Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Attention Deficit Hyperactivity Disorder. 
Treatment: Vyvanse 40 mg cap. 

The insurer denied Vyvanse 40 mg cap. 
The determination is overturned. 

The patient was diagnosed with attention deficit hyperactivity disorder (ADHD)-inattentive type. The patient has demonstrated a response to Vyvanse 40 milligrams (mg) daily with noted benefit from this medication. The patient has tried and failed treatment with generic formulations of Adderall and with dextroamphetamine which caused adverse effects with tolerability, and has serious side effects with other generic formulations of stimulants. 
The patient's prescribing clinician is requesting continued coverage for her treatment of ADHD with Vyvanse for ADHD with the daily dose of one 40 mg capsule. The Vyvanse is targeting symptoms of ADHD with positive effect and improved social and occupational functioning in response to the medication. 
The Vyvanse was denied by the plan indicating that all formulary alternatives must be tried and failed before a coverage exception would be allowed for a non-formulary medication. Formulary alternatives include generic formulations of Adderall and Strattera, as well as methylphenidate extended release (generic Concerta and Metadate controlled drug (CD) or extended release (ER)).
The health plan documents including correspondence were reviewed. Appeal documents and correspondence from the patient's prescribing clinician were reviewed. The health plan medication specific criteria for coverage of Vyvanse was reviewed, as submitted per the prior authorization criteria and plan guidelines pertaining to lisdexamfetamine (Vyvanse). The health plan rationale for the denial of coverage of Vyvanse was reviewed and the plan language (Summary Plan Description) was reviewed. 

At issue is whether the formulary drugs will be or have been ineffective, would not be as effective as the non-formulary drug Vyvanse 40 mg cap or would have adverse effects. 

In this case scenario, the formulary drugs [generic Adderall (dextroamphetamine/amphetamine), atomoxetine, methylphenidate ER or extended release (such as generic Concerta, Metadate CD and Metadate ER) and dexmethylphenidate ER (generic Focalin XR)] will be ineffective, and would not be as effective as the non-formulary drug Vyvanse 40 mg cap, as this patient has a history of serious adverse effects with generic stimulants. 

The patient has been successfully and effectively treated with Vyvanse with a daily dose of 40 mg with tolerability and improved functioning; she has an executive level position and Vyvanse has been effective in addressing the symptoms of ADHD with coverage of Vyvanse provide by her previous health plan before joining the current plan. Thus, it is unwise to switch the patient from a medication that is effective and tolerated to one of the formulary alternatives in view of the treatment history. Indeed, in this case scenario, any formulary alternative poses a higher risk for adverse effect and provides only a 50-70 percent probability of a clinical response with medical certainty. 
The requested benefit of Vyvanse at a daily dose of 40 mg per day is medically necessary and clinically appropriate with regard to the indications for use. Vyvanse is being prescribed by a mental health practitioner. Additionally, Vyvanse is prescribed for a patient who benefits with regard to improved symptoms and functioning, and who has been effectively treated at the current dose of 40 mg daily. 
The requested Vyvanse is backed by scientific evidence that means the results of controlled clinical trials or other studies are published in peer-reviewed, medical literature; the requested medication for the diagnosis of attention deficit hyperactivity disorder is generally recognized by the relevant medical specialty community; and is consistent with prevailing medical standards and clinical guidelines including national consensus statements, nationally recognized clinical guidelines, and national specialty society guidelines. Vyvanse at a daily dosage of 40 mg daily for the treatment of attention deficit hyperactivity disorder (ADHD) is reasonable, in the patient's best interest, and consistent with prevailing standards of medical practice, as well as the Food and Drug Administration (FDA) indicated use for the treatment of ADHD at a dose that has been prescribed. 
In this case, the patient has demonstrated a clinical response to the requested treatment with Vyvanse 40 mg daily; thus, it is in the patient's best interest to remain on this medication that provides clear therapeutic benefit, especially with respect to daily functioning as opposed to a switch to a formulary alternative that poses greater risk for adverse effects and lower probability of a clinical response. The requested benefit with Vyvanse 40 mg daily is provided for the purpose of treating ADHD, as clinically appropriate and indicated; and is consistent with nationally recognized scientific evidence as available, and prevailing medical standards and clinical guidelines, referenced below.