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Home , Vitamin K antagonist

Low-Molecular-Weight

Policy Number: Original Effective Date: MM.04.019 10/15/2007 Line(s) of Business: Current Effective Date: HMO; PPO; QUEST 01/01/2014 Section: Prescription Drugs Place(s) of Service: Home; Office; Outpatient

I. Description Low-molecular-weight heparin (LMWH) is an drug used in the prevention and treatment venous thromboembolism (VTE). LMWH may be used in some circumstances as an alternative to or unfractionated heparin therapy. The LMWH preparations have different biochemical and pharmacologic properties and are not interchangeable. The decision to use a LMWH preparation for a specific clinical indication should be based upon the available clinical trial data for that particular preparation. This policy only addresses LMWH when used in an outpatient setting. It does not apply to the inpatient use of these drugs. II. Criteria/Guidelines A. LMWH is covered (subject to Limitations/Exclusions and Administrative Guidelines) for the prevention of VTE in any of the following situations: 1. Total hip arthroplasty, total knee arthroplasty and hip fracture surgery; for up to 35 days post operatively. 2. Abdominal or pelvic surgery for cancer and patient is considered at high risk for VTE (e.g., Caprini score ≥ 5; see Appendix II); for up to 28 days post operatively. B. LMWH is covered (subject to Limitations/Exclusions and Administrative Guidelines) in the treatment of the following conditions: 1. Acute deep vein (DVT) and/or (PE) for up to six months for patients with cancer (diagnosed or treated for cancer within the previous six months). 2. Acute DVT and/or PE when used in conjunction with warfarin sodium; used for a minimum of five days and continued until the international normalized ratio (INR) is 2.0 or above for at least 24 hours. Low-Molecular-Weight Heparin 2

3. Superficial vein thrombosis of the lower limb of at least 5 cm in length; may use for up to 45 days. C. LMWH is covered (subject to Limitations/Exclusions and Administrative Guidelines) during pregnancy for the following indications: 1. Prevention and/or treatment of VTE during pregnancy. 2. Prevention and/or treatment of VTE after delivery as follows: a. LMWH will be covered for up to an additional six weeks in patients who at the time of delivery are expected to remain on anticoagulation for no longer than six weeks. b. LMWH will be covered for up to an additional two weeks (to allow time to transition to antagonist) in patients who at the time of delivery are expected to remain on anticoagulation for longer than six weeks. D. LMWH is covered (subject to Limitations/Exclusions and Administrative Guidelines) when used in perioperative bridge therapy for patients requiring interruption of vitamin K antagonist who have the following conditions and are at moderate*-to high-risk of thromboembolism. 1. Mechanical heart valves: a. Moderate-risk are those patients with bileaflet aortic valve prosthesis and one of the following: i. Atrial fibrillation ii. Prior stroke or transient ischemic attack (TIA) iii. Hypertension iv. Diabetes v. Congestive heart failure vi. Age is greater than 75 yrs b. High-risk are those patients with one of the following: i. Any mitral valve prosthesis ii. Older (caged-ball or tilting disc) aortic valve prosthesis iii. Stroke or TIA within six months 2. Atrial fibrillation

a. Moderate-risk are those patients with a CHADS2 score (see Appendix II) of 3 or 4 b. High-risk are those with one of the following: i. CHADS2 score of 5 or 6 ii. Stroke or TIA within three months iii. Rheumatic valvular heart disease 3. Venous thromboembolism (VTE) a. Moderate- risk are those patients with one of the following: i. VTE within the past three to 12 months ii. Nonsevere thrombophilic conditions (e.g., heterozygous Factor V Leiden mutation or prothrombin gene mutation) iii. Recurrent VTE iv. Active cancer (treated within six months or palliative) Low-Molecular-Weight Heparin 3

b. High-risk are those patients with one of the following: i. VTE within three months ii. Severe thrombophilia (e.g., deficiency of , protein S or , antiphospholipid antibodies, or multiple abnormalities). ∗ The determination whether to bridge or not to bridge should be based on an assessment of individual patient-and surgery -related factors. III. Limitations/Exclusions LMWH is not covered for the following: A. Perioperative bridge therapy for patients who are not at moderate- to high- risk for thromboembolism. B. Perioperative bridge therapy for the following procedures: 1. Minor dental procedures, e.g., single or multiple tooth extractions and endodontic (root canal) procedures. 2. Minor dermatologic procedures, e.g., excisions of basal and squamous cell carcinomas, actinic keratoses and malignant or premalignant nevi. 3. Minor ophthalmologic procedures, e.g., cataract extraction. 4. Upper gastrointestinal endoscopy with or without biopsy. C. Prevention and/or treatment of thromboembolism before pregnancy, i.e., before conception, and after delivery (except as noted in Criteria/Guidelines II.B.2) as use of vitamin K antagonist is not contraindicated. D. Prevention of DVT during airplane flights as it has not been shown to be more effective than conservative measures. E. Prevention of VTE in patients undergoing knee arthroscopy with no prior history of VTE. IV. Administrative Guidelines A. Precertification is required for the following: 1. Treatment exceeding the standard durations mentioned in II.A -C. Documentation supporting the need for therapy beyond the standard duration must be submitted. 2. Treatment of acute DVT and/or pulmonary embolism beyond six months in patients with cancer. Documentation supporting the need for therapy beyond six months must be submitted. 3. Perioperative bridge therapy. Documentation indicating the procedure to be performed as well as clinical notes supporting the patient’s moderate to high risk status. B. Complete HMSA's drug review request and fax or mail the form as indicated C. For services that do not require precertification, documentation must be kept in the patient's medical record and made available to HMSA upon request. HMSA reserves the right to perform retrospective reviews using the above criteria to validate if services rendered met payment determination criteria.

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V. Important Reminder The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician. Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii's Patients' Bill of Rights and Responsibilities Act (Hawaii Revised Statutes § 432E-1.4), generally accepted standards of medical practice, and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA's determination as to medical necessity in a given case, the physician may request that HMSA reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation.

VI. References 1. American Society for Gastrointestinal Endoscopy guideline: The Management of Low- Molecular-Weight Heparin and Nonaspirin Antiplatelet Agents for Endoscopic Procedures. Gastrointestinal Endoscopy 2005, Vol. 61, No. 2. 2. Bick RL, Hoppensteadt D. Recurrent Miscarriage Syndrome and Infertility due to Blood Protein/Platelet Defects: A Review and Update. Clin Appl Thromb Hemost. 2005 Jan; 11(1):1-13. 3. Gage BF, et al. Validation of Clinical Classification Schemes for Predicting Stroke: Results from the National Registry of Atrial Fibrillation. JAMA 2001 285 (22): 2864–70. 4. Goodin S. Selecting an Anticoagulant for Recurrent Venous Thromboembolism in Cancer. Am J Health Syst Pharm. 2005 Nov 15; 62(22 Suppl. 5):S10-3. 5. Lee AY, Levine MN, Baker RI et al. Randomized Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulation Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer (CLOT) Investigators. Low-Molecular-Weight Heparin versus Coumadin for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer. New Engl J Med 2003; 349: 146-153. 6. Lovenox () prescribing information. Sanofi-aventis U.S. LLC Bridgewater, NJ. June 2013. 7. Kearon C, Akl EA, Comerota AJ, et al: Therapy for VTE Disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141(2 suppl):e419S-e494S. 8. Management of Venous Thromboembolism: A Clinical Practice Guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med. 2007; 146-204-210 9. Drugdex Drug Point Summary: Enoxaparin Sodium. Last modified: May 28, 2013. Low-Molecular-Weight Heparin 5

10. Kahn SR, Lim W, Dunn AS, et al: Prevention of VTE in Nonsurgical Patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence- Based Clinical Practice Guidelines. Chest 2012; 141(2 suppl):e195S-e226S. 11. Bates SM, Greer IA, Middeldorp S, et al: VTE, Thrombophilia, Antithrombotic Therapy, and Pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141(2 suppl):e691S-e736S. 12. Douketis JD, Spyropoulos AC, Spencer FA, et al: Perioperative Management of Antithrombotic Therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (2 suppl):e326Se350S. 13. National Comprehensive Cancer Network. Venous Thromboembolic Disease Guidelines. Version 2.2013.

VII. Appendices

Appendix I

CHADS2 Score Points Congestive heart failure 1 Hypertension 1 Age at least 75 years 1 Diabetes mellitus 1 Prior stroke or transient ischemic attack 2

Appendix II

Caprini VTE Risk Assessment Model Risk Points 41 to 60 years 1 Age 61 to 74 years 2 75 years or greater 3 VTE, personal 3 VTE, family 3 History Unexplained or spontaneous abortion 1 Inflammatory bowel disease 1 Minor surgery 1 Surgery Major open surgery (longer than 45 minutes) 2 Low-Molecular-Weight Heparin 6

Laparoscopic surgery (longer than 45 2 minutes) Arthroscopic surgery 2 Elective arthroplasty 5 Medical patient at bed rest 1 Ambulation Confined to bed longer than 72 hours 2 Thrombophilic Factor V Leiden 3 condition Prothrombin 20210A 3 BMI greater than 25 kg/m(2) 1 Swollen legs 1 Varicose veins 1 Pregnancy or postpartum 1 Oral contraceptives or hormone replacement 1 Sepsis less than 1 month 1 Serious lung disease, including pneumonia, less than 1 month 1 Abnormal pulmonary function 1 Acute myocardial infarction 1 Congestive heart failure, less than 1 month 1 Malignancy 2 Immobilizing plaster cast 2 Central venous access 2 Lupus anticoagulant 3 Anticardiolipin antibodies 3 Elevated serum homocysteine 3 Heparin-induced thrombocytopenia 3 Congenital or acquired thrombophilia 3 Stroke, less than 1 month 5 Hip, pelvis, or leg fracture 5 Acute spinal cord injury, less than 1 month 5