Orkambi

Drug - Orkambi™ (lumacaftor/ivacaftor) [Vertex Pharmaceuticals Inc.]

January 2017

Therapeutic area - Cystic fibrosis

Approval criteria

Patient is 6 years of age or older AND
Patient has a diagnosis of cystic fibrosis AND
Patient is homoxyzygous for the F508del mutation in the CFTR gene as documented by and FDA approved CF mutation test (documentation of CF mutation analysis test must be provided as part of the prior authorization request) 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

Maximum of 4 tablets per day (136 tablets per 34 days)

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
- Maintained or improved body mass index
- Reductions in pulmonary exacerbations

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