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202211-155496

2023

Community Blue

HMO

Immunologic Disorders

Pharmacy/ Prescription Drugs

Experimental/Investigational

Overturned

Case Summary

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 systemic lupus erythematosus (SLE) and Raynaud's syndrome. She is currently treated with Benlysta infusions, Plaquenil, Celebrex and sildenafil 20 mg (milligrams) daily. For her Raynaud's symptoms, she failed treatment with the calcium channel blockers amlodipine and nifedipine, as well as topical nitroglycerin. Her Raynaud's symptoms have been successfully managed with sildenafil 20 mg (milligrams) daily since one and a half years ago, which was approved by her prior insurance. She held treatment with sildenafil after cholecystectomy and appendectomy and her provider now wishes to resume sildenafil in the setting of increased Raynaud's symptoms. Sildenafil was denied coverage by the health plan for this patient, because Raynaud's syndrome is not an FDA (United States Food and Drug Administration)-approved indication for sildenafil. The appeal is for sildenafil for the treatment of Raynaud's syndrome.

The health plan should cover the requested sildenafil for the treatment of Raynaud's syndrome.

This patient with SLE (systemic lupus erythematosus) and Raynaud's syndrome failed treatment with the calcium channel blockers amlodipine and nifedipine, as well as topical nitroglycerin. Her Raynaud's symptoms have been successfully managed with sildenafil 20 mg (milligrams) daily for a year and a half which was approved by her prior insurance. She held treatment with sildenafil after cholecystectomy and appendectomy and her provider now wishes to resume sildenafil in the setting of increased Raynaud's symptoms. Although sildenafil is not FDA (United States Food and Drug Administration)-approved for the treatment of Raynaud's syndrome, per Sildenafil: Drug information, Lexicomp, Raynaud's syndrome is an acceptable off-label indication for sildenafil. Per a recent UpToDate review, low-dose phosphodiesterase 5 (PDE) inhibitors such as sildenafil may be used in patients with uncomplicated Raynaud's phenomenon in whom calcium channel blockers are not tolerated. A meta-analysis of six randomized trials found that there was a modest benefit of PDE (phosphodiesterase) inhibitors (sildenafil, tadalafil and vardenafil) on the frequency and duration of Raynaud's phenomenon attacks. Therefore, resuming sildenafil for the treatment of Raynaud's phenomenon in this SLE (systemic lupus erythematosus) patient who failed treatment with amlodipine, nifedipine and as topical nitroglycerin is clinically appropriate and in accordance with standard of care in the medical community. Therefore, the health plan should cover the requested sildenafil for the treatment of Raynaud's syndrome.
The requested sildenafil for the treatment of Raynaud's syndrome is more beneficial than standard of care calcium channel blockers and topical nitroglycerin.

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