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Migraine Prevention With CGRP Drugs: Cost, Safety

migraine-prevention-cgrpYou’ve probably heard that monoclonal antibodies that inhibit CGRP are the exciting treatment in development for migraine prevention, but details have been scarce. New Migraine Drugs Promise Relief—But at a Steep Price is a different look at the drugs than has been published thus far. I’ve hit some highlights below and added my own thoughts, too.

Migraine Prevention is Costly & Access is Restricted

  • Monoclonal antibodies are made from living cells and are expensive to produce. They are among the most expensive drugs on the market right now.
  • Experts the writer interviewed gave cost estimates of between $8,000 and $20,000 per year. The CEO of Alder BioPharmaceuticals, which is one company working to develop these drugs, compared them to antibodies used to lower cholesterol. Those cost $14,000 a year when they came out. “I suspect we might be in that ballpark,” said Alder’s CEO.
  • Insurance companies tend to restrict drugs with hefty price tags. Think about the hoops people have to jump through for Botox, which costs insurance companies $6,000 to $10,000 per year.
  • Like with Botox, many insurance companies will likely require patients to fail trials of other medications before approving them for these new drugs. It’s likely that Botox will be one of those drugs that patients have to fail.

My Thoughts on Cost

  • How many insurance policies will simply exclude these drugs? Writing this post prompted me to see what Botox costs with my current insurance coverage (which I’m quite happy with). I assumed I would have to pay 30% of the cost. Nope, Botox is not covered at all. Even if it my doctor says I need it and even if it’s the only drug in the world available for my condition, my insurance will not cover Botox. Will they really cover an even more expensive drug?
  • Although studies are looking at both episodic and chronic migraine, I wonder how difficult it will be to get insurance companies to cover the drugs for people with episodic migraine. Drug coverage restrictions often center around quantity, but what are the rules are for a drug where quantity is always the same? If a drug has FDA approval for episodic migraine, can insurance companies require that a person have a minimum number of migraine attacks per month before they’ll cover it? If so, will this ultimately mean only people with chronic migraine get the drug?
  • On the bright side, these new drugs are likely to bring down the cost of Botox.

 

Drug Safety is Still in Question

  • These drugs are in Phase 2 trials. Half of drugs fail in Phase 3 studies or do not receive FDA approval.
  • When Phase 3 trials test the drugs on thousands more patients, dangerous side effects could be discovered.
  • We don’t know what the long-term effects of inhibiting CGRP will be.
  • CGRP is distributed throughout the body and is involved in many process, including regulating blood flow and wound-healing.

My Thoughts on Safety

  • Thus far, studies have shown a low side effect risk for these drugs. This is encouraging, but studies have had limited numbers of participants. More people using the drugs—both in late-stage trials and, if approved, in widespread use—will be required before we can really know what the side effects will be.
  • The very novelty that makes these drugs exciting also makes them scary—CGRP hasn’t been inhibited before. What will the long-term effects of the drugs be? How will they impact other physiological processes? What will research find after the drugs have been in use five years? fifteen? thirty?
  • I probably wouldn’t be thinking much about the long-term safety if it weren’t for recent studies linking anticholinergic drugs to dementia and cognitive impairment. Anticholinergics have been used widely for at least 70 years, but the first of these studies (that I can find) was published just 11 years ago. How many people were negatively affected by these drugs before the link was found?

I’m still excited about the potential of the drugs, but my concerns weigh heavily. Maybe these worries will shake out by the time the drugs are available in a few years. Right now, I don’t see myself clamoring to try them as soon as they’re available… although if my migraine attacks are back to being severe by then, I’ll probably camping out to secure my place toward the front of the line.

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I Have Given Up

“Research is finding new treatments, but nothing is available to help you now,” my headache specialist said. “You’re the same age as my daughter. I would want her to have relief while she waits for better medicines.” This is how the doctor announced that he’d reached his limit of treatments to try for me. He then prescribed Opana, a long-acting opioid. As kind and compassionate as he was, the prescription combined with the conversation to reverberate through my mind: YOU WILL NEVER FEEL BETTER.

This was in June 2009. It kicked off The Worst Year of My Life. I spent that year in horrific pain and housebound in a city where Hart and I had no support system. When I did get out of the apartment, the weather was miserable, the city was overstimulating, and people were aggressive (especially compared to Seattle’s friendly superficial social interactions). All those factors contributed to a terrible year. But the worst part was that I had given up hope of ever finding an effective treatment.

The future I saw before me was an interminable hell: days of vicious pain with no possible relief, nausea so severe I could barely eat, going to bed in tears each night wondering how I could survive another day. Even reading, which has been my escape since I learned to decipher written words, was impossible. For months, suicide seemed like the only alternative to this future.

I began writing this story after three readers responded to Blindsided By Grief by telling me they have given up hope. My heart aches for them because I know what it’s like to feel desperate and helpless. I’m also worried that I inadvertently made them feel worse. What I should have written was “I will never, never, never again give up trying to feel better.” Because I have given up before. My hopelessness multiplied already terrible physical symptoms to the point that they became nearly unbearable.

I don’t see my determination to never again give up as a sign of some superhuman strength. When my options came down to die, live in misery, or believe in a better future, the latter felt like my only reasonable option. If I stop trying to get better, I stop wanting to live. I will do everything I can to avoid feeling that way ever again. I must believe in the possibility of a better future—and that it’s my job to find the most effective treatment for me—to keep the helplessness and hopelessness at bay.

I did not realize until today what a pivotal role my former headache specialist played in my loss of hope. I have never faulted him before. He was truly sorry he could not help. But he didn’t say *he* was out of ideas, he told me that nothing existed that could help me. He told me to hang on until science caught up with me. It’s as if he took lessons in how to destroy a patient’s spirit. And to think that I found relief three years later with cyproheptadine, one of the oldest migraine preventives available.

Telling someone else to have hope won’t automatically instill it in them. Instead, I’m sharing my story to show that it’s possible to find hope again even when it feels lost for good. For me, hope came back even stronger and more realistic than it was before. Sometimes hope doesn’t feel like enough, sometimes it feels like the despair will gobble me up. But most of the time, it’s a life preserver that I cling to so I won’t drown.

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Would you donate your brain to research?

I imagine that migraine has worn grooves into my brain, creating a map that will help researchers explore the wilderness of migraine. Although I know the changes are not so literal and visible, I’ve talked about donating my brain to migraine research for at least a decade. I want the agony I have endured to be used to further the understanding of migraine. I know my work does that to some extent; I want to do more. I want to impact the science. The American Registry for Migraine Research, which is getting up and running this year, will provide a place to do that. (Not only by donating brain tissue, but donating blood and saliva samples as well as data.)

I was interested in donating my body to science since well before chronic migraine disabled me. Then I started to read Stiff: The Curious Lives of Cadavers. It was so disturbing that I didn’t get beyond learning that cadavers are used for all sorts of science, including cosmetic surgery and crash testing cars. To me, donating my body to science is a way to advance medical knowledge. Having someone practice a nose job or tummy tuck on my dead body is less idealistic. I know those procedures are not always for cosmetic reasons, but the vast majority are.

I remain undecided about donating my entire body to research. Fortunately, this is not a decision I have to make. Not only because I don’t plan to die soon, but because the migraine registry will allow me to donate brain tissue to migraine research without committing the rest of my body to science.

Would you donate your brain to research?

 

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Blindsided By Grief

plant sprouting in sandAs I checked my blood sugar, my heart fell to the cold tile bathroom floor and shattered. I was doing something to bring myself delight, to distract from the frustrations of the ketogenic diet. Instead, I was blindsided by grief while watching a Dave Matthews Band video.

Last year I told the friend I used to see shows with that I was done. I said I loved the music and dancing, but the obnoxiously drunk frat boy crowd was more than I could deal with. Until 30 minutes ago, I believed this to be true. I believed not going to shows was a conscious decision. When grief walloped me upside the head, I discovered that migraine had make the decision for me.

My grief is not about a band. It’s not about going to concerts. I’m grieving the release of throwing myself into music and dancing for hours. It’s a high that carries me for days when I see any band play live, and for months when it’s my favorite band. Dancing at shows is not just an activity, it’s a vital part of my happiness.

Despite what I told my friend and myself, I haven’t moved on. Saying otherwise was an attempt at self-preservation. I miss going to shows so desperately that I’d convinced myself otherwise so I wouldn’t have to face the loss. How do you move on from losing a fundamental part of what makes you who you are?

This kind of grief is so hard. It’s a reminder of all that I’ve lost and a realization that I may never get it back. It makes me wonder what else I’ve convinced myself of, what other grief will tear into my chest unexpectedly. It makes me wonder how many other fundamental parts of myself migraine will consume. It makes me wonder….

OK, Kerrie. Time to stop ruminating. What are you feeling in your body?

My chest is tight. It’s so hard to breathe that I feel like I’m on the verge of hyperventilating. My stomach twists, pulling me down so I’m curled in a ball.

It hurts so much.

How do I move on from losing a fundamental part of what makes me who I am? I will do it by remembering that losses aren’t forever, even though they feel like it at the time. I will remind myself of the four long years in which I couldn’t read. Now, four years after I started reading again, I still cry when I think about how much I missed it. I will think of all the treatments, technology, devices, and drugs I have left to try. Most importantly, I will keep trying—trying new treatments and trying to do the activities I love.

When a band I like announces a local concert, I put it on the calendar. The day of the show, I take it easy and try to minimize food triggers. I do this despite missing every show since January 2015. My heart hurts each time I confirm that I won’t be able to go out, but I keep making plans. I have to. To stop would mean believing I will never feel better. And I refuse to believe that.

The first time I “got” meditation, lyrics from my a Dave Matthews Band came to mind: “Honey, honey, come and dance with me.” A song about living and loving wholeheartedly, it has always felt like it was written for me. For better and for worse, I live voraciously. My grief is so intense because my joy has been so great.

Dancing, traveling, practicing yoga, baking, eating, laughing with my friends, and spending time with my family bring me such great pleasure that I will never, never, never give up on trying to feel better. Even if I have to sweep up my shattered heart and piece it back together from time to time.

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The Dance of Chronic Migraine Treatment: Optimism Peppered With Despair

“Your optimism is so inspiring,” a reader tweeted last week. I saw the tweet on Monday after a weekend of desperation, frustration, anger, exhaustion, helplessness, and hopelessness.Sunday culminated in a sobfest. Optimism was in short supply. My attempts to control the hypoglycemia weren’t working. Once again, it looked like I’d have to give up on the diet.

Hart and I went to Tucson for the weekend to watch our niece play softball. My blood sugar hit a low on Friday night and I spent Saturday trying unsuccessfully to increase it. Hart went to the softball game; I watched it via webcast. My spirits were low, but the tears were fleeting. When we decided to go home early, I could no longer hold the tears in. I had talked to my niece for five minutes on Friday and gave her a hug. That was it. I won’t see her for another year. Yet again, migraine was to blame.

I’m sick of how much control migraine has over my life. I want to make plans without an eternal asterisk. While the ketogenic diet has made me a little more functional, it requires even more attention than any other diet I’ve done and it’s results are ever-changing. Just when I think maybe I’m onto something good, another piece shifts and it’s back to looking like I’ll have to stop the diet. The fluctuating highs and lows have worn me out.

Monday brought another change to the diet. I’m not counting any chickens (except for weighing the amount of chicken breast I eat with each meal), but it’s going a bit better. This lower ratio may enable me to eat without triggering a migraine attack chronic-migraine-treatmentand avoid hypoglycemia. If it doesn’t, I really think I’m at the end of the line with the diet.

Just a few days ago, that last sentence would have brought me to tears. Today it makes me sad, but not heartbroken. When I responded to the reader’s tweet that I wasn’t feeling too optimistic, she said, “Optimism is like happiness—can’t have it all the time, but it’s whether you can find it again after its lost!”

So that’s where I am—in an ongoing dance of optimism peppered with despair. Chronic migraine pulls me onto the dance floor for this number far too often.