Tag: Alzheimer’s disease

MRI Predicts Cognitive Decline

Posted on by Brian Casey

Early detection of cognitive decline is becoming increasingly important as new therapies become available for conditions like Alzheimer’s disease. A new 20-year study in JAMA Network Open shows that MRI can detect structural brain changes indicating future cognitive decline – years before symptoms occur. 

Longitudinal research has shown that subtle changes in body structure – be they in the heart, brain, or other organs – can predict future disease risk, in some cases decades in advance.

  • That enables the possibility of targeted treatments or behavioral interventions to reduce risk before sick patients experience a cascade of expensive and invasive therapies. 

Mild cognitive impairment is an excellent example. MCI can be a transition to more serious diseases like Alzheimer’s, and previous research has connected it to vascular risk factors that are signs of brain atrophy. 

  • In the current paper, researchers analyzed MRI scans acquired as part of the BIOCARD cohort, a longitudinal study started in 1995 in which cognitively normal participants got baseline brain MRI scans and follow-up exams. 

In a group of 185 BIOCARD participants, researchers tracked how many transitioned to MCI over a mean follow-up period of 20 years, then compared structural brain changes on MRI, finding …

  • 60 participants (32%) progressed to MCI, eight of whom later developed dementia (4.3%).
  • Those with white-matter atrophy on MRI had an 86% higher chance of progression to MCI, the highest rate of any variable studied.
  • Participants with enlargement of the ventricles on MRI had 71% higher risk.
  • Other variables like diabetes and amyloid pathology also had higher risk, but not at the rate of the MRI-detected variables. 

The findings indicate that white-matter volume is closely associated with cognitive function in aging, and that people with higher rates of change are more likely to develop MCI. 

  • The association of diabetes with MCI was not a shock, but researchers said they were surprised there was no association from risk factors like hypertension, dyslipidemia, and smoking.

The Takeaway

The new findings demonstrate the power of MRI to predict pathology years in advance – the question is how and whether to put this knowledge into clinical practice. One could almost see structural brain scans incorporated into whole-body MRI screening exams (if anyone’s listening).

PET’s Milestone Moment

Posted on by Brian Casey

In a milestone moment for PET, CMS has ended its policy of only paying for PET scans of dementia patients if they are enrolled in a clinical trial. The move paves the way for broader use of PET for conditions like Alzheimer’s disease as new diagnostic and therapeutic agents become available. 

CMS said it was rescinding its coverage with evidence development (CED) requirement for PET payments within Medicare and Medicaid. 

  • Advocates for PET have chafed at the policy since it was established in 2013, claiming that it restricted use of PET to detect buildup of amyloid and tau in the brain – widely considered to be precursors to Alzheimer’s disease. The policy limits PET payments to one scan per lifetime for patients enrolled in clinical trials. 

But the landscape began changing with the arrival of new Alzheimer’s treatments like Leqembi, approved in January 2023. CMS telegraphed its changing position in July, when it announced a review of the CED policy, and followed through with the change on October 13. The new policy…

  • Eliminates the requirement that patients be enrolled in clinical trials
  • Ends the limit of one PET scan per Alzheimer’s patient per lifetime
  • Allows Medicare Administrative Contractors (MACs) to make coverage decisions on Alzheimer’s PET
  • Rejects requests to have the policy applied retroactively, such as to when Leqembi was approved

CMS specifically cited the introduction of new anti-amyloid treatments as one of the reasons behind its change in policy. 

  • The lifetime limit is “outdated” and “not clinically appropriate” given the need for PET for both patient selection and to potentially discontinue treatment if it’s ineffective or if it’s worked to clear amyloid from the brain – a key need for such expensive therapies. 

The news was quickly applauded by groups like SNMMI and MITA, which have long advocated for looser reimbursement rules.

The Takeaway

The CMS decision is great news for the PET community as well as for patients facing a diagnosis of Alzheimer’s disease. The question remains as to what sort of reimbursement rates providers will see from the various MACs around the US, and whether commercial payers will follow suit.

CMS May Shake Up PET Payments

Posted on by Brian Casey

In a major victory for PET advocates, CMS this week said it was opening a review of its reimbursement policy on PET scans for Alzheimer’s disease. The review could lead to more generous Medicare and Medicaid payments for PET to detect amyloid buildup in the brain, long known as a link to the debilitating – and inevitably fatal – disease. 

Medicare’s current policy on PET for Alzheimer’s has been in place since 2013 and is based on its coverage with evidence (CED) framework; it restricts reimbursement to a single scan per lifetime for patients who must be participating in clinical trials. The CED policy reflects not only CMS’ cautious approach to new technology, but also the fact that for years there have been no effective treatments for Alzheimer’s disease. 

That’s all changed within the last year. A new class of drugs that target amyloid buildup in the brain has begun to receive FDA approval, the most recent being Leqembi from Esai/Biogen in January 2023. And this week, Eli Lilly reported positive results for its amyloid-targeting treatment donanemab (see below), with approval expected by the end of 2023. 

The new drugs have changed the game when it comes to diagnosis and treatment of Alzheimer’s disease: 

  • PET can now be used to identify eligible patients and monitor their treatment
  • Thanks to PET, patients won’t continue to be given expensive drugs after amyloid buildup has been eliminated
  • Expanded PET reimbursement could boost the use of PET diagnostic tracers for identifying amyloid buildup 

CMS is taking comments on its proposal through August 16. If the agency eliminates the CED policy in favor of a national coverage decision, then decisions on PET reimbursement will be made by local Medicare Administrative Contractors (MACs). 

This week’s news could be a Pyrrhic victory if PET reimbursement levels are set too low. One positive sign is that CMS has said it also plans to review its policy that bundles radiotracer payments together with scan payments, which tends to depress reimbursement.

The Takeaway

The nuclear medicine and molecular imaging community has chafed for years under CMS’ restrictive policies on PET for Alzheimer’s disease, with groups like SNMMI lobbying for the change. This week’s news should have wide-ranging benefits not only for the PET business sector, but also for patients who are facing the scourge of Alzheimer’s disease.

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