RXMP-17 Collagenase Clostridium Histolyticum (Xiaflex) Form

Collagenase Clostridium Histolyticum (Xiaflex)

Updated on: 10/25/2025

Page 1 of 3 Policy Number RXMP-17 Line of Business Medicare and Medicaid Effective Date 1/1/2025 Revision Date 10/25/2025

Products: Collagenase Clostridium Histolyticum (Xiaflex)

Override(s)
Approval Duration
Prior Authorization
• Dupuytren’s Contracture: 58 billable unit per cord, up to 3 times, 4 weeks apart (max of 12 weeks) (no more than 2 injections in the same hand) • Peyronie’s Disease: 58 billable unit every 2 days, 1-3 days apart every 6 weeks, maximum 4 times

HCPCS Description Medical Benefit: Authorization Required; Pharmacy Benefit: Not Covered J0775 Injection, collagenase, clostridium histolyticum, 0.01 mg

Medicare Criteria Medicare Part B Coverage Criteria
Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • No LCD/NCD/LCA found as of 10/25/2025. Review using Xiaflex criteria below Medicare Part B 90-Day Transition Period For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of-network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage. Medicare Part B Step Therapy Criteria • For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.
• No step therapy

Approval Criteria Products J0775 Injection, collagenase, clostridium histolyticum, 0.01 mg (Xiaflex) Line of Business Medicare and Medicaid Diagnosis Dupuytren’s Contracture Approval Length 58 billable unit per cord, up to 3 times, 4 weeks apart (max of 12 weeks) (no more than 2 injections in the same hand) Override Type PA, QL Initial Criteria Dupuytren’s Contracture Initial Request (limited to max of 12 weeks treatment total)

1. Member is 18 years of age or older; AND
2. Diagnosis of Dupuytren’s Contracture with a palpable cord; AND
3. Documented contracture of ≥ 20 degrees flexion for a metacarpophalangeal (MP) joint contracture or proximal interphalangeal (PIP) joint contracture; AND
4. Documentation that the flexion deformity results in functional limitations; AND
5. The member has had a trial with a corticosteroid injection or the inflammation that has been refractory to steroid and hand therapy; AND
6. Member has not received surgical treatment on the selected primary joint within the last 90 days; AND
7. If two injections (two vials) are requested, they are for one of the following:
   a. One cord affecting two joints in the same finger; OR

Collagenase Clostridium Histolyticum (Xiaflex)

Updated on: 10/25/2025

Page 2 of 3 b. Two cords affecting two joints in the same hand AND

8. The total number of injections does not exceed 3 injections per cord at approximately 4-week intervals; AND
9. Authorization is for no more than 2 injections in the same hand
   Renewal Criteria Dupuytren’s Contracture Continuation of Therapy (limited to max of 12 weeks treatment total)
10. Member is 18 years of age or older; AND
11. Diagnosis of Dupuytren’s Contracture with a palpable cord; AND
12. Documented contracture of ≥ 20 degrees flexion for a metacarpophalangeal (MP) joint contracture or proximal interphalangeal (PIP) joint contracture; AND
13. The total number of injections does not exceed 3 injections per cord at approximately 4-week intervals; AND

14. Authorization is for no more than 2 injections in the same hand

    Products J0775 Injection, collagenase, clostridium histolyticum, 0.01 mg (Xiaflex) Line of Business Medicare and Medicaid Diagnosis Peyronie’s Disease Approval Length 58 billable unit every 2 days, 1-3 days apart every 6 weeks, maximum 4 times Override Type PA, QL Initial Criteria

15. Member is 18 years of age or older; AND
16. Diagnosis of Peyronie’s disease with both of the following:
    a. Palpable plaque; AND
    b. Curvature deformity of ≥ 30 degrees at the start of therapy. AND
17. Authorization is for no more than two injections and 6 weeks duration. Renewal Criteria
18. Member is 18 years of age or older AND
19. Diagnosis of Peyronie’s disease; AND
20. The request is written by or in consultation with a urologist; AND
21. The member’s curvature deformity is 15 degrees or greater; AND

22. Authorization is for no more than two injections and 6 weeks duration.

    Limitations/Exclusion Approval will be granted for 12 weeks for a diagnosis of Dupuytren’s Contracture per cord and may not be renewed
    • Subsequent approvals for a diagnosis of Dupuytren’s Contracture will require a new authorization
    • Approval will be granted for 6 weeks for a diagnosis of Peyronie’s Disease and may be renewed a maximum of 3 times
    • As serious complications or damage may occur, Xiaflex should only be administered by a health care professional experienced with hand injections (for Dupuytren’s contracture) or urologists (for Peyronie’s disease) who have received certification in the Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program.

    FDA Indications & Dosing Indication(s) Usual Dosing The treatment of adult patients with Dupuytren’s contracture with a palpable cord • Inject 0.58 mg of XIAFLEX into each palpable Dupuytren’s cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint according to the injection procedure.
    • Up to two joints in the same hand may be treated during a treatment visit.
    • Approximately 24 to 72 hours following an injection, perform a finger extension procedure if a contracture persists. • Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals.

Collagenase Clostridium Histolyticum (Xiaflex)

Updated on: 10/25/2025

Page 3 of 3 Indication(s) Usual Dosing • • 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. 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 • Inject 0.58 mg XIAFLEX into the target plaque once on each of 2 days, 1 to 3 days apart, according to the injection procedure.
• Perform a penile modeling procedure 1 to 3 days after the second injection of each treatment cycle.
• For each plaque causing the curvature deformity, up to 4 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.

References

1. UpToDate, Dupuytren’s Contracture, accessed 1/17/2025
2. UpTODate, Peyronie's disease: Diagnosis and medical management, accessed 1/17/2025
3. IPD Analytics, accessed 1/17/2025

4. Xiaflex Prescribing Information. Endo USA. Revised 08/2022.

   Change History 1/17/2025 HB new 4/2/2025 AP Added Continuity of Care requirement