I dream of a medical world in which the doctor makes a treatment decision based on what their expert subspecialty fellowship training and years of clinical experience lead them to conclude has the best evidence and the most likelihood of improving a patient’s migraine associated pain and suffering.
Unfortunately, I am jolted from that recurrent dream on a daily basis when I wake in a drenching sweat, with clenched fists and clenched jaw masseters in anger by the nightmare of insurance treatment policies dictating how their “treatment algorithm” wants the patient to be treated, because they clearly know better. Ok, maybe that’s a bit dramatic, but you get the point. Honestly, the daily fight with insurance company treatment denials and prior authorization paperwork on just about everything prescribed is the absolute worst part about practicing medicine, and it shouldn’t be that way.
If you follow me on Twitter here, you know how much I hate insurance companies. More specifically, I hate when they make policies that interfere with proper patient care and prevent the physician from treating the patient how they feel would be most beneficial at improving their patient’s pain and quality of life.
These never-ending denials and long appeal processes prolong the misery, pain, and disability of the patient. All of this excess unnecessary time spent fighting these denials could be spent on patient care and helping more people. It is a very frustrating process for both the patient and physician. I’m convinced these companies don’t care about patients, and only care about their cost savings, revenue, and pleasing their shareholders. None of these factors should have any influence on what should be the only goal; maximizing patient care, improving quality of life and limiting disability. Sadly, that’s clearly not their goal.
What’s even more aggravating is that most of these decisions have no supporting evidence behind them. Furthermore, there is almost always published evidence to support the treatment being recommended by the physician. That’s when you need to stuff that evidence in their face until they choke on it and reverse their greedy policies (ok maybe too harsh, I’ll calm down…).
That is the purpose of this blog. I hope that it provides a framework of supporting references and appeal letter templates that you and your doctor can use in fighting back against unfair and unfounded treatment denials in a variety of common denial scenarios that I run into constantly. If enough people push for these appeals with the following supporting evidence and appeal letters, hopefully these insurance companies will eventually reverse some of these senseless policies and start to fold.
Many times, it is a denial of using two different types of therapies together. What these companies don’t understand is that to obtain improvement in migraine, often times the synergistic (working together) effects of medications and other treatments working together to target different receptor systems and migraine pathways are key to finally receiving significant benefit. Well, they may understand that, but the problem is that they just don’t want to pay for it.
When a medication is sent to the pharmacy, it is either approved or denied. It may require a prior authorization before approval, or may be denied automatically. This is when the office will receive a prior authorization form to fill out documenting past medication trials and reasoning why the treatment is desired. Or, they may just straight up send a denial notification.
If prior authorization or denial appeal paperwork is started, the most recent office notes will be requested (which I am almost 100% certain they never even read based on my peer to peer appeal discussions) along with the paperwork to fill out. This is the commencement of the absolute euphoric joy of spending countless hours of wasted time and frustration fighting ridiculous baseless decisions.
Thus, to minimize the overall pain and abuse these processes take on you, it is crucial to always document in every office note:
1) A list of past trials of all abortive and preventive treatments and medications. This is key to include. In our EMR, we have a template that medications and treatments can be continuously entered and updated in the office note into a running list of past medications and treatments, categorized into different classes. This past medicine list is cumulative and populates in every note (since the last note is usually what insurance requests during prior auth or denial requests).
2) Clear symptoms documented and specifically written out fitting the criteria of migraine headache according to ICHD3 criteria. In other words, “this patient has moderate to severe headaches lasting more than 4 hours associated with nausea +/- vomiting and/or photophobia and photophobia, clearing fitting migraine diagnostic criteria”. It is also important to document if the patient has episodic migraine (1-14 days per month) or chronic migraine (15-30 headache days per month with at least 8 or more migraine days included), and include the number of overall headache days per month, as well as migraine days per month.
With that said, I’d like to get on my soapbox for a moment here. In my opinion, this differentiation of episodic and chronic migraine is a nightmare and should be abolished in terms of insurance policies and guidelines. Basing treatment approvals and denials on migraine frequency is really senseless. My rationale is because migraine is a very fluid and dynamic chronic disorder. It will fluctuate between periods of lower episodic migraine frequency and periods of higher chronic migraine frequency, although it can certainly get stuck in either phase for long periods of time too. What the migraine is doing at one point in time is often not what it is doing at a different point in time. The patient may improve from chronic migraine to episodic migraine, so chronic migraine treatments will then start to get denied because they are in episodic migraine, or vice versa. This would be the same as an insurance company denying a blood pressure medication because blood pressure has normalized while the patient is being treated with it, so they stop covering it. That would equally be senseless.
They will often deny an abortive (such as a gepant) if the patient is in chronic migraine. Patients need to have an abortive whether they are in episodic or chronic migraine! It shouldn’t matter what frequency phase they are in. They may deny Botox for a chronic migraine treatment if there is associated medication overuse headache (rebound headache). The patient needs that preventive treatment to be able to pull out of rebound headache! It doesn’t matter what frequency phase they are in. Therefore, episodic migraine and chronic migraine terminology should be merged simply into migraine for insurance policies regarding migraine treatments because it really is one single chronic fluctuating disorder. This differentiation between episodic and chronic migraine that insurance policies base most of these decisions around is really the source of the majority of these denial issues and frustration.
MIGRAINE MEDICATION AND TREATMENT DENIALS AND HOW TO APPEAL WITH SUPPORTING EVIDENCE.
For starters, below are just a few examples of common reasons for denials of various migraine medications and treatments that I run into often. I will have many more coming, but I wanted to start by at least getting these ones off my chest.
Within each section, I have also written a denial appeal letter template to help your doctor fight the denial, along with supporting published evidence. The letters can be tweaked to fit specific practice and clinical scenarios. Feel free to cut and paste them!
This will be an ongoing blog article that I will continue to update as new denial issues arise, new ways to fight the denials are found to be successful, along with supporting evidence to help fight denials, so stay tuned!…
BOTOX USE WITH CGRP MONOCLONAL ANTIBODIES (mAbs)
The denial of using both Botox and CGRP mAbs (Aimovig, Ajovy, Emgality, Vyepti) together is a common and senseless reason for denial. Botox and CGRP mAbs are entirely different treatments with entirely different molecules, migraine receptor targets, and mechanisms of action. Therefore, it would make perfect sense that patients would do much better when combined as opposed to each individually, and that is what published evidence confirms. The letter below includes a list of published references that support the synergistic increased benefit and safety of using Botox with CGRP mAbs in chronic migraine.
To Whom It May Concern:
Hello, I am the headache specialist and neurologist caring for *** in the *** Headache Center. It has come to my attention that your company has denied the use of (insert the CGRP mAb) because my patient is currently using Botox for prevention of chronic migraine. (Or you can write this vice versa to fit the clinical scenario if it is reversed.) This patient easily meets ICHD3 criteria for chronic migraine. *** has *** migraine days per month, lasting 4 or more hours each, with throbbing/pounding pain, nausea/vomiting, and photophobia and phonophobia. Please refer to the office notes for the extensive list of previously tried abortives and preventives.
Calcitonin gene-related peptide (CGRP) has become an important target for both the acute and preventive treatment of migraine. Randomized controlled trials have established the efficacy of CGRP signal-blocking monoclonal antibodies (CGRP mAbs) for the preventive treatment of migraine.
The synergistic benefit of CGRP mAbs and Botox being used together for chronic migraine prevention is well documented and supported by extensive published evidence, some of which I have listed at the bottom of the letter. These published studies confirm that treatment benefit is stronger when these medications are used together (which would be expected based on their completely different molecular structures, migraine receptor targets, and mechanisms of action) compared to each individually. This beneficial synergistic effect is also commonly seen clinically in our headache clinic. It is medically necessary in my patient.
I am requesting your medical director to provide me with written documentation of rationale and published evidence supporting the denial of these treatments being used together for synergistic benefit for my patient, so I can document the denial with reasoning in the medical record. My supporting published evidence is listed below.
It is our hope that the use of (insert CGRP mAb) for the preventive treatment of migraine along with Botox for chronic migraine prevention will significantly decrease my patient’s total migraine days and severity by 50% or more; thus improving overall level of functioning and quality of life, while preventing migraine associated disability.
Cohen F, Armand C, Lipton RB, Vollbracht S. Efficacy and Tolerability of Calcitonin Gene-Related Peptide-Targeted Monoclonal Antibody Medications as Add-on Therapy to OnabotulinumtoxinA in Patients with Chronic Migraine. Pain Med. 2021 Aug 6;22(8):1857-1863.
Blumenfeld AM, Frishberg BM, Schim JD, Iannone A, Schneider G, Yedigarova L, Adams AM. Real-World Evidence for Control of Chronic Migraine Patients Receiving CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA: A Retrospective Chart Review. Pain Ther. 2021 Dec;10(2):809-826.
Suri H, Nandyala AS, Dougherty CO, Ailani J. Combination of Erenumab (Aimovig) and Onabotulinum Toxin a (BoNT-A or Botox) Is Safe and Effective. 62nd American Headache Society Scientific meeting, June 2020. Volume 60, Issue S1, Pages 1-156.
Silvestro M, Tessitore A, di Clemente FS, Battista G, Tedeschi G, Russo A. Additive Interaction Between Onabotulinumtoxin-A and Erenumab in Patients With Refractory Migraine. Front Neurol. 2021 Apr 8;12:656294. eCollection 2021.
Armanious M, Khalil N, Lu Y, Jimenez-Sanders R. Erenumab and OnabotulinumtoxinA Combination Therapy for the Prevention of Intractable Chronic Migraine without Aura: A Retrospective Analysis. J Pain Palliat Care Pharmacother. 2021 Mar;35(1):1-6.
Ozudogru S, Bartell J, Yuan H, Digre K, Baggaley S. The Effect of Adding Calcitonin Gene-Related Peptide Monoclonal Antibodies to Onabotulinum Toxin A Therapy on Headache Burden: A Retrospective Observational Study. Headache. Volume 60, Issue 7, July/August 2020, 1442-1443.
Yuan H, Baggaley S, Ozudogru S, Digre K. CGRP Antibodies as Adjunctive Prophylactic Therapy for Prolonging the Therapeutic Effect of OnabotulinumtoxinA Injections Among Chronic Migraine Patients. P09. 61st Annual Scientific Meeting American Headache Society, July 2019.
Ailani J, Burch RC, Robbins MS, Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache. 2021 Jul;61(7):1021-1039.
Robblee J, Devick KL, Mendez N, Potter J, Slonaker J, Starling AJ. Real-World Patient Experience With Erenumab for the Preventive Treatment of Migraine. Headache. 2020 Oct;60(9):2014-2025.
Faust E, Pivneva I, Yang K, Betts KA, Ahmed Z, Joshi S, Hogan R, Blumenfeld A, Schim J, Feoktistov A, Carnes K, Bensink M, Wu EQ, Chou DE, Chandler D. Real-World Treatment Profiles, Clinical Outcomes, and Healthcare Resource Utilization of Patients with Migraine Prescribed Erenumab: A Multicenter Chart-Review Study of US Headache Centers. Neurol Ther. 2021 Jun; 10(1): 293–306.
GEPANT USE WITH CGRP MONOCLONAL ANTIBODIES
This is another one that drives me crazy (as they all do). The denial of using a gepant (Nurtec, Ubrelvy), with a CGRP mAb (Aimovig, Ajovy, Emgality, Vyepti) also makes no sense. Again, the gepants (Nurtec, Ubrelvy, Qulipta) and CGRP mAbs are entirely different treatments and molecules with entirely different mechanisms of action and metabolized entirely differently. Yes, they both work on the CGRP mechanism of migraine, but they work differently. So theoretically, it would make sense that using an abortive CGRP medication (gepant; Nurtec or Ubrelvy (Qulipta is preventive only)) on top of a CGRP preventive medication (CGRP mAb) would give synergistic benefit.
To go a step further, using a CGRP preventive medication targeting the CGRP protein (Emgality, Ajovy, Vyepti) and a CGRP abortive medication targeting the CGRP receptor (Nurtec ODT, Ubrelvy) seems like a fantastic therapeutic approach. Similarly, using a CGRP preventive medication targeting the CGRP receptor (Aimovig) combined with a CGRP abortive medication also targeting the CGRP receptor (Nurtec ODT, Ubrelvy) would make a lot of sense too.
Here is a letter template including published references that support the synergistic increased benefit and safety of using gepants with CGRP mAbs.
To Whom It May Concern:
Hello, I am the headache specialist and neurologist caring for ***. It has come to my attention that your company has denied the use of (insert CGRP mAb), a CGRP signal-blocking monoclonal antibody (CGRP mAb) because she is currently taking (insert gepant), an oral CGRP receptor antagonist. (Or you can write this vice versa to fit the clinical scenario.)
Calcitonin gene-related peptide (CGRP) has become an important target for both the acute and preventive treatment of migraine. Randomized controlled trials have established the efficacy of large molecule CGRP signal-blocking monoclonal antibodies (CGRP mAbs) for the preventive treatment of migraine and small molecule CGRP receptor antagonists (gepants) for acute treatment (as well as recently some for preventive treatment as well). This patient meets ICHD3 criteria for (choose Chronic Migraine or Episodic Migraine). *** has *** migraine days per month, lasting 4 or more hours each, with throbbing/pounding pain, nausea/vomiting, and photophobia and phonophobia. Please refer to the office notes for the extensive list of previously tried abortives and preventives.
A long-term safety study in adults with migraine evaluated the concomitant use of large molecule CGRP mAbs and small molecule CGRP receptor antagonists (gepants). The study showed that use of a gepant abortively in patients receiving CGRP mAbs as preventive treatment were well tolerated being used together. No safety issues were identified by the dual use of both medications.
The synergistic benefit of CGRP mAbs (for prevention) and gepants (for abortive) being used together is also supported by published evidence. This data showed that treatment benefit is stronger when these medications are used together (which would be expected based on their completely different molecular structures and mechanisms of action) compared to each individually. This beneficial synergistic effect is frequently seen clinically as well in our headache clinic.
CHOOSE 1 OF THE FOLLOWING CLINICAL SCENARIOS:
(Ajovy, Emgality or Vyepti) is targeting the CGRP ligand (protein) preventively, whereas the gepant (Nurtec or Ubrelvy) is targeting the CGRP receptor abortively. These medications are not even working on the same receptor target, nor do they have the same mechanism of action or molecular structure. So, the combination would be expected to provide a much better synergistic effect. Therefore, there is no sensible basis for denying these medications to be used together. In fact, the evidence suggests they work better and safely together (as would be expected), and it is medically necessary in my patient.
Aimovig is targeting the CGRP receptor, whereas the gepant (choose Nurtec or Ubrelvy) is targeting the CGRP receptor via a different molecular structure, approach, and mechanism. So, the combination would be expected to provide a much better synergistic effect. Therefore, there is no sensible basis for denying these medications to be used together. In fact, the evidence suggests they work better and safely together (as would be expected), and it is medically necessary in my patient.
I am requesting that your medical director provide me with written documentation of rationale and published evidence supporting the denial of these medications being used together for synergistic benefit for my patient, so I can document the denial with reasoning in the medical record. There is currently no published evidence that suggests that these medications should not be used together. My supporting published evidence is listed below.
It is our hope that the use of (insert CGRP mAb choice) for the preventive treatment of migraine along with (insert gepant choice) for the acute treatment of migraine breakthrough attacks will significantly decrease my patient’s total migraine days and severity by 50% or more; thus improving overall level of functioning, quality of life, and migraine associated disability.
Berman G, Croop R, Kudrow D, Halverson P, Lovegren M, Thiry AC, Conway CM, Coric V, Lipton RB. Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine. Headache. 2020 Sep;60(8):1734-1742.
Mullin K, Kudrow D, Croop R, Lovegren M, Conway CM, Coric V, Lipton RB. Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy. Neurology. 2020 May 19;94(20):e2121-e2125.
Jakate A, Boinpally R, Butler M, et al. Safety and tolerability of ubrogepant for the acute treatment of migraine following co-administration with preventive monoclonal antibody treatment. 62nd American Headache Society Scientific meeting, June 2020. Volume 60, Issue S1, Pages 1-156.
Jakate A, Blumenfeld AM, Boinpally R, Butler M, Borbridge L, Contreras-De Lama J, McGeeney D, Periclou A, Lipton RB. Pharmacokinetics and safety of ubrogepant when coadministered with calcitonin gene-related peptide-targeted monoclonal antibody migraine preventives in participants with migraine: A randomized phase 1b drug-drug interaction study. Headache. 2021 Apr;61(4):642-652.
Jakate A, Blumenfeld AM, Boinpally R, Butler M, Borbridge L, Contreras-De Lama J, McGeeney D, Periclou A, Lipton RB. Pharmacokinetics, Safety, and Tolerability of Ubrogepant for the Acute Treatment of Migraine Following Coadministration With Preventive Monoclonal Antibody Treatment (1250). Neurology. April 13, 2021; 96 (15 Supplement).
DENIAL OF INCREASING VYEPTI FROM 100 MG TO 300 MG WITHOUT FIRST FAILING A 200 MG DOSE
Vyepti is the newest of the CGRP mAbs. It is a very effective once quarterly (every 3 months) 30-minute IV treatment for migraine prevention. I have repeatedly run into this senseless requirement that some insurance companies will deny increasing from 100 mg to 300 mg without failing 200 mg. Well, here’s what makes no sense about that. There is no 200 mg dose, and there was no 200 mg dose studied in any of the trials, nor FDA approved for treatment.
The letter template below reinforces the fact that there is no supporting evidence for a 200 mg dose because it was never studied. It also includes references for the studies showing benefit of 100 mg and 300 mg doses only.
To Whom It May Concern,
Hello, I am the headache specialist and neurologist caring for ***. Your company has denied the use of Eptinezumab (Vyepti) 300 mg every 3 months. Vyepti is a calcitonin gene-related peptide (CGRP) monoclonal antibody used for migraine prevention, administered by IV infusion every 3 months. This patient meets ICHD3 criteria for (choose Chronic Migraine or Episodic Migraine). *** has *** migraine days per month, lasting 4 or more hours each, with throbbing/pounding pain, nausea/vomiting, and photophobia and phonophobia. Please refer to the office notes for the extensive list of previously tried abortives and preventives.
*** has received *** doses of 100 mg of Vyepti, and has had some improvement with this dose in migraine frequency and severity, but has some early wearing off before the next dose. I suspect *** would do significantly better with the more effective 300 mg quarterly dose.
Vyepti dosages are available only in 100 and 300 mg doses only. A dosage of 200 mg is not an available dosage of Vyepti, nor was it a dose studied, nor does it have FDA approval for use. Supporting references can be seen below. Since 200 mg is not an available, studied, or approved dose, 300 mg of Vyepti is medically necessary as the next option for an increase from 100 mg. I am requesting that you reverse this unfounded denial for a 300 mg dose.
I am requesting that your medical director provide me with written documentation of rationale and published evidence supporting and recommending an off-label unstudied 200 mg dose (which doesn’t exist), so I can document the denial with reasoning in the medical record. My supporting published evidence is listed below.
With the dose increase from 100 mg to 300 mg of Vyepti, it is our hope that we will significantly decrease total headache days and headache severity by 50% or more. Thus, limiting the amount of abortive medications required by the patient, restoring a higher level of function, and limiting disability.
Lipton RB, Goadsby PJ, Smith J, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Cady R. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar 31;94(13):e1365-e1377.
Ashina M, Saper J, Cady R, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Smith J. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020 Mar;40(3):241-254.
Silberstein S, Diamond M, Hindiyeh NA, Biondi DM, Cady R, Hirman J, Allan B, Pederson S, Schaeffler B, Smith J. Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy-2) study. J Headache Pain. 2020 Oct 6;21(1):120.
DENIAL OF A GEPANT BECAUSE MIGRAINE FREQUENCY IS NOT AT LEAST 9 ATTACKS PER MONTH
This one I have still been unable to wrap my brain around. At this point, I feel like insurance companies are just randomly making up numbers and policy requirements with absolutely no reasoning behind them other than to make it as hard and time consuming as possible, so the doctor gives up trying. That’s the only logical conclusion I’m beginning to come to for most of these denials.
So, if the patient is having 8 migraines a month (which would be considered high frequency episodic migraine and absolutely needing an effective abortive), that is not enough misery yet to allow them an effective abortive?? This one drives me absolutely insane, especially when the gepant trials included patients with 8 migraines or less per month. The following letter template lists those references, and also addresses this seemingly made up number.
To whom it may concern,
Hello, I am the headache specialist and neurologist caring for ***. I have prescribed (insert Nurtec or Ubrelvy) as a migraine abortive medicine. This medication was FDA approved as a migraine abortive treatment with well-established efficacy.
I was notified that your company has denied my patient this medication because they did not have at least 9 migraines per month. This makes no sense at all, and is not consistent with how the medicine was studied and approved.
In the pivotal trial that led to FDA approval for Nurtec, it was studied as a migraine abortive treatment for patients averaging 8 or less migraines per month, with less than 15 headache days (migraine +/- non-migraine) allowed per month overall. In the Ubrelvy pivotal trials which led to FDA approval, patients averaged 2-8 migraines per month, and patients were excluded if they averaged 15 or more headache days per month. The published references supporting these migraine frequencies can be seen below.
I am requesting that your medical director provides me with written documentation of published evidence-based literature and rationale that supports this baseless policy, so I can document the denial with reasoning in the medical record.
Croop R, Peter J Goadsby PJ, Stock DA, Conway CM, Forshaw M, Elyse G Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737-745.
Lipton RB, Croop R, Stock EG, et al. Rimegepant, an oral calcitonin gene-related peptide receptor antagonist, for migraine. N Engl J Med. 2019;381(2):142-149.
Dodick DW, Lipton RB, Ailani J, Lu K, Finnegan M, Trugman JM, Szegedi A. Ubrogepant for the Treatment of Migraine. (ACHIEVE I) N Engl J Med. 2019 Dec 5;381(23):2230-2241.
Lipton RB, Dodick DW, Ailani J, Lu K, Finnegan M, Szegedi A, Trugman JM. Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial. JAMA. 2019 Nov 19;322(19):1887-1898.
APPROVAL OF QULIPTA FOR A LOWER QUANTITY THAN 30 PILLS PER MONTH
This is another insurance issue I’ve recently starting running into, and like the other policies, makes zero sense other than making the physician give up trying to help the patient receive it. The following letter template addresses the fact that Qulipta is a once daily medication, so allowing only 12 pills would not be rational. Supporting references are also included in the bottom.
To whom it may concern,
Hello, I am the headache specialist and neurologist caring for ***. I have prescribed Qulipta (Atogepant) 60 mg once daily as a migraine preventive medicine. This medication was studied and developed purely as a once daily migraine preventive medication. It is not an abortive (as needed) medication.
The FDA approved dose, and the ONLY dose studied and approved, was 10 mg, 30 mg, or 60 mg once daily. The standard recommended starting dose is 60 mg once daily, with a standard quantity of 30 pills per month, accounting for its once daily dosing approval and indication.
Your company has approved Qulipta for ***, but inexplicably only as a quantity of 12 pills per month, which makes absolutely no sense at all. This medication needs to be taken the way that it was studied and approved, which is a once daily pill.
I am requesting that your medical director provides me with written rationale and published evidence-based literature to support this senseless quantity of 12 pills per month allowance rather than the required, studied, and approved 30 pills per month. I would like to document the denial with reasoning in the medical record. I have listed my supporting published references for the proper dosing of Qulipta below.
Ailani J, Lipton RB, Goadsby PJ, Guo H, Miceli R, Severt L, Finnegan M, Joel M Trugman JM, ADVANCE Study Group. Atogepant for the Preventive Treatment of Migraine. N Engl J Med. 2021 Aug 19;385(8):695-706.
Goadsby PJ, Dodick DW, Ailani J, Trugman JM, Finnegan M, Lu K, Szegedi A. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Lancet Neurol. 2020 Sep;19(9):727-737.
DENIAL OF BOTOX FOR CHRONIC MIGRAINE (ESPECIALLY IF PRIOR FAILURE OF 2 PREVENTIVE MEDICATION CLASSES)
This is still one that often pops up and never gets less irritating. I’m sure the purpose is to put up as many delays and barriers as possible so that the patient and doctor eventually give up fighting, just as the others are meant to do. The following letter template is comprehensive and should cover all points, along with references as the bottom.
To whom it may concern:
Hello, I am the neurologist and headache specialist who cares for *** with a history of migraine headaches which have converted to chronic daily headaches, also known as chronic migraine.
On 10/15/10, the FDA approved Botox (Onabotulinum Toxin Type A) for the prophylactic (preventive) treatment of headaches in adults with chronic migraine after multiple research studies have proven overwhelming evidence of efficacy. The most recent study which confirmed the positive results of prior studies was PREEMPT (Phase III REsearch Evaluating Migraine Prophylaxis Therapy), referenced below.
Chronic migraine is defined by 15 or more headache days per month with at least 8 migraine days, each lasting more than 4 hours. *** has been clearly diagnosed with chronic migraine, with attacks that include throbbing/pounding pain, nausea/vomiting and/or photophobia and phonophobia. Based on my clinical experience as well as published clinical studies of Botox use in these conditions, I would like to treat *** with Botox.
I plan on using 155-200 units of Botox and injecting muscles which may include procerus, frontalis, temporalis, corrugator, occipitalis, cervical paraspinals, upper trapezius, splenius capitus, semispinalis capitis and the sternocleidomastoid, with some adjustments based on pain pattern on exam. If the patient responds, the treatment is repeated in 3-month intervals. My clinical expectations for treatment with Botox are a minimum of a 50% reduction in the frequency, duration and severity of the condition, but clinical experience is normally significantly more than this. This should result in less dependency on, or elimination of preventative and acute therapies which translates to decreased overall health costs, missed workdays, and disability.
Chronic daily headache (CDH) refers to a group of headache disorders that are defined, in part, by the presence of headache meeting the criteria for migraine or tension-type headache on at least 15 days per month for more than 3 months. Patients with CDH are severely disabled by their headaches. CDH patients frequently have failed multiple therapies by the time they seek treatment from a headache specialist. Abortive treatment is not effective in these patients and can result in medication overuse. The few treatments (e.g., beta-blockers, anticonvulsants) approved by the FDA as preventive medications for migraine are often ineffectual for CDH, may be associated with significant side effects, or may be contraindicated in certain patients.
In addition to the FDA-approved agents for preventive therapy of migraine (all of which are approved only for episodic migraine, not chronic migraine), a few drugs approved for other uses have published studies regarding their efficacy in clinical trials with CDH such as Botox, anticonvulsants, antidepressants, antihypertensives, and are used by some headache specialists as initial therapeutic options for selected patients with CDH. However, Botox has been used on the largest number of patients in such clinical trials. Regardless, only a few of these medications are actually FDA-approved for episodic migraine (and otherwise used off-label), and NONE are approved for chronic migraine. We are clearly dealing with chronic migraine by diagnostic criteria here, and Botox is the ONLY FDA-approved treatment for chronic migraine.
Many patients with chronic daily headache have concomitant medication overuse that may worsen their headache and which requires intensive management. In current clinical practice, many of these CDH patients with concomitant medication overuse and prolonged headaches require inpatient hospitalization to break the “headache cycle”. The cost of inpatient treatment is much higher than outpatient treatment.
An alternative to inpatient admissions, frequent emergency department visits, that can reduce headache frequency, and reduce acute medication overuse on an outpatient basis should be strongly considered by the physician and would provide considerable value for the patient and for the third party who covers that patient. The clinical trial data for Botox in patients with CDH, especially those with frequent medication overuse and chronic migraine, meet these criteria.
Both for the benefit of patients and as a potential value for you as an insurer, we believe that a reasonable trial of Botox for chronic migraine patients who have failed outpatient therapies is practical, scientifically supported, proven, medically appropriate, and prudent to help decrease overall medical costs associated with frequent acute and preventive treatments, hospitalizations, frequent visits to the emergency department and frequent outpatient appointments.
Therefore, with a clear indication for the use of Botox for chronic migraine, I am requesting that your medical director send to me written rationale and documentation that they prefer that I continue to use oral preventive medications off-label for chronic migraine, as opposed to using Botox, the only medication that is FDA-approved for chronic migraine. I would like to document this denial and rationale in the medical record. I have included my references below.
Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF, PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010 Jun;50(6):921-36.
Aurora SK, Dodick DW, Turkel CC, DeGryse RE, Silberstein SD, Lipton RB, Diener HC, Brin MF, PREEMPT 1 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia. 2010 Jul;30(7):793-803.
Diener HC, Dodick DW, Aurora SK, Turkel CC, DeGryse RE, Lipton RB, Silberstein SD, Brin MF, PREEMPT 2 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. 2010 Jul;30(7):804-14.
I’m just getting started here and more to come so stay tuned! If you have some migraine medication denial scenarios you would like me to formulate a response to, feel free to drop them as a reply on my Twitter feed…
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