The first annual American College of Radiology (ACR) meeting started off on a brilliant note here in balmy Washington DC. With exhibits all set up, sessions began, and brimmed with reports on latest research, the status of various healthcare policies, and their impact on radiology.
I attended two very interesting sessions on Monday that covered both the clinical and the policy sides of radiology. The first, an in-depth look at the status of molecular imaging in dementia and the second, an economics forum on some of the macroeconomic trends in healthcare and specific policy implications for imaging. In this blog post, I?m going to tau-lk about the former?which was a three-part look at dementia imaging, focused on clinical research and the translation in to the clinical space.
Part 1: Dr. Frey led the session by outlining some pretty surprising statistics. Did you know dementia has a prevalence of 25% in 80-90 year olds? On top of that, the direct and indirect costs associated with dementia top $150 billion annually. So, why should we care about molecular imaging in dementia, he asked? Because, if the goal is better management and treatment (and one day, a cure), it is crucial to understand which patients have what underlying conditions. By harnessing the power of molecular imaging, the success of the idea/study approach in question can be better measured. Dr. Frey then took a deeper dive in to the various conditions that make up the umbrella term ?dementia?. Neuropathologists are able to best categorize a patient's condition based on the accumulation of various substances in the brain. One of these is amyloid and another is tau?the varying volumes of which present themselves as different neurological conditions. While there are currently 3 amyloid tracers on the market (and another one its way), there's a great need for better tau imaging agents. Once these tracers are developed, movement disorders and other subtypes of frontotemporal dementia (FTD) will be more easily identified.
So, why is a better diagnosis for dementia patients important? This question helped set the stage for part 2 of the session.
Part 2: In looking at the track record for anti-amyloid clinical trials, Dr. Seibyl highlighted the high failure rate of these studies. He pointed out that a key reason behind these disappointing results was that the researchers weren?t getting the right types of patients in the studies! Without the use of amyloid imaging, many patients were incorrectly being included in or excluded from these studies. Therefore, adopting more specific and differentiating molecular imaging (rather than relying solely upon physician testing), patients can be better categorized and screened, thus leading to more accurate results in the clinical trials. With numerous promising trials on the horizon for dementia treatment, the diagnosis and ensuring the correct patients get in to these trials has never been more important.
Part 3: Dr. Herscovitch summed up the session with a sobering look at the FDA approval process and CMS coverage situation for amyloid radiopharmaceuticals. In a nutshell: it's not easy. The FDA requires extremely high safety and toxicology requirements for phase 1 and 2 trials, which mirrors the approval pathway for therapeutic drugs, despite the fact that radiopharmaceuticals are only diagnostic tools. Furthermore, hurdles such as tracer half-life, one-off use of the radiopharmaceutical in a patient and regulatory hurdles for PET insurance coverage are major barriers. And it doesn?t end there. Even if an agent does receive FDA approval, it does not mean it will be covered by the CMS. A key criterion for CMS coverage is that the radiopharmaceutical needs to show clinically meaningful health outcomes, such as improved quality of life and symptom improvement; all of these are high demands for an imaging agent.
Nonetheless, there is optimism in this field. With an increase in papers on amyloid scanning on patient health outcomes, such as the IDEAS study, reimbursement for amyloid scanning may not be too far off. Overall, I think it's exciting to see the changes in the clinical trials enrollment screening, progress towards reimbursement as well as the multiple studies for potential treatment options in this space. Judging by the trend thus far, I can only hope that progress continues on its positive trajectory, and look forward to seeing the outcomes in this dynamic field over the coming years.