Pharma Pulse: Medicare Price Negotiations Heat Up, as FDA Approves SMA Gene Therapy

Welcome to Pharma Pulse, a Pharmaceutical Commerce podcast where we bring you the latest insights shaping patient access, supply chain/logistics, data & tech, and healthcare innovation. I’m your host, and let’s get into today’s headlines.

• First up, a major market mover. The federal government is set to announce the newly negotiated prices for 15 high-cost drugs under Medicare. This is the second round of price negotiations authorized by the Inflation Reduction Act, or IRA. Among the medications drawing the most attention are the GLP-1 weight-loss blockbusters, Ozempic and Wegovy. These drugs, along with several high-cost treatments for cancer and diabetes, are now subject to direct negotiation between manufacturers and the Centers for Medicare & Medicaid Services. The results of this round are scheduled to take effect in 2027, and they will likely influence pricing strategies across the entire US healthcare system.
• Moving to corporate news, Novartis is planning to cut up to 550 full-time jobs at its Stein facility in Switzerland by the end of 2027. The cuts are part of a strategic shift as the Swiss pharma giant ends the production and packaging of tablets and capsules at that site.
• Lastly, a major win for patients. The FDA has approved Novartis’s gene replacement therapy, Itvisma, for a broad population of patients with spinal muscular atrophy, or SMA. Itvisma, which is a new formulation of the active ingredient in Zolgensma, is approved for children two years and older, teens, and adults with a confirmed SMN1 gene mutation. What makes this approval transformative is its administration: it is a one-time, fixed-dose injection delivered directly into the cerebrospinal fluid, offering a new, accessible route for older patients who previously had limited curative options.

That’s it for this episode of Pharma Pulse. For more insights on trends transforming pharmaceutical access and care delivery, visit pharmaceuticalcommerce.com.

Thanks for listening—until next time, stay well and stay informed.

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