Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Asthma.

Treatment: Alvesco (ciclesonide).

The insurer denied coverage for Alvesco (ciclesonide).

The denial is upheld.

This is a child with a history of a congenital diaphragmatic hernia and resulting right lung hypoplasia. The patient required a tracheostomy tube and although noted in the medical record to have tracheomalacia there is a note in the record of a normal bronchoscopy. There is also a history of a tracheal cutaneous fistula, which is closed. 

The patient was diagnosed with mild persistent asthma and pulmonary function testing showed moderate airflow obstruction, which improved following bronchodilator. The patient was started on Flovent 44 micrograms (mcg) twice daily (BID), and the medical record indicates that the patient has improved and is doing well with no asthma episodes. The patient is playing baseball with no shortness of breath. The patient has short stature and was seen by endocrinology. The patient was treated with a sample of Alvesco for 2 months and is noted to have tolerated this medication. It is noted that the patient failed to improve with Flovent and the request is approval for ongoing treatment with Alvesco because the other formulary options are breath-activated devices and cannot be used with an aero chamber and because Alvesco has the lowest risk of impacting growth in children.

The insurer has recommended that the formulary options for treatment for this child are Arnuity Ellipta, Flovent Diskus, Flovent hydrofluoroalkane (HFA), Pulmicort Flexhaler, and QVAR Redihaler. Alvesco is not an approved drug on the insurer's formulary.

The formulary drug is not likely to cause an adverse reaction.

The formulary drug has not been ineffective based on clinical history.

The requested drug is not likely to be more effective than the formulary drug.

The patient has been treated with Flovent with a good clinical response. The patient is playing baseball with no shortness of breath and has had no asthma exacerbations while taking Flovent. This does not support the note from the appealer that the patient did not respond to treatment with Flovent.

The theoretical benefit of Alvesco being a prodrug and therefore reducing the risk of long-term steroid side effects is not a reason for the prescription of a non-formulary medication for a child who has had a good clinical response to a formulary medication. As per Up to Date "The effect of chronic inhaled glucocorticoid use in children on adult height appears small. Ciclesonide appears to have lower systemic absorption and therefore fewer systemic side effects, but a systematic review found no clear benefit-to-harm ratio favoring ciclesonide over budesonide or fluticasone."  In addition, it is important to note that Alvesco has not been approved for use in children under 12 years of age.

ALVESCO Inhalation Aerosol is a prescription medicine used for the control and prevention of asthma in adults and children 12 years of age and older. IMPORTANT LIMITATIONS OF USE: Alvesco is NOT indicated for children under 12 years of age.

The carrier's denial of a request for a Formulary Exception for Alvesco (ciclesonide) is upheld.