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.
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,
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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SOURCE Portola Pharmaceuticals, Inc.®