Texas Prior Authorization Program Clinical Criteria Drug/Drug Class Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor Combination Agents This criteria was recommended for review by an MCO to ensure appropriate and safe utilization Clinical Information Included in this Document Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical criteria Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical criteria rules Logic diagram: a visual depiction of the clinical criteria logic Supporting tables: a collection of information associated with the steps within the criteria (diagnosis codes, procedure codes, and therapy codes); provided when applicable References: clinical publications and sources relevant to this clinical criteria Note: Click the hyperlink to navigate directly to that section. Revision Notes Initial publication and presentation to the DUR Board July 27, 2018 Copyright 2011-2018 Health Information Designs, LLC 1
Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name GCN INVOKAMET 150-1000 MG TABLET 36859 INVOKAMET 150-500 MG TABLET 36953 INVOKAMET 50-1000 MG TABLET 36857 INVOKAMET 50-500 MG TABLET 36954 INVOKAMET XR 150-1000 MG TABLET 42315 INVOKAMET XR 150-500 MG TABLET 42314 INVOKAMET XR 50-1000 MG TABLET 42313 INVOKAMET XR 50-500 MG TABLET 42312 SEGLUROMET 2.5-1000 MG TABLET 44285 SEGLUROMET 2.5-500 MG TABLET 44284 SEGLUROMET 7.5-1000 MG TABLET 44287 SEGLUROMET 7.5-500 MG TABLET 44286 SYNJARDY 12.5-1000 MG TAB 38932 SYNJARDY 12.5-500 MG TAB 39378 SYNJARDY 5-1000 MG TAB 38929 SYNJARDY XR 10-1000 MG TAB 42788 SYNJARDY XR 12.5-1000 MG TAB 42787 SYNJARDY XR 25-1000 MG TAB 42789 SYNJARDY XR 5-1000 MG TAB 42786 XIDDUO XR 10-1000 MG TAB 37344 XIGDUO XR 10-500 MG TAB 37342 XIGDUO XR 5-100 0MG TAB 37343 XIGDUO XR 5-500 MG TAB 37339 July 27, 2018 Copyright 2011-2018 Health Information Designs, LLC 2
Clinical Criteria Logic 1. Is the client greater than or equal to ( ) 18 years of age? [ ] Yes (Go to #2) [ ] No (Deny) 2. Does the client have a diagnosis of type 2 diabetes in the last 730 days? [ ] Yes (Go to #3) [ ] No (Deny) 3. Does the client have a diagnosis of hepatic impairment in the last 365 days? [ ] Yes (Deny) [ ] No (Go to #4) 4. Does the client have a diagnosis of severe renal impairment (egfr less than 30 ml/minute/1.73m 2 ), end stage renal disease (ESRD) or dialysis in the last 365 days? [ ] Yes (Deny) [ ] No (Go to #5) 5. Is the daily dose less than or equal to ( ) 2 tablets daily? [ ] Yes (Approve 365 days) [ ] No (Deny) July 27, 2018 Copyright 2011-2018 Health Information Designs, LLC 3
Clinical Criteria Logic Diagram Step 1 Step 2 Step 3 Step 4 Is the client 18 years of age? Yes Does the client have a diagnosis of type 2 diabetes in the last 730 days? Yes Does the client have a diagnosis of hepatic impairment in the last 365 days? No Does the client have a diagnosis of severe renal impairment, ESRD or dialysis in the last 365 days? No No Yes Yes No Step 5 Deny Request Deny Request Deny Request Is the dose 2 tablets daily? No Yes Deny Request Approve Request (365 days) July 27, 2018 Copyright 2011-2018 Health Information Designs, LLC 4
Clinical Criteria Supporting Tables ICD-10 Code E1100 E1101 E1121 E1122 E1129 E11311 E11319 E11321 E11329 E11331 E11339 E11341 E11349 E11351 E11359 E1136 E1139 E1140 E1141 E1142 Step 2 (diagnosis of type II diabetes) Description Look back timeframe: 730 days TYPE 2 DIABETES MELLITUS WITH HYPEROSMOLARITY WITHOUT NONKETOTIC HYPERGLYCEMIC-HYPEROSMOLAR COMA (NKHHC) TYPE 2 DIABETES MELLITUS WITH HYPEROSMOLARITY WITH COMA TYPE 2 DIABETES MELLITUS WITH DIABETIC NEPHROPATHY TYPE 2 DIABETES MELLITUS WITH DIABETIC CHRONIC KIDNEY DISEASE TYPE 2 DIABETES MELLITUS WITH OTHER DIABETIC KIDNEY COMPLICATION TYPE 2 DIABETES MELLITUS WITH UNSPECIFIED DIABETIC RETINOPATHY WITH MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH UNSPECIFIED DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH MILD NONPROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH MILD NONPROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH MODERATE NONPROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH MODERATE NONPROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH PROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH PROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA TYPE 2 DIABETES MELLITUS WITH DIABETIC CATARACT TYPE 2 DIABETES MELLITUS WITH OTHER DIABETIC OPHTHALMIC COMPLICATION TYPE 2 DIABETES MELLITUS WITH DIABETIC NEUROPATHY, UNSPECIFIED TYPE 2 DIABETES MELLITUS WITH DIABETIC MONONEUROPATHY TYPE 2 DIABETES MELLITUS WITH DIABETIC POLYNEUROPATHY July 27, 2018 Copyright 2011-2018 Health Information Designs, LLC 5
E1143 E1144 E1149 E1151 E1152 E1159 E11610 E11618 E11620 E11621 E11622 E11628 E11630 E11638 E11641 E11649 E1165 E1169 E118 E119 Step 2 (diagnosis of type II diabetes) Look back timeframe: 730 days TYPE 2 DIABETES MELLITUS WITH DIABETIC AUTONOMIC (POLY)NEUROPATHY TYPE 2 DIABETES MELLITUS WITH DIABETIC AMYOTROPHY TYPE 2 DIABETES MELLITUS WITH OTHER DIABETIC NEUROLOGICAL COMPLICATION TYPE 2 DIABETES MELLITUS WITH DIABETIC PERIPHERAL ANGIOPATHY WITHOUT GANGRENE TYPE 2 DIABETES MELLITUS WITH DIABETIC PERIPHERAL ANGIOPATHY WITH GANGRENE TYPE 2 DIABETES MELLITUS WITH OTHER CIRCULATORY COMPLICATIONS TYPE 2 DIABETES MELLITUS WITH DIABETIC NEUROPATHIC ARTHROPATHY TYPE 2 DIABETES MELLITUS WITH OTHER DIABETIC ARTHROPATHY TYPE 2 DIABETES MELLITUS WITH DIABETIC DERMATITIS TYPE 2 DIABETES MELLITUS WITH FOOT ULCER TYPE 2 DIABETES MELLITUS WITH OTHER SKIN ULCER TYPE 2 DIABETES MELLITUS WITH OTHER SKIN COMPLICATIONS TYPE 2 DIABETES MELLITUS WITH PERIODONTAL DISEASE TYPE 2 DIABETES MELLITUS WITH OTHER ORAL COMPLICATIONS TYPE 2 DIABETES MELLITUS WITH HYPOGLYCEMIA WITH COMA TYPE 2 DIABETES MELLITUS WITH HYPOGLYCEMIA WITHOUT COMA TYPE 2 DIABETES MELLITUS WITH HYPERGLYCEMIA TYPE 2 DIABETES MELLITUS WITH OTHER SPECIFIED COMPLICATION TYPE 2 DIABETES MELLITUS WITH UNSPECIFIED COMPLICATIONS TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS ICD-10 Code B160 B161 B162 B169 B170 B1710 B1711 Step 3 (diagnosis of hepatic impairment) Description Look back timeframe: 365 days ACUTE HEPATITIS B WITH DELTA-AGENT WITH HEPATIC COMA ACUTE HEPATITIS B WITH DELTA-AGENT WITHOUT HEPATIC COMA ACUTE HEPATITIS B WITHOUT DELTA-AGENT WITH HEPATIC COMA ACUTE HEPATITIS B WITHOUT DELTA-AGENT AND WITHOUT HEPATIC COMA ACUTE DELTA-(SUPER) INFECTION OF HEPATITIS B CARRIER ACUTE HEPATITIS C WITHOUT HEPATIC COMA ACUTE HEPATITIS C WITH HEPATIC COMA July 27, 2018 Copyright 2011-2018 Health Information Designs, LLC 6
B172 B178 B179 B180 B181 B182 B188 B189 B190 B1910 B1911 B1920 B1921 B199 K700 K7010 K7011 K702 K7030 K7031 K7040 K7041 K709 K710 K7110 K7111 K712 K713 K714 K7150 K7151 K716 K717 K718 K719 Step 3 (diagnosis of hepatic impairment) Look back timeframe: 365 days ACUTE HEPATITIS E OTHER SPECIFIED ACUTE VIRAL HEPATITIS ACUTE VIRAL HEPATITIS, UNSPECIFIED CHRONIC VIRAL HEPATITIS B WITH DELTA-AGENT CHRONIC VIRAL HEPATITIS B WITHOUT DELTA-AGENT CHRONIC VIRAL HEPATITIS C OTHER CHRONIC VIRAL HEPATITIS CHRONIC VIRAL HEPATITIS, UNSPECIFIED UNSPECIFIFED VIRAL HEPATITIS WITH HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS B WITHOUT HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS B WITH HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS C WITHOUT HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS C WITH HEPATIC COMA UNSPECIFIED VIRAL HEPATITIS WITHOUT HEPATIC COMA ALCOHOLIC FATTY LIVER ALCOHOLIC HEPATITIS WITHOUT ASCITES ALCOHOLIC HEPATITIS WITH ASCITES ALCOHOLIC FIBROSIS AND SCLEROSIS OF LIVER ALCOHOLIC CIRRHOSIS OF LIVER WITHOUT ASCITES ALCOHOLIC CIRRHOSIS OF LIVER WITH ASCITES ALCOHOLIC HEPATIC FAILURE WITHOUT COMA ALCOHOLIC HEPATIC FAILURE WITH COMA ALCOHOLIC LIVER DISEASE, UNSPECIFIED TOXIC LIVER DISEASE WITH CHOLESTASIS TOXIC LIVER DISEASE WITH HEPATIC NECROSIS WITHOUT COMA TOXIC LIVER DISEASE WITH HEPATIC NECROSIS WITH COMA TOXIC LIVER DISEASE WITH ACUTE HEPATITIS TOXIC LIVER DISEASE WITH CHRONIC PERSISTENT HEPATITIS TOXIC LIVER DISEASE WITH CHRONIC LOBULAR HEPATITIS TOXIC LIVER DISEASE WITH CHRONIC ACTIVE HEPATITIS WITHOUT ASCITES TOXIC LIVER DISEASE WITH CHRONIC ACTIVE HEPATITIS WITH ASCITES TOXIC LIVER DISEASE WITH HEPATITIS, NOT ELSEWHERE CLASSIFIED TOXIC LIVER DISEASE WITH FIBROSIS AND CIRRHOSIS OF LIVER TOXIC LIVER DISEASE WITH OTHER DISORDERS OF LIVER TOXIC LIVER DISEASE, UNSPECIFIED July 27, 2018 Copyright 2011-2018 Health Information Designs, LLC 7
K7200 K7201 K7210 K7211 K7290 K7291 K730 K731 K732 K738 K739 K740 K741 K742 K743 K744 K745 K7460 K7469 K750 K751 K752 K753 K754 K7581 K7589 K759 K761 K763 K7689 K769 K77 Step 3 (diagnosis of hepatic impairment) Look back timeframe: 365 days ACUTE AND SUBACUTE HEPATIC FAILURE WITHOUT COMA ACUTE AND SUBACUTE HEPATIC FAILURE WITH COMA CHRONIC HEPATIC FAILURE WITHOUT COMA CHRONIC HEPATIC FAILURE WITH COMA HEPATIC FAILURE, UNSPECIFIED WITHOUT COMA HEPATIC FAILURE, UNSPECIFIED WITH COMA CHRONIC PERSISTENT HEPATITIS, NOT ELSEWHERE CLASSIFIED CHRONIC LOBULAR HEPATITIS, NOT ELSEWHERE CLASSIFIED CHRONIC ACTIVE HEPATITIS, NOT ELSEWHERE CLASSIFIED OTHER CHRONIC HEPATITIS, NOT ELSEWHERE CLASSIFIED CHRONIC HEPATITIS, UNSPECIFIED HEPATIC FIBROSIS HEPATIC SCLEROSIS HEPATIC FIBROSIS WITH HEPATIC SCLEROSIS PRIMARY BILIARY CIRRHOSIS SECONDARY BILIARY CIRRHOSIS BILIARY CIRRHOSIS, UNSPECIFIED UNSPECIFIED CIRRHOSIS OF LIVER OTHER CIRRHOSIS OF LIVER ABSCESS OF LIVER PHLEBITIS OF PORTAL VEIN NONSPECIFIC REACTIVE HEPATITIS GRANULOMATOUS HEPATITIS, NOT ELSEWHERE CLASSIFIED AUTOIMMUNE HEPATITIS NONALCOHOLIC STEATOHEPATITIS (NASH) OTHER SPECIFIED INFLAMMATORY LIVER DISEASES INFLAMMATORY LIVER DISEASE, UNSPECIFIED CHRONIC PASSIVE CONGESTION OF LIVER INFARCTION OF LIVER OTHER SPECIFIED DISEASES OF LIVER LIVER DISEASE, UNSPECIFIED LIVER DISORDERS IN DISEASES CLASSIFIED ELSEWHERE July 27, 2018 Copyright 2011-2018 Health Information Designs, LLC 8
ICD-10 Code V56 V560 V561 V562 V563 V5631 V5632 V568 N184 Step 4 (diagnosis of severe renal impairment, ESRD or dialysis) Description Look back timeframe: 730 days ENCOUNTER FOR DIALYSIS AND DIALYSIS CATHETER CARE RENAL DIALYSIS ENCOUNTER FT/ADJ XTRCORP DIAL CATH FIT/ADJ PERIT DIAL CATH ENCOUNTER FOR ADEQUACY TESTING FOR DIALYSIS HEMODIALYSIS TESTING PERITONEAL DIALYSIS TEST DIALYSIS ENCOUNTER, NEC CHRONIC KIDNEY DISEASE, STAGE 4 (SEVERE) N185 CHRONIC KIDNEY DISEASE, STAGE 5 N186 Z4901 Z4902 Z4931 Z4932 END STAGE RENAL DISEASE ENCOUNTER FOR FITTING AND ADJUSTMENT OF EXTRACORPOREAL DIALYSIS CATHETER ENCOUNTER FOR FITTING AND ADJUSTMENT OF PERITONEAL DIALYSIS CATHETER ENCOUNTER FOR ADEQUACY TESTING FOR HEMODIALYSIS ENCOUNTER FOR ADEQUACY TESTING FOR PERITONEAL DIALYSIS July 27, 2018 Copyright 2011-2018 Health Information Designs, LLC 9
Clinical Criteria References 1. 2018 ICD-10-CM Diagnosis Codes. 2018. Available at www.icd10data.com. Accessed on June 11, 2018. 2. Clinical Pharmacology [online database]. Tampa, FL: Elsevier/Gold Standard, Inc.; 2018. Available at www.clinicalpharmacology.com. Accessed on June 11, 2018. 3. Micromedex [online database]. Available at www.micromedexsolutions.com. Accessed on June 11, 2018. 4. Invokamet Prescribing Information. Titusville, NJ. Janssen Pharmaceuticals, Inc. August 2017. 5. Invokamet XR Prescribing Information. Titusville, NJ. Janssen Pharmaceuticals, Inc. January 2018. 6. Segluromet Prescribing Information. Whitehouse Station, NJ. Merck Sharp & Dohme Corp. December 2017. 7. Synjardy Prescribing Information. Ridgefield, CT. Boehringer Ingelheim Pharmaceuticals, Inc. December 2017. 8. Synjardy XR Prescribing Information. Ridgefield, CT. Boehringer Ingelheim Pharmaceuticals, Inc. December 2017. 9. Xigduo XR Prescribing Information. Wilmington, DE. AstraZeneca Pharmaceuticals LP. July 2017. 10.American Diabetes Association. Standards of Medical Care in Diabetes-2018. Diabetes Care 2018;41(Suppl 1). 11.Qaseem A, Humphrey LL, Sweet DE, et al, for the Clinical Guidelines Committee of the American College of Physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2012 Feb 7;156(3):218-31. 12.Rosenzweig JL, Ferrannini E, Grundy SM, et al. Primary Prevention of Cardiovascular Disease and Type 2 Diabetes in Patients at Metabolic Risk: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. October 2008, 93(10):3671-3689. July 27, 2018 Copyright 2011-2018 Health Information Designs, LLC 10
Publication History The Publication History records the publication iterations and revisions to this document. Notes for the most current revision are also provided in the Revision Notes on the first page of this document. Publication Date Notes 07/27/2018 Initial publication and presentation to the DUR Board July 27, 2018 Copyright 2011-2018 Health Information Designs, LLC 11