SOUTH SAN FRANCISCO, Calif., May 14, 2020 /PRNewswire/ --Portola Pharmaceuticals, Inc..® (Nasdaq: PTLA) announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has proposed extending the New Technology Add-on Payment (NTAP) for Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo] through federal fiscal year 2021, for eligible Medicare beneficiaries treated in the inpatient hospital setting. Andexxa, first approved for use in the United States in May 2018, received its NTAP designation effective October 1, 2018.
The proposed rule concerning the Hospital Inpatient Prospective Payment System and CMS Fiscal Year 2021 was released on Monday, May 11, 2020 (https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-10122.pdf), and will be published in the Federal Register on May 29, 2020. Public comments on the proposal will be accepted through July 10, 2020, and CMS is expected to release the final rule on or around September 1, 2020. Finalization of the proposed continuation of NTAP status for Andexxa would go into effect on October 1, 2020.
"CMS' recommendation to extend NTAP designation aligns with our ongoing efforts and broader mission to expand access to Andexxa, the first and only FDA-approved reversal agent for the Factor Xa inhibitors rivaroxaban or apixaban," said Sheldon Koenig, Portola's chief commercial officer. "We believe the proposed extension will help broaden patient access to Andexxa in U.S. hospitals and further supports making Andexxa the standard of care for patients who experience major, life-threatening bleeds."
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.
As of October 1, 2019, the maximum NTAP reimbursement for a qualifying case involving the use of Andexxa increased to $18,281.25, or 65% of the wholesale acquisition cost of the standard dose. With publication of the final rule for extension, NTAP is expected to remain in effect at this level until the cost of Andexxa is included in the recalibration of the Medicare Severity Diagnosis-Related Group (MS-DRG) payment rates.
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Important Safety Information
The most frequently reported adverse reactions in clinical trials in healthy subjects with Andexxa were mild or moderate infusion-related reactions comprising symptoms such as flushing and feeling hot (very common), and cough, dysgeusia, and dyspnea (common). Amongst bleeding patients, commonly reported side effects were ischemic stroke and pyrexia, with uncommon reported side effects of cerebral infarction, cerebrovascular accident, transient ischemic attack, acute myocardial infarction, cardiac arrest, myocardial infarction, deep vein thrombosis, iliac artery occlusion, pulmonary embolism.
Please refer to full Prescribing Information for more information, including Boxed Warning, at www.Andexxa.com.
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a global, commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics that could significantly advance the fields of thrombosis and other hematologic conditions. The Company's first two commercialized products are Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], marketed in Europe as Ondexxya® (andexanet alfa), and Bevyxxa® (betrixaban). The company also is advancing cerdulatinib, a SYK/JAK inhibitor being developed for the treatment of hematologic cancers. Founded in 2003 in South San Francisco, California, Portola has operations in the United States and Europe.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, including statements relating to Portola Pharmaceuticals' expectations regarding the potential commercial and medical impact of receiving the NTAP for Andexxa. Risks that contribute to the uncertain nature of the forward-looking statements include: the final rule by CMS regarding NTAP extension, the risk that physicians, patients and payers may not see the benefits of utilizing Andexxa for the indications for which it is approved; our ability to continue to manufacture our products and to expand approved manufacturing facilities; the possibility of unfavorable results from additional clinical trials or other studies involving Andexxa; our ability to grow our commercial operations in the EU and generate product revenue within projected timelines and budget; the risk that we may not obtain additional regulatory approvals necessary to expand approved indications for Andexxa; our expectation that we will incur losses for the foreseeable future and will need additional funds to finance our operations; the accuracy of our estimates regarding expenses and capital requirements; our ability to successfully build a hospital-based sales force and commercial infrastructure; our ability to obtain and maintain intellectual property protection for our product candidates; and our ability to retain key scientific or management personnel and general market conditions. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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