This guidance will hopefully reduce the requirements without comprising patient safety.
#Netspot radiopharmaceutical full#
Additionally the guidance helps sponsors facilitate timely conduct of clinical trials, reducing the use of animals, use of drug development resources, and provides recommendations for a pathway to full drug development for microdose RP diagnostic drugs. It reduces or eliminates additional toxicology requirements, and clarifies other non-clinical requirements for microdose diagnostic RPs for Phase 1–3 studies. The US FDA Diagnostic Guidance, Microdose Radiopharmaceutical (RP) Diagnostic Drugs: Nonclinical Study Recommendations (Microdose Radiopharmaceutical Diagnostic Drugs, n.d), intends to refine nonclinical study recommendations for diagnostic RP drugs given its unique characteristics which include microdosing and single or infrequent clinical use. What are the new non-clinical guidance documents recently developed in the US? We here summarize these recent documents from both the US and European perspective. The US and the European Union appear to be moving in a similar direction focussing and refining preclinical safety data requirements for both radiodiagnostics and radiotherapeutics. Take five-minutes, write to your lawmakers, and urge them to support this important legislation.New regulatory guidance documents from the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recently been finalized or are in draft format outlining new pathways for preclinical safety testing. You can quickly and easily send a letter to Congress by visiting the Right Scan Right Time website. 3772, the Medicare Diagnostic Radiopharmaceutical Payment Equity Act, which would reform the Medicare payment system to ensure that hospitals are appropriately paid when providing advanced nuclear imaging services.Ĭhange can happen, but we all need to speak up for Congress to fully understand what is at stake. How You Can Get InvolvedĬongress can fix this issue and protect access to these precision diagnostics by passing H.R. From a cost perspective, too, earlier diagnosis can shorten the length and depth of treatment, resulting in lower overall costs. Of course, when talking about conditions such as cancer, early diagnosis and appropriate treatment are crucial for improving patient outcomes. America’s patients deserve a health care system that supports and encourages access to innovative imaging techniques.” Diagnostic tests that are less accurate can lead to less optimal treatment decisions. “When it comes at the expense of patients like me who face life-threatening diseases, we have a problem that needs to be fixed. As he acknowledges, most Americans are not in this position. When he was diagnosed with a pancreatic neuroendocrine tumor in 2007, he was fortunate enough to have the resources to be able to travel and pay for innovative diagnostic imaging. Josh Mailman wrote about this issue in a piece for The Hill. The result is that healthcare providers– who are already financially strapped due to the COVID-19 pandemic–are forced to make the choice of taking a financial loss or stop offering the procedure, even though the less expensive alternatives may not provide the needed diagnosis.Īs a result, patients are losing access to these imaging procedures, which may be vital for diagnosis, treatment planning and maintaining their health. At the end of the “pass-through” period, Medicare then “packages” them with the older, lower cost radiopharmaceuticals and the procedure costs. Initially, Medicare separately reimburses hospitals for the new radiopharmaceuticals. Pass-through status is a transitional period of two to three years during which CMS allows for separate payment of diagnostic radiopharmaceuticals. What is Pass-Through Status and Why Does it Matter? Let’s take a closer look at pass-through status and how you can get involved. Precision radiopharmaceutical diagnostic imaging procedures help identify abnormalities early in the progress of a disease -before many medical problems are apparent with other diagnostic tests.ĭespite the proven effectiveness of radiopharmaceuticals, such as Axumin and NETSPOT, countless patients are limited in their access because of Medicare’s flawed payment system.Ĭhanges to pass-through status will result in patients who are unable to access these advanced diagnostic procedures.
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