OncoSil Medical has moved to secure a Medicare reimbursement pathway for its targeted internal radiation device in the United States, following the Food and Drug Administration’s humanitarian approval of the treatment for a rare and difficult-to-treat form of bile duct cancer.
The ASX-listed company said it submitted an application to the US Centers for Medicare and Medicaid Services on 1 September seeking Transitional Pass Through payment status for OncoSil in unresectable, non-metastatic distal cholangiocarcinoma.
The application proposes a payment of US$55,000 for each dose of the device. OncoSil expects CMS to decide by 1 January 2027, with any approval intended to take effect from that date.
The company says Transitional Pass Through status would provide separate, supplemental Medicare reimbursement for up to three years after launch. This would sit above ordinary procedure payments and is intended to reduce the financial barrier for hospitals considering early adoption of the device.
OncoSil’s immediate commercial focus is likely to be academic medical centres participating in a mandatory FDA post-approval study. The study is expected to enrol 30 patients across five centres and will monitor patients for about 24 months after the final enrolment. OncoSil said it will engage with the FDA after completion of enrolment in the 30-patient study.
FDA approval was granted under the Humanitarian Device Exemption pathway on 14 August for use of OncoSil in patients with unresectable, non-metastatic distal cholangiocarcinoma as an addition to systemic therapy. The exemption is designed for devices aimed at relatively small patient populations and requires post-approval evidence collection.
OncoSil uses phosphorus 32 microparticles to deliver beta radiation directly into tumour tissue. The company argues that the approach can provide a high radiation dose within the tumour while limiting exposure to surrounding organs.
Chief executive Nigel Lange described the reimbursement application as the next critical step in the company’s US commercialisation strategy.
“Securing TPT status would give academic medical centres the reimbursement certainty they require to bring OncoSil to patients with dCCA quickly and lays the foundation for broader US payer coverage as we scale,” he said.
