Collagenase clostridium histolyticum (Xiaflex)

Xiaflex is covered only for FDA‑approved uses—adult Dupuytren’s contracture with a palpable cord and adult Peyronie’s disease with a palpable plaque—and non‑FDA uses are excluded. Coverage requires age ≥18, baseline deformity thresholds (Dupuytren’s ≥20° for MP/PIP; Peyronie’s ≥30° or ≥15° if prior Xiaflex), administration by an experienced provider (hand injection specialist for Dupuytren’s; urology for Peyronie’s), adherence to dosing/injection limits (0.58 mg per injection; Dupuytren’s max 3 injections per cord, ≤2 cords per visit, ≥4 weeks between cord injections; Peyronie’s max 8 injections/4 cycles with two injections per cycle 1–3 days apart and ~6 weeks between cycles), specified approval durations (3 months Dupuytren’s, 6 months Peyronie’s), and documentation of baseline measurements, prior treatment, and planned/prior injections.

"Treatment of adult patients with Dupuytren's contracture with palpable cord (FDA-approved indication)."