Clinical Policy: Levonorgestrel Intrauterine Device (Mirena), Noncontraceptive Use Reference Number: CP.MP.HN494

Transcription

1 Clinical Policy: Levonorgestrel Intrauterine Device (Mirena), Noncontraceptive Use Reference Number: CP.MP.HN494 Effective Date: 9/09 Last Review Date: 7/17 See Important Reminder at the end of this policy for important regulatory and legal information. Coding Implications Revision Log Description The levonorgestrel releasing intrauterine system, Mirena (LNG-IUD or LNG/IUS) has been FDA approved for intrauterine contraception for a number of years. It is also utilized for noncontraceptive use. Policy/Criteria I. It is the policy of Health Net of California that the non-contraceptive use of levonorgestrel intrauterine system (e.g., Mirena) is medically necessary for the following indications: A. Idiopathic menorrhagia, B. Adenomyosis, leiomyomas, C. Pain due to endometriosis D. Hemostatic disorders with commensuate reduction in dysmenorrhea and anemia, E. There are no contraindicatons such as: i. Pregnancy or suspicion of pregnancy ii. Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity iii. Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy iv. Postpartum endometritis or infected abortion in the past 3 months v. Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear vi. Genital bleeding of unknown etiology vii. Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled viii. Acute liver disease or liver tumor (benign or malignant) ix. Conditions associated with increased susceptibility to pelvic infections x. A previously inserted IUD that has not been removed xi. Hypersensitivity to any component of this product xii. Known or suspected carcinoma of the breast. II. It is the policy of Health Net of California that the non-contraceptive use of levonorgestrel intrauterine system (e.g., Mirena) is considered investigational for other indication. Background In 2000, the U.S. Food and Drug Administration (FDA) approved the levonorgestrel releasing intrauterine system, Mirena (LNG-IUD or LNG/IUS) for intrauterine contraception for up to 5 Page 1 of 8

2 years. The system consists of a 32-mm T-shaped polyethylene frame with a steroid reservoir containing a mixture of 52 mg of levonorgestrel and silicone covered by a silicone membrane. After insertion, the initial release of levonorgestrel into the uterine cavity is 20 mcg/d. A stable plasma concentration of pg/ml is achieved after the first few weeks. Although some degradation of concentration is seen over time, the concentration is maintained for at least 5 years and the typical histologic changes in the endometrium induced by the levonorgestrel intrauterine system have been observed for up to 7 years. The plasma concentration of levonorgestrel in patients using the levonorgestrel intrauterine system is less than 25% of that seen with 150 mcg of oral levonorgestrel. The most common side effects resulting in discontinuation of levonorgestrel intrauterine system therapy include irregular bleeding and hormonal side effects such as breast tenderness, mood changes, and acne. Other potential drawbacks include abdominal pain, infection, and difficult insertions requiring cervical dilation. The only LNG-IUD approved at this time is the Mirena IUD. New lower dose (10 and 14 mcg per day) and smaller sized LNG-IUS (MLS, FibroPlant- LNG) are currently under clinical development and investigation. In October 2009, the U.S. Food and Drug Administration (FDA) approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. Previously, the IUD was approved for intrauterine contraception for up to 5 years. The LNG-IUD is also being used as a treatment for dysfunctional uterine bleeding (DUB), also known as idiopathic menorrhagia, defined as excessively heavy, regular menses in the absence of intracavitary pathology or coagulopathy in premenopausal women as a minimally invasive alternative to the more definitive treatments such as endometrial ablation and hysterectomy. The goal of this therapy is to reduce excessive menstrual blood loss and related symptoms and improve quality of life. According to the American College of Obstetricians and Gynecologists (ACOG), the levonorgestrel intrauterine system appears to reduce menstrual blood loss significantly in women with idiopathic menorrhagia. According to an ACOG committee opinion on noncontraceptive uses of the levonorgestrel intrauterine system (2006, reaffirmed 2008): "There is sufficient evidence to support the use of the levonorgestrel intrauterine system as a treatment option for idiopathic menorrhagia. In January 2010, the American College of Obstetricians and Gynecologist (ACOG) replaced Committee Opinion number 337 (Noncontraceptive uses of the Levonorgestrel Intrauterine System) with a Practice Bulletin (Number 110), Noncontraceptive uses of Hormonal Contraception. Per the bulletin, The levonorgestrel intrauterine system is a highly effective contraceptive method with significant noncontraceptive benefits in women with excessive menstrual bleeding and dysmenorrhea. Numerous studies have confirmed the effectiveness of the levonorgestrel intrauterine system for reduction of menstrual blood loss from idiopathic Page 2 of 8

3 menorrhagia, adenomyosis, leiomyomas, pain due to endometriosis and hemostatic disorders with commensuate reduction in dysmenorrhea and anemia. A guideline from the Faculty of Family Planning and Reproductive Health Care regarding the non-contraceptive uses of LNG-IUS made the following recommendations: "The LNG-IUS can be used as a first-line option to treat menorrhagia. Surgery (hysterectomy, endometrial resection, or ablation) is more effective than the LNG-IUS in treating menorrhagia at 1 year. The LNG-IUS is as effective as conservative surgery (resection and ablation) in the management of menorrhagia after the first year. Patient satisfaction and quality of life appear similar following LNG-IUS or surgical treatment of menorrhagia. (Grade A recommendation) Luo et al (2013), in a Cochrane review, reported that a review of the evidence found no randomized controlled studies (RCTs) of the efficacy and safety of the LNG IUS for treating women with a diagnosis of atypical endometrial hyperplasia. RCTS are required in this area. Levonorgestrel intrauterine systems (LNG IUS) devices containing less than 52 mg levonorgestrel (Skyla, Kyleena ) for off-label non-contraceptive use are considered investigational. There is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. Coding Implications This clinical policy references Current Procedural Terminology (CPT ). CPT is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2015, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. CPT Description Codes Insertion of intrauterine device (IUD) Removal of Intrauterine Device HCPCS Codes J7297 J7298 Description Levonorgestrel - releasing intrauterine contraception system, 52mg, 3 year duration Levonorgestrel - releasing intrauterine contraception system, 52mg, 5 year duration ICD-10-CM Diagnosis Codes that Support Coverage Criteria Page 3 of 8

4 ICD-10-CM Description Code N92.0-N92.6 Excessive, frequent and irregular menstruation N93.8 Other specified abnormal uterine and vaginal bleeding N93.9 Abnormal uterine and vaginal bleeding, unspecified N95.0 Postmenopausal bleeding N95.1 Menopausal and female climacteric states N95.8 Other specified menopausal and perimenopausal disorders N95.9 Unspecified menopausal and perimenopausal disorder Z Hormone replacement therapy (postmenopausal) Reviews, Revisions, and Approvals Date Approval Date Initial Approval 9/09 Updated policy statement that LNG-IUS is considered medically necessary 9/10 for long-term menstrual suppression. Annual review code updates 7/11 9/12 7/13 7/14 7/15 7/16 Update on new template 7/17 References 1. American College of Obstetricians and Gynecologists. Non Contraceptive uses of Hormonal Contraception. Number 110. Jan Replaces Committee Opinion Number 337, June 2006) Reaffirmed American College of Obstetricians and Gynecologists. Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Number 121. (Replaces Practice Bulletin Number 59, January Reaffirmed 2015) 3. Bradley LD, Gueye NA. 1.The medical management of abnormal uterine bleeding in reproductive-aged women. Am J Obstet Gynecol Jan;214(1): Gupta JK, Daniels JP, Middleton LJ, et al. A randomised controlled trial of the clinical effectiveness and cost-effectiveness of the levonorgestrel-releasing intrauterine system in primary care against standard treatment for menorrhagia: the ECLIPSE trial. Health Technol Assess Oct;19(88):i-xxv, Kim MK, Seong SJ, Kim JW, et al. Management of Endometrial Hyperplasia With a Levonorgestrel-Releasing Intrauterine System: A Korean Gynecologic-Oncology Group Study. Int J Gynecol Cancer May;26(4): Kiseli M, Kayikcioglu F, Evliyaoglu O, Haberal A. Comparison of Therapeutic Efficacies of Norethisterone, Tranexamic Acid and Levonorgestrel-Releasing Intrauterine System for the Treatment of Heavy Menstrual Bleeding: A Randomized Controlled Study. Gynecol Obstet Invest Mar 8. Page 4 of 8

5 7. Li L, Leng JH, Dai Y, et al. A prospective cohort study on effects of levonorgestrelreleasing intrauterine system for adenomyosis with severe dysmenorrheal. Zhonghua Fu Chan Ke Za Zhi May 25;51(5): Papadakis EP, El-Nashar SA, Laughlin-Tommaso SK, et al.. Combined Endometrial Ablation and Levonorgestrel Intrauterine System Use in Women Levonorgestrel Intrauterine Device (Mirena), Noncontraceptive Use Jul With Dysmenorrhea and Heavy Menstrual Bleeding: Novel Approach for Challenging Cases. J Minim Invasive Gynecol Nov-Dec;22(7): Senol T, Kahramanoglu I, Dogan Y, et al. Levonorgestrel-releasing intrauterine device use as an alternative to surgical therapy for uterine leiomyoma. Clin Exp Obstet Gynecol. 2015;42(2): Soini T, Hurskainen R, Grénman S, et al. Levonorgestrel-releasing intrauterine system and the risk of breast cancer: A nationwide cohort study. Acta Oncol. 2016;55(2): Gallos ID, Krishan P, Shehmar M, et al. Relapse of endometrial hyperplasia after conservative treatment: a cohort study with long-term follow-up. Hum Reprod May;28(5): Gupta J, Kai J, Middleton L, et al. Levonorgestrel intrauterine system versus medical therapy for menorrhagia. N Engl J Med Jan 10;368(2): Hartmann KE, Jerome RN, Lindegren ML, et al. Primary Care Management of Abnormal Uterine Bleeding. [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Mar. 15. Ismail MT, Fahmy DM, Elshmaa NS. Efficacy of levonorgestrel-releasing intrauterine system versus oral progestins in treatment of simple endometrial hyperplasia without atypia. Reprod Sci Jan;20(1): Kaunitz AM, Bissonnette F, Monteiro I, et al. Levonorgestrel-releasing intrauterine system for heavy menstrual bleeding improves hemoglobin and ferritin levels. Contraception Nov;86(5): Lee BS, Ling X, Asif S, et al. Levonorgestrel-releasing intrauterine system versus conventional medical therapy for heavy menstrual bleeding in the AsiaPacific region. Int J Gynaecol Obstet Apr;121(1): Luo L, Luo B, Zheng Y, et al. Levonorgestrel-releasing intrauterine system for atypical endometrial hyperplasia. Cochrane Database Syst Rev Jun 5;6:CD Machado RB, de Souza IM, Beltrame A, et al. The levonorgestrel-releasing intrauterine system: its effect on the number of hysterectomies performed in perimenopausal women with uterine fibroids. Gynecol Endocrinol May;29(5): Matteson KA, Rahn DD, Wheeler TL 2nd, et al. Nonsurgical Management of Heavy Menstrual Bleeding: A Systematic Review. Obstet Gynecol Mar;121(3): Palmara V, Sturlese E, Villari D, et al. Levonorgestrel-releasing intrauterine device in the treatment of abnormal uterine bleeding: a 6- and 12-month morphological and clinical follow-up. Aust N Z J Obstet Gynaecol May Silva-Filho AL, Pereira Fde A, de Souza SS, et al. Five-year follow-up of levonorgestrelreleasing intrauterine system versus thermal balloon ablation for the treatment of heavy menstrual bleeding: a randomized controlled trial. Contraception Apr;87(4): Page 5 of 8

6 23. Sesti F, Piancatelli R, Pietropolli A, et al. Levonorgestrel-releasing intrauterine system versus laparoscopic supracervical hysterectomy for the treatment of heavy menstrual bleeding: a randomized study. J Womens Health (Larchmt) Aug;21(8): Singh S, Best C, Dunn S, et al. Abnormal uterine bleeding in pre-menopausal women. J Obstet Gynaecol Can May;35(5): Wong AW, Chan SS, Yeo W, Yu MY, Tam WH. Prophylactic use of levonorgestrelreleasing intrauterine system in women with breast cancer treated with tamoxifen: a randomized controlled trial. Obstet Gynecol May; 121(5): Bhattacharya S, Middleton LJ, Tsourapas A, et al. Hysterectomy, endometrial ablation and Mirena for heavy menstrual bleeding: a systematic review of clinical effectiveness and cost-effectiveness analysis. Health Technol Assess Apr;15(19):iii-xvi, Chattopdhyay B, Nigam A, Goswami S, Chakravarty PS. Clinical outcome of levonorgestrel intra-uterine system in idiopathic menorrhagia. Eur Rev Med Pharmacol Sci Jul;15(7): Haoula ZJ, Walker KF, Powell MC. Levonorgestrel intra-uterine system as a treatment option for complex endometrial hyperplasia. Eur J Obstet Gynecol Reprod Biol Nov;159(1): Kaunitz AM, Inki P. The levonorgestrel-releasing intrauterine system in heavy menstrual bleeding: a benefit-risk review. Drugs Jan 22;72(2): Leminen H, Heliövaara-Peippo S, Halmesmäki K, et al. The effect of hysterectomy or levonorgestrel-releasing intrauterine system on premenstrual symptoms in women treated for menorrhagia: secondary analysis of a randomized controlled trial. Acta Obstet Gynecol Scand Mar;91(3): Somboonporn W, Panna S, Temtanakitpaisan T, et al. Effects of the levonorgestrelreleasing intrauterine system plus estrogen therapy in perimenopausal and postmenopausal women: systematic review and metaanalysis. Menopause Oct;18(10): Tanmahasamut P, Rattanachaiyanont M, Angsuwathana S, et al. Postoperative levonorgestrel-releasing intrauterine system for pelvic endometriosis-related pain: a randomized controlled trial. Obstet Gynecol Mar;119(3): Yoo HJ, Lee MA, Ko YB, et al. The efficacy of the levonorgestrel-releasing intrauterine system in perimenopausal women with menorrhagia or dysmenorrhea. Arch Gynecol Obstet Jan;285(1): Giuntoli R, Zacur H. Management of Endometrial Hyperplasia. In: UpToDate Online Journal, Waltham, MA: UpToDate; updated October Luo L, Luo B, Zheng Y, Zhang H, Li J, Sidell N. Levonorgestrel releasing intrauterine system for atypical endometrial hyperplasia. Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD DOI: / CD pub2 Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted Page 6 of 8

7 standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. Health Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services. Page 7 of 8

8 Note: For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy. Note: For Medicare members, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at for additional information Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation. Page 8 of 8