Texas Prior Authorization Program PDL Edit Criteria Drug/Drug Class Hypoglycemics, Lantus Insulin Information Included in this Document Hypoglycemics, Lantus Insulin Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical edit Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical edit criteria rules Logic diagram: a visual depiction of the clinical edit 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 edit Note: Click the hyperlink to navigate directly to that section. Revision Notes Lantus insulin moved from non-preferred status to preferred status. Edit removed. 03/26/2015 Copyright 2014-15 Health Information Designs, LLC 1
Drugs Requiring Prior Authorization Lantus Insulin Label Name GCN LANTUS 100 UNITS/ML VIAL 13072 LANTUS SOLOSTAR 100 UNITS/ML 98637 03/26/2015 Copyright 2014-15 Health Information Designs, LLC 2
PDL Edit Criteria Logic 1. Is the client less than (<) 18 years of age? [ ] Yes (Go to #2) [ ] No (Go to #3) 2. Does the client have a diagnosis of type I diabetes in the last 730 days? [ ] Yes (Approve 365 days) [ ] No (Go to #3) 3. Has the client failed a 30-day treatment trial with at least 1 preferred agent within the past 180 days? [ ] Yes (Approve 365 days) [ ] No (Go to #4) 4. Is there a documented allergy or contraindication to preferred agents in this class? [ ] Yes (Approve 365 days) [ ] No (Deny) 03/26/2015 Copyright 2014-15 Health Information Designs, LLC 3
PDL Edit Criteria Logic Diagram Step 1 Step 2 Is the client less than 18 years of age? Yes Does the client have a diagnosis of type I diabetes in the last 730 days? Yes Approve Request (365 days) No No Step 3 Has the client failed a 30-day treatment trial with at least 1 preferred agent within the past 180 days? Yes Approve Request (365 days) No Step 4 Is there a documented allergy or contraindication to preferred agents in this class? Yes Approve Request (365 days) No Deny Request 03/26/2015 Copyright 2014-15 Health Information Designs, LLC 4
PDL Edit Criteria Supporting Tables ICD-9 Code Description Step 2 (diagnosis of type I diabetes) Required quantity: 1 Look back timeframe: 730 days 25001 DIABETES MELLITUS W/O MENTION OF COMPLICATION, TYPE 1 [JUVENILE TYPE], NOT STATED AS UNCONTROLLED 25003 DIABETES MELLITUS W/O MENTION OF COMPLICATION, TYPE 1 [JUVENILE TYPE], UNCONTROLLED 25011 DIABETES WITH KETOACIDOSIS, TYPE I [JUVENILE TYPE], NOT STATED AS UNCONTROLLED 25013 DIABETES WITH KETOACIDOSIS, TYPE I [JUVENILE TYPE], UNCONTROLLED 25021 DIABETES WITH HYPEROSMOLARITY, TYPE 1 [JUVENILE TYPE], NOT STATED AS UNCONTROLLED 25023 DIABETES WITH HYPEROSMOLARITY, TYPE 1 [JUVENILE TYPE], UNCONTROLLED 25031 DIABETES WITH OTHER COMA, TYPE 1 [JUVENILE TYPE], NOT STATED AS UNCONTROLLED 25033 DIABETES WITH OTHER COMA, TYPE 1 [JUVENILE TYPE], UNCONTROLLED 25041 DIABETES WITH RENAL MANIFESTATIONS, TYPE 1 [JUVENILE TYPE], NOT STATED AS UNCONTROLLED 25043 DIABETES WITH RENAL MANIFESTATIONS, TYPE 1 [JUVENILE TYPE], UNCONTROLLED 25051 DIABETES WITH OPHTHALMIC MANIFESTATIONS, TYPE 1 [JUVENILE TYPE], NOT STATED AS UNCONTROLLED 25053 DIABETES WITH OPHTHALMIC MANIFESTATIONS, TYPE 1 [JUVENILE TYPE], UNCONTROLLED 25061 DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE 1 [JUVENILE TYPE], NOT STATED AS UNCONTROLLED 25063 DIABETES WITH NEUROLOGICAL MANIFESTATIONS, TYPE 1 [JUVENILE TYPE], UNCONTROLLED 25071 DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE 1 [JUVENILE TYPE], NOT STATED AS UNCONTROLLED 25073 DIABETES WITH PERIIPHERAL CIRCULATORY DISORDERS, TYPE 1 [JUVENILE TYPE], UNCONTROLLED 25081 DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE 1 [JUVENILE TYPE], NOT STATED AS UNCONTROLLED 25083 DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE 1 [JUVENILE TYPE], UNCONTROLLED 25091 DIABETES WITH UNSPECIFIED COMPLICATION, TYPE 1 [JUVENILE TYPE], NOT STATED AS UNCONTROLLED 03/26/2015 Copyright 2014-15 Health Information Designs, LLC 5
ICD-9 Code Description Step 2 (diagnosis of type I diabetes) Required quantity: 1 Look back timeframe: 730 days 25093 DIABETES WITH UNSPECIFIED COMPLICATION, TYPE 1 [JUVENILE TYPE], UNCONTROLLED ICD-10 Code E10 Description TYPE 1 DIABETES MELLITUS E10.1 TYPE 1 DIABETES MELLITUS WITH KETOACIDOSIS E10.10 TYPE 1 DIABETES MELLITUS WITH KETOACIDOSIS, WITHOUT COMA E10.11 TYPE 1 DIABETES MELLITUS WITH KETOACIDOSIS, WITH COMA E10.2 TYPE 1 DIABETES MELLITUS WITH KIDNEY COMPLICATIONS E10.21 TYPE 1 DIABETES MELLITUS WITH DIABETIC NEPHROPATHY E10.22 TYPE 1 DIABETES MELLITUS WITH DIABETIC CHRONIC KIDNEY DISEASE E10.29 TYPE 1 DIABETES MELLITUS WITH OTHER DIABETIC KIDNEY COMPLICATION E10.3 TYPE 1 DIABETES MELLITUS WITH OPHTHALMIC COMPLICATIONS E10.31 TYPE 1 DIABETES MELLITUS WITH UNSPECIFIED DIABETIC RETINOPATHY E10.311 TYPE 1 DIABETES MELLITUS WITH UNSPECIFIED DIABETIC RETINOPATHY WITH MACULAR EDEMA E10.319 TYPE 1 DIABETES MELLITUS WITH UNSPECIFIED DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA E10.32 TYPE 1 DIABETES MELLITUS WITH MILD NONPROLIFERATIVE DIABETIC RETINOPATHY E10.321 TYPE 1 DIABETES MELLITUS WITH MILD NONPROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA E10.329 TYPE 1 DIABETES MELLITUS WITH MILD NONPROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA E10.33 TYPE 1 DIABETES MELLITUS WITH MODERATE NONPROLIFERATIVE DIABETIC RETINOPATHY E10.331 TYPE 1 DIABETES MELLITUS WITH MODERATE NONPROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA E10.339 TYPE 1 DIABETES MELLITUS WITH MODERATE NONPROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA E10.34 TYPE 1 DIABETES MELLITUS WITH SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY E10.341 TYPE 1 DIABETES MELLITUS WITH SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA E10.349 TYPE 1 DIABETES MELLITUS WITH SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA E10.35 TYPE 1 DIABETES MELLITUS WITH PROLIFERATIVE DIABETIC RETINOPATHY E10.351 TYPE 1 DIABETES MELLITUS WITH PROLIFERATIVE DIABETIC RETINOPATHY WITH MACULAR EDEMA E10.359 TYPE 1 DIABETES MELLITUS WITH PROLIFERATIVE DIABETIC RETINOPATHY WITHOUT MACULAR EDEMA E10.36 TYPE 1 DIABETES MELLITUS WITH DIABETIC CATARACT E10.39 TYPE 1 DIABETES MELLITUS WITH OTHER DIABETIC OPHTHALMIC COMPLICATION 03/26/2015 Copyright 2014-15 Health Information Designs, LLC 6
ICD-10 Code Description Step 2 (diagnosis of type I diabetes) Required quantity: 1 Look back timeframe: 730 days E10.4 TYPE 1 DIABETES MELLITUS WITH NEUROLOGICAL COMPLICATION E10.40 TYPE 1 DIABETES MELLITUS WITH DIABETIC NEUROPATHY, UNSPECIFIED E10.41 TYPE 1 DIABETES MELLITUS WITH DIABETIC MONONEUROPATHY E10.42 TYPE 1 DIABETES MELLITUS WITH DIABETIC POLYNEUROPATHY E10.43 TYPE 1 DIABETES MELLITUS WITH DIABETIC AUTONOMIC (POLY)NEUROPATHY E10.44 TYPE 1 DIABETES MELLITUS WITH DIABETIC AMYOTROPHY E10.49 TYPE 1 DIABETES MELLITUS WITH OTHER DIABETIC NEUROLOGICAL COMPLICATION E10.5 TYPE 1 DIABETES MELLITUS WITH CIRCULATORY COMPLICATIONS E10.51 TYPE 1 DIABETES MELLITUS WITH DIABETIC PERIPHERAL ANGIOPATHY WITHOUT GANGRENE E10.52 TYPE 1 DIABETES MELLITUS WITH DIABETIC PERIPHERAL ANGIOPATHY WITH GANGRENE E10.59 TYPE 1 DIABETES MELLITUS WITH OTHER CIRCULATORY COMPLICATIONS E10.6 TYPE 1 DIABETES MELLITUS WITH OTHER SPECIFIED COMPLICATIONS E10.61 TYPE 1 DIABETES MELLITUS WITH DIABETIC ARHROPATHY E10.610 TYPE 1 DIABETES MELLITUS WITH DIABETIC NEUROPATHIC ARTHROPATHY E10.618 TYPE 1 DIABETES MELLITUS WITH OTHER DIABETIC ARTHROPATHY E10.62 TYPE 1 DIABETES MELLITUS WITH SKIN COMPLICATION E10.620 TYPE 1 DIABETES MELLITUS WITH DIABETIC DERMATITIS E10.621 TYPE 1 DIABETES MELLITUS WITH FOOT ULCER E10.622 TYPE 1 DIABETES MELLITUS WITH OTHER SKIN ULCER E10.628 TYPE 1 DIABETES MELLITUS WITH OTHER SKIN COMPLICATIONS E10.63 TYPE 1 DIABETES MELLITUS WITH ORAL COMPLICATIONS E10.630 TYPE 1 DIABETES MELLITUS WITH PERIODONTAL DISEASE E10.638 TYPE 1 DIABETES MELLITUS WITH OTHER ORAL COMPLICATIONS E10.64 TYPE 1 DIABETES MELLITUS WITH HYPOGLYCEMIA E10.641 TYPE 1 DIABETES MELLITUS WITH HYPOGLYCEMIA WITH COMA E10.649 TYPE 1 DIABETES MELLITUS WITH HYPOGLYCEMIA WITHOUT COMA E10.65 TYPE 1 DIABETES MELLITUS WITH HYPERGLYCEMIA E10.69 TYPE 1 DIABETES MELLITUS WITH OTHER SPECIFIED COMPLICATION E10.8 TYPE 1 DIABETES MELLITUS WITH UNSPECIFIED COMPLICATIONS E10.9 TYPE 1 DIABETES MELLITUS WITHOUT COMPLICATIONS 03/26/2015 Copyright 2014-15 Health Information Designs, LLC 7
Step 3 (alternate therapy) Required quantity: 1 Look back timeframe: 180 days Label Name GCN HUM INSULIN NPH/REG INSULIN HM 24486 HUM INSULIN NPH/REG INSULIN HM 50001 HUM INSULIN NPH/REG INSULIN HM 50101 HUM INSULIN NPH/REG INSULIN HUM 00890 INSULIN ASP PRT/IINSULIN ASPART 19057 INSULIN ASP PRT/INSULIN ASPART 17074 INSULIN ASP PRT/INSULIN ASPART 17074 INSULIN ASPART 92326 INSULIN ASPART 92336 INSULIN ASPART 92886 INSULIN DETEMIR 22836 INSULIN DETEMIR 25305 INSULIN LISPRO 05679 INSULIN NPL/INSULIN LISPRO 22681 INSULIN NPL/INSULIN LISPRO 97507 INSULIN REGULAR, HUMAN 05473 INSULIN REGULAR, HUMAN 09631 INSULIN REGULAR, HUMAN 09633 INSULIN REGULAR, HUMAN 11642 INSULIN REGULAR, HUMAN 15518 INSULIN ZINC HUMAN REG 05720 NPH, HUMAN INSULIN ISOPHANE 05331 NPH, HUMAN INSULIN ISOPHANE 11660 NPH, HUMAN INSULIN ISOPHANE 18488 03/26/2015 Copyright 2014-15 Health Information Designs, LLC 8
PDL Edit Criteria References 1. Clinical Pharmacology [online database]. Tampa, FL: Elsevier / Gold Standard, Inc.; 2014. Available at http://www.clinicalpharmacology.com. Accessed on April 17, 2014. 2. 2014 ICD-9-CM Diagnosis Codes, Volume 1. 2013. Available at http://www.icd9data.com/. Accessed on April 17, 2014. 3. 2014 ICD-10-CM Diagnosis Codes, Volume 1. 2013. Available at http://www.icd9data.com/. Accessed on April 17, 2014. 4. Lantus prescribing information. Bridgewater, NJ: Sanofi-Aventis U.S. LLC. December 2013. 03/26/2015 Copyright 2014-15 Health Information Designs, LLC 9
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 05/01/2014 Initial publication and posting on website. 01/22/2015 Lantus moved from non-preferred status to preferred status. Edit removed. 03/26/2015 Lantus no longer requires a PDL edit. Guide removed from website. 03/26/2015 Copyright 2014-15 Health Information Designs, LLC 10