Novel anti-amyloid therapies could revolutionize the treatment of Alzheimer’s disease, but only if we meet the challenge of early and accurate diagnosis. Our healthcare leaders must adapt to expand patient access to effective diagnostics while priming the health care system for uptake of diagnostic innovations that can improve clinical and cost effectiveness.
This represents a serious challenge to current policy and practice. More than six million Americans have Alzheimer’s disease, yet only about 16 percent of adults over age 65 are routinely screened for dementia. Many patients are not assessed until cognitive and functional impairments are obvious. While Medicare encourages cognitive assessment in annual wellness visits, diagnosis of mild cognitive impairment among Medicare beneficiaries may be as low as 8 percent of expected cases.
The launch of new therapies could trigger a surge in demand for earlier screening and diagnosis with two standard diagnostic procedures, PET imaging and analysis of cerebrospinal fluid (CSF). Repeated tests will be necessary, first to prescribe anti-amyloid therapies, then to monitor patients for side effects and track the impact of therapies on the disease. In October 2023 Medicare recognized this necessity and reversed its policy that had restricted coverage of PET amyloid to one image per patient per lifetime. Other barriers remain.
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.
Looking ahead, federal policy should seize opportunities to expedite introduction of non-intrusive cognitive, neurobehavioral and laboratory tests. Key federal policies on diagnostics are now poised for change. The FDA is proposing a major overhaul in regulation of laboratory-developed tests, while CMS is proposing expedited Medicare coverage of novel medical devices but excluding these tests. Many of the most promising innovations in Alzheimer’s diagnostics are in development or already marketed as such.
New payment models will also be crucial. CMS took an important step forward in July with announcement of its Guiding an Improved Dementia Experience (GUIDE) model, a payment model to support dementia care, including support for caregivers. However, the proposed model does not include support for timely and accurate diagnosis, an exclusion that may deserve inclusion.
Researchers increasingly see Alzheimer’s disease as a complex process involving multiple pathologies of the brain, a finding reflected in the multiple targets found in the international drug development pipeline for new therapies. The steps we take now will not only enable safe and effective use of the new generation of anti-amyloid therapies but lay the groundwork for the additional therapies we hope and expect to see in the future.
Tom Hubbard is Senior Vice President of Policy Research at the Network for Excellence in Health Innovation.
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