Injectable Collagenase Clostridium Histolyticum (Xiaflex)

Policy ID: I-107-011

Section: Injections

Effective Date: July 01, 2018

Revised Date: March 14, 2022

Revision Effective Date: May 01, 2022

Last Reviewed: March 23, 2023

Applies To: Commercial and Medicaid Expansion

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.

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

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.

Policy ID: I-107-010

Section: Injections

Effective Date: July 01, 2018

Revised Date: July 07, 2021

Revision Effective Date: September 01, 2021

Last Reviewed: July 22, 2021

Archived Date: April 30, 2022

Applies To: Commercial and Medicaid Expansion

Description

Criteria

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

Treatment of Dupuytren's Contracture

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

Injection of collagenase clostridium histolyticum (Xiaflex) into a palpable Dupuytren's cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint; and
No more than two joints in the same hand may be treated with collagenase clostridium histolyticum (Xiaflex) during a treatment visit; and
Approximately 24 to 72 hours following an injection, perform a finger extension procedure if a contracture persists; and
Injections and finger extension procedures may be administered up to three (3) times per cord at approximately four (4)-week intervals; and
Inject up to two cords in the same hand at a treatment visit. If an individual has other cords with contractures, inject those cords at another treatment visit.

Note: *Collagenase clostridium histolyticum (Xiaflex) injections for Dupuytren's contracture should 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.

Procedure Codes

20527

26341

J0775

Treatment of Peyronie's Disease

Collagenase clostridium histolyticum (Xiaflex) may be considered medically necessary for the following:

Treatment for Peyronie's disease may be for a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy; and
The injection of the corpora cavernosa with pharmacologic agent(s) (e.g., papaverine, phentolamine) may be considered medically necessary to determine where the injection of collagenase clostridium histolyticum (Xiaflex) should be administered on the penis. If the penis does not detumesce, then an injection of a medication to pharmacologically reduce the swelling may be considered medically necessary.

A treatment course for Peyronie’s disease consists of a maximum of four (4) treatment cycles. Each treatment cycle consists of two (2) collagenase clostridium histolyticum injection procedures (in which injectable collagenase clostridium histolyticum is injected directly into the collagen-containing structure of the penis) and one penile modeling procedure.

Note: *Collagenase clostridium histolyticum (Xiaflex) injections for Peyronie’s disease should be administered by a healthcare provider experienced in 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.

Procedure Codes

54200

54205

54235

96372

J0775

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

Links

References (PDF)

Disclaimer

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