FDA is expected to approve a new Alzheimer’s drug soon. While this is a welcome development for patients, our health system is not ready to meet the demand. Expanding access to diagnostic technologies is a crucial step in ensuring the new medicine will benefit patients.
Writing in RealClearHealth, Tom Hubbard, Senior Vice President of Policy Research at the non-profit Network for Excellence in Health Innovation, highlights some of the challenges and opportunities ahead.
Medicare has delegated the details of PET coverage to regional Medicare administrative contractors and to Medicare Advantage plans—a decision that could result in inconsistent coverage and inequitable access. Moreover, PET facilities are not evenly distributed in the U.S., disadvantaging rural, low-income and minority patients. CSF analysis does not require specialized facilities, but uptake is hampered by a lack of well-trained providers, often compounded by patient fear of the procedure, which requires a spinal tap.
As demand increases, new cognitive and neurobehavioral assessments will be critical for detecting and monitoring the changes in memory, mental processing and daily functioning that disable Alzheimer’s patients, and which caregivers and clinicians will consider as the best evidence that therapies are effective. Promising innovations now in development include telehealth-delivered versions of standard cognitive assessments, and development of “digital biomarkers,” including sensor-detected measures of patient speech patterns, gait, and eye moments that may yield objective measurement of dementia biomarkers.
Innovations in laboratory tests are also promising. A first generation of blood-based biomarker tests for amyloid detection are now available and may point the way to a future in which diagnosis of amyloid, tau and other pathologies of Alzheimer’s will start with blood samples drawn in primary care visits.
In the short term, key steps can be taken to ensure appropriate Alzheimer’s diagnosis and treatment.
First, while Medicare has delegated coverage policies to its regional contractors, Medicare’s national office should still take care to see that coverage among the Medicare regions is consistent and equitable. Other barriers to PET imaging must be addressed as well. Medicare reimburses hospitals for outpatient PET imaging on a “packaged” or bundled basis that effectively caps payment for PET imaging irrespective of the type of PET imaging agents (radiopharmaceuticals for imaging) that may be required to meet the needs of individual patients. Packaged payment has often led hospitals to pick and choose among the types of imaging they offer. Medicare has signaled openness to reconsider this approach but has yet to change course, despite the launch of new and more effective PET imaging agents.
Meanwhile, to ensure that referrals to PET imaging and CSF analysis are both clinically wise and cost effective, Medicare should promote greater use of dementia screening and cognitive-behavioral assessment. The Medicare wellness visit is an ideal but under-utilized vehicle for dementia screening that deserves consideration for inclusion in Medicare’s schedule of physician performance incentives.
Physicians who administer Leqembi to Medicare beneficiaries are required to enter data in a patient registry under Medicare’s Coverage with Evidence Development (CED) program. (When approved, donanemab will be subject to the same requirement). The intent of this requirement is to generate real world evidence on the effectiveness of therapy—evidence which will require judicious use of diagnostics over an extended period of time. However it is not yet clear how the CED registry will generate robust evidence of clinical effectiveness, as opposed to simply tracking utilization of the new therapies. Previous iterations of the CED program have been criticized for producing open-ended and inconclusive studies. It remains to be seen if the outputs of the registry will be able to inform new standards for diagnosis.
You can read Tom’s full article here.