SOUTH SAN FRANCISCO, Calif.,
April 7, 2020 /PRNewswire/
-- 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.
About ANDEXXA
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.
Forward-Looking Statements
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.
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SOURCE Portola Pharmaceuticals, Inc.®