Symdeko (tezacaftor/ivacaftor) — CareFirst (Caremark)

Initial criteria

• Prescribed by or in consultation with a pulmonologist
• Genetic testing was conducted to detect a mutation in the CFTR gene
• Member is homozygous for the F508del mutation (positive for the F508del mutation on both alleles) OR has at least one of the following CFTR gene mutations: A120T, A234D, A349V, A455E, A554E, A1006E, A1067T, D110E, D110H, D192G, D443Y, D443Y;G576A;R668C, D579G, D614G, D836Y, D924N, D979V, D1152H, D1270N, E56K, E60K, E92K, E116K, E193K, E403D, E588V, E822K, E831X, F191V, F311del, F311L, F508C, F508C;S1251N, F575Y, F1016S, F1052V, F1074L, F1099L, G126D, G178E, G178R, G194R, G194V, G314E, G551D, G551S, G576A, G576A;R668C, G622D, G970D, G1069R, G1244E, G1249R, G1349D, H939R, H1054D, H1375P, I148T, I175V, I336K, I601F, I618T, I807M, I980K, I1027T, I1139V, I1269N, I1366N, K1060T, L15P, L206W, L320V, L346P, L967S, L997F, L1324P, L1335P, L1480P, M152V, M265R, M952I, M952T, P5L, P67L, P205S, Q98R, Q237E, Q237H, Q359R, Q1291R, R31L, R74Q, R74W, R74W;D1270N, R74W;V201M, R74W;V201M;D1270N, R75Q, R117C, R117G, R117H, R117L, R117P, R170H, R258G, R334L, R334Q, R347H, R347L, R347P, R352Q, R352W, R553Q, R668C, R751L, R792G, R933G, R1066H, R1070Q, R1070W, R1162L, R1283M, R1283S, S549N, S549R, S589N, S737F, S912L, S945L, S977F, S1159F, S1159P, S1251N, S1255P, T338I, T1036N, T1053I, V201M, V232D, V562I, V754M, V1153E, V1240G, V1293G, W1282R, Y109N, Y161S, Y1014C, Y1032C, 546insCTA, 711+3A→G, 2789+5G→A, 3272-26A→G, 3849+10kbC→T
• Member age ≥ 6 years
• Symdeko will not be used in combination with another CFTR modulator for the treatment of cystic fibrosis (e.g., Kalydeco, Trikafta)

Reauthorization criteria

• Member continues to meet initial criteria for cystic fibrosis
• Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement (e.g., improvement in FEV1 from baseline)

Approval duration

12 months