Spesolimab (Spevigo) (ARCHIVED)

Policy ID: I-9254-004

Section: Injections

Effective Date: December 01, 2022

Revised Date: October 21, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-9254-004

Section: Injections

Effective Date: December 01, 2022

Revised Date: October 21, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Spesolimab (Spevigo ^(R) ) is a novel, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a key part of the signaling pathway within the immune system shown to be involved in the cause of generalized pustular psoriasis (GPP).

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.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Spesolimab (Spevigo) may be considered medically necessary when ALL of the following criteria are met:

The individual has a diagnosis of generalized pustular psoriasis (GPP); and
The individual is experiencing a moderate to severe flare of GPP; and
The individual is 18 years of age or older; and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., dermatologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual has not received two (2) or more infusions for the current flare.

Length of approval: One (1) month for up to two 900mg doses

The use of spesolimab (Spevigo) 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 Codes

J1747

NOTE: The individual should be tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent prior to treatment with the requested agent and if the individual is positive, the individual should receive treatment for latent TB prior to initiation of treatment with the requested agent.

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

Diagnosis Codes

L40.1

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-29-2022 - Effective December 01, 2022

Adopted new precertification policy

Internal Medical Policy Committee 3-23-2023 Effective April 01, 2023

Added new code, J1747, to the policy

Internal Medical Policy Committee 3-19-2024 Effective May 01, 2024

Updated to the standard criteria used for age

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived 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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