Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Varicose Veins
Treatment: Injection of Non-Compounded Foam Sclerosant 
(Varithena) 
The insurer denied Injection of Non-Compounded Foam Sclerosant (Varithena). 
The denial is upheld.

The patient is an adult female with reported incompetence of the right greater saphenous vein. The patient was seen for endovenous foam sclerosant ablation of the right greater saphenous vein below the knee. No preoperative duplex study is provided. The patient also underwent ultrasound guided occlusion of patent perforators (unclear of the technique for the perforator occlusion). Follow-up duplex study showed reflux in the right accessory greater saphenous vein that measured 9.8 centimeters. The review is a retrospective review for injection of foam sclerosant (Varithena [polidocano]). The service was denied coverage by the health plan on the basis that injection of 
non-compounded foam sclerosant with ultrasound compression maneuvers in the greater or accessory saphenous vein(s) is not demonstrated through peer-reviewed medical literature to be safe and effective for treating the patient's condition. The service was determined to be experimental / investigational under the plan.
The patient has filed the appeal stating how effective the procedure was for her condition after three separate procedures more than 30 years ago. Articles are included about the efficacy of the procedure.

The health plan should not cover the requested health service.

This is an adult female with reported incompetence of the right greater saphenous vein. The patient was seen for endovenous foam sclerosant ablation with Varithena of the right greater saphenous vein below the knee. Follow-up duplex study showed reflux in the right accessory greater saphenous vein that measured 9.8 centimeters. There is no record that the accessory saphenous vein was treated previously or at present. No preoperative duplex study is provided. Treatment of reflux in the saphenous venous system is indicated for severe symptoms that have not responded to conservative therapy. The patient reports that she had venous procedures 30 years ago. It is unclear what these procedures consisted of. There is no record of the preoperative duplex study, history of conservative therapy, or history as to what prior procedures had been done. Finally, foam sclerosant for reflux in the greater saphenous is considered not the optimal treatment. Therefore, the health plan should not cover the requested health service. 
The requested health service is no more beneficial than standard treatment which is radiofrequency or endovenous laser ablation for greater saphenous reflux. The use of Varithena (polidocanol) is considered investigational for treatment of reflux in the 
saphenous veins. The articles provided with the review do not support its use. One of the articles provided in support of the Varithena (1) only addresses the bubble size of Varithena compared to physician-compounded foams. A second article (2) started with the premise that Varithena overcomes the variability and inconsistencies of physician-compounded foam. Clinical trials of Varithena have demonstrated efficacy and safety outcomes equivalent or better than physician-compounded foam but only in comparison to placebo alone. The author concluded, "Varithena is a promising step towards creation of an ideal sclerosant foam," and further assessment in independent randomized controlled clinical trials is required to establish the advantages of Varithena over and above the current best practice physician-compounded foam.