Summary
Alyftrek (vanzacaftor, tezacaftor and deutivacaftor) is considered not medically necessary under this BCBSMS policy because there are other options covered by the Plan for cystic fibrosis. Kalydeco, Orkambi, Symdeko and Trikafta require prior authorization and are medically necessary for the listed age groups when the CFTR gene mutation is confirmed by genetic testing. The revision effective 09/01/2025 removed the CFTR gene mutation tables and revised the age, initial and renewal criteria, and the 05/26/2026 review left the policy statements unchanged.
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What to do
Action · 9 steps
01Already effective 09/01/2025: Alyftrek is considered not medically necessary under this policy because other options are covered by the Plan for cystic fibrosis.
02Get prior authorization before billing Kalydeco, Orkambi, Symdeko or Trikafta, because prior authorization is required.
03Confirm the age minimums are met: Kalydeco for 1 month of age or older, Orkambi for 1 year of age or older, Symdeko for 6 years of age or older, and Trikafta for 2 years of age or older.
04Include medical records showing a documented cystic fibrosis diagnosis and a CFTR gene mutation confirmed by genetic testing according to the FDA label for the requested agent.
05For Kalydeco, the individual must not have F508del mutations on both alleles.
06The requested agent must not be used in combination with another CFTR modulator, the prescriber must be a specialist or have consulted one, the dosage must be within the program quantity limits, and there must be no FDA labeled contraindication.
07Initial approval length is 12 months.
08Renewal requires prior BCBSMS PA approval, documented clinical improvement from baseline, no combination with another CFTR modulator, a specialist prescriber, a dosage within the program quantity limits, and no FDA labeled contraindication; renewal approval length is 12 months.
09Services related to delivery or administration of a medication not approved through the BCBSMS PA review process will be considered not medically necessary.
Codes mentioned
E84.0E84.9Z14.1
Original notice
Cystic Fibrosis
bcbsms.com · Always check the source before changing claims.
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