Crovalimab (Piasky) (Medicaid Expansion)

Policy ID: ME-I-131-018-01

Section: Injections

Effective Date: January 01, 2025

Last Reviewed: November 19, 2024

Applies To: Medicaid Expansion Only

Description

Crovalimab-akkz (Piasky) is a recombinant humanized monoclonal antibody that binds to complement protein C5 and inhibits its enzymatic cleavage, blocks formation of the terminal complement complex, and thus prevents red cell lysis.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Crovalimab-akkz (Piasky) may be considered medically necessary for the treatment of adult and pediatric individuals 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) when the following criteria are met:

Initial Criteria

The requested medication must be prescribed by, or in consult with, a hematologist; and
The member must have failed a six (6)-month trial with Ultomiris with Voydeya, as evidenced by paid claims or printouts, with at least one transfusion, persistent anemia (Hb less than 9.5 g/dL) and absolute reticulocyte count greater than or equal to 120 × 109 /L, as evidenced by paid claims or printouts.

Renewal Criteria

The member must have experienced meaningful clinical benefit since starting treatment with the requested medication, as evidenced by one of the following:
- Member has not required transfusion in the past six (6) months; or
- Increase in hemoglobin by greater than or equal to two (2) g/dL from baseline; or
- Normal LDH levels less than or equal to 280 U/L.

The use of crovalimab-akkz (Piasky) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J1307

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Code

D59.5

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-19-2024 Effective January 01, 2025

Adopted Medicaid Expansion specific policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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