Trikafta — Medical Mutual

Initial criteria

• Patient is age ≥ 2 years; AND
• Trikafta is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of CF; AND
• Patient meets ONE of the following (i or ii): i. Patient has at least one copy of the F508del mutation in the CFTR gene; OR ii. Patient has at least one specific CFTR gene mutation that laboratory testing shows is susceptible to treatment with Trikafta; AND
• Patient meets at least ONE of the following (i, ii, or iii): i. Positive cystic fibrosis newborn screening test; OR ii. Family history of cystic fibrosis; OR iii. Clinical presentation consistent with signs and symptoms of cystic fibrosis; AND
• Patient has evidence of abnormal CFTR function demonstrated by at least ONE of the following (i, ii, or iii): i. Elevated sweat chloride test; OR ii. Two CF-causing CFTR mutations; OR iii. Abnormal nasal potential difference

Reauthorization criteria

• Patient continues to meet all initial criteria; AND
• Patient has been using Trikafta for at least 6 months; AND
• Patient has experienced an adequate response to therapy (e.g. improvement in FEV1 and/or other lung function tests, improvement in sweat chloride, decrease in pulmonary exacerbations or infections, increase in weight, decrease in hospitalizations) compared to baseline

Approval duration

initial: 6 months; continuation: 1 year