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Gross-to-Net Bubble Update: 2023 Pricing Realities at 10 Top Drugmakers

Drug Channels

It’s time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. These data remain inconvenient for drug pricing flat earthers (#DPFE): When rebates and discounts were factored in, brand-name drug prices again declined—or grew slowly—in 2023.

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Navigating 340B Program Changes in 2025

Proxsys Rx

billion annually because of these restrictions, as drug companies limit 340B discounts on medications purchased through contract pharmacies. billion in 340B savings is at risk, due to increasing limitations imposed by pharmaceutical manufacturers which could further strain the healthcare safety net and patient care services.

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CMS Issues Proposed Rule on the Medicare Part B and Part D Inflation Rebate Program; HPM Issues Detailed Summary

FDA Law Blog: Biosimilars

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. On July 31, 2024, CMS published a proposed rule to codify its guidances, with some changes.

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The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

FDA Law Blog: Biosimilars

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

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January 2025 Newsletter

Safe Biologics

This expansion continues a flawed policy that threatens innovation and jeopardizes patient access to critical treatments, including drugs vital for cancer treatment and popular new weight loss medications that have transformed the management of obesity and related conditions. What Will 2025 Mean for Medicare Drug Price Setting Under the IRA?