G1 Therapeutics Granted New Technology Add-On Payment (NTAP) for COSELA™ (Trilaciclib) by Centers for Medicare & Medicaid Services (CMS)
August 04 2021 - 08:00AM
G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today announced that the Centers for Medicare &
Medicaid Services (CMS) has granted a new technology add-on payment
(NTAP) for COSELA™ (trilaciclib) when administered to Medicare
beneficiaries in the hospital inpatient setting. It will become
effective for provider billing on October 1, 2021. An NTAP provides
additional payment to hospitals above the standard Medicare
Severity Diagnosis-Related Group (MS-DRG) payment amount.
This grant follows the receipt of a C Code for pass through
hospital outpatient system use (effective July 1, 2021) and a
permanent J Code for all sites of care (effective October 1,
2021).
The NTAP will provide hospitals with a payment, in addition to
the standard-of-care DRG reimbursement, of up to 65 percent of the
average cost of the technology if the cost of the discharge exceeds
the full DRG payment. As such, beginning on October 1, 2021, CMS
will provide an additional maximum payment
of $5,526.30 for COSELA when used in the inpatient
hospital setting for fiscal year 2022. Congress created the NTAP
program to ensure that Medicare beneficiaries have timely access to
innovative therapies while the agency collects data about them to
use in future rate-setting.
“CMS’ issuance of an NTAP for COSELA recognizes its potential to
address an urgent need for proactive multilineage myeloprotection
in patients living with extensive stage small cell lung cancer,”
said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “We
believe the decision to include COSELA in the NTAP program is an
important step that will help increase patient access to this
important drug. We applaud CMS for their decision; the need for
effective tools to help clinicians reduce or prevent
myelosuppressive events is critical for extensive stage small cell
lung cancer patients undergoing chemotherapy.”
About COSELA™ (trilaciclib) for Injection
COSELA (trilaciclib) was approved by the U.S. Food and Drug
Administration on February 12, 2021.
IndicationCOSELA™ (trilaciclib) is indicated to
decrease the incidence of chemotherapy-induced myelosuppression in
adult patients when administered prior to a
platinum/etoposide-containing regimen or topotecan-containing
regimen for extensive-stage small cell lung cancer.
Important Safety InformationCOSELA is
contraindicated in patients with a history of serious
hypersensitivity reactions to trilaciclib.
Warnings and precautions include injection-site reactions
(including phlebitis and thrombophlebitis), acute drug
hypersensitivity reactions, interstitial lung disease
(pneumonitis), and embryo-fetal toxicity.
The most common adverse reactions (>10%) were fatigue,
hypocalcemia, hypokalemia, hypophosphatemia, aspartate
aminotransferase increased, headache, and pneumonia.
This information is not comprehensive. Please click here for
full Prescribing Information.
https://www.g1therapeutics.com/cosela/pi/
To report suspected adverse reactions, contact G1 Therapeutics
at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit
www.fda.gov/medwatch.
About G1 TherapeuticsG1 Therapeutics, Inc. is a
commercial-stage biopharmaceutical company focused on the
development and commercialization of next generation therapies that
improve the lives of those affected by cancer, including the
Company’s first commercial product, COSELA™ (trilaciclib). G1 has a
deep clinical pipeline and is executing a tumor-agnostic
development plan evaluating COSELA in a variety of solid tumors,
including colorectal, breast, lung, and bladder cancers. G1
Therapeutics is based in Research Triangle Park, N.C. For
additional information, please visit www.g1therapeutics.com and
follow us on Twitter @G1Therapeutics.
G1 Therapeutics™ and the G1 Therapeutics logo and COSELA™ and
the COSELA logo are trademarks of G1 Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "may," "will," "expect," "plan," "anticipate,"
"estimate," "intend" and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
Forward-looking statements in this press release include, but are
not limited to, those relating to the urgent need for COSELA
(trilaciclib) and the company’s ability to increase access to
COSELA. Each of these forward-looking statements involves risks and
uncertainties. Factors that may cause the company’s actual results
to differ from those expressed or implied in the forward-looking
statements in this press release are discussed in the company’s
filings with the U.S. Securities and Exchange Commission, including
the "Risk Factors" sections contained therein and include, but are
not limited to, the company’s dependence on the commercial success
of COSELA; the development and commercialization of new drug
products is highly competitive; the company’s ability to complete
clinical trials for, obtain approvals for and commercialize any of
its product candidates; the company’s initial success in ongoing
clinical trials may not be indicative of results obtained when
these trials are completed or in later stage trials; the inherent
uncertainties associated with developing new products or
technologies and operating as a development-stage company; and
market conditions. Except as required by law, the company assumes
no obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
Will RobertsVice President, Investor Relations & Corporate
Communications919-907-1944 wroberts@g1therapeutics.com
Rebecca LevineDirector, Corporate Communications and Public
Relations(919) 667-8711 rlevine@g1therapeutics.com
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