Coverage is subject to the specific terms of the member’s benefit plan.
The use of plasminogen, human-tvmh (Ryplazim) may be considered medically necessary when ALL of the following criteria are met:
- The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
- The prescriber is or has consulted with a hematologist or specialist in treated condition; and
- The individual must have a diagnosis of plasminogen deficiency type 1 confirmed by the following (as evidenced with submitted documentation):
- Baseline plasminogen activity level less than or equal to 45% (If the patient is receiving plasminogen supplementation with fresh frozen plasma, allow for a 7-day washout period before obtaining baseline plasminogen activity level.); and
- Documented history of lesions (e.g., ligneous conjunctivitis, ligneous gingivitis, occlusive hydrocephalus, abnormal wound healing); and
- Genetic testing to confirm biallelic pathogenic PLG mutation.
Initial Authorization: Three (3) months
Continuation of therapy with plasminogen, human-tvmh (Ryplazim) may be considered medically necessary when the following are met:
- The individual must have experienced meaningful clinical benefit since starting treatment with the requested medication, as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review) including the following:
- Member has demonstrated a 50% resolution of lesions, with no active or recurrent lesions; and
- Trough plasminogen activity levels are greater than 10% above baseline.
Continuation Authorization: 12 months, a one-time six (6)-month approval for dose adjustment allowed for members not meeting renewal criteria upon request
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.