Symdeko®

Drug - Symdeko® (tezacaftor and ivacaftor) [Vertex Pharmaceuticals Incorporated]

December 2018

Therapeutic Area - Cystic Fibrosis

Approval criteria

Patient must be 12 years old or older AND
Patient must have a diagnosis of cystic fibrosis (CF) AND
Patient must be homozygous for the F508del mutation in the CFTR gene as confirmed by a FDA-cleared CF mutation test OR
Patient must have 1 of the following mutations in the CFTR gene as confirmed by a FDA-cleared CF mutation test: E56K, P67L, R74W, D110E, D110H, R117C, E193K, L206W, R347H, R352Q, A455E, D579G, 711+3A→G, E831X, S945L, S977L, F1052V, K1060T, A1067T, R1070W, F1074L, D1152H, D1270N, 2789+5G→A, 3272-26A→G, or 3849+10kbC→T AND
Patient must be seen at least twice a year by a provider who is on staff at a Cystic Fibrosis (CF) Care Center accredited by the CF Foundation AND
Patient’s baseline body mass index, FEV1 and liver function tests (AST/ALT) must be provided at time of request AND
Patient must not have known hypersensitivity to tezacaftor or ivacaftor

At time of request, documentation that demonstrates patient has been seen at least twice a year by a provider who is on staff at a CF Care Center accredited by the CF Foundation AND
At time of request, prescriber must provide documentation of liver function tests (AST/ALT) obtained within the last three months AND
Prescriber provides documentation that the patient has achieved a clinically meaningful response by meeting one of the following criteria:
- Maintained or improved FEV1 (obtained within the previous 30 days)
- Maintained or improved body mass index
- Reductions in pulmonary exacerbations AND
Patient must not have received a lung transplant

MHCP Provider Call Center 651-431-2700 or 800-366-5411