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Clinical Policy Bulletin:
Lepirudin (Refludan)
Number: 0861


Policy

Aetna considers lepirudin (Refludan) medically necessary for anticoagulation in persons with heparin induced thrombocytopenia (HIT) and associated thromboembolic disease: Lepirudin is considered experimental and investigational for all other indications.

Note: Unless contraindicated, long-term anticoagulation should be done using warfarin.



Background

Up to 4 additional courses of LEPIRUDIN were safe & efficacious in 4 HIT patients with anti-hirudin antibodies; no thromboembolism occurred; re-exposure was 2 x 25 milligrams subcutaneously for 8 to 27 days (Harenberg et al, 2000).

 
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
96365 - 96368
96369 - 96371
96372
96374 - 96376
96379
HCPCS codes covered if selection criteria are met:
J1945 Injection, lepirudin, 50 mg
ICD-9 codes covered if selection criteria are met:
289.84 Heparin-induced thrombocytopenia (HIT)
ICD-9 codes not covered for indications listed in the CPB:
444.01 Saddle embolus of abdominal aorta
444.09 Other arterial embolism and thrombosis of abdominal aorta
444.1 Embolism and thrombosis of thoracic aorta
444.21 Embolism and thrombosis of arteries of upper extremity
444.22 Embolism and thrombosis of arteries of lower extremity
444.81 Embolism and thrombosis of iliac artery
444.89 Embolism and thrombosis of other specified artery


The above policy is based on the following references:
  1. Refludan [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals; December 2006.
  2. Harenberg J, Huhle G, Wang C, Hoffmann U, Song X H. Re-exposure to recombinant (r)-hirudin in antihirudin antibody-positive patients with a history of heparin-induced thrombocytopenia. British Journal of Hematology 2000;109:360-363.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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