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Clinical Policy Bulletin:
Lepirudin (Refludan)
Number: 0861


Aetna considers lepirudin (Refludan) medically necessary for anticoagulation in persons with heparin-induced thrombocytopenia (HIT) and associated thromboembolic disease.

Aetna considers lepirudin experimental and investigational for all other indications.

Note: Bayer HealthCare announced that they discontinued marketing Refludan on May 31, 2012 and no further product is expected to be shipped to wholesalers in the United States after that date.


Harenberg et al (2000) reported that patients with a history of heparin-induced thrombocytopenia (HIT) and antibodies to hirudin were re-exposed to recombinant (r)-hirudin for prophylaxis of thromboembolism.  A toal of 4 patients were re-exposed to 2 x 25 mg of subcutaneous r-hirudin for 8 to 27 days; 2 patients were re-exposed once, 1 patient twice and 1 patient 4 times.  Re-exposure was well-tolerated in all patients and no thromboembolism occurred.  Antihirudin IgG (4/4 patients), IgA and IgM (1/4 patients) antibody levels increased.  Baseline ecarin clotting times showed high variability.  Patients with antibodies to hirudin may be re-exposed but anticoagulant monitoring is mandatory.

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

CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
96365 - 96368 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug)
96369 - 96371 Subcutaneous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug)
96372 Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular
96374 - 96376 Therapeutic, prophylactic, or diagnostic injection (specify substance or drug)
96379 Unlisted therapeutic, prophylactic or diagnostic intravenous or intra-arterial I injection or infusion
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)

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, et al. Re-exposure to recombinant (r)-hirudin in antihirudin antibody-positive patients with a history of heparin-induced thrombocytopenia. Br J Haematol. 2000;109(2):360-363.
  3. Bayer Healthcare Pharmaceuticals. Discontinuation of Refludan [lepirudin (rDNA) for injection]. Wayne, NJ: Bayer Healthcare; May 31, 2012.

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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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