Almost everyday insurance companies request pre-authorization for stimulant medication for my patients. While many of these requests are approved, many others are not. One obstacle to approval is stimulant dosing. Insurance companies routinely deny coverage for any stimulant dose that exceeds FDA drug label maximum dose. You might believe this is a safety issue and insurance companies are serving you well. I’d like to believe this too. Unfortunately, their decisions are often a guise for cost savings.

In order for you to understand the process, you need to know how the FDA approves the dosing of medication that it approved for a disease/disorder. Let’s take Concerta for example. The registration trial submitted to the FDA was conducted in the U.S. (Adler L, et al) with another trial conducted in German. The U.S. trial for adults had a dosing started at 36 mg in the morning and could be adjusted up to 108 mg in the morning if the subject had not achieved a predetermined improvement level. The FDA approved Concerta 72 mg as the maximum daily dose in adults. Why? Didn’t you say the trial went to 108 mg a day?

Yes, I did. The FDA decided that the higher doses (90 and 108 mg daily) didn’t produce any greater improvement than 72 mg daily. However, the trial was not designed to answer the question “If you don’t response to 72 mg, would your ADHD symptoms decline with 90 or 108 mg?”. Well then, of the subjects in the trial, what was the distribution of doses amongst all the adult subjects? (Remember, the researcher could increase Concerta dose if the subject hadn’t improved to a defined threshold on an ADHD rating scale)

Dose(mg)             % of subjects

36                                 34%

54                                  15%

72                                   18%

90                                   15%

108                                 21%

So, you’ll notice that 36% (15+21) of adult subjects needed a dose over the FDA max daily dose.  That’s 1 out of 3 subjects. Imagine that you are that patient whose ADHD needs a higher dose. Imagine that your doctor, unfamiliar with this research, tells you he can’t prescribe at doses higher than FDA approved max daily doses. Imagine that your insurance company denies what would otherwise be an effective dose. Imagine that you believe that the FDA max dose is related to safety (it’s not in this case). Imagine that the insurance company uses language to intimate safety concern.

The outcome of this imagination? UNDERTREATMENT. Persistent symptoms and daily impairments.

I provide this information so that my patients are educated about the state of the art for ADHD treatment and how to understand the avalanche of information available. Make the distinction between being informed by information and being educated by information.Being informed means having access to the information. Being educated means you understand how to interpret the information. The internet provides the former, I hope your physician provides the later.