Research data not currently used to make coverage decisions
The Affordable Care Act invested significantly in comparative effectiveness research (CER), but at the same time, states that no decisions coming out of CER should determine what treatments are covered by insurers, notes Norman Daniels, PhD, professor of ethics and population health at Harvard School of Public Health in Boston, MA.
"So there is a real aversion to letting evidence play a role in thinking about what we should do," he says. "Ethically, I find that really problematic."
Daniels says one ethical concern with CER is that it can’t answer the question of whether an increase in the effectiveness of some drugs is worth the extra price. "There are some people who are trying to introduce cost in the process — but if you look at the actual definitions, they don’t include cost," he says.
CER can determine whether one drug or intervention is more effective than another, but it won’t tell you anything about the extra value you get compared to the cost, he explains. Similarly, if there is only one intervention for a certain condition, which is often the case for a period of time, then CER doesn’t tell you whether the price of that treatment is worth the value or cost.
"CER could be helpful in telling us that something works better than something else, or doesn’t work any better, and that might help us avoid some forms of waste, but may not tell us whether it’s worth the price," says Daniels.
Always offering the more effective treatment regardless of price is an unsustainable system, says Daniels, and this is an important issue ethically.
"The kind of constraints that have been imposed on processes for making those judgments, by people who think of it as a kind of death panel, is really to tie both hands behind the back of decision makers in making any kinds of value judgments about health investments," says Daniels.
A fragmented health care system makes it more difficult to come to grips with making difficult but necessary choices about cost, argues Daniels. "If we were in a system in which payments for services all came out of the same pot, then you would have to make these choices," he says.
While insurers make all kinds of decisions about what’s covered or not, "there are no processes or tools for the government to do so, says Daniels. "That strikes me as very bad thinking for how to value health investments."
Denial of access is ethical concern
CER involves comparing the outcomes of different treatment options for a specific medical condition for a specific population of patients, notes Lisa S. Parker, PhD, associate professor of human genetics and director of graduate education at the University of Pittsburgh’s Center for Bioethics and Health Law.
Thus, it is important to ensure that the results of CER are then applied in practice to the same sort of patients as the population that was studied, she says, or, alternatively, that the potential for "slippage" of applicability of study results to the present population be taken into account.
"While treatment A may be found to work better than treatment B — the type of finding that results from CER — this finding is applicable primarily to the CER-study population," says Parker. That population may differ from the clinical population in a different health care system or different demographic group.
"Indeed, for a particular individual patient, it may be that treatment B would be superior," says Parker.
CER yields epidemiological results (i.e., results that are accurate at the population level, but that are not necessarily true of every member of even the population studied), explains Parker.
Therefore, a categorical denial of access to treatment B — or the decision to place A on a hospital’s formulary and never prescribe B — may not best serve an individual patient’s interests.
"Depending on the circumstances, it may be appropriate to review appeals from individual patients who want access to an option that does not emerge from CER as the superior intervention," says Parker.
SOURCES
- Norman Daniels, PhD, Professor of Ethics and Population Health, Harvard School of Public Health, Boston, MA. Phone: (617) 432-2360. E-mail: ndaniels@hsph.harvard.edu.
- Lisa S. Parker, PhD, Associate Professor of Human Genetics/Director of Graduate Education, Center for Bioethics and Health Law, University of Pittsburgh. E-mail: lisap@pitt.edu.