Portola Pharmaceuticals, Inc.® (NASDAQ:PTLA) today announced the presentation of new data demonstrating that using Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo] to treat patients with intracranial hemorrhage (ICH) associated with the oral Factor Xa inhibitors apixaban or rivaroxaban is projected to provide a net reduction in costs to an acute care hospital. The data was presented by John Fanikos, B.Pharm., M.B.A., executive director of pharmacy services at Brigham and Women's Hospital, Boston, in a poster session at the Emergencies in Medicine Meeting, which is taking place March 1-6 in Park City, Utah.
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"This model, and the projected cost savings with Andexxa compared to 4F-PCC outlined in our study, is important to share among hospital pharmacists and administrators," said Mr. Fanikos. "The findings demonstrate that healthcare providers can focus on FDA-approved indications for use, clinical evidence and society guidelines when providing care to patients rather than the cost of treatment."
The analysis compared a clinical scenario with Andexxa – the first and only antidote approved by the U.S. Food and Drug Administration (FDA) for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding – to one without it where patients were given 4-Factor Prothrombin Complex Concentrate (4F-PCC), which is only approved for the reversal of warfarin and has no impact on anti-Factor Xa levels. Key findings from this analysis related to the net cost reduction Andexxa can provide for the treatment of ICH associated with oral Factor Xa inhibitors include:
The total cost per hospitalization, considering new technology add-on payment (NTAP) reimbursement for eligible claims, was $49,291 for patients treated with Andexxa and $54,699 for patients treated with 4F-PCC – demonstrating a cost reduction of $5,408 with the use of Andexxa. As a result, the analysis projected a potential total annual cost reduction of $259,608 for a hospital treating 48 of these patients per year with Andexxa in place of 4F-PCC.
Andexxa generated reductions in all cost components – intubation, intensive care unit (ICU) and surgery costs – except drug costs, though drug costs were offset by the NTAP reimbursement.
The projected net cost reduction related to the use of Andexxa over three years totaled $392,652, assuming a proportional share of 4F-PCC use (based initially on current utilization in clinical practice).
Based on previously published clinical evidence, the model assumes a lower risk of hematoma expansion and surgery in patients treated with Andexxa compared to patients treated with 4F-PCC. The model also considered the NTAP reimbursement available for Andexxa, a CMS designation enabling hospitals to recoup up to 65% of the cost of the drug when applied successfully.
"This analysis supports two of our key initiatives. First, it is part of the comprehensive educational strategy we have developed to demonstrate the unique value of Andexxa compared to 4F-PCC. Second, it provides additional data underscoring the importance of utilizing the NTAP reimbursement, which we can leverage in our ongoing work to support U.S. hospitals in their efforts to streamline and secure reimbursement," said Rajiv Patni, M.D., Portola's chief medical officer. "We look forward to building on this evidence with additional clinical and economic presentations and publications throughout the year, including new data on the potential effect of Andexxa versus 4F-PCC on 30-day mortality at the upcoming American College of Cardiology Annual Scientific Session/World Congress of Cardiology."
In addition to the poster presented by Mr. Fanikos, three additional Portola-sponsored posters were presented at the Emergencies in Medicine Meeting. These retrospective studies demonstrated that (1) the use of 4F-PCC in gastrointestinal bleeding associated with oral Factor Xa inhibitors led to similar lengths of stay and readmission costs, along with a doubling of costs of the index hospital treatment and stay compared to patients not managed with 4F-PCC; (2) the use of 4F-PCC in trauma cases associated with oral Factor Xa inhibitors is associated with a high length of stay and burden for hospitals; and (3) the healthcare economic burden associated with the treatment of major bleeding events associated with oral factor Xa inhibitors is substantial.