Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Attention deficit hyperactivity disorder (ADHD)
Treatment: Formulary exception for Adzenys XR-ODT 
The insurer denied: Formulary exception for Adzenys XR-ODT
The denial is overturned.

The patient is an adult female diagnosed with attention deficit hyperactivity disorder (ADHD). The patient has been prescribed Adzenys XR-ODT (extended release orally disintegrating tablet) 18.8 milligrams daily with a satisfactory clinical response without side effects for several years. Comorbid conditions include bipolar II disorder treated with Abilify and Lexapro, as well as hypertension and type II diabetes mellitus with associated treatments together with a history of gastric bypass surgery. The patient's prescribing clinician is requesting coverage for continued treatment with Adzenys XR-ODT (extended release orally disintegrating tablet) for ADHD (attention deficit 
hyperactivity disorder). The patient was previously treated with extended-release formulations of amphetamine-dextroamphetamine mixed salts and methylphenidate without benefit and/or adverse effects causing tolerability problems. The denial is based on plan criteria and health plan guidelines for a coverage exception requiring that three formulary alternatives be tried and fail before coverage is allowed for a non-formulary drug (step therapy). Formulary alternatives include amphetamine-dextroamphetamine mixed salts extended-release, methylphenidate extended-release, dexmethylphenidate extended-release, and Azstarys. The denial determination indicates that the requested medication is not covered, as 
there is insufficient evidence to show superiority to formulary alternatives. The appeal notes that Adzenys XR-ODT (extended release orally disintegrating tablet) is the only stimulant medication that does not pose a risk for raising heart rate in a patient with hypertension.

The health plan should cover the Formulary exception for Adzenys XR-ODT (extended release orally disintegrating tablet).

There is no evidence that the remaining formulary drugs would be as effective as the requested non-formulary drug or would have adverse effects for this patient who has been treated with 
Adzenys XR-ODT (extended release orally disintegrating tablet) since 2016 with a positive therapeutic effect and tolerability. Moreover, the appeal reasonably indicates that to discontinue a drug that is effective and well tolerated would be detrimental to the patient, and the use of Adzenys XR-ODT (extended release orally disintegrating tablet) is favored due to the lower risk for adverse cardiovascular effects. The treatment provided is in keeping with prevailing standards of medical practice for the condition under treatment in this case with an evidence-base treatment; and the requested services/treatment being provided in this case is clinically appropriate and is backed by credible scientific evidence known to benefit patients with the condition diagnosed in this case. Specifically, in this case, the patient has been prescribed the requested treatment with Adzenys XR-ODT (extended release orally disintegrating tablet) 18.8 milligrams daily in order to address symptoms of ADHD (attention deficit hyperactivity disorder). Thus, it is in the patient's best interest to continue to receive this medication that provides clear therapeutic benefit. The requested benefit with Adzenys XR-ODT (extended release orally disintegrating tablet) 12.5 milligrams daily is provided for the purpose of treating ADHD (attention deficit hyperactivity disorder), and is clinically appropriate and indicated; and is entirely consistent with nationally recognized scientific evidence and prevailing medical standards and clinical guidelines, including a review provided in The Medical Letter and the scientific article by Elliot et al (2020) that outline the benefit of the requested benefit of Adzenys including the unique pharmacology with regard to an ODT (orally disintegrating tablet) delivery system. The requested medication is medically appropriate.