Healthcare Industry News: AndexXa
News Release - April 7, 2020
Portola Pharmaceuticals Announces the Establishment of a Permanent J-code for Andexxa by the Centers for Medicare & Medicaid Services, Effective July 1, 2020SOUTH SAN FRANCISCO, Calif., April 7, 2020 -- (Healthcare Sales & Marketing Network) -- Portola Pharmaceuticals, Inc.® (NASDAQ: PTLA) today announced that the Centers for Medicare & Medicaid Services (CMS) established a new permanent J-code for AndexXa® [coagulation factor Xa (recombinant), inactivated-zhzo] facilitating reimbursement in the hospital outpatient setting. The code, J7169 (Injection, coagulation factor Xa (recombinant), inactivated-zhzo (AndexXa), 10 mg), published online in the Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Decisions (page 41), will take effect on July 1, 2020 and it is expected to replace the previously issued temporary C-code.
"The J-code is specific to AndexXa and will serve as the permanent code for use of AndexXa in the hospital outpatient setting," said Sheldon Koenig, Portola's executive vice president and chief commercial officer. "Treating patients in emergency rooms before transporting them to another institution is a common practice, particularly in the setting of hemorrhagic stroke where 35% of patients are transferred for further treatment. This J-code brings us a step closer to ensuring greater patient access by providing hospitals with a clearer reimbursement pathway when administering AndexXa in this setting and will support our efforts to increase utilization in existing and new hospital accounts."
With the J-code taking effect in July, all hospital outpatient departments and freestanding emergency facilities in the United States will have one consistent HCPCS code to standardize the submission and payment of AndexXa insurance claims across Medicare, Medicare Advantage, Medicaid and commercial plans. The reimbursement rate under the J-code is expected to mirror the calculation under the current C-code.
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, statements regarding patient access to AndexXa, the effect of the J-code on drug utilization and the expected reimbursement rate under the J-code. Risks that contribute to the uncertain nature of the forward-looking statements include: reimbursement rates under the J-code, 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 annual report on Form 10-K. 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.
Source: Portola Pharmaceuticals
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