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.
The use of plasminogen, human-tvmh (Ryplazim) may be considered medically necessary when
ALL
of the following criteria are met:
-
The individual has a diagnosis of plasminogen deficiency Type I (hypoplasminogenemia);
and
-
The individual has symptomatic internal or external lesions consistent with plasminogen deficiency Type I (i.e., ligneous conjunctivitis, ligneous gingivitis, and/or pseudomembranous lesions on mucus membranes [middle ear, respiratory tract gastrointestinal tract]);
and
-
The individual's baseline (before treatment with plasminogen, human-tvmh (Ryplazim)) plasminogen activity has been assessed;
and
- The prescriber is a specialist in the area of the individual's diagnosis (e.g., ophthalmologist, specialist from a hemophilia and thrombosis treatment center) or the prescriber has consulted with a specialist in the area of the individual's diagnosis.
Reauthorization Criteria
Continuation of therapy with plasminogen, human-tvmh (Ryplazim) may be considered medically necessary when the following are met:
-
The individual has been previously approved for the requested agent through the Blue Cross Blue Shield of North Dakota's precertification process;
and
-
ONE of the following:
-
The individual has had at least a 10% increase in plasminogen activity from baseline (before treatment with the requested agent);
or
-
The individual has had a 50% improvement in symptomatic internal or external lesion numbers or size from baseline (before treatment with the requested agent);
or
-
The prescriber has provided information supporting the continued use of the requested agent;
and
- The prescriber is a specialist in the area of the individual's diagnosis (e.g., ophthalmologist, specialist from a hemophilia and thrombosis treatment center) or the prescriber has consulted with a specialist in the area of the individual's diagnosis.
The use of plasminogen, human-tvmh (Ryplazim) 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
