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202305-163310

2023

Aetna

PPO

Respiratory System

Pharmacy/ Prescription Drugs

Formulary Exception

Upheld

Case Summary

Diagnosis: Asthma
Treatment: Alvesco (Ciclesonide) inhaler
The insurer denied coverage for Alvesco (Ciclesonide) inhaler
The denial is upheld

Patient is an adult who has a history of mild persistent asthma and allergic rhinitis. She was followed by her allergist. As per clinical notes, the allergist was recommending an inhaled corticosteroids (ICS) Alvesco (Ciclesonide) instead of the formulary preferred ICS Flovent (Fluticasone) hydrofluoroalkane (HFA) and Pulmicort (Budesonide) Flexhaler.

Patient is followed for her asthma by her allergist and is on Alvesco (Ciclesonide) inhaler and nasal steroids (Flonase) and Allegra for allergies. Reportedly she had seen her dentist and was to undergo a dental procedure and her dentist was recommending another product instead of Pulmicort which according to her was causing cuts and sores in her tongue and mouth. Her allergist recommended Alvesco as it as a different breakdown in the oral cavity and is mainly activated in the lungs. However, the physical examinations documented in the medical records does not reflect any pathology such as thrush etc.

Moreover, comparative studies between these products - Ciclesonide, Budesonide and Fluticasone have not shown any superiority of Ciclesonide over these two products which are similar products (which are on the preferred drug list of the insurance company) Though theoretically there may be some lower deposition of the product in the mouth because of its mechanism of activation, the clinical notes provided do not reveal any such findings on this patient's clinical exam.

Based on above, Alvesco cannot be approved at this time without demonstration that the patient has tried the 2 available alternatives and has either failed to respond or has side efficacy from them.

The formulary drugs are not expected to cause adverse effects.

The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.

The formulary drug is not expected to be ineffective.

The non- formulary drug is not expected to be more effective than the formulary alternatives.

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

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