Shortage of Cardiac Amyloidosis Radiotracers Should Ease in Late March

Why It Matters

Restoring radiotracer supply is critical for timely cardiac amyloidosis diagnosis, directly affecting patient outcomes and hospital revenue streams. Continued shortages could delay treatment initiation and strain nuclear cardiology services.

Key Takeaways

• ASNC reports radiotracer shortage easing by late March.
• Curium released PYP lot in mid‑February, HMDP due late March.
• Sun Pharmaceutical still lacks PYP, shortage persists Q2 2026.
• FDA lists both tracers on drug shortage registry.
• Clinics advised to check local pharmacies for availability.

Pulse Analysis

Cardiac amyloidosis, particularly the transthyretin (ATTR) variant, relies on technetium‑99m‑based scintigraphy for non‑invasive diagnosis. The shortage of Tc‑99m PYP and HMDP has forced many nuclear cardiology labs to postpone scans, increasing wait times and potentially delaying therapeutic decisions. Given the disease’s rapid progression, any diagnostic lag can translate into poorer prognoses and higher healthcare costs. The situation underscores the fragile nature of the radiopharmaceutical supply chain, where a single raw‑material bottleneck can ripple across the entire diagnostic ecosystem.

The current disruption traces back to a raw‑material deficit that began in January, affecting both Curium and Sun Pharmaceutical, the two primary U.S. manufacturers. Curium’s recent FDA approval of a new active‑ingredient supplier enabled a mid‑February PYP lot release and a planned HMDP shipment in late March, signaling the first tangible relief. However, Curium cautions that its Technescan PYP inventory will remain constrained while stockpiles are rebuilt. Sun Pharmaceutical, lacking any PYP inventory, anticipates its shortage persisting through at least Q2 2026, leaving a sizable gap in national capacity.

For clinicians and hospital administrators, the immediate priority is to monitor local pharmacy inventories and adjust scheduling to prioritize high‑risk patients. Longer‑term strategies may include diversifying supplier relationships, investing in on‑site cyclotron capabilities, or exploring alternative imaging agents where clinically appropriate. As the supply stabilizes, the focus should shift to reinforcing supply‑chain resilience to prevent future disruptions, ensuring that cardiac amyloidosis patients receive prompt, accurate diagnoses without unnecessary delays.