Medical Affairs Policy

Transcription

1 Medical Affairs Policy Service: Omnibus Pharmacy Policy for Treatments Reviewed by Medical Affairs PUM Medical Policy Committee Approval 12/01/17 Effective Date 04/01/18 Prior Authorization Needed Yes Disclaimer: This policy is for informational purposes only and does not constitute medical advice, plan authorization, an explanation of benefits, or a guarantee of payment. Benefit plans vary in coverage and some plans may not provide coverage for all services listed in this policy. Coverage decisions are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations, and to applicable state and federal law. Some benefit plans administered by the organization may not utilize Medical Affairs medical policy in all their coverage determinations. Contact customer services as listed on the member card for specific plan, benefit, and network status information. Medical policies are based on constantly changing medical science and are reviewed annually and subject to change. The organization uses tools developed by third parties, such as the evidence-based clinical guidelines developed by MCG to assist in administering health benefits. This medical policy and MCG guidelines are intended to be used in conjunction with the independent professional medical judgment of a qualified health care provider. To obtain additional information about MCG, medical.policies@wpsic.com. Description: This policy addresses the internal review process for certain drugs listed on the Drug Preauthorization list that are not reviewed by Express Scripts or EnvoyHealth (Diplomat). These drugs require more in-depth understanding of member health plan language combined with review of submitted clinical information to establish primary eligibility (e.g. weight loss, infertility, sexual dysfunction). Indications of Coverage: A. Infertility products (e.g. HCG, Clomiphene, including progesterone prescribed pre-pregnancy to treat infertility or recurrent early pregnancy loss) 1. Review request to determine if member has infertility benefits. 2. If so, approve per plan language. If not, deny per plan language. B. Progesterone products for the maintenance of pregnancy (for Makena [hydroxyprogesterone caproate] injection - skip to NOTE below) Page 1 of 6

2 1. Review request to determine if pregnancy is confirmed. 2. If so, approve. If not pregnant, use criteria in section A NOTE: Makena (hydroxyprogesterone caproate) is prescribed in the second trimester of pregnancy starting in week 16 of gestation through week 36. For Prior Authorization (pre-treatment), have provider contact Express Scripts for review. Makena can be self-administered. C. Progesterone products for non-pregnancy and non-infertility use (e.g. menopause, peri-menopause, and irregular menses) may be approved. Note: progesterone injection for treatment of menopausal symptoms is not the standard of care. 1. Verify if drug will be self-administered or provider administered to determine processing of the authorization. D. Testosterone products for hormonal deficiency (injectable or implantable). Initial treatment: 1. Review request to determine if member has hormonal deficiency (testosterone level 270 ng/dl measured on 3 separate days in the morning) AND associated symptoms/conditions 2. If deficient and symptoms/conditions exist other than sexual dysfunction (e.g. Hypogonadism, malaise), approve. o Note: testosterone cypionate or enanthate is typically given every 2-4 weeks. Aveed (long acting injection) and Testopel (pellets) requires failure to topicals and testosterone cypionate/enanthate. 3. If deficient and no other symptoms other than sexual dysfunction, verify if member has coverage of sexual dysfunction. If so, approve. If not, deny per plan language. 4. If member has testosterone levels within normal limits, deny as not medically necessary. Continued treatment: 5. Review the request to determine whether the member had at least one pretreatment testosterone level that was low, as defined by the normal laboratory reference values, AND persistent signs and symptoms (e.g., depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis) of Page 2 of 6

3 testosterone deficiency (pre-treatment). 6. If so, approve. If not, deny per plan language. NOTE: Topical and oral testosterone are reviewed by Express Scripts. Self - administered testosterone cypionate/enanthate is also reviewed by Express Scripts. E. Hormone Treatment for Gender Dysphoria (e.g. Testosterone injection). 1. Criteria for starting hormone therapy requires documentation of: a. Persistent, well-documented gender dysphoria/gender incongruence. b. Results of the client s physical and psychosocial assessment, including any diagnoses. c. Relevant medical or mental health issues are well controlled. d. The World Professional Association for Transgender Health (WPATH) criteria for hormonal treatment have been met e. The patient s capacity to make a well-informed decision. f. A statement that informed consent regarding the risks and benefits of hormonal treatment has been obtained g. Ongoing medical monitoring, including regular physical and laboratory examination to monitor hormone effectiveness and side effects h. Communication, as needed, with the patient s primary care provider, mental health professional, and surgeon 2. If member meets above criteria, then hormone treatment will be allowed consistent with that described in the Standards of Care for Gender Identity Disorders at: ociation_webpage_menu=1351. NOTE: Topical and oral testosterone / androgens are reviewed by Express Scripts. Testosterone cypionate/enanthate may also be reviewed by Express Scripts when being self-administered. F. Weight Loss Drugs (e.g. orlisat [Xenical], lorcaserin [Belviq], phenterminetopiramate [Qsymia], bupropion-naltrexone [Contrave], liraglutide [Victoza or Saxenda], benzphetamine [Didrex], diethylpropion [Tenuate], phentermine [Suprenza, Adipex-P, Lomaira], and phendimetrazine [Bontril]) Page 3 of 6

4 1. Review plan language to determine if plan covers weight loss drugs AND if member meets the plan definition for coverage (e.g. Morbid obesity). 2. If so, approve or deny per plan language. G. Prialt (Ziconotide) Intrathecal Infusion 1. Determine if: a. The member meets criteria for intrathecal therapy. Use MCG guideline: Intrathecal Pump Implantation. AND b. The member is intolerant of, or pain is refractory to intrathecal morphine. 2. If criteria are met, the intrathecal pump (e.g. Medtronic SynchroMed II Infusion System, and the CADD-Micro Ambulatory Infusion Pump) and drug are approved. If not, deny as not medically necessary. H. Varithena (Polidocanol Injectable foam): Review using Varicose Vein Treatments Medical Policy Limitations of Coverage: A. Review contract and endorsements for exclusions and prior authorization or benefit requirements. B. Custom compounded bioidentical hormones (CCBH), and CCBH with dose adjustment based upon serial monitoring, are typically an exclusion of the health plan. They are also considered experimental, investigational, and unproven to affect health outcomes. Their safety and efficacy are unproven. The American College of Gynecologists and Surgeons (ACOG), North American Menopause Society, and The Endocrine Society have all issued scientific statements against the use of CCBH. See also Non-Covered Services and Procedures Medical Policy. Documentation Required: Office notes documenting drug name, diagnosis, location service will be provided (self-administration versus office) Page 4 of 6

5 References: Laboratory reports when applicable 1. UpToDate. Clinical features and diagnosis of male hypogonadism Literature review current through Oct Topic last updated Sept 21, UpToDate. Clinical manifestations and diagnosis of menopause. Literature review current through Oct Topic last updated Oct 20, UpToDate. Treatment of menopausal symptoms with hormone therapy. Literature review current through Oct Topic last updated Nov 21, UpToDate. Obesity in adults: Drug therapy. Literature review current through Oct Topic last updated Feb 17, UpToDate. Overview of testosterone deficiency in older men. Literature review current through Oct Topic last updated July 31, UpToDate. Testosterone treatment of male hypogonadism. Literature review current through Oct Topic last updated Apr 12, Prialt (ziconoide) prescribing information. Jazz Pharmaceuticals. Accessed 10/25/16 available at: 8. UpToDate. Cancer Pain Management: Interventional Strategies. Literature review current through Oct Topic Last Updated Oct 13, World Professional Association for Transgender Health (WPATH): 2012 WPATH Standards of care for the health of transsexual, transgender, and gender nonconforming people, version 7. Accessed 7/10/17 available at: ation_webpage_menu=1351. Page 5 of 6

6 Review History: Implemented 01/01/17, 04/01/18 Medical Policy 12/09/16, 12/1/17 Committee Approval Process Revised 12/1/17 Developed 12/09/16 Approved by the Medical Director Page 6 of 6