American Patients First

In this week's Healthcare HotShots, I get in the wayback machine and revisit May 2018 to look at President Trump's American Patients First blueprint to see if I can figure out what a second Trump Administration might do to lower prescription drug costs.

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Bridging the Gap: The Long Road from FDA Approval to Medicare Coverage

A new study published in JAMA Health Forum reveals that the road to Medicare coverage for novel medical technologies is a long and winding one. Researchers found that only 44% of innovative devices and diagnostics approved by the FDA from 2016-2019 had even “nominal” Medicare coverage by 2022. This data highlights major hurdles in the system that delay patient access to beneficial emerging technologies. About the Research The study examined 281 novel products cleared through the FDA from 2016-2019 via the high-risk premarket approval, de novo, and breakthrough 510(k) pathways. These included things like groundbreaking diagnostic tests, implantable devices, and other innovative treatment technologies. The goal was to measure how long it took to establish national or regional Medicare coverage policies for these newly approved products. This is important because Medicare coverage is required before hospitals, physicians and patients can reliably access new technologies. Key Findings The

The Problem of Limited-Supply Agreements for Medicare Price Negotiation

A recent JAMA Viewpoint article discusses how limited-supply agreements between brand name and generic drug makers could impact Medicare price negotiation under the Inflation Reduction Act (IRA). These agreements allow brand manufacturers to maintain some market exclusivity by limiting the supply of generic competitors. The article suggests these deals may increase as the Centers for Medicare and Medicaid Services (CMS) implements the IRA's price negotiation provisions. From a business perspective, it's understandable why brand manufacturers might find limited-supply agreements preferable to having their drugs subject to Medicare negotiation. Maintaining even partial exclusivity is likely better for revenue than triggering government-dictated price reductions. However, policymakers and patients are increasingly concerned that these deals keep prices high despite generic availability. The use of limited supply agreements could also produce unintended consequences. Balancing som

FDA Pilot Program for Certain In Vitro Diagnostic Tests

The U.S. Food and Drug Administration (FDA) has announced a pilot program designed to improve oncology patient care by establishing minimum performance standards for in vitro diagnostic tests (IVDTs) used with a limited number of oncology drug products. An IVDT is a device that provides critical information for the safe and effective use of a therapeutic product. The FDA typically requires a companion diagnostic to receive marketing authorization concurrently with the approval of the corresponding therapeutic product. However, in cases where no satisfactory alternative treatment exists for a serious or life-threatening condition, the FDA may approve a therapeutic product even without a companion IVDT. Currently, laboratory developed tests (LDTs) are being used in such cases, and the FDA exercises enforcement discretion regarding these tests. The pilot program aims to improve drug selection and patient care by establishing minimum performance characteristics for certain LDTs used in id

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