Texas Prior Authorization Program Clinical Criteria. Allergen Extracts

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1 Texas Prior Authorization Program Clinical Criteria Drug/Drug Class Clinical Information Included in this Document Oralair (Mixed Grass Pollens Allergen Extract)) 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. Ragwitek (Short Ragweed Pollen Allergen Extract) 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. vember 9, 2018 Copyright 2018 Health Information Designs, LLC 1

2 Revision tes Removed criteria for Grastek drug is currently not on formulary Removed GCN for Odactra, page 12 vember 9, 2018 Copyright 2018 Health Information Designs, LLC 2

3 Oralair (Grass Pollen Allergen Extract) Drugs Requiring Prior Authorization Oralair Label Name GCN ORALAIR 300 IR SUBLINGUAL TABLET vember 9, 2018 Copyright 2018 Health Information Designs, LLC 3

4 Oralair (Grass Pollen Allergen Extract) Clinical Criteria Logic 1. Is the client greater than or equal to ( ) 10 years of age? [] Go to #2 [] Deny 2. Is the client less than or equal to ( ) 65 years of age? [] Go to #3 [] Deny 3. Does the client have a diagnosis of allergic rhinitis in the last 730 days? [] Go to #4 [] Deny 4. Has the client had hypersensitivity testing in the last 5 years? [] Go to #5 [] - Deny 5. Does the client have 1 claim for auto-injectable epinephrine in the last 365 days or is the patient receiving auto-injectable epinephrine concurrently? [] Go to #6 [] - Deny 6. Does the client have a history of severe, unstable or uncontrolled asthma OR a history of eosinophilic esophagitis in the last 365 days? [] Deny [] Go to #7 7. Does the client have 1 claim for a medication not recommended to be taken in conjunction with Oralair in the last 60 days? [] Deny [] Approve (365 days) vember 9, 2018 Copyright 2018 Health Information Designs, LLC 4

5 Oralair (Grass Pollen Allergen Extract) Clinical Criteria Logic Diagram Step 1 Is the client 10 years of age? Step 2 Is the client 65 years of age? Step 3 Does the client have a diagnosis of allergic rhinitis in the last 730 days? Step 4 Has the client had hypersensitivity testing in the last 5 years? Deny Request Deny Request Deny Request Deny Request Step 5 Does the client have 1 claim for autoinjectable epinephrine in the last 365 days (either previous or concurrent claim)? Deny Request Step 6 Does the client have severe, unstable or uncontrolled asthma or eosinophilic esophagitis in the last 365 days? Deny Request Step 7 Does the client have 1 claim for a contraindicated medication in the last 60 days? Deny Request Approve Request (365 days) vember 9, 2018 Copyright 2018 Health Information Designs, LLC 5

6 Oralair (Grass Pollen Allergen Extract) Clinical Criteria Supporting Tables Step 3 (diagnosis of allergic rhinitis) Look back timeframe: 730 days ICD-10 Code J300 J301 J302 J3089 J309 Description VASOMOTOR RHINITIS ALLERGIC RHINITIS DUE TO POLLEN OTHER SEASONAL ALLERGIC RHINITIS OTHER ALLERGIC RHINITIS ALLERGIC RHINITIS, UNSPECIFIED CPT Code Description Step 4 (hypersensitivity testing) Look back timeframe: 5 years ALLERGEN SPECIFIC IGE; QUANTITATIVE OR SEMIQUANTITATIVE, EACH ALLERGEN ALLERGEN SPECIFIC IGE; QUALITATIVE, MULTIALLERGEN SCREEN TOTAL QUANTITATIVE IGE TOTAL QUALITATIVE IGE PERCUTANEOUS TESTS WITH ALLERGENIC EXTRACTS, IMMEDIATE TYPE REACTION, INCLUDING TEST INTERPRETATION AND REPORT INTRACUTANEOUS (INTRADERMAL) TESTS WITH ALLERGENIC EXTRACTS, IMMEDIATE TYPE REACTION, INCLUDING TEST INTERPRETATION AND REPORT INTRACUTANEOUS (INTRADERMAL) TESTS, SEQUENTIAL AND INCREMENTAL, WITH ALLERGENIC EXTRACTS FOR AIRBORNE ALLERGENS, IMMEDIATE TYPE REACTION, INCLUDING TEST INTERPRETATION AND REPORT INTRACUTANEOUS (INTRADERMAL) TESTS WITH ALLERGENIC EXTRACTS, DELAYED TYPE REACTION, INCLUDING READING vember 9, 2018 Copyright 2018 Health Information Designs, LLC 6

7 Step 5 (history of auto-injectable epinephrine) Look back timeframe: 365 days GCN Description ADRENACLICK 0.15MG AUTO-INJECTOR ADRENACLICK 0.3MG AUTO-INJECTOR AUVI-Q 0.15MG AUTO-INJECTOR AUVI-Q 0.3MG AUTO-INJECTOR EPINEPHRINE 0.15MG AUTO-INJECTOR EPINEPHRINE 0.3MG AUTO-INJECTOR EPIPEN 0.3MG AUTO-INJECTOR EPIPEN JR 0.15MG AUTO-INJECTOR Step 6 (diagnosis of asthma or eosinophilic esophagitis) Look back timeframe: 365 days ICD-10 Code J4520 J4521 J4522 J4530 J4531 J4532 J4540 J4541 J4542 J4550 J4551 J4552 J45901 J45902 J45909 J45990 J45991 J45998 K200 Description MILD INTERMITTENT ASTHMA, UNCOMPLICATED MILD INTERMITTENT ASTHMA WITH (ACUTE) EXACERBATION MILD INTERMITTENT ASTHMA WITH STATUS ASTHMATICUS MILD PERSISTENT ASTHMA, UNCOMPLICATED MILD PERSISTENT ASTHMA WITH (ACUTE) EXACERBATION MILD PERSISTENT ASTHMA WITH STATUS ASTHMATICUS MODERATE PERSISTENT ASTHMA, UNCOMPLICATED MODERATE PERSISTENT ASTHMA, WITH (ACUTE) EXACERBATION MODERATE PERSISTENT ASTHMA, WITH STATUS ASTHMATICUS SEVERE PERSISTENT ASTHMA, UNCOMPLICATED SEVERE PERSISTENT ASTHMA, WITH (ACUTE) EXACERBATION SEVERE PERSISTENT ASTHMA, WITH STATUS ASTHMATICUS UNSPECIFIED ASTHMA, WITH (ACUTE) EXACERBATION UNSPECIFIED ASTHMA, WITH STATUS ASTHMATICUS UNSPECIFIED ASTHMA, UNCOMPLICATED EXERCISE INDUCED BRONCHOSPASM COUGH VARIANT ASTHMA OTHER ASTHMA EOSINOPHILIC ESOPHAGITIS vember 9, 2018 Copyright 2018 Health Information Designs, LLC 7

8 Step 7 (claim for a non-recommended medication) Look back timeframe: 60 days GCN Description ACEBUTOLOL 200MG CAPSULE ACEBUTOLOL 400MG CAPSULE ATENOLOL 100MG TABLET ATENOLOL 25MG TABLET ATENOLOL 50MG TABLET ATENOLOL-CHLORTHAL MG TAB ATENOLOL-CHLORTHAL 50-25MG TAB BETAPACE 120MG TABLET BETAPACE 160MG TABLET BETAPACE 80MG TABLET BETAXOLOL 10MG TABLET BETAXOLOL 20MG TABLET BISOPROLOL FUMARATE 10MG TABLET BISOPROLOL FUMARATE 5MG TABLET BISOPROLOL-HCTZ MG TABLET BISOPROLOL-HCTZ MG TABLET BISOPROLOL-HCTZ MG TABLET BYSTOLIC 10MG TABLET BYSTOLIC 2.5MG TABLET BYSTOLIC 20MG TABLET BYSTOLIC 5MG TABLET CARDURA 1MG TABLET CARDURA 2MG TABLET CARDURA 4MG TABLET CARDURA 8MG TABLET CARVEDILOL 12.5MG TABLET CARVEDILOL 25MG TABLET CARVEDILOL 3.125MG TABLET CARVEDILOL 6.25MG TABLET COREG 12.5MG TABLET COREG 25MG TABLET COREG 3.125MG TABLET COREG 6.25MG TABLET COREG CR 10MG CAPSULE COREG CR 20MG CAPSULE COREG CR 40MG CAPSULE COREG CR 80MG CAPSULE vember 9, 2018 Copyright 2018 Health Information Designs, LLC 8

9 Step 7 (claim for a non-recommended medication) Look back timeframe: 60 days GCN Description CORZIDE 40-5 TABLET CORZIDE 80-5 TABLET D.H.E. 45 1MG/ML AMPULE DIHYDROERGOTAMINE 1MG/ML AMPULE DOXAZOSIN MESYLATE 1MG TABLET DOXAZOSIN MESYLATE 2MG TABLET DOXAZOSIN MESYLATE 4MG TABLET DOXAZOSIN MESYLATE 8MG TABLET DUTOPROL MG TABLET DUTOPROL MG TABLET DUTOPROL MG TABLET ERGOLOID MESYLATES 1MG TABLET HEMANGEOL 4.28MG/ML ORAL SOLN INDERAL LA 120MG CAPSULE INDERAL LA 60MG CAPSULE INDERAL LA 80MG CAPSULE INNOPRAN XL 120MG CAPSULE INNOPRAN XL 80MG CAPSULE LABETALOL HCL 100MG TABLET LABETALOL HCL 200MG TABLET LABETALOL HCL 300MG TABLET LEVATOL 20MG TABLET LOPRESSOR 100MG TABLET LOPRESSOR 50MG TABLET METHERGINE 0.2MG/ML AMPULE METHYLERGONOVINE 0.2MG TABLET METHYLERGONOVINE 0.2MG/ML AMPULE METOPROLOL SUCC ER 100MG TABLET METOPROLOL SUCC ER 200MG TABLET METOPROLOL SUCC ER 25MG TABLET METOPROLOL SUCC ER 50MG TABLET METOPROLOL TARTRATE 100MG TABLET METOPROLOL TARTRATE 25MG TABLET METOPROLOL TARTRATE 50MG TABLET METOPROLOL-HCTZ MG TAB METOPROLOL-HCTZ MG TAB METOPROLOL-HCTZ 50-25MG TAB vember 9, 2018 Copyright 2018 Health Information Designs, LLC 9

10 Step 7 (claim for a non-recommended medication) Look back timeframe: 60 days GCN Description MIGERGOT SUPPOSITORY MINIPRESS 1MG CAPSULE MINIPRESS 2MG CAPSULE MINIPRESS 5MG CAPSULE NADOLOL 20MG TABLET NADOLOL 40MG TABLET NADOLOL 80MG TABLET NADOLOL-BENDROFLU 40-5MG TABLET NADOLOL-BENDROFLU 80-5MG TABLET PINDOLOL 10MG TABLET PINDOLOL 5MG TABLET PRAZOSIN 1MG CAPSULE PRAZOSIN 2MG CAPSULE PRAZOSIN 5MG CAPSULE PROPRANOLOL 10MG TABLET PROPRANOLOL 20MG TABLET PROPRANOLOL 20MG/5ML SOLUTION PROPRANOLOL 40MG/5ML SOLUTION PROPRANOLOL 40MG TABLET PROPRANOLOL 60MG TABLET PROPRANOLOL 80MG TABLET PROPRANOLOL ER 120MG CAPSULE PROPRANOLOL ER 60MG CAPSULE PROPRANOLOL ER 80MG CAPSULE PROPRANOLOL-HCTZ 40-25MG TABLET PROPRANOLOL-HCTZ 80-25MG TABLET SOTALOL 120MG TABLET SOTALOL 160MG TABLET SOTALOL 240MG TABLET SOTALOL 80MG TABLET ZOTYLIZE 5MG/ML ORAL SOLUTION TENORETIC 100 TABLET TENORETIC 50 TABLET TENORMIN 100MG TABLET TENORMIN 25MG TABLET TENORMIN 50MG TABLET TERAZOSIN 10MG CAPSULE vember 9, 2018 Copyright 2018 Health Information Designs, LLC 10

11 Step 7 (claim for a non-recommended medication) Look back timeframe: 60 days GCN Description TERAZOSIN 1MG CAPSULE TERAZOSIN 2MG CAPSULE TERAZOSIN 5MG CAPSULE TIMOLOL MALEATE 10MG TABLET TIMOLOL MALEATE 20MG TABLET TIMOLOL MALEATE 5MG TABLET TOPROL XL 100MG TABLET TOPROL XL 200MG TABLET TOPROL XL 25MG TABLET TOPROL XL 50MG TABLET TRANDATE 100MG TABLET TRANDATE 200MG TABLET TRANDATE 300MG TABLET ZIAC MG TABLET ZIAC MG TABLET ZIAC MG TABLET vember 9, 2018 Copyright 2018 Health Information Designs, LLC 11

12 Ragwitek (Short Ragweed Pollen Allergen Extract) Drugs Requiring Prior Authorization Label Name GCN RAGWITEK SUBLINGUAL TABLET vember 9, 2018 Copyright 2018 Health Information Designs, LLC 12

13 Ragwitek (Short Ragweed Pollen Allergen Extract) Clinical Criteria Logic 1. Is the client greater than or equal to ( ) 18 years of age? [] Go to #2 [] Deny 2. Is the client less than or equal to ( ) 65 years of age? [] Go to #3 [] Deny 3. Does the client have a diagnosis of allergic rhinitis in the last 730 days? [] Go to #4 [] Deny 4. Has the client had hypersensitivity testing in the last 5 years? [] Go to #5 [] Deny 5. Does the client have 1 claim for auto-injectable epinephrine in the last 365 days or is the patient receiving auto-injectable epinephrine concurrently? [] Go to #6 [] - Deny 6. Does the client have a history of severe, unstable or uncontrolled asthma OR a history of eosinophilic esophagitis in the last 365 days? [] Deny [] Go to #7 7. Does the client have 1 claim for a medication not recommended to be taken in conjunction with Ragwitek or Odactra in the last 60 days? [] Deny [] Approve (365 days) vember 9, 2018 Copyright 2018 Health Information Designs, LLC 13

14 Ragwitek (Short Ragweed Pollen Allergen Extract) Clinical Criteria Logic Diagram Step 1 Is the client 18 years of age? Step 2 Is the client 65 years of age? Step 3 Does the client have a diagnosis of allergic rhinitis in the last 730 days? Step 4 Has the client had hypersensitivity testing in the last 5 years? Deny Request Deny Request Deny Request Deny Request Step 5 Does the client have 1 claim for autoinjectable epinephrine in the last 365 days (either previous or concurrent claim)? Deny Request Step 6 Does the client have severe, unstable or uncontrolled asthma or eosinophilic esophagitis in the last 365 days? Deny Request Step 7 Does the client have 1 claim for a contraindicated medication in the last 60 days? Deny Request Approve Request (365 days) vember 9, 2018 Copyright 2018 Health Information Designs, LLC 14

15 Ragwitek (Short Ragweed Pollen Allergen Extract) Clinical Criteria Supporting Tables Step 3 (diagnosis of allergic rhinitis) Look back timeframe: 730 days For the list of allergic rhinitis diagnosis codes that pertain to this step, see the Allergic Rhinitis Diagnoses table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 4 (hypersensitivity testing) Look back timeframe: 5 years For the list of hypersensitivity testing CPT codes that pertain to this step, see the Hypersensitivity Testing CPT codes table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 5 (history of auto-injectable epinephrine) Look back timeframe: 180 days For the list of auto-injectable epinephrine GCNs that pertain to this step, see the Auto-Injectable Epinephrine GCNs table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. Step 6 (diagnosis of asthma or eosinophilic esophagitis) Look back timeframe: 365 days For the list of asthma/eosinophilic esophagitis diagnosis codes that pertain to this step, see the Asthma / Eosinophilic Esophagitis Diagnoses table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. vember 9, 2018 Copyright 2018 Health Information Designs, LLC 15

16 Step 7 (claim for a non-recommended medication) Look back timeframe: 60 days For the list of non-recommended medication GCNs that pertain to this step, see the n-recommended Medication GCNs table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. vember 9, 2018 Copyright 2018 Health Information Designs, LLC 16

17 Clinical Criteria References ICD-9-CM Diagnosis Codes, Volume Available at Accessed on July 31, ICD-10-CM Diagnosis Codes, Volume Available at Accessed on July 31, Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma & Immunology. Allergen immunotherapy: A practice parameter third update. JACI 2011;127(1):S1-S55. Available at Accessed January 2, Wallace DV, Dykewicz MS, et al. The diagnosis and management of rhinitis: and updated practice parameter. JACI 2008;122:S1-84. Available at Accessed January 2, Clinical Pharmacology [online database]. Tampa, FL: Elsevier/Gold Standard, Inc.; Available at Accessed on February 23, Micromedex [online database]. Available at Accessed on February 23, Grastek Prescribing Information. ALK-Abello A/S. Horsholm, Denmark. April Oralair Prescribing Information. Greer Laboratories. Lenoir, NC. 9. Ragwitek Prescribing Information. ALK-Abello A/S. Horsholm, Denmark. April Seidman MD, Gurgel RK, Lin SY, et al. Clinical Practice Guideline: Allergic Rhinitis. Otolaryngology Head and Neck Surgery February 2015;152:S1-S Greenhawt M, Oppenheimer J, Nelson M, et al. Sublingual immunotherapy: A focused allergen immunotherapy practice parameter update. Ann Allergy Asthma Immunol 118(2017); vember 9, 2018 Copyright 2018 Health Information Designs, LLC 17

18 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 01/29/2015 Presented to the DUR Board 02/27/2015 Initial publication and posting to website 07/31/2015 Review of ICD-9 and ICD-10 codes 08/01/2018 Annual review by staff Removed ICD-9 codes Updated Table 7, pages 8-11 Added GCN for Odactra, page 17 Updated references, page 22 11/09/2018 Removed criteria for Grastek drug is not currently on formulary Removed GCN for Odactra, page 12 vember 9, 2018 Copyright 2018 Health Information Designs, LLC 18