G1 Therapeutics Granted New Technology Add-On Payment (NTAP) for COSELA™ (Trilaciclib) by Centers for Medicare & Medicaid Services (CMS)

Rhea-AI Summary

G1 Therapeutics, Inc. (GTHX) announced that the Centers for Medicare & Medicaid Services has approved a new technology add-on payment for COSELA™ (trilaciclib), effective October 1, 2021. This payment provides up to $5,526.30 in addition to standard Medicare reimbursements for hospitals administering COSELA to eligible patients. This decision follows the recent receipt of a C Code and permanent J Code for COSELA. CEO Jack Bailey stated that this decision enhances patient access to COSELA, addressing a vital need in treating extensive-stage small cell lung cancer.

Positive

• CMS approval of NTAP for COSELA™ could enhance hospital adoption and patient access.
• The NTAP adds a maximum payment of $5,526.30 to standard reimbursements for COSELA in inpatient settings.

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• None.

RESEARCH TRIANGLE PARK, N.C., Aug. 04, 2021 (GLOBE NEWSWIRE) -- 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.

Indication
COSELA™ (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 Information
COSELA 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 Therapeutics
G1 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 Roberts
Vice President, Investor Relations & Corporate Communications
919-907-1944
wroberts@g1therapeutics.com

Rebecca Levine
Director, Corporate Communications and Public Relations
(919) 667-8711
rlevine@g1therapeutics.com  

FAQ

What is the NTAP for COSELA by GTHX?

The NTAP provides additional payments for COSELA when administered to Medicare patients, allowing hospitals to receive up to $5,526.30 beyond standard reimbursements.

When will the NTAP for COSELA become effective?

The NTAP for COSELA will be effective for provider billing starting October 1, 2021.

What impact does the NTAP have on patient access to COSELA?

The NTAP aims to improve access to COSELA for patients with extensive-stage small cell lung cancer by providing added financial support to hospitals.

What is COSELA (trilaciclib) used for?

COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in patients undergoing chemotherapy for extensive-stage small cell lung cancer.