IMFINZI is a monoclonal antibody, a type of protein. The most common side effects that occurred in 20% or more of patients receiving Imfinzi were: fatigue, nausea, constipation, decreased appetite, abdominal pain, rash and fever. Durvalumab (IMFINZI ), a fully human monoclonal antibody against programmed cell death-ligand 1 (PD-L1), is approved for use in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of. 4ml. IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer. 3) 09/2022 Dosage and Administration (2. NDC Packaging CDC Cost/ Dose Private Sector Cost/ Dose Contract End Date Manufacturer Contract Number; Hepatitis A Adult Vaqta® 00006-4096-02: 10 pack – 1 dose syringe: $38. 68 mg/mL), 4 mg (1. To report via data exchange, providers would report using the NDC code that is specific to the dose administered. The current update (2016) adds 34 drugs and includes a review of the 2004 list. Bahamas. To convert a 10-digit NDC to an 11-digit HIPAA standard NDC, a leading zero is added to the appropriate segment to create the 11-digit configuration as defined above. Depending. Some side effects may occur during the injection. CMS Local Coverage Determinations (LCDs) and Articles LCD Article Contractor Medicare Part A Medicare Part B L34648 Bisphosphonate Drug Therapy A56907 Billing and Coding: Bisphosphonate Drug Therapy WPS . 70461-0323-03 Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. The recommended dose of ZYNRELEF is based on the size of the surgical site up to a maximum dose of 400 mg/12 mg (14 mL). Code 91317 for Pfizer-BioNTech COVID-19. Coverage Period Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 2. 2) 0X/2020Admni siter IMFINZI proi r to chemothearpy on the same day . Other changes to the CPT code set. To report via data exchange, providers would report using the NDC codeThe FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy to treat adult patients with stage 4 nonsmall-cell lung cancer (NSCLC). Always bill device in the category described by HCPCS code C1832 with 1 of the following CPT codes: • CPT code 15110 (Epidermal autograft, trunk, arms, legs; first 100 sq cm or less, or 1% of body area of infants and children), which is assigned to APC 5054 for. Structural formula: OZEMPIC is a sterile, aqueous, clear, colorless solution. through . Group 1 Codes. • HCPCS Level II Procedure and Modifier Codes: Primarily include non-physician products, supplies, and procedures not included in CPT. claim form as follows: 1. locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy; or; who have disease progression within 12 months of neoadjuvant or adjuvant treatment with. • 300 mg (NDC 0024-5914-00) • 200 mg (NDC 0024-5918-00) • 100 mg (NDC 0024-5911-00) Pre-filled pen: • 300 mg (NDC 0024-5915-00). Updated Nationally Determined Contribution of the Republic of Azerbaijan. This is not a complete list of. Loncastuximab tesirine is an ADC composed of a humanized monoclonal antibody that binds to human CD19 and. 90716 can be used for the administration of the chickenpox vaccine (varicella) 12002 can be used when a healthcare provider stitches up a 1-inch cut on your arm. The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. FDA Approved: Yes (First approved May 1, 2017) Brand name: Imfinzi Generic name: durvalumab Dosage form: Injection Company: AstraZeneca Treatment for: Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Biliary Tract Tumor,. g Medicare requires that you bill code G0008 when billing for the administration of influenza vaccines. Table 1. Example of NDC Labeler code assignment. Active. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17 ICD-10 Annual Update, 10/17 Incomplete Manage Change Requests and Enrollment Applications, 09/17 Maintain Eligibility Process, 06/17, 07/17, 08/17, 09/17, 10/17This page provides the clinical criteria documents for all injectable, infused, or implanted prescription drugs and therapies covered under the medical benefit. S. 66019-0310-10 Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. Indication: Indicated in adults and children with Hemophilia A for: On-demand. 58%), as well those showing a durable response at one year (23% vs. . The FDA has approved updated labeling for Imfinzi (durvalumab; AstraZeneca) to include overall survival data for patients with unresectable, Stage III non-small cell lung cancer (NSCLC). IMFINZI contains the active ingredient durvalumab. 10, 2021: NDC requirements have been postponed until 2022. It applies to all plans except Medicare Supplemental plans. Adding National Drug Codes (NDC) to ClaimsIMFINZI 120mg Injection 2. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. durvalumab injection, for intravenous use (Imfinzi®) 10 mg. Q: Does the requirement to bill NDCs apply to all plans? A: No. The labeler code is the first segment of the National Drug Code. Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. J1745. 094 Section: Prescription Drugs Effective Date: October 1, 2022 Subsection: Antineoplastic Agents Original Policy Date: May 12, 2017 Subject: Imfinzi Page: 1 of 4 Last Review Date: September 9, 2022 Imfinzi Description Imfinzi (durvalumab) Background Imfinzi (durvalumab) is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. 94 Section: Prescription Drugs Effective Date: July 1, 2022 Subsection: Antineoplastic Agents Original Policy Date: May 12, 2017 Subject: Imfinzi Page: 1 of 4 Last Review Date: June 16, 2022 Imfinzi Description Imfinzi (durvalumab) Background Imfinzi (durvalumab) is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody thatGreater than or equal to 30 kg: 1,500 mg every 3 weeks in combination with tremelimumab-actl 75 mg and platinum-based chemotherapy for 4 cycles, and then administer Imfinzi 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed maintenance therapy every 4 weeks, and a fifth dose of tremelimumab-actl. 21. Imfinzi will be available as a 50-mg/ml concentrate for solution for infusion . Bevacizumab should be billed based on units, not total number of milligrams. and revised HCPCS codes effective April 1, 2022, which include A4238, E2102, K1028-K1033, and V2525. com. However, their Bladder Cancer guidelines have not been updated since the manufacturer’s decision in 2/2021 to withdraw this indication from the FDA label due to Imfinzi’s inability to meet the overall survival primary outcome measures in theDurvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. Tunney’s Pasture, A. S. 25 mL single-dose vial: 25 units: 0310-4505-25: 300. Example: rilpivirine STR=ndc_active_ingredient. For the following CPT/HCPCS code(s) either the short description and/or the long description was changed. (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. Imfinzi is a medicine used to treat lung cancer. 90672. Page 3 | Imfinzi® (durvalumab) Prior Auth Criteria Proprietary Information. Durvalumab side effects. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals LP”. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. Approval: 2017 total bilirubin elevation. Prev Section 2. IMFINZI may cause serious or life threatening infusion reactions and infections. 1 Recommended Dosage. muscle cramps and stiffness. Imfinzi durvalumab J9173. (NDC 0310-4611-50) 120 mg/2. 1 All shared Healthcare Common Procedure Coding System (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. Dosing Limits Quantity Limit (max daily dose) [NDC Unit]: Imfinzi 120 mg/2. One (1) unit represents 10 mg of (J9035) or bevacizumab ordered/administered to patient. Contact your patient’s• Administer IMFINZI as an intravenous infusion over 60 minutes. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. Restricted Access – Do not disseminate or copyImfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the. The official update of the HCPCS code system is available as a public use file below. (2. Per 2023 CPT/HCPCS updates, HCPCS codes C7501 and C7502 were added to Group 1. Axitinib % % % %j9173 imfinzi q5103 inflectra j1290 kalbitor j9271 keytruda j9119 libtayo j2778 lucentis j0221 lumizyme . The Cancer Medications Enquiry Database (CanMED) is a two-part resource for cancer drug treatment related studies. Imjudo is a monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), blocking it and contributing to T. If you have any questions about these medicines, ask your doctor. If the NDC on the package label is less than 11 digits, a leading zero must be added to the appropriate segment to create a 5-4-2 configuration. (B) A product code consisting of 3 digits and a package code consisting of 2 digits for a total NDC length of 10 or 11 digits (5–3–2 or 6–3–2). HCPCS code V2790 (amniotic membrane for surgical reconstruction, per procedure) should not be billed to Part B separately except as noted below: •HCPCS code V2790 can be reimbursed separately in an office setting when billed with CPT Code 65780. 3 spasmodic torticollis; payment may be made under off-label use circumstances outlined in Indications and Limitations of the LCD Botulinum Toxin Type A and B Policy (L35170). January 2024 Alpha-Numeric HCPCS Files (ZIP) - Updated 11/21/2023. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. This code is effective on 11/1/2018. Example claim with HCPCS by itself: HCPCS rate changed 5/19. 58 g/mol. Dosage Modifications for Adverse Reactions . 65 Unit of measure (UOM) is mL Pricing calculation: 105% of the wholesale acquisition cost (WAC) of the NDC billed by the provider. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. 4 Adverse Reaction Severity1 Dosage Modification than 5 and up to 10 times ULN or AST or ALT is more than 3 and up to 5 times ULN at baseline and increases to more. Imfinzi (Durvalumab Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug. A firm. Information last updated by Dr. It works by helping your immune system fight the cancer cells. Trade name: Macrilen . The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy ar e presented in Table 1 [see . Imfinzi durvalumab J91731All shared Healthcare Common Procedure Coding System (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. See . ATC code: L01FF03. By blocking these interactions, Imfinzi may help the body’s immune system attack. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. HCPCS code describes JEMPERLI. Payers may require the submission of the 11-digit NDC on health care claim forms, and electronic claims may be denied for drugs billed without a valid 11-digit NDC. IMFINZI may be given in combination with otheranti-cancermedicines. 5. About NDC HCPCS Product NDC: 00310-4611 Brand Name: Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route: Intravenous Substances: Name: Durvalumab Strength: 500. X 11335. Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. 88 mg/mL meloxicam. They are owned by CMS and are available for use. 2 DOSAGE AND ADMINISTRATION 2. Effective Jan. ─ NDC units are billed at the NDC level and not at the HCPCS level ─ Example: NDC Units = 9,999 and the HCPCS unit = 1. Influenza vaccines are licensed each year with new NDCs, so it is important to report the correct code for the products you are using to avoid having claims deny with edit 00996 (Mismatched NDC) which will require the claim to be resubmitted with the correct. July 2023 Alpha-Numeric HCPCS File (ZIP) -. The first sentence in the “Coding Information” section has been revised to add ranibizumab-nuna and faricimab-svoa: The administration for ranibizumab, ranibizumab-nuna, aflibercept, brolucizumab-dbll or faricimab-svoa must be billed on the same claim as the drug, with. Pre-Stata13 had a string length limit of 244 characters. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14 days Xolair omalizumab 600 mg J2357 120 HCPCS units (5 mg per unit) Bavencio avelumab 800 mg J9023 80 HCPCS units (10 mg per unit) Imfinzi durvalumab 1,500 mg J9173 150 HCPCS units (10 mg per unit) Keytruda pembrolizumab 400 mg J9271 400 HCPCS units (1 mg per unit) Libtayo cemiplimab-rwlc 350 mg J9119 350 HCPCS units (1 mg per unit) Durvalumab Injection, For Intravenous Use (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17 Immune globulin subcutaneous (Human), 20 Percent solution (CuvitruTM) HCPCS code J3590: Billing Guidelines, 02/17 Durvalumab: A Review in Extensive-Stage SCLC. What is a J-code’s unit? Each J-code’s descriptor includes a dosage amount, known as the HCPCS code dosage, which is the billable unit for that code. However, their Bladder Cancer guidelines have not been updated since the manufacturer’s decision in 2/2021 to withdraw this indication from the FDA label due to Imfinzi’s inability to meet the overall survival primary outcome measures in the Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. No dose reduction for IMFINZI is recommended. 2 Q: Are the NDC units dispensed different from the HCPCS, CPT, and Revenue code units? A: Yes. Revised: 03/2021 Page 2 . The product's dosage form is injection, solution, and is administered via intravenous form. However, their Bladder Cancer guidelines have not been updated since the manufacturer’s decision in 2/2021 to withdraw this indication from the FDA label due to Imfinzi’s inability to meet the overall survival primary outcome measures in theImfinzi 50 mg/mL concentrate for solution for infusion - Summary of Product Characteristics. References 1. Format revision completed. FOLFIRINOX is used to treat: Pancreatic cancer that has metastasized (spread to other parts of the body). Seventeen5. Questions and Answers 1 Q: How do I report HCPCS code G0378 for observation care. Identify the specific product and package size. pneumonitis * ( inflammation of the lungs) hair loss. WARNINGS AND PRECAUTIONS Tellyourdoctor before you are given IMFINZI if you have:2. Short descriptor: SARSCOV2 VAC BVL 10MCG/0. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. A product code consisting of 3 digits and a package code consisting of 2 digits for a total NDC length of 10 or 11 digits (5-3-2 or 6-3-2). Establish new Level II HCPCS code J9227 "Injection, isatuximab-irfc, 10 mg" Effective: 10/01/2020 . 5 mL dosage, for. Imfinzi Generic Name durvalumab. Code Description. 3. MRP ₹45500. Imfinzi [prescribing information]. Report the supply separately using a HCPCS (Healthcare Procedural Coding System) code: J7307 Etonogestrel [contraceptive] implant system, including implant and. 66019-0308-10. Wilmington, DE; AstraZeneca Pharmaceuticals LP; July 2021. Covered codes. (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all. The Drug Name and NDC Reference Data file: The Drug Name and NDC Reference Data are delivered in one pipe-delimited . 6%). IMFINZI ® (durvalumab) injection, for intravenous use Initial U. The NDC, NDC units of measure and NDC quantity must be submitted in addition to the applicable HCPCS or CPT codes and the number of HCPCS CPT units. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. The National Library of Medicine (NLM)’s DailyMed searchable database provides the most recent labeling submitted to the Food and Drug Administration (FDA) by companies and currently in use (i. 1 Melanoma KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. 1%) patient and Grade 3-4 in six (0. A. 2 Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-lineThe recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 12 months. 1 Recommended Dosage The recommended dosages for IMFINZI as a single agent and IMFINZI in combination withSide Effects of Imfinzi are Nasopharyngitis (inflammation of the throat and nasal passages), Upper respiratory tract infection, Rash, Flu, Dermatitis, Bronchitis (inflammation of the airways), Eczema, Swelling of lymph nodes, Oropharyngeal pain. Appendix X Revisions Log . On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. Last updated on Jun 28, 2023. The product's dosage form is injection, solution and is administered via intravenous form. IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: • for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer. e. g. • Submit the NDC code in the red-shaded portion of the detail line item starting in positions 01 • Precede the NDC with the qualifier N4 and follow it immediately by the 11-digit NDC code (e. NDC11: 00904629161: National Drug Code (NDC) in the 11 digit (no dashes) form, also referred to as the CMS 11-digit NDC derivative. 70461-0321-03. Do not freeze or shake. Full prescribing. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug List Print. The units submitted for HCPCS, CPT, and Revenue codes are based on the HCPCS,. Imfinzi, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). Applicable Procedure Codes J9173 Injection, durvalumab, 10mg, 1 billable unit = 10mg Applicable NDCs 0310-4611-50. 82. The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) has updated its list of hazardous drugs for 2016. Therapy should continue as long as clinical benefit is observed or until unacceptable toxicity. NDC=National Drug Code. Do not freeze or shake. Applicant suggested language: JXXXX macimorelin 60 mg, oral solution. 21, including objective evidence of efficacy and safety are met for the proposed indication. 3 CWF shall send/display data in separate records for Dates of Service (DOS) and NPI of each PPV HCPCS codes (90670 and 90732) from new Auxiliary to: •The third set of digits is the package code, which identifies package sizes and types. 2 8. It is supplied by AstraZeneca. 5 days (range: 24-423 days). Key points to remember. macugen. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Enter the information on the . Axitinib % % % % hcpcs or cpt ® code(s) drug j0256 aralast np q5121 avsola j9023 bavencio j0490 benlysta j0179 beovu j0598 cinqair j0586 dysport j9217 eligard j1325 epoprostenol sodium j0178 eylea j0180 fabrazyme j0517 fasenra j1325 flolan j0257 glassia j9173 imfinzi q5103 inflectra j1290 kalbitor j9271 keytruda j9119 libtayo j2778 lucentis This review will provide an update on the regulatory approvals of anti-PD-1/PD-L1 therapeutics along with their companion and complementary diagnostic devices. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). 1007/s11523-021-00843-0. Format of NDC: Under the proposed rule, the NDC would remain a three-segment numerical code consisting of the labeler code, the product code, and the package code. Do not report 90460, 90471-90474 for the administration of COVID vaccines. 099. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. 2 DOSAGE AND ADMINISTRATION . (2. j1726. PD-L1 can be induced by. 150: 33332-0322-03: 0. Description . havediseaseprogressionwithin12monthsofneoadjuvantoradjuvanttreatmentwithplatinum-containingchemotherapy. Until we get public consultationon national Medicare benefit category determinations and payment determinations for these codes, the Medicare benefit category and coverage/paymentdevice category described by HCPCS code C1832 (Auto cell process). Exclusivity End Date:0154A, 0164A, 0171A, 0172A, 0173A, 0174A), patient age, manufacturer name, vaccine name(s), 10- and 11-digit National Drug Code (NDC) Labeler Product ID, and interval between doses. Imfinzi is a monoclonal antibody that counters the tumor's immune-evading tactics. . The new formulation the. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . It is for use in adults with: non-small cell lung cancer (NSCLC) that is locally advanced (meaning it has spread into tissues around the lungs, but not to other parts of the body) and cannot be removed by surgery and is not getting worse after radiation treatment and platinum-based chemotherapy (medicines to treat cancer). Generic Name: durvalumab. 5-fl-oz (340-mL) Bottle / Case of 12Effective with date of service Jan. fever. , N412345678901) When entering supplemental information for NDC, add in the following order: – N4 qualifier – 11-digit NDC code – 1 spaceQ: Why is anNDC needed when drugs are already being billed with HCPCS codes? A: Billing NDCs for shared HCPCS drug codes and NOC drug codes provides the ability to determine precisely which drugs are administered. 5. HMO . infections. Contents of the pack and other information . 708: 6/30/2023:. Drugs are identified and reported using a unique, three-segment number called the National Drug Code (NDC) which serves as the FDA’s identifier for drugs. For example, the same drug may be produced by many different manufacturers or the same drug may have different dosages. It’s given as an IV infusion. 3, IMFINZI. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. This document provides the latest information about the dosage, side effects, warnings, and interactions of IMFINZI. 2021 Nov;16 (6):857-864. 2. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with. Code Description Vial size Billing units. Table 1. 00 Inclusive of all taxes. The Imfinzi-Imjudo-platinum chemotherapy treatment also cut the risk of cancer progression or death by a significant 28%. Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. NCCN Clinical Practice Guidelines in Oncology ® Non-Small Cell Lung Cancer. Submit PA requests . The approval was based on data from the Phase III PACIFIC trial. Food and Drug Administration (FDA), AstraZeneca has announced that Imfinzi (durvalumab) — which last year failed a confirmatory Phase 3 trial — will no longer be available in the U. 1 6. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. IMFINZI is a prescription medicine used to treat different types of cancer, such as lung, bladder, and liver cancer. FDA approvals of PD-1/PD-L1 mAbs. due to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020). Bavencio avelumab 800 mg J9023 80 HCPCS units (10 mg per unit) Imfinzi durvalumab 1,500 mg J9173 150 HCPCS units (10 mg per unit) Keytruda pembrolizumab 400 mg J9271 400 HCPCS units (1 mg per unit). National. 31, 2018. 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. The second and third segments of NDC Labeler code are assigned by the labeler. The NDC code would be unique for all of them and can help you distinguish between those result. The active substance of Imfinzi is durvalumab, an antineoplastic monoclonal antibody (ATC code: L01XC28) that potentiates T-cell response, including anti-tumour response, through blockade of PD -L1 binding to PD-1. 7 6. On September 2, 2022, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for adult patients with locally advanced. S. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. Report code only with appropriate primary procedure. Payers may require the. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint. (2. 5 Blepharospasm and G24. For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. ‡ C9399, J3490 Aralast NP* alpha 1-proteinase inhibitor* J0256 Aranesp* darbepoetin alfa* J0881, J0882 Asceniv* immune globulin* J1554 Asparlas calaspargase pegol-mknl J9118 Atgam lymphocyte immune globulin J7504 Avastin (Authorization required only for. 68 mg/mL). How to store IMFINZI . Accessed on May 11, 2021. The approval is based on the phase III PACIFIC trial, in which the PD-L1 inhibitor Imfinzi improved median progression-free. • NDC (National Drug Codes): The US Federal Drug Administration (FDA) Data Standards Council assigns the first 5 digits of the 11 digit code. HCPCS code(s) below does not signify or imply member coverage or provider reimbursement. Effective date is noted in the file title. NDC: 58160-0815-52 (1 dose T-L syringes. first two segments of the National Drug Code: NDC 3 segment: 0781-1506-10; 60429-324-77; 11523-7020-1; three segment format of the National Drug Code. NovoLogix Carelon Quantity limits . Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. g. g. 200 mg are administered = 4 units are billed. Refer to. (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. MM. Topic/Issue: Request to establish a new Level II HCPCS code to identify macimorelin. J-codes are a subset of the Healthcare Common Procedure Coding System (HCPCS) codes. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added J12. The product's dosage form is injection, solution and is administered via intravenous form. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). The National Drug Code (NDC) Directory is updated daily. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14. 2 DOSAGE AND ADMINISTRATION 2. Use the units' field as a multiplier to arrive at the dosage amount. Example 3: HCPCS description of drug is 1 mg. 1, 2020, the Medicaid and NC Health Choice programs cover famotidine injection (Pepcid®) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3490 - Unclassified drugs. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging. The FDA had granted Imfinzi with its bladder cancer indication through the accelerated appr oval program in 2017, with continued approval contingent upon verification of clinical benefit in confirmatory trials. Group 1. Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. 1)] Grade 2 Withhold doseb Initial dose of 1mg/kg/day to 2mg/kg/day prednisone or equivalent followed by a taper Grade 3 or 4. 4%) patients. 5 mLCPT/HCPCS code update effective 01/01/2021: In CPT/HCPCS Group One Codes and Miscellaneous Radiopharmaceuticals Deleted: 78135. More common side effects in people taking Imfinzi for small cell lung cancer include. J0588 - Labeled indications for Xeomin are limited to G24. CPT codes provided in the vaccine code sets are to assist with. 5. Imfinzi (durvalumab) may be considered medically necessary for the treatment of adults with: • Unresectable, stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy • First-line treatment of extensive-stage small cell lung cancerThe HIPAA standard 11-digit NDC format is standardized such that the labeler code is always 5 digits, the product code is always 4 digits, and the package code always 2 digits. hcpcs or cpt® code(s) drug j9217 lupron depot (1-month) j9217 lupron depot (3-month) j1950 lupron depot (3-month) j9217 lupron depot (4-month) j9217 lupron depot (6-month) j2503. ) Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347. As of April 2020, the Alpha-Numeric HCPCS File is a quarterly file. V. CanMED: NDC. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Page 5 of 52 Urothelial Carcinoma The recommended dose of IMFINZI is 10 mg/kg every 2 weeks or 1500 mg every 4 weeks. The NDC Number for each drug will be different. Brand Generic Codes Amvuttra vutrisiran J0225 Aphexda †,. Generic name: durvalumab [ dur-VAL-ue-mab ] Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors) Medically reviewed by. Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with. (2. AstraZeneca has opted to voluntarily withdraw. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. 82 due to reconsideration requests. May 2021. Imfinzi is. D. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. IRST . 2 7. 10 mg vial of drug is administered = 10 units are billed. NOTE: Dates of service for Terminated HCPCS codes not needed. The National Drug Code (NDC) Directory is updated daily. S. S. 2.