Emflaza (deflazacort)

Texas Prior Authorization Program Clinical Criteria

Drug/Drug Class

Emflaza (deflazacort)

This criteria was recommended for review by the Texas Medicaid Vendor Drug Program to ensure appropriate and safe utilization. Additional MCO recommendations have been incorporated.

Clinical Information Included in this Document Emflaza Tablets 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 Removed specialist requirement from criteria

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Texas Prior Authorization Program Clinical Criteria

Emflaza (deflazacort)

Emflaza (deflazacort)

Drugs Requiring Prior Authorization

Drugs Requiring Prior Authorization

Label Name

GCN

EMFLAZA 18 MG TABLET EMFLAZA 22.75 MG/ML ORAL SUSP EMFLAZA 30 MG TABLET EMFLAZA 36 MG TABLET EMFLAZA 6 MG TABLET

43012 43016 23762 43015 23761

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Texas Prior Authorization Program Clinical Criteria

Emflaza (deflazacort)

Emflaza (deflazacort)

Clinical Criteria Logic

Initial Requests:

1. Is the client greater than or equal to () 2 years of age? [ ] Yes (Go to #2) [ ] No (Deny)

2. Does the client have a diagnosis of Duchenne muscular dystrophy (DMD) in the last 730 days? [ ] Yes (Go to #3) [ ] No (Deny)

3. Has the client tried prednisone for greater than or equal to () 6 months, AND have one of the following adverse events as a result of prednisone use [Manual]: a. Cushingoid appearance b. Central (truncal) obesity c. Undesirable weight gain (defined as greater than or equal to [] 10% body weight gain over a 6-month period) d. Diabetes and/or hypertension that is difficult to manage according to the prescribing physician [ ] Yes (Go to #5) [ ] No (Go to #4)

4. Has the client experienced a severe behavioral adverse event while on prednisone therapy that has or will require a prednisone dose reduction [Manual]? [ ] Yes (Go to #5) [ ] No (Deny

5. Does the client have a claim for a moderate or strong CYP3A4 inducer in the last 90 days? [ ] Yes (Deny) [ ] No (Approve ? 365 days)

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Texas Prior Authorization Program Clinical Criteria

Emflaza (deflazacort)

Renewal Requests:

1. Does the physician state that the client continues to have a positive response to therapy [Manual]? [ ] Yes (Go to #2) [ ] No (Deny)

2. Does the client have a claim for a moderate or strong CYP3A4 inducer in the last 90 days? [ ] Yes (Deny) [ ] No (Approve ? 365 days)

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Texas Prior Authorization Program Clinical Criteria

Emflaza (deflazacort)

Emflaza (deflazacort)

Clinical Criteria Logic Diagram

Initial Requests:

Step 1 Is the client 2 years Yes

of age?

No

Step 2

Does the client have a Yes diagnosis of

Duchenne muscular dystrophy in the last

730 days?

No

Step 3

Has the client tried

No

prednisone for 6

months AND have a

listed adverse event?

[Manual]

Yes Yes

Step 4

Has the client experienced a severe behavioral

adverse event that has or will require dose reduction of prednisone? [Manual]

No

Deny Request

Deny Request

Step 5

Does the client have a Yes claim for a moderate

or strong CYP3A4 inducer in the last 90

days?

Deny Request

No

Approve Request (365 days)

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Texas Prior Authorization Program Clinical Criteria

Renewal Requests:

Emflaza (deflazacort)

Step 1

Does the physician Yes state that the client continues to have a positive response to therapy? [Manual]

No

Step 2

Does the client have a No claim for a moderate

or strong CYP3A4 inducer in the last 90

days?

Yes

Approve Request (365 days)

Deny Request

Deny Request

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Texas Prior Authorization Program Clinical Criteria

Emflaza (deflazacort)

Emflaza (deflazacort)

Clinical Criteria Supporting Tables

Step 2 (diagnosis of Duchenne muscular dystrophy) Required diagnosis: 1

Look back timeframe: 730 days

ICD-10 Code Description

G710

MUSCULAR DYSTROPHY

Step 3a (claim for prednisone) Required days supply: 180

Look back timeframe: 200 days

Label Name

GCN

PREDNISONE 1 MG TABLET PREDNISONE 10 MG TABLET PREDNISONE 2.5 MG TABLET PREDNISONE 20 MG TABLET PREDNISONE 5 MG TABLET PREDNISONE 5 MG/5 ML SOLUTION PREDNISONE 5 MG/5 ML SOLUTION PREDNISONE 50 MG TABLET

27171 27172 27173 27174 27176 27161 27160 27177

Step 5 (claim for a moderate/strong CYP3A4 inducer) Required claims: 1

Look back timeframe: 90 days

Label Name

GCN

ACTOPLUS MET 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 ALOGLIPTIN-PIOGLIT 12.5-15 MG ALOGLIPTIN-PIOGLIT 12.5-30 MG

25445 25444 28620 28622 92991 93001 93011 34080 34083

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Texas Prior Authorization Program Clinical Criteria

Emflaza (deflazacort)

Step 5 (claim for a moderate/strong CYP3A4 inducer) Required claims: 1

Look back timeframe: 90 days

Label Name

GCN

ALOGLIPTIN-PIOGLIT 12.5-45 MG ALOGLIPTIN-PIOGLIT 25-15 MG TB ALOGLIPTIN-PIOGLIT 25-30 MG TB ALOGLIPTIN-PIOGLIT 25-45 MG TB APTIOM 200MG TABLET APTIOM 400MG TABLET APTIOM 600MG TABLET APTIOM 800MG TABLET ATRIPLA 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 CARBAMAZEPINE ER 100 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 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 LYSODREN 500MG TABLET MODAFINIL 100MG TABLET MODAFINIL 200MG TABLET

34084 34077 34078 34079 36098 36099 36106 27409 27346 92373 17460 47500 17450 23934 23932 27821 23933 27822 27820 23934 23932 23933 17700 17241 17701 17250 97181 97180 17450 13781 13805 13818 99318 29424 32035 37810 26101 26102

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