Alyftrek™ (vanzacaftor/tezacaftor/deutivacaftor tablets – Vertex) — Cigna

Initial criteria

• Patient has a diagnosis of cystic fibrosis AND
• Patient has at least one cystic fibrosis transmembrane conductance regulator gene mutation responsive to Alyftrek (list includes: S1045Y, Y301C, D110H, G1061R, I1027T, L967S, R1070W, S108F, Y569C, D1270N, G1069R, I105N, L997F, R1162L, S1118F, Y913C, D1445N, G1123R, I1139V, M1101R, R117C, S1159P, D192G, G1247R, I1234Vdel6aa, M1137V, R117C;G576A;R668C, S1235R, D443Y, G1249R, I125T, M150K, R117G, S1255P, D443Y;G576A;R668C, G126D, I1269N, M152V, R117H, S13F, D513G, G1349D, I331N, M265R, R117L, S341P, D565G, G149R, I1366N, M952I, R117P, S364P, D579G, G178E, I1398S, M952T, R1283M, S492F, D614G, G178R, I148N, N1088D, R1283S, S549I, D836Y, G194R, I148T, N1303I, R170H, S589N, D924N, G194V, I175V, N1303K, R258G, S737F, D979V, G27E, I502T, N186K, R297Q, S912L, D993Y, G27R, I506L, N187K, R31C, S977F, E116K, G314E, I506T, N418S, R31L, T1036N, 1341G→A, 2789+2insA, 3041-15T→G, 3849+10kbC→T, 3850-3T→G, 5T;TG13, 711+3A→G, 1898+3A→G, 2789+5G→A, 3272-26A→G, 3849+4A→G, 4005+2T→C, 621+3A→G, E831X 2752-26A→G, 296+28A→G, 3600G→A, 3849+40A→G, 5T;TG12) AND
• Patient meets at least ONE of the following (i, ii, or iii): i. Positive cystic fibrosis newborn screening test; OR ii. Family history of cystic fibrosis; OR iii. Clinical presentation consistent with signs and symptoms of cystic fibrosis (e.g., meconium ileus, sino-pulmonary symptoms, bronchiectasis, sinusitis, failure to thrive, pancreatic insufficiency) AND
• Patient has evidence of abnormal cystic fibrosis transmembrane conductance regulator function as demonstrated by at least ONE of the following (i, ii, or iii): i. Elevated sweat chloride test; OR ii. Two cystic fibrosis-causing cystic fibrosis transmembrane conductance regulator mutations; OR iii. Abnormal nasal potential difference AND
• The medication is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis