -$50m -2,000 Technologies are divisible Technologies exhibit diminishing returns to scale Agent cannot reallocate Higher budget -1,000 0 1,000 2,000 Value of new technology (QALY equivalents) Indivisible Technologies $50m Higher budget Expenditure on new technology $40m $30m Lower budget $20m $10m $0m -$10m All decision makers have perfect information -$20m All decision makers place no weight on other ‘value’ considerations -$30m Technologies are indivisible Lower budget -$40m -$50m -2,000 Returns to scale irrelevant if technologies are indivisible Higher budget (overlap) -1,000 0 Agent cannot reallocate 1,000 2,000 Value of new technology (QALY equivalents) Imperfect Information and Other ‘Value’ Considerations $50m Initial allocator and agent have perfect information Higher and reallocator has budget poor information Expenditure on new technology $40m Higher budget Initial allocator and agent place small weight and reallocator places large weight on other ‘value’ considerations $30m $20m Lower budget Lower budget Technologies are divisible Technologies exhibit diminishing returns to scale $10m Agent cannot reallocate $0m Reallocator and agent have Threshold perfect information and initial allocator has 'kinks' poor information Threshold 'kinks' -$10m Reallocator and agent place small weight and initial allocator places large weight on other ‘value’ considerations -$20m -$30m Lower budget -$40m -$50m -2,000 Higher budget Lower budget Technologies are divisible Higher Technologies exhibit diminishing budgetreturns to scale Agent cannot reallocate -1,000 0 1,000 2,000 Value of new technology (QALY equivalents) Agent Has Authority to Reallocate $50m Initial allocator and agent have perfect information and reallocator has poor information Expenditure on new technology $40m Higher budget Initial allocator and agent place small weight and reallocator places large weight on other ‘value’ considerations $30m $20m Lower budget Technologies are divisible Technologies exhibit diminishing returns to scale $10m Agent can reallocate $0m -$10m Threshold 'kink' -$20m Lower budget -$30m -$40m Higher budget -$50m -2,000 -1,000 0 1,000 2,000 Value of new technology (QALY equivalents) Conclusions • The conventional ‘CE threshold’ model is merely a special case among many approaches for determining a value threshold • Departing from this special case allows for consideration of: • Differences in the information available to, the values held by, and the objectives pursued by, multiple interacting decision makers • The specific value characteristics of each technology • This has potentially significant implications for the appropriate specification of value thresholds used for decision making • Our findings provide insights for future theoretical work, as well as a rich source of potential hypotheses for researchers conducting empirical research in this area Questions 1. Why should value considerations be accounted for within the threshold used for CE analysis? Isn’t it sufficient to simply apply weights to new technologies or to consider ‘values’ separately? 2. Why might differences in information, values and objectives across multiple interacting decision makers result in: a) Different thresholds for net investments and net disinvestments? b) Thresholds that cross into the SE and NW quadrants of the CE plane? 3. Why is the threshold dependent upon the agent’s authority? Are there any implications for the recommendations made by CADTH or for the decisions of Canadian policy makers who depend upon CADTH’s guidance? References • Claxton et al. (2013). Methods for the Estimation of the NICE Cost Effectiveness Threshold. CHE Research Paper 81. York: University of York. • Drummond et al. (2005). Methods for the Economic Evaluation of Health Care Programmes. Third Edition. Oxford: Oxford University Press. • Sendi et al. (2002). Opportunity costs and uncertainty in the economic evaluation of health care interventions. Health Economics, 11(1), 23–31. • National Institute for Health and Care Excellence (2009). Appraising lifeextending, end of life treatments. London: NICE. • National Institute for Health and Care Excellence (2014). Consultation Paper: Value Based Assessment of Health Technologies. London: NICE. • Paulden et al. (2014). Some Inconsistencies in NICE’s Consideration of Social Values. PharmacoEconomics. November 2014, 32(11), 1043-1053.
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