Cystic Fibrosis Agents
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- Marybeth Francis
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1 Texas Prior Authorization Program Clinical Criteria Clinical Information Included in this Document Kalydeco (Ivacaftor) 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. Orkambi (Lumacaftor/Ivacaftor) 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. April 28, 2018 Copyright Health Information Designs, LLC 1
2 Symdeko (Tezacaftor/Ivacaftor and Ivacaftor) 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. Revision tes Added criteria for Symdeko, pages Criteria approved by the DUR Board on April 27, Updated references, page 27. April 28, 2018 Copyright Health Information Designs, LLC 2
3 Kalydeco (Ivacaftor) Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name KALYDECO 150MG TABLET KALYDECO 50MG GRANULES PACKET KALYDECO 75MG GRANULES PACKET April 28, 2018 Copyright Health Information Designs, LLC 3
4 Kalydeco (Ivacaftor) Clinical 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 one of the following mutations in the CFTR gene: A1067T, A455E, D110E, D110H, D1152H, D1270N, D579G, E193K, E56K, E821X, F1052V, F1074L, G1069R, G1244E, G1349D, G178R, G551D, G551S, K1060T, L206W, P67L, R1070Q, R1070W, R117C, R117H, R347H, R352Q, R74W, S1251N, S1255P, S549N, S549R, S945L, S977F, G, A, kbC or 711+3A? [ ] (Approve 365 days) [ ] (Deny) April 28, 2018 Copyright Health Information Designs, LLC 4
5 Kalydeco (Ivacaftor) Clinical 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 April 28, 2018 Copyright Health Information Designs, LLC 5
6 Kalydeco (Ivacaftor) Clinical Criteria Supporting Tables Step 2 (history of a CYP3A4 inducer) Look back timeframe: 45 days Label Name ACTOPLUS MED MG TABLET ACTOPLUS MET MG TABLET ACTOPLUS MET XR MG TABLET ACTOPLUS MET XR MG TABLET ACTOS 15MG TABLET ACTOS 30MG TABLET ACTOS 45MG TABLET ALOGLIPTIN-PIOGLIT MG ALOGLIPTIN-PIOGLIT MG ALOGLIPTIN-PIOGLIT MG ALOGLIPTIN-PIOGLIT 25-15MG TB ALOGLIPTIN-PIOGLIT 25-30MG TB ALOGLIPTIN-PIOGLIT 25-45MG TB ATRIPLA TABLET 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 April 28, 2018 Copyright Health Information Designs, LLC 6
7 Step 2 (history of a CYP3A4 inducer) Look back timeframe: 45 days Label Name DUETACT 30-4MG TABLET EPITOL 200 MG TABLET EQUETRO 100 MG CAPSULE EQUETRO 200 MG CAPSULE EQUETRO 300 MG CAPSULE MYCOBUTIN 150 MG CAPSULE NEVIRAPINE 200MG TABLET NEVIRAPINE 50MG/5ML SUSPENSION NEVIRAPINE ER 400MG TABLET OSENI MG TABLET OSENI MG TABLET OSENI MG TABLET OSENI 25-15MG TABLET OSENI 25-30MG TABLET OSENI 25-45MG 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 PIOGLITAZONE HCL 15 MG TABLET PIOGLITAZONE HCL 30 MG TABLET April 28, 2018 Copyright Health Information Designs, LLC 7
8 Step 2 (history of a CYP3A4 inducer) Look back timeframe: 45 days Label Name PIOGLITAZONE HCL 45 MG TABLET PIOGLITAZONE-GLIMEPIRIDE PIOGLITAZONE-GLIMEPIRIDE PIOGLITAZONE-METFORMIN PIOGLITAZONE-METFORMIN 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 SUSTIVA 200MG CAPSULE SUSTIVA 50MG CAPSULE SUSTIVA 600MG TABLET 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 VIRAMUNE 200MG TABLET VIRAMUNE 50MG/5ML SUSPENSION VIRAMUNE XR 100MG TABLET VIRAMUNE XR 400MG TABLET XTANDI 40MG CAPSULE Step 3 (history of a strong CYP3A4 inhibitor) Look back timeframe: 45 days Label Name BIAXIN 250 MG TABLET BIAXIN 250 MG/5 ML SUSPENSION April 28, 2018 Copyright Health Information Designs, LLC 8
9 Step 3 (history of a strong CYP3A4 inhibitor) Look back timeframe: 45 days Label Name BIAXIN 500 MG TABLET CARDIZEM 120 MG TABLET CARDIZEM 30 MG TABLET CARDIZEM 60 MG TABLET CARDIZEM CD 120 MG CAPSULE CARDIZEM CD 180 MG CAPSULE CARDIZEM CD 240 MG CAPSULE CARDIZEM CD 300 MG CAPSULE CARDIZEM CD 360 MG CAPSULE CARDIZEM LA 120 MG TABLET CARDIZEM LA 180 MG TABLET CARDIZEM LA 360 MG TABLET CARDIZEM LA 420 MG TABLET CARTIA XT 120MG CAPSULE CARTIA XT 180MG CAPSULE CARTIA XT 240MG CAPSULE CARTIA XT 300MG CAPSULE CLARITHROMYCIN 125 MG/5 ML SUS CLARITHROMYCIN 250 MG TABLET CLARITHROMYCIN 250 MG/5 ML SUS CLARITHROMYCIN 500 MG TABLET CLARITHROMYCIN ER 500 MG TAB CRIXIVAN 200 MG CAPSULE CRIXIVAN 400 MG CAPSULE DILTIAZEM 120 MG TABLET DILTIAZEM 12HR ER 120 MG CAP DILTIAZEM 12HR ER 60 MG CAP DILTIAZEM 12HR ER 90 MG CAP DILTIAZEM 24HR ER 120 MG CAP DILTIAZEM 24HR ER 180 MG CAP DILTIAZEM 24HR ER 240 MG CAP DILTIAZEM 24HR ER 300 MG CAP DILTIAZEM 24HR ER 360 MG CAP DILTIAZEM 30 MG TABLET DILTIAZEM 60 MG TABLET DILTIAZEM 90 MG TABLET April 28, 2018 Copyright Health Information Designs, LLC 9
10 Step 3 (history of a strong CYP3A4 inhibitor) Look back timeframe: 45 days Label Name DILTIAZEM ER 120 MG CAPSULE DILTIAZEM ER 120 MG CAPSULE DILTIAZEM ER 180 MG CAPSULE DILTIAZEM ER 180 MG CAPSULE DILTIAZEM ER 240 MG CAPSULE DILTIAZEM HCL ER 240 MG CAP DILTIAZEM HCL ER 300 MG CAP DILTIAZEM HCL ER 360 MG CAP DILTIAZEM HCL ER 420 MG CAP EVOTAZ MG TABLET GENVOYA TABLET INVIRASE 200 MG CAPSULE INVIRASE 500 MG TABLET ITRACONAZOLE 100 MG CAPSULE KALETRA MG TABLET KALETRA MG TABLET KALETRA /5 ML ORAL SOLU KETEK 300 MG TABLET KETEK 400 MG TABLET KETOCONAZOLE 200 MG TABLET LANSOPRAZOL-AMOXICIL-CLARITHRO MATZIM LA 180MG TABLET MATZIM LA 240MG TABLET MATZIM LA 300MG TABLET MATZIM LA 360MG TABLET MATZIM LA 420MG TABLET NEFAZODONE 100MG TABLET NEFAZODONE 150MG TABLET NEFAZODONE 200MG TABLET NEFAZODONE 250MG TABLET NEFAZODONE 50MG TABLET NORVIR 100 MG SOFTGEL CAP NORVIR 100 MG TABLET NORVIR 80 MG/ML SOLUTION NOXAFIL 40 MG/ML SUSPENSION NOXAFIL DR 100 MG TABLET April 28, 2018 Copyright Health Information Designs, LLC 10
11 Step 3 (history of a strong CYP3A4 inhibitor) Look back timeframe: 45 days Label Name PREVPAC PATIENT PACK PREZCOBIX 150MG TABLET SPORANOX 10 MG/ML SOLUTION SPORANOX 100 MG CAPSULE STRIBILD TABLET TAZTIA XT 120MG CAPSULE TAZTIA XT 180MG CAPSULE TAZTIA XT 240MG CAPSULE TAZTIA XT 300MG CAPSULE TAZTIA XT 360MG CAPSULE TECHNIVIE DOSE PACK TIAZAC ER 120MG CAPSULE TIAZAC ER 180MG CAPSULE TIAZAC ER 240MG CAPSULE TIAZAC ER 300MG CAPSULE TIAZAC ER 360MG CAPSULE TIAZAC ER 420MG CAPSULE TYBOST 150MG TABLET VFEND 200 MG TABLET VFEND 40 MG/ML SUSPENSION VFEND 50 MG TABLET VFEND IV 200 MG VIAL VICTRELIS 200 MG CAPSULE VIEKIRA PAK VIEKIRA XR TABLET VIRACEPT 250 MG TABLET VIRACEPT 625 MG TABLET VORICONAZOLE 200 MG TABLET VORICONAZOLE 200 MG VIAL VORICONAZOLE 40 MG/ML SUSP VORICONAZOLE 50 MG TABLET ZYDELIG 100MG TABLET ZYDELIG 150MG TABLET April 28, 2018 Copyright Health Information Designs, LLC 11
12 Step 4 (history of a moderate CYP3A4 inhibitor) Look back timeframe: 45 days Description BUNAVAIL MG FILM BUNAVAIL MG FILM BUNAVAIL MG FILM CALAN 120 MG TABLET CALAN 80 MG TABLET CALAN SR 120 MG CAPLET CALAN SR 180 MG CAPLET CALAN SR 240 MG CAPLET DIFLUCAN 10 MG/ML SUSPENSION DIFLUCAN 100 MG TABLET DIFLUCAN 150 MG TABLET DIFLUCAN 200 MG TABLET DIFLUCAN 40 MG/ML SUSPENSION DIFLUCAN 50 MG TABLET E.E.S. 200 MG/5 ML GRANULES E.E.S. 400 FILMTAB EMEND 125MG CAPSULE EMEND 40MG CAPSULE EMEND 80MG CAPSULE EMEND TRIPACK ERYPED 200 MG/5 ML SUSPENSION ERYPED 400 MG/5 ML SUSPENSION ERY-TAB EC 250 MG TABLET ERY-TAB EC 333 MG TABLET ERY-TAB EC 500 MG TABLET ERYTHROCIN 250 MG FILMTAB ERYTHROCIN 500 MG ADDVNT VL ERYTHROCIN 500 MG VIAL ERYTHROMYCIN 250 MG FILMTAB ERYTHROMYCIN 500 MG FILMTAB ERYTHROMYCIN EC 250 MG CAP ERYTHROMYCIN ES 400 MG TAB FLUCONAZOLE 10 MG/ML SUSP FLUCONAZOLE 100 MG TABLET FLUCONAZOLE 150 MG TABLET FLUCONAZOLE 200 MG TABLET April 28, 2018 Copyright Health Information Designs, LLC 12
13 Step 4 (history of a moderate CYP3A4 inhibitor) Look back timeframe: 45 days Description FLUCONAZOLE 40 MG/ML SUSP FLUCONAZOLE 50 MG TABLET FLUCONAZOLE-DEXT 200 MG/100 ML FLUCONAZOLE-NACL 200 MG/100 ML FLUCONAZOLE-NACL 400 MG/200 ML FLUCONAZOLE-NS 200 MG/100 ML GLEEVEC 100MG TABLET GLEEVEC 400MG TABLET LEXIVA 50MG/ML SUSPENSION LEXIVA 700MG TABLET PCE 333 MG TABLET PCE 500 MG TABLET PREZISTA 100MG/ML SUSPENSION PREZISTA 150MG TABLET PREZISTA 600MG TABLET PREZISTA 75MG TABLET PREZISTA 800MG TABLET REYATAZ 150MG CAPSULE REYATAZ 200MG CAPSULE REYATAZ 300MG CAPSULE REYATAZ 50MG POWDER PACK SUBOXONE 12 MG-3 MG SL FILM SUBOXONE 2 MG-0.5 MG SL FILM SUBOXONE 4 MG-1 MG SL FILM SUBOXONE 8 MG-2 MG SL FILM TRANDOLAPR-VERAPAM ER MG TRANDOLAPR-VERAPAM ER MG TRANDOLAPR-VERAPAM ER MG TRANDOLAPR-VERAPAM ER MG VERAPAMIL 120 MG TABLET VERAPAMIL 360 MG CAP PELLET VERAPAMIL 40 MG TABLET VERAPAMIL 80 MG TABLET VERAPAMIL ER 120 MG CAPSULE VERAPAMIL ER 120 MG TABLET VERAPAMIL ER 180 MG CAPSULE April 28, 2018 Copyright Health Information Designs, LLC 13
14 Step 4 (history of a moderate CYP3A4 inhibitor) Look back timeframe: 45 days Description VERAPAMIL ER 180 MG TABLET VERAPAMIL ER 240 MG CAPSULE VERAPAMIL ER 240 MG TABLET VERAPAMIL ER PM 100 MG CAPSULE VERAPAMIL ER PM 200 MG CAPSULE VERAPAMIL ER PM 300 MG CAPSULE VERELAN 120 MG CAP PELLET VERELAN 180 MG CAP PELLET VERELAN 240 MG CAP PELLET VERELAN 360 MG CAP PELLET VERELAN PM 100 MG CAP PELLET VERELAN PM 200 MG CAP PELLET VERELAN PM 300 MG CAP PELLET April 28, 2018 Copyright Health Information Designs, LLC 14
15 Orkambi (Lumacaftor/Ivacaftor) Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name ORKAMBI 100MG-125MG TABLET ORKAMBI 200MG-125MG TABLET April 28, 2018 Copyright Health Information Designs, LLC 15
16 Orkambi (Lumacaftor/Ivacaftor) Clinical Criteria Logic 1. Is the request for Orkambi 100mg/125mg tablets? [ ] (Go to #2) [ ] (Go to #3) 2. Is the client greater than or equal to ( ) 6 years of age and less than (<) 12 years of age? [ ] (Go to #5) [ ] (Deny) 3. Is the request for Orkambi 200mg/125mg tablets? [ ] (Go to #4) [ ] (Deny) 4. Is the client greater than or equal to ( ) 12 years of age? [ ] (Go to #5) [ ] (Deny) 5. Does the client have a claim for a narrow therapeutic index CYP3A4 substrate in the last 90 days? [ ] (Deny) [ ] (Go to #6) 6. Does the client have a claim for a strong CYP3A4 inducer in the last 90 days? [ ] (Deny) [ ] (Go to #7) 7. Is the requested quantity greater than (>) 4 tablets per day? [ ] (Deny) [ ] (Go to #8) 8. 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) April 28, 2018 Copyright Health Information Designs, LLC 16
17 Orkambi (Lumacaftor/Ivacaftor) Clinical Criteria Logic Diagram Step 1 Is the request for Orkambi 100mg/ 125mg tablets? Step 2 Is the client 6 and < 12 years of age? Step 5 Does the client have a claim for a narrow therapeutic index CYP3A4 substrate in the last 90 days? Step 6 Does the client have a claim for a strong CYP3A4 inducer in the last 90 days? Deny Request Step 3 Step 7 Is the request for Orkambi 200mg/ 125mg tablets? Deny Request Deny Request Is the requested quantity > 4 tablets per day? Deny Request Step 4 Step 8 Is the client 12 years of age? Deny Request Does the client have a diagnosis of cystic fibrosis with the listed mutation in the CFTR gene? [manual step] Deny Request Go to Step 5 Approve Request (365 days) April 28, 2018 Copyright Health Information Designs, LLC 17
18 Orkambi (Lumacaftor/Ivacaftor) Clinical Criteria Supporting Tables Step 5 (history of a narrow therapeutic index CYP3A4 substrate) Look back timeframe: 90 days Description AFINITOR 10MG TABLET AFINITOR 2.5MG TABLET AFINITOR 5MG TABLET AFINITOR 7.5MG TABLET AFINITOR DISPERZ 2MG TABLET AFINITOR DISPERZ 3MG TABLET AFINITOR DISPERZ 5MG TABLET CYCLOSPORINE 100MG CAPSULE CYCLOSPORINE 100MG/ML SOLN CYCLOSPORINE 25MG CAPSULE CYCLOSPORINE MODIFIED 100MG CYCLOSPORINE MODIFIED 25MG CYCLOSPORINE MODIFIED 50MG ENVARSUS XR 0.75MG TABLET ENVARSUS XR 1MG TABLET ENVARSUS XR 4MG TABLET GENGRAF 100MG CAPSULE GENGRAF 100MG/ML SOLUTION GENGRAF 25MG CAPSULE GENGRAF 50MG CAPSULE NEORAL 100MG GELATIN CAPSULE NEORAL 100MG/ML SOLUTION NEORAL 25MG GELATIN CAPSULE PROGRAF 0.5MG CAPSULE PROGRAF 1MG CAPSULE PROGRAF 5MG CAPSULE RAPAMUNE 0.5MG TABLET RAPAMUNE 1MG TABLET RAPAMUNE 1MG/ML ORAL SOLN April 28, 2018 Copyright Health Information Designs, LLC 18
19 Step 5 (history of a narrow therapeutic index CYP3A4 substrate) Look back timeframe: 90 days Description RAPAMUNE 2MG TABLET SANDIMMUNE 100MG CAPSULE SANDIMMUNE 100MG/ML SOLN SANDIMMUNE 25MG CAPSULE SIROLIMUS 0.5MG TABLET SIROLIMUS 1MG TABLET SIROLIMUS 2MG TABLET TACROLIMUS 0.5MG CAPSULE TACROLIMUS 1MG CAPSULE TACROLIMUS 5MG CAPSULE TRIAZOLAM 0.125MG TABLET TRIAZOLAM 0.25MG TABLET ZORTRESS 0.25MG TABLET ZORTRESS 0.5MG TABLET ZORTRESS 0.75MG TABLET Step 6 (history of a strong CYP3A4 inducer) Look back timeframe: 90 days Description ACTOPLUS MED MG TABLET ACTOPLUS MET MG TABLET ACTOPLUS MET XR MG TABLET ACTOPLUS MET XR MG TABLET ACTOS 15MG TABLET ACTOS 30MG TABLET ACTOS 45MG TABLET ALOGLIPTIN-PIOGLIT MG ALOGLIPTIN-PIOGLIT MG ALOGLIPTIN-PIOGLIT MG ALOGLIPTIN-PIOGLIT 25-15MG TB ALOGLIPTIN-PIOGLIT 25-30MG TB ALOGLIPTIN-PIOGLIT 25-45MG TB ATRIPLA TABLET CARBAMAZEPINE 100 MG TAB CHEW April 28, 2018 Copyright Health Information Designs, LLC 19
20 Step 6 (history of a strong CYP3A4 inducer) Look back timeframe: 90 days Description CARBAMAZEPINE 100 MG/5 ML SUSP CARBAMAZEPINE 200 MG TABLET CARBAMAZEPINE ER 100 MG CAP CARBAMAZEPINE ER 100 MG TABLET 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 EPITOL 200 MG TABLET EQUETRO 100 MG CAPSULE EQUETRO 200 MG CAPSULE EQUETRO 300 MG CAPSULE MYCOBUTIN 150 MG CAPSULE NEVIRAPINE 200MG TABLET NEVIRAPINE 50MG/5ML SUSPENSION NEVIRAPINE ER 400MG TABLET OSENI MG TABLET OSENI MG TABLET OSENI MG TABLET OSENI 25-15MG TABLET OSENI 25-30MG TABLET OSENI 25-45MG 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 April 28, 2018 Copyright Health Information Designs, LLC 20
21 Step 6 (history of a strong CYP3A4 inducer) Look back timeframe: 90 days Description 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 PIOGLITAZONE HCL 15 MG TABLET PIOGLITAZONE HCL 30 MG TABLET PIOGLITAZONE HCL 45 MG TABLET PIOGLITAZONE-GLIMEPIRIDE PIOGLITAZONE-GLIMEPIRIDE PIOGLITAZONE-METFORMIN PIOGLITAZONE-METFORMIN 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 SUSTIVA 200MG CAPSULE SUSTIVA 50MG CAPSULE SUSTIVA 600MG TABLET TEGRETOL 100 MG/5 ML SUSP TEGRETOL 200 MG TABLET TEGRETOL XR 100 MG TABLET April 28, 2018 Copyright Health Information Designs, LLC 21
22 Step 6 (history of a strong CYP3A4 inducer) Look back timeframe: 90 days Description TEGRETOL XR 200 MG TABLET TEGRETOL XR 400 MG TABLET VIRAMUNE 200MG TABLET VIRAMUNE 50MG/5ML SUSPENSION VIRAMUNE XR 100MG TABLET VIRAMUNE XR 400MG TABLET XTANDI 40MG CAPSULE April 28, 2018 Copyright Health Information Designs, LLC 22
23 Symdeko (Tezacaftor/Ivacaftor and Ivacaftor) Drugs Requiring Prior Authorization Drugs Requiring Prior Authorization Label Name SYMDEKO 100/ MG TABS April 28, 2018 Copyright Health Information Designs, LLC 23
24 Symdeko (Tezacaftor/Ivacaftor and Ivacaftor) Clinical 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 CYP3A4 inducer in the last 45 days? [ ] (Deny) [ ] (Go to #3) 3. Does the client have a diagnosis of cystic fibrosis in the last 730 days? [ ] (Go to #4) [ ] (Deny) 4. Manual step Is the client homozygous for the F508del mutation OR does the client have at least one of the following mutations in the CFTR gene: A1067T, A455E, D110E, D110H, D1152H, D1270N, D579G, E193K, E56K, E831X, F1052V, F1074L, K1060T, L206W, P67L, R1070W, R117C, R347H, R352Q, R74W, S945L, S977F, 711+3A- G, G- A, A- G, kbC- T? [ ] (Approve 365 days) [ ] (Deny) April 28, 2018 Copyright Health Information Designs, LLC 24
25 Symdeko (Tezacaftor/Ivacaftor and Ivacaftor) Clinical Criteria Logic Diagram Step 1 Step 2 Step 3 Is the client 12 years of age? Does the client have a claim for a CYP3A4 inducer in the last 45 days? Does the client have a diagnosis of cystic fibrosis in the last 730 days? Deny Request Step 4 Deny Request Deny Request Is the client homozygous for the F508del mutation OR have a listed mutation in the CFTR gene? [manual step] Deny Request Approve Request (365 days) April 28, 2018 Copyright Health Information Designs, LLC 25
26 Symdeko (Tezacaftor/Ivacaftor and Ivacaftor) Clinical Criteria Supporting Tables Step 2 (claim for a CYP3A4 inducer) Look back timeframe: 45 days For the list of s that pertain to this step, see the CYP3A4 inducer table in the previous Supporting Tables section. te: Click the hyperlink to navigate directly to the table. April 28, 2018 Copyright Health Information Designs, LLC 26
27 Agents for Cystic Fibrosis Clinical Criteria References 1. Kalydeco Prescribing Information. Vertex Pharmaceuticals Incorporated. Boston, MA. July Clinical Pharmacology [online database]. Tampa, FL: Elsevier / Gold Standard, Inc Available at Accessed on April 27, 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. September Indiana University, Department of Medicine, Clinical Pharmacology Research Institute. P450 Interaction Table. Available at medicine.iupui.edu. Accessed on February 19, U.S. Food and Drug Administration (FDA). Drug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers. Available at Accessed on February 19, Symdeko Prescribing Information. Vertex Pharmaceuticals Incorporated. Boston, MA. February April 28, 2018 Copyright Health Information Designs, LLC 27
28 Agents for Cystic Fibrosis 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 02/26/2016 Updated CYP3A4 inhibitor/inducer tables 11/15/2016 Updated Table 2, page 6 Updated Table 3, page 8 Updated Table 4, page 12 Added for Orkambi 100mg/125mg tablet to Drugs Requiring PA, page 15 Updated Criteria Logic, page 16 Updated Logic Diagram, page 17 Updated Table 2, page 18 Updated Table 3, page 19 Updated References, page 23 05/30/2017 Updated Kalydeco criteria logic, page 4 updated step 8 to include the following mutations on the CFTR gene: A1067T, A455E, D110E, D110H, D1152H, D1270N, D579G, E193K, E56K, F1052V, F1074L, G1069R, K1060T, L206W, P67L, R1070Q, R1070W, R117C, R347H, R352Q, R74W, S945L and S977F Updated References, page 23 08/02/2017 Updated Kalydeco criteria logic, page 4 updated step 8 to include the following mutations on the CFTR gene: G, A, kbC, 711+3A and E821X Updated References, page 23 04/27/2018 Added criteria for Symdeko, pages Criteria approved by the DUR Board on April 27, 2018 Updated references, page 27 April 28, 2018 Copyright Health Information Designs, LLC 28
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