TOBI Podhaler (tobramycin inhalation powder) prior authorization
Defines Cigna's prior authorization requirements and coverage criteria for TOBI Podhaler for treatment of cystic fibrosis and continuation of therapy; applies to providers prescribing for Cigna members.
No material clinical or coverage changes in this revision.
Coverage Criteria for TOBI Podhaler
Continuation Therapy
Covered when the following is met:
Continuation approvals are short-term (1 month).
Use of TOBI® Podhaler for indications beyond the covered cystic fibrosis population is considered experimental, investigational or unproven. The policy lists TOBI Podhaler as not covered for any other use(s) and will update criteria only as new published data become available.
Safety and efficacy have not been demonstrated in certain populations and clinical situations, including patients < 6 years of age, patients with FEV1 < 25% or > 80% predicted, or patients colonized with Burkholderia cepacia; these limits inform the policy’s coverage exclusions.
TOBI® Podhaler is not covered for any indications other than those specifically listed with supportive evidence in this policy (the FDA‑approved CF indication and the limited continuation approval). Use for other indications lacks sufficient evidence of safety and efficacy and is therefore considered experimental, investigational, or unproven.
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