G1 Therapeutics Announces Permanent J-Code from Centers for Medicare and Medicaid Services

On October 1, 2021 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the permanent J-code for COSELA (trilaciclib) that was issued in July 2021 by the Centers for Medicare & Medicaid Services (CMS) is now effective for provider billing for all sites of care (Press release, G1 Therapeutics, OCT 1, 2021, View Source [SID1234590614]). The permanent J-code for COSELA, J1448 (Injection, trilaciclib, 1mg.), published online on the CMS website here (page 5).

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J-codes are permanent, product specific reimbursement codes assigned to outpatient and physician administered "buy and bill" products under Medicare Part B and are used by commercial insurers and government payers to facilitate and standardize claims submissions and reimbursements for medications like COSELA. With the permanent J-code now in effect, all hospital outpatient departments, ambulatory surgery centers and physician offices in the United States will have one consistent Healthcare Common Procedure Coding System (HCPCS) code to standardize the submission and payment of COSELA insurance claims across Medicare, Medicare Advantage, Medicaid and commercial plans.

"Given the emergent presentation of extensive-stage small cell lung cancer, and the clinical benefits of COSELA as a proactive multilineage myeloprotection drug when give prior to chemotherapy, it is absolutely essential that patients have timely access to it," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "We are pleased to receive this new permanent J-code for all sites of care as it will enable a more efficient billing process, which will ultimately help facilitate patient access to COSELA."

G1’s new technology add-on payment (NTAP) for COSELA which provides additional payment to inpatient hospitals above the standard Medicare Severity Diagnosis-Related Group (MS-DRG) payment amount also became effective for provider billing today, October 1, 2021.

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

Juntendo University and Astellas Establish "Direct Reprogramming Regenerative Medicine Course" for Scientific Breakthroughs

On October 1, 2021 Juntendo University (President: Hajime Arai, M.D., Ph.D.) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that the parties have established, inside Juntendo University Graduate School of Medicine, a joint research course entitled, "Direct Reprogramming Regenerative Medicine Course" (Professor & Director, Diagnostics and Therapeutics of Interactable Diseases, Intractable Disease Research Center, Genome Medical Center: Yasushi Okazaki M.D., Ph.D., Specially Appointed Professor: Masahito Matsumoto, Ph.D.) (Press release, Astellas, OCT 1, 2021, View Source [SID1234590612]). The course will be retained for a term of three years from October 2021.

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This joint research course aims to create a new modality that maximizes the therapeutic effect for diseases with high unmet medical needs, such as type 1 diabetes, by direct reprogramming using the K factor*1 . Itwill also conduct research to expand this modality to other diseases. Juntendo University Graduate School of Medicine will be acquiring the basic data including the study of the optimal combination of direct reprogramming factors that include the K factor, and Astellas will be conducting the applied research for disease treatment by gene therapy using this factor and selection of the optimal modality.

Direct reprogramming is a biology that directly converts the fate of cells without passing through the pluripotent state. The technology that enables direct reprogramming in vivo has attracted attention as a new regenerative medicine technology. Unlike conventional therapies, direct reprogramming not only removes unwanted cells or replenishes necessary cells; it also converts unnecessary cells into necessary cells. It is therefore expected to show high efficacy against intractable diseases that have been thought to be incurable.

Juntendo University and Astellas have been conducting joint research collaboration on the establishment of differentiation methods for therapeutic cells by direct reprogramming based on the agreement executed in 2018. This time, as part of this joint research collaboration, the two parties have established this joint research course to further strengthen the partnership and progressively conduct research on direct reprogramming as a new therapeutic paradigm.

Through this joint research course, Juntendo University and Astellas will take on the challenge of drug discovery based on direct reprogramming technology, with the aim of providing patients with new treatment options.