Drug Alerts and Special Reports

Key reimbursement alerts for office-administered drugs — C-Code, J-Code, NDC, and NCCN alerts plus pricing updates, sent on behalf of pharma manufacturers.

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FDA Approved 07/10/2023

Now Approved: A Once-Weekly Echinocandin - 7/10/23

Now Approved: A ONCE-WEEKLY echinocandin Available Summer 2023 REZZAYO TM (rezafungin for injection) is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. How Supplied: NDC Package Description WAC Pricing 70842-240-01 200 mg as a solid (cake or powder) in a single-dose vial for reconstitution $1950/vial Potential Diagnosis Codes: ICD-10-CM Description B37.1 Pulmonary candidiasis B37.7 Candidal sepsis B37.81 Candidiasis of other sites B37.82 Candidal enteritis B37.89 Other sites of candidiasis INDICATION AND USAGE REZZAYO TM (rezafungin for injection) is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical…

Biosimilar 07/10/2023

Samsung Bioepis Biosimilar Market Report 2nd Edition, Q3 2023 - 7/10/23

SAMSUNG BIOEPIS Biosimilar Market Report 2 nd Edition, Q3 2023 Download Here In this second edition of our report, we have included the 8 Humira biosimilars' WAC price that have launched within pharmacy benefits and updated the most recent market share and ASP trends of all molecules for biosimilar(s) that have launched in the US. Moving forward each Market Report will consist of comprehensive updates on pricing and market penetration for all marketed biosimilars in the US. We invite you to download the 2 nd Samsung Bioepis Biosimilar Market Report here: Download Here © 2023 Samsung Bioepis Co., Ltd. All Rights Reserved. 6/2023. BuyandBill.com SAMSUNG…

FDA Approved 07/07/2023

Now Approved – ROCTAVIAN (valoctocogene roxaparvovec-rvox) - 7/5/2023

Please see Important Safety Information and full Prescribing Information NOW APPROVED ROCTAVIAN is the only one-time gene therapy indicated for the treatment of severe hemophilia A in eligible adults. Please see Important Safety Information below as well as the full Prescribing Information. Potential Coding Options for ROCTAVIAN The coding information provided is not comprehensive and is subject to change without notice. Providers are responsible for all coding determinations and submitting accurate claims for products and services rendered. Contact payers for specific information on their coding, coverage, and payment policies. The following coding examples may not apply, are not inclusive of all potential codes that may be used, and are provided for consideration only. NDC Code NDC Descriptor Dose WAC 68135-0927-48 Each carton of ROCTAVIAN contains one single dose vial with an extractable volume of not less than 8 mL, containing 16 × 10 13 vector genomes (vg). The recommended dose…

J-Code 06/27/2023

New J Code for Panzyga - J1576 - 6/20/23

Effective July 1, 2023 the new Healthcare Common Procedure Coding System (HCPCS) J-Code for panzyga will be J1576 (Injection, immune globulin , intravenous, non-lyophilized , 500 mg). Until July 1, 2023, customers are advised to continue using current HCPCS code J1599 All pending claims with date of service prior to July 1, 2023 submitted for reimbursement after the effective date should still be submitted with HCPCS code J1599 For questions or reimbursement support, please contact the Octapharma reimbursement team. <! --> Office: 201.716.4056 | Direct: 551.329.7298 Email: [email protected] INDICATIONS AND USAGE Panzyga (Immune Globulin Intravenous - ifas) is indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older, for chronic immune thrombocytopenia (cITP) in adults, and for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Contraindications Panzyga is…

Pricing 06/27/2023

Effective July 1, 2023: A Medicare Payment Limit and ASP has been published for J1954 - 6/16/2023

Cipla USA's LEUPROLIDE ACETATE INJECTION DEPOT (Leuprolide Acetate for Depot Suspension) Effective July 1, 2023: A Medicare Payment Limit and ASP 1 has been published by CMS for: J1954:Injection, leuprolide acetate for depot suspension (cipla), 7.5 mg J1954 is a unique HCPCS code for Cipla's version of LEUPROLIDE ACETATE INJECTION DEPOT (Leuprolide Acetate for Depot Suspension) and sh ould not be used for billing other leuprolide formulations. HCPCS Code HCPCS Code Descriptor NDC Number Medicare Payment Limit Effective 7/1/23 ASP J1954 Injection, leuprolide acetate for depot suspension (cipla), 7.5 mg 69097-0909-50 $425.48 $401.39 We respectfully request the update of all claims and reimbursement systems to include the ASP for J1954: Injection, leuprolide acetate for depot suspension (cipla), 7.5 mg. effective July 1, 2023 Please contact us @ [email protected] Reference: 1 . Centers for Medicare and Medicaid, Q3 2023 ASP file…

05/31/2023

New Treatment Option Available for Fabry Disease - 5/25/2023

New Treatment Option Available for Fabry Disease Dear Payer, We are pleased to announce the recent FDA approval of Elfabrio® (pegunigalsidase alfa-iwxj); a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adults with confirmed Fabry disease. 1 Click here to access the press release! Dosage and Administration 1 : The recommended dosage is 1 mg/kg administered every…

Biosimilar 04/20/2023

Samsung Bioepis Biosimilar Market Report (Q2 2023) - 4/19/23

To support all the stakeholders involved in this exciting journey of biosimilars in the US, Samsung Bioepis will bring you this Samsung Bioepis Biosimilar Market Report. The Samsung Bioepis Biosimilar Market Report will be published quarterly in conjunction with the release of the CMS ASP file. In the 1 st edition of the Samsung Bioepis Biosimilar Market Report, we provide an in-depth analysis of pricing and market share trends in the US market and for the following biosimilar categories: Oncology / Supportive Care / Immunology / Ophthalmology / Endocrinology We will also review the topic of biologic interchangeability and its implications for the biosimilar market moving forward. Each subsequent issue of the Samsung Bioepis Biosimilar Market Report will provide a complete overview of the latest pricing and utilization trends for the entire biosimilar market along with a review of the most important topics in the biosimilar sphere. We invite you to download our first Samsung Bioepis…

04/11/2023

New combination therapy for treatment of locally advanced or metastatic urothelial cancer - 4/10/23

Recent FDA Indication Approval in Locally Advanced/Metastatic Urothelial Cancer (mUC) Important Safety Information | Full Prescribing Information including BOXED WARNING New Indication of PADCEV in Combination With Pembrolizumab Now Approved as a First-Line Treatment Option On April 3, 2023, PADCEV’s indication was expanded based on data from the EV-103 trial. PADCEV, as a single agent, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who: • have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or • are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy PADCEV, in combination with pembrolizumab, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin-containing chemotherapy. This…

J-Code 04/10/2023

Permanent HCPCS J-Code for SPEVIGO - 3/27/23

Permanent HCPCS J-Code for SPEVIGO EFFECTIVE APRIL 1, 2023 A monoclonal IgG1 antibody for the treatment of generalized pustular psoriasis (GPP) flares in adults. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimabsbzo or to any of the excipients in SPEVIGO. Reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS). Please see additional Important Safety Information below and full Prescribing Information , including Medication Guide . Coding for SPEVIGO* Code Type Code Description ICD-10-CM L40.1 Generalized pustular psoriasis CPT 96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour 96366 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure) HCPCS J Code J1747 Injection…

04/10/2023

New HCPCS Code Descriptor for J1954 Cipla USA's LEUPROLIDE ACETATE INJECTION DEPOT - 3/14/23

Effective April 1, 2023: New HCPCS Code Descript or for J1954: Injection, leuprolide acetate for depot suspension (cipla), 7.5 mg. J1954 is a unique HCPCS code for Cipla's version of LEUPROLIDE ACETATE INJECTION DEPOT (Leuprolide Acetate for Depot Suspension) and sh ould not be used for billing other leuprolide formulations. HCPCS Code HCPCS Code Descriptor NDC Number Strength WAC Per Package HCPCS Units Per Package J1954 Injection, leuprolide acetate for depot suspension (cipla), 7.5 mg 69097-0909-50 22.5 mg $1,355.07 3 We respectfully request the update of all claims and reimbursement systems to include the new HCPCS code descriptor for J1954: Injection, leuprolide acetate for depot suspension (cipla), 7.5 mg. effective April 1, 2023 Please contact us @ [email protected] © Copyright 2023 Cipla USA Inc. All rights reserved April 2023…

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