Blue Cross Blue Shield Expands Coverage for HistoSonics’ Liver Tumor Treatment

Highmark Blue Cross Blue Shield has granted insurance coverage to more liver tumor histotripsy patients.

The health insurance behemoth recently issued four new positive medical policy decisions for the use of HistoSonics’ Edison Histotripsy System in treating liver tumors. The decision expands insurance coverage across Highmark’s commercial plans across four states including New York, Delaware, Pennsylvania, and West Virginia, broadening access to HistoSonics’ non-invasive therapy for approximately 7 million members.

The Edison Histotripsy System, which received FDA De Novo clearance in October 2023, uses non-invasive focused ultrasound energy to mechanically destroy and liquefy targeted tissue and tumors at a sub-cellular level and without the invasiveness or toxicity of traditional procedures. To date, almost 2,000 patients have been treated with histotripsy at more than 50 U.S. medical centers and others in the United Arab Emierates and Hong Kong. Clinical data, including outcomes from the #HOPE4LIVER trial, have demonstrated a 90% local tumor control rate at 12 months across all tumor types treated, comparing favorably to existing therapies and setting a strong precedent for continued payer adoption.

“This expanded Highmark coverage marks another critical step in delivering histotripsy to more patients who urgently need safe, non-invasive options,” HistoSonics President/CEO Mike Blue stated. “Highmark’s decision not only reinforces the clinical value of our technology but also helps establish broader payer confidence as we continue working to expand access nationwide.”

Highmark’s decision to cover histotripsy, effective July 1, 2024, joins a growing list of commercial insurers recognizing histotripsy’s safety and efficacy, following earlier coverage from Blue Cross Blue Shield of Michigan. In addition, the United Network for Organ Sharing (UNOS) recognizes histotripsy as an approved loco-regional therapy option for patients awaiting liver transplantation.

The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete ablation of unresectable liver tumors using histotripsy. The U.S. Food and Drug Administration has not evaluated the Edison System for treating any specific disease, including cancer, nor has it assessed outcomes such as local tumor control, five-year survival, or overall survival.

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel action mechanism that uses focused ultrasound to mechanically destroy and liquefy unwanted tissue and tumors. The company is currently focused on commercializing the Edison System in the United States and select global markets for liver treatment while expanding histotripsy applications into other organs such as kidney, pancreas, and prostate. HistoSonics maintains offices in Ann Arbor, Mich.; and Minneapolis, MN.