DrugS

Lilly USA, LLC is pleased to announce recent major label changes for Retevmo^® (selpercatinib, 80 mg and 40 mg capsules). Read press release here. 

NCCN GUIDELINES^®: Sacituzumab govitecan-hziy (TRODELVY) is recommended as a Category 1 preferred treatment option for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Read More. 

Learn more about TRODELVY.  Please click to see full Prescribing Information. 

The National Comprehensive Cancer Network® (NCCN®) has published new NCCN Guidelines for Patients®: Breast Cancer Screening and Diagnosis to help people understand their personal risk for breast cancer, when they should begin screening, and how often to screen—in order to detect cancer earlier, for more treatment options and better outcomes. With this information, they are equipped to have more informed conversations with their health care providers and be active decision-makers in their long-term health. Read More. 

The NCCN released new Kidney Cancer guidelines (v1.2023) on June 17th and has elevated Fotivda (tivozanib) to be the only Category 1 recommended regimen, for patients that have failed 2 or more systemic treatments.  More Information.  Full Prescribing Information. 

Agios Pharmaceuticals, Inc., a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today reported new data further underscoring the significant burden of disease in adults with pyruvate kinase (PK) deficiency regardless of genotype and supporting the potential benefits of treatment with PYRUKYND® for these patients.  Read More.

Randomized Phase 3 Clinical Trial of ADCETRIS Combination Met Key Secondary OS Endpoint, Demonstrating a 41% Reduction in Risk of Death vs. Standard of Care in Patients With Advanced Hodgkin Lymphoma.  Read More.

Beginning February 14, 2022, there is a new NDC number for TIBSOVO® (72694-0617-60)*, the old NDC number was 71334-0100-01. SERVIER has new product packaging. The product itself remains the same. Listed below are pictures of the updated product packaging and ordering information.

Updated Product Ordering Information:

DESCRIPTION	STRENGTH/SIZE	NEW NDC#
TIBSOVO® (ivosidenib tablets)	250 mg tablet   60 tablets/bottle	10 Digit # 72694-617-60  (11 Digit # for ordering 72694-0617-60)

*Per the TIBSOVO® label, the NDC code is 10 digits. We are supplying the 11-digit code for ordering convenience.

The ordering process for TIBSOVO® remains the same.

For full prescribing information regarding TIBSOVO®, please visit www.tibsovo.com.

Servier understands the importance of supplying product to our patients and are committed to ensuring there will be no interruption in supply. We look forward to working with you.

The U.S. Food and Drug Administration (FDA) is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib) approved to treat two specific types of lymphomas, which are cancers that affect the body’s immune system. Read More.

Neulasta® (pegfilgrastim) Onpro® and Neulasta® have an updated Healthcare Common Procedure Coding System (HCPCS) Code and dose descriptor, effective January 1, 2022.

The UPDATED HCPCS CODE is J2506.  The UPDATED DOSE DESCRIPTOR is Injection, pegfilgrastim, excludes biosimilar, 0.5 mg.  This updated dose descriptor can be billed in multiple units to accommodate a variety of doses. Providers should note the new dose descriptor is now 0.5 mg. Per label, the dose for Neulasta® (pegfilgrastim) is 6 mg. Please accurately report service units when billing.

Key dates: For dates of service on and after January 1, 2022, providers must use the updated HCPCS Code J2506, and dose descriptor, and discontinue use of the HCPCS Code J2505, as it will no longer be accepted. Providers may only use J2505 for dates of service on or before December 31, 2021.

Information on the updated code and dose descriptor is summarized in the following attachments:

• Neulasta® (pegfilgrastim) Onpro® and Neulasta® J-Code Flashcard, which contains the effective date, coding, and support service information and Neulasta® (pegfilgrastim) Onpro® and Neulasta® Billing and Coding Guide, which will provide you with detailed coding, dosing and administration, and support service information.
• Hospital Outpatient Coding and Billing Information Sheet 
• Physician Office Coding and Billing Information Sheet
• Please see full Prescribing Information for Neulasta® (pegfilgrastim) Onpro® and Neulasta® by clicking the link below:  Neulasta® Prescribing Information

The CMS 2021 ASP Drug Pricing Files for the 4th quarter effective October 1, 2021 through December 31, 2021 reflects updates for ISTODAX® (romidepsin) for injection, for intravenous use.  The update includes the following changes which are effective October 1, 2021:

• Discontinued HCPCS Code J9315 “Injection, romidepsin, 1mg” on September 30, 2021 and established J9319 “Injection, romidepsin, lyophilized, 0.1mg” on October 1, 2021.
• Changed the HCPCS Code Dosage from 1mg to 0.1 mg.

Per CMS, this change in J-code needed to be made because: “A new HCPCS code for Romidepsin Injection, non-lyophilized liquid is needed because it is a single source drug approved under a unique NDC number, and it needs to be differentiated from the existing HCPCS code for a multi-sourced Romidepsin drug in lyophilized powder form."