Diagnosis: Cystic Fibrosis (CF)

Treatment: Trikafta

The insurer denied coverage for Trikafta

The denial is upheld

Patient is a with history of (H/O) Cystic Fibrosis.

Patient is presently on Ivacaftor for her CF. As per clinic notes the patient has had Pneumonia X 2 in the past month which required treatment with Oral and intravenous (IV) antibiotics (Abx). The patient's symptoms included wheezing, coughing and hemoptysis. Patient was also noted to have some decline in her lung functions
FVC (forced vital capacity) 2.22 68%
FEV (forced expiratory volume) 1 1.25 48%
FEV1/FVC ratio 56 %.

For patient's mutation Ivacaftor and Tezacaftor / Ivacaftor is also approved but the patient did not tolerate it.

The patient's medical doctor (MD) is requesting approval for Trikafta a combination of Elexacaftor, Tezacaftor and Ivacaftor.

This combination has not been approved by the FDA (food and drug administration) for the mutation that this patient has. There are no studies that have shown benefit of this product in patients with mutation that this patient has. The data is anecdotal.

Based on above Trikafta cannot be approved for this patient at this time.

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for Trikafta is upheld.