Update: Dancing with the Devil
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The Summer 2022 issue of this magazine included an article entitled “Dancing with the Devil”. That article addressed the challenge headache medicine providers faced in obtaining authorization from insurers to use the revolutionary new therapies for migraine that recently had been developed.
Not much has changed since that article was published. Providers continue to waste a tremendous amount of time struggling with insurers in what is far too often a futile effort to implement an optimal therapeutic management plan for their migraine patients. Migraineurs suffer from lack of access to the therapies recommended by their providers. And in a time when the cost of healthcare is soaring exponentially, we continue to waste a lot of money.
Atogepant (Qulipta) serves as a pretty good example of the Gordian knot that persists. Qulipta received FDA approval for migraine prevention late in 2021. As an investigator in the multicenter national research studies that established Qulipta as a safe, well-tolerated and effective treatment for migraine, I was impressed with the drug’s effectiveness in reducing migraine burden and even more so by the rapidity with which it exerted its therapeutic effect in those destined to respond. Our research subjects randomized to the active drug were reporting significant improvements in their headache disorders as early as 1 to 2 weeks after beginning treatment; until we were unblinded at the conclusion of the randomized, placebo-controlled study, I was convinced this likely reflected a placebo response. I have continued to observe that same attribute of rapid response over the 4+ years that I have been prescribing the drug to patients in my clinical practice.
Consider Sarah G.
A 36-year-old mother of 3 who had developed from scratch a now-thriving business in interior design, Ms. G had a long-standing history of migraine and had been suffering from chronic migraine (CM) for the past 2 years. When I first saw her, she had been averaging about 18 days of headache per month for almost a year, and although she typically did her best to “push through them”, on about 4 or 5 of those 18 days she was functionally incapacitated by headache. On three occasions within the prior year she had sought treatment in a ER for an especially severe migraine attack that she was unable to control or terminate with self-administered medications (in part due to her intractable migraine-associated nausea and vomiting with consequent dehydration); on 1 occasion she required overnight hospitalization for intravenous rehydration and control of her headache and vomiting. She previously had tried and failed no less than 5 different therapies for migraine prevention.
I prescribed Qulipta for headache prevention, and within two weeks she was largely free of headache. That most welcome improvement persisted over the ensuing months, and after she had been on Qulipta for a total of 1 year, I tapered her off the drug and advised her to try treating her migraine with “as needed” therapy only. Over the 2 years she has been off Qulipta she has continued to have a low headache burden.
In contrast, consider one of my active patients, Caroline L.
This 42 year-old assistant professor who teaches English literature at a local university has a headache history paralleling that of Ms. G, but in her case she has tried to avoid taking “too much medication”. She has tried and failed only 1 pharmacologic therapy for migraine prevention, nortriptyline (an older, cheap and generic drug which possesses a rather thin evidence base for use in migraine generall and none for use in CM ). I prescribed Qulipta, but her insurer denied authorization for coverage of that medication, mandating that she first must have “adequate” trials of at least 2 other prevention medications which – as with nortriptyline – are cheaper than Qulipta and generic but either more difficult to tolerate, lacking a particularly solid evidence base or both. Unfortunately, an “adequate” trial required at least 3 months of treatment. If CL failed both medications, this would entail her residing for another 6 months in the unhappy swamp of CM. That in itself would be sufficiently unpleasant, but making things even worse was the possibility that the delay in implementing effective prevention therapy would increase the effort and time required to produce the type of positive response experienced by Sarah G.
Qulipta is not a cheap therapy; the wholesale acquisition cost of Qulipta is about $13,000 annually. Even at that price, however, and in addition to the benefit derived by responding patients, the drug can save the healthcare insurer money. If the annual direct costs are restricted simply to 3 ER visits and an overnight hospitalization – as with patient SG pre-Qulipta – and do not include either other direct costs (egs, symptomatic medication for frequent acute headaches, unscheduled visits to an urgent care center or clinic) or the “indirect” costs associated with work absences, impaired productivity at work or a general decrease in quality of life – the total is about $26,000. $13,000 vs $26,000. You do the math. Apparently healthcare insurers cannot (will not?).
In a study whose results were published in 2014 (12 years ago!), my colleagues and I found that during the 6 months following initiation of treatment with onabotulinumtoxinA (BotoxA) for suppression of CM, ER utilization went down by 55%, urgent care visits by 59% and hospitalizations for migraine by 57%. Just this reduction in direct costs alone offset 50% of the cost of administering BotoxA. That was 2014, BotoxA had been FDA-approved for treating CM in 2010 and yet – mirable dictu! – even now, 16 years after its approval as the 1st therapy indicated for suppression of chronic migraine, insurers frequently require that the CM patient fail 2 or 3 other prevention medications that are cheaper than BotoxA and generic but either more difficult to tolerate, bereft of a solid evidence base or both. Sound familiar?
I don’t know how to put this any more plainly. In the often vain effort to increase profits, the healthcare insurers are stifling innovation, sabotaging effective treatment of migraine, driving up the cost of healthcare and reducing quality of life for migraine patients and their providers. As a physician I live with this every day, and so do those of my all too few colleagues who undertake the effort to treat the millions of Americans who require assistance in managing their migraine. As a migraineur, you also live with migraine – or the threat of migraine - every day. What are you going to do about this problem?
For one thing, you can stop blaming your doctors. We are your advocates, and not only do you often fail to appreciate that, you even hold us responsible for your inability to obtain the therapies we feel you deserve and spend countless hours fighting to obtain for you. Your problem is your healthcare insurer, and we, your physicians, are being placed directly between you and the source of your problem. Whether we like it or not. And guess what: we really, really don’t like it. I now waste far too much of my time – up to 20 hours per week - arm-wrestling with insurers in the effort to obtain for my patients the treatment I feel they deserve. That time is financially uncompensated, and it subtracts from the time available for me to provide direct clinical care to patients, conduct research, educate trainees, spend time with my family, etc. It adds insult to injury when the physician who is “caught in the middle” often may be blamed by patients for that physician’s inability to obtain the therapies that he/she has prescribed.
Blame the pharmaceutical industry if you want, but without their funding I cannot think of one – not one – migraine therapy that has emerged within the last 35 years which otherwise would have made its way to clinical practice. New and effective migraine therapies do not drop from the sky. Neither the National Institutes of Health (NIH) nor any other major independent source of research funding is going to develop new therapies for migraine. The NIH spends a tiny fraction of its publicly-derived funding for research – less than $4 million out of an annual budget of almost $40 billion – on investigating therapies for a medical disorder that actively afflicts 12-15% of the American population and costs the US economy almost $80 billion annually. Again, do the math. In my decades spent conducting research in the clinical neurosciences, I have participated as an investigator in 14 NIH-funded studies involving the treatment of stroke. I have served as an investigator in 45 migraine treatment studies funded by the pharmaceutical industry, but I have never participated in a federally funded study involving treatment of migraine.
This is all an unsustainable mess, and the escalating conflict between healthcare insurers and healthcare providers is one of the leading reasons why physician burnout has reached epidemic proportions. Physicians are caught in the middle, and – I can assure you – it ain’t no fun. An increasing number of headache providers and would-be providers are opting out. Some do so passively by avoiding the newer therapies and prescribing suboptimal medications for which the insurers will authorize coverage. Others alter their business model to practice on a fee for service/no insurance accepted basis. Others retire from the practice of headache medicine. Others avoid entering the field in the 1st place.
What can be done to resolve this mess? To repeat: stop blaming your doctors. Instead, start advocating for yourself. Be a squeaky wheel. Share this article with others. Read the March 6th “All Things Migraine” Substack post on this topic. Share it. Write your own. Write your insurer to express your dissatisfaction with their performance. Best of all, if you receive insurance coverage through your job, notify your employer, the entity that has picked your healthcare coverage plan, that you are not pleased with the coverage provided and specify the source of your displeasure. Lobby for reform that permits you to choose your healthcare insurer. Be proactive. You have nothing to lose but suboptimal medical care that focuses on profit rather than patient.
JFR
[Editor’s note: ironically, a somewhat more detailed version of this essay that I co-authored with Dr. Robert Cowan was rejected outright for publication by Headache, the official journal of the American Headache Society and rightfully considered by many to be the leading medical journal on the topic of headache. Also ironic, I served as editor-in-chief for that journal for 12 years, and during my tenure I welcomed controversial submissions. Dr. Cowan, my co-author, is the widely respected director of Stanford’s headache medicine program. Together we have about 80-90 years of clinical and research experience – and perspective - in headache “No solutions offered”, my co-author and I were advised when our submission was rejected. Not an altogether inaccurate observation – short of encouraging patients to advocate or inciting overt revolution amongst providers, I had no solutions to offer then...and I still don’t. But the 1st step in solving a problem involves acknowledging that a problem exists. As the title of that rejected submission urged: “Wake Up!”]
