Medical Necessity Determination for Xiaflex Continuation Therapy

Initial Treatment Criteria

• The American Urological Association recommends intralesional collagenase clostridium histolyticum combined with modeling for patients with stable Peyronie's disease with curvature between 30° and 90°, with a moderate recommendation (Evidence Strength Grade B) 1, 2
• The European Association of Urology recommends CCH for stable disease with appropriate curvature range and intact erectile function 5, 2

Treatment Protocol

• The FDA-approved protocol consists of a maximum of 4 treatment cycles, with 2 injections per cycle, and a total maximum of 8 injections over approximately 24 weeks 1, 2
• Mandatory modeling exercises are performed by clinician and patient after each injection cycle 1, 2

Expected Clinical Outcomes

• The IMPRESS I and II trials demonstrated a mean curvature reduction of 17° with CCH versus 9.3° with placebo at one-year follow-up 1
• Improvement in patient-reported bother and sexual function was also observed 1

Safety Considerations

• The safety and efficacy of administering more than 8 total injections has not been established in clinical trials or post-marketing surveillance 1, 2
• Common adverse events within the approved protocol include penile ecchymosis, swelling, and pain, while serious but rare events include corporal rupture and penile hematoma 1

Alternative Management Options

• For patients who complete 8 injections but have persistent curvature, alternative options include observation, penile traction therapy, and surgical intervention 2, 5
• Surgical options include tunical plication, tunical lengthening with grafting, and penile prosthesis, with reported improvement rates of >90%, 25-100%, and >80%, respectively 2

Documentation Requirements

• Documentation must include confirmation of stable disease, objective measurement of penile curvature, palpable plaque confirmation, assessment of erectile function status, and cumulative injection count from all previous treatments 1, 3, 4