Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the
www.fepblue.org
website.
Pozelimab-bbfg (Veopoz) may be considered medically necessary when
ALL
the following criteria are met
:
-
Individual is one (1) year of age or older;
and
-
Confirmed diagnosis of CD55-deficient protein-losing enteropathy (CHAPLE disease) consisting of
ALL
the following:
-
Hypoalbuminemia (serum albumin concentration of less than 3.2 g/dL);
and
-
History of
one or more
of the following symptoms:
-
Diarrhea;
or
-
Facial edema;
or
-
Peripheral edema;
or
-
Abdominal pain;
and
-
Genetic test confirming biallelic CD55 loss-of-function mutation.;
and
-
Individual is not receiving concomitant therapy with intravenous immunoglobulins (IVIG).
Reauthorization Criteria
Continuation of therapy with pozelimab-bbfg (Veopoz) may be considered medically necessary when the following criteria are met:
- Provider attestation that individual has demonstrated positive clinical response to therapy (i.e. normalization of serum albumin concentrations and improvement of symptoms).
The use of pozelimab-bbfg (Veopoz) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code