Lantheus expects sales of ‘blockbuster’ cancer imaging agent to surpass $1B in 2024
Drugmaker Lantheus on Monday said it expects sales of its imaging agent Pylarify to surpass $1 billion in 2024.
The product is a targeted PET agent for pinpointing suspected metastasis or recurrence of prostate cancer. Approved by the U.S. Food and Drug Administration in 2021, Lantheus sees enormous potential for Pylarify in 2025.
Its announcement comes after Medicare recently finalized new regulations related to delivering such radiopharmaceuticals in hospital outpatient settings. Previously, the federal program packaged payment for products such as Pylarify together with the imaging procedure. But now, Medicare will issue separate reimbursement for radiopharmaceuticals with a per-day cost greater than $630.
This change will enable diagnostic agents to be paid separately for traditional fee-for-service Medicare beneficiaries in hospital outpatient settings beginning Jan. 1.
“[Lantheus] continues to commend CMS for recognizing the value of and ensuring broad patient access to specialized diagnostic radiopharmaceuticals,” the North Billerica, Massachusetts-based company said in a Nov. 11 announcement. “With Pylarify (piflufolastat F 18) on track to exceed $1 billion in sales in 2024, Lantheus reaffirms its 2025 outlook for Pylarify as a blockbuster brand that will continue to be the clear standard and #1 ordered PSMA PET imaging agent in the U.S.”
Blue Earth Diagnostics, part of the larger Bracco Company, also praised the policy change on Nov. 4. It noted that affected agents will include Posluma (which will maintain its current pass-through status until Sept. 30, 2026) and Axumin (which lost such status in 2020 but will regain separate payment under the policy change).
“This rule corrects a significant reimbursement gap that previously hampered the adoption of innovative radiopharmaceutical products, and patient access,” Terri Wilson, president of Oxford, United Kingdom-headquartered Blue Earth Diagnostics, said in a statement. “Although the updated payment methodology provides for separate payment for diagnostic radiopharmaceuticals, payment will differ for pass-through and non-pass-through diagnostic radiopharmaceuticals,” she added later. “Our field reimbursement team continues to work with hospitals to ensure they understand the new rule and its implications.”
Melbourne, Australia-based Telix also highlighted the Medicare policy change on Nov. 4. The company said the new separate payment rule will impact its imaging agent Illuccix after its pass-through status expires July 1. It also will apply to Telix’s pipeline of investigational diagnostic imaging agents, which include TLX007-CDx, a new product for PSMA imaging of prostate cancer; TLX250-CDx (Zircaix) for kidney cancer imaging; and TLX101-CDx (Pixclara) for brain cancer (glioma) imaging (if approved and reimbursed under CMS, and after pass-through expires).
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.