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
Renewal criteria
- 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
Quantity limits
Questions?
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