This policy is consistent with Medicare’s coverage determination for blinatumomab (Blincyto). The Company’s payment methodology may differ from Medicare.
Subject to the applicable Evidence of Coverage, blinatumomab (Blincyto) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria and Dosing and Frequency Requirements listed in this medical policy are met.
Certain drugs are available only through the member's medical benefit (Part B benefit), depending on how the drug is prescribed, dispensed, or administered. For Medicare Advantage members, blinatumomab (Blincyto) is covered ONLY under a member's medical benefit (Part B benefit).
US FOOD AND DRUG ADMINISTRATION (FDA) STATUS
Blinatumomab (Blincyto) was approved by the FDA on December 3, 2014, for the treatment of Philadelphia chromosome–negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL). Supplemental approvals for blinatumomab (Blincyto) have since been issued by the FDA.
The safety and effectiveness of blinatumomab (Blincyto) have been established in the pediatric population with relapsed or refractory B-ALL. The effectiveness has also been established based on extrapolation from adequate and well-controlled studies in adults with MRD-positive B-cell precursor ALL.