Diagnosis: Asthma.
Treatment: Ventolin HFA.

The insurer denied Ventolin HFA. The denial is upheld.

The patient is a male with a history of asthma who is requesting coverage for brand name Ventolin HFA (albuterol). In an appeal letter, his provider stated that the patient's asthma was well controlled on brand name Ventolin, but, according to the patient, a recently tried generic form of the medication was ineffective. There are no medical records further documenting the aforementioned clinically ineffective trial, or other previous ineffective trials.

The health plan's determination is upheld.

Besides the brand name Ventolin HFA, there are six other generic metered dose albuterol inhalers on the market that are approved by the Food and Drug Administration (FDA). To gain FDA approval for a generic product, the manufacturer needs to demonstrate that their product must perform the same in the body as the brand name, meet the same high standards of quality in manufacturing, and use the same active ingredients. The patient's pharmacy plan requires evidence of failure of at least two of the preferred agents. In this case, there is relatively weak evidence (the patient's report documented in an appeal letter) that he failed only one trial of generic albuterol. Therefore, based on the standard of care, as well as the peer reviewed literature, FDA's recommendations, the numerous generic options, it cannot be demonstrated the formulary drugs would not be effective for this patient.