Depending. NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. Approval: 2017 total bilirubin elevation. The current update (2016) adds 34 drugs and includes a review of the 2004 list. Bahamas. The Drug Name and NDC Reference Data file: The Drug Name and NDC Reference Data are delivered in one pipe-delimited . The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agentsare presented in Table 1. Note: ICD-10 codes are scheduled to go into effect October 1, 2015. 3 . Generic name . macugen. Get help with Imprint Code FAQs. Imfinzi Generic Name durvalumab. Imfinzi durvalumab J9173A. Providers must bill with CPT code: 90750 - Zoster (shingles) vaccine, (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . HCPCS (90670 and 90732) to get the Dates of Services for these PPV HCPCS code. Contact your patient’s• Administer IMFINZI as an intravenous infusion over 60 minutes. FDA approvals of PD-1/PD-L1 mAbs. Bahamas Updated. The approval of IMFINZI is based on the positive PFS data from the Phase III PACIFIC trial in which IMFINZI demonstrated an improvement in median PFS of 11. HCPCS code(s) below does not signify or imply member coverage or provider reimbursement. 21. Other changes to the CPT code set. 20. liver dysfunction. It’s given as an IV infusion. provider administered drugs page 2 of 3 . Wilmington, DE; AstraZeneca Pharmaceuticals LP; July 2021. For example, the same drug may be produced by many different manufacturers or the same drug may have different dosages. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. 05 ICD-10-CM. ─ NDC units are billed at the NDC level and not at the HCPCS level ─ Example: NDC Units = 9,999 and the HCPCS unit = 1. The recommended dosefor IMFINZI monotherapyandIMFINZI combination therapy ispresented in Table 1. What is National Drug Code (NDC)? • A unique . Each single-dose glass vial is filled with a solution of 29. 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. AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has received FDA approval for treatment of adult patients with unresectable hepatocellular carcinoma (HCC). dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks Imfinzi (durvalumab) is an immunotherapy used in a variety of cancers, including lung cancer and liver cancer. Imfinzi [package insert]. PPO . 2 DOSAGE AND ADMINISTRATION . 70461-0323-03 Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. This corresponded to a. 2 DOSAGE AND ADMINISTRATION 2. code . The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. skin rash *. Search by NDC: (Type the 4 or 5 digit NDC Labeler Code with the hyphen (e. 0601C. There are 11 disease interactions with Imfinzi (durvalumab) which include: adrenal insufficiency. Sean Bohen, MD, Phd. The FDA offers an NDC searchable database. 57 rescinds legacy NHRIC and NDC numbers and requires discontinuation of their use on device labels and packages, the UDI Rule does not prohibit use of 11-digit numbers or other. IMFINZI™ (durvalumab) Injection. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. 6. Cancer Oncology Rx required. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1,. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 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,. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. The CPT procedure codes do not include the cost of the supply. The NDC is 00024-5841-01 (the qualifier is N4) The unit of measure is ML The quantity (number of NDC units administered ) is 16 The quantity (number of J-code units administered) is 1 The price per unit also must be included On the CMS-1500, the data would be entered as follows: N400024584101 ML16 480. National Comprehensive Cancer Network, Inc. 50. The approval was based on the results of the CASPIAN clinical trial, which showed that. (2. PD-L1 can be induced by inflammatory signals (e. 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. 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. paper. This page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. 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). active_ingredient_code Multum’s ingredient is a simple description of the generic chemical name of the drug. 5-fl-oz (340-mL) Bottle / Case of 12Effective with date of service Jan. com. pneumonitis * ( inflammation of the lungs) hair loss. Generic Name: durvalumab. This medication can cause rare, but serious. UB-04. Serious side effects reported with use of Imfinzi include: rash*. PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. IMFINZI. Second claim should be billed from 5/3 through 5/31 with the HCPCS on the 5/3 - 5/31 claim. NDC notation containing asterisks is not accepted. The approval is based on the phase III PACIFIC trial, in which the PD-L1 inhibitor Imfinzi improved median progression-free. Report the supply separately using a HCPCS (Healthcare Procedural Coding System) code: J7307 Etonogestrel [contraceptive] implant system, including implant and. The official update of the HCPCS code system is available as a public use file below. The product's dosage form is injection, solution and is administered via intravenous form. Recommended dose of IMFINZImonotherapy and combination therapy Indication Recommended IMFINZI dose Duration of therapy Monotherapy Locally Advanced. Possible side effects . The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. IMFINZI® (durvalumab) COPYRIGHT 2017 - 2022 ASTRAZENECA CANADA INC. csv file. 4 mL in 1 VIAL Effective Date: May 1, 2017 Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 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. (2) Each person who is assigned an NDC labeler code must update the information submitted under paragraph (c)(1)of this section within 30 calendar days after any change to that information. havediseaseprogressionwithin12monthsofneoadjuvantoradjuvanttreatmentwithplatinum-containingchemotherapy. 10 mg vial of drug is administered = 10 units are billed. 82 due to reconsideration requests. Generic name . Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. The product's dosage form is injection, solution and is administered via intravenous. 9 in addition to the appropriate flu vaccine and administration codes. The FDA approval was based on the results of the Phase 3 PACIFIC clinical trial ( NCT02125461 ). 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. First claim should be billed from 5/1 through 5/2. allergic reaction *. Although AstraZeneca did not provide specific data in its press release, the company said that patients who were. 10-digit, 3-segment number. 65 Unit of measure (UOM) is mL Pricing calculation: 105% of the wholesale acquisition cost (WAC) of the NDC billed by the provider. 90674. In Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein. 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. No dose reductions are recommended. 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. Both the product and package codes are assigned by the firm. Pre-Stata13 had a string length limit of 244 characters. As of December 2020, six anti-PD-1/PD-L1 mAbs have been approved with supplemental indications across 19 cancer types and two tissue-agnostic. 4 OVERDOSE 10 DESCRIPTION 12 12. HCPCS Level II Code. IRST . The following CPT codes are to be reported for the procedures performed. Brand name . Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. This is not a complete list of side effects and others may occur. J9035 is defined in the HCPCS manual as: Injection, bevacizumab, 10 mg. Granted under priority review, the approval allows Imfinzi to be administered at a fixed dose of 1,500 mg every four weeks for patients. 1. 1. Imfinzi comes as a liquid solution in single-dose vials. nervousness. Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with. 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). • Administer IMFINZI as an intravenous infusion over 60 minutes. Coverage PeriodExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. This revision is due to the Q1 2021 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 1/1/2021. Rx only. See full prescribing information for IMFINZI. The National Drug Code (NDC) Directory is updated daily. HCPCS Quarterly Update. 01 Learn More About Medical Coding Section 2. 94 Section: Prescription Drugs Effective Date: April 1, 2020 Subsection: Antineoplastic Agents Original Policy Date: May 12, 2017 Subject: Imfinzi Page: 1 of 5 Last Review Date: March 13, 2020 Imfinzi Description Imfinzi (durvalumab) Background Imfinzi (durvalumab) is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody thatcough, feeling short of breath; cold symptoms such as stuffy nose, sneezing, sore throat; painful urination; hair loss; rash; or. S. 3%) patients including fatal pneumonitis in one (0. All other Codes (ICD-10, Bill Type, and Revenue) have moved to Articles for DME MACs, as they have for the other Local Coverage MAC types. 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 patients with extensive-stage small cell lung cancer (ES-SCLC). 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. . For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. One Medicaid unit of coverage is 0. The service must be reasonable and necessary in the specific case and must meet the criteria specified in this determination. 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. Discard unused portion. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. The following table shows common 10-digit National Drug Code (NDC) formatsYescarta is billed using HCPCS code Q2041 – Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per2. Do not report 90460, 90471-90474 for the administration of COVID vaccines. 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. indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). CPT Code CVX NDC PRESENTATION DESCRIPTION BRAND NAME VFC COVERED? 317 Adults Covered? Public Clinic "Billables"? 90686. 21. Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. Additionally, either the long or short description of CPT code 19499 has been updated. Sometimes, it’s used together with other immunotherapies and chemotherapy. 094 Section: Prescription Drugs Effective Date: April 1, 2023 Subsection: Antineoplastic Agents Original Policy Date: May 12, 2017 Subject: Imfinzi Page: 1 of 5 Last Review Date: March 10, 2023 Imfinzi Description Imfinzi (durvalumab) Background Imfinzi (durvalumab) is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody thatAt 18 months, 34% of Imfinzi-treated patients were alive, as were 25% of those in the control group. Table 1. 4 mL injection Availability Prescription only Drug Class Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint. Note: Third party payers may have specific policies and guidelines that might require providing additional information on their claim forms. 90672. Injection, infliximab, 10 mg. List of Vaccine Names, Best ASIIS Selection and CPT/CVX Codes This list matches the vaccine name or codes in Arizona State Immunization Information System (ASIIS) with the brand name or other common names. S. Tell your caregiver right away if you feel light-headed or itchy, or if you have a fever, chills, neck or back pain, trouble breathing,. 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). 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. The product-specific HCPCS code for REMICADE® is J1745, infliximab, 10 mg. Claims cannot list 9,999 on the Procedure Code Line but must be input into the NDC Line and vice versa. Qualifying notice amendment for Imfinzi. 8. diabetes. It applies to all plans except Medicare Supplemental plans. 1 6. Subject: Imfinzi Page: 4 of 4 1. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. Applicant suggested language: JXXXX macimorelin 60 mg, oral solution. Dosing for infants and children age 6 through 35 months: • Afluria 0. Converting National Drug Code (NDC) from a 10-digit to an 11-digit format requires a strategically placed zero, dependent upon the 10-digit format. Billing Code/Information J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg Prior authorization of bene fits is not the. 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. The list of results will include documents which contain the code you entered. Level I HCPCS (CPT-4 codes) for hospital providers; Level II HCPCS codes for hospitals, physicians and other health professionals who bill Medicare A-codes for ambulance services and radiopharmaceuticals; C-codes; G-codes; J-codes, and; Q-codes (other than Q0163 through Q0181) Formulate and submit the specific question you have. Listen to a soundcast of the September 2nd, 2022 FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer. g. PPENDIX . More common side effects in people taking Imfinzi for small cell lung cancer include. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. 7 6. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. Approval: 2017 . The units submitted for HCPCS, CPT, and Revenue codes are based on the HCPCS,. 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. This study has 2 parts: dose finding and dose confirmatory. Attention Pharmacist: Dispense the accompanying Medication. A: Yes, the NDC information must be submitted in addition to the applicable HCPCS, CPT or Revenue code(s) and the number of HCPCS, CPT or Revenue code units. These Prior Approval supplementals biologics application provide for the addition of alternate treatment schedule of 1500 mg every 4 weeks for stage 3 unresectable non-small cell lung cancer and urothelial carcinoma. Fig. The National Drug Code (NDC) Directory data is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use. CPT/ HCPCS Code Laboratory Code Long Descriptor Target 1. 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). Store at 2° to 8°C (36° to 46°F). JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. 150: 33332-0322-03: 0. A new formulation to incorporate Omicron strain BA. 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. OUT OF STOCK. Page 5 of 52 Urothelial Carcinoma The recommended dose of IMFINZI is 10 mg/kg every 2 weeks or 1500 mg every 4 weeks. 5 mL 10 pre-filled syringes seasonal influenza, quadrivalent, preservative free: 90688 150; 33332-0422-10 multi-dose vial, 5 mL (0. 5 mL dose) seasonal influenza,HCPCS code Q5124 has been added to the CPT/HCPCS code section. Loncastuximab Tesirine is for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). Please see the HCPCS Quarterly Update webpage for those updates. Also include the NDC. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . C. in a 10-digit format. A. Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. Learn more about how IMJUDO® (tremelimumab-actl) is approved in combination with IMFINZI® (durvalumab) as a treatment option for patients with unresectable HCC and metastatic NSCLC. 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. Imfinzi (durvalumab) may be used as a single agent for consolidation therapy (for a total of 1Imfinzi FDA Approval History. Dosage Modifications for Adverse Reactions . code . HCPCS code describes JEMPERLI. colitis. Control #:. . 1 mL. Store at 2° to 8°C (36° to 46°F). HCPCS/CPT code: J0744 HCPCS/CPT code description: Ciprofloxacin for intravenous infusion, 200 MG Number of HCPCS/CPT units 6 NDC (11-digit billing format): 00409-4765-86 NDC description: Ciprofloxacin IV SOLN 200 MG/20 ML NDC unit of measure ML 8. Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. com) document for additional details . In addition to the new alternateBe attentive to the long description of the HCPCS code. All other Codes (ICD-10, Bill Type, and Revenue) have moved to Articles for DME MACs, as they have for the other Local Coverage MAC types. 25 mg/mL bupivacaine and 0. 34 mg/mL), or 8 mg (2. As of December 2020, six anti-PD-1/PD-L1 mAbs have been approved with supplemental indications across 19 cancer types and. 099. The Imfinzi-Imjudo-platinum chemotherapy treatment also cut the risk of cancer progression or death by a significant 28%. They may not be reported prior to effective date. ─ All claims being submitted with an NDC also require a HCPCS code as well as the appropriate number of HCPCS units. 120 mg/2. Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. The safety and tolerability of the Imfinzi combination was consistent with previous. Coverage of Imfinzi is available when the following criteria have been met: • Member is at least 18 years of age AND. Applicable Procedure Codes J9173 Injection, durvalumab, 10mg, 1 billable unit = 10mg Applicable NDCs 0310-4611-50. Effective Jan. Article revised and published on 01/22/2015 to reflect the annual CPT/HCPCS code updates. 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. 5. 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). Do not freeze or shake. Enter the code you're looking for in the "Enter keyword, code, or document ID" box. • NDC (National Drug Codes): The US Federal Drug Administration (FDA) Data Standards Council assigns the first 5 digits of the 11 digit code. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. Researchers randomized patients to receive either Imfinzi or a placebo every two weeks for up to 12. IMFINZI 20 mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg. Establish new Level II HCPCS code J9227 "Injection, isatuximab-irfc, 10 mg" Effective: 10/01/2020 . (2. 82 to Group 1, ICD-10-CM Codes that Support Medical Necessity. # Step therapy required through a Humana preferred drug as part of preauthorization. IMFINZI works by helping your immune system fight your cancer. Updated Nationally Determined Contribution of the Republic of Azerbaijan. 1. EALTH . By attaching to PD-L1 and blocking its effects, Imfinzi increases the ability of the immune. Do not freeze or shake. HCPCS code = J3490 HCPCS units = 1 -National Drug Code (NDC) is 00009-470913 NDC units = 0. Mechanism of action. ES-SCLC: Until disease progression, unacceptabletoxicity. Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. 6%). The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Finished drug products. fatigue (lack of energy) upper respiratory infection such as the common cold. After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity. 4. Administer IMFINZI as an intravenous infusion after dilutionas recommended [seeDosage and Administration (2. Q: Does the requirement to bill NDCs apply to all plans? A: No. Imfinzi disease interactions. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. CanMED: NDC. 3. How you are given IMFINZI . 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. ‡ 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. A unique HCPCS code is needed to implement payment provisions of the Social Security Act. Example 1: HCPCS description of drug is 6 mg. 6 mg are administered = 1 unit is billed. Discard unused portion. Submit PA requests . Starting April 19, 2021, a valid National Drug Code (NDC) number, unit of measure, and units dispensed for drugs administered by health care professionals in ambulatory care settings will be required on all professional and facility drug claims. Imfinzi comes as a liquid solution in single-dose vials. The 835 electronic transactions will include the reprocessed claims along with other claims. May 2021. or HCPCS Codes and/or How to Obtain Prior Authorization . Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. The UOM codes are: F2 = international unit. 2. • Should not be assigned to non-drug products. due to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020). It includes information on dosage, administration, warnings, adverse reactions, clinical studies, and more. Current through: 11/21/2023. 0 Unit: mg/10mL Packages: Code: 00310-4611-50 Description: 1 VIAL in 1 CARTON (0310-4611-50) / 10 mL in 1 VIAL Effective Date: May 1, 2017 CPT codes covered if selection criteria are met: VENTANA PD-L1 (SP263) Assay - no specific code: Other CPT codes related to the CPB: 96413 - 96417 : Chemotherapy administration; intravenous infusion technique : HCPCS codes covered if selection criteria are met: J9173 : Injection, durvalumab, 10 mg: Other HCPCS codes related to the CPB: C9147 NDC 0310-4500-12. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with. e When tetanus or rabies products are given as part of wound management, use a primary ICD-10 code which describes the patient’s condition. On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and. 90672. IMFINZI safely and effectively. NDC Code(s): 0310-4500-12, 0310-4611-50 Packager: AstraZeneca Pharmaceuticals LP; Category: HUMAN PRESCRIPTION DRUG LABEL ; DEA Schedule: None; Marketing Status: Biologic Licensing Application Coding Resource Indications for IMFINZI IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: havediseaseprogressionduringorfollowingplatinum-containingchemotherapy. Seventeen5. While always displayed as 6 digits in this file; for labeler codes 2 through. Marketing Approval Date: 03/27/2020. IMFINZI in combination with IMJUDO can cause immune-mediated rash or. Coding Resource Indications for IMFINZI IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:. The U. The list of results will include documents which contain the code you entered. IMFINZI 20 mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg. Proper billing of a National Drug Code (NDC) requires an 11-digit number in a 5-4-2 format. Related Local Coverage Documents N/A. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added D89. Bevacizumab should be billed based on units, not total number of milligrams. About NDC HCPCS Product NDC: 00310-4611 Brand Name: Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route:. Specifically, we are proposing. They are the basis for your reimbursements. This medication may cause a serious reaction during the injection. The following HCPCS codes are considered medically necessary when filed with the ICD-10 diagnosis codes listed below. 99397 can be used for a preventive exam if you are over age 65. 2 mL dosage, for intramuscular use. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed. X . 40av2 Medical Guideline Disclaimer. Are assigned by the Food and Drug Administration. 7 months in the control arm, according to an FDA announcement regarding the approval. Health Service Act for Imfinzi (durvalumab) Injection, for intravenous use. The NDC is actually a 10-digit number that contains the three segments noted above. Providers must include the HCPCS procedure code, billing units and corresponding covered NDC number on the claim form. feeling cold. skin rash *. 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. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. change_type,covered_recipient_type,teaching_hospital_ccn,teaching_hospital_id,teaching_hospital_name,covered_recipient_profile_id,covered_recipient_npi,covered. Below example explain how to assign a labeler code. Please see Important Safety Information throughout and Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO. Under the approval, durvalumab can be used as an initial treatment for people with extensive-stage SCLC. ) Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347. The next 4 digits identify the specific drug product and are. 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. 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. IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The 835 electronic transactions will include the reprocessed claims along with other claims. Injection, epoetin alfa (for non-ESRD use), 1000 units. • 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. Indication: Indicated in adults and children with Hemophilia A for: On-demand. 1 vial = 10 units. fever. 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. 2. 4 mL:The active substance in Imfinzi, durvalumab, is a monoclonal antibody, a type of protein designed to attach to a protein called PD-L1, which is present on the surface of many cancer cells. 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. Imfinzi also increased the percentage of patients responding to treatment (68% vs. headache. Axitinib % % % %j9173 imfinzi q5103 inflectra j1290 kalbitor j9271 keytruda j9119 libtayo j2778 lucentis j0221 lumizyme . 2 7. 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. [medical citation needed]Durvalumab is an immune checkpoint. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). ATC code: L01FF03. 5. Prev Section 2.