Xiaflex denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Xiaflex for treatment of his medical condition. Findings: The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. Peyronie’s disease is caused by scar tissue which forms along the length of the penis in the corpora cavernosa. Depending on the severity of the condition, this can cause penile curvature with erection. The curvature can make intercourse difficult and/or painful for the patient and his partner. Potential treatment options for Peyronie’s disease include surgery, minimally invasive treatment options, and medications. The results for most previously available medications and minimally invasive therapies have been inconsistent or lacked empirical support for effectiveness.

Nature of Statutory Criteria/Case Summary: An enrollee requested Xiaflex for medical treatment of his Peyronie’s disease. Findings: The physician reviewer found that Peyronie’s disease is caused by scar tissue, called plaque, which forms along the length of the penis in the corpora cavernosa. Depending on the severity of the condition, this condition can cause penile curvature with erection. The curvature can make intercourse difficult and/or painful for the patient and his partner. Potential treatments for Peyronie’s disease include surgery, minimally invasive treatment options, and medications. The results for most previously available medications and minimally invasive therapies have been inconsistent or lacked empirical support for effectiveness.

Where the denial was upheld

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested reimbursement for a Xiaflex injection and/or prospective authorization and coverage for two cycles of Xiaflex injections (two injections per cycle). Xiaflex is indicated for the treatment of patients with symptomatic Peyronie’s disease with a palpable plaque and greater than 30 degrees of penile curvature. The U.S. Food and Drug Administration (FDA) recommends eight total injections of Xiaflex for such patients. In this case, the patient has a history of symptomatic Peyronie’s disease. The patient underwent four cycles (eight injections) with Xiaflex. However, the patient still has significant residual penile curvature of 30 degrees.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Xiaflex for treatment of his Peyronie’s disease. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. This patient has been diagnosed with Peyronie’s disease. Intralesional injection therapies for patients with Peyronie’s disease seek to reduce plaque production, contracture, and improve on recurrence rate and progression. However, at this time, the most effective treatment is surgery. While there is data suggesting intralesional injection with Xiaflex may be beneficial, the findings are preliminary and further investigation is necessary to confirm long-term efficacy. As noted in a study by Egui Rojo and colleagues, although Xiaflex has been approved by the U.S.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Xiaflex, then check the rights and deadlines that apply to your plan.