Info

Type of study

Advantages and disadvantages

Application to oncology

Clinical outcomes alone

Easy to perform. Ignores costs.

Clinical outcomes alone

Cost only

Costs and clinical outcomes together Cost minimization: assumes two strategies are equal; lowest cost strategy is preferred.

Cost-effectiveness:

Compares two strategies; assigns $ per additional year of life (LY) saved by strategy.

Cost-utility: assigns $ per additional year of life (LY) saved by strategy, then estimates the quality of that benefit in $/quality adjusted (QALY).

Cost-benefit: Compares two strategies but converts the clinical benefits to money, e.g., a year of life is worth $100,000.

Easy to perform. Ignores costs.

Ignores clinical outcomes.

Easy to do if there are direct comparisons.

Requires a trial that directly compares strategies, and economic analysis alongside that trial. "Only accept treatments that gain a year of life for under $100,000/life year."

Compares two strategies, with their quality of life comparisons converted to utility, or the value placed on time in a health state, e.g., time spent on chemo = 0.7 compared to a healthy individual whose utility = 1.0.

Possible but rarely done due to difficulty in assigning $ value to human life.

Traditional way to make decisions, e.g., imitinab mesylate (gleevec) works for chronic myelogenous leukemia (CML). Use it. Pay what the manufacturer demands.

Often used by insurers as first reaction to "sticker shock" of new drugs, e.g., zevalin at $22,000-$28,000/dose.

For instance, if darbopoietin is equivalent to epoietin for chemotherapy-associated anemia, choose the least expensive drug.

There are very few direct comparisons of drugs and strategies. The trials typically must be large to detect small differences, are unexciting compared to new drug trials, and have no willing sponsor.

There are few interventions that make a large difference in utility. Also, there is rarely one simple yardstick of utility that covers all health states.

Would almost certainly be unfavorable to most palliative interventions, as patients rarely work or generate income.

The standard cost-effectiveness equation is AC/AE = (C2 - Ci)/(E2 - Ei) where C = costs and E = effectiveness of treatment measured in time. For intervention 2, as its cost decreases or effectiveness improves, its CE ratio improves, i.e., decreased cost per year of life gained. When utility, or (life year gained) x (utility factor), is calculated, the equation becomes AC/AU where AU = U2 - U1. For example, a therapy that does not improve survival but decreases utility factor to 10% will decrease U by (1 year) x (0.10) = 0.1 year. If this treatment costs an additional $10,000/year, then the cost-utility ratio is AC = C2 - C1 = $10,000 = $100,000/QALY (the intervention is "less effective" because it adversely affects morbidity).

TABLE 11.2. Difficulties in application of cost-effectiveness analysis or rationing by any method.

Factor Pros, cons, and comment

We should not ration health care at all.

There are no accepted guidelines to use.

The cost-effectiveness ratio of $50,000/LY is too low.

There are no unbiased studies.

Clinicians should not ration at the bedside.

The individual always comes first.

Avoids the issues—for those able to afford unlimited care. Unsustainable, and not morally defensible in the current high-cost environment.6 Rationing goes on all the time now, based on ability to pay.

This is one of the most daunting tasks: to have a uniform standard. For many years, an unwritten rule has been that technologies that cost $50,000/LY or less were acceptable, based on the incremental cost of dialysis vs. no dialysis.3 The great majority of published studies referenced that standard.45 Laupacis and colleagues in Canada proposed that therapies under $20,000/LY ($ Canadian, 1992) be automatically accepted, that therapies $20,000-$100,000 be considered, and that therapies over $100,000 be rejected.46

Recently, Ubel and colleagues have proposed that one of the main reasons cost-effectiveness is not more widely used is that $50,000 is too low, and that with inflation and the affluence of the United States, a benchmark of $100,000-$200,000 is more appropriate.45

Initial evidence was that industry-sponsored studies were more likely to be published if positive for their product47 and that industry sponsored more cost-minimization studies, to show that their product was as cost-effective as the competition, but not to address the issue of whether the therapy was a good buy for society.48 A comprehensive review suggests that quality control in most studies was low regardless of funding source and that industry-sponsored trials have improved.49

Clinicians have no training in this aspect of care, no framework for decisions, and were not able to adequately judge the appropriateness of their patient for care versus others.50 Others argue that the healthcare budget should not be balanced by denying services to vulnerable groups such as the elderly.51,52 Although clinicians may elect to not do these tasks, a more reasonable view is that clinicians should at least be involved, because someone must do it, and the decisions should be best informed.5

Hadorn gave the name "the rule of rescue" to the compelling need of one visible patient (in this case, a 7-year-old with relapsed acute leukemia who might have a small chance of cure with a matched unrelated stem cell transplant) to the less-visible needs of many others who might also need those same healthcare dollars.53 This rule nearly collapsed the Oregon expansion of Medicaid services to the uninsured; a mechanism for appeals of individual decisions is always necessary, but some services cannot be provided.

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