Sildenafil denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for sildenafil. The European League Against Rheumatism (EULAR) guidelines recommend calcium channel blockers as the first-line therapy for the treatment of patients with systemic sclerosis-related Raynaud’s syndrome. The guidelines also indicate that phosphodiesterase 5 inhibitors, such as sildenafil, should be used as a second-line therapy for the treatment of patients with systemic sclerosis and severe Raynaud’s syndrome, and/or patients who do not satisfactorily respond to calcium channel blockers. In this case, the patient has a history of limited systemic sclerosis and Raynaud’s syndrome. A review of the record indicates that the patient’s Raynaud’s syndrome was refractory.

Nature of Statutory Criteria/ Case Summary: The enrollee is requesting authorization and coverage for the medication, Sildenafil six tablets every thirty days. Findings: The physician reviewer found that according to the record, the enrollee has a history of obesity and erectile dysfunction, testicular hypofunction and sleep apnea. Sildenafil for erectile dysfunction has been prescribed by his current physician for many years. He was seen by his physician and a refill of his sildenafil citrate 100mg tabs was prescribed with instructions to take one half to one tablet, as needed approximately one hour before sexual activity. The medical literature indicates that phosphodiesterase type-5 inhibitors, which include Sildenafil, are considered a first-line treatment for erectile dysfunction (ED) because of their safety and efficacy.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for sildenafil. One study demonstrated no favorable significance of sildenafil in improving maximal oxygen consumption in patients with Fontan circulation. Although the patient has a condition where elevated pulmonary vascular pressures and resistance are detrimental, there is a lack of a recent diagnostic study for this patient which has demonstrated pulmonary hypertension. In fact, the most recent cardiac catheterization demonstrated normal pulmonary artery pressures. Moreover, the patient is asymptomatic per the provider’s records with normal oxygen saturation on room air.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for sildenafil 20 mg tablets taken three times a day for 90 days for a total of 270 tablets. This patient’s records support a diagnosis of limited cutaneous scleroderma associated with CREST syndrome with calcinosis, esophageal dysmotility, telangiectasias and Raynaud’s syndrome, but not systemic sclerosis. The records report that she did not respond to nifedipine and antiplatelet therapy. However, the patient does not have documented pulmonary artery hypertension, for which sildenafil would be indicated. In addition, she has been responsive to current medications and also has not tried and failed other standard therapies such as Prazosin or Cozaar.

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 Sildenafil, then check the rights and deadlines that apply to your plan.