Uncertainty for Molecular Imaging, Diagnostic Radiopharmaceuticals


Regulatory questions shed uncertainty on molecular imaging and diagnostic radiopharmaceutical industry.

The past few months have placed a cloud of uncertainty over the future of health care in the United States. At the time of writing this article, Senate Republicans have failed to secure the necessary votes to pass the Better Care Reconciliation Act (BCRA). An assessment of the two failed acts, the American Healthcare Act and the BCRA is indicative of the fact that future iterations are expected to be along the same lines in terms of policy with minor changes and concessions.

Rollback of Medicaid expansion will continue to remain a key priority and the phased replacement of Medicaid expansion with state-wise lump sum payments will result in millions of Americans losing their health insurance. This coupled with continued Medicare cuts, and greater leeway given to insurers in deciding premiums will further contribute to a significant reduction in the insured population over a period of time. With the delay of Bundled Payments till 2018-which include bundles for acute myocardial infarction and coronary artery bypass graft coupled with an unlikely, but possible shift away from value-based models in favor of older fee-for-service models-participants across the entire health care value chain have more questions than answers.[[{"type":"media","view_mode":"media_crop","fid":"61906","attributes":{"alt":"Tanvir Jaikishen","class":"media-image media-image-right","id":"media_crop_2614365240947","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"7835","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"height: 251px; width: 200px; border-width: 0px; border-style: solid; margin: 1px; float: right;","title":"Tanvir Jaikishen, Senior Research Analyst - Transformational Health, Frost & Sullivan ","typeof":"foaf:Image"}}]]

An Upward Trajectory
With greater emphasis on value-based care, in which reimbursement is tied to quality of care provision and improved patient outcomes, clinicians are increasingly justifying the use of molecular imaging to ensure more accurate disease diagnosis and staging, as well as better assess efficacy of current treatment protocols. Frost & Sullivan estimates that currently, 95% of PET scans use Flurodeoxyglucose (FDG) for oncology and about 90% of SPECT scans use Technetium 99m (Tc-99m) for cardiology screening. However, newly approved PET and SPECT radiopharmaceuticals coupled with several more in various developmental stages are pushing molecular imaging into new clinical areas such as neurology and orthopedics.

PET scans are increasingly used for earlier detection and better understanding of neurodegenerative diseases like Alzheimer’s Diseases. Likewise, new PET radiopharmaceuticals are also being applied for better myocardial perfusion imaging. Radiopharmaceuticals such as Axumin and Ga-68 NETSPOT are used for more precise detection of recurrent prostate cancer and neuroendocrine tumors, respectively, when compared to FDG. Frost & Sullivan estimates that over the next five to seven years, only 80% of PET scans will continue to use FDG, while only 75% of SPECT scans will use Tc-99m, the rest being taken up by new radiopharmaceuticals.

PET/CT and SPECT/CT technologies have also made significant leaps in terms of technology over the last few years. Both PET and SPECT have seen tremendous improvements in quantitation accuracy, with market participants developing software to help reduce scan times, lower dosage, and improve efficiency without compromising on image clarity. The question, however, is whether molecular imaging will continue to thrive in an uncertain future.

Resilience in Face of Uncertainty
Despite the possibility of tremendous change in the U.S. health care landscape, molecular imaging has and will continue to cement its place as an essential requirement towards both research and improving quality of care provision. Taking into account affordability of the end user, molecular imaging original equipment manufacturers (OEMs) have emphasized upgradeability and modularity of design. Customers with limited budgets can purchase SPECT/CT and PET/CT platforms with low CT slice count, for example, 16 slice and then upgrade in-field based on future requirements and availability of funding. OEMs have also developed small footprint, mobile platforms with a focus on smaller care providers such as small imaging centers to increase adoption of molecular imaging modalities.

The launch of the Biograph Horizon Flow Edition PET/CT by Siemens Healthineers is illustrative of this industry-wide strategy. The launch of cadmium zinc telluride (CZT) SPECT by GE Healthcare, which represents a significant upgrade from the sodium iodide (NaI) camera, is also indicative of the improvements in molecular imaging technology. The NM CT 670 CZT SPECT/CT can be used for simultaneous visualization of physiological and anatomical functions and will play a crucial role in research and care provision.

Launch of new radiopharmaceuticals are also playing a key role in expanding the adoption of molecular imaging. Radiopharmaceuticals such as Amyvid are increasingly used for research into and detection of neurodegenerative diseases. New oncology radiopharmaceuticals such as Axumin and Ga-68 NETSPOT are used for more accurate tumor diagnosis and staging, while cardiology radiopharmaceuticals such as N-13 and Flurpiridaz F-18 (currently under clinical trials) offer highly accurate myocardial perfusion imaging. These new radiopharmaceuticals, among others, provide high quality images that remain unmatched when compared to those produced from premium CT and MRI modalities. New radiopharmaceuticals also play a critical role in better understanding how diseases are caused, how they can be better managed or treated and enable more robust and quicker assessment of efficacy of new drugs and treatments during the clinical trial process.

Should a new health care act along the lines of the BCRA become law, it is certain that many Americans will lose their health insurance. However, with 10,000 Americans qualifying for Medicare every day, molecular imaging will play a key role in managing a range of cardiovascular, neurodegenerative, and musculoskeletal diseases and tumors that are common among the aging population. With the CMS increasingly approving the reimbursement of PET and SPECT procedures as well as use of new radiopharmaceuticals, the industry is confident that both payors and providers will continue to reward efforts to develop better technologies and radiopharmaceuticals. In the eventuality, however remote, that the United States shifts to a single payor Medicare-for-all model, molecular imaging will continue to thrive.

Given that the number of PET and SPECT scans continues to increase each year in European countries following a single payor model, it is safe to assume that molecular imaging has the capacity to adapt to changing regulatory and reimbursement policies without major disruptions to the industry.

Regardless of the politics surrounding health care, there is a clear need to reduce overall health care spending, while continuing to improve quality of care. With an aging population and large incidence of lifestyle diseases, there is a pressing need to manage health care more efficiently across the entire provider continuum.

Molecular imaging has the potential to offer care providers a means by which diseases can be better understood, managed, and treated, thus contributing to better quality of care. As molecular imaging technologies continue to evolve and new radiopharmaceuticals continue to enter the market, PET and SPECT scans will increasingly become mandatory requirements in care protocols for different diseases. Going forward, the molecular imaging industry will continue to take a revolutionary approach to innovation as opposed to a reactionary approach, and will hence continue to thrive irrespective of a challenging regulatory environment.

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