Well, it looks like we have a good old fashioned war of words developing over Alzheimer’s drug coverage. And given the tremendous amount of dementia care delivered in skilled care facilities, this battle royal is well worth watching.
At issue is a decision last week by the Centers for Medicare & Medicaid Services. Specifically, the agency denied a request to reconsider a national coverage determination (NCD) for the use of monoclonal antibodies in treating Alzheimer’s disease.
That’s a mouthful. Put in simpler terms, regulators rejected a request to have Medicare cover a new but extremely expensive and largely unproven treatment. Should this denial be considered fair or foul? Depends on whom you ask.
As far as CMS is concerned, the rejection is warranted for clinical reasons alone.
“We recognize that [monoclonal antibodies] are a unique, new class of drugs, and we regret that the decision could not be more favorable,” the agency noted. “After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration.”
The Alzheimer’s Association wasn’t buying it. CMS covers all other FDA-approved drugs but those in this new drug class, the organization countered.
“CMS’s role is to provide healthcare coverage. Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate,” said Joanne Pike, DrPH, president of the association.
Could it be that more than care considerations are at play here? Patient advocates sure seem to think so.
“We believe that CMS is standing by the decision to deny medically necessary care because they want to control costs,” said Jim Taylor, president and CEO of Voices of Alzheimer’s, an advocate for Alzheimer’s treatment access.
In fairness to CMS, costs were not cited in the rejection letter. Regardless, those costs could be astronomical.
It has been nearly two months since the Food and Drug Administration granted Leqembi an accelerated approval, leading to the first recorded sales and patient infusion of the drug weeks later. But there’s no denying that this is no bargain-basement option. In its marketing application for Leqembi, Eisai listed the drug for $26,500 per year per patient.
CMS says it will reconsider its denial of the Alzheimer’s drug if requesters can provide additional information that shows criteria for reconsideration has been met. Or if they can demonstrate that CMS “materially misinterpreted” the evidence provided in the request.
So it would appear we are in a bit of a standoff. How will the matter be resolved? I suppose it’s anyone’s guess. But my suspicion is that one of two things will occur.
The first is that a more effective and affordable treatment will come along, making the arguments here moot.
The second, more likely outcome, is that someone with enough political clout to end the argument one way or the other will do just that.
John O’Connor is editorial director for McKnight’s.
Opinions expressed in McKnight’s Long-Term Care News columns are not necessarily those of McKnight’s.
