Ryplazim®

Drug - Ryplazim® (plasminogen, human-tvmh) [Prometic Biotherapeutics, Inc.]

October 2022

Therapeutic area - Hypoplasminogenemia

Initial approval criteria

Patient is at least 11 months of age AND
Patient has a diagnosis of plasminogen deficiency type 1 (hypoplasminogenemia) AND
Patient has a history of visible or non-visible lesions (e.g.,confirmed by computed tomography, magnetic resonance imaging, ultrasound) AND
Patient must not have hypersensitivity to plasminogen or any component of the product AND
Provider attestation that the patient’s blood pressure is controlled prior to initiation of treatment AND
Patient has healing of lesions or wounds suspected as a source of a recent bleeding event prior to initiating therapy AND
Patient has had a baseline plasminogen activity measured prior to therapy and plasminogen activity level is ≤ 45% (Note: If patient is receiving plasminogen supplementation with fresh frozen plasma, allow for a 7-day washout period before obtaining baseline plasminogen activity level) AND
Patients on concomitant therapy with anticoagulants, antiplatelet drugs, or other agents that may interfere with normal coagulation will be monitored during and for 4 hours after infusion of Ryplazim
Initial approval is for 12 weeks

Patient must continue to meet the above criteria AND
Patient has not had unacceptable toxicity from the drug (e.g., severe bleeding, respiratory distress, anaphylaxis, severe allergic reactions) AND
Patient has demonstrated a beneficial response to therapy (e.g., resolution of lesions) OR
Patient’s lesions have not resolved after an initial 12 weeks of therapy OR there are new or recurrent lesions AND
- Patient will increase dosage frequency based on plasminogen level (per the prescribing information), in 1 day increments every 4 to 8 weeks up to the max dosing frequency (e.g., every 2 days) AND
- Re-assess trough plasminogen activity level if, after 12 additional weeks of dose optimization, no clinical effect has been noted AND
- If trough plasminogen activity level is < 10% above baseline, repeat trough. If low plasminogen is confirmed AND no clinical effect has been demonstrated, consider treatment discontinuation AND
Renewal is for an additional 12 weeks for patient with less than complete response OR
Renewal is for 12 months for patient with complete response

Ryplazim must be billed as a medical claim

MHCP Provider Resource Center 651-431-2700 or 800-366-5411