See Important Reminder at the end of this policy for important regulatory and legal information.

Transcription

1 Policy: Sodium-Glucose Co-Transpter 2 (SGLT2) Inhibits Reference Number: TCHP.PHAR.182 Effective Date: Last Review Date: Line of Business: Oregon Health Plan Revision Log See Imptant Reminder at the end of this policy f imptant regulaty and legal infmation. Goal(s): Promote cost-effective and safe step-therapy f management of type 2 diabetes mellitus (T2DM). Length of Authization: Up to 6 months Requires PA: All SGLT-2 inhibits Covered Alternatives: Current Trillium Preferred Drug List listed at: o Approval Criteria 1. Is this a request f renewal of a previously Yes: Go to Renewal No: Go to #2 approved pri authization? Criteria 2. What is diagnosis is being treated? Recd ICD-10 code. 3. Does the patient have a diagnosis of T2DM? Yes: Go to #4 No: Pass to RPh. Deny; medical appropriateness. 4. Has the patient tried and failed metfmin and a sulfonylurea, have contraindications to these treatments is requesting a SGLT-2 inhibit to be used with metfmin and a sulfonylurea? (document contraindication, if any) 5. Is the request f the following treatments (including combination products) with an associated estimated glomerular filtration rate (egfr): Canagliflozin and egfr <45 ml/min/1.73 m 2, Empagliflozin and egfr <45 ml/min/1.73 m 2, Dapagliflozin and egfr <60 ml/min.1.73 m 2? 6. Has the patient tried and failed (unable to maintain goal A1c) all of the following drugs, have contraindications to all of these drugs? Page 1 of 5 Yes: Go to #5 Yes: Pass to RPh. Deny; medical appropriateness Yes: Approve f up to 6 months No: Pass to RPh. Deny and recommend trial of metromin sulfonylurea. See below f metfmin titration schedule. No: Go to #6 No: Pass to RPh. Deny and require a trial of insulin,

2 Insulin Thiazolidinedione DPP-4 inhibit GLP-1 recept agonist Amylin analog Renewal Criteria 1. Is the request f the following treatments (including combination products) with an associated estimated glomerular filtration rate (egfr): Canagliflozin and egfr <45 ml/min/1.73 m 2, Empagliflozin and egfr <45 ml/min/1.73 m 2, Dapagliflozin and egfr <60 ml/min.1.73 m 2? Yes: Pass to RPh. Deny; medical appropriateness thiazolidinedione, DPP-4 inhibit, GLP- 1 agonist, and amylin analog. No: Approve f up to 6 months. I. Initiating Metfmin 1. Begin with low-dose metfmin (500 ) taken once twice per day with meals (breakfast and/ dinner) 850 once per day. 2. After 5-7 days, if gastrointestinal side effects have not occurred, advance dose to 850, two 500 tablets, twice per day (medication to be taken befe breakfast and/ dinner). 3. If gastrointestinal side effects appear with increasing doses, decrease to previous lower dose and try to advance the dose at a later time. 4. The maximum effective dose can be up to 1,000 twice per day but is often 850 twice per day. Modestly greater effectiveness has been observed with doses up to about 2,500 /day. Gastrointestinal side effects may limit the dose that can be used. II. General Infmation: Per the 2018 American Diabetes Association (ADA) and 2017 American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) guidelines: o Metfmin is recommended f all patients with type 2 diabetes. Monotherapy is recommended f o most patients; however: Starting with dual therapy (i.e., metfmin plus another agent, such as a sulfonylurea, thiazolidinedione, DPP-4 inhibit, SGLT2 inhibit, glucagon-like peptide 1 [GLP-1] recept agonist, basal insulin) may be considered f patients with baseline HbA1c 9% per the ADA ( 7.5% per the AACE/ACE). Starting with combination injectable therapy (i.e., with GLP-1 recept agonist insulin) may be considered f patients with baseline HbA1c 10% per the ADA ( 9% if symptoms are present per the AACE/ACE). If the target HbA1c is not achieved after approximately 3 months of monotherapy, dual therapy should be initiated. If dual therapy is inadequate after 3 months, triple therapy should be initiated. Finally, if triple therapy fails to bring a patient to goal, combination injectable therapy should be initiated. Each non-insulin agent added to initial therapy can lower HbA1c by %. III.Dosage and Administration Page 2 of 5

3 Drug Name Dosing Regimen Maximum Dose Farxiga (dapagliflozin) 5 PO once daily 10 /day Glyxambi 10/5 PO once daily 25/5 /day (empagliflozin/linagliptin) Invokamet One 50/500 tablet PO 300/2000 /day (canagliflozin/metfmin) twice daily Invokamet XR Two 50/500 tablets PO 300/2000 /day (canagliflozin/metfmin) once daily Invokana (canagliflozin) 100 PO once daily 300 /day Jardiance (empagliflozin) 10 PO once daily 25 /day Segluromet Individualized dose PO 15/2000 /day (ertugliflozin/metfmin) twice daily Steglatro (ertugliflozin) 5 PO once daily 15 /day Steglujan One 5/100 tablet PO 15/100 /day (ertugliflozin/sitagliptin) once daily Synjardy Individualized dose PO 25/2000 /day (empagliflozin/metfmin) twice daily Synjardy XR Individualized dose PO once 25/2000 /day (empagliflozin/metfmin) daily Xigduo XR (dapagliflozin/metfmin) Individualized dose PO once daily 10/2000 /day IV. Product Availability Drug Name Farxiga (dapagliflozin) Glyxambi (empagliflozin/linagliptin) Invokamet (canagliflozin/metfmin) Invokamet XR (canagliflozin/metfmin) Invokana (canagliflozin) Jardiance (empagliflozin) Segluromet (ertugliflozin/metfmin) Steglatro (ertugliflozin) Steglujan (ertugliflozin/sitagliptin) Synjardy (empagliflozin/metfmin) Synjardy XR (empagliflozin/metfmin) Xigduo XR (dapagliflozin/metfmin) Availability Tablets: 5, 10 Tablets: 10/5, 25/5 Tablets: 50/500, 50/1000, 150/500, 150/1000 Tablets: 50/500, 50/1000, 150/500, 150/1000 Tablets: 100, 300 Tablets: 10, 25 Tablets: 2.5/500, 2.5/1000, 7.5/500, 7.5/1000 Tablets: 5, 15 Tablets: 5/100, 15/100 Tablets: 5/500, 5/1000, 12.5/500, 12.5/1000 Tablets: 5/1000, 10/1000, 12.5/1000, 25/1000 Tablets: 2.5/1000, 5/500, 5/1000, 10/500, 10/1000 V. References Page 3 of 5

4 1. Sodium-Glucose Cotranspter-2 Inhibits (SGLT-2 Inhibits). Oregon Health Plan Current Drug Use Criteria. Available at: Accessed March 19, American Diabetes Association. Standards of medical care in diabetes Diabetes Care. 2018; 41(suppl 1): S1-S Garber AJ, Abrahamson MJ, Barzilay, JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algithm 2017 executive summary. Endocr Pract. 2017; 23(2): Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed March 19, Reviews, Revisions, and Approvals Date P&T Approval Date Policy created Supersedes the following Centene Policies: CP.PST.19 Sodium-Glucose Co-Transpter 2 (SGLT2) Inhibits Approved by Trillium Oregon Health Plan P&T Imptant 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 standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional ganizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical infmation. The Health Plan makes no representations and accepts no liability with respect to the content of any external infmation used 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 administered, in whole in part, by Centene Management Company, LLC, 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 guarantee regarding payment 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 regulaty requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal regulaty requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend 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 medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment Page 4 of 5

5 in providing the most appropriate care, and are solely responsible f the medical advice and treatment of members. This clinical policy is not intended to recommend treatment f members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Providers referred to in this clinical policy are independent contracts who exercise independent judgment and over whom the Health Plan has no control right of control. Providers are not agents employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthized copying, use, and distribution of this clinical policy any infmation 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/ submitting claims f payment f such services. Note: F 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 f any coverage provisions pertaining to this clinical policy. Page 5 of 5