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REBLOZYL access and reimbursement

Authorized distributors

REBLOZYL can only be purchased through authorized distributors for administration in physician offices, hospital outpatient facilities, institutions, Veterans Affairs, and the Department of Defense. The following distributors are authorized to sell REBLOZYL and are able to service qualified accounts.

Authorized distributor network

Community practices Phone Fax
Cardinal Specialty 1-877-453-3972
McKesson Specialty Health 1-800-482-6700 1-800-289-9285
Oncology Supply 1-800-633-7555 1-800-248-8205
Institutions/hospital outpatient facilities
AmerisourceBergen 1-844-222-2273 1-888-292-9774
ASD Healthcare 1-800-746-6273 1-800-547-9413
Cardinal Specialty 1-866-677-4844
McKesson Pharma 1-855-625-6285 1-800-599-9893
Puerto Rico hospitals and clinics
Cardinal Health P.R. 1-787-625-4200
Cesar Castillo, Inc. 1-787-641-5242
(Hospitals)
1-787-641-5082
(Specialty Pharmacy)		 1-787-999-1614

Extended dating terms may be available for REBLOZYL. Please contact your authorized distributor for more information.

Pursuant to the agreement with your authorized distributor, Celgene is committed to providing product within 1 business day of your order for REBLOZYL.

NDC and how supplied

National Drug Codes (NDC) and packaging information

Product/strength Package/description 11-digit NDC
REBLOZYL injection 25 mg 25-mg lyophilized powder for solution for injection in a single-dose vial for reconstitution 59572-0711-01
REBLOZYL injection 75 mg 75-mg lyophilized powder for solution for injection in a single-dose vial for reconstitution 59572-0775-01

The red zero converts the 10-digit NDC to the 11-digit NDC. Payer requirements regarding the use of NDCs may vary. Electronic data exchange generally requires use of the 11-digit NDC.

Billing and coding

HCPCS codes
J3490 Not otherwise classified drugs
J3590 Not otherwise classified biologics
J9999 Not otherwise classified anti-neoplastic drugs
C9399 Unclassified or biologicals (hospital outpatient use only)
CPT® code
96372 Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular
96401 (For potential use only in MDS) Chemotherapy administration, subcutaneous or intramuscular;
non-hormonal anti-neoplastic
ICD-10-CM diagnosis codes for beta thalassemia
D56.1 Beta thalassemia major and intermediate

  • Beta thalassemia major
  • Cooley’s anemia
  • Homozygous beta thalassemia
  • Severe beta thalassemia
  • Thalassemia intermedia
  • Thalassemia major
D56.5
  • Hemoglobin E-beta thalassemia
ICD-10-CM diagnosis codes for MDS
D46.1 Refractory anemia with ring sideroblasts
D46.A Refractory cytopenia with multilineage dysplasia
D46.B Refractory cytopenia with multilineage dysplasia and ring sideroblasts
D46.4 Refractory anemia, unspecified
D46.Z Other myelodysplastic syndromes
D46.9 Myelodysplastic syndrome, unspecified

CPT, Current Procedural Terminology; HCPCS, Healthcare Common Procedure Coding System; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification.

CPT® codes and descriptions are copyright 2020 American Medical Association (AMA). All rights reserved. CPT® is a registered trademark of the AMA.

Depending on payer preferences for billing and coding, the required miscellaneous J code for claim submission may vary.

Therefore, the provider will want to confirm preference with payer prior to submitting.

Note the use of a miscellaneous C code (C9399) for when REBLOZYL is used in a hospital infusion center.

The 2020 version of ICD-10-CM took effect on October 1, 2019.

The information contained herein is not intended to provide specific coding and reimbursement advice for any specific patient or situation. You should check with your coding specialist to ensure appropriate submissions.

How to Order & Access REBLOZYL

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Indication

REBLOZYL is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

REBLOZYL is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Thrombosis/Thromboembolism

In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.

Hypertension

Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 1.8% to 8.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In adult patients with MDS with normal baseline blood pressure, 26 (29.9%) patients developed SBP ≥130 mm Hg and 23 (16.4%) patients developed DBP ≥80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.

Embryo-Fetal Toxicity

REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.

ADVERSE REACTIONS

Beta-Thalassemia

  • Serious adverse reactions occurred in 3.6% of patients on REBLOZYL. Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML)
  • Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%)

Myelodysplastic Syndromes

  • Grade ≥3 (≥2%) adverse reactions included fatigue, hypertension, syncope and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients
  • The most common (≥10%) adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection

LACTATION

It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.

Please click here for full Prescribing Information for REBLOZYL.