ADAKVEO® (crizanlizumab-tmca) J-code J0791 effective 7/1/2020
On June 19th, 2020
Novartis is pleased to announce that for dates of service on or after July 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific J-code: J0791 for injection, crizanlizumab-tmca, 5 mg. The updated billing unit is 5 mg.
The new and unique J-code replaces all previous HCPCS codes for ADAKVEO® (crizanlizumab-tmca) for IV Infusion 10 mg/mL. The permanent J-code is used by all payer types.
Please note: For dates of service before July 1, 2020, use either J3490 (unclassified drugs, all sites of care) or J3590 (unclassified biologics, all sites of care). For dates of service between April 1, 2020, and June 30, 2020, some payers may allow the use of C9053 (Injection, crizanlizumab-tmca, 1 mg, Hospital outpatient).
Important billing and coding information:
ADAKVEO is supplied as a solution in a single-dose vial. See below for coding details:
Unique J-code for ADAKVEO Description Vial size Billing unit J0791 Injection, crizanlizumab-tmca, 5 mg 100 mg/10 mL (10 mg/mL) 20
· 1 unit = 5 mg
· The JW modifier must be used to report the amount of drug in single-dose or single-use packaging that is discarded and eligible for payment
Should you have any questions, please contact me at 817.313.0041
Indication
ADAKVEO® (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged
16 years and older, with sickle cell disease.
Important Safety Information Infusion-Related Reactions
In the SUSTAIN clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg. Monitor patients for signs and symptoms of infusion-related reactions, which may include fever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, or shortness of breath or wheezing. Discontinue ADAKVEO infusion for severe reactions and institute appropriate medical care.
Laboratory Test Interference: Platelet Counts
Interference with automated platelet counts (platelet clumping) has been observed following administration of ADAKVEO, in particular, when blood samples were collected in tubes containing EDTA.
Run blood samples within 4 hours of blood collection or collect blood samples in tubes containing citrate. When needed, estimate platelet count via peripheral blood smear.
Pregnancy
Based on animal data ADAKVEO has the potential to cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. ADAKVEO should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.
Most Common Adverse Reactions
The most frequently reported adverse reactions (≥10%) in patients treated with ADAKVEO were nausea (18%), arthralgia (18%), back pain (15%), and pyrexia (11%).
Other Clinically Important Adverse Reactions
Clinically relevant adverse reactions (all grades) that were reported in <10% of patients treated with ADAKVEO included: oropharyngeal pain, abdominal pain (abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness), diarrhea, vomiting, pruritus (pruritus and vulvovaginal pruritus), musculoskeletal chest pain, myalgia, infusion-site reaction (infusion-site extravasation, infusion-site pain, and infusion-site swelling), and infusion-related reaction.
Please see full Prescribing Information at https://www.novartis.us/sites/www.novartis.us/files/adakveo.pdf.
Novartis is pleased to announce that for dates of service on or after July 1, 2020, the Centers for Medicare and Medicaid Services (CMS) has issued a product-specific J-code: J0791 for injection, crizanlizumab-tmca, 5 mg. The updated billing unit is 5 mg.
The new and unique J-code replaces all previous HCPCS codes for ADAKVEO® (crizanlizumab-tmca) for IV Infusion 10 mg/mL. The permanent J-code is used by all payer types.
Please note: For dates of service before July 1, 2020, use either J3490 (unclassified drugs, all sites of care) or J3590 (unclassified biologics, all sites of care). For dates of service between April 1, 2020, and June 30, 2020, some payers may allow the use of C9053 (Injection, crizanlizumab-tmca, 1 mg, Hospital outpatient).
Important billing and coding information:
ADAKVEO is supplied as a solution in a single-dose vial. See below for coding details:
| Unique J-code for ADAKVEO | Description | Vial size | Billing unit |
| J0791 | Injection, crizanlizumab-tmca, 5 mg | 100 mg/10 mL (10 mg/mL) | 20 |
· 1 unit = 5 mg
· The JW modifier must be used to report the amount of drug in single-dose or single-use packaging that is discarded and eligible for payment
Should you have any questions, please contact me at 817.313.0041
Indication
ADAKVEO® (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged
16 years and older, with sickle cell disease.
Important Safety Information Infusion-Related Reactions
In the SUSTAIN clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg. Monitor patients for signs and symptoms of infusion-related reactions, which may include fever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, or shortness of breath or wheezing. Discontinue ADAKVEO infusion for severe reactions and institute appropriate medical care.
Laboratory Test Interference: Platelet Counts
Interference with automated platelet counts (platelet clumping) has been observed following administration of ADAKVEO, in particular, when blood samples were collected in tubes containing EDTA.
Run blood samples within 4 hours of blood collection or collect blood samples in tubes containing citrate. When needed, estimate platelet count via peripheral blood smear.
Pregnancy
Based on animal data ADAKVEO has the potential to cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. ADAKVEO should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.
Most Common Adverse Reactions
The most frequently reported adverse reactions (≥10%) in patients treated with ADAKVEO were nausea (18%), arthralgia (18%), back pain (15%), and pyrexia (11%).
Other Clinically Important Adverse Reactions
Clinically relevant adverse reactions (all grades) that were reported in <10% of patients treated with ADAKVEO included: oropharyngeal pain, abdominal pain (abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness), diarrhea, vomiting, pruritus (pruritus and vulvovaginal pruritus), musculoskeletal chest pain, myalgia, infusion-site reaction (infusion-site extravasation, infusion-site pain, and infusion-site swelling), and infusion-related reaction.
Please see full Prescribing Information at https://www.novartis.us/sites/www.novartis.us/files/adakveo.pdf.
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