Xiaflex (collagenase clostridium histolyticum)

POLICY NUMBER

L.5.01.492

Xiaflex (collagenase clostridium histolyticum)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

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. Collagenases are enzymes that digest native collagen and may be used for treatment of fibroproliferative disorders, such as Dupuytren’s contracture and Peyronie’s disease. Injection of Xiaflex (collagenase clostridium histolyticum) into a Dupuytren’s cord or a Peyronie’s plaque, which are comprised mostly of collagen, may result in enzymatic disruption of the plaque; the injection provides a non-operative treatment option for these fibroproliferative disorders.

Xiaflex (collagenase clostridium histolyticum) is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord and for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

 Initial Evaluation

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

1. The individual is 18 years of age or older;

2. ONE of the following:

   1. The individual has a documented diagnosis of Dupuytren’s contracture and ALL of the following;

      1. The individual has a palpable cord with a contracture of at least 20 degrees in a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint;

      2. The individual has functional impairment in the hand due to the contracture; AND

      3. The individual has not received surgical treatment (e.g., fasciectomy, fasciotomy) on the selected primary joint within the last 90 days; OR

   2. The individual has a documented diagnosis of Peyronie’s disease and ALL of the following:

      1. The individual has a palpable plaque AND curvature deformity of at least 30 degrees;

      2. The plaque does not involve the penile urethra;

      3. The prescriber is a certified provider through the Xiaflex REMS Program (see Policy Guidelines section); AND

      4. The individual has intact erectile function (with or without use of medications);

3. The individual does not have any FDA labeled contraindications to the requested agent; AND

4. The requested dose is within the FDA labeled dosing for the requested indication (see Policy Guidelines section).

Length of Approval:  3 months for Dupuytren’s Contracture (3 treatment cycles)                                 6 months for Peyronie’s Disease (4 treatment cycles)

Xiaflex (collagenase clostridium histolyticum) is considered investigational for all other indications including, but not limited to adhesive capsulitis.

Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Xiaflex REMS Program

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. Xiaflex is available for the treatment of Peyronie's disease only through the Xiaflex REMS Program. The Xiaflex REMS Program requirements include:

• Training for healthcare providers on the risks of corporal rupture and other serious injuries to the penis, and how to properly administer Xiaflex

• Certification in the Xiaflex REMS Program by completing training and enrollment in the program

• Patient Counseling about the risks of corporal rupture and other serious injuries to the penis and the importance of patient adherence to post-injection instructions. Healthcare Providers must give patients the Patient Counseling Tool, "What You Need to Know About XIAFLEX Treatment for Peyronie's Disease: A Patient Guide," after each XIAFLEX injection.

• Restricted Distribution through specially certified healthcare settings (e.g., pharmacies, practitioners, hospitals or outpatient settings)

Xiaflex Dosing and Administration

Dupuytren’s Contracture

One treatment cycle for Dupuytren’s Contracture consists of a 0.58mg injection of Xiaflex (collagenase clostridium histolyticum) into a palpable cord followed by a finger extension procedure approximately 24-72 hours after injection if a contracture persists to facilitate cord disruption. If contracture remains, the treatment cycle may be repeated up to 3 times per cord at 4 week intervals.

Note: Perform up to 2 injections in the same hand according to the injection procedure during a treatment visit. If other palpable cords with contractures of MP or PIP joints are present, inject those cords at another treatment visit approximately 4 weeks apart.

Peyronie’s Disease

One treatment cycle for Peyronie’s Disease consists of two injection procedures and one penile modeling procedure. The first 0.58mg injection of Xiaflex (collagenase clostridium histolyticum) should be injected into a Peyronie’s plaque followed by the second 0.58mg injection approximately 24-72 hours later and the penile modeling procedure approximately 24-72 hours after the second injection. Up to 4 treatment cycles may be completed at 6 week intervals. The treatment course, therefore, consists of a maximum of 8 injection procedures and 4 penile modeling procedures. The safety of more than one treatment cycle is unknown.

Note: If the curvature deformity is less than 15 degrees after the first, second, or third treatment cycle, or if further treatment is not clinically indicated, then subsequent treatment cycles should not be administered.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/22/2010: Approved by Medical Policy Advisory Committee.

06/13/2011: Policy reviewed; no changes.

12/09/2011: Policy statement revised to state that effective 12/09/2011, injectable clostridial collagenase for the treatment of Dupuytren’s contracture in adult patients with a palpable cord may be considered medically necessary, for up to three injections at intervals of at least thirty days. Prior Authorization is required. Added HCPCS code J0775 to the Code Reference section and deleted the unlisted code J3590. Added ICD-9 code 728.6 to the Covered Codes table.

01/17/2012: Added 20527 to the Covered Codes table.

11/28/2012: Policy reviewed; no changes.

12/13/2013: Policy reviewed; no changes.

11/06/2014: Medically necessary policy statement updated to remove "Effective 12/09/2011" and add: Inject up to two cords in the same hand at a treatment visit. If a patient has other cords with contractures, inject those cords at another treatment visit. Approximately 24-72 hours following an injection, a finger extension procedure can be performed if a contracture persists.

03/03/2015: Added the following policy statement for treatment of Peyronie's disease: Xiaflex administered by a certified provider through the Xiaflex REMS Program (see Policy Guidelines) may be considered medically necessary for the treatment of Peyronie’s disease in adult men with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. For each plaque causing the curvature deformity, up to four treatment cycles may be administered. Each treatment cycle may be repeated at approximately 6-week intervals. If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if further treatment is not clinically indicated, then subsequent treatment cycles should not be administered. Added the Xiaflex REMS Program requirements to the Policy Guidelines; link to program added to Sources section. Added ICD-9 code 607.85 to the Code Reference section.

06/26/2015: Policy Exceptions section updated regarding SHP members to state that Clostridial Collagenase-Xiaflex does not require prior authorization. However, it will be reviewed for medical necessity based on medical policy guidelines.

08/28/2015: Medical policy revised to add ICD-10 codes.

05/31/2016: Policy number L.5.01.492 added.

06/13/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

05/16/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

03/27/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

10/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title changed from "Injectable Clostridial Collagenase for Fibroproliferative Disorders (Xiaflex®)" to "Xiaflex (collagenase clostridium histolyticum)." Added statement to perform a formulary drug search on the patient's member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member's benefit plan. Policy description revised. Added policy statement that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. First medically necessary statement revised to state that Xiaflex for the treatment of Dupuytren's contracture in adult patients with a palpable cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint may be considered medically necessary. Added length of approval of one treatment course. Sources updated.

02/18/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding injection of Xiaflex. Policy section updated to list medically necessary criteria. Added statement that services related to delivery and/or administration of a medication which have not been approved through the BCSMS PA review process will be considered not medically necessary. Policy Guidelines updated regarding Xiaflex Dosing and Administration and BCBSMS request for medical records. Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

03/15/2023: Code Reference section updated to add CPT code 54200.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.

07/01/2025: Effective 09/01/2025 - Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding fibrotic tissue disorders and indications for Xiaflex (collagenase clostridium histolyticum). Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Medically necessary criteria regarding diagnosis of Dupuytren’s contracture revised to add that the palpable cord has a contracture of "at least 20 degrees." Added criteria regarding surgical treatment. Policy Exceptions updated to remove statement regarding the Federal Employee Program. Policy Guidelines updated regarding Dupuytren’s contracture. Sources updated. Policy update effective 09/01/2025.

SOURCE(S)

1. Blue Cross Blue Shield Association policy # 5.01.19 

2. Xiaflex prescribing information. Endo USA, Inc. April 2024. Last accessed May 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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