Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Blincyto (Blinatumomab) requires prior authorization.

I. Initial Approval Criteria

A. Acute Lymphoblastic Leukemia (must meet all):

1. Diagnosis of B-ALL;

2. Prescribed by or in consultation with an oncologist or hematologist;

3. Requested as treatment for (a or b):

a. B-ALL in remission but MRD-positive;

b. Relapsed or refractory B-ALL (i or ii):

i. Philadelphia chromosome-negative (Ph-) disease;

ii. Philadelphia chromosome-positive (Ph+) disease and intolerant or refractory to at least one second- or subsequent-generation tyrosine kinase inhibitor* (TKI; i.e., imatinib, Sprycel®, Tasigna®, Bosulif®, Iclusig®);

*Prior authorization may be required for these agents.

4. Request meets one of the following (a or b):*

a. Dose does not exceed 28 mcg per day;

b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration: 6 months

II. Continued Therapy

A. Acute Lymphoblastic Leukemia (must meet all):

1. Currently receiving medication via QualChoice benefit, or documentation supports that member is currently receiving Blincyto for a covered indication and has received this medication for at least 30 days;

2. Member is responding positively to therapy;

3. If request is for a dose increase, request meets one of the following (a or b):*

a. New dose does not exceed 28 mcg per day;

b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

*Prescribed regimen must be FDA-approved or recommended by NCCN

Approval duration: 12 months

Codes Used in this BI:

J9039             Injection, Blinatumomab, 1mcg (Blincyto) effective 1/1/2016

1. Blincyto Prescribing Information. Thousand Oaks, CA: Amgen, Inc.; February 2022. Available at: http://pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/blincyto/blincyto_pi_hcp_english.ashx. Accessed May 2, 2022.

2. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at nccn.org. Accessed May 2, 2022.

3. National Comprehensive Cancer Network Guidelines. Acute Lymphoblastic Leukemia Version 1.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Accessed May 2, 2022.

4. National Comprehensive Cancer Network Guidelines. Pediatrics Acute Lymphoblastic Leukemia Version 1.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/ped_all.pdf. Accessed May 2, 2022.

5. Clinical Pharmacology [database online]. Elsevier, Inc.; 2022. Available at: https://www.clinicalkey.com/pharmacology/. Accessed May 2, 2022.

Addendum:

Effective 11/01/2023: Updated ALL criteria set.