SOUTH SAN FRANCISCO, Calif.,
March 5, 2020 /PRNewswire/
-- Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA)
today announced the presentation of new data demonstrating that
using Andexxa® [coagulation factor Xa (recombinant),
inactivated-zhzo] to treat patients with intracranial hemorrhage
(ICH) associated with the oral Factor Xa inhibitors apixaban or
rivaroxaban is projected to provide a net reduction in costs to an
acute care hospital. The data was presented by John Fanikos, B.Pharm., M.B.A., executive
director of pharmacy services at Brigham and Women's Hospital,
Boston, in a poster session at the
Emergencies in Medicine Meeting, which is taking place March 1-6 in Park City,
Utah.
"This model, and the projected cost savings with Andexxa
compared to 4F-PCC outlined in our study, is important to share
among hospital pharmacists and administrators," said Mr. Fanikos.
"The findings demonstrate that healthcare providers can focus on
FDA-approved indications for use, clinical evidence and society
guidelines when providing care to patients rather than the cost of
treatment."
The analysis compared a clinical scenario with Andexxa – 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 – to one without it where
patients were given 4-Factor Prothrombin Complex Concentrate
(4F-PCC), which is only approved for the reversal of warfarin and
has no impact on anti-Factor Xa levels. Key findings from this
analysis related to the net cost reduction Andexxa can provide for
the treatment of ICH associated with oral Factor Xa inhibitors
include:
- The total cost per hospitalization, considering new technology
add-on payment (NTAP) reimbursement for eligible claims, was
$49,291 for patients treated with
Andexxa and $54,699 for patients
treated with 4F-PCC – demonstrating a cost reduction of
$5,408 with the use of Andexxa. As a
result, the analysis projected a potential total annual cost
reduction of $259,608 for a hospital
treating 48 of these patients per year with Andexxa in place of
4F-PCC.
- Andexxa generated reductions in all cost components –
intubation, intensive care unit (ICU) and surgery costs – except
drug costs, though drug costs were offset by the NTAP
reimbursement.
- The projected net cost reduction related to the use of Andexxa
over three years totaled $392,652,
assuming a proportional share of 4F-PCC use (based initially on
current utilization in clinical practice).
Based on previously published clinical evidence, the model
assumes a lower risk of hematoma expansion and surgery in patients
treated with Andexxa compared to patients treated with 4F-PCC. The
model also considered the NTAP reimbursement available for Andexxa,
a CMS designation enabling hospitals to recoup up to 65% of the
cost of the drug when applied successfully.
"This analysis supports two of our key initiatives. First, it is
part of the comprehensive educational strategy we have developed to
demonstrate the unique value of Andexxa compared to 4F-PCC. Second,
it provides additional data underscoring the importance of
utilizing the NTAP reimbursement, which we can leverage in our
ongoing work to support U.S. hospitals in their efforts to
streamline and secure reimbursement," said Rajiv Patni, M.D., Portola's chief medical officer. "We look
forward to building on this evidence with additional clinical and
economic presentations and publications throughout the year,
including new data on the potential effect of Andexxa versus 4F-PCC
on 30-day mortality at the upcoming American College of Cardiology
Annual Scientific Session/World Congress of Cardiology."
In addition to the poster presented by Mr. Fanikos, three
additional Portola-sponsored
posters were presented at the Emergencies in Medicine Meeting.
These retrospective studies demonstrated that (1) the use of 4F-PCC
in gastrointestinal bleeding associated with oral Factor Xa
inhibitors led to similar lengths of stay and readmission costs,
along with a doubling of costs of the index hospital treatment and
stay compared to patients not managed with 4F-PCC; (2) the use of
4F-PCC in trauma cases associated with oral Factor Xa inhibitors is
associated with a high length of stay and burden for hospitals; and
(3) the healthcare economic burden associated with the treatment of
major bleeding events associated with oral factor Xa inhibitors is
substantial.
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
projected cost reductions relating to use of Andexxa, the effect
and availability of NTAP reimbursement, assumptions regarding
clinical outcomes associated with the use of Andexxa and our plans
for additional clinical and economic presentations throughout the
year. Risks that contribute to the uncertain nature of the
forward-looking statements include: the risk that physicians,
patients and payers may not see the benefits of utilizing Andexxa
for the indications for which it is approved; we may not receive
favorable pricing reimbursement in the United Kingdom and Germany and other EU countries; our ability to
continue to manufacture our products and to expand approved
manufacturing facilities; the possibility of unfavorable results
from additional clinical trials involving Andexxa; our clinical
trials may take longer and be more costly than anticipated; 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. 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.®