Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Systemic lupus erythematosus, inflammatory arthritis, malar rash, photosensitivity, oral ulcers and Raynaud's phenomenon
Treatment: Sildenafil 20mg (milligrams)
The insurer denied: Sildenafil 20mg (milligrams)
The denial is overturned

The patient is an adult female with a diagnosis of systemic lupus erythematosus (SLE) with significant Raynaud's phenomenon. The patient is currently on Benlysta, hydroxychloroquine, and Celebrex. She recently had cholecystectomy and appendectomy and was off sildenafil. She is noted to have increased symptoms of Raynaud's phenomena especially given the winter weather. Her rheumatologist wants to start her back on sildenafil, which was recently denied coverage by the health plan. 
Sildenafil was denied coverage by the health plan, as its use was considered to be experimental/investigational for the patient's diagnosis. It does not meet the criteria and drug therapy guideline pulmonary hypertension. The patient diagnosis is not an FDA (United States Food and Drug Administration)-approved indication for requested product. The patient's rheumatologist is appealing the determination, as the patient has diagnosis of systemic lupus erythematosus with significant Raynaud's phenomena. She has tried amlodipine and nifedipine in the past without relief. Nitroglycerin topical on appointment was of minimal success. The patient has been on sildenafil 20 mg (milligram) tablets and it has proven to be the best therapeutic option for her. The patient has recently changed her insurance, and sildenafil was denied coverage by the new insurance. Her doctor would like her to resume sildenafil and treatment.

The health plan should cover the requested Sildenafil.

The Raynaud phenomenon (RP) is an exaggerated vascular response to cold temperature or to emotional stress, which is manifested clinically by sharply demarcated color changes of the skin of the digits. Treatment includes patient education and general measures taken by the patient to prevent and treat attacks and may include pharmacologic interventions and surgical sympathetic blockade to prevent and treat digital ischemia. The patient has secondary Raynaud's due to her systemic sclerosis. Patients with secondary RP (Raynaud phenomenon) are more likely to have severe attacks, and disease management is more likely to be based upon pharmacologic agents, while continuing non-pharmacologic measures. The goals of therapy are to improve quality of life and to prevent ischemic tissue injury. Literature supports the addition or substitution of other pharmacologic agents, such as topical nitrates or phosphodiesterase (PDE) 5 inhibitors (Sildenafil), if calcium channel blockers (CCB), such as nifedipine which the patient is on, are insufficient. In patients who do not respond adequately to a CCB (calcium channel blocker) alone, experts suggest the addition of a PDE (phosphodiesterase) inhibitor (e.g., Sildenafil). In patients in whom a PDE (phosphodiesterase) inhibitor is not available, effective, or well-tolerated, experts suggest the use of topical nitrates. Therefore, given the above, the requested sildenafil should be covered the health plan for treatment of Raynaud's phenomenon related to systemic lupus erythematosus.
Given that the treatment for this patient has been beneficial in the past and given the fact that there is good clinical evidence and literature supporting the use of sildenafil for Raynaud's, the requested sildenafil should be approved, as it is more beneficial than any standard treatment for the patient's disease.