Ingrezza (Valbenazine)

Texas Prior Authorization Program Clinical Criteria

Drug/Drug Class

Ingrezza (Valbenazine)

This criteria was recommended for review by the Texas Medicaid Vendor Drug Program to ensure appropriate and safe utilization.

Clinical Information Included in this Document 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); 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 Added GCN for Ingrezza 80mg capsule, page 2 Updated criteria logic and diagram to include dosing for 80mg capsule, pages 3 and 4

November 7, 2017

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Texas Prior Authorization Program Clinical Criteria

Ingrezza (Valbenazine)

Ingrezza (Valbenazine)

Drugs Requiring Prior Authorization

Drugs Requiring Prior Authorization

Label Name

GCN

INGREZZA 40 MG CAPSULE INGREZZA 80 MG CAPSULE

43266 43934

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Texas Prior Authorization Program Clinical Criteria

Ingrezza (Valbenazine)

Ingrezza (Valbenazine)

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 tardive dyskinesia in the last 730 days? [ ] Yes (Go to #3) [ ] No (Deny)

3. Does the client have a diagnosis of long QT syndrome in the last 365 days? [ ] Yes (Deny) [ ] No (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? [ ] Yes (Deny) [ ] No (Go to #5)

5. Does the client have a claim for Xenazine (tetrabenazine) or Austedo (deutetrabenazine) in the last 30 days? [ ] Yes (Deny) [ ] No (Go to #6)

6. Does the client have a diagnosis of moderate to severe hepatic impairment in the last 365 days? [ ] Yes (Go to #8) [ ] No (Go to #7)

7. Does the client have a claim for a strong CYP3A4 inhibitor in the last 90 days? [ ] Yes (Go to #8) [ ] No (Go to #9)

8. Is the requested dose less than or equal to () one 40mg capsule per day? [ ] Yes (Approve ? 365 days) [ ] No (Deny)

9. Is the requested dose less than or equal to () 1 capsule per day? [ ] Yes (Approve ? 365 days) [ ] No (Deny)

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Texas Prior Authorization Program Clinical Criteria

Ingrezza (Valbenazine)

Ingrezza (Valbenazine)

Clinical Criteria Logic Diagram

Step 1

Is the client 18 years Yes of age?

Step 2

Step 3

Does the client have a Yes Does the client have a No

diagnosis of tardive

diagnosis of long QT

dyskinesia in the last

syndrome in the last

730 days?

365 days?

Step 4

Does the client have a Yes claim for MAOI or

CYP3A4 inducer in the last 90 days?

Deny Request

No Deny Request

No Deny Request

Yes Deny Request

No

Step 5

Does the client have a Yes claim for Xenazine or Austedo in the last 30

days?

Deny Request

Deny Request

No

Step 6

Does the client have a No diagnosis of hepatic impairment in the last 365 days?

Step 7

Does the client have a claim for a strong CYP3A4 inhibitor in the last 90 days?

Yes

Yes

No

Step 8

No Is the requested dose one 40mg capsule per day?

Step 9

Is the requested dose 1 capsule per day?

Yes

Yes

No

Approve Request (365 days)

Deny Request

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Texas Prior Authorization Program Clinical Criteria

Ingrezza (Valbenazine)

Ingrezza (Valbenazine)

Clinical Criteria Supporting Tables

ICD-9 Code 33372 33385 ICD-10 Code G2401 G2402 G2409

Step 2 (diagnosis of tardive dyskinesia) Required diagnoses: 1

Look back timeframe: 730 days

Description ACUTE DYSTONIA DUE TO DRUGS SUBACUTE DYSKINESIA DUE TO DRUGS Description DRUG INDUCED SUBACUTE DYSKINESIA DRUG INDUCED ACUTE DYSTONIA OTHER DRUG INDUCED DYSTONIA

ICD-10 Code I4581

Step 3 (diagnosis of long QT syndrome) Required diagnoses: 1

Look back timeframe: 365 days

Description LONG QT SYNDROME

GCN

25445 25444 28620 28622 92991 93001 93011 36098 36099

Step 4 (MAOI or CYP3A4 inducer) Required number of claims: 1 Look back timeframe: 90 days

Label Name ACTOPLUS MED 15-850MG TABLET ACTOPLUS MET 15-500MG TABLET ACTOPLUS MET XR 15-1000MG TABLET ACTOPLUS MET XR 30-1000MG TABLET ACTOS 15MG TABLET ACTOS 30MG TABLET ACTOS 45MG TABLET APTIOM 200MG TABLET APTIOM 400MG TABLET

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Texas Prior Authorization Program Clinical Criteria

GCN 36106 27409 27346 27081 24654 92373 17460 47500 17450 23934 23932 27821 23933 27822 23934 23932 23933 17700 17241 17701 17250 97181 97180 26614 26612 26613 17450 13781 13805 13818 99318 29424 32035 26870 26873 37810 16416

Step 4 (MAOI or CYP3A4 inducer) Required number of claims: 1 Look back timeframe: 90 days

Label Name APTIOM 600MG TABLET APTIOM 800MG TABLET ATRIPLA TABLET AZILECT 0.5MG TABLET 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

Ingrezza (Valbenazine)

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Texas Prior Authorization Program Clinical Criteria

GCN

26101 26102 29810 17321 17322 16417 31420 31421 29767 42366 39008 34080 34083 34084 34077 34078 34079 16418 16417 12975 12892 12971 97706 12956 12973 97965 12972 97966 12894 97967 15038 15037 17241 17250 17200 17700 15038 15037

Step 4 (MAOI or CYP3A4 inducer) Required number of claims: 1 Look back timeframe: 90 days

Label Name

MODAFINIL 100MG TABLET MODAFINIL 200MG TABLET MYCOBUTIN 150 MG CAPSULE MYSOLINE 250MG TABLET MYSOLINE 50MG TABLET NARDIL 15MG TABLET NEVIRAPINE 200MG TABLET NEVIRAPINE 50MG/5ML SUSPENSION NEVIRAPINE ER 400MG TABLET ORKAMBI 100-125MG TABLET ORKAMBI 200-125MG TABLET OSENI 12.5-15MG TABLET OSENI 12.5-30MG TABLET OSENI 12.5-45MG 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

Ingrezza (Valbenazine)

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Texas Prior Authorization Program Clinical Criteria

GCN 92991 93001 93011 97181 97180 25444 25445 45911 17321 17322 26101 26102 29810 41260 41261 41470 89800 41260 41261 41470 14142 15603 15600 43303 43301 15555 34723 34724 92373 47500 17450 27820 27821 27822 14979 14978 16418 31420

Step 4 (MAOI or CYP3A4 inducer) Required number of claims: 1 Look back timeframe: 90 days

Label Name PIOGLITAZONE HCL 15 MG TABLET PIOGLITAZONE HCL 30 MG TABLET PIOGLITAZONE HCL 45 MG TABLET PIOGLITAZONE-GLIMEPIRIDE 30-2 PIOGLITAZONE-GLIMEPIRIDE 30-4 PIOGLITAZONE-METFORMIN 15-500 PIOGLITAZONE-METFORMIN 15-850 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

Ingrezza (Valbenazine)

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