Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Attention deficit hyperactivity disorder
Treatment: Formulary Exception for Mydayis 25 mg (milligrams) CPTP (cyclopentyl-triazolo-pyrimidine) 24 hours
The insurer denied the formulary exception for Mydayis 25 mg CPTP 24 hours.
The denial is overturned.

This case involves an adult female family nurse practitioner diagnosed with attention deficit hyperactivity disorder (ADHD). She is currently prescribed and treated with stimulant medication, Mydayis (dextroamphetamine-amphetamine) extended release at a dosage of 25 mg (milligrams) daily. The patient demonstrated sub-optimal response to the usually effective dosages of Vyvanse and dextroamphetamine-amphetamine mixed salts (immediate and extended release). The patient indicates that family members have not responded to methylphenidate-based medications for ADHD. Moreover, the patient indicates that she has had a positive clinical response to Mydayis for over a year at the effective dose of 25 mg. 

The patient's health plan has denied coverage of the requested Mydayis; the health plan limits coverage of the medication with coverage exception criteria that requires that all formulary alternatives have been tried and failed before allowing a coverage exception.  Formulary alternatives include methylphenidate extended release and LA (long acting), and dextroamphetamine ER (extended release) and dextroamphetamine-amphetamine extended-release formulations, as well as atomoxetine and Vyvanse. Denial determination is on the basis of plan guidelines and the non-formulary review policy.

The appeal argues that Mydayis has a positive clinical response with tolerability and relative stability and improved functioning at work referencing long hours. The appeal notes that Mydayis has a "triple bead" delivery system that allows coverage for 9-14 hours, as opposed to the 3-8 hours of coverage with the formulary alternatives. The appeal references the failed trials of three other ADHD Stimulant medications, and notes that the denial determination is detrimental and a hindrance. The appeal also indicates that atomoxetine is contraindicated due to the risk for orthostasis and interaction with the patient's blood pressure medication, and that switching from a medication that is effective is not reasonable in her case. 

The health plan should cover the proposed treatment.

The appeal from the patient, a family nurse practitioner, reasonably argues that the continued treatment with Mydayis provides a more effective clinical response than all formulary alternatives, and that to switch from a medication that is effective and tolerated to another formulary alternative would pose risk for adverse effects and would not be as effective as the current treatment with Mydayis. Thus, the health plan should provide continued coverage for Mydayis, as was the case with the patient's previous health plan. Additionally, the appeal reasonably argues that the "triple bead" delivery system of Mydayis with a 9-14 hour half-life is a distinct advantage over all other stimulant formulary alternatives that are considered first-line treatment options for ADHD. This answer is consistent with prevailing standards of medical practice and with the scientific literature, referenced below.