Portola Pharmaceuticals issued the following announcement on Aug. 3.
Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], 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.
In the final rule concerning the Hospital Inpatient Prospective Payment System and CMS Fiscal Year 2019 (scheduled for publication in the Federal Register on August 17, 2018), CMS states that Andexxa meets all criteria for approval for new technology add-on payments. Additional information on the CMS final rule and its discussion of NTAP and Andexxa can be found on pages 783-806 of the pre-publication on the Federal Register.
“We are pleased that CMS has recognized the breakthrough innovation of Andexxa and the substantial clinical value of rapidly reversing the anticoagulating effects of the Factor Xa inhibitors. rivaroxaban and apixaban, in the event of life-threatening or uncontrolled bleeding,” said John T. Curnutte, M.D., Ph.D., interim co-president of Portola and head of research and development. “The establishment of a NTAP for Andexxa is an important decision for a very vulnerable patient population, as it both broadens Medicare beneficiary access to Andexxa, and supports the hospitals who are incorporating this important therapy into their treatment protocols.”
Introduced in 2001, the CMS NTAP program was created by Congress to support timely access to innovative therapies used to treat Medicare beneficiaries in the hospital inpatient setting. For a new technology to qualify for an add-on payment, it must meet the NTAP definition of “new,” demonstrate a substantial clinical improvement and meet specific cost thresholds.
Effective for the Fiscal Year 2019 starting October 1, 2018, the maximum NTAP for a case involving the use of Andexxa is $14,062.50, or 50 percent of the wholesale acquisition cost of the standard dose. NTAP is expected to remain in effect for a period of two to three years until the cost of Andexxa is included in the recalibration of the DRG payment rates.
Original source can be found here.
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