Concerta denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that a patient has requested reimbursement and prospective authorization and coverage for the brand name medication, Concerta. Stimulant medications, including methylphenidate formulations, are first-line pharmacological treatment for patients with attention-deficit hyperactivity disorder (ADHD). Approximately 70% of patients with ADHD demonstrate immediate improvement in attentiveness and reduced distractibility with stimulant therapy, with moderate-to-large effect sizes. Extended-release (ER) formulations such as Concerta provide six to 10 hours of symptom control with once-daily dosing, which improves medication adherence compared to immediate-release formulations. In this case, the patient has tried and failed multiple generic Concerta alternatives in the past, as well as multiple other stimulants and stimulant formations.

Nature of Statutory Criteria/Case Summary: The enrollee has requested authorization and coverage for Concerta.Findings: A study has concluded that adult ADHD is a prevalent but under-recognized disorder in psychiatry. Failure to identify and treat adult ADHD is linked to negative outcomes. Adult ADHD responds well to integrated pharmacological and psychotherapeutic intervention.In this case, the patient has been diagnosed with adult ADHD previously and has benefited from treatment with Concerta. The submitted records are consistent with a lack of misuse of the stimulant, and they reflect a clear benefit in her ADHD symptoms from the medication regimen. The patient has benefited from a low dose of Concerta, with her medication dosage remaining stable for 18 years, and without any medication adverse effects.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for methylphenidate HCL (Concerta) 54 mg, 90 count every 25 days, at dosage interval of four times a day. The U.S. Food and Drug Administration (FDA) approves the use of Concerta for the treatment of attention deficit hyperactivity disorder (ADHD). The FDA notes that the recommended dosage for adult patients should not exceed 72 mg/day. Researchers report, “The choice of stimulant is influenced by several factors; the most influential factor is the duration of action. Long-acting medication provides benefits long after school and work. It also increases the likelihood of once-daily dosing, thereby eliminating the need for mid-day dosing, making the treatment more private, avoiding stigma and improving adherence to medication.” Concerta is intended to be used once daily.

Nature of Statutory Criteria/Case Summary: An enrollee requested authorization and coverage for Concerta and modafinil for treatment of the enrollee’s major depressive disorder. Findings: The physician reviewer found that Concerta is a methylphenidate-based product that was approved by the U.S. Food and Drug Administration (FDA) for the treatment of attention deficit hyperactivity disorder (ADHD) in 2000. Concerta is a central nervous system psychostimulant that is thought to exert its clinical effect by blocking the reuptake of norepinephrine and dopamine in the prefrontal cortex. The unique extended-release tablet relies on osmotic pressure to steadily deliver methylphenidate resulting in a duration of effect that can approach 12 hours. The typical dose range of Concerta is between 18 mg and 72 mg once a day.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Concerta, then check the rights and deadlines that apply to your plan.