- Coding & Pricing
Current Procedural Terminology (CPT) Drug Administration Code
CPT codes are 5-digit numeric codes established by the American Medical Association (AMA) that describe medical procedures and services. DACOGEN® is administered as an IV infusion. The following CPT codes may be appropriate to report DACOGEN® administration services:
| CPT Code | Description |
|---|---|
| 96413 | Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug |
| 96415 | Chemotherapy administration, intravenous infusion technique; each additional hour (List separately in addition to code for primary procedure) |
Payors may require physicians to report a different drug administration CPT code when billing for DACOGEN®. We recommend verifying a health plan’s coding policies. The Eisai Assistance Program can provide information to patients and healthcare professionals relating to payor-specific policies and can address other questions at: 1-866-61-EISAI or 1-866-61-34724.
Indication
- The treatment of patients with myelodysplastic syndromes (MDS) including:
- Previously treated and untreated
- De novo and secondary MDS
- All French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups.
Important Safety Information:
Treatment with DACOGEN® is associated with neutropenia and thrombocytopenia. Complete blood and platelet counts should be performed as needed to monitor response and toxicity but at a minimum prior to each dosing cycle. Clinicians should consider the need for early institution of growth factors and/or antimicrobial agents for the prevention or treatment of infections in patients with MDS.
DACOGEN® may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with DACOGEN® and for 1 month following completion of treatment. Men should be advised not to father a child while receiving treatment with DACOGEN® and for 2 months following completion of treatment.
In the phase 3 clinical trial, the highest incidences of Grade 3 or Grade 4 adverse events in the DACOGEN® arm were neutropenia (87%), thrombocytopenia (85%), febrile neutropenia (23%), and leukopenia (22%). Bone marrow suppression was the most frequent cause of dose reduction, delay, and discontinuation. Six patients had fatal events associated with their underlying disease and myelosuppression (anemia, neutropenia, and thrombocytopenia) that were considered at least possibly related to drug treatment. Of the 83 DACOGEN®-treated patients, 8 permanently discontinued therapy for adverse events compared to 1 of 81 patients in the supportive care arm.
In the single-arm study, the highest incidence of Grade 3 or Grade 4 adverse events was neutropenia (37%), thrombocytopenia (24%), and anemia (22%). Seventy-eight percent of patients had dose delays. Hematologic toxicities and infections were the most frequent causes of dose delays and discontinuation. Eight patients had fatal events due to infection and/or bleeding that were considered at least possibly related to drug treatment. Nineteen of 99 patients permanently discontinued therapy for adverse events.
Other commonly occurring reactions include fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea, and hyperglycemia.
If hematologic recovery from a previous DACOGEN® treatment cycle requires more than 6 weeks when administering the 3-day dosing, then the next DACOGEN® cycle should be delayed and dosing temporarily reduced. When administering the 5-day dosing, the DACOGEN® cycle should be delayed until there is hematologic recovery. If the following nonhematologic toxicities are present, DACOGEN® treatment should not be restarted until the toxicity is resolved: (1) serum creatinine ≥2 mg/dL; (2) SGPT, total bilirubin ≥2 × ULN; and (3) active or uncontrolled infection.
Because there are no data on use of DACOGEN® in patients with renal or hepatic dysfunction, DACOGEN® should be used with caution in these patients.
For more information about DACOGEN® please see full Prescribing Information.
Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payor, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payors following the receipt of claims. For additional information, customers should consult with their payors for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record.
This information is intended for use by our healthcare professionals in the United States only. Eisai Inc. recognizes the Internet is a global communications medium; however, laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here is not appropriate for use outside the United States. This site contains information about products that may have different product labeling in different countries.
DACOGEN® is a registered trademark used by Eisai Inc. under license from Astex Pharmaceuticals, Inc., Dublin, CA, U.S.A.
Distributed and marketed by Eisai Inc. CORP74BR6 ©2012 Eisai Inc. All rights reserved.
This site was last modified on : December 19, 2011 at 5:45pm ET
