Alyftrek — Medical Mutual
Cystic Fibrosis (CF)
Initial criteria
- Patient age ≥ 6 years
- Medication is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis
- Patient has at least ONE pathogenic or likely pathogenic CFTR gene variant listed in policy
- Patient meets at least ONE of the following: (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
- Patient has evidence of abnormal cystic fibrosis transmembrane conductance regulator function demonstrated by at least ONE of the following: (i) elevated sweat chloride test; OR (ii) two cystic fibrosis-causing CFTR mutations; OR (iii) abnormal nasal potential difference
Reauthorization criteria
- Patient continues to meet all criteria for new starts
- Patient has been using Alyftrek for at least 6 months
- 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; reauth 12 months