Berlin and Würzburg, Germany, November 4, 2024 – Pentixapharm, a biopharmaceutical company developing innovative first-in-class radiopharmaceuticals, welcomes the recent announcement by the U.S. Centers for Medicare & Medicaid Services (CMS) to implement separate payments for specialized diagnostic radiopharmaceuticals used in the hospital outpatient setting, extending beyond the transitional pass-through payment period. This significant policy shift could have a direct impact on future reimbursement streams for Pentixapharm’s Ga68-PentixaFor, a diagnostic radiopharmaceutical for which Pentixapharm intends to start a U.S. centric phase III clinical trial next year. The pivotal clinical trial could lead to a U.S. market authorization in primary aldosteronism (PA), one of the major causes of secondary hypertension, as early as 2028.

The CMS pass-through payment period is a temporary reimbursement mechanism under the Hospital Outpatient Prospective Payment System (OPPS). Lasting up to three years, this period provides additional payments for newly introduced medical devices, drugs, and biologicals, encouraging hospitals to adopt cutting-edge technologies by covering their costs beyond standard rates. However, under previous policies, after the pass-through period ended, products would typically revert to standard OPPS payment bundles. With this new policy announcement, CMS has changed this approach, allowing for separate payments beyond the pass-through period for qualifying high-cost diagnostics.

This decision by CMS is highly significant given the size and impact of the Medicare and Medicaid systems, which together insure more than 140 million Americans. As the primary healthcare payer for older adults and individuals with disabilities, CMS’s reimbursement policies shape access to medical innovations across the country. The new rule, effective in 2025, also has the potential to set a market precedent that may influence private insurers to follow CMS’s lead in reimbursing innovative diagnostic tools, further expanding the accessibility of these advanced diagnostics. By providing consistent reimbursement for diagnostic radiopharmaceuticals that exceed a per-day cost threshold of US$630, CMS encourages other insurers to consider similar reimbursement strategies.

The separate payment rule will most likely apply to Pentixapharm's lead diagnostic compound, Ga68-PentixaFor, following its anticipated approval and the expiration of its pass-through status. Ga68-PentixaFor is a novel tracer for positron emission tomography (PET) imaging used to detect aldosterone-hypersecreting adenomas in patients diagnosed with primary Aldosteronism (PA). With rising prevalence rates for PA, now exceeding 20% in some populations with resistant hypertension, the need for accessible and precise diagnostics is greater than ever.

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

PentixaFor (Gallium (⁶⁸Ga) boclatixafortide) is an innovative PET tracer that specifically targets the chemokine-4 receptor (CXCR4), with broad applications in oncological, cardiovascular, and inflammatory diseases. Particularly in hypertension, PentixaFor has the potential to significantly improve patient management by identifying the presence of hormone-secreting adenomas through non-invasive and broadly available PET/CT imaging.

Apart from PentixaFor, the clinical pipeline also encompasses PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL). Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Recently, the EMA granted PRIME status to PentixaFor in the indication PA.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations

Tel.