The debate over a new treatment for depression has all the elements a new panel was set up to resolve: There's conflict over its effectiveness, it isn’t cheap, and it could be used by millions of Americans.
The approach involves sending magnetic pulses into the brain to stimulate a region thought to affect mood. Called repetitive transcranial magnetic stimulation, or rTMS, the procedure was first approved in 2008 and is spreading rapidly around the country.
So how did it stack up against other treatments for resistant depression?
Late last year, the group of doctors, patients and policymakers -- called the New England Comparative Effectiveness Public Advisory Council -- voted 10 to 5 that rTMS provides a health benefit equal to, or better than traditional care, which includes psychotherapy and antidepressants. Six of the 10 panelists said the treatment represented a "reasonable" value compared with traditional care, while four said it was a "low"value.
The panel reviewed studies of how rTMS compared to other treatments for depression. It also considered an analysis that estimated that 24 insurers in six New England states currently spend $1.7 billion a year on patients with treatment-resistant depression. Using a complex formula, the report estimated that adding rTMS to a treatment protocol would add between 21 cents and 59 cents per month for every health plan enrollee in private insurance and Medicaid, or $19 million to $53 million a year.
"It’s not perfect data," acknowledged Teresa Fama, a Vermont rheumatologist and panel member. "But at least there is a standard process, and you can put the cost in some kind of context."
While it can’t make policy, the group is one of a handful of state or regional advisory groups trying to assess new technologies using medical research evidence. The panel was created in 2011 through a three-year grant from the federal Agency for Healthcare Research and Quality. (The 2010 health law also created a national advisory group, the nonprofit Patient-Centered Outcomes Research Institute, to examine the relative effectiveness of different treatments.)
A month after the New England panel’s assessment, the Medicare administrator in the five-state New England region reversed an earlier decision not to cover rTMS, citing the panel’s work as a factor. That means Medicare beneficiaries in Maine, Massachusetts, New Hampshire, Vermont and Rhode Island can have the treatment covered. But other regional Medicare administrators and private insurers are not bound by the ruling.
The advisory panel is seen as a model of how decision-making about new treatments might occur in the future – with public airing of both the science and the costs.
"We’re aiming for a transparent process …without the discussion being driven by a company, or clinicians, or desperate patients," said Steven Pearson president of the Institute for Clinical and Economic Review, an academic research group that manages and directs the panel. "Those views are legitimate, but it’s important that they not be the only voice."
In its decision, Pearson said, the council showed that "comparative effectiveness research doesn’t necessarily lead to a 'no'" on coverage, despite the fears many have that it will be used to ration or limit care.
While costs are generally considered by private insurers when evaluating a new drug or treatment, Medicare is barred from taking that into consideration in making coverage decisions.
Fama said it is naïve not to consider costs as part of the process of weighing the value of different treatments.
But, she added, there will always need to be exceptions. "If I have a patient who has tried everything ... and is running out of options, I might want to go for something that is not backed up by that much data."