Pharmacy Prior Authorization Criteria

Xiaflex (collagenase clostridium histolyticum)

Indications for Prior Authorization

Xiaflex (collagenase clostridium histolyticum)

• For diagnosis of Dupuytren's Contracture
  Indicated for the treatment of adult patients with Dupuytren's contracture with a palpable cord.

• For diagnosis of Peyronie's Disease
  Indicated 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.

Criteria

Xiaflex

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Dupuytren’s contracture

• Diagnosis of Dupuytren’s contracture with a palpable cord
AND
• Patient has a positive “table top test” (defined as the inability to simultaneously place the affected finger and palm flat against a table top) [A]
AND
• Patient has a documented contracture of at least 20 degrees flexion for a metacarpophalangeal joint or a proximal interphalangeal joint [B]
AND
• Patient has a flexion deformity that results in functional limitations

Xiaflex

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Peyronie’s disease

• Diagnosis of Peyronie’s disease
AND
• Patient has a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy [C]
AND
• The plaques do not involve the penile urethra
AND
• Patient has a curvature deformity that results in pain (e.g., pain upon erection or intercourse) [C]

Xiaflex

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Peyronie’s disease

• Diagnosis of Peyronie’s disease
AND
• Patient has a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy
AND
• The plaques do not involve the penile urethra
AND
• Patient has a curvature deformity that results in pain (e.g., pain upon erection or intercourse)
AND
• Patient has a new plaque that results in a curvature deformity

P & T Revisions

2024-03-27, 2023-03-28, 2022-03-28, 2021-09-27, 2021-05-25, 2020-03-12

References

1. Xiaflex Prescribing Information. Endo Pharmaceuticals, Inc. Malvern, PA. July 2022.

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End Notes

1. Dupuytren’s disease diagnosis can include a table top test to assess the severity of the disease. When a patient is unable to place his or her palm and the affected finger flat on the table, the test can help diagnosis Dupuytren’s disease. [1]
2. Dupuytren’s disease is associated with joint contracture. Xiaflex was studied in a patient population with joint contracture of at least 20 degrees. Evidence does not support any benefit in patients with joint contracture less than 20 degrees. Our program requires that the patient has a flexion deformity that results in functional limitations to protect against cosmetic use. [1]
3. Peyronie’s disease is characterized by a curvature deformity. Xiaflex was studied in a patient population with a curvature deformity of at least 30 degrees. Evidence does not support any benefit in patients with a curvature deformity less than 30 degrees. To prevent cosmetic use, patients must also have a curvature deformity that results in pain. [1]

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Revision History

• 2024-03-27: 2024 UM Annual Review. No criteria changes.
• 2023-03-28: 2023 Annual Review. No criteria changes. Updated references
• 2022-03-28: 2022 Annual Review - no changes to criteria, updated background information
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2020-03-12: Annual Review - Updated References

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