Ryplazim RX.PA.067 Form

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RX.PA.067.CCH RYPLAZIM (PLASMINOGEN INJECTION) The purpose of this policy is to define the prior authorization process for Ryplazim (plasminogen injection) for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia).

POLICY
It is the policy of the Health Plan to maintain a prior authorization process that promotes appropriate utilization of specific drugs with potential for misuse or limited indications. This process involves a review using Food and Drug Administration (FDA) criteria to make a determination of Medical Necessity, and approval by the Medical Policy Committee.

The drug, Ryplazim (plasminogen injection, is subject to the prior authorization process.

PROCEDURE Initial Authorization Criteria: Must meet all the criteria listed under the respective diagnosis:

• Must be ≥ 11 months of age • Must have a diagnosis of plasminogen deficiency type 1 (hypoplasminogenemia) with documentation of ALL the following:
o Plasminogen activity level ≤ 45% (NOTE: If member is receiving fresh frozen plasma, allow for a 7-day washout period before obtaining) o History of lesions and symptoms consistent with a diagnosis of congenital plasminogen deficiency (e.g., ligneous conjunctivitis, ligneous gingivitis, and/or pseudomembranous lesions on mucus membranes [middle ear, respiratory tract gastrointestinal tract]) • Must be prescribed by, or consulted with, a provider specialized in the patient’s diagnosis (e.g., ophthalmologist, specialist from a hemophilia and thrombosis treatment center)
• Must not be initiated at a dosing frequency of less than every-3-days; more frequent dosing intervals are allowable following trough plasminogen activity levels

RYPLAZIM (PLASMINOGEN) POLICY NUMBER: RX.PA.067.CCH REVISION DATE: 04/2024 PAGE NUMBER: 2 of 3

Proprietary and Confidential Information of Evolent Health LLC
© 2024 Evolent Health LLC All Rights Reserved Reauthorization Criteria: All prior authorization renewals are reviewed on an annual basis to determine the Medical Necessity for continuation of therapy. Authorization may be extended at 1-year intervals based upon chart documentation of the following:
• Must have chart documentation confirming a positive response to therapy as evidenced by at least ONE of the following: o Reduction in lesion number or size o Plasminogen activity trough level has increased at least 10% from baseline o Improvement in wound healing • Must be prescribed at a dose within the manufacturer’s dosing guidelines (based on diagnosis, weight, etc.) listed in the FDA approved labeling

Limitations:

If the established criteria are not met, the request is referred to a Medical Director for review, if required for the plan and level of request.

Codes: CPT Codes / HCPCS Codes / ICD-10 Codes Code Brand Description J2998 Ryplazim Injection, plasminogen, human-tvmh, 1mg

References:

1. Ryplazim [package insert]. Fort Lee, NJ: Prometic Bioproduction Inc; November 2021.

2. Celkan T. Plasminogen deficiency. J Thromb Thrombolysis. 2017;43(1):132-138. doi:10.1007/s11239- 016-1416-6

   Revision History

   DESCRIPTION OF REVIEW / REVISION DATE APPROVED New Policy 04/2024

   Length of Authorization (if above criteria met) Initial Authorization Up to 12 months Reauthorization Same as initial

RYPLAZIM (PLASMINOGEN) POLICY NUMBER: RX.PA.067.CCH REVISION DATE: 04/2024 PAGE NUMBER: 3 of 3

Proprietary and Confidential Information of Evolent Health LLC
© 2024 Evolent Health LLC All Rights Reserved

Record Retention Records Retention for Evolent Health documents, regardless of medium, are provided within the Evolent Health records retention policy and as indicated in CORP.028.E Records Retention Policy and Procedure.

Disclaimer CountyCare medical payment and prior authorization policies do not constitute medical advice and are not intended to govern or otherwise influence the practice of medicine. The policies constitute only the reimbursement and coverage guidelines of CountyCare and its affiliated managed care entities. Coverage for services varies for individual members in accordance with the terms and conditions of applicable Certificates of Coverage, Summary Plan Descriptions, or contracts with governing regulatory agencies.

CountyCare reserves the right to review and update the medical payment and prior authorization guidelines in its sole discretion. Notice of such changes, if necessary, shall be provided in accordance with the terms and conditions of provider agreements and any applicable laws or regulations.

These policies are the proprietary information of Evolent Health. Any sale, copying, or dissemination of said policies is prohibited.