The lack of clinically useful diagnostics is hindering the growth of personalized medicine.
According to research by the Tufts Center for the Study of Drug Development, without clinically useful diagnostics, personalized medicine growth will occur at a relatively slow pace.
And personalized medicine represents the future of healthcare around the world.
That’s why the recent CMS decision to deny coverage for contrast-enhanced PET scans is a disturbing harbinger of the continued battle between short-term cost concerns on the one side and long-term patient care and medical innovation on the other.
CMS released a draft decision memo indicating that Medicare would pay for contrast-enhanced PET scans aimed at visualizing beta-amyloid protein plaques in patients brains only in the context of rigorous clinical trials, under the agency's "coverage with evidence development" (CED) policy.
The Alzheimer's Association said it was "disappointed" by the government's tentative decision last week not to allow broad Medicare coverage for brain amyloid imaging.
"With 5 million Americans living with Alzheimer's and more than 15 million people providing care, the need to accelerate improved care and an early and accurate diagnosis today, when scientifically supported, is critical," the group said in a statement.
The Alzheimer's Association noted that, in the past, it has taken as long as 7 years for CMS to move from a CED designation for new medical technologies to full coverage.
"The timeframe at which CMS has conducted CED processes is wholly unsuited and unacceptable to both the pace of scientific and technological innovation in the Alzheimer's field, and more importantly, the rapidly increasing needs posed by the escalating Alzheimer's epidemic," the group's statement said.
Eli Lilly & Co., which sells the only currently approved PET contrast agent (AmyVid), said it was disappointed in the CMS's draft decision memo, as did the Medical Imaging and Technology Alliance.
All three organizations pointed to "appropriate use criteria" published earlier this year by an expert panel that backed clinical use of the technology in select patient groups.
The panel, convened by the Alzheimer's Association and the Society for Nuclear Medicine and Molecular Imaging, said PET amyloid scans would be appropriate for patients with unexplained cognitive impairments, those with tentative Alzheimer's disease diagnoses who show unusual clinical presentations, and those with progressive dementia occurring before age 65.
The Alzheimer Association and Lilly noted that the memo is currently open for public comment (through August 2) and that CMS could still decide to allow broader coverage.
Let’s cut to the chase, if we are going to take meaningful strides both in addressing Alzheimer’s Disease specifically and in personalized medicine more broadly, we should not rely on Coverage with Evidence Development (CED) criteria in cases where the FDA’s approval process has expressly evaluated and endorsed the use of a drug or biologic in a specific patient population.
Fact: The evidence on amyloid imaging supports coverage for the population as identified by the Amyloid Imaging Task Force through Appropriate Use Criteria (AUC). A task force, convened by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging, recommends coverage in this population based on a comprehensive review of the literature and expert consensus.
Fact: CMS currently covers similar PET technologies to aid in the diagnosis of Alzheimer’s Disease and other forms of cognitive decline. The agency has not previously required evidence of health outcome improvement as a condition of such coverage.
Fact: Using CED alone will deny Medicare beneficiaries adequate and rapid access to this technology, as the path to implementation is unclear. Such uncertainty in the reimbursement process strongly dis-incentivizes future investments in research and development. And without innovation there will not be advances in personalized medicine.
Wither “sustainable innovation?”
Why even bother with expedited review and similar FDA pathways? Clearly closer FDA/CMS coordination is required to address both the will of Congress – and the future of American healthcare.