Last Review Date: 10/30/2023

Date of Origin: 01/01/2012

Dates Reviewed: 12/2011, 02/2013, 01/2014, 08/2014, 12/2014, 10/2015, 10/2016, 10/2017, 10/2018, 11/2019, 11/2020, 11/2021, 11/2022, 11/2023

1. Length of Authorization ¹

• Dupuytren’s Contracture: Coverage will be provided for 3 months and may be renewed for a maximum of 3 injections per joint/cord.
• Peyronie’s Disease: Coverage will be provided for 6 weeks and may be renewed for a maximum of 4 total treatment cycles for each plaque causing the curvature deformity.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Xiaflex 0.9mg injection: 2 vials per 28 days

B. Max Units (per dose and over time) [HCPCS Unit]:

   Dupuytren’s Contracture

• 180 billable units every 28 days

   Peyronie’s Disease

• 180 billable units every 42 days

3.  Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Dupuytren’s Contracture † Ф ^1-3

• Patient has a palpable cord; AND
• Documented flexion contracture of 20° to 100° in a metacarpophalangeal (MP) joint or 20° to 80° in a proximal interphalangeal (PIP) joint; AND
• Documentation of a positive “table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top; AND
• Patient has not received a surgical treatment (e.g., fasciectomy, fasciotomy) on the selected joint within 90 days before the first injection; AND
• Documentation that the flexion deformity results in functional limitations

Peyronie’s Disease † Ф ^1,4-6

• Prescriber is enrolled in the XIAFLEX REMS Program; AND
• Patient has a palpable plaque on penis; AND
• Patient has stable disease with penis curvature deformity of > 30° and < 90°; AND
• Patient has intact erectile function (with or without use of medications); AND
• Patient does not have a ventral curvature deformity, an isolated hourglass deformity, or a calcified plaque; AND
• Plaque(s) do not involve the penile urethra; AND
• Will be used in combination with penile modeling procedures

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the indication-specific relevant criteria identified in section III; AND

Dupuytren’s Contracture

• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: hypersensitivity reactions (including anaphylaxis), abnormal coagulation, tendon ruptures or other serious injury to the injected extremity, vasovagal reactions (e.g., syncope and presyncope), etc.; AND
• Disease response with treatment as defined by reduction in contracture of the selected primary joint compared to baseline; AND
• Patient has not exceeded 3 injections per joint/cord; AND
• Patient has not received a collagenase injection for this condition within the past 4 weeks

Peyronie’s Disease

• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: hypersensitivity reactions (including anaphylaxis), abnormal coagulation, corporal rupture (penile fracture) or other serious injury to the penis, acute post-injection back pain reactions, vasovagal reactions (e.g., syncope and presyncope), etc.; AND
• Disease response with treatment as defined by the reduction in curvature of the penis compared to baseline or improvement in Bother Domain score of the Peyronie’s Disease Questionnaire (PDQ); AND
• Patient continues to have penis curvature deformity ≥ 15° after previous treatment cycle(s); AND
• Patient has not exceeded 4 total treatment cycles for each plaque causing the curvature deformity; AND
• Patient has not received a collagenase injection for this condition within the past 6 weeks

5. Dosage/Administration¹

6. Billing Code/Availability Information

HCPCS Code:

• J0775 – Injection, collagenase, clostridium histolyticum, 0.01 mg; 0.01 mg = 1 billable unit

NDC:

• Xiaflex 0.9 mg powder for injection: 66887-0003-xx

7. References

1. Xiaflex [package insert]. Malvern, PA; Endo Pharmaceuticals, Inc.; July 2023. Accessed October 2023.
2. Hurst LC, Badalamente MA, Hentz VR et al. Injectable collagenase clostridium histolyticum for Dupuytren’s contracture. N Engl J Med. 2009; 361:968-79.
3. Hurst LC, Badalamente MA, Wang ED. Injectable clostridial collagenase: striving toward non- operative treatment options for fibroproliferative disorders. Available at http://www.aaos.org/research/committee/research/Kappa/KD2009_Hurst.pdf.
4. Gelbard M, Goldstein I, Hellstrom WJ, et al. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013 Jul; 190(1):199-207. doi: 10.1016/j.juro.2013.01.087. Epub 2013 Jan 31.
5. Nehra A, Alterowitz R, Culkin DJ, et. al. Peyronie's Disease: AUA Guideline. J Urol. 2015 Sep;194(3):745-53. doi: 10.1016/j.juro.2015.05.098.
6. Bella AJ, Lee JC, Grober ED, et al. 2018 Canadian Urological Association guideline for Peyronie’s disease and congenital penile curvature. Can Urol Assoc J. 2018 May; 12(5): E197–E209.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Articles (LCAs), and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A