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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

Renewal criteria

  • 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

Quantity limits

  • 6.6 mg/kg every 2 days
  • Patient’s body weight (in kg) must be submitted at time of request

Billing for Ryplazim

Ryplazim must be billed as a medical claim


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

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