Ryplazim (plasminogen) for plasminogen deficiency type 1 — Coverage Criteria
Customize your policy alerts
Sign up for all blue cross blue shield - tennessee policy alerts
Know when blue cross blue shield - tennessee releases new policies or updates existing guidance.
Monitor payer policy activity
Covers use of Ryplazim (plasma-derived human plasminogen) for treatment of members with plasminogen deficiency type 1 when approval criteria are met; applies to BlueCross BlueShield of Tennessee members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Ryplazim (plasminogen)
Initial and renewal coverage for Ryplazim
Covered when ALL of the following are met:
Baseline plasminogen activity is required for initial authorization.
Continuation requests should include medical records documenting stability or improvement.
Ryplazim (plasma-derived human plasminogen) is FDA-approved for the treatment of members with plasminogen deficiency type 1 (hypoplasminogenemia). Use for any indication other than this FDA-approved indication is considered experimental/investigational.
Use of Ryplazim for any indication other than plasminogen deficiency type 1 (hypoplasminogenemia) is not medically necessary and may be denied.
Key Coding and Thresholds
Prior Authorization and Documentation Requirements
Prior Authorization Required
Prior authorization is required for Ryplazim (plasminogen) for initial and continuation requests. Initial requests must include documentation of a baseline plasminogen activity level and medical records demonstrating a history of lesions and symptoms consistent with plasminogen deficiency type 1 (e.g., ligneous conjunctivitis, ligneous gingivitis or gingival overgrowth, vision abnormalities, respiratory distress/obstruction, abnormal wound healing). Continuation requests must include medical records documenting disease stability or improvement. Authorizations when criteria are met may be granted for up to 12 months.
- Initial requests: baseline plasminogen activity level and medical records documenting lesions/symptoms
- Continuation requests: medical records documenting disease stability or improvement
- Authorization duration when criteria met: up to 12 months
Non‑FDA Indications — Denial Risk
Requests for use of Ryplazim for any indication other than the FDA‑approved indication (treatment of plasminogen deficiency type 1 / hypoplasminogenemia) will be considered experimental/investigational and are not medically necessary. Providers should include justification and supporting clinical data if requesting coverage for non‑FDA indications; however, such requests are likely to be denied.
- FDA‑approved indication: plasminogen deficiency type 1 (hypoplasminogenemia)
- All other indications: experimental/investigational — not medically necessary
Documentation Requirements for Review
Submit medical records to support the prior authorization request. For initial requests, include documentation of baseline plasminogen activity and a detailed history of lesions and symptoms consistent with plasminogen deficiency type 1. For continuation requests, include recent chart notes and lab reports demonstrating stability or improvement.
- Examples of acceptable documentation: chart notes, laboratory reports, imaging, operative reports
- Initial request required items: baseline plasminogen activity level; documentation of lesions/symptoms consistent with diagnosis
- Continuation request required items: records showing disease stability or improvement
Clinical Background
Plasminogen deficiency type 1 (hypoplasminogenemia) is a congenital deficiency of plasminogen that can lead to formation of ligneous lesions (for example, ligneous conjunctivitis and ligneous gingivitis/gingival overgrowth), abnormal wound healing, and respiratory obstruction. Ryplazim is indicated to treat patients with this deficiency.
Definitions
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.