Orkambi — Highmark
cystic fibrosis
Initial criteria
- age ≥ 1 year
- diagnosis of cystic fibrosis
- has the homozygous F508del mutation as detected by an FDA-approved test
Reauthorization criteria
- Documented improvement or stabilization of forced expiratory volume (FEV1) compared to baseline FEV1
- Increased Body Mass Index
- Decreased pulmonary exacerbations
- Improved quality of life as demonstrated by Cystic Fibrosis Questionnaire
Approval duration
initial up to 6 months (12 months for Delaware Commercial fully-insured and ACA members); reauthorization up to 12 months