On August 4, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported 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 (Press release, G1 Therapeutics, AUG 4, 2021, View Source [SID1234587577]). 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.

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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. View Source

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.