CurrentUnitedHealthcarePolicy CSOH2O25D007O.C

Ryplazim (Plasminogen, Human-Tvmh) (for Ohio Only)

This policy governs coverage and medical necessity criteria for Ryplazim (plasminogen, human-tvmh) for treatment of plasminogen deficiency type 1 (hypoplasminogenemia) for UnitedHealthcare members in Ohio.

Policy Summary

PayerUnitedHealthcare

PolicyRyplazim (Plasminogen, Human-Tvmh) (for Ohio Only)

Policy CodePolicy CSOH2O25D007O.C

Change TypeNo material changes

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization demonstrating plasminogen activity <45%, clinical signs/symptoms, dosing per FDA label, and hematology involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J2998HCPCS code listed for drug

E88.02Diagnosis code

12 moInitial auth duration

12 moReauth duration

<45%Plasminogen activity threshold

Coverage and Medical Necessity Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met

Initial therapy criteria: Diagnosis of hypoplasminogenemia as measured by plasminogen activity level < 45% of laboratory standard; presence of clinical signs and symptoms of the disease (e.g., ligneous conjunctivitis, gingivitis, tonsillitis, abnormal wound healing); dosing in accordance with FDA-approved labeling; prescribed by or in consultation with a hematologist; initial authorization for no more than 12 months.plasminogen activity <45%

From Coverage Rationale

inv-02: Continuation Therapy

Covered when ALL of the following are met

Continuation therapy criteria: Patient has previously received treatment with Ryplazim; patient has experienced a positive clinical response to Ryplazim therapy (e.g., reduction in lesion number/size, improved wound healing, or plasminogen activity trough increased by ≥ 10 percentage points from baseline); dosing in accordance with FDA-approved labeling; prescribed by or in consultation with a hematologist; reauthorization for no more than 12 months.

Policy Summary

PayerUnitedHealthcare

PolicyRyplazim (Plasminogen, Human-Tvmh) (for Ohio Only)

Policy CodePolicy CSOH2O25D007O.C

Change TypeNo material changes

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization demonstrating plasminogen activity <45%, clinical signs/symptoms, dosing per FDA label, and hematology involvement.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ryplazim (plasminogen, human-tvmh). Requests must document the diagnosis, laboratory evidence, clinical signs/symptoms, prescribing provider specialty, and proposed dosing consistent with FDA labeling. Initial authorizations are limited to up to 12 months; reauthorizations are limited to up to 12 months.

Affected HCPCS: J2998 (Injection, plasminogen; human-tvmh, 1 mg)
Diagnosis: E88.02 (Plasminogen deficiency)
Initial authorization: up to 12 months
Reauthorization: up to 12 months

Step Therapy

No Step Therapy Required

No step therapy is required beyond the clinical criteria listed in the coverage rationale. There is no requirement to fail other systemic therapies prior to approval when ALL clinical criteria are met.

Documentation Required

Required Documentation

Provide documentation that supports the diagnosis of hypoplasminogenemia and medical necessity for Ryplazim. Include objective laboratory values, treatment history, and clinical response data.

Plasminogen activity level (must be < 45% of laboratory standard for initial diagnosis)
Clinical signs/symptoms consistent with disease (e.g., ligneous conjunctivitis, gingivitis, tonsillitis, impaired wound healing)
Prescribing provider specialty or documentation of consultation with a hematologist
Proposed dose and schedule consistent with FDA-approved labeling
For continuation/reauthorization: documentation of prior Ryplazim therapy and evidence of positive clinical response (e.g., reduction in lesion number/size, improved wound healing, or plasminogen activity trough increase ≥ 10 percentage points from baseline)

Denial Risk

Denial Triggers / Documentation Risks

Common reasons for denial include missing or insufficient documentation, laboratory thresholds not met, therapy requested for excluded indications, or dosing inconsistent with FDA labeling.

Insufficient documentation of diagnosis (no plasminogen activity level reported or value ≥ 45%)
Lack of documented clinical signs/symptoms of hypoplasminogenemia
No documentation of hematology involvement (prescribing or consult note)
Requested dosing or duration not consistent with FDA-approved labeling
Request for use in excluded indication (e.g., idiopathic pulmonary fibrosis) or other unproven uses
No evidence of prior Ryplazim therapy when continuation criteria are claimed, or no documented clinical benefit for reauthorization

Definitions

inv-14: Plasminogen deficiency type 1

DefinitionPlasminogen deficiency type 1 (hypoplasminogenemia) is a rare autosomal‑recessive disorder of the fibrinolytic system characterized by deficiency of plasminogen levels and abnormal extravascular accumulation of fibrin‑rich ligneous pseudomembranous lesions on mucous membranes.

Common clinical manifestationLigneous conjunctivitis: inflamed, woody growth on conjunctival membranes that can lead to visual impairment or blindness if untreated.

Other clinical featuresLesions may occur throughout mucous membranes (e.g., gingivitis, tonsillitis, abnormal wound healing).

Therapeutic implicationReplacement therapy with plasminogen (Ryplazim) can increase plasma plasminogen temporarily and reduce extravascular fibrinous lesions; coverage requires documented clinical signs/symptoms and hematology involvement.

OpenPayer

Ryplazim (Plasminogen, Human-Tvmh) (for Ohio Only)

Coverage and Medical Necessity Criteria

Billing Codes, Diagnosis Codes, and Test Thresholds

Prior Authorization, Documentation, and Billing Guidance

Clinical Background

Definitions