Texas Prior Authorization Program Clinical Criteria

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Texas Prior Authorization Program Clinical Criteria Drug/Drug Class Aldurazyme Adagen Carbaglu Ceprotin Elaprase Fabrazyme Lumizyme Naglazyme Orfandin Ravicti Vimizim Note: Click the hyperlink to

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

1 Texas Prior Authorization Program Clinical Criteria Drug/Drug Class Aldurazyme Adagen Carbaglu Ceprotin Elaprase Fabrazyme Lumizyme Naglazyme Orfandin Ravicti Vimizim Note: Click the hyperlink to navigate directly to that section. 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 December 27, 2017 Copyright 2017 Health Information Designs, LLC 1

4 Aldurazyme Clinical Criteria Logic 1. Does the client have a diagnosis of mucopolysaccharidosis I (also called MPS I and/or Hurler-Scheie syndrome) in the past 730 days? [ ] Yes (Approve 365 days) [ ] No (Deny) December 27, 2017 Copyright 2017 Health Information Designs, LLC 4

5 Aldurazyme Clinical Criteria Logic Diagram Step 1 Does the client have a diagnosis of MPS I (Hurler-Scheie syndrome) in the past 730 days? Yes Approve Request (365 days) No Deny Request December 27, 2017 Copyright 2017 Health Information Designs, LLC 5

7 Adagen Clinical Criteria Logic 1. Does the client have a diagnosis of severe combined immunodeficiency disease in the past 730 days? [ ] Yes (Go to #2) [ ] No (Deny) 2. Is the client less than or equal to ( ) 18 years of age? [ ] Yes (Go to #3) [ ] No (Deny) 3. Does the client have a diagnosis of thrombocytopenia in the past 365 days? [ ] Yes (Deny) [ ] No (Approve 365 days) December 27, 2017 Copyright 2017 Health Information Designs, LLC 7

8 Adagen Clinical Criteria Logic Diagram Step 1 Step 2 Step 3 Does the client have a diagnosis of severe combined immunodeficiency disease in the past 730 days? Yes Is the client less than or equal to ( ) 18 years old? Yes Does the client have No a diagnosis of thrombocytopenia in the past 365 days? No Approve Request (365 days) No No Yes Deny Request Deny Request Deny Request December 27, 2017 Copyright 2017 Health Information Designs, LLC 8

10 Carbaglu Clinical Criteria Logic 1. Does the client have a diagnosis of hyperammonemia due to the deficiency of N-acetylglutamate synthase (NAGS) in the past 730 days? [ ] Yes (Approve 365 days) [ ] No (Deny) December 27, 2017 Copyright 2017 Health Information Designs, LLC 10

11 Carbaglu Clinical Criteria Logic Diagram Step 1 Does the client have a diagnosis of hyperammonemia due to the defieciency of NAGS in the last 730 days? No Deny Request Yes Approve Request (365 days) December 27, 2017 Copyright 2017 Health Information Designs, LLC 11

13 Ceprotin Clinical Criteria Logic 1. Does the client have a diagnosis of severe congenital protein C deficiency in the past 730 days? [ ] Yes (Approve 365 days) [ ] No (Deny) December 27, 2017 Copyright 2017 Health Information Designs, LLC 13

14 Ceprotin Clinical Criteria Logic Diagram Step 1 Does the client have a diagnosis of severe congenital protein C deficiency in the past 730 days? Yes Approve Request (365 days) No Deny Request December 27, 2017 Copyright 2017 Health Information Designs, LLC 14

16 Elaprase Clinical Criteria Logic 1. Does the client have a diagnosis of mucopolysaccharidosis II (Hunter syndrome) in the past 730 days? [ ] Yes (Approve 365 days) [ ] No (Deny) December 27, 2017 Copyright 2017 Health Information Designs, LLC 16

17 Elaprase Clinical Criteria Logic Diagram Step 1 Does the client have a diagnosis of MPS II (Hunter syndrome) in the past 730 days? Yes Approve Request (365 days) No Deny Request December 27, 2017 Copyright 2017 Health Information Designs, LLC 17

19 Fabrazyme Clinical Criteria Logic 1. Is the client less than (<) 8 years of age? [ ] Yes (Deny) [ ] No (Go to #2) 2. Does the client have a diagnosis of Fabry disease in the past 730 days? [ ] Yes (Approve 365 days) [ ] No (Deny) December 27, 2017 Copyright 2017 Health Information Designs, LLC 19

20 Fabrazyme Clinical Criteria Logic Diagram Step 1 Is the client < 8 years of age? Yes Deny Request No Step 2 Does the client have a diagnosis of Fabry disease in the last 730 days? No Deny Request Yes Approve Request (365 days) December 27, 2017 Copyright 2017 Health Information Designs, LLC 20

22 Lumizyme Clinical Criteria Logic 1. Does the client have a diagnosis of Pompe disease in the past 730 days? [ ] Yes (Approve 365 days) [ ] No (Deny) December 27, 2017 Copyright 2017 Health Information Designs, LLC 22

23 Lumizyme Clinical Criteria Logic Diagram Step 1 Does the client have a diagnosis of Pompe disease in the past 730 days? Yes Approve Request (365 days) No Deny Request December 27, 2017 Copyright 2017 Health Information Designs, LLC 23

25 Naglazyme Clinical Criteria Logic 1. Is the client less than (<) 5 years of age? [ ] Yes (Deny) [ ] No (Go to #2) 2. Does the client have a diagnosis of mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome) in the past 730 days? [ ] Yes (Approve 365 days) [ ] No (Deny) December 27, 2017 Copyright 2017 Health Information Designs, LLC 25

26 Naglazyme Clinical Criteria Logic Diagram Step 1 Is the client < 5 years of age? Yes Deny Request No Step 2 Does the client have a diagnosis of Maroteaux-Lamy syndrome in the last 730 days? No Deny Request Yes Approve Request (365 days) December 27, 2017 Copyright 2017 Health Information Designs, LLC 26

27 Orfadin Label Name GCN ORFADIN 2 MG CAPSULE ORFADIN 5 MG CAPSULE ORFADIN 10 MG CAPSULE ORFADIN 20 MG CAPSULE ORFADIN 4 MG/ML SUSPENSION December 27, 2017 Copyright 2017 Health Information Designs, LLC 27

28 Orfadin Clinical Criteria Logic 1. Does the client have a diagnosis of hereditary tyrosinemia type 1 (HT-1) in the past 730 days? [ ] Yes (Approve 365 days) [ ] No (Deny) December 27, 2017 Copyright 2017 Health Information Designs, LLC 28

29 Orfadin Clinical Criteria Logic Diagram Step 1 Does the client have a diagnosis of hereditary tyrosinemia type 1 (HT-1) in the last 730 days? No Deny Request Yes Approve Request (365 days) December 27, 2017 Copyright 2017 Health Information Designs, LLC 29

31 Ravicti Clinical Criteria Logic 1. Does the client have a diagnosis of a urea cycle disorder (UCD) in the past 730 days? [ ] Yes (Approve 365 days) [ ] No (Deny) December 27, 2017 Copyright 2017 Health Information Designs, LLC 31

32 Ravicti Clinical Criteria Logic Diagram Step 1 Does the client have a diagnosis of a urea cycle disorder in the last 730 days? No Deny Request Yes Approve Request (365 days) December 27, 2017 Copyright 2017 Health Information Designs, LLC 32

34 Vimizim Clinical Criteria Logic 1. Is the client greater than or equal to ( ) 5 years of age? [ ] Yes (Go to #2) [ ] No (Deny) 2. Does the client have a diagnosis of mucopolysaccharidosis IVA (also called Morquio A syndrome) in the past 730 days? [ ] Yes (Approve 365 days) [ ] No (Deny) December 27, 2017 Copyright 2017 Health Information Designs, LLC 34

35 Vimizim Clinical Criteria Logic Diagram Step 1 Is the client 5 years of age? No Deny Request Yes Step 2 Does the client have a diagnosis of Morquio A syndrome in the last 730 days? No Deny Request Yes Approve Request (365 days) December 27, 2017 Copyright 2017 Health Information Designs, LLC 35

36 Clinical Criteria Supporting Tables Diagnosis of mucopolysaccharidosis I Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description 2775 MUCOPOLYSACCHARIDOSIS ICD-10 Code Description E7601 HURLER S SYNDROME E7602 HURLER-SCHEIE SYNDROME E7603 SCHEIE S SYNDROME ICD-9 Code Diagnosis of severe combined immunodeficiency disease Description Required diagnosis: 1 Look back timeframe: 730 days 2792 COMBINED IMMUNITY DEFICIENCY ICD-10 Code D810 D811 D812 D8189 D819 Description SEVERE COMBINED IMMUNODEFICIENCY (SCID) WITH RETICULAR DYSGENESIS SEVERE COMBINED IMMUNODEFICIENCY (SCID) WITH LOW T- AND B- CELL NUMBERS SEVERE COMBINED IMMUNODEFICIENCY (SCID) WITH LOW OR NORMAL B-CELL NUMBERS OTHER COMBINED IMMUNODEFICIENCIES COMBINED IMMUNODEFICIENCY, UNSPECIFIED Diagnosis of hyperammonemia due to NAGS deficiency Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description 2706 DISORDERS OF UREA CYCLE METABOLISM ICD-10 Code Description E7229 OTHER DISORDERS OF UREA CYCLE METABOLISM December 27, 2017 Copyright 2017 Health Information Designs, LLC 36

37 Diagnosis of severe congenital protein C deficiency Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description PRIMARY HYPERCOAGULABLE STATE ICD-10 Code Description D6859 OTHER PRIMARY THROMBOPHILIA Diagnosis of mucopolysaccharidosis II (Hunter Syndrome) Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description 2775 MUCOPOLYSACCHARIDOSIS ICD-10 Code Description E761 MUCOPOLYSACCHARIDOSIS, TYPE II (HUNTER SYNDROME) Diagnosis of Fabry disease Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description 2727 LIPIDOSES 3302 CEREBRAL DEGENERATION IN GENERALIZED LIPIDOSES ICD-10 Code Description E7521 FABRY (-ANDERSON) DISEASE Diagnosis of Pompe disease Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description 2710 GLYCOGENOSIS ICD-10 Code Description E7402 POMPE DISEASE December 27, 2017 Copyright 2017 Health Information Designs, LLC 37

38 Diagnosis of Maroteaux-Lamy Syndrome Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description 2775 MUCOPOLYSACCHARIDOSIS ICD-10 Code Description E7629 OTHER MUCOPOLYSACCHARIDOSES Diagnosis of hereditary tyrosinemia type 1 (HT-1) Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description 2702 OTHER DISTURBANCES OF AROMATIC AMINO-ACID METABOLISM ICD-10 Code Description E7021 TYROSINEMIA Diagnosis of thrombocytopenia Required diagnosis: 1 Look back timeframe: 365 days ICD-9 Code Description 2871 QUALITATIVE PLATELET DEFECTS PRIMARY THROMBOCYTOPENIA, UNSPECIFIED IMMUNE THROMBOCYTOPENIC PURPURA EVANS SYNDROME CONGENITAL AND HEREDITARY THROMBOCYTOPENIC PURPURA OTHER PRIMARY THROMBOCYTOPENIA POSTTRANSFUSION PURPURA OTHER SECONDARY THROMBOCYTOPENIA 2875 THROMBOCYTOPENIA, UNSPECIFIED 2878 OTHER SPECIFIED HEMORRHAGIC CONDITIONS ICD-10 Code Description D693 IMMUNE THROMBOCYTOPENIC PURPURA D694 OTHER PRIMARY THROMBOCYTOPENIA D6941 EVANS SYNDROME D6942 CONGENITAL AND HEREDITARY THROMBOCYTOPENIA PURPURA D6949 OTHER PRIMARY THROMBOCYTOPENIA D695 SECONDARY THROMBOCYTOPENIA D6951 POSTTRANSFUSION PURPURA December 27, 2017 Copyright 2017 Health Information Designs, LLC 38

39 D6959 D696 D698 Diagnosis of thrombocytopenia Required diagnosis: 1 Look back timeframe: 365 days OTHER SECONDARY THROMBOCYTOPENIA THROMBOCYTOPENIA, UNSPECIFIED OTHER SPECIFIED HEMORRHAGIC CONDITIONS Diagnosis of a urea cycle disorder (UCD) Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description 2706 DISORDERS OF UREA CYCLE METABOLISM ICD-10 Code Description E7220 DISORDER OF UREA CYCLE METABOLISM, UNSPECIFIED E7221 ARGININEMIA E7222 ARGINOSUCCINIC ACIDURIA E7223 CITRULLINEMIA E7229 OTHER DISORDERS OF UREA CYCLE METABOLISM Diagnosis of mucopolysaccharidosis IVA (Morquio A syndrome) Required diagnosis: 1 Look back timeframe: 730 days ICD-9 Code Description 2775 MUCOPOLYSACCHARIDOSIS ICD-10 Code Description E76210 MORQUIO A MUCOPOLYSACCHARIDOSES December 27, 2017 Copyright 2017 Health Information Designs, LLC 39

40 Clinical Criteria References 1. Aldurazyme prescribing information. Cambridge, MA: Genzyme Corporation. April Adagen prescribing information. Gaithersburg, MD: Sigma-Tau Pharmaceuticals, Inc. June Carbaglu prescribing information. Lebanon, NJ. Recordati Rare Diseases Inc. November Ceprotin prescribing information. Westlake Village, CA: Baxter Healthcare Corporation. September Elaprase prescribing information. Lexington, MA: Shire Human Genetic Therapies, Inc. June Fabrazyme prescribing information. Cambridge, MA: Genzyme Corporation. May Lumizyme prescribing information. Cambridge, MA: Genzyme Corporation. August Naglazyme prescribing information. Novato, CA: Biomarin Pharmaceutical Inc. March Orfadin prescribing information. Waltham, MA. Swedish Orphan Biovitrum. September Ravicti prescribing information. Lake Forest, IL. Horizon Therapeutics. April Vimizim prescribing information. Novato, CA. BioMarin Pharmaceutical Inc. February ICD-9-CM Diagnosis Codes, Volume Available at Accessed on March 26, ICD-10-CM Diagnosis Codes, Volume Available at Accessed on March 26, Clinical Pharmacology [online database]. Tampa, FL: Elsevier/Gold Standard, Inc.; Available at Accessed on June 9, Micromedex [online database]. Available at Accessed on June 9, December 27, 2017 Copyright 2017 Health Information Designs, LLC 40

41 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 05/16/2014 Initial publication and posting to website 08/11/2017 Annual review by staff Added criteria logic and diagram for Carbaglu, pages 10 and 11 Added criteria logic and diagram for Ravicti, pages 28 and 29 Added criteria logic and diagram for Vimizim, pages 31 and 32 Added diagnoses codes for hyperammonemia due to NAGS deficiency, page 33 Added diagnoses codes for urea cycle disorders and Morquio A syndrome, page 36 Updated references, page 37 11/22/2017 Added criteria logic and diagram for Orfadin, pages Updated references, page 40 12/06/2017 Updated criteria logic and logic diagram for Fabrazyme, pages Added age check to criteria logic and logic diagram for Vimizim, pages /27/2017 Updated criteria logic for Elaprase, page 16 December 27, 2017 Copyright 2017 Health Information Designs, LLC 41

Texas Prior Authorization Program Clinical Criteria

Texas Prior Authorization Program Clinical Criteria Drug/Drug Class Clinical Criteria Information Included in this Document Drugs requiring prior authorization: the list of drugs requiring prior authorization