15 December 2012. The quest for health insurance coverage of brain amyloid scanning just took a twist. On 13 December 2012, the Centers for Medicare and Medicaid Services (CMS), the government agency that administers the Medicare program, proposed lifting a nationwide exclusion on coverage of new positron emission tomography (PET) tracers, but only for agents used in oncology. The CMS will continue to exclude coverage of other new PET ligands, including amyloid imaging agents. Most private payers follow CMS’ lead. The CMS decided to defer a decision on amyloid agents until next July.
A petition brought last July by the Medical Imaging and Technology Alliance, which lobbies on behalf of the industry, asked CMS to lift the national non-coverage language from its National Coverage Determination Manual, and instead allow decisions to be made at a local level (see ARF related news story and CMS National Coverage Analysis). Some saw this request as an attempted end-run around a national policy. This now looks likely to succeed for oncology radioligands. CMS requests public comments on the proposed change and expects to make a final decision on 11 January 2013.
The ruling leaves the future of β amyloid imaging agents dependent on a second petition that was submitted by Eli Lilly and Company last October. Lilly asked CMS to specifically consider covering β amyloid imaging agents for use in diagnosing dementia. Lilly’s radiotracer Amyvid® received FDA approval last April (see ARF related news story), and similar tracers under development are expected to follow suit (see ARF related news story). However, without insurance coverage these tracers may see limited clinical use because of the expense, which can run from $3,000 to $6,000 for one scan. In response to the request, CMS opened a National Coverage Analysis of the issue. The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) comprises independent clinicians and researchers, and advises CMS on a regular basis. This group will meet on 30 January 2013 to vote on whether there is sufficient evidence that PET imaging of brain β amyloid improves health outcomes in patients. The committee’s input will advise CMS but will not determine the final decision, which will be made in July 2013.
What factors will likely influence CMS’ ruling? The key question for insurers is whether new diagnostic tests improve patient care, according to a white paper released 12 December 2012 by The Institute for Clinical and Economic Review (ICER), an academic research group based at Massachusetts General Hospital’s Institute for Technology Assessment, Boston (see press release). ICER independently assesses the value and clinical benefit of various healthcare interventions. In its report, ICER reviewed published evidence on the diagnostic use of AD biomarkers in general, including amyloid imaging agents. Its analysis found that very few studies examined whether biomarker use actually improves AD diagnosis. No study asked whether patients do better as a result. That is where the rubber hits the road for insurers. The issue may soon become pressing, as amyloid imaging will likely be only the first AD biomarker to move into the clinic. The report recommends that researchers should use randomized controlled trials to evaluate the effect of potential diagnostic tests on treatment in order to provide a basis for insurance coverage decisions. ICER president Steven Pearson will present the findings at the 30 January 2013 CMS meeting to provide background information for the MEDCAC committee, but will not make any recommendations.
According to the ICER white paper, evidence that a diagnostic test works can be viewed at six levels (see also Fryback and Thornbury, 1991). The first two ask if tests are technically reliable and accurate. Most studies of AD biomarkers focus on these criteria. At levels three and four, researchers look at whether the test affects a clinician’s diagnosis and plan of treatment, respectively. To date, only five AD studies have measured whether biomarkers change physicians’ diagnoses, ICER found. Level five evidence looks at changes in patient health as a result of the test, while level six examines the cost effectiveness of diagnostic testing to society. No AD studies have yet touched on these last two. Insurers pay most attention to level five and six data, but look at level three and four as well, the report noted.
Of the five level-three AD studies, only one examined amyloid imaging. Commissioned by Lilly, the study is ongoing and unpublished, but has reported interim results. As described in the white paper, more than 200 patients at 19 sites received Amyvid PET scans. These scans led physicians to change their diagnosis about half the time, and to alter their proposed treatment plan about 85 percent of the time. Alterations included canceling plans for further diagnostic testing, as well as changing drug prescriptions. Two other level-three studies found that clinicians changed their diagnoses from 10 to 16 percent of the time after viewing cerebrospinal fluid biomarker data or FDG-PET data, respectively (see Kester et al., 2010; Foster et al., 2007). The remaining two measured only the change in clinicians’ confidence in their diagnoses after seeing various types of imaging data (see Heckemann et al., 2008; Raji et al., 2010).
The ICER paper recommends that more studies gather information on how diagnostic results affect physicians’ decisions. Direct examination of long-term patient outcomes may not always be feasible because of the length of follow-up needed and the cost, but changes in treatment plans can link diagnostic tests to the likelihood of patient benefits, Pearson told Alzforum. For example, a biomarker test that clearly indicated AD might allow patients to skip additional costly brain scans or lumbar punctures. A test that ruled out AD could keep patients off unnecessary medications, such as cholinesterase inhibitors or memantine. A negative AD diagnostic might also lead to further testing that could reveal a treatable condition, such as normal pressure hydrocephalus. All of these would be positive outcomes for patients, noted Dan Ollendorf, ICER chief review officer. This kind of information would be useful to insurers in deciding whether to cover a diagnostic.
The white paper also suggests that future drug trials collect data on potential biomarkers that may prove cheaper, less invasive, or more accessible than current “gold standard” biomarkers. For example, blood-based biomarkers or tests of early AD-related visual impairment (see, e.g., ARF related news story) might be preferable to brain imaging and cerebrospinal fluid measures for widespread clinical use, Ollendorf said. This would represent emerging technology, as no plasma or visual diagnostic tests have yet been validated for AD.
Will academic researchers adopt these recommendations? Pearson sees some encouraging signs. To develop the white paper, ICER convened a 22-member policy development group comprising clinicians, researchers, and patient advocates, as well as representatives from insurance groups and manufacturers of medical equipment and supplies. The list includes many researchers involved in the three large AD prevention initiatives (see ARF related news story). The dialogue helped researchers and insurers better understand each other’s perspectives, Pearson said. “[These groups] want to work together to make sure we get better evidence on diagnostics going forward,” he said. Group members are disseminating what they learned by participating in meetings and panels, he added. The Amyloid Imaging Task Force assembled by the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging is also considering how amyloid imaging technology can be best used in clinical practice (see ARF related news story).––Madolyn Bowman Rogers.