Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: ADHD
Treatment: Formulary exception for Jornay PM CAP (capsule) 20MG ER (extended release)
The insurer denied the Formulary exception for Jornay PM CAP (capsule) 20MG ER (extended release)
The denial is overturned

The patient is an adolescent male diagnosed with attention deficit hyperactivity disorder (ADHD) combined type and co-morbid autism spectrum disorder (Asperger Syndrome). The patient is prescribed Jornay PM once daily in the evening with potential benefit from this medication's unique mechanism of action and/or method of release, noted by the patient's prescribing clinician. The patient has failed to benefit from several alternatives including methylphenidate extended release (Concerta) and immediate release methylphenidate (Ritalin), Focalin immediate and extended release, Adderall XR (extended release) and immediate release (amphetamine-dextroamphetamine mixed salts), Vyvanse and supplemental use of guanfacine that were not effective. The case is complicated by fatigue, as well as other symptoms characteristic of ADHD (attention deficit hyperactivity disorder), including concentration difficulties and performance problems with school work.

The health plan denied coverage for the requested medication, Jornay PM, indicating that not all formulary medications were tried and failed. These formulary medications included dextroamphetamine (Dexedrine), which is the remaining formulary medication not tried and failed. The denial is on the basis of plan policy and guidelines that require that the non-formulary medication be used for an FDA (United States Food and Drug Administration) indication, not have been started with samples, and that records show that formulary medications were tried and failed and that the requested medication is medically necessary.

The clinician points out that the patient has been tried on immediate-release and extended- release formulations of various stimulants, as noted, and combinations of immediate release and extended-release stimulants, as well as supplemental use of guanfacine without an adequate or sustained clinical response. Again, the patient is prescribed Jornay PM once daily in the evening with potential benefit from this medication's unique mechanism of action and/or method of release, noted by the patient's prescribing clinician. Thus, the patient's clinician is requesting coverage for treatment with Jornay PM at an initial dose of 20 mg (milligrams) daily, indicating that the evening dosing strategy is more convenient for this patient who has demonstrated tolerability problems or lack of efficacy with multiple formulary alternatives, including use in combination.

Yes,  the health plan should cover the Formulary exception for Jornay PM.
In this case scenario, the only remaining formulary drug, dextroamphetamine, would also be ineffective for this patient, with medical certainty in view of the mechanism of action similar to other formulary alternatives. It would not be as effective as the requested non-formulary drug due to the unique method of release and evening dosing strategy with Jornay PM. It is not known whether the remaining formulary alternative or Jornay PM would differ in risk for adverse effects for this patient, as neither have been prescribed, and the request for Jornay PM is a pre-service request.

The appeal by the patient's clinician is reasonable and in the patient's best interest, and the rationale for the coverage exception reflects sound medical judgment in view of the patient's treatment history and clinical features. The services provided are in keeping with prevailing standards of medical practice for the condition under treatment in this case with an evidence-base treatment and in keeping with an FDA (United States Food and Drug Administration) approved indication. The requested treatment in this case is clinically appropriate and backed by credible scientific evidence known to benefit patients with the condition diagnosed in this case. The requested benefit with Jornay PM at the initial dose of 20 mg (milligrams) daily dosed in the evening is provided for the purpose of treating ADHD (attention deficit hyperactivity disorder), as clinically appropriate and indicated. It is entirely consistent with nationally recognized scientific evidence as available, and prevailing medical standards and the scientific literature and guidelines, referenced below.

The requested benefit of Jornay PM should be approved for 12 months, as the medication is being prescribed for a chronic condition that will require ongoing maintenance therapy in keeping with published guidelines, referenced below, and in keeping with prevailing standards of medical practice.