Denying reimbursement for the use of thrombectomy devices in stroke patients who are ineligible for intravenous tissue-type plasminogen activator (t-PA) treatment would be unfair and may lead to poor outcomes, according to IMS III researchers.
IMS III (Interventional Management of Stroke III) was an international, Phase III, open-label trial that was stopped early due to futility. The study found no difference in safety outcomes and functional independence with endovascular therapy after t-PA compared with intravenous t-PA alone in patients with moderate-to-severe acute ischemic stroke.
A second study called SYNTHESIS (Local Versus Systemic Thrombolysis for Acute Ischemic Stroke) also put a damper on endovascular therapy when it failed to show its superiority over intravenous t–PA in patients with acute ischemic stroke. Both studies were published earlier this year in the New England Journal of Medicine.
Based on findings from the two trials, insurers are pondering whether to withdraw reimbursement for thrombectomy devices to treat ischemic stroke patients. Writing in the May issue of Stroke, IMS III investigators Joseph P. Broderick, MD, and Thomas A. Tomsick, MD, both of the University of Cincinnati Neuroscience Institute, warned that the change may apply to patients who have contraindications that make them ineligible for t-PA.
Denying reimbursement to ischemic stroke patients who are ineligible for t-PA might lead to patients not receiving reperfusion because the hospital would be denied reimbursement or the patient would have to foot the bill for an endovascular procedure, they argued. They recommended that the Centers for Medicare & Medicaid Services and insurers cover patients treated with thrombectomy devices in future randomized trials as well as reimburse hospitals that treat ischemic stroke patients contraindicated for t-PA with endovascular therapy within four and a half hours of symptom onset.
“The key principle to treatment is that reperfusion therapy, whether pharmacological with IV t-PA or mechanical with endovascular thrombectomy, results in good outcomes when applied early,” they wrote.
The editorial was endorsed by the Cerebrovascular Coalition, which represents numerous neurological societies.