CurrentViva HealthPolicy IC-0611

Ryplazim (plasminogen, human-tvmh) (Intravenous) — Coverage Criteria

Defines prior authorization, coverage, dosing, and renewal criteria for Ryplazim for treatment of congenital plasminogen deficiency (Type 1) for Viva Health members.

Policy Summary

PayerViva Health

PolicyRyplazim (plasminogen, human-tvmh) (Intravenous) — Coverage Criteria

Policy CodePolicy IC-0611

Change TypeNo material change

Effective Date

Next Review DateMay 5, 2026

Key ActionObtain prior authorization (initial approval for 12 weeks) and document baseline plasminogen activity ≤45% before initiation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weeksinitial prior authorization period

757 mgmax units per dose

6.6 mg/kgrecommended dose

E88.02covered diagnosis

J2998HCPCS code

Coverage and Medical Necessity Criteria

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Approval Criteria: Member is at least 11 months of age; AND Member's blood pressure is controlled prior to initiation of treatment; AND Member has healing of lesions or wounds suspected as a source of a recent bleeding event prior to initiating therapy; AND Member has had baseline plasminogen activity measured prior to therapy and plasminogen activity level is ≤45% (allow a 7-day washout if receiving fresh frozen plasma); AND Members with bleeding diatheses or on concomitant anticoagulant/antiplatelet therapy will be monitored during and for 4 hours after infusion; AND Member has a history of visible or non-visible lesions consistent with Type 1 hypoplasminogenemia; AND therapy is initiated at a frequency of every 3 days.≤45% baseline plasminogen activity

Criteria drawn from Initial Approval, Universal Criteria, and Type 1 indication sections.

Continuation/Renewal and Dosing Optimization

Renewal and dosing adjustment logic (treatment continuation and optimization):

Renewal Criteria: Member continues to meet universal and indication-specific criteria and has absence of unacceptable toxicity (examples include severe bleeding, respiratory distress due to tissue sloughing, hypersensitivity including anaphylaxis); AND member has demonstrated a beneficial response (resolution of lesions) OR member's lesions have not resolved after an initial 12 weeks of therapy or there are new/recurrent lesions; AND member may increase dosing frequency in one-day increments every 4-8 weeks up to a maximum frequency of every 2 days; AND reassess trough plasminogen activity after 12 additional weeks of dose optimization; AND if trough plasminogen activity is <10% above baseline, repeat trough and if low is confirmed and no clinical effect is demonstrated, consider treatment discontinuation.

From Renewal Criteria section.

Dosing Frequency Determination: Obtain baseline plasminogen activity (allow 7-day washout if receiving fresh frozen plasma); AND obtain a trough plasminogen activity approximately 72 hours after the initial dose and prior to the second dose; IF trough <10% absolute change above baseline, change dosing frequency to every 2 days; IF trough ≥10% and ≤20% absolute change above baseline, maintain every 3 days; IF trough >20% absolute change above baseline, change to every 4 days; maintain the determined frequency for 12 weeks while treating active lesions; if lesions resolved by week 12, continue same frequency and monitor every 12 weeks; if lesions not resolved or new/recurrent lesions, increase frequency in one-day increments every 4-8 weeks up to every 2 days; after 12 weeks of optimization, if trough ≥10% above baseline consider other treatments in addition to plasminogen; if trough <10% above baseline obtain a second trough to confirm and consider discontinuation if confirmed and no clinical benefit.absolute % change from baseline

From Dosage/Administration section; use absolute % change from baseline for thresholds.

This policy applies to treatment of congenital Plasminogen Deficiency Type 1 (hypoplasminogenemia) characterized by a history of visible or non-visible lesions. Coverage and prior authorization criteria address only this indication; other indications are not specified in this policy. All members initiating therapy must start at a dosing frequency of every 3 days as described in the dosing guidance.

For ongoing therapy, prior authorization may be renewed when the member continues to meet initial and universal criteria and has no unacceptable toxicity (examples include severe bleeding, respiratory distress from tissue sloughing, or hypersensitivity). Renewal requires either demonstrated clinical benefit (e.g., lesion resolution) or persistence/new/recurrent lesions despite treatment. When lesions persist, dosing frequency may be escalated in one-day increments every 4–8 weeks up to a maximum frequency of every 2 days with reassessment after dose optimization.

Dosing frequency is determined by serial plasminogen activity measurements: obtain a baseline plasminogen activity (with a 7-day washout if receiving fresh frozen plasma) and a trough approximately 72 hours after the initial dose prior to the second dose. If the trough is <10% above baseline, change to every 2 days; if the trough is ≥10% and ≤20% above baseline, maintain every 3 days; if the trough is >20% above baseline, change to every 4 days. Maintain the determined frequency for 12 weeks while treating active lesions. If after dose optimization the trough plasminogen activity is confirmed to be <10% above baseline and there is no clinical effect, consider repeating the trough; if confirmed low and no benefit is demonstrated, consider treatment discontinuation.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval is provided for 12 weeks. Renewals may be approved per renewal criteria: if lesions have resolved, renew every 12 months (365 days); if lesions have not resolved or there are new/recurrent lesions, renew for an additional 12 weeks to optimize dosing frequency.

Initial prior authorization validity = 12 weeks
Renewal options: every 12 months if lesions resolved; additional 12 weeks if lesions persist or recur

Documentation Required

Pre-treatment Requirements

Before initiating therapy, obtain and document baseline clinical and laboratory information: member age, controlled blood pressure, healing of any lesions/wounds that could be a recent bleeding source, and baseline plasminogen activity. If the member has received fresh frozen plasma, allow a 7-day washout period before measuring baseline plasminogen activity. Ensure plasminogen activity is ≤ 45% prior to starting therapy.

Member age ≥ 11 months
Document controlled blood pressure prior to initiation
Document healing of lesions/wounds suspected as source of recent bleeding
Baseline plasminogen activity measured prior to therapy and ≤ 45%
If receiving fresh frozen plasma, allow 7-day washout before baseline plasminogen test

Denial Risk

Triggers for Denial

Requests may be denied if required pre-treatment documentation or baseline labs are missing, if blood pressure is uncontrolled, or if lesions/wounds suspected as sources of bleeding have not healed prior to initiation. Denial risk also applies when baseline plasminogen activity is not documented or exceeds required thresholds, or when unacceptable toxicity (for renewals) is present and not addressed.

Missing baseline plasminogen activity measurement
No documentation of member age or controlled blood pressure
Unresolved bleeding source or unhealed lesions/wounds
Absent documentation of baseline plasminogen activity level ≤ 45%
Unacceptable toxicity (e.g., severe bleeding, respiratory distress, anaphylaxis) noted at renewal

OpenPayer

Ryplazim (plasminogen, human-tvmh) (Intravenous) — Coverage Criteria

Coverage and Medical Necessity Criteria

Billing and Code Information

Prior Authorization, Documentation, and Provider Requirements

Clinical Background

Key Definitions and Laboratory Measures