In my previous blog, I wrote, in general, about the increasing obstacles set up by insurance companies to restrict psychiatric medications to patients. Today, I’ll tell you a specific example of how a medication dosing thoughtful established for a patient was denied despite both clinical and research evidence to support my dosing recommendations.
My patient Jill (not her really name) is a high functioning woman in her early 60s who is employed by a federal scientific agency. She was diagnosed with ADHD 20 years ago by very knowledgable psychiatrists and treated with medication over the years. When Jill started seeing me in August 2015, her dosing of Focalin XR was 20 mg twice a day but the effect was not lasting throughout the day. A single dose of Focalin XR 20 lasted approximately 4 hours so the dosing was increased to 20 mg three times a day. This dosing would be considered outside product label as the PDR max daily dose is 40 mg. Yet, without adequate duration of action, 3 times a day dosing is very reasonable. Blood pressure and pulse were not elevated.
Because even 3 times a day dosing wasn’t adequate, I changed to Concerta because the delivery technology is different and, perhaps, the absorption of drug would be better. However, because it was clear the absorption and/or the metabolism was accelerated, I anticipated the need for higher dosing of Concerta.
Concerta was gradually increased to 108 mg in AM and 54 mg at 1pm. With this dosing, patient was satisfied with the effect and duration of action of the medication. The afternoon dose mitigated the wear-off effect at 2 pm of the morning dose.
The challenge to this dosing came from the insurance company who initially denied the dosing on the basis of PDR listing max daily dose of 72 mg in adults. I filed an appeal given the patient’s positive response and research support for this dosing.
Dr. Tellioglu , an addiction physician in Rhode Island, was assigned the case review for BlueCross BlueShield Federal Employee Program and called me to review the specifics. When we spoke, he informed me that he had no information on the patient “not even a birth date”. Really? He didn’t even have the letter I sent to the insurance company with supporting information for the patient’s dose.
I explained how I arrived at the dosing and the likely interference of effect by absorption and/or metabolism. He asked if I had run a genetic profile to establish metabolic issues. “No.”, I replied as there are no such tests. While genetic profiling can be ordered to look at liver enzymes for metabolism, methylphenidate, the drug in Concerta, is not metabolized through the liver, instead it is metabolized through the blood serum and this enzyme is not assayed. Blood levels of methylphenidate can be obtained but the blood sample has to be processed quickly or the methylphenidate degrades in the test tube. So, I explained, given these variables, effective dosing is established based on clinical response and symptom reduction.
Dr.Tellioglu went on to explain that the FDA max daily dose was established for efficacy and safety. I pointed out that that was not the case and highlighted that the U.S. clinical trial with Concerta in adult ADHD dosed subjects to 108 mg in the morning (Adler et al 2009). At that dose, there were no significant safety concerns by the FDA and the study had been approved by an IRB (agency responsible for overseeing the safety of clinical research trials). In fact, in that trial, over 30% of the adult subjects were on ≥90mg in the morning. Notice that one third of the adults needed a Concerta dose higher that what the FDA approved for max daily dose.
He was unfamiliar with this research and said “I don’t need to read that to come to my conclusion.” I also pointed out there is a published study in adult ADHD with dosing to 144 mg in AM (Biederman et al, 2005) with no report of significant safety findings. A study in children and adolescents with ADHD investigated methylphenidate blood level with high Concerta dosing (mean dose 170 mg in AM) found unexpectedly low blood levels of methylphenidate with no significant safety issues (Stevens et al, 2010). Remember, this was a child, not adult, study. I offered to forward these studies to him but he repeated his position that the FDA didn’t authorize dosing above 72 mg a day.
So, despite research publications to support higher Concerta dosing in adults with ADHD and a thoughtful clinical approach, he expressed no interest in reviewing this literature. This literature does support using higher than usual dosing in those adults who have suboptimal reduction of ADHD symptoms at “recommended daily dosing”. Absorption can be disrupted by gastric acid content that is modified by Nexium, which Jill was on.
Here is the explanation from the insurance company following their review of the appeal.
“the dosage requested exceeds maximum prescribing guidelines and therefore medical necessity is not established for this drug. Medical necessity is determined by adherence to generally accepted standards of medical practice in the United States, is clinically appropriate, in terms of type, frequency, extent, site, duration and considered effective for the patient’s illness, injury, disease, or its symptoms.”
Do you think this was written by a doctor or lawyer? Was I naive to believe I would get anything other than a pro forma template letter?
In my previous blog, I outlined some of the conflict of interests inherent in these “independent reviews”. In my opinion, the circumstance of this patient’s review reflect a disregard by Dr Tellioglu for patient care to the benefit of the insurance company and the physician reviewer. While I understand the motives of cost containment for the insurance company, in my opinion, the physician reviewer’s ethics are compromised when in the face of reasonable clinical decisions and research support, he/she finds in favor of their “employer’s” interests. Physician ethics dictate that a patient’s medical interest is first and foremost.
If you have reached this paragraph, you have been interested in the story and eagerly awaited “What can I do?”
- If an appeal is needed, discuss with your physician/prescription writer how to coordinate the effort. While the physician can provide the medical justification, it is VERY important that you contact and write your concerns and need for your medication to the insurance company. Believe it or not, the companies actually are concerned about patients opinions, as social media becomes very influential.
- If the response from the company is unsatisfactory, take the documentation that your physician provided to the insurance, write a letter of explanation of circumstance and send it to your state Insurance Commissioner Office. They in turn will likely send it to the insurance company for “reconsideration”. Insurance companies don’t like these offices accumulating complaints against them.
- It may be possible to get the name and phone number of the physician reviewer from your doctor. Give that reviewer a call yourself and explain your circumstance and experience with previous treatment. I confess, the reviewer will not be happy to hear from you and may express anger. So what! That person has some responsibility for your medical care and needs to know it effects a real person’s life.
- You may also consider send a copy of your letter (without the medical documents) to a state senator. In Maryland, I have been impressed with the attention some of my patients have received.
- However, the strength of your position and the need for the specific medical treatment lies in the clinical course of symptoms/treatment and research support. You don’t get what you want just because you want it.
This is a very long blog and I apologize. Unfortunately, there was simply no way for me to convey briefly the complexity of this situation. For those of you who have encountered this situation, I hope this illustration and information is helpful in better arming you for these challenges.
David W. Goodman, M.D.
