Agents for Cystic Fibrosis
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1 Texas Prior Authorization Program Clinical Edit Criteria Clinical Edit Information Included in this Document Kalydeco (Ivacaftor) Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical edit Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical edit criteria rules Logic diagram: a visual depiction of the clinical edit 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 edit te: Click the hyperlink to navigate directly to that section. Orkambi (Lumacaftor/Ivacaftor) Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical edit Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical edit criteria rules Logic diagram: a visual depiction of the clinical edit 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 edit te: Click the hyperlink to navigate directly to that section. Revision tes Updated to include Orkambi October 29, 2015 Copyright Health Information Designs, LLC 1
2 Kalydeco (Ivacaftor) Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name KALYDECO 150MG TABLET KALYDECO 50MG GRANULES PACKET KALYDECO 75MG GRANULES PACKET October 29, 2015 Copyright Health Information Designs, LLC 2
3 Kalydeco (Ivacaftor) Clinical Edit Criteria Logic 1. Is the client greater than or equal to ( ) 2 years of age? [ ] (Go to #2) [ ] (Deny) 2. Does the client have a claim for a CYP3A4 inducer in the last 45 days? [ ] (Deny) [ ] (Go to #3) 3. Does the client have a claim for a strong CYP3A4 inhibitor in the last 45 days? [ ] (Go to #5) [ ] (Go to #4) 4. Does the client have a claim for a moderate CYP3A4 inhibitor in the last 45 days? [ ] (Go to #6) [ ] (Go to #7) 5. Is the requested quantity greater than (>) nine tablets or packets per claim (2 units per week)? [ ] (Deny) [ ] (Go to #8) 6. Is the requested quantity greater than (>) one tablet or packet per day? [ ] (Deny) [ ] (Go to #8) 7. Is the requested quantity greater than (>) two tablets or packets per day? [ ] (Deny) [ ] (Go to #8) 8. Manual step Does the client have a diagnosis of cystic fibrosis with a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation in the CFTR gene? [ ] (Approve 365 days) [ ] (Deny) October 29, 2015 Copyright Health Information Designs, LLC 3
4 Kalydeco (Ivacaftor) Clinical Edit Criteria Logic Diagram Step 1 Is the client 2 years of age? Deny Request Step 2 Step 6 Does the client have a claim for a CYP3A4 inducer in the last 45 days? Deny Request Is the requested quantity > 1 tablet or packet per day? Go to Step 8 Step 3 Step 4 Step 7 Does the client have a claim for a strong CYP3A4 inhibitor in the last 45 days? Does the client have a claim for a moderate CYP3A4 inhibitor in the last 45 days? Is the requested quantity > 2 tablets or packets per day? Go to Step 8 Step 5 Is the requested quantity > 9 tablets or packets per claim (2 units/week)? Deny Request Deny Request Step 8 Does the client have a diagnosis of cystic fibrosis with a listed mutation in the CFTR gene? [manual step] Approve Request (365 days) Deny Request October 29, 2015 Copyright Health Information Designs, LLC 4
5 Kalydeco (Ivacaftor) Clinical Edit Criteria Supporting Tables Step 2 (history of a CYP3A4 inducer) Look back timeframe: 45 days Label Name BELLADONA-PHENOBARBITAL TAB CARBAMAZEPINE 100MG CHEW TAB CARBAMAZEPINE 100MG/5ML SUSPENSION CARBAMAZEPINE ER 100MG CAPSULE CARBAMAZEPINE ER 200MG CAPSULE CARBAMAZEPINE ER 300MG CAPSULE CARBAMAZEPINE XR 200MG TABLET CARBAMAZEPINE XR 400MG TABLET CARBAMEZEPINE 200MG TABLET DILANTIN 30MG CAPSULE DILANTIN 50MG INFATAB EQUETRO 100MG CAPSULE EQUETRO 200MG CAPSULE EQUETRO 300MG CAPSULE MYCOBUTIN 150MG CAPSULE PHENOBARBITAL 20MG/5ML SOLUTION PHENOBARBITAL 15MG TABLET PHENOBARBITAL 16.2 TABLET PHENOBARBITAL 30MG TABLET PHENOBARBITAL 32.4MG TABLET PHENOBARBITAL 60MG TABLET PHENOBARBITAL 64.8 TABLET PHENOBARBITAL 97.2 TABLET PHENOBARBITAL 100MG TABLET PHENYTOIN 125MG/5ML SUSPENSION PHENYTOIN SOD EXT 100MG CAPSULE PHENYTOIN SOD EXT 200MG CAPSULE PHENYTOIN SOD EXT 300MG CAPSULE RIFAMPIN 150MG CAPSULE RIFAMPIN 300MG CAPSULE October 29, 2015 Copyright Health Information Designs, LLC 5
6 Step 2 (history of a CYP3A4 inducer) Look back timeframe: 45 days Label Name TEGRETOL XR 100MG TABLET Step 3 (history of a strong CYP3A4 inhibitor) Look back timeframe: 45 days Label Name AGENERASE 15MG/ML ORAL SOLUTION CLARITHROMYCIN 125MG/ML SUSPENSION CLARITHROMYCIN 250MG/ML SUSPENSION CLARITHROMYCIN 250MG TABLET CLARITHROMYCIN 500MG TABLET CLARITHROMYCIN ER 500MG TABLET CRIXIVAN 100MG CAPSULE CRIXIVAN 200MG CAPSULE CRIXIVAN 333MG CAPSULE CRIXIVAN 400MG CAPSULE EVOTAZ MG TABLET INVIRASE 200MG CAPSULE INVIRASE 500MG TABLET ISONIAZID 50MG/5ML SYRUP ISONIAZID 100MG TABLET ISONIAZID 300MG TABLET ITRACONAZOLE 100MG CAPSULE KALETRA MG TABLET KALETRA MG SOFTGEL KALETRA MG TABLET KALETRA MG/5ML SOLUTION KETEK 300MG TABLET KETEK 400MG TABLET KETOCONAZOLE 200MG TABLET NEFAZODONE HCL 50MG TABLET NEFAZODONE HCL 100MG TABLET NEFAZODONE HCL 150MG TABLET NEFAZODONE HCL 200MG TABLET NEFAZODONE HCL 250MG TABLET October 29, 2015 Copyright Health Information Designs, LLC 6
7 Step 3 (history of a strong CYP3A4 inhibitor) Look back timeframe: 45 days Label Name NORVIR 80MG/ML SOLUTION NORVIR 100MG SOFTGEL CAP NORVIR 100MG TABLET NOXAFIL 40MG/ML SUSPENSION PREZCOBIX MG TABLET RESCRIPTOR 100MG TABLET RESCRIPTOR 200MG TABLET REYATAZ 100MG CAPSULE REYATAZ 150MG CAPSULE REYATAZ 200MG CAPSULE REYATAZ 300MG CAPSULE SPORANOX 10MG/ML SOLUTION SPORANOX 250MG KIT SYNERCID 500MG VIAL TYBOST 150MG TABLET VFEND 40MG/ML SUSPENSION VICTRELIS 200MG CAPSULE VIRACEPT 250MG TABLET VIRACEPT 625MG TABLET VORICONAZOLE 50MG TABLET VORICONAZOLE 200MG TABLET Step 4 (history of a moderate CYP3A4 inhibitor) Look back timeframe: 45 days Description DILTIAZEM 120MG TABLET 2363 DILTIAZEM 24HR ER 120MG CAPSULE 2326 DILTIAZEM 24HR ER 180MG CAPSULE 2323 DILTIAZEM 24HR ER 240MG CAPSULE 2324 DILTIAZEM 24HR ER 300MG CAPSULE 2325 DILTIAZEM 24HR ER 360MG TABLET 7460 DILTIAZEM 24HR ER 420MG TABLET DILTIAZEM 30MG TABLET 2360 DILTIAZEM 60MG TABLET 2361 October 29, 2015 Copyright Health Information Designs, LLC 7
8 Step 4 (history of a moderate CYP3A4 inhibitor) Look back timeframe: 45 days Description DILTIAZEM 90MG TABLET 2362 DILTIAZEM ER 60MG 12-HR CAPSULE 2322 DILTIAZEM ER 90MG 12-HR CAPSULE 2320 DILTIAZEM ER 120MG CAPSULE 2330 DILTIAZEM ER 180MG CAPSULE 7461 DILTIAZEM ER 240MG CAPSULE 7462 DILTIAZEM ER 360MG CAPSULE 2328 DILTIAZEM ER 420MG CAPSULE ERY-TAB EC 250MG TABLET ERY-TAB EC 500MG TABLET ERYTHROMYCIN 200MG/5ML GRANULES ERYTHROMYCIN 250MG FILMTAB ERYTHROMYCIN 333MG TABLET EC ERYTHROMYCIN 400MG/5ML SUSPENSION ERYTHROMYCIN 500MG FILMTAB ERYTHROMYCIN EC 250MG CAPSULE ERYTHROMYCIN ES 400MG TABLET ERYTHROMYCIN ST 250MG TABLET ERYTHROMYCIN ST 500MG TABLET ERYTHROMYCIN/SULFISOXAZOLE SUSPENSION FLUCONAZOLE 10MG/ML SUSPENSION FLUCONAZOLE 40MG/ML SUSPENSION FLUCONAZOLE 50MG TABLET FLUCONAZOLE 100MG TABLET FLUCONAZOLE 150MG TABLET FLUCONAZOLE 200MG TABLET MULTAQ 400MG TABLET PCE 333MG TABLET PCE 500MG TABLET VERAPAMIL 40MG TABLET VERAPAMIL 80MG TABLET 2342 VERAPAMIL 120MG TABLET 2341 VERAPAMIL 360MG CAPSULE PELLET 3004 VERAPAMIL ER 120MG CAPSULE 3003 VERAPAMIL ER 120MG TABLET October 29, 2015 Copyright Health Information Designs, LLC 8
9 Step 4 (history of a moderate CYP3A4 inhibitor) Look back timeframe: 45 days Description VERAPAMIL ER 180MG CAPSULE 3001 VERAPAMIL ER 180MG TABLET VERAPAMIL ER 240MG CAPSULE 3002 VERAPAMIL ER 240MG TABLET VERAPAMIL ER PM 100MG CAPSULE VERAPAMIL ER PM 200MG CAPSULE VERAPAMIL ER PM 300MG CAPSULE October 29, 2015 Copyright Health Information Designs, LLC 9
10 Orkambi (Lumacaftor/Ivacaftor) Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name ORKAMBI 200MG-125MG TABLET October 29, 2015 Copyright Health Information Designs, LLC 10
11 Orkambi (Lumacaftor/Ivacaftor) Clinical Edit Criteria Logic 1. Is the client greater than or equal to ( ) 12 years of age? [ ] (Go to #2) [ ] (Deny) 2. Does the client have a claim for a narrow therapeutic index CYP3A4 substrate in the last 90 days? [ ] (Deny) [ ] (Go to #3) 3. Does the client have a claim for a strong CYP3A4 inducer in the last 90 days? [ ] (Deny) [ ] (Go to #4) 4. Is the requested quantity greater than (>) 4 tablets per day? [ ] (Deny) [ ] (Go to #5) 5. Manual step Is Orkambi being used for the treatment of cystic fibrosis in a client that is homozygous for the F508del mutation in the CFTR gene? [ ] (Approve 365 days) [ ] (Deny) October 29, 2015 Copyright Health Information Designs, LLC 11
12 Orkambi (Lumacaftor/Ivacaftor) Clinical Edit Criteria Logic Diagram Step 1 Is the client 12 years of age? Step 2 Does the client have a claim for a narrow therapeutic index CYP3A4 substrate in the last 90 days? Step 3 Does the client have a claim for a strong CYP3A4 inducer in the last 90 days? Step 4 Is the requested quantity > 4 tablets per day? Deny Request Step 5 Deny Request Deny Request Deny Request Does the client have a diagnosis of cystic fibrosis with the listed mutation in the CFTR gene? [manual step] Deny Request Approve Request (365 days) October 29, 2015 Copyright Health Information Designs, LLC 12
13 Orkambi (Lumacaftor/Ivacaftor) Clinical Edit Criteria Supporting Tables Step 2 (history of a narrow therapeutic index CYP3A4 substrate) Look back timeframe: 90 days Description COUMADIN 5MG VIAL WARFARIN SODIUM 10MG TABLET WARFARIN SODIUM 1MG TABLET WARFARIN SODIUM 2.5MG TABLET WARFARIN SODIUM 2MG TABLET WARFARIN SODIUM 3MG TABLET WARFARIN SODIUM 4MG TABLET WARFARIN SODIUM 5MG TABLET WARFARIN SODIUM 6MG TABLET WARFARIN SODIUM 7.5MG TABLET Step 3 (history of a strong CYP3A4 inducer) Look back timeframe: 90 days Description 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 300 MG CAP CARBAMAZEPINE XR 200 MG TABLET CARBAMAZEPINE XR 400 MG TABLET CARBATROL ER 100MG CAPSULE CARBATROL ER 200MG CAPSULE CARBATROL ER 300MG CAPSULE DILANTIN 100MG CAPSULE October 29, 2015 Copyright Health Information Designs, LLC 13
14 Description Step 3 (history of a strong CYP3A4 inducer) Look back timeframe: 90 days DILANTIN 125MG/5ML DILANTIN 30MG CAPSULE DILANTIN 50MG INFATAB EPITOL 200MG TABLET EQUETRO 100MG CAPSULE EQUETRO 200MG CAPSULE EQUETRO 300MG CAPSULE MYCOBUTIN 150MG CAPSULE PHENOBARBITAL 100 MG TABLET 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 97.2 MG TABLET PHENYTEK 200MG CAPSULE PHENYTEK 300MG CAPSULE PHENYTOIN 125 MG/5 ML SUSP PHENYTOIN 50 MG INFATAB PHENYTOIN 50 MG/ML VIAL PHENYTOIN SOD EXT 100 MG CAP PHENYTOIN SOD EXT 200 MG CAP PHENYTOIN SOD EXT 300 MG CAP RIFABUTIN 150MG CAPSULE RIFADIN 150MG CAPSULE RIFADIN 300MG CAPSULE RIFAMPIN 150MG CAPSULE RIFAMPIN 300MG CAPSULE TEGRETOL 100MG/5ML SUSPENSION TEGRETOL 200MG TABLET TEGRETOL XR 100MG TABLET TEGRETOL XR 200MG TABLET TEGRETOL XR 400MG TABLET October 29, 2015 Copyright Health Information Designs, LLC 14
15 Clinical Edit Criteria References 1. Kalydeco Prescribing Information. Vertex Pharmaceuticals Incorporated. Boston, MA. March Clinical Pharmacology [online database]. Tampa, FL: Elsevier / Gold Standard, Inc Available at Accessed on May 14, Indiana University, Department of Medicine, Clinical Pharmacology Research Institute. P450 Interaction Table. Available at medicine.iupui.edu. Accessed on August 31, Orkambi Prescribing Information. Vertex Pharmaceuticals Incorporated. Boston, MA. July October 29, 2015 Copyright Health Information Designs, LLC 15
16 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 04/03/2013 Initial publication and posting to website 10/30/2014 Added additional mutations to the CFTR gene in the clinical edit criteria 02/05/2015 Added R117H mutation in the CFTR gene to the indicated diagnoses Updated prescribing information reference 03/20/2015 Added s for Tybost, Prezcobix and Evotaz to supporting tables, Step 3 05/14/2015 Updated to add Kalydeco granules 09/09/2015 Updated to include Orkambi October 29, 2015 Copyright Health Information Designs, LLC 16
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