Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Asthma.
Treatment: Asmanex HFA (mometasone furoate).

The insurer denied coverage for Asmanex HFA (mometasone furoate).  The denial is overturned.

The insurer has denied coverage for Asmanex HFA (mometasone furoate). In a Final Adverse Determination letter, they stated that the medication is medically necessary when the Food and Drug Administration (FDA) has approved the drug for the patient's health condition or professional medical sources indicate that the drug works well for the patient's condition. The medication may be approved if the patient is 6 years and older and the patient cannot be treated with a formulary medication. Also, there can be documentation that the patient may not be able to take the formulary alternative due to an inadequate treatment response. The formulary alternative is Pulmicort Flexhaler. 

The patient's Pediatrician is appealing. The summary of the appeal stated that the patient has been on Asmanex with good control of asthma symptoms. The physician recommended continuing with Asmanex. 

This is a child with a history of asthma. The patient also has delayed speech and development. Since being diagnosed with asthma this child has been maintained on 2 puffs twice daily inhalation treatment with Asmanex hydrofluoroalkane (HFA) via an aero chamber with a mask. The physician has determined that this therapy has been effective in controlling the child's asthma symptoms.

The insurer has developed a new formulary, which does not include any HFA inhaled steroid metered dose inhaler devices and they are requiring that this child be switched to the use of the Pulmicort Flexhaler, which is a dry powder inhaler device. The pediatrician is concerned that this device is not appropriate for this young child and has filed an external appeal requesting that this child be permitted to continue to be treated with prescribed Asmanex 50 microgram (mcg) for use 2 puffs twice daily (BID) to prevent asthma.

The delivery of aerosolized medication to children is complicated by anatomic and physiologic differences in their respiratory system compared to adults. A basic knowledge of the uses and limitations of aerosol delivery systems, the properties of the effective aerosols, and the anatomic considerations affecting aerosol delivery in children is essential to the optimum use of this therapeutic modality. The formulary preferred medication Pulmicort Flexhaler device is a dry powdered breath activated inhaler (DPI) and is much more difficult to administer appropriately in young children because to be effectively administered a high inspiratory flow rate is required to deaggregate and aerosolize the drug. Young children have a difficult time generating an inspiratory flow rate of 30 liters per minute (L/min) and a rapid inhalation after closing their lips around the mouthpiece that is required to insure optimal lung deposition. The difficulties in young children have with the administration of this device clearly will impact the benefit of this device for use in young children.

The insurer should reconsider their formulary change to require young children to be treated with corticosteroids using a dry powder inhaler.

The patient should be permitted to continue daily treatment with Asmanex HFA or an alternative HFA preparation.

The formulary drug is likely to cause the patient an adverse reaction. 

The formulary drug has been ineffective based on patient characteristics. 

The requested drug would be more effective than the formulary drug. 

The carrier's denial of a request for a Formulary Exception for Asmanex HFA (mometasone furoate) is reversed.