CurrentEmblemHealthPolicy MG.MM.PH.346

Ryplazim (human plasminogen), injection

Covers medical necessity and prior authorization criteria for Ryplazim (plasminogen, human-tvmh) for treatment of plasminogen deficiency type 1 for EmblemHealth members and affiliated plans.

Policy Summary

PayerEmblemHealth

PolicyRyplazim (human plasminogen), injection

Policy CodePolicy MG.MM.PH.346

Change TypeAnnual review — no material changes

Effective Date

Next Review DateFeb 19, 2025

Key ActionSubmit prior authorization with clinical and laboratory/genetic documentation confirming plasminogen deficiency type 1.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weeksinitial authorization duration

1 yearcontinuation duration

6.6 mg/kg q2-4drecommended dosing

J2998billing code

E88.02ICD-10

Coverage and Medical Necessity Criteria

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Initial Approval Criteria

Covered when ALL of the following are met for initial approval:

Initial Approval for Plasminogen deficiency type 1: A. Patient has a diagnosis of plasminogen deficiency type 1 confirmed by BOTH: i) biallelic mutations in the PLG gene; AND ii) baseline plasminogen activity level (prior to initiating Ryplazim) ≤ 45% of normal based on the reference range for the reporting laboratory. AND B. Patient has a history of lesions and symptoms consistent with a diagnosis of congenital plasminogen deficiency. AND C. Ryplazim is prescribed by or in consultation with a hematologist.

Renewal Criteria

Renewal approved when ALL of the following are met for patients currently receiving Ryplazim:

Renewal criteria: A. Patient meets one of: i) clinical response to Ryplazim as determined by the prescriber (examples: resolution of active lesions, stabilization of current lesions, prevention of new or recurrent lesions); OR ii) trough plasminogen activity level ≥ 10% absolute increase above the baseline trough level (prior to initiating Ryplazim). AND B. Ryplazim is prescribed by or in consultation with a hematologist.

No specific clinical exclusions for Ryplazim are listed in this policy. The revision history documents administrative updates (for example, code changes and template transfer) but does not add any clinical exclusion criteria or alter the coverage requirements set forth elsewhere in the policy. Providers should follow the stated medical necessity criteria for approval.

The treating physician or primary care provider must submit clinical evidence demonstrating that the member meets the policy criteria. Without this documentation, EmblemHealth will not be able to properly review the request for preauthorization or post-payment review and the request may be denied for lack of supporting documentation.

Billing Codes, Dosage, and Diagnosis Codes

Applicable Procedure CodesHCPCSCovered

J2998

Ryplazim 68.8mg Solution Reconstituted J2998 Injection, plasminogen, human-tvmh, 1 mg

Applicable NDCsNDC

70573-0099-01	Ryplazim 68.8mg/vial, single dose vial
70573-0099-02	Ryplazim 68.8mg/vial, single dose vial

ICD-10 DiagnosesICD-10

E88.02

Plasminogen Deficiency

Dose per labeling — Ryplazim

Recommended dose (weight-based)6.6 mg/kg body weight

FrequencyEvery 2 to 4 days

Billable units example759 billable units (759 mg) every 2 days

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ryplazim (J2998). Submit a prior authorization request before providing treatment. Include the diagnosis, baseline laboratory results, and genetic testing confirming biallelic PLG mutations to support medical necessity.

Affected code: J2998 (Ryplazim, injection, plasminogen, human-tvmh, 1 mg)
Required diagnosis code: E88.02 (Plasminogen Deficiency)
Required labs/genetics: baseline plasminogen activity ≤ 45% of normal; documentation of biallelic PLG mutations

Documentation Required

Clinical Evidence Submission Required

The treating physician or primary care provider must submit clinical evidence demonstrating that the member meets the policy criteria. This includes documentation of clinical history of lesions/symptoms consistent with congenital plasminogen deficiency and a statement that Ryplazim is prescribed by or in consultation with a hematologist.

Clinical history of lesions and symptoms consistent with congenital plasminogen deficiency
Documentation that prescribing clinician is a hematologist or consulted with a hematologist

Denial Risk

Documentation Required for Review

Documentation required for review: without the genetic test results (biallelic PLG mutations), baseline plasminogen activity level (≤ 45% of normal), and clinical history, EmblemHealth will be unable to properly review the prior authorization request and may deny the request or delay coverage.

Biallelic PLG mutation report (genetic testing)
Baseline plasminogen activity level with lab reference range and value (≤ 45% of normal)
Clinical notes describing lesions/symptoms and prior treatments, if any
Consultation note or attestation from a hematologist

Note

Provider Action — Submit Complete Records

Provider action: submit all required documentation with the prior authorization request. Failure to provide complete records may prevent review and lead to denial. (Placeholder: additional short actionable item from inventory.)