Injectable Collagenase Clostridium Histolyticum (Xiaflex) (ARCHIVED)

Policy ID: I-107-013

Section: Injections

Effective Date: July 01, 2018

Revised Date: October 25, 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**This policy has been Archived effective December 08, 2024.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-107-013

Section: Injections

Effective Date: July 01, 2018

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Injection with collagenase clostridium histolyticum (Xiaflex®) is intended to provide a non-operative treatment option for fibroproliferative disorders. Fibrotic tissue disorders, characterized by excessive collagen deposits, can affect the musculoskeletal system, causing pain and limitation of movement and reduction of joint range of motion. Examples of fibroproliferative disorders include Dupuytren's contracture, and Peyronie's disease.

Dupuytren's contracture is a benign fibroproliferative condition characterized by excessive collagen deposition causing abnormal thickening of the fascia. This results in the formation of a ropelike cord beneath the skin of the palm, stretching from the palm into the fingers. Gradually, the progression of these cords may cause the fingers to bend into the palm resulting in permanent joint contractures. Collagenase clostridium histolyticum (Xiaflex) is the first FDA-approved nonsurgical option for the treatment of adult individuals with Dupuytren's contracture with a palpable cord.

Peyronie's disease is caused by scar tissue that develops under the skin of the penis. This scar tissue causes an abnormal bend during erection and can cause problems such as bothersome symptoms during intercourse.

Policy Criteria

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.

Treatment of Dupuytren's Contracture

Collagenase clostridium histolyticum (Xiaflex) may be considered medically necessary for the treatment of Dupuytren's contracture when ALL of the following are met:

Individual is 18 years of age or older ; and
Individual has diagnosis of Dupuytren's contracture with a palpable cord ; and
Individual has documented metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint contracture of 20 degrees or greater at baseline ; and
Individual will not be treated for more than two (2) joints in the same hand at the same visit ; and
Individual will not be treated for more than a maximum of three (3) injections per cord at approximately four (4)-week intervals; and
Injection will be administered by a healthcare provider experienced in injection procedures of the hand and certified in the *Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program.

The use of collagenase clostridium histolyticum (Xiaflex) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

20527

26341

J0775

Treatment of Peyronie's Disease

Collagenase clostridium histolyticum (Xiaflex) may be considered medically necessary when ALL of the following are met:

Individual is 18 years of age or older ; and
Individual has diagnosis of Peyronie's disease with BOTH of the following:
- Presence of a palpable plaque; and
- Curvature deformity of at least 30 degrees at the start of therapy; and
Injection will be administered by a healthcare provider experienced in injection procedures the treatment of male urological diseases and certified in the *Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program. A copy of the REMS certification must be attached to the claim; and
Individual will not be treated with more than a total of eight (8) injections per Peyronie's plaque per lifetime.

Collagenase clostridium histolyticum (Xiaflex) and related procedures is considered experimental/investigational for all other indications and therefore non-covered. Scientific evidence does not support its use for any other indications.

Procedure Codes

54200

54205

54235

96372

J0775

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

Covered Diagnosis Code for Procedure Codes 54200; 54205; 54235; 96372; and J0775

N48.6

Covered Diagnosis Code for Procedure Codes 20527; 26341; and J0775

M72.0

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Annual review, no clinical content change

Internal Medical Policy Committee 7-22-2020 Criteria revised

Internal Medical Policy Committee 7-22-2021 Annual review, no clinical content change

Internal Medical Policy Committee 3-23-2022 Updated criteria

Internal Medical Policy Committee 3-23-2023 Annual review, no clinical content change

Internal Medical Policy Committee 3-19-2024 Annual review, no clinical content change

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

Annual review no clinical content change

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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Injectable Collagenase Clostridium Histolyticum (Xiaflex) (ARCHIVED)

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

Description

Policy Criteria

Criteria

Treatment of Dupuytren's Contracture

Procedure Codes

Treatment of Peyronie's Disease

Procedure Codes

Diagnosis Codes

ND Committee Review

Links

Disclaimer

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