TMS in Clinical Practice: Patient Selection, Insurance Considerations and Logistic Aspects

Simon Kung, M.D.

Associate Professor of Psychiatry
Mayo Clinic

Last updated: March 14, 2019

 

  • Efficacy of TMS is similar to antidepressants, but not as good as ECT.
  • If insurance covers TMS, there might be requirements such as 4 failed antidepressant or psychotropic trials.
  • Use caution in patients with history of seizures; ferromagnetic materials within 30 cm of coil is contraindicated.

So next I’ll talk about some of the practical clinical aspects of TMS

So one question is always: Where does TMS fit into all of the different treatment options we have for patients? We have medications. We have ECT. Where does it fit? So one way to look at this is looking at the STAR*D study and that was – that study was – the results were mostly published in 2006. And in that study, they took depressed patients, gave them citalopram. And at followup, they looked at how many people met remission. So the first step, they showed about 28% of people met remission. So after that, what they did was they either switched the patients to another medicine or they added something to the citalopram. So that was level 2. And they looked at remission rates again and it’s about 21% to 30%. For the patients who did not remit after level 2, they did it again, switched to another medicine or added yet another medicine. And 16% to 20% and you can see on that graph.


So when one thinks about the remission numbers from the TMS studies that we looked at previously, the numbers range anywhere from like 14% with the NIMH trial to somewhere about 17% also for the Neuronetics trial. So when we look at that, we see that probably TMS fits somewhere within the first few medication trials. The official FDA indication for TMS is if a patient has failed one antidepressant trial, then TMS is doable. It turns out that most insurance companies in the US have different criteria. Most of them will say the patient has to have failed at least four different antidepressants or sometimes augmentation agents. And the information I’m showing you on the slides here is from a generic Medicare guideline in the US.


So the idea is the patient has to have major depression and either lack of response to antidepressants or antidepressant intolerance and there is a certain number of trials that they have to meet, for example, four different medicines that they couldn’t tolerate. A lot of these insurance companies will say if the patient has had TMS before and gotten better with it, then they’ll go ahead and approve it. The patient doesn’t have to jump through the hoops of another four different antidepressant trials if they’ve had TMS before and it helped. And a lot of the insurance companies will also say if ECT is recommended but there are some reasons that ECT cannot be done, then TMS would be reasonable. In addition to all of that, frequently insurance companies will say the patient also has to be in some kind of psychotherapy.


There are times when we do not want to do TMS on a patient and that’s if there’s a history of seizures and/or if there’s a seizure disorder. If they have cerebrovascular disease, dementia, increased intracranial pressure, severe head trauma, tumors, those are also conditions that we would say it’s better not to do TMS. And also if a patient has any kind of metal, either an implanted device within 30 cm from the magnetic coil such as a VNS stimulator where there’s a wire that ties up the vagal nerve, sometimes pacemakers if they go that high, sometimes if there’s some shrapnel, other ferromagnetic materials within 30 cm of the coil, cochlear implants, things like these, then we also do not want to give TMS. The worry there is because it’s ferromagnetic, it can really heat up. The device might heat up the implant and then that would cause some damage.


So off-label clinical use of TMS. So officially from the FDA, TMS is approved and there’s a certain age range. It’s actually ages 22 to 70. It’s what the FDA approved TMS for. So anything that we give a treatment that’s not FDA approved, we call it off-label. So if you’re treating a patient older than 70 years old, if you’re thinking it’s reasonable to do that, it would be considered off-label, similarly if it’s somebody younger than age 22. Bipolar depression is off-label. Other significant Axis I or Axis II co-morbidities are also off-label. Off-label use does occur in real life and insurance companies do not cover off-label use.


There are some practical selection criteria for TMS as well. A lot of times, patients come to us and they say – when you ask them, “How long have you been depressed?” they’ll say, “I’ve been depressed for 20 years.” So you want to kind of narrow down what is the current episode of depression. So hopefully, the patient will say I’ve been depressed for 20 years but really my current episode is the last year when such and such happened. A lot of times, I look for moderate treatment resistance. If a patient has been on 20 different antidepressants that have not helped, I’m less hopeful that TMS is going to fix that episode of depression. And sometimes if patients are not tolerant to medicines, that might be a good reason to try TMS as well. But remember that many patients don’t need medications after TMS.

The thought is TMS is not for psychotic depression. ECT would be a better choice if the patient has psychotic features of depression. TMS is not for psychiatric emergencies or urgent situations. And if somebody didn’t do well with ECT, I think it’s less likely they’re going to do well with TMS. But you will find case reports of a patient who didn’t do well with ECT but lo and behold TMS later on did help them.


Other considerations when you’re treating a patient with TMS are the logistics. So can the patient get to your facility for 30 treatments? So that’s six weeks that they have to go there every day, Monday through Friday. Usually, we don’t like patients to miss more than one day per week. Also the cost of TMS. Does the patient’s insurance cover TMS? And in terms of cost, a rough cost will be US$10,000 for 30 treatments and that also depends on the device that’s used because some devices it turns out you can – the way it’s used, you can get a lower cost. And some regions of the country are less expensive and sometimes patients might go to another country where TMS is also less expensive.


The key point for this section is the efficacy of TMS is similar to antidepressants but not as good as ECT. And if insurance covers TMS, there might be some requirements such as four failed antidepressant or psychotropic trials. And use caution if the patient has a history of seizures or any ferromagnetic materials within 30 cm of the coil is contraindicated.

 

References

  1. Trivedi, M. H. et al (2006). Evaluation of outcomes with citalopram for depression using measurement-based care in STAR* D: implications for clinical practice. American journal of Psychiatry, 163(1), 28-40.

 

 

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