Kalydeco — Medical Mutual

Initial criteria

• Patient has at least one mutation of the cystic fibrosis transmembrane conductance regulator (CFTR) gene that laboratory testing shows is susceptible to treatment with Kalydeco
• Patient age ≥ 1 month
• Kalydeco is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of CF

Reauthorization criteria

• Kalydeco is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of CF
• Patient has experienced a beneficial response to therapy such as increase in weight; improvement in sweat chloride; improvement in predicted FEV1 or other lung function tests; decrease in amount/frequency of pulmonary exacerbations; decrease in amount/frequency of pulmonary infections; decrease in hospitalizations

Approval duration

initial 6 months; reauth 1 year