lumacaftor/ivacaftor — CareFirst (Caremark)
Cystic fibrosis in patients homozygous for the F508del mutation in the CFTR gene
Initial criteria
- 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) of the CFTR gene
- Member age ≥ 1 year
- Medication prescribed by or in consultation with a pulmonologist
- Orkambi will not be used in combination with another CFTR modulator for the treatment of cystic fibrosis (e.g., Alyftrek, Symdeko)
Reauthorization criteria
- 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