Recently, the FDA provided approval for the use of two new PET radiopharmaceuticals, Cerianna and Tauvid. Cerianna is a molecular imaging agent indicated for use in PET imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
The second, Tauvid, is indicated for use in patients to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease.
Let’s dive in and discuss the potential impact of Tauvid.
Who Is Tauvid for and What Is Tauvid Designed to Do?
According to the Alzheimer’s Association, it is estimated that more than 5 million Americans are currently living in the USA with Alzheimer’s Disease (AD). This equates to millions more individuals who are impacted by the disease; caregivers, healthcare providers, family members and friends. What is an even more staggering statistic is that 1 in 3 seniors dies with Alzheimer’s Disease – more deaths than breast and prostate cancer combined.
One of the more troubling factors that must be considered is how difficult it can be to diagnose AD while an individual is still alive. There are cognitive tests that can be performed and diagnostic imaging exams that may be performed – but at what cost?
Available cognitive tests cannot pinpoint the exact cause of cognitive decline or impairment, but are used to help narrow down the possible causes. Treatments are, in a sense, created by this process of elimination. Diagnostic imaging exams using PET/CT imaging are able to provide a more accurate diagnosis, but reimbursement is not currently available, leaving physicians and family members with few options.
Enter Tauvid. Recently approved by the FDA, Tauvid helps to pinpoint the density and distribution of aggregated tau neurofibrillary tangles (NFTs), which can be prevalent in patients with AD. This new tool in the physician’s arsenal will help providers identify patients that are highly likely to have Alzheimer’s Disease versus another form of cognitive decline or impairment.
Tauvid Availability and Reimbursement
While it is still too early to tell what the extent of the imaging agents availability will look like, it is expected to be rolled out in late 2020 / early 2021 throughout the country, with select locations currently in production.
Facilities interested in utilizing Tauvid for their own approved clinical trials should reach out to The Lily Answers Center support line, (800) 545-5979.
Unlike oncology imaging agents, neurology tracers (including Tauvid) are not automatically covered by CMS when they receive FDA approval. At the time of publication (6/20), CMS has not determined if and what the reimbursement scenario will look like.
It is recommended that any facility interested in utilizing the radiopharmaceutical should reach out to their local radiopharmacy or Avid Radiopharmaceutical representative.
Impact of Diagnosis
As with any introduction of a non-oncologic imaging agent, there are two impact points; the short term and the long term. In the short term or near future, the impact of this radiopharmaceutical may be limited. Many facilities will be interested in utilizing the imaging agent but do not have the resources or desire to manage a clinical trial. Until reimbursement and availability questions are addressed, it is most likely going to be a slow start for this tracer.
What does the long term impact look like? The nuclear medicine and AD communities are hopeful that, once reimbursement and availability are addressed, Tauvid will enable healthcare providers to diagnose Alzheimer’s Disease more accurately and earlier. This will lead to an enhanced quality of life, proper care being implemented and overall, better outcomes for these patients.
Clinical trial results
There have been two clinical studies performed using Tauvid to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs). In each study, Tauvid imaging was interpreted by five independent readers who were blinded to clinical information. Results were reported as positive or negative and are shown in the table below.
What is Next for Tauvid?
Could Tauvid be the imaging agent that we’ve been waiting for? While we are hopeful, only time will tell. What is important is that we continue to make great strides in the fight against Alzheimer’s Disease and demonstrate the critical role nuclear medicine plays in our communities.