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ADHD medication

Dr. Goodman discusses stimulant medications for ADHD on HCPLive

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With 28+ stimulant medications for the treatment of ADHD, there are many choices. The good news is there are many options, unfortunately this leads to confusion for the prescriber. A panel of national experts discussed topics on ADHD and I offered information on a basic concept to thoughtful choose medications. This information is useful for prescribers and patients who choose to understand the sequence of medication trials after the first one doesn’t work, doesn’t last long enough, or has side effects.

This segment is a portion of the longer discussion on ADHD topics by the panel. You can view other segments at HCPLive.

Better information for better treatment. Thank you for your interest.

David W. Goodman, M.D.

NBC News interviews Dr. David W. Goodman for the new study on stimulants for ADHD and psychosis risk. March 21, 2019

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Stimulants for ADHD and risk of psychosis has been a clinical concern but the risk has thought to be quite low. Dr. Goodman’s comments about the study can be read here. The recent New England Journal of Medicine study has demonstrated the risk of psychosis with amphetamines is 0.2% and methylphenidate is 0.1%. These findings were generated from two very large health insurance databases. The study analysis are statistically sound and the authors duely note limitations to be considered when interpreting the data. While the risk of psychosis is a clinical concern and should be identified quickly when it occurs, it is a rare phenomenon. The Number Needed to Harm is 1 in 660. That means that this event may occur once in 660 patients.

For patients, families, and prescribers, effective medications for ADHD should not be avoided because of these findings. While the risk of psychosis from stimulants is rare, the negative consequences of ADHD are numerous: more likely to not finish high school, more likely to drop out of college, more likely to take longer to finish college degree, more likely to be involve in criminal behavior and get arrested, more likely to abuse drugs and alcohol, more likely to have concussions, more likely to have multiple jobs over 10 years, more likely to be in motor vehicle accidents/injuries, more likely to get divorced, more likely to declare personal bankrupcy, more likely to be fired from a job….get the idea! Untreated ADHD impact on life is far greater than the rare risk of psychosis occurring.

If you or a loved one starts acting peculiar or saying things that sound bizarre while on ADHD medication, this is the time to consider psychosis. Contact the treating prescriber and alert them. The person should get evaluated as quickly as possible.

David W. Goodman, M.D., FAPA

Insurance companies restrict psychiatric medications for this patient Part 2

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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?”

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

Arbitrary medication denials leads to restriction of optimal treatment

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In my periodic entries of insurance companies’ denial of ADHD medication dosing, I offer you this recent example.

A female in her late 20s treated for ADHD with a combination of Adderall XR and Strattera. Strattera adds a benefit for her executive function not optimized with Adderall XR. I carefully dosed the Strattera upward and suggested increase to 120 mg daily.

Well, the folks at BlueCross Northeastern Pennsylvania denied the dose “As per the FDA recommended dosing guidelines for Strattera in adults the maximum dose is 100 mg per day.” Correctly stated per the package insert for Strattera. “There are no data that support increased effectiveness at higher doses. Therefore medical necessity for 120 mg of Strattera per day has not been met.”

This last statement is a misrepresentation of the purpose of a drug package insert. In fact, the adult registration trial for Strattera submitted to the FDA lists the dose that was used as up to 120 mg daily. Registration trials are designed for the purpose of seeking drug approval for a specific disease state. This research DOES NOT answer the question “If the patient is suboptimally treated with x dose, will they improve further with a higher dose?” So the logic of their denial is a misrepresentation of research for the sole purpose of constricting treatment and conserving money, in my opinion.

Yet more damage is done with these letters. People reading these letters may think the doctor is over-dosing them and not considering safety issues. This is simply not true since safety data on medications are routinely undertaken at much higher doses. There was no unusual safety concern with Strattera at 120 mg daily in the adult registration trial.

It is unfortunate that I find myself blogging about the denial of medication authorizations for my patients who clearly need better outcomes from their medications. While these companies have set up appeal processes, this tends to administratively time consuming without any guarantee that the medical necessity and logic of the dose request will be reviewed with the patient’s interest in mind.

So, what can YOU do if this happens to you? Here are the steps:

1. Call the insurance company and respectfully explain why you need your medicine. If the person is unresponsive, ask to speak to supervisor. If you don’t get to speak to someone with authority, ask if the conversation is being recorded and tell them to “tag” the audio file so that the State Insurance Comissioner’s Office with be able to listen to the audio file. Now, write down the date and time.

2. File a complaint with your state insurance commissioner’s office. You can find the contact information online by searching “<your state> insurance commissioner office”. In your complaint, which should only be one page (no reads anymore), state your brief history of medication history and why it is necessary to have the new dosing authorized for coverage. Write that you spoke with the insurance on what date and time.

In my experience, more often than not, you’ll be getting your approval. However, no guarantees. Good luck.

 

Insurance companies routinely denying higher stimulant doses

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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.

 

 

FDA improves Drug Labeling for Pregnancy and Lactation

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Over the years, it has been challenging for psychiatrists to manage the risks of psychiatric medications in patients who considered childbearing, become pregnant, and chose to breastfeed. And while there is some information on many psychiatric medications, there remains little in regards to stimulant medications. Unfortunately, there is no registry for stimulant exposed pregnancy by which we can gain insight into their relative risk. The information we do have is related to animal research or people who have been active substance abusers. Very little of this research helps me in discussing evidence-based medication decisions with my patients. In my capacity as a researcher, I have had conversations about creating a stimulant pregnancy exposure registry with the pharmaceutical companies involved in ADHD but to no avail as yet.

With the proposed FDA changes in drug label for pregnancy and lactation, I hope we’ll have a better method of reviewing and evaluating relative risks and patients/families will be better informed.

The following article was distributed today, December 8, 2014 by the American Psychiatric Association, Psychiatric News Alerts.

FDA to Change Pregnancy and Lactation Labeling Information for Prescription Drugs

On Wednesday, the Food and Drug Administration (FDA) published a final rule that will set new standards for presentation of information concerning pregnancy and breastfeeding on labels of prescription drugs and biological products. The rule goes into effect June 15, 2015. “The [current] letter category system [A, B, D, and X] was overly simplistic and was misinterpreted as a grading system, which gave an oversimplified view of the product risk,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, in a press statement. “The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus, and the breastfeeding child.” The information provided under the new labeling requirements will be divided into the following categories:

Pregnancy: Containing information such as dosing and potential risks to the developing fetus and will require information about whether there is a registry that collects and maintains data on how pregnant women are affected when they use the drug.

Lactation: Containing information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed child.

Females and Males of Reproductive Potential: Containing information about pregnancy testing, contraception, and infertility as it relates to the drug.

“The new system is potentially more informative and more useful than the old grading system, … [but] a great deal will depend on the content of the information that is provided under the new requirements, particularly for psychotropic medicines,” stated Nada Stotland, M.D., a professor of psychiatry at Rush University and an expert in OB-GYN psychiatry, in an interview with Psychiatric News. “If the information provided is reasonable and clear, it should help decrease the anxiety both psychiatrists and patients may feel regarding these medication decisions.” Stotland, a former APA president, emphasized that psychiatrists must continue to inform the public about multiple treatment options—including psychotherapies and social support therapies—that can safely aid in lessening symptoms of mental illnesses during pregnancy. “If left untreated—or unsuccessfully treated—mental illness can have adverse consequences for both mother and child,” she emphasized.

David W. Goodman, M.D.

Yes, you are losing medical benefits slowly and surely!

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As time goes on, my patients are increasingly complaining about the loss of medication coverage or no longer affordable medication copays. Well, they are right and here is the proof. The following text was posted today by the American Medical Association with a link to Bloomberg News. Unfortunately, the public was never informed that the Affordable Care Act would prompt the insurance companies to change contract coverage to deny your medication that had effectively treated you for years. Health care has clearly morphed from effective treatment to contracted treatment. And this is the difference between being a patient (treatment under ethical guidelines) and being a consumer (treatment under legal parameters). Choose to be a patient first and consumer second, not the other way around.

Analysis: Benefit managers excluding more medications next year to cap costs.

In a 1,900 word analysis, Bloomberg News (11/26, Langreth) examines the trend for healthcare benefit managers such as Express Scripts to increase the number of drugs they exclude from coverage in order to keep a lid on prices. Express Script will be excluding 66 branded therapies from its main formulary next year, an increase from 48 this year, including the rheumatoid arthritis drug Simponi (golimumab). Meanwhile, CVS Health is excluding 95 drugs from its 2015 formulary.

To those of you who read this information, thank you for your interest and I hope it is insightful.

David W. Goodman, M.D.

Sav-Rx reverses denial of effective Adderall XR dose for my adult patient

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Sav-Rx reversed its initial denial of my patient’s Adderall XR 80 mg  daily after receiving my letter of appeal. In my letter, I highlighted the stable effective dose had been prescribed for quite sometime. Their initial reason for denial was a citing that FDA approved max daily dose was 60 mg in the morning. In fact, the package insert for Adderall XR has no stated max daily dose for adults with ADHD.  Fortunately for my patient, Sav-Rx reconsidered its decision.  See below for my original blog describing the situation.

With an increasing number of adults being nearly diagnosed with ADHD, the expense of ADHD medications for insurance companies has escalated. While the annual prescription increase for childhood ADHD is less than 3%, the ADHD prescription market is growing at approximately 10% per year. As a result of this change, companies are under increased pressure to reduce their pharmacy expense. While this issue is certainly not limited to ADHD medication, my patients are finding the course of the medication treatment disrupted by insurance companies obstructionistic prior approval requests for long-acting stimulant medications.

Patients and their treating physicians may struggle for some time to find the most effective individualized medication dose that produces an optimal reduction in symptoms with tolerable side effects. Patients have recently found insurance companies changing their coverage of authorized medications. That means, that despite prior approval for your current medication, the new coverage change may no longer authorize the medication and/or dose. This is becoming extremely disruptive to my patients finding themselves forced to change medication because of high deductibles, leaving them paying hundreds of dollars a month for their prior effective medication.

To give you a specific example, SavRx,  a prescription management service in Fremont, Nebraska, informed my patient who has been treated with Adderall XR  80 mg in the morning for the past six months that the coverage for this was no longer available to her, despite the fact that it had been approved by the previous pharmacy management company. Having submitted the documentation of effective treatment for months, SavRx is still not approving her optimal dose.

My recent experience indicates that this approach to medication authorization is increasing in frequency across several companies. I will continue to post blogs giving examples from other companies.

My suggestion to patients who encounter this issue with their treatment is to call your insurance company and complain about your specific case. The insurance companies may not be aware of what is happening and they certainly don’t want unhappy subscribers, let alone bad public press. We will soldier on.

CVS/Caremark deny prescription for bogus reason

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With each passing day, I encounter an increasing number of obstructions by insurance companies to authorize and provide my patients with their much needed medication. In my last blog, I highlighted Sav-Rx bogus reason to deny my patient the authorization to continue effective medication because of a change in policy coverage despite being on this dose for over 6 months .

Today, I’ll highlight CVS/Caremark’s explanation for “canceled” prescription to a patient who was on Vyvanse 70 mg in AM but needed to reduce the dose to 60 mg in the morning because of difficulty falling asleep. Here is the quote for canceling the 60 mg prescription sent to them.

“We were unable to fill this prescription because taking it is not advised based on your allergies, health conditions or potential interaction with another drug you are taking. Please contact your prescriber for assistance.”

While you might think there is legitimacy in this reason under the guise of safety, the fact is that the patient has been on Vyvanse since 2008 and there has been no clinical relevant change in his treatment that merits CVS/Caremark’s reason.

Such denials under the seeming auspicious of patient safety seem to be nothing more than denial of coverage for cost containment, in my opinion.

I encourage patients to call insurance companies and complain. When that doesn’t work, file a one page complaint with the State of Maryland Insurance Commissioner’s office. This office needs to be aware of the denial of treatment by insurance companies with regard to medication treatments for ADHD.

I intend to post more examples of such denials by specific companies along with the quoted explanation of denial. Perhaps someone with influence over this issue will find these examples ample evidence to formally question the insurance coverage of this and other medical treatments.

October is National ADHD Awareness Month and this issue should be part of the discussion. Please make your comments here so I can see if I’m hitting a nerve.

SavRx disrupts effective ADHD treatment

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With an increasing number of adults being nearly diagnosed with ADHD, the expense of ADHD medications for insurance companies has escalated. While the annual prescription increase for childhood ADHD is less than 3%, the ADHD prescription market is growing at approximately 10% per year. As a result of this change, companies are under increased pressure to reduce their pharmacy expense. While this issue is certainly not limited to ADHD medication, my patients are finding the course of the medication treatment disrupted by insurance companies obstructionistic prior approval requests for long-acting stimulant medications.

Patients and their treating physicians may struggle for some time to find the most effective individualized medication dose that produces an optimal reduction in symptoms with tolerable side effects. Patients have recently found insurance companies changing their coverage of authorized medications. That means, that despite prior approval for your current medication, the new coverage change may no longer authorize the medication and/or dose. This is becoming extremely disruptive to my patients finding themselves forced to change medication because of high deductibles, leaving them paying hundreds of dollars a month for their prior effective medication.

To give you a specific example, SavRx,  a prescription management service in Fremont, Nebraska, informed my patient who has been treated with Adderall XR  80 mg in the morning for the past six months that the coverage for this was no longer available to her, despite the fact that it had been approved by the previous pharmacy management company. Having submitted the documentation of effective treatment for months, SavRx is still not approving her optimal dose.

My recent experience indicates that this approach to medication authorization is increasing in frequency across several companies. I will continue to post blogs giving examples from other companies.

My suggestion to patients who encounter this issue with their treatment is to call your insurance company and complain about your specific case. The insurance companies may not be aware of what is happening and they certainly don’t want unhappy subscribers, let alone bad public press. We will soldier on.

 

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