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)    Elrexfio (elranatamab-bcmm) requires prior authorization.

2)    Elrexfio is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma.

3)    Elrexfio is covered under the medical benefit.

Initial Approval Criteria

I.             Multiple Myeloma (must meet all):

a.    Diagnosis of MM;

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

c.    Age > 18 years;

d.    Disease is relapsed or refractory;

e.    One of the following (i or ii):

                       i.    Member has measurable disease as evidenced by one of the following assessed:

1.    Serum M-proten > 5g/dL;

2.    Urine M-protein > 200 mg/23h;

3.    Serum free light chain (FLC) assay: involved FLC level > 10mg/dL (100mg/L) provided serum FLC ratio is abnormal;

                      ii.    Member has progressive disease, as defined by the IMWG response criteria assessed with 60 days following the last dose of the last anti-myeloma drug regimen received.

f.     Elrexfio is prescribed as monotherapy;

g.    Member has received or has documented intolerance to > 4 prior lines of therapy that include all of the following:

                       i.    One proteasome inhibitor (e.g. bortezomib, Kyprolis, Ninlaro)

                      ii.    One immunomodulatory drug (e.g. Revlmid, pomalidomide, Thalomid)

                     iii.    One anti-CD38 antibody (e.g. Darzalex/Darzalex Faspro), Sarclisa)

h.    Dose is consistent with FDA labeling

Approval Duration: 6 months

Continued Therapy Criteria

1.    Member is responding positively to therapy

2.    Dose is consistent with FDA labeling.

Continued Therapy Duration: 12 months

1.    Elrexfio Prescribing Information. New York, NY: Pfizer Inc.; August 2023. Available at: www.Elrexfio.com. Accessed August 30, 2023.

2.    National Comprehensive Cancer Network. Multiple Myeloma Version 4.2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Accessed August 30, 2023.

3.    Lesokhin AM, Tomasson MH, Arnulf B, et al. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med. 2023 Aug 15. doi: 10.1038/s41591-023-02528-9.