Therapeutic Class Code: N1B
Therapeutic Class Description: Hematinics, Other
| Medication | Generic Code Number(s) |
| Procrit, Epogen (Erythropoietin) | 24059 , 25110, 25111, 25112, 25113, 25114, 25115 |
| Aranesp (Darbepoetin Alfa) | 14044, 14045, 14046, 14047, 14048, 14049, 14053,14054, 14055, 14056, 14891, 14893, 14894, 15202,17763, 17764, 19967, 19968, 19969, 19971, 19972, 19973, 20913, 20916, 27164, 97010, 97011, 97012, 97015, 97063, 97064, 97065, 97066, 97072, 97010, 97011, 97012, 97015, 98250, 98251, 98252, 98253 |
Early Periodic Screening, Diagnostic and Treatment Provision
Early Periodic Screening, Diagnostic and Treatment (EPSDT) allows a recipient less than 21 years of age to receive services in excess of the limitations or restrictions below and without meeting the specific criteria in this section when such services are medically necessary health care services to correct or ameliorate a defect, physical or mental illness, or a condition [health problem]; that is, documentation shows how the service product or procedure will correct or improve or maintain the recipient’s health in the best condition possible, compensate for a health problem, prevent it from worsening, or prevent the development of additional health problems.EPSDT DOES NOT ELIMINATE THE REQUIREMENT FOR PRIOR APPROVAL IF PRIOR APPROVAL IS REQUIRED. Additional information on EPSDT guidelines may be access at http://www.ncdhhs.gov/dma/epsdt/
Approval will be considered in the following circumstances:
1. Anemia associated with renal failure OR
2. Anemia associated with HIV Infection OR
3. Anemia associated with chemotherapy OR
4. Anemia associated with myelodysplastic syndromes OR
5. Drug induced anemia such as with ribavarin or zidovudine
Initial Therapy - patient must meet all requirements
1. Hemoglobin less than or equal to 11 for initial therapy AND
2. Lab data within 3 months of PAContinuation of Therapy - Patient must meet all requirements
1. Hemoglobin less than or equal to 12 AND
2. Lab data within 3 months of PAMay be approved for up to six months.
References:
1.Epoetin alfa. Drug facts and comparisons. St. Louis (MO): Facts and Comparisons, Inc; Clinisphere 2.0 Tutorial;2001.
2. Ortho-Biotech, Inc. Procrit package insert. Thousand Oaks (CA): 1999 Oct.
3. Turner R et al. Epoetin alfa in cancer patients; evidence-based guidelines. J Pain Symptom Manage 2001 Nov;22(5):954-65.
4. Littlewood TJ. The impact of hemoglobin levels on treatment outcomes in patients with cancer. Semin Oncol 2001 Apr;28(2 Suppl 8):49-53.
5. Abrams DI, Steinhart C and Frascino R. Epoetin alfa therapy for anaemia in HIV-infected patients: impact on quality of life. Int J STD AIDS 2000 Oct; 11(10):659-65.
6. Soignet S. Management of cancer-related anemia: epoetin alfa and quality of life. Semin Hematol 2000 Oct;37(4 Suppl 6):9-13.
7. Gabrilove J. Overview: erythropoiesis, anemia and the impact of erythropoetin. Semin Hematol 2000 Oct;37(4 Suppl 6):1-3.
8. FDA Public Health Advisory on Epoetin alfa and Darbepoetin following publication of NEJM articles on Nov 16, 2006
9. Meta-analysis is by Bohlius J Natl Cancer Inst 2006 98: 708-714.
10. NEJM editorial Remuzzi G, Ingelfinger JR. Correction of anemia – payoff and problems. NEJM. 2006. 355(20): 2144-2146
11. Systematic review of the literature. Ross SD, Allen E, Henry DH, Seaman C, Sercus B, Goodnough LT. Clinical benefits and risks associated with epoeitin and darbepoetin in patients with chemotherapy induced anemia: a systematic review of the literature. Clinical Therapeutics. 2006. 28(6): 801-831.