Initial Approval Criteria A. Cold Agglutinin Disease
(must meet all):
1.
Diagnosis of primary cold agglutinin disease (CAD);
2.
Prescribed by or in consultation with a hematologist or oncologist;
3. Age
≥ 18 years;
4.
Secondary CAD has been ruled out (i.e., cold agglutinin syndrome secondary to
infection, rheumatologic disease, or active hematologic malignancy);
5.
Member meets all of the following (a, b, c, and d):
a. Active hemolysis as
evidenced by elevated total bilirubin;
b. Polyspecific direct
antiglobulin test (DAT) (i.e., Coombs test) is positive;
c. Monospecific DAT shows
both of the following (i and ii):
i. C3d DAT: strongly
positive;
ii. IgG DAT: negative or
weakly positive;
d. Cold agglutinin titer
≥ 64 at 4 degrees Celsius;
6.
Hemoglobin ≤ 10 g/dL;
7.
Enjaymo is not prescribed concurrently with rituximab or rituximab-based
regimens (i.e., rituximab with bendamustine or fludarabine);
8.
Dose does not exceed one of the following (a or b):
a. For body weight 39 kg
to < 75 kg: 6,500 mg (6 vials) on Day 0, Day 7, then every 2 weeks thereafter;
b. For body weight ≥ 75
kg: 7,500 m (7 vials) on Day 0, Day 7, then every 2 weeks thereafter.
Approval duration: 6 months
Continued Therapy
A.
Cold Agglutinin Disease
(must meet all):
1.
Currently receiving medication via Centene benefit or member has previously met
initial approval criteria;
2.
Member is responding positively to therapy as evidenced by one of the following
since initiation of Enjaymo therapy (a and b):
a. Increase in hemoglobin
> 1.5 g/dL or hemoglobin level > 12 g/dL;
b. Transfusion free or
decreased number of transfusions/blood units;
3. If
request is for a dose increase, new dose does not exceed one of the following (a
or b):
a. For body weight 39 kg
to < 75 kg: 6,500 mg (6 vials) every 2 weeks;
b. For body weight ≥ 75
kg: 7,500 mg (7 vials) every 2 weeks.
Approval duration: 12 months
Codes
Used In This BI:
1)
C9094 – Inj,
sutimlimab-jome, 10mg (code deleted & replaced by J1302 eff 10-1-22)
2)
J1302 - Inj,
sutimlimab-jome, 10 mg