Vesicular Monoamine Transporter 2 (VMAT2) Inhibitors

Transcription

1 Texas Prior Authorization Program Clinical Criteria Drug/Drug Class Vesicular Monoamine Transporter 2 (VMAT2) Inhibitors Clinical Edit Information Included in this Document Austedo (Deutetrabenazine) / Xenazine (Tetrabenazine) 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) References: clinical publications and sources relevant to this clinical criteria te: Click the hyperlink to navigate directly to that section. Ingrezza (Valbenazine) 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) References: clinical publications and sources relevant to this clinical criteria te: Click the hyperlink to navigate directly to that section. July 23, 2018 Copyright 2018 Health Information Designs, LLC 1

2 Revision tes Added psychiatrists to question 2 in criteria logic and logic diagram, pages 4-5. July 23, 2018 Copyright 2018 Health Information Designs, LLC 2

3 Austedo / Xenazine Drugs Requiring Prior Authorization AUSTEDO 12 MG TABLET AUSTEDO 6 MG TABLET AUSTEDO 9 MG TABLET TETRABENAZINE 12.5 MG TABLET TETRABENAZINE 25 MG TABLET XENAZINE 12.5 MG TABLET XENAZINE 25 MG TABLET July 23, 2018 Copyright 2018 Health Information Designs, LLC 3

4 Austedo / Xenazine Clinical Criteria Logic 1. Is the client greater than or equal to ( ) 18 years of age? [ ] Go to #2 [ ] Deny 2. Is the medication being prescribed by, or its use overseen by, a neurologist or a psychiatrist? [Manual] [ ] Go to #3 [ ] Deny 3. Does the client have a diagnosis of Huntington-induced chorea or, if the request is for deutetrabenazine, tardive dyskinesia in the last 365 days? [ ] Go to #4 [ ] Deny 4. Does the client have a diagnosis of severe depression or suicide attempt/ideation in the last 180 days? [ ] Deny [ ] Go to #5 5. Does the client have a diagnosis of hepatic impairment in the last 365 days? [ ] Deny [ ] Go to #6 6. Does the client have 1 claim for an MAO inhibitor in the last 90 days? [ ] Deny [ ] Go to #7 7. Has the client had 1 claim for a strong CYP2D6 inhibitor in the last 90 days? [ ] Go to #8 [ ] Approve (365 days) 8. Is the daily dose less than or equal ( ) to 50mg (tetrabenazine) or 36mg (deutetrabenazine)? [ ] Approve (365 days) [ ] - Deny July 23, 2018 Copyright 2018 Health Information Designs, LLC 4

5 Austedo / Xenazine Clinical Criteria Logic Diagram Step 1 Step 2 Step 3 Is the client 18 years of age? Is the medication being prescribed by, or its use overseen by, a neurologist or psychiatrist? [Manual] Does the client have a diagnosis of Huntington-induced chorea, or, if the request is for deutetrabenazine, tardive dyskinesia in the last 365 days? Deny Request Step 4 Deny Request Deny Request Does the client have a diagnosis of severe depression or suicide attempt/ ideation in the last 180 days? Deny Request Step 5 Does the client have a diagnosis of hepatic impairment in the last 365 days? Deny Request Step 6 Does the client have 1 claim for an MAO inhibitor in the last 90 days? Deny Request Step 8 Step 7 Approve Request (365 days) Is the daily dose 50mg (tetrabenazine) or 36mg (deutetrabenazine)? Has the client had 1 claim for a strong CYP2D6 inhibitor in the last 90 days? Approve Request (365 days) Deny Request July 23, 2018 Copyright 2018 Health Information Designs, LLC 5

6 Austedo / Xenazine Clinical Edit Criteria Supporting Tables Step 3a (diagnosis of Huntington-induced chorea) Required quantity: 1 Look back timeframe: 365 days ICD-10 Code G10 Description HUNTINGTON S DISEASE Step 3b (diagnosis of tardive dyskinesia) Required quantity: 1 Look back timeframe: 365 days ICD-10 Code G2401 G2402 G2409 Description DRUG INDUCED SUBACUTE DYSKINESIA DRUG INDUCED ACUTE DYSTONIA OTHER DRUG INDUCED DYSTONIA Step 4 (diagnosis of severe depression or suicide attempt/ideation) Required quantity: 1 Look back timeframe: 180 days ICD-10 Code F322 F323 F332 F333 R45851 T1491XA T1491XD T1491XS X710XXA Description MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, SEVERE WITHOUT PSYCHOTIC FEATURES MAJOR DEPRESSIVE DISORDER, SINGLE EPISODE, SEVERE WITH PSYCHOTIC FEATURES MAJOR DEPRESSIVE DISORDER, RECURRENT SEVERE WITHOUT PSYCHOTIC FEATURES MAJOR DEPRESSIVE DISORDER, RECURRENT, SEVERE WITH PSYCHOTIC SYMPTOMS SUICIDAL IDEATIONS SUICIDE ATTEMPT INITIAL SUICIDE ATTEMPT SUBSEQUENT SUICIDE ATTEMPT SEQUELA INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION WHILE IN BATHTUB INITIAL July 23, 2018 Copyright 2018 Health Information Designs, LLC 6

7 X710XXD X710XXS X711XXA X711XXD X711XXS X712XXA X712XXD X712XXS X713XXA X713XXD X713XXS X718XXA X718XXD X718XXS X719XXA X719XXD X719XXS X72XXXA X72XXXD X72XXXS X730XXA X730XXD X730XXS Step 4 (diagnosis of severe depression or suicide attempt/ideation) Required quantity: 1 Look back timeframe: 180 days INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION WHILE IN BATHTUB SUBSEQUENT INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION WHILE IN BATHTUB SEQUELA INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION WHILE IN SWIMMING POOL INITIAL INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION WHILE IN SWIMMING POOL SUBSEQUENT INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION WHILE IN SWIMMING POOL SEQUELA INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION AFTER JUMP INTO SWIMMING POOL INITIAL INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION AFTER JUMP INTO SWIMMING POOL SUBSEQUENT INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION AFTER JUMP INTO SWIMMING POOL SEQUELA INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION IN NATURAL WATER INITIAL INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION IN NATURAL WATER SUBSEQUENT INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION IN NATURAL WATER SEQUELA OTHER INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION INITIAL OTHER INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION SUBSEQUENT OTHER INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION SEQUELA INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION, UNSPECIFIED INITIAL INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION, UNSPECIFIED SUBSEQUENT INTENTIONAL SELF-HARM BY DROWNING AND SUBMERSION, UNSPECIFIED SEQUELA INTENTIONAL SELF-HARM BY HANDGUN DISCHARGE, INITIAL INTENTIONAL SELF-HARM BY HANDGUN DISCHARGE, SUBSEQUENT INTENTIONAL SELF-HARM BY HANDGUN DISCHARGE, SEQUELA INTENTIONAL SELF-HARM BY SHOTGUN DISCHARGE INITIAL INTENTIONAL SELF-HARM BY SHOTGUN DISCHARGE SUBSEQUENT INTENTIONAL SELF-HARM BY SHOTGUN DISCHARGE SEQUELA July 23, 2018 Copyright 2018 Health Information Designs, LLC 7

8 X731XXA X731XXD X731XXS X732XXA X732XXD X732XXS X738XXA X738XXD X738XXS X739XXA X739XXD X739XXS X7401XA X7401XD X7401XS X7402XA X7402XD X7402XS X7409XA X7409XD X7409XS X748XXA X748XXD X748XXS X749XXA Step 4 (diagnosis of severe depression or suicide attempt/ideation) Required quantity: 1 Look back timeframe: 180 days INTENTIONAL SELF-HARM BY HUNTING RIFLE DISCHARGE INITIAL INTENTIONAL SELF-HARM BY HUNTING RIFLE DISCHARGE SUBSEQUENT INTENTIONAL SELF-HARM BY HUNTING RIFLE DISCHARGE SEQUELA INTENTIONAL SELF-HARM BY MACHINE GUN DISCHARGE INITIAL INTENTIONAL SELF-HARM BY MACHINE GUN DISCHARGE SUBSEQUENT INTENTIONAL SELF-HARM BY MACHINE GUN DISCHARGE SEQUELA INTENTIONAL SELF-HARM BY OTHER LARGER FIREARM DISCHARGE INITIAL INTENTIONAL SELF-HARM BY OTHER LARGER FIREARM DISCHARGE SUBSEQUENT INTENTIONAL SELF-HARM BY OTHER LARGER FIREARM DISCHARGE SEQUELA INTENTIONAL SELF-HARM BY UNSPECIFIED LARGER FIREARM DISCHARGE INITIAL INTENTIONAL SELF-HARM BY UNSPECIFIED LARGER FIREARM DISCHARGE SUBSEQUENT INTENTIONAL SELF-HARM BY UNSPECIFIED LARGER FIREARM DISCHARGE SEQUELA INTENTIONAL SELF-HARM BY AIRGUN INITIAL INTENTIONAL SELF-HARM BY AIRGUN SUBSEQUENT INTENTIONAL SELF-HARM BY AIRGUN SEQUELA INTENTIONAL SELF-HARM BY PAINTBALL GUN INITIAL INTENTIONAL SELF-HARM BY PAINTBALL GUN SUBSEQUENT INTENTIONAL SELF-HARM BY PAINTBALL GUN SEQUELA INTENTIONAL SELF-HARM BY OTHER GAS, AIR OR SPRING-OPERATED GUN INITIAL INTENTIONAL SELF-HARM BY OTHER GAS, AIR OR SPRING-OPERATED GUN SUBSEQUENT INTENTIONAL SELF-HARM BY OTHER GAS, AIR OR SPRING-OPERATED GUN SEQUELA INTENTIONAL SELF-HARM BY OTHER FIREARM DISCHARGE INITIAL INTENTIONAL SELF-HARM BY OTHER FIREARM DISCHARGE SUBSEQUENT INTENTIONAL SELF-HARM BY OTHER FIREARM DISCHARGE SEQUELA INTENTIONAL SELF-HARM BY UNSPECIFIED FIREARM DISCHARGE INITIAL July 23, 2018 Copyright 2018 Health Information Designs, LLC 8

9 X749XXD X749XXS X75XXXA X75XXXD X75XXXS X76XXXA X76XXXD X76XXXS X780XXA X780XXD X780XXS X781XXA X781XXD X781XXS X782XXA X782XXD X782XXS X788XXA X788XXD X788XXS X789XXA X789XXD X789XXS X79XXXA X79XXXD X79XXXS X80XXXA X80XXXD Step 4 (diagnosis of severe depression or suicide attempt/ideation) Required quantity: 1 Look back timeframe: 180 days INTENTIONAL SELF-HARM BY UNSPECIFIED FIREARM DISCHARGE SUBSEQUENT INTENTIONAL SELF-HARM BY UNSPECIFIED FIREARM DISCHARGE SEQUELA INTENTIONAL SELF-HARM BY EXPLOSIVE MATERIAL INITIAL INTENTIONAL SELF-HARM BY EXPLOSIVE MATERIAL SUBSEQUENT INTENTIONAL SELF-HARM BY EXPLOSIVE MATERIAL SEQUELA INTENTIONAL SELF-HARM BY SMOKE, FIRE AND FLAMES, INITIAL INTENTIONAL SELF-HARM BY SMOKE, FIRE AND FLAMES, SUBSEQUENT INTENTIONAL SELF-HARM BY SMOKE, FIRE AND FLAMES, SEQUELA INTENTIONAL SELF-HARM BY SHARP GLASS INITIAL INTENTIONAL SELF-HARM BY SHARP GLASS SUBSEQUENT INTENTIONAL SELF-HARM BY SHARP GLASS SEQUELA INTENTIONAL SELF-HARM BY KNIFE INITIAL INTENTIONAL SELF-HARM BY KNIFE SUBSEQUENT INTENTIONAL SELF-HARM BY KNIFE SEQUELA INTENTIONAL SELF-HARM BY SWORD OR DAGGER INITIAL INTENTIONAL SELF-HARM BY SWORD OR DAGGER SUBSEQUENT INTENTIONAL SELF-HARM BY SWORD OR DAGGER SEQUELA INTENTIONAL SELF-HARM BY OTHER SHARP OBJECT INITIAL INTENTIONAL SELF-HARM BY OTHER SHARP OBJECT SUBSEQUENT INTENTIONAL SELF-HARM BY OTHER SHARP OBJECT SEQUELA INTENTIONAL SELF-HARM BY UNSPECIFIED SHARP OBJECT INITIAL INTENTIONAL SELF-HARM BY UNSPECIFIED SHARP OBJECT SUBSEQUENT INTENTIONAL SELF-HARM BY UNSPECIFIED SHARP OBJECT SEQUELA INTENTIONAL SELF-HARM BY BLUNT OBJECT, INITIAL INTENTIONAL SELF-HARM BY BLUNT OBJECT, SUBSEQUENT INTENTIONAL SELF-HARM BY BLUNT OBJECT, SEQUELA INTENTIONAL SELF-HARM BY JUMPING FROM A HIGH PLACE, INITIAL INTENTIONAL SELF-HARM BY JUMPING FROM A HIGH PLACE, SUBSEQUENT July 23, 2018 Copyright 2018 Health Information Designs, LLC 9

10 X80XXXS X810XXA X810XXD X810XXS X811XXA X811XXD X811XXS X818XXA X818XXD X818XXS X820XXA X820XXD X820XXS X821XXA X821XXD X821XXS X822XXA X822XXD X822XXS X828XXA X828XXD X828XXS X830XXA X830XXD Step 4 (diagnosis of severe depression or suicide attempt/ideation) Required quantity: 1 Look back timeframe: 180 days INTENTIONAL SELF-HARM BY JUMPING FROM A HIGH PLACE, SEQUELA INTENTIONAL SELF-HARM BY JUMPING OR LYING IN FRONT OF MOTOR VEHICLE INITIAL INTENTIONAL SELF-HARM BY JUMPING OR LYING IN FRONT OF MOTOR VEHICLE SUBSEQUENT INTENTIONAL SELF-HARM BY JUMPING OR LYING IN FRONT OF MOTOR VEHICLE SEQUELA INTENTIONAL SELF-HARM BY JUMPING OR LYING IN FRONT OF (SUBWAY) TRAIN INITIAL INTENTIONAL SELF-HARM BY JUMPING OR LYING IN FRONT OF (SUBWAY) TRAIN SUBSEQUENT INTENTIONAL SELF-HARM BY JUMPING OR LYING IN FRONT OF (SUBWAY) TRAIN SEQUELA INTENTIONAL SELF-HARM BY JUMPING OR LYING IN FRONT OF OTHER MOVING OBJECT INITIAL INTENTIONAL SELF-HARM BY JUMPING OR LYING IN FRONT OF OTHER MOVING OBJECT SUBSEQUENT INTENTIONAL SELF-HARM BY JUMPING OR LYING IN FRONT OF OTHER MOVING OBJECT SEQUELA INTENTIONAL COLLISION OF MOTOR VEHICLE WITH OTHER MOTOR VEHICLE INITIAL INTENTIONAL COLLISION OF MOTOR VEHICLE WITH OTHER MOTOR VEHICLE SUBSEQUENT INTENTIONAL COLLISION OF MOTOR VEHICLE WITH OTHER MOTOR VEHICLE SEQUELA INTENTIONAL COLLISION OF MOTOR VEHICLE WITH TRAIN INITIAL INTENTIONAL COLLISION OF MOTOR VEHICLE WITH TRAIN SUBSEQUENT INTENTIONAL COLLISION OF MOTOR VEHICLE WITH TRAIN SEQUELA INTENTIONAL COLLISION OF MOTOR VEHICLE WITH TREE INITIAL INTENTIONAL COLLISION OF MOTOR VEHICLE WITH TREE SUBSEQUENT INTENTIONAL COLLISION OF MOTOR VEHICLE WITH TREE SEQUELA OTHER INTENTIONAL SELF-HARM BY CRASHING OF MOTOR VEHICLE INITIAL OTHER INTENTIONAL SELF-HARM BY CRASHING OF MOTOR VEHICLE SUBSEQUENT OTHER INTENTIONAL SELF-HARM BY CRASHING OF MOTOR VEHICLE SEQUELA INTENTIONAL SELF-HARM BY CRASHING OF AIRCRAFT INITIAL INTENTIONAL SELF-HARM BY CRASHING OF AIRCRAFT SUBSEQUENT July 23, 2018 Copyright 2018 Health Information Designs, LLC 10

11 X830XXS X831XXA X831XXD X831XXS X832XXA X832XXD X832XXS X838XXA X838XXD X838XXS Step 4 (diagnosis of severe depression or suicide attempt/ideation) Required quantity: 1 Look back timeframe: 180 days INTENTIONAL SELF-HARM BY CRASHING OF AIRCRAFT SEQUELA INTENTIONAL SELF-HARM BY ELECTROCUTION INITIAL INTENTIONAL SELF-HARM BY ELECTROCUTION SUBSEQUENT INTENTIONAL SELF-HARM BY ELECTROCUTION SEQUELA INTENTIONAL SELF-HARM BY EXPOSURE TO EXTREMES OF COLD INITIAL INTENTIONAL SELF-HARM BY EXPOSURE TO EXTREMES OF COLD SUBSEQUENT INTENTIONAL SELF-HARM BY EXPOSURE TO EXTREMES OF COLD SEQUELA INTENTIONAL SELF-HARM BY OTHER SPECIFIED MEANS INITIAL INTENTIONAL SELF-HARM BY OTHER SPECIFIED MEANS SUBSEQUENT INTENTIONAL SELF-HARM BY OTHER SPECIFIED MEANS SEQUELA Step 5 (diagnosis of hepatic impairment) Required diagnoses: 1 Look back timeframe: 365 days ICD-10 Code B160 B161 B162 B169 B170 B1710 B1711 B172 B178 B179 B180 B181 B182 B188 B189 B190 B1910 Description 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 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 July 23, 2018 Copyright 2018 Health Information Designs, LLC 11

12 ICD-10 Code 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 K7200 K7201 K7210 K7211 K7290 K7291 K730 K731 K732 Step 5 (diagnosis of hepatic impairment) Description Required diagnoses: 1 Look back timeframe: 365 days 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 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 July 23, 2018 Copyright 2018 Health Information Designs, LLC 12

13 Step 5 (diagnosis of hepatic impairment) Required diagnoses: 1 Look back timeframe: 365 days ICD-10 Code K738 K739 K740 K741 K742 K743 K744 K745 K7460 K7469 K750 K751 K752 K753 K754 K7581 K7589 K759 K761 K763 K7689 K769 K77 Description 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 Step 6 (MAO inhibitor) Look back timeframe: 90 days AZILECT 0.5MG TABLET AZILECT 1MG TABLET EMSAM 12MG/24 HOURS PATCH EMSAM 6MG/24 HOURS PATCH EMSAM 9MG/24 HOURS PATCH LINEZOLID 600MG TABLET LINEZOLID 600MG/300ML IV SOLN July 23, 2018 Copyright 2018 Health Information Designs, LLC 13

14 Step 6 (MAO inhibitor) Look back timeframe: 90 days MARPLAN 10MG TABLET NARDIL 15MG TABLET PARNATE 10MG TABLET PHENELZINE SULFATE 15MG TABLET SELEGILINE HCL 5MG CAPSULE SELEGILINE HCL 5MG TABLET TRANYLCYPROMINE 10MG TABLET ZELAPAR 1.25 MG ODT TABLET ZYVOX 100MG/5ML SUSPENSION ZYVOX 600MG TABLET ZYVOX 600MG/300ML IV SOLN Step 7 (strong CYP2D6 inhibitor) Look back timeframe: 90 days APLENZIN ER 174 MG TABLET APLENZIN ER 348 MG TABLET APLENZIN ER 522 MG TABLET BRISDELLE 7.5 MG CAPSULE BUPROPION HCL 100 MG TABLET BUPROPION HCL 75 MG TABLET BUPROPION HCL SR 100 MG TABLET BUPROPION HCL SR 150 MG TABLET BUPROPION HCL SR 150 MG TABLET BUPROPION HCL SR 200 MG TABLET BUPROPION HCL XL 150 MG TABLET BUPROPION HCL XL 300 MG TABLET FLUOXETINE 20 MG/5 ML SOLUTION FLUOXETINE DR 90 MG CAPSULE FLUOXETINE HCL 10 MG CAPSULE FLUOXETINE HCL 10 MG TABLET FLUOXETINE HCL 20 MG CAPSULE FLUOXETINE HCL 20 MG TABLET FLUOXETINE HCL 40 MG CAPSULE FLUOXETINE HCL 60 MG TABLET July 23, 2018 Copyright 2018 Health Information Designs, LLC 14

15 Step 7 (strong CYP2D6 inhibitor) Look back timeframe: 90 days FORFIVO XL 450 MG TABLET OLANZAPINE-FLUOXETINE MG OLANZAPINE-FLUOXETINE MG OLANZAPINE-FLUOXETINE 3-25 MG OLANZAPINE-FLUOXETINE 6-25 MG OLANZAPINE-FLUOXETINE 6-50 MG PAROXETINE ER 12.5 MG TABLET PAROXETINE ER 25 MG TABLET PAROXETINE ER 37.5 MG TABLET PAROXETINE HCL 10 MG TABLET PAROXETINE HCL 20 MG TABLET PAROXETINE HCL 30 MG TABLET PAROXETINE HCL 40 MG TABLET PAROXETINE MESYLATE 7.5 MG CAP PAXIL 10 MG TABLET PAXIL 10 MG/5 ML SUSPENSION PAXIL 20 MG TABLET PAXIL 30 MG TABLET PAXIL 40 MG TABLET PAXIL CR 12.5 MG TABLET PAXIL CR 25 MG TABLET PAXIL CR 37.5 MG TABLET PEXEVA 10 MG TABLET PEXEVA 20 MG TABLET PEXEVA 30 MG TABLET PEXEVA 40 MG TABLET PROZAC 10 MG PULVULE PROZAC 20 MG PULVULE PROZAC 40 MG PULVULE QUINIDINE GLUC ER 324 MG TAB QUINIDINE SULFATE 200 MG TAB QUINIDINE SULFATE 300 MG TAB SENSIPAR 30 MG TABLET SENSIPAR 60 MG TABLET SENSIPAR 90 MG TABLET SYMBYAX MG CAPSULE SYMBYAX MG CAPSULE SYMBYAX 3-25 MG CAPSULE July 23, 2018 Copyright 2018 Health Information Designs, LLC 15

16 Step 7 (strong CYP2D6 inhibitor) Look back timeframe: 90 days SYMBYAX 6-25 MG CAPSULE SYMBYAX 6-50 MG CAPSULE WELLBUTRIN SR 100 MG TABLET WELLBUTRIN SR 150 MG TABLET WELLBUTRIN SR 200 MG TABLET WELLBUTRIN XL 150 MG TABLET WELLBUTRIN XL 300 MG TABLET ZYBAN SR 150 MG TABLET July 23, 2018 Copyright 2018 Health Information Designs, LLC 16

17 Ingrezza Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization INGREZZA 40 MG CAPSULE INGREZZA 80 MG CAPSULE July 23, 2018 Copyright 2018 Health Information Designs, LLC 17

18 Ingrezza Clinical Criteria Logic 1. Is the client greater than or equal to ( ) 18 years of age? [ ] (Go to #2) [ ] (Deny) 2. Does the client have a diagnosis of tardive dyskinesia in the last 730 days? [ ] (Go to #3) [ ] (Deny) 3. Does the client have a diagnosis of long QT syndrome in the last 365 days? [ ] (Deny) [ ] (Go to #4) 4. Does the client have a claim for a monoamine oxidase inhibitor (MAOI) or a strong CYP3A4 inducer in the last 90 days? [ ] (Deny) [ ] (Go to #5) 5. Does the client have a claim for Xenazine (tetrabenazine) or Austedo (deutetrabenazine) in the last 30 days? [ ] (Deny) [ ] (Go to #6) 6. Does the client have a diagnosis of moderate to severe hepatic impairment in the last 365 days? [ ] (Go to #8) [ ] (Go to #7) 7. Does the client have a claim for a strong CYP3A4 inhibitor in the last 90 days? [ ] (Go to #8) [ ] (Go to #9) 8. Is the requested dose less than or equal to ( ) one 40mg capsule per day? [ ] (Approve 365 days) [ ] (Deny) 9. Is the requested dose less than or equal to ( ) 1 capsule per day? [ ] (Approve 365 days) [ ] (Deny) July 23, 2018 Copyright 2018 Health Information Designs, LLC 18

19 Ingrezza Clinical Criteria Logic Diagram Step 1 Step 2 Step 3 Step 4 Is the client 18 years of age? Does the client have a diagnosis of tardive dyskinesia in the last 730 days? Does the client have a diagnosis of long QT syndrome in the last 365 days? Does the client have a claim for MAOI or CYP3A4 inducer in the last 90 days? Deny Request Step 5 Deny Request Deny Request Deny Request Does the client have a claim for Xenazine or Austedo in the last 30 days? Deny Request Step 6 Step 7 Does the client have a diagnosis of hepatic impairment in the last 365 days? Does the client have a claim for a strong CYP3A4 inhibitor in the last 90 days? Step 8 Step 9 Deny Request Is the requested dose one 40mg capsule per day? Is the requested dose 1 capsule per day? Approve Request (365 days) Deny Request July 23, 2018 Copyright 2018 Health Information Designs, LLC 19

20 Ingrezza Clinical Criteria Supporting Tables Step 2 (diagnosis of tardive dyskinesia) Required quantity: 1 Look back timeframe: 730 days For the list of tardive dyskinesia diagnosis codes that pertain to this step, see the Tardive Dyskinesia Diagnoses table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 3 (diagnosis of long QT syndrome) Required diagnoses: 1 Look back timeframe: 365 days ICD-10 Code I4581 Description LONG QT SYNDROME Step 4 (MAOI or CYP3A4 inducer) Look back timeframe: 90 days ACTOPLUS MED MG TABLET ACTOPLUS MET MG TABLET ACTOPLUS MET XR MG TABLET ACTOPLUS MET XR MG TABLET ACTOS 15MG TABLET ACTOS 30MG TABLET ACTOS 45MG TABLET APTIOM 200MG TABLET APTIOM 400MG TABLET APTIOM 600MG TABLET APTIOM 800MG TABLET ATRIPLA TABLET AZILECT 0.5MG TABLET July 23, 2018 Copyright 2018 Health Information Designs, LLC 20

21 Step 4 (MAOI or CYP3A4 inducer) Look back timeframe: 90 days AZILECT 1MG TABLET BEXAROTENE 75MG CAPSULE CARBAMAZEPINE 100 MG TAB CHEW CARBAMAZEPINE 100 MG/5 ML SUSP CARBAMAZEPINE 200 MG TABLET CARBAMAZEPINE ER 100 MG CAP CARBAMAZEPINE ER 200 MG CAP CARBAMAZEPINE ER 200 MG TABLET CARBAMAZEPINE ER 300 MG CAP CARBAMAZEPINE ER 400 MG TABLET CARBATROL ER 100 MG CAPSULE CARBATROL ER 200 MG CAPSULE CARBATROL ER 300 MG CAPSULE DILANTIN 100 MG CAPSULE DILANTIN 125 MG/5 ML SUSP DILANTIN 30 MG CAPSULE DILANTIN 50 MG INFATAB DUETACT 30-2MG TABLET DUETACT 30-4MG TABLET EMSAM 12MG/24 HOURS PATCH EMSAM 6MG/24 HOURS PATCH EMSAM 9MG/24 HOURS PATCH EPITOL 200 MG TABLET EQUETRO 100 MG CAPSULE EQUETRO 200 MG CAPSULE EQUETRO 300 MG CAPSULE INTELENCE 100MG TABLET INTELENCE 200MG TABLET INTELENCE 25MG TABLET LINEZOLID 600MG TABLET LINEZOLID 600MG/300ML IV SOLN LYSODREN 500MG TABLET MARPLAN 10MG TABLET MODAFINIL 100MG TABLET MODAFINIL 200MG TABLET MYCOBUTIN 150 MG CAPSULE MYSOLINE 250MG TABLET July 23, 2018 Copyright 2018 Health Information Designs, LLC 21

22 Step 4 (MAOI or CYP3A4 inducer) Look back timeframe: 90 days MYSOLINE 50MG TABLET NARDIL 15MG TABLET NEVIRAPINE 200MG TABLET NEVIRAPINE 50MG/5ML SUSPENSION NEVIRAPINE ER 400MG TABLET ORKAMBI MG TABLET ORKAMBI MG TABLET OSENI MG TABLET OSENI MG TABLET OSENI MG TABLET OSENI 25-15MG TABLET OSENI 25-30MG TABLET OSENI 25-45MG TABLET PARNATE 10MG TABLET PHENELZINE SULFATE 15MG TABLET PHENOBARBITAL 100 MG TABLET PHENOBARBITAL 130 MG/ML VIAL PHENOBARBITAL 15 MG TABLET PHENOBARBITAL 16.2 MG TABLET PHENOBARBITAL 20 MG/5 ML ELIX PHENOBARBITAL 30 MG TABLET PHENOBARBITAL 32.4 MG TABLET PHENOBARBITAL 60 MG TABLET PHENOBARBITAL 64.8 MG TABLET PHENOBARBITAL 65 MG/ML VIAL PHENOBARBITAL 97.2 MG TABLET PHENYTEK 200 MG CAPSULE PHENYTEK 300 MG CAPSULE PHENYTOIN 125 MG/5 ML SUSP PHENYTOIN 50 MG TABLET CHEW PHENYTOIN 50 MG/ML VIAL PHENYTOIN SOD EXT 100 MG CAP PHENYTOIN SOD EXT 200 MG CAP PHENYTOIN SOD EXT 300 MG CAP PIOGLITAZONE HCL 15 MG TABLET PIOGLITAZONE HCL 30 MG TABLET PIOGLITAZONE HCL 45 MG TABLET PIOGLITAZONE-GLIMEPIRIDE 30-2 July 23, 2018 Copyright 2018 Health Information Designs, LLC 22

23 Step 4 (MAOI or CYP3A4 inducer) Look back timeframe: 90 days PIOGLITAZONE-GLIMEPIRIDE PIOGLITAZONE-METFORMIN PIOGLITAZONE-METFORMIN PRIFTIN 150MG TABLET PRIMIDONE 250MG TABLET PRIMIDONE 50MG TABLET PROVIGIL 100MG TABLET PROVIGIL 200MG TABLET RIFABUTIN 150 MG CAPSULE RIFADIN 150 MG CAPSULE RIFADIN 300 MG CAPSULE RIFADIN IV 600 MG VIAL RIFAMATE CAPSULE RIFAMPIN 150 MG CAPSULE RIFAMPIN 300 MG CAPSULE RIFAMPIN IV 600 MG VIAL RIFATER TABLET SELEGILINE HCL 5MG CAPSULE SELEGILINE HCL 5MG TABLET SUSTIVA 200MG CAPSULE SUSTIVA 50MG CAPSULE SUSTIVA 600MG TABLET TAFINLAR 50MG CAPSULE TAFINLAR 75MG CAPSULE TARGRETIN 75MG CAPSULE TEGRETOL 100 MG/5 ML SUSP TEGRETOL 200 MG TABLET TEGRETOL XR 100 MG TABLET TEGRETOL XR 200 MG TABLET TEGRETOL XR 400 MG TABLET TRACLEER 125MG TABLET TRACLEER 62.5MG TABLET TRANYLCYPROMINE 10MG TABLET VIRAMUNE 200MG TABLET VIRAMUNE 50MG/5ML SUSPENSION VIRAMUNE XR 100MG TABLET VIRAMUNE XR 400MG TABLET XTANDI 40MG CAPSULE July 23, 2018 Copyright 2018 Health Information Designs, LLC 23

24 Step 4 (MAOI or CYP3A4 inducer) Look back timeframe: 90 days ZELAPAR 1.25 MG ODT TABLET ZYVOX 100MG/5ML SUSPENSION ZYVOX 600MG TABLET ZYVOX 600MG/300ML IV SOLN Step 5 (Xenazine or Austedo) Look back timeframe: 30 days AUSTEDO 6 MG TABLET AUSTEDO 9 MG TABLET AUSTEDO 12 MG TABLET XENAZINE 12.5 MG TABLET XENAZINE 25 MG TABLET Step 6 (diagnosis of hepatic impairment) Required quantity: 1 Look back timeframe: 365 days For the list of hepatic impairment diagnosis codes that pertain to this step, see the Hepatic Impairment Diagnoses table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 7 (strong CYP3A4 inhibitor) Look back timeframe: 90 days BIAXIN 250 MG TABLET BIAXIN 250 MG/5 ML SUSPENSION BIAXIN 500 MG TABLET CARDIZEM 120 MG TABLET CARDIZEM 30 MG TABLET CARDIZEM 60 MG TABLET CARDIZEM CD 120 MG CAPSULE July 23, 2018 Copyright 2018 Health Information Designs, LLC 24

25 Step 7 (strong CYP3A4 inhibitor) Look back timeframe: 90 days CARDIZEM CD 180 MG CAPSULE CARDIZEM CD 240 MG CAPSULE CARDIZEM CD 300 MG CAPSULE CARDIZEM CD 360 MG CAPSULE CARDIZEM LA 120 MG TABLET CARDIZEM LA 180 MG TABLET CARDIZEM LA 360 MG TABLET CARDIZEM LA 420 MG TABLET CARTIA XT 120MG CAPSULE CARTIA XT 180MG CAPSULE CARTIA XT 240MG CAPSULE CARTIA XT 300MG CAPSULE CLARITHROMYCIN 125 MG/5 ML SUS CLARITHROMYCIN 250 MG TABLET CLARITHROMYCIN 250 MG/5 ML SUS CLARITHROMYCIN 500 MG TABLET CLARITHROMYCIN ER 500 MG TAB CRIXIVAN 200 MG CAPSULE CRIXIVAN 400 MG CAPSULE DILTIAZEM 120 MG TABLET DILTIAZEM 12HR ER 120 MG CAP DILTIAZEM 12HR ER 60 MG CAP DILTIAZEM 12HR ER 90 MG CAP DILTIAZEM 24HR ER 120 MG CAP DILTIAZEM 24HR ER 180 MG CAP DILTIAZEM 24HR ER 240 MG CAP DILTIAZEM 24HR ER 300 MG CAP DILTIAZEM 24HR ER 360 MG CAP DILTIAZEM 30 MG TABLET DILTIAZEM 60 MG TABLET DILTIAZEM 90 MG TABLET DILTIAZEM ER 120 MG CAPSULE DILTIAZEM ER 120 MG CAPSULE DILTIAZEM ER 180 MG CAPSULE DILTIAZEM ER 180 MG CAPSULE DILTIAZEM ER 240 MG CAPSULE DILTIAZEM HCL ER 240 MG CAP DILTIAZEM HCL ER 300 MG CAP July 23, 2018 Copyright 2018 Health Information Designs, LLC 25

26 Step 7 (strong CYP3A4 inhibitor) Look back timeframe: 90 days DILTIAZEM HCL ER 360 MG CAP DILTIAZEM HCL ER 420 MG CAP EVOTAZ MG TABLET GENVOYA TABLET INVIRASE 200 MG CAPSULE INVIRASE 500 MG TABLET ITRACONAZOLE 100 MG CAPSULE KALETRA MG TABLET KALETRA MG TABLET KALETRA /5 ML ORAL SOLU KETEK 300 MG TABLET KETEK 400 MG TABLET KETOCONAZOLE 200 MG TABLET LANSOPRAZOL-AMOXICIL-CLARITHRO MATZIM LA 180MG TABLET MATZIM LA 240MG TABLET MATZIM LA 300MG TABLET MATZIM LA 360MG TABLET MATZIM LA 420MG TABLET NEFAZODONE 100MG TABLET NEFAZODONE 150MG TABLET NEFAZODONE 200MG TABLET NEFAZODONE 250MG TABLET NEFAZODONE 50MG TABLET NORVIR 100 MG SOFTGEL CAP NORVIR 100 MG TABLET NORVIR 80 MG/ML SOLUTION NOXAFIL 40 MG/ML SUSPENSION NOXAFIL DR 100 MG TABLET OMECLAMOX-PAK COMBO PACK PREVPAC PATIENT PACK PREZCOBIX MG TABLET SPORANOX 10 MG/ML SOLUTION SPORANOX 100 MG CAPSULE STRIBILD TABLET TAZTIA XT 120MG CAPSULE TAZTIA XT 180MG CAPSULE TAZTIA XT 240MG CAPSULE July 23, 2018 Copyright 2018 Health Information Designs, LLC 26

27 Step 7 (strong CYP3A4 inhibitor) Look back timeframe: 90 days TAZTIA XT 300MG CAPSULE TAZTIA XT 360MG CAPSULE TECHNIVIE DOSE PACK TIAZAC ER 120MG CAPSULE TIAZAC ER 180MG CAPSULE TIAZAC ER 240MG CAPSULE TIAZAC ER 300MG CAPSULE TIAZAC ER 360MG CAPSULE TIAZAC ER 420MG CAPSULE TYBOST 150MG TABLET VFEND 200 MG TABLET VFEND 40 MG/ML SUSPENSION VFEND 50 MG TABLET VFEND IV 200 MG VIAL VICTRELIS 200 MG CAPSULE VIEKIRA PAK VIEKIRA XR TABLET VIRACEPT 250 MG TABLET VIRACEPT 625 MG TABLET VORICONAZOLE 200 MG TABLET VORICONAZOLE 200 MG VIAL VORICONAZOLE 40 MG/ML SUSP VORICONAZOLE 50 MG TABLET ZYDELIG 100MG TABLET ZYDELIG 150MG TABLET July 23, 2018 Copyright 2018 Health Information Designs, LLC 27

28 Clinical Edit Criteria References 1. Clinical Pharmacology [online database]. Tampa, FL: Elsevier / Gold Standard, Inc Available at Accessed on April 10, Micromedex [online database] Available at Accessed on April 10, ICD-9-CM Diagnosis Codes Available at Accessed on April 3, ICD-10-CM Diagnosis Codes Available at Accessed on April 3, American Medical Association data files ICD-9-CM Diagnosis Codes. Available at 6. American Medical Association data files ICD-10-CM Diagnosis Codes. Available at 7. Austedo Prescribing Information. rth Wales, PA. Teva Pharmaceuticals. August Ingrezza Prescribing Information. Neurocrine Biosciences, Inc. San Diego, CA. October Xenazine Prescribing Information. Deerfield, IL. Lundbeck. September July 23, 2018 Copyright 2018 Health Information Designs, LLC 28

29 Publication History The Publication History records the publication iterations and revisions to this document. tes for the most current revision are also provided in the Revision tes on the first page of this document. Publication Date tes 01/30/2014 Presented to the DUR Board 03/03/2014 Initial publication and posting to website 04/03/2015 Updated to include ICD-10s 04/10/2018 Annual review by staff Removed ICD-9 codes Added s for Austedo to Drugs Requiring PA, page 3 Added questions 4, 5, 6 and 7 to logic and logic diagram, pages 4-5 Added Table 4, 5, 6 and 7 to supporting tables, pages 6-16 Added Ingrezza criteria to guide, pages Updated references, page 28 07/23/2018 Added psychiatrists to question 2 in criteria logic and logic diagram, pages 4-5. July 23, 2018 Copyright 2018 Health Information Designs, LLC 29