Sildenafil / Tadalafil

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Texas Prior Authorization Program Clinical Criteria Drug/Drug Class Sildenafil / Tadalafil Clinical Criteria 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 Annual review by staff Added Adcirca to Drugs Requiring PA, page 2 Updated Table 2, pages 5-8 Updated References, page 21 August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 1

Sildenafil / Tadalafil Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name GCN ADCIRCA 20 MG TABLET 26587 REVATIO 20 MG TABLET 24758 REVATIO 10MG/ML ORAL SUSPENSION 33186 SILDENAFIL 20 MG TABLET 24758 August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 2

Sildenafil / Tadalafil Clinical Criteria Logic 1. Does the client have a diagnosis of pulmonary hypertension in the last 180 days? [ ] Yes (Go to #2) [ ] No (Deny) 2. Does the client have a history of using a denial drug (nitrates, alpha blockers, tamsulosin, or lopinavir/ritonavir) in the past 45 days? [ ] Yes (Deny) [ ] No (Go to #3) 3. Does the client have a history of a denial diagnosis (sickle cell disorders, multiple myeloma, leukemia, in the last 180 days? [ ] Yes (Deny) [ ] No (Go to #4) 4. Does the client have a diagnosis of retinitis pigmentosa in the last 730 days? [ ] Yes (Deny) [ ] No (Go to #5) 5. Is the total daily dose less than or equal to ( ) 60mg? [ ] Yes (Approve 365 days) [ ] No (Deny) August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 3

Sildenafil / Tadalafil Clinical Criteria Logic Diagram Step 1 Step 2 Step 3 Does the client have a diagnosis of pulmonary hypertension in the last 180 days? Yes Does the client have a history of using a denial drug (nitrates, alpha blockers, tamsulosin, or lopinavir/ ritonavir) in the last 45 days? No Does the client have a history of a denial diagnosis (sickle cell disorders, multiple myeloma, leukemia, in the last 180 days? Yes Deny Request No Yes No Step 4 Deny Request Deny Request Does the client have a diagnosis of retinitis pigmentosa in the last 730 days? Yes Deny Request No Step 5 Approve Request (365 days) Yes Is the total daily dose 60mg? No Deny Request August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 4

Sildenafil / Tadalafil Clinical Criteria Supporting Tables Step 1 (diagnosis of pulmonary hypertension) ICD-9 Code Description 4160 PRIM PULM HYPERTENSION 4161 KYPHOSCOLIOTIC HEART DIS 4168 CHR PULMON HEART DIS NEC ICD-10 Code Description I270 PRIMARY PULMONARY HYPERTENSION I271 KYPHOSCOLIOTIC HEART DISEASE I272 OTHER SECONDARY PULMONARY HYPERTENSION I2789 OTHER SPECIFIED PULMONARY HEART DISEASES Step 2 (history of nitrates, alpha blockers, tamsulosin, or lopinavir/ritonavir) Required quantity: 1 Look back timeframe: 45 days Label Name GCN ADEMPAS 0.5 MG TABLET 35376 ADEMPAS 1 MG TABLET 35377 ADEMPAS 1.5 MG TABLET 35383 ADEMPAS 2 MG TABLET 35384 ADEMPAS 2.5 MG TABLET 35385 ALFUZOSIN HCL ER 10 MG TABLET 92024 BIAXIN 250 MG TABLET 48852 BIAXIN 250 MG/5 ML SUSPENSION 11671 BIAXIN 500 MG TABLET 48851 BIDIL TABLET 24925 CARDURA 1 MG TABLET 33431 CARDURA 2 MG TABLET 33432 CARDURA 4 MG TABLET 33433 CARDURA 8 MG TABLET 33434 CLARITHROMYCIN 125 MG/5 ML SUS 11670 CLARITHROMYCIN 250 MG TABLET 48852 August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 5

Step 2 (history of nitrates, alpha blockers, tamsulosin, or lopinavir/ritonavir) Required quantity: 1 Look back timeframe: 45 days Label Name GCN CLARITHROMYCIN 250 MG/5 ML SUS 11671 CLARITHROMYCIN 500 MG TABLET 48851 CLARITHROMYCIN ER 500 MG TAB 48850 CRIXIVAN 200 MG CAPSULE 26820 CRIXIVAN 400 MG CAPSULE 26822 DILATRATE-SR 40 MG CAPSULE 01910 DOXAZOSIN MESYLATE 1 MG TAB 33431 DOXAZOSIN MESYLATE 2 MG TAB 33432 DOXAZOSIN MESYLATE 4 MG TAB 33433 DOXAZOSIN MESYLATE 8 MG TAB 33434 FLOMAX 0.4 MG CAPSULE 48191 INVIRASE 200 MG CAPSULE 26760 INVIRASE 500 MG TABLET 23952 ISOSORBIDE DN 10 MG TABLET 01942 ISOSORBIDE DN 20 MG TABLET 01944 ISOSORBIDE DN 30 MG TABLET 01945 ISOSORBIDE DN 5 MG TABLET 01947 ISOSORBIDE DN ER 40 MG TABLET 01960 ISOSORBIDE MN 10 MG TABLET 01932 ISOSORBIDE MN 120 MG TAB SA 48103 ISOSORBIDE MN 20 MG TABLET 01931 ISOSORBIDE MN 60 MG TAB SA 48102 ISOSORBIDE MN ER 30 MG TABLET 48104 ITRACONAZOLE 100 MG CAPSULE 49101 JALYN 0.5-0.4 MG CAPSULE 28596 KALETRA 100-25 MG TABLET 99101 KALETRA 200-50 MG TABLET 25919 KALETRA 400-100/5 ML ORAL SOLU 31782 KETEK 300 MG TABLET 25905 KETEK 400 MG TABLET 15175 KETOCONAZOLE 200 MG TABLET 42590 LANSOPRAZOL-AMOXICIL-CLARITHRO 64269 MINIPRESS 1 MG CAPSULE 01250 MINIPRESS 2 MG CAPSULE 01251 MINIPRESS 5 MG CAPSULE 01252 August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 6

Step 2 (history of nitrates, alpha blockers, tamsulosin, or lopinavir/ritonavir) Required quantity: 1 Look back timeframe: 45 days Label Name GCN NEFAZODONE 100MG TABLET 16406 NEFAZODONE 150MG TABLET 16407 NEFAZODONE 200MG TABLET 16408 NEFAZODONE 250MG TABLET 16409 NEFAZODONE 50MG TABLET 16404 NITRO-BID 2% OINTMENT 01720 NITRO-DUR 0.1 MG/HR PATCH 01741 NITRO-DUR 0.2 MG/HR PATCH 01742 NITRO-DUR 0.3 MG/HR PATCH 01743 NITRO-DUR 0.4 MG/HR PATCH 01740 NITRO-DUR 0.6 MG/HR PATCH 01744 NITRO-DUR 0.8 MG/HR PATCH 01746 NITROGLYCERIN 0.1 MG/HR PATCH 01741 NITROGLYCERIN 0.2 MG/HR PATCH 01742 NITROGLYCERIN 0.4 MG/HR PATCH 01740 NITROGLYCERIN 0.6 MG/HR PATCH 01744 NITROGLYCERIN ER 2.5 MG CAP 01681 NITROGLYCERIN LINGUAL 0.4 MG 92257 NITROLINGUAL 0.4 MG SPRAY 92257 NITROMIST 400 MCG SPRAY 03380 NITROSTAT 0.3 MG TABLET SL 01771 NITROSTAT 0.4 MG TABLET SL 01772 NITROSTAT 0.6 MG TABLET SL 01773 NORVIR 100 MG SOFTGEL CAP 26812 NORVIR 100 MG TABLET 28224 NORVIR 80 MG/ML SOLUTION 26810 NOXAFIL 40 MG/ML SUSPENSION 26502 NOXAFIL DR 100 MG TABLET 35649 PRAZOSIN 1 MG CAPSULE 01250 PRAZOSIN 2 MG CAPSULE 01251 PRAZOSIN 5 MG CAPSULE 01252 PREVPAC PATIENT PACK 64269 SPORANOX 10 MG/ML SOLUTION 49100 SPORANOX 100 MG CAPSULE 49101 TAMSULOSIN HCL 0.4 MG CAPSULE 48191 August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 7

Step 2 (history of nitrates, alpha blockers, tamsulosin, or lopinavir/ritonavir) Required quantity: 1 Look back timeframe: 45 days Label Name GCN TERAZOSIN 1 MG CAPSULE 47124 TERAZOSIN 10 MG CAPSULE 47127 TERAZOSIN 2 MG CAPSULE 47125 TERAZOSIN 5 MG CAPSULE 47126 TRACLEER 125 MG TABLET 14978 TRACLEER 62.5 MG TABLET 14979 UROXATRAL 10 MG TABLET 92024 VFEND 200 MG TABLET 17498 VFEND 40 MG/ML SUSPENSION 21513 VFEND 50 MG TABLET 17497 VFEND IV 200 MG VIAL 17499 VICTRELIS 200 MG CAPSULE 29941 VIEKIRA PAK 37614 VIRACEPT 250 MG TABLET 40312 VIRACEPT 625 MG TABLET 19717 VORICONAZOLE 200 MG TABLET 17498 VORICONAZOLE 200 MG VIAL 17499 VORICONAZOLE 40 MG/ML SUSP 21513 VORICONAZOLE 50 MG TABLET 17497 ICD-9 Code Description 203 MULTIPLE MYELOMA AND IMMUNOPROLIFERATIVE NEOPLASMS 2030 MULTIPLE MYELOMA 20300 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED 20301 MULT MYELM W 20302 MULTIPLE MYELOMA, IN RELAPSE 2031 PLASMA CELL LEUKEMIA 20310 PLASMA CELL LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 8

20311 PLSM CELL LEUK W RMSON 20312 PLASMA CELL LEUKEMIA, IN RELAPSE 2038 OTHER IMMUNOPROLIFERATIVE NEOPLASMS 20380 OTHER IMMUNOPROLIFERATIVE NEOPLASMS, WITHOUT MENTION OF HAVING ACHIEVED 20381 OTH IMNPRFL NPL W RMSN 20382 OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE 204 LYMPHOID LEUKEMIA 2040 ACUTE LYMPHOID LEUKEMIA 20400 ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20401 ACT LYM LEUK W RMSION 20402 ACUTE LYMPHOID LEUKEMIA, IN RELAPSE 2041 CHRONIC LYMPHOID LEUKEMIA 20410 CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20411 CHR LYM LEUK W RMSION 20412 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE 2042 SUBACUTE LYMPHOID LEUKEMIA 20420 SUBACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20421 SBAC LYM LEUK W RMSION 20422 SUBACUTE LYMPHOID LEUKEMIA, IN RELAPSE 2048 OTHER LYMPHOID LEUKEMIA 20480 OTHER LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20481 OTH LYM LEUK W RMSION 20482 OTHER LYMPHOID LEUKEMIA, IN RELAPSE 2049 UNSPECIFIED LYMPHOID LEUKEMIA 20490 UNSPECIFIED LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20491 UNS LYM LEUK W RMSION 20492 UNSPECIFIED LYMPHOID LEUKEMIA, IN RELAPSE 205 MYELOID LEUKEMIA 2050 ACUTE MYELOID LEUKEMIA 20500 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20501 ACT MYL LEUK W RMSION 20502 ACUTE MYELOID LEUKEMIA, IN RELAPSE 2051 CHRONIC MYELOID LEUKEMIA 20510 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 9

20511 CHR MYL LEUK W RMSION 20512 CHRONIC MYELOID LEUKEMIA, IN RELAPSE 2052 SUBACUTE MYELOID LEUKEMIA 20520 SUBACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20521 SBAC MYL LEUK W RMSION 20522 SUBACUTE MYELOID LEUKEMIA, IN RELAPSE 2053 MYELOID SARCOMA 20530 MYELOID SARCOMA, WITHOUT MENTION OF HAVING ACHIEVED 20531 MYL SRCOMA W RMSION 20532 MYELOID SARCOMA, IN RELAPSE 2058 OTHER MYELOID LEUKEMIA 20580 OTHER MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20581 OTH MYL LEUK W RMSION 20582 OTHER MYELOID LEUKEMIA, IN RELAPSE 2059 UNSPECIFIED MYELOID LEUKEMIA 20590 UNSPECIFIED MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20591 UNS MYL LEUK W RMSION 20592 UNSPECIFIED MYELOID LEUKEMIA, IN RELAPSE 206 MONOCYTIC LEUKEMIA 2060 ACUTE MONOCYTIC LEUKEMIA 20600 ACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20601 ACT MONO LEUK W RMSION 20602 ACUTE MONOCYTIC LEUKEMIA, IN RELAPSE 2061 CHRONIC MONOCYTIC LEUKEMIA 20610 CHRONIC MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20611 CHR MONO LEUK W RMSION 20612 CHRONIC MONOCYTIC LEUKEMIA, IN RELAPSE 2062 SUBACUTE MONOCYTIC LEUKEMIA 20620 SUBACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20621 SBAC MONO LEUK W RMSION 20622 SUBACUTE MONOCYTIC LEUKEMIA, IN RELAPSE 2068 OTHER MONOCYTIC LEUKEMIA 20680 OTHER MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20681 OTH MONO LEUK W RMSION August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 10

20682 OTHER MONOCYTIC LEUKEMIA, IN RELAPSE 2069 UNSPECIFIED MONOCYTIC LEUKEMIA 20690 UNSPECIFIED MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20691 UNS MONO LEUK W RMSION 20692 UNSPECIFIED MONOCYTIC LEUKEMIA, IN RELAPSE 207 OTHER SPECIFIED LEUKEMIA 2070 ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA 20700 ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20701 ACT ERTH/ERYLK W RMSON 20702 ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, IN RELAPSE 2071 CHRONIC ERYTHREMIA 20710 CHRONIC ERYTHREMIA, WITHOUT MENTION OF HAVING ACHIEVED 20711 CHR ERYTHRM W REMISION 20712 CHRONIC ERYTHREMIA, IN RELAPSE 2072 MEGAKARYOCYTIC LEUKEMIA 20720 MEGAKARYOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20721 MGKRYCYT LEUK W RMSION 20722 MEGAKARYOCYTIC LEUKEMIA, IN RELAPSE 2078 OTHER SPECIFIED LEUKEMIA 20780 OTHER SPECIFIED LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED 20781 OTH SPF LEUK W REMSION 20782 OTHER SPECIFIED LEUKEMIA, IN RELAPSE 208 LEUKEMIA OF UNSPECIFIED CELL TYPE 28241 SICKLE-CELL THALASSEMIA WITHOUT CRISIS 28242 SICKLE-CELL THALASSEMIA WITH CRISIS 2825 SICKLE-CELL TRAIT 2826 SICKLE-CELL DISEASE, UNSPECIFIED 28260 SICKLE-CELL DISEASE, UNSPECIFIED 28261 HB-SS DISEASE WITHOUT CRISIS 28262 HB-SS DISEASE WITH CRISIS 28263 SICKLE-CELL/HB-C DISEASE WITHOUT CRISIS 28264 SICKLE-CELL/HB-C DISEASE WITH CRISIS 28268 OTHER SICKLE-CELL DISEASE WITHOUT CRISIS 28269 OTHER SICKLE-CELL DISEASE WITH CRISIS 4010 MALIGNANT HYPERTENSION August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 11

410 ACUTE MYOCARDIAL INFARCTION 4100 ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL WALL 41000 AMI ANTEROLATERAL,UNSPEC 41001 AMI ANTEROLATERAL, INIT 41002 AMI ANTEROLATERAL,SUBSEQ 4101 ACUTE MYOCARDIAL INFARCTION OF OTHER ANTERIOR WALL 41010 AMI ANTERIOR WALL,UNSPEC 41011 AMI ANTERIOR WALL, INIT 41012 AMI ANTERIOR WALL,SUBSEQ 4102 ACUTE MYOCARDIAL INFARCTION OF INFEROLATERAL WALL 41020 AMI INFEROLATERAL,UNSPEC 41021 AMI INFEROLATERAL, INIT 41022 AMI INFEROLATERAL,SUBSEQ 4103 ACUTE MYOCARDIAL INFARCTION OF INFEROPOSTERIOR WALL 41030 AMI INFEROPOST, UNSPEC 41031 AMI INFEROPOST, INITIAL 41032 AMI INFEROPOST, SUBSEQ 4104 ACUTE MYOCARDIAL INFARCTION OF OTHER INFERIOR WALL 41040 AMI INFERIOR WALL,UNSPEC 41041 AMI INFERIOR WALL, INIT 41042 AMI INFERIOR WALL,SUBSEQ 4105 ACUTE MYOCARDIAL INFARCTION OF OTHER LATERAL WALL 41050 AMI LATERAL NEC, UNSPEC 41051 AMI LATERAL NEC, INITIAL 41052 AMI LATERAL NEC, SUBSEQ 4106 TRUE POSTERIOR WALL INFARCTION 41060 TRUE POST INFARCT,UNSPEC 41061 TRUE POST INFARCT, INIT 41062 TRUE POST INFARCT,SUBSEQ 4107 SUBENDOCARDIAL INFARCTION 41070 SUBENDO INFARCT, UNSPEC 41071 SUBENDO INFARCT, INITIAL 41072 SUBENDO INFARCT, SUBSEQ 4108 ACUTE MYOCARDIAL INFARCTION OF OTHER SPECIFIED SITES 41080 AMI NEC, UNSPECIFIED 41081 AMI NEC, INITIAL 41082 AMI NEC, SUBSEQUENT 4109 ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 12

41090 AMI NOS, UNSPECIFIED 41091 AMI NOS, INITIAL 41092 AMI NOS, SUBSEQUENT 411 OTHER ACUTE AND SUBACUTE FORMS OF ISCHEMIC HEART DISEASE 4110 POST MI SYNDROME 4111 INTERMED CORONARY SYND 4118 OTHER ACUTE AND SUBACUTE FORMS OF ISCHEMIC HEART DISEASE 41181 ACUTE CORONARY OCCLUSION WITHOUT MYOCARDIAL INFARCTION 41189 AC ISCHEMIC HRT DIS NEC 427 CARDIAC DYSRHYTHMIAS 4270 PAROX ATRIAL TACHYCARDIA 4271 PAROX VENTRIC TACHYCARD 4272 PAROX TACHYCARDIA NOS 4273 ATRIAL FIBRILLATION AND FLUTTER 42731 ATRIAL FIBRILLATION 42732 ATRIAL FLUTTER 4274 VENTRICULAR FIBRILLATION AND FLUTTER 42741 VENTRICULAR FIBRILLATION 42742 VENTRICULAR FLUTTER 4275 CARDIAC ARREST 4276 PREMATURE BEATS 42760 PREMATURE BEATS NOS 42761 ATRIAL PREMATURE BEATS 42769 PREMATURE BEATS NEC 4278 OTHER SPECIFIED CARDIAC DYSRHYTHMIAS 42781 SINOATRIAL NODE DYSFUNCT 42789 CARDIAC DYSRHYTHMIAS NEC 4279 CARDIAC DYSRHYTHMIA NOS 428 HEART FAILURE 4280 CONGESTIVE HEART FAILURE, UNSPECIFIED 4281 LEFT HEART FAILURE 4282 SYSTOLIC HEART FAILURE 42820 UNSPECIFIED SYSTOLIC HEART FAILURE 42821 ACUTE SYSTOLIC HEART FAILURE 42822 CHRONIC SYSTOLIC HEART FAILURE 42823 ACUTE ON CHRONIC SYSTOLIC HEART FAILURE 4283 DIASTOLIC HEART FAILURE 42830 UNSPECIFIED DIASTOLIC HEART FAILURE August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 13

42831 ACUTE DIASTOLIC HEART FAILURE 42832 CHRONIC DIASTOLIC HEART FAILURE 42833 ACUTE ON CHRONIC DIASTOLIC HEART FAILURE 4284 COMBINED SYSTOLIC AND 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 4289 HEART FAILURE NOS 458 HYPOTENSION 4580 ORTHOSTATIC HYPOTENSION 4581 CHRONIC HYPOTENSION 4582 IATROGENIC HYPOTENSION 45821 HYPOTENSION OF HEMODIALYSIS 45829 OTHER IATROGENIC HYPOTENSION 4588 OTHER SPECIFIED HYPOTENSION 4589 HYPOTENSION NOS 60789 DISORDER OF PENIS NEC ICD-10 Code C882 C883 C888 C889 C9000 C9001 C9002 C9010 C9011 C9012 C9020 C9021 C9022 C9030 C9031 C9032 C9100 C9101 C9102 Description HEAVY CHAIN DISEASE IMMUNOPROLIFERATIVE SMALL INTESTINAL DISEASE OTHER MALIGNANT IMMUNOPROLIFERATIVE DISEASES MALIGNANT IMMUNOPROLIFERATIVE DISEASE, UNSPECIFIED MULTIPLE MYELOMA NOT HAVING ACHIEVED MULTIPLE MYELOMA IN MULTIPLE MYELOMA IN RELAPSE PLASMA CELL LEUKEMIA NOT HAVING ACHIEVED PLASMA CELL LEUKEMIA IN PLASMA CELL LEUKEMIA IN RELAPSE EXTRAMEDULLARY PLASMACYTOMA NOT HAVING ACHIEVED EXTRAMEDULLARY PLASMACYTOMA IN EXTRAMEDULLARY PLASMACYTOMA IN RELAPSE SOLITARY PLASMACYTOMA NOT HAVING ACHIEVED SOLITARY PLASMACYTOMA IN SOLITARY PLASMACYTOMA IN RELAPSE ACUTE LYMPHOBLASTIC LEUKEMIA NOT HAVING ACHIEVED ACUTE LYMPHOBLASTIC LEUKEMIA, IN ACUTE LYMPHOBLASTIC LEUKEMIA, IN RELAPSE August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 14

C9110 C9111 C9112 C9130 C9131 C9132 C9150 C9151 C9152 C9160 C9161 C9162 C9190 C9191 C9192 C91A0 C91A1 C91A2 C91Z0 C91Z1 C91Z2 C9200 C9201 C9202 C9210 C9211 C9212 C9220 C9221 C9222 C9230 CHRONIC LYMPHOCYTIC LEUKEMIA OF B-CELL TYPE NOT HAVING ACHIEVED CHRONIC LYMPHOCYTIC LEUKEMIA OF B-CELL TYPE IN CHRONIC LYMPHOCYTIC LEUKEMIA OF B-CELL TYPE IN RELAPSE PROLYMPHOCYTIC LEUKEMIA OF B-CELL TYPE NOT HAVING ACHIEVED PROLYMPHOCYTIC LEUKEMIA OF B-CELL TYPE, IN PROLYMPHOCYTIC LEUKEMIA OF B-CELL TYPE, IN RELAPSE ADULT T-CELL LYMPHOMA/LEUKEMIA (HTLV-1-ASSOCIATED) NOT HAVING ACHIEVED ADULT T-CELL LYMPHOMA/LEUKEMIA (HTLV-1-ASSOCIATED), IN ADULT T-CELL LYMPHOMA/LEUKEMIA (HTLV-1-ASSOCIATED), IN RELAPSE PROLYMPHOCYTIC LEUKEMIA OF T-CELL TYPE NOT HAVING ACHIEVED PROLYMPHOCYTIC LEUKEMIA OF T-CELL TYPE, IN PROLYMPHOCYTIC LEUKEMIA OF T-CELL TYPE, IN RELAPSE LYMPHOID LEUKEMIA, UNSPECIFIED NOT HAVING ACHIEVED LYMPHOID LEUKEMIA, UNSPECIFIED, IN LYMPHOID LEUKEMIA, UNSPECIFIED, IN RELAPSE MATURE B-CELL LEUKEMIA BURKITT-TYPE NOT HAVING ACHIEVED MATURE B-CELL LEUKEMIA BURKITT-TYPE, IN MATURE B-CELL LEUKEMIA BURKITT-TYPE, IN RELAPSE OTHER LYMPHOID LEUKEMIA NOT HAVING ACHIEVED OTHER LYMPHOID LEUKEMIA, IN OTHER LYMPHOID LEUKEMIA, IN RELAPSE ACUTE MYELOBLASTIC LEUKEMIA, NOT HAVING ACHIEVED ACUTE MYELOBLASTIC LEUKEMIA, IN ACUTE MYELOBLASTIC LEUKEMIA, IN RELAPSE CHRONIC MYELOID LEUKEMIA, BCR/ABL-POSITIVE, NOT HAVING ACHIEVED CHRONIC MYELOID LEUKEMIA, BCR/ABL-POSITIVE, IN CHRONIC MYELOID LEUKEMIA, BCR/ABL-POSITIVE, IN RELAPSE ATYPICAL CHRONIC MYELOID LEUKEMIA, BCR/ABL-NEGATIVE, NOT HAVING ACHIEVED ATYPICAL CHRONIC MYELOID LEUKEMIA, BCR/ABL-NEGATIVE, IN ATYPICAL CHRONIC MYELOID LEUKEMIA, BCR/ABL-NEGATIVE, IN RELAPSE MYELOID SARCOMA, NOT HAVING ACHIEVED August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 15

C9231 C9232 C9240 C9241 C9242 C9250 C9251 C9252 C9260 C9261 C9262 C9290 C9291 C9292 C92A0 C92A1 C92A2 C92Z0 C92Z1 C92Z2 C9300 C9301 C9302 C9310 C9311 C9312 C9330 C9331 C9332 C9390 C9391 C9392 C93Z0 MYELOID SARCOMA, IN MYELOID SARCOMA, IN RELAPSE ACUTE PROMYELOCYTIC LEUKEMIA, NOT HAVING ACHIEVED ACUTE PROMYELOCYTIC LEUKEMIA, IN ACUTE PROMYELOCYTIC LEUKEMIA, IN RELAPSE ACUTE MYELOMONOCYTIC LEUKEMIA, NOT HAVING ACHIEVED ACUTE MYELOMONOCYTIC LEUKEMIA, IN ACUTE MYELOMONOCYTIC LEUKEMIA, IN RELAPSE ACUTE MYELOID LEUKEMIA WITH 11Q23-ABNORMALITY NOT HAVING ACHIEVED ACUTE MYELOID LEUKEMIA WITH 11Q23-ABNORMALITY IN ACUTE MYELOID LEUKEMIA WITH 11Q23-ABNORMALITY IN RELAPSE MYELOID LEUKEMIA, UNSPECIFIED, NOT HAVING ACHIEVED MYELOID LEUKEMIA, UNSPECIFIED IN MYELOID LEUKEMIA, UNSPECIFIED IN RELAPSE ACUTE MYELOID LEUKEMIA WITH MULTILINEAGE DYSPLASIA, NOT HAVING ACHIEVED ACUTE MYELOID LEUKEMIA WITH MULTILINEAGE DYSPLASIA, IN ACUTE MYELOID LEUKEMIA WITH MULTILINEAGE DYSPLASIA, IN RELAPSE OTHER MYELOID LEUKEMIA NOT HAVING ACHIEVED OTHER MYELOID LEUKEMIA, IN OTHER MYELOID LEUKEMIA, IN RELAPSE ACUTE MONOBLASTIC/MONOCYTIC LEUKEMIA, NOT HAVING ACHIEVED ACUTE MONOBLASTIC/MONOCYTIC LEUKEMIA, IN ACUTE MONOBLASTIC/MONOCYTIC LEUKEMIA, IN RELAPSE CHRONIC MYELOMONOCYTIC LEUKEMIA NOT HAVING ACHIEVED CHRONIC MYELOMONOCYTIC LEUKEMIA, IN CHRONIC MYELOMONOCYTIC LEUKEMIA, IN RELAPSE JUVENILE MYELOMONOCYTIC LEUKEMIA, NOT HAVING ACHIEVED JUVENILE MYELOMONOCYTIC LEUKEMIA, IN JUVENILE MYELOMONOCYTIC LEUKEMIA, IN RELAPSE MONOCYTIC LEUKEMIA, UNSPECIFIED, NOT HAVING ACHIEVED MONOCYTIC LEUKEMIA, UNSPECIFIED IN MONOCYTIC LEUKEMIA, UNSPECIFIED IN RELAPSE OTHER MONOCYTIC LEUKEMIA, NOT HAVING ACHIEVED August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 16

C93Z1 C93Z2 C9400 C9401 C9402 C9420 C9421 C9422 C9430 C9431 C9432 C9480 C9481 C9482 D45 D5700 D5701 D5702 D571 D5720 D57211 D57212 D57219 D573 D5740 D57411 D57412 D57419 D5780 D57811 D57812 D57819 I10 I200 I2101 I2102 OTHER MONOCYTIC LEUKEMIA, IN OTHER MONOCYTIC LEUKEMIA, IN RELAPSE ACUTE ERYTHROID LEUKEMIA, NOT HAVING ACHIEVED ACUTE ERYTHROID LEUKEMIA, IN ACUTE ERYTHROID LEUKEMIA, IN RELAPSE ACUTE MEGAKARYOBLASTIC LEUKEMIA NOT HAVING ACHIEVED ACUTE MEGAKARYOBLASTIC LEUKEMIA, IN ACUTE MEGAKARYOBLASTIC LEUKEMIA, IN RELAPSE MAST CELL LEUKEMIA NOT HAVING ACHIEVED MAST CELL LEUKEMIA, IN MAST CELL LEUKEMIA, IN RELAPSE OTHER SPECIFIED LEUKEMIAS NOT HAVING ACHIEVED OTHER SPECIFIED LEUKEMIAS, IN OTHER SPECIFIED LEUKEMIAS, IN RELAPSE POLYCYTHEMIA VERA HB-SS DISEASE WITH CRISIS, UNSPECIFIED HB-SS DISEASE WITH ACUTE CHEST SYNDROME HB-SS DISEASE WITH SPLENIC SEQUESTRATION SICKLE-CELL DISEASE WITHOUT CRISIS SICKLE-CELL/HB-C DISEASE WITHOUT CRISIS SICKLE-CELL/HB-C DISEASE WITH ACUTE CHEST SYNDROME SICKLE-CELL/HB-C DISEASE WITH SPLENIC SEQUESTRATION SICKLE-CELL/HB-C DISEASE WITH CRISIS, UNSPECIFIED SICKLE-CELL TRAIT SICKLE-CELL THALASSEMIA WITHOUT CRISIS SICKLE-CELL THALASSEMIA WITH ACUTE CHEST SYNDROME SICKLE-CELL THALASSEMIA WITH SPLENIC SEQUESTRATION SICKLE-CELL THALASSEMIA WITH CRISIS, UNSPECIFIED OTHER SICKLE-CELL DISORDERS WITHOUT CRISIS OTHER SICKLE-CELL DISORDERS WITH ACUTE CHEST SYNDROME OTHER SICKLE-CELL DISORDERS WITH SPLENIC SEQUESTRATION OTHER SICKLE-CELL DISORDERS WITH CRISIS, UNSPECIFIED ESSENTIAL (PRIMARY) HYPERTENSION UNSTABLE ANGINA ST ELEVATION (STEMI) MYOCARDIAL INFARCTION INVOLVING LEFT MAIN CORONARY ARTERY ST ELEVATION (STEMI) MYOCARDIAL INFARCTION INVOLVING LEFT ANTERIOR DESCENDING CORONARY ARTERY August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 17

I2109 I2111 I2119 I2121 I2129 I213 I214 I220 I221 I222 I228 I229 I240 I241 I248 I249 I25110 I25700 I25710 I25720 I25730 I25750 I25760 I25790 I462 I468 I469 ST ELEVATION (STEMI) MYOCARDIAL INFARCTION INVOLVING OTHER CORONARY ARTERY OF ANTERIOR WALL ST ELEVATION (STEMI) MYOCARDIAL INFARCTION INVOLVING RIGHT CORONARY ARTERY ST ELEVATION (STEMI) MYOCARDIAL INFARCTION INVOLVING OTHER CORONARY ARTERY OF INFERIOR WALL ST ELEVATION (STEMI) MYOCARDIAL INFARCTION INVOLVING LEFT CIRCUMFLEX CORONARY ARTERY ST ELEVATION (STEMI) MYOCARDIAL INFARCTION INVOLVING OTHER SITES ST ELEVATION (STEMI) MYOCARDIAL INFARCTION OF UNSPECIFIED SITE NON-ST ELEVATION (NSTEMI) MYOCARDIAL INFARCTION SUBSEQUENT ST ELEVATION (STEMI) MYOCARDIAL INFARCTION OF ANTERIOR WALL SUBSEQUENT ST ELEVATION (STEMI) MYOCARDIAL INFARCTION OF INFERIOR WALL SUBSEQUENT NON-ST ELEVATION (NSTEMI) MYOCARDIAL INFARCTION SUBSEQUENT ST ELEVATION (STEMI) MYOCARDIAL INFARCTION OF OTHER SITES SUBSEQUENT ST ELEVATION (STEMI) MYOCARDIAL INFARCTION OF UNSPECIFIED SITE ACUTE CORONARY THROMBOSIS NOT RESULTING IN MYOCARDIAL INFARCTION DRESSLER'S SYNDROME OTHER FORMS OF ACUTE ISCHEMIC HEART DISEASE ACUTE ISCHEMIC HEART DISEASE, UNSPECIFIED ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITH UNSTABLE ANGINA PECTORIS ATHEROSCLEROSIS OF CORONARY ARTERY BYPASS GRAFT(S), UNSPECIFIED, WITH UNSTABLE ANGINA PECTORIS ATHEROSCLEROSIS OF AUTOLOGOUS VEIN CORONARY ARTERY BYPASS GRAFT(S) WITH UNSTABLE ANGINA PECTORIS ATHEROSCLEROSIS OF AUTOLOGOUS ARTERY CORONARY ARTERY BYPASS GRAFT(S) WITH UNSTABLE ANGINA PECTORIS ATHEROSCLEROSIS OF NONAUTOLOGOUS BIOLOGICAL CORONARY ARTERY BYPASS GRAFT(S) WITH UNSTABLE ANGINA PECTORIS ATHEROSCLEROSIS OF NATIVE CORONARY ARTERY OF TRANSPLANTED HEART WITH UNSTABLE ANGINA ATHEROSCLEROSIS OF BYPASS GRAFT OF CORONARY ARTERY OF TRANSPLANTED HEART WITH UNSTABLE ANGINA ATHEROSCLEROSIS OF OTHER CORONARY ARTERY BYPASS GRAFT(S) WITH UNSTABLE ANGINA PECTORIS CARDIAC ARREST DUE TO UNDERLYING CARDIAC CONDITION CARDIAC ARREST DUE TO OTHER UNDERLYING CONDITION CARDIAC ARREST, CAUSE UNSPECIFIED August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 18

I470 I471 I472 I479 I480 I481 I482 I483 I484 I4891 I4892 I4901 I4902 I491 I492 I493 I4940 I4949 I495 I498 I499 I501 I5020 I5021 I5022 I5023 I5030 I5031 I5032 I5033 I5040 I5041 I5042 I5043 I509 I950 RE-ENTRY VENTRICULAR ARRHYTHMIA SUPRAVENTRICULAR TACHYCARDIA VENTRICULAR TACHYCARDIA PAROXYSMAL TACHYCARDIA, UNSPECIFIED PAROXYSMAL ATRIAL FIBRILLATION PERSISTENT ATRIAL FIBRILLATION CHRONIC ATRIAL FIBRILLATION TYPICAL ATRIAL FLUTTER ATYPICAL ATRIAL FLUTTER UNSPECIFIED ATRIAL FIBRILLATION UNSPECIFIED ATRIAL FLUTTER VENTRICULAR FIBRILLATION VENTRICULAR FLUTTER ATRIAL PREMATURE DEPOLARIZATION JUNCTIONAL PREMATURE DEPOLARIZATION VENTRICULAR PREMATURE DEPOLARIZATION UNSPECIFIED PREMATURE DEPOLARIZATION OTHER PREMATURE DEPOLARIZATION SICK SINUS SYNDROME OTHER SPECIFIED CARDIAC ARRHYTHMIAS CARDIAC ARRHYTHMIA, UNSPECIFIED 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 IDIOPATHIC HYPOTENSION August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 19

I951 I952 I953 I9581 I9589 I959 N485 N4881 N4882 N4883 N4889 R001 ORTHOSTATIC HYPOTENSION HYPOTENSION DUE TO DRUGS HYPOTENSION OF HEMODIALYSIS POSTPROCEDURAL HYPOTENSION OTHER HYPOTENSION HYPOTENSION, UNSPECIFIED ULCER OF PENIS THROMBOSIS OF SUPERFICIAL VEIN OF PENIS ACQUIRED TORSION OF PENIS ACQUIRED BURIED PENIS OTHER SPECIFIED DISORDERS OF PENIS BRADYCARDIA, UNSPECIFIED Step 4 (diagnosis of retinitis pigmentosa) Look back timeframe: 730 days ICD-9 Code Description 36274 PIGMENT RETINA DYSTROPHY ICD-10 Code Description H3552 PIGMENTARY RETINAL DYSTROPHY August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 20

Sildenafil / Tadalafil Clinical Criteria References 1. American Medical Association data files. 2015 ICD-9-CM Diagnosis Codes. Available at www.commerce.ama-assn.org. 2. American Medical Association data files. 2015 ICD-10-CM Diagnosis Codes. Available at www.commerce.ama-assn.org. 3. Clinical Pharmacology [online database]. Tampa, FL: Elsevier/Gold Standard, Inc.; 2017. Available at www.clinicalpharmacology.com. Accessed on June 9, 2017. 4. Micromedex [online database]. Available at www.micromedexsolutions.com. Accessed on June 9, 2017. 5. Revatio Prescribing Information. New York, NY. Pfizer Inc. April 2015. 6. Adcirca Prescribing Information. Indianapolis, IN. Eli Lilly and Company. April 2015. 7. Indiana University, Department of Medicine, Clinical Pharmacology Research Institute. P450 Interaction Table. Available at medicine.iupui.edu. Accessed on June 9, 2017. 8. U.S. Food and Drug Administration (FDA). Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers. Available at www.fda.gov. Accessed on June 9, 2017. 9. Galie N, Corris PA, Frost A, et al. Updated Treatment Algorithm of Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2013;62(25S). 10.Taichman DB, Ornelas J, Chung L, et al. Pharmacologic Therapy for Pulmonary Arterial Hypertension in Adults: CHEST Guideline and Expert Panel Report. Chest. 2014;146(2):449-75. 11.McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension: A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association: Developed in Collaboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association. Circulation. 2009;119:2250-2294. August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 21

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 02/17/2012 Added a new section to specify the drugs requiring prior authorization In the Clinical Edit Criteria Supporting Tables section, revised tables to specify the diagnosis codes pertinent to steps 1, 3, and 4 of the logic diagram In the Clinical Edit Criteria Supporting Tables section, revised table to specify the drug names and GCNs pertinent to step 2 of the logic diagram In the Clinical Edit Criteria Logic section, revised wording associated with steps 2 and 3 to further clarify the information In the Clinical Edit Criteria Diagram section, revised wording associated with steps 2 and 3 to further clarify the information 2/27/2015 Added GCN for Revatio oral suspension in the Drugs Requiring Prior Authorization table 04/03/2015 Updated to include ICD-10s 07/29/2015 Updated Step 5 in the Clinical Edit Criteria logic and logic diagram to mg/day (replaces units/day) Updated GCNs in Step 2 of Supporting Tables 08/11/2017 Annual review by staff Added Adcirca to Drugs Requiring PA, page 2 Updated Table 2, pages 5-8 Updated References, page 21 August 11, 2017 Copyright 2011-2017 Health Information Designs, LLC 22