CurrentAvMedPolicy Pub. 100-2

Ryplazim (plasminogen, human-tvmh) medical prior authorization

Defines prior authorization, clinical criteria, dosing, and documentation requirements for Ryplazim (J2998) for members covered by AvMed; applies to providers requesting medical benefit coverage for this drug.

Policy Summary

PayerAvMed

PolicyRyplazim (plasminogen, human-tvmh) medical prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization form signed by the prescribing physician with baseline and trough plasminogen labs and supporting documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 wksInitial authorization duration

12 moReauthorization interval

11 vialsMax quantity

<45%Diagnostic threshold

Coverage Criteria for Ryplazim (plasminogen, human-tvmh)

Initial Authorization

Covered when ALL of the following are met:

Prescriber: Prescribed by or in consultation with a hematologist

Diagnostic confirmation: Diagnosis of hypoplasminogenemia confirmed by a plasminogen level < 45% of laboratory standard (submit baseline plasminogen labs)<45%

Clinical signs: Member has presented with at least ONE clinical sign or symptom such as ligneous conjunctivitis, gingivitis, tonsillitis, abnormal wound healing, or other specified lesion (submit documentation)1+

Policy Summary

PayerAvMed

PolicyRyplazim (plasminogen, human-tvmh) medical prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization form signed by the prescribing physician with baseline and trough plasminogen labs and supporting documentation.

SourceLink

On This Page

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Starting dose: Recommended dosage is 6.6 mg/kg IV every 2 to 4 days; initiate dosing at a frequency of every 3 days6.6 mg/kg

Obtain baseline plasminogen activity level (allow 7-day washout if receiving fresh frozen plasma)

Adjust frequency based on trough: Obtain trough plasminogen activity level 72 hours after the initial dose and prior to the second dose. If trough < 10% above baseline → increase frequency to every 2 days; if ≥10% and ≤20% above baseline → maintain every 3 days; if >20% above baseline → decrease to every 4 days% above baseline

Maintain chosen frequency for 12 weeks while treating active lesions

Nonresponse management: If lesions have not resolved after 12 weeks or new/recurrent lesions develop → increase dosing frequency in one-day increments every 4–8 weeks up to every 2 days and reassess trough. If trough ≥10% above baseline consider other treatments; if trough <10% above baseline repeat trough and consider discontinuation if no clinical efficacy12 weeks

Assess trough plasminogen activity level as part of adjustments

Reauthorization

Reauthorization covered when ALL of the following are met:

Toxicity: Member has NOT experienced unacceptable toxicity from the drug (e.g., severe bleeding, respiratory distress, anaphylaxis)

Response: Member has demonstrated a beneficial response to therapy (resolution of lesions). For members with complete response, coverage will be renewed annually; for less than complete response, coverage may be renewed for an additional 12 weeks to optimize frequency

Submit progress notes documenting response

Nonresponse pathway: If lesions have not resolved after the initial 12 weeks OR new/recurrent lesions have developed, provider will increase dosage frequency in one-day increments every 4–8 weeks up to every two days and re-assess trough plasminogen activity level

Refer to determination of dosing frequency table

Coding and Diagnostic Thresholds

Covered HCPCS CodesHCPCSCovered

J2998

Injection, plasminogen, human-tvmh

Diagnostic plasminogen level

Diagnostic plasminogen level< 45% of laboratory standard

Supporting requirementSubmit baseline plasminogen labs to confirm diagnosis

Authorization duration at initiationInitial authorization: 12 weeks

Maximum quantity limits

Maximum quantity limits11 vials (68.8 mg per SDV) = 757 mg every 2 days

Dose form referenceQuantity limits represent maximum daily dose for Ryplazim

Titration noteDosing frequency may be adjusted based on trough plasminogen activity levels (every 2–4 days) per monitoring guidance

Prior Authorization and Provider Responsibilities

Prior Authorization

Prior authorization required for J2998 (Ryplazim)

Prior authorization is required for Ryplazim (plasminogen, human-tvmh) billed as J2998 under the medical benefit; the prescribing physician must sign and clearly print their name on the prior authorization request and submit the required documentation with the request.

Drug requested: Ryplazim (plasminogen, human-tvmh) (J2998) (Medical)
Prescribing physician must sign and clearly print name on the request (preprinted stamps not valid)

Step Therapy

Samples do not meet prior therapy requirements

Medication samples do not satisfy step-edit or preauthorization requirements; initiation with samples will not meet criteria and prior therapies may be verified by pharmacy paid claims or submitted chart notes.

Use of samples to initiate therapy does not meet step edit/ preauthorization criteria
Previous therapies will be verified through pharmacy paid claims or submitted chart notes

Documentation Required

Required supporting documentation

Submit a completed prior authorization form signed by the prescribing physician plus supporting clinical documentation: baseline plasminogen labs, trough plasminogen activity levels, imaging for non-visible lesions when applicable, and progress/clinic notes documenting response or toxicity.

Completed PA form signed and clearly printed by the prescribing physician (preprinted stamps not valid) [[see citation]]
Baseline plasminogen labs (diagnostic confirmation: plasminogen < 45%)
Trough plasminogen activity level (72 hours after initial dose) and subsequent troughs as required for dosing adjustments
Imaging results (CT, MRI, or ultrasound) when non-visible lesions are present
Progress notes documenting response/toxicity and any prior therapy documentation

Denial Risk

Incomplete or illegible requests may be delayed or denied

Incomplete, incorrect, or illegible information on the authorization request or missing supporting documentation (labs, diagnostics, chart notes) may delay review or result in denial of the authorization.

If information provided is not complete, correct, or legible, authorization can be delayed
Missing documentation such as lab results, diagnostics, or chart notes may lead to denial

Background

Type I hypoplasminogenemia is treated with replacement of human plasminogen to resolve ligneous and other mucocutaneous lesions. Ryplazim (plasminogen, human-tvmh) is dosed at a recommended 6.6 mg/kg IV administered every 2 to 4 days (initiate every 3 days) with adjustments guided by measured plasminogen activity. Baseline plasminogen testing to confirm diagnosis (<45% of laboratory standard) and trough plasminogen activity levels (72 hours after the initial dose) are required to determine and modify dosing frequency; maintain an effective frequency for 12 weeks while treating active lesions and reassess response thereafter.

OpenPayer

Ryplazim (plasminogen, human-tvmh) medical prior authorization

Coverage Criteria for Ryplazim (plasminogen, human-tvmh)

Coding and Diagnostic Thresholds

Prior Authorization and Provider Responsibilities

Background

Definitions and Dosing Summary