Texas Prior Authorization Program Clinical Criteria Drug/Drug Class Clinical Criteria Information Included in this Document Excluding Valsartan / Ramipril 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 Valsartan / Ramipril 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. May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 1
Revision Notes Added the following drugs to the DRO criteria: Benazepril, Captopril, Enalapril, Lisinopril, Moexipril, Quinapril, Benazepril/HCTZ, Enalapril/HCTZ, Lisinopril/HCTZ, Moexipril/HCTZ, Quinapril/HCTZ, Candesartan/HCTZ, Telmisartan/HCTZ, Valsartan/HCTZ, Benazepril/Amlodipine, Telmisartan/Amlodipine, Amlodipine/Valsartan, Amlodipine/Valsartan/HCTZ, Desvenlafaxine, Fluoxetine, Quetiapine XR, Paliperidone, Olanzapine/Fluoxetine, Atenolol, Betaxolol, Bisoprolol, Metoprolol XL, Nadolol, Myrbetriq, Toviaz, Vesicare, Rapaflo, Diltiazem CD, Actoplusmet XR, Alogliptin, Alogliptin/Pioglitazone, Farxiga, Fortamet ER, Januvia, Jardiance, Onglyza, Pioglitazone, Sitagliptin/Metformin XR, Advicor, Amlodipine/Atorvastatin, Livalo, Dexilant, Aptensio XR, Modafinil, Quillichew ER and Vyvanse. May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 2
Excluding Valsartan / Ramipril Clinical Criteria Logic 1. Are the requested units less than the established units per day limit? [ ] Yes (Approve 365 days) [ ] No (Go to #2) 2. Is the client greater than or equal to () 18 years of age? [ ] Yes (Go to #3) [ ] No (No PA Required) 3. Is the request being submitted by phone? [ ] Yes (Approve 365 days) [ ] No (Deny) May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 3
Excluding Valsartan/Ramipril Clinical Criteria Logic Diagram Step 1 Step 2 Step 3 Are the requested units less than the established units per day limit? No Is the client > 18 years of age? Yes Is the request being submitted by phone? Yes Approve Request (365 days) Yes No No Approve Request (365 days) No PA Required Deny Request May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 4
Excluding Valsartan/Ramipril Clinical Criteria Supporting Tables Drug Strength Units per Day Alpha Blockers Doxazosin 1mg, 2mg, 4mg 2 Terazosin 1mg, 5mg 2 Angiotensin Converting Enzyme Inhibitors (ACE Inhibitors) Benazepril 5mg, 10mg, 20mg 2 Captopril 12.5mg, 25mg, 50mg 2 Enalapril 2.5mg, 5mg, 10mg 2 Fosinopril 10mg, 20mg 2 Lisinopril 2.5mg, 5mg, 10mg, 2 20mg Moexipril 7.5mg 2 Perindopril 2mg, 4mg 2 Ramipril 1.25mg, 2.5mg, 5mg 2 Quinapril 5mg, 10mg, 20mg 2 Trandolapril 1mg, 2mg 2 ACE Inhibitor/Diuretic Combinations Benazepril/HCTZ 5/6.25mg, 10/12.5mg 2 Enalapril/HCTZ 5/12.5mg 2 Lisinopril/HCTZ 10/12.5 2 Moexipril/HCTZ 7.5/12.5 2 Quinapril/HCTZ 10/12.5 2 Angiotensin II Receptor Blockers (ARBs) Candesartan 4mg, 8mg, 16mg 2 Irbesartan 75mg, 150mg 2 Losartan 25mg, 50mg 2 Losartan/HCTZ 50/12.5mg 2 Olmesartan 20mg 2 Telmisartan 20mg, 40mg 2 Valsartan 80mg, 160mg 2 ARB/Diuretic Combinations Candesartan/HCTZ 16/12.5mg 2 Telmisartan/HCTZ 40/12.5mg 2 Valsartan/HCTZ 80/12.5mg, 160/12.5mg 2 ARB Combinations Benazepril/Amlodipine 2.5/10mg, 5/10mg, 5/20mg Telmisartan/Amlodipine 40/5mg 2 2 May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 5
Drug Strength Units per Day Amlodipine/Valsartan 5/160mg 2 Amlodipine/Valsartan/HCTZ 5/160/12.5mg 2 Antidepressants Bupropion XL 150mg 2 Desvenlafaxine 25mg, 50mg 2 Fluoxetine 10mg, 20mg 2 Mirtazapine 7.5mg, 15mg 2 Mirtazapine ODT 15mg 2 Venlafaxine XR 37.5mg, 75mg 2 Antihyperlipidemics Advicor 20/500mg 2 Amlodipine/Atorvastatin 2.5/10mg, 2.5/20mg, 2.5/40mg, 5/10mg, 5/20mg, 5/40mg Atorvastatin 10mg, 20mg, 40mg 2 Fluvastatin 20mg, 40mg 2 Livalo 1mmg, 2mg 2 Lovastatin IR/SR 10mg, 20mg 2 Niacin SA 500mg 2 Pravastatin 10mg, 20mg, 40mg 2 Rosuvastatin 5mg, 10mg, 20mg 2 Simvastatin 5mg, 10mg, 20mg, 40mg 2 Antipsychotics Aripiprazole 5mg, 10mg, 15mg 2 Olanzapine 2.5mg, 5mg, 7.5mg, 2 10mg Olanzapine ODT 5mg, 10mg 2 Olanzapine/Fluoxetine 3/25mg, 6/25mg 2 Paliperidone 1.5mg, 3mg 2 Risperidone 0.25mg, 0.5mg, 1mg, 2 2mg Risperidone microsphere injection 25mg 0.072 Risperidone ODT 0.5mg, 1mg, 2mg 2 Quetiapine XR 150mg, 200mg 2 Beta Blockers Atenolol 25mg, 50mg 2 Betaxolol 10mg 2 Bisoprolol 5mg 2 Carvedilol CR 10mg, 20mg, 40mg 2 Metaprolol XL 25mg, 50mg, 100mg 2 Nadolol 25mg, 50mg, 100mg 2 Bladder Relaxant Preparations Darifenacin 7.5mg 2 Myrbetriq 25mg 2 2 May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 6
Drug Strength Units per Day BPH Agents Oxybutynin 5mg 2 Solifenacin 5mg 2 Tolterodine LA 2mg 2 Toviaz 4mg 2 Vesicare 5mg 2 Rapaflo 4mg 2 Calcium Channel Blockers Amlodipine 2.5mg, 5mg 2 Diltiazem CD 120mg, 180mg 2 Felodipine 2.5mg, 5mg 2 Nifedipine SR 30mg 2 Nisoldipine 10mg, 20mg 2 Verapamil 24hr SR 100mg 2 Diabetes Agents Actoplusmet XR 5/500mg 2 Alogliptin 6.25mg. 12.5mg 2 Alogliptin/Pioglitazone 12.5/15mg 2 Farxiga 5mg 2 Fortamet ER 500mg 2 Glipizide XL 2.5mg, 5mg 2 Januvia 25mg, 50mg 2 Jardiance 25mg 2 Onglyza 2.5mg 2 Pioglitazone 15mg 2 Sitagliptin/Metformin XR 50/500mg 2 Miscellaneous Agents Cetirizine 5mg 2 Divalproex 250mg 2 Donepezil 5mg 2 Donepezil ODT 5mg 2 Galantamine 8mg 2 Meloxicam 7.5mg 2 Proton Pump Inhibitors Dexilant 30mg 2 Esomeprazole 20mg 2 Lansoprazole 15mg 2 Omeprazole 10mg, 20mg 2 Pantoprazole 20mg 2 SSRI Agents Citalopram 10mg, 20mg 2 Escitalopram 5mg, 10mg 2 Paroxetine 10mg, 12.5mg, 20mg 2 May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 7
Drug Strength Units per Day Stimulants Sertraline 25mg, 50mg 2 Amphetamine/ Dextroamphetamine XL 5mg, 10mg, 15mg 2 Aptensio XR 10mg, 20mg, 30mg 2 Dexmethylphenidate XR 5mg, 10mg, 15mg, 20mg 2 Dextroamphetamine SR 5mg 2 Methylphenidate ER capsules 10mg, 20mg 2 Methylphenidate ER tablets 10mg, 18mg, 27mg 2 Methylphenidate patch 10mg, 15mg 2 Modafinil 100mg 2 Quillichew ER 20mg 2 Vyvanse 10mg, 20mg, 30mg 2 May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 8
Valsartan / Ramipril Clinical Criteria Logic 1. Are the requested units less than the established units per day limit? [ ] Yes (Approve 365 days) [ ] No (Go to #2) 2. Is the client greater than or equal to () 18 years of age? [ ] Yes (Go to #3) [ ] No (No PA Required) 3. Does the client have a history of heart failure in the last 365 days? [ ] Yes (Approve 365 days) [ ] No (Go to #4) 4. Is the request being submitted by phone? [ ] Yes (Approve 365 days) [ ] No (Deny) May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 9
Valsartan/Ramipril Clinical Criteria Logic Diagram Step 1 Step 2 Step 3 Are the requested units less than the established units per day limit? No Is the client > 18 years of age? Yes Does the client have a history of heart failure in the last 365 days? Yes Approve Request (365 days) Yes No No Step 4 Approve Request (365 days) No PA Required Is the request being submitted by phone? Yes Approve Request (365 days) No Deny Request May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 10
Valsartan/Ramipril Clinical Criteria Supporting Tables Drug Strength Units per Day Ramipril 1.25mg, 2.5mg, 5mg 2 Valsartan 40mg, 80mg, 160mg 2 May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 11
ICD-9 Code Description Step 3 (diagnosis of heart failure) Required diagnosis: 1 Look back timeframe: 365 days 4280 CONGESTIVE HEART FAILURE, UNSPECIFIED 4281 LEFT HEART FAILURE 4289 HEART FAILURE NOS 42820 UNSPECIFIED SYSTOLIC HEART FAILURE 42821 ACUTE SYSTOLIC HEART FAILURE 42822 CHRONIC SYSTOLIC HEART FAILURE 42823 ACUTE ON CHRONIC SYSTOLIC HEART FAILURE 42830 UNSPECIFIED DIASTOLIC HEART FAILURE 42831 ACUTE DIASTOLIC HEART FAILURE 42832 CHRONIC DIASTOLIC HEART FAILURE 42833 ACUTE ON CHRONIC DIASTOLIC HEART FAILURE 42840 UNSPECIFIED COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE 42841 ACUTE COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE 42842 CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE 42843 ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE ICD-10 Code I501 I5020 I5021 I5022 I5023 I5030 I5031 I5032 I5033 I5040 I5041 I5042 I5043 I509 Description LEFT VENTRICULAR FAILURE UNSPECIFIED SYSTOLIC (CONGESTIVE) HEART FAILURE ACUTE SYSTOLIC (CONGESTIVE) HEART FAILURE CHRONIC SYSTOLIC (CONGESTIVE) HEART FAILURE ACUTE ON CHRONIC SYSTOLIC (CONGESTIVE) HEART FAILURE UNSPECIFIED DIASTOLIC (CONGESTIVE) HEART FAILURE ACUTE DIASTOLIC (CONGESTIVE) HEART FAILURE CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE ACUTE ON CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE UNSPECIFIED COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE ACUTE COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE CHRONIC COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE ACUTE ON CHRONIC COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE HEART FAILURE, UNSPECIFIED May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 12
Clinical Criteria References 1. Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academy Press, 2001. 2. Chernew M, Smith DG, Kirking DM, Fendrick AM. Decomposing pharmaceutical cost growth in different types of health plans. Am J Manag Care. 2001; 7:667-673. 3. Berg JS, et al. Medication compliance: a health care problem. Ann Pharmacother. 1993; 27(9 suppl):s5-s19. 4. Bayliss, E, et al. How can I improve patient adherence to prescribed medications? J Fam Pract. 2001; 50(4): 303-304. 5. Eisen SA, Miller DK, Woodward RS, Spitznagel E, Przybeck TR. The effect of prescribed daily dose frequency on patient medication compliance. Arch Intern Med. 1990; 150:1881-1884. 6. Leenen FH, et al. Patterns of compliance with once versus twice daily antihypertensive drug therapy in primary care: a randomized clinical trial using electronic monitoring. Can J Cardiology. 1997; 13(10): 914-920. 7. Brown, BG, et al. Moderate dose, three-drug therapy with niacin, lovastatin, and colestipol to reduce low-density lipoprotein cholesterol < 100mg/dl in patients with hyperlipidemia and coronary artery disease. Am J Cardiol. 1997; 80: 111-115. 8. Ernst, M, et al. Prescription medication costs. Arch Fam Med. 2000; 9: 1002-1007. 9. Reichert, S, et al. Physicians attitudes about prescribing and knowledge of the costs of common medications. Arch Intern Med. 2000; 160: 2799-2803. 10.Dubois RW, Shawla AJ, Neslusan CA, Smith MW, Wade S. Explaining drug spending trends: does perception match reality? Health Aff 2000; 19(2):231-239. 11.2015 ICD-9-CM Diagnosis Codes. 2015. Available at www.icd9data.com. Accessed on April 3, 2015. 12.2015 ICD-10-CM Diagnosis Codes. 2015. Available at www.icd10data.com. Accessed on April 3, 2015. May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 13
13.American Medical Association data files. 2015 ICD-9-CM Diagnosis Codes. Available at www.commerce.ama-assn.org. 14.American Medical Association data files. 2015 ICD-10-CM Diagnosis Codes. Available at www.commerce.ama-assn.org. May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 14
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 01/31/2011 Initial publication and posting to website 07/18/2012 Removed sitagliptin from DRO edit, per client request 04/03/2015 Updated to include ICD-10s 05/08/2017 Annual review by staff Added the following drugs to the DRO criteria: Benazepril, Captopril, Enalapril, Lisinopril, Moexipril, Quinapril, Benazepril/HCTZ, Enalapril/HCTZ, Lisinopril/HCTZ, Moexipril/HCTZ, Quinapril/HCTZ, Candesartan/HCTZ, Telmisartan/HCTZ, Valsartan/HCTZ, Benazepril/Amlodipine, Telmisartan/Amlodipine, Amlodipine/Valsartan, Amlodipine/Valsartan/HCTZ, Desvenlafaxine, Fluoxetine, Quetiapine XR, Paliperidone, Olanzapine/Fluoxetine, Atenolol, Betaxolol, Bisoprolol, Metoprolol XL, Nadolol, Myrbetriq, Toviaz, Vesicare, Rapaflo, Diltiazem CD, Actoplusmet XR, Alogliptin, Alogliptin/Pioglitazone, Farxiga, Fortamet ER, Januvia, Jardiance, Onglyza, Pioglitazone, Sitagliptin/Metformin XR, Advicor, Amlodipine/Atorvastatin, Livalo, Dexilant, Aptensio XR, Modafinil, Quillichew ER and Vyvanse. May 8, 2017 Copyright 2011-2017 Health Information Designs, LLC 15