Portola Pharmaceutical's (NASDAQ:PTLA) andexanet alfa for factor Xa inhibitor anticoagulation reversal, faces high pricing hurdles, yet unmet need supports low-quantity purchasing, experts said. Lack of a specific factor Xa inhibitor standard of care (SOC) supports first-line use, however, one expert added that prothrombin complex concentrate (PCC)’s affordability may hinder first-line potential.
Andexanet alfa is a recombinant, modified factor Xa molecule developed as an antidote for patients anticoagulated with an oral or injectable factor Xa inhibitor, experiencing serious uncontrolled bleeding, or requiring emergent surgery, according to Portola’s website.
On 5 February, this new service reported promising FDA approval prospects following Phase III efficacy demonstration, whilst a complete patient response and no thrombotic events supports uptake. Andexanet alfa’s PDUFA date is 17 August, according to a Portola press release.
Expense is the largest reimbursement hurdle andexanet alfa will likely face, and the product will probably cost in excess of USD 7,500-USD 8,000 per one-off application, said Norman Smith, president, Viewpoint Consulting, Langhorne, Pennsylvania.