My 2nd ICER Submission for CGRP Review
To find out more about ICER (Institute for Clinical & Economic Review) watch this video or check out the Patient Input Guide. This is my submission to ICER about the importance their review of new CGRP inhibitor drugs will have on my life and our entire community. -Katie
ICER OPEN COMMENT PERIOD ON CGRP INHIBITORS FOR MIGRAINE
I had my first migraine attack with aura at age five. My vision was obstructed by a sparkling crescent moon shape. Within 20 minutes it had disappeared. Next it felt like someone was pounding a nail into my skull, over and over again. My parents held me in their arms for hours as I screamed in pain. I became dehydrated from crying, only making the searing pain in my head worse. The daylight streaming in from the window felt like more daggers. After six hours of torture, I vomited until my stomach was empty and the demon inside lessened his hold on me.
I slept. I had no appetite. I didn’t leave my room for three days. I was weak. I missed school. I felt like I had been run over by a truck. I remember this vividly because the pattern was the same for every attack I had growing up.
The same pattern of migraine attacks followed me into adulthood. I learned to save vacation days for migraine days, because I always ran out of sick time. I had an employer deny me reimbursement of tuition for college courses taken relating to my job, citing that I took too many days off for migraine attacks.
Right before my 30th birthday, I had a migraine attack that has never ended. No trauma had occurred to propel the attacks to become continuous. I missed work for two months straight. At the third month mark, I will never forget the day that my headache specialist told me that my condition was now chronic. I cannot describe the desperation and loss I felt in that moment.
Saying Goodbye to My Career
This was not my plan in life. I was the youngest vice president at a small community bank, with an expertise in commercial and construction real estate financing. I was in my second semester of graduate school at Georgetown University. I had an active social life. I was involved in community theatre. I loved my job and my life. All of this disappeared away within a matter of weeks. My quality of life was stolen from me the day the never-ending migraine hit.
When my health changed overnight, my employer bent over backwards to accommodate me. My normal 50-60-hour work week became a roller coaster of inconsistency. My boss was gracious enough to let me work on a flexible schedule that would accommodate frequent doctor’s visits and allow me to recover when I was completely incapacitated. If I was not in the office, I was working from home every waking hour to catch up on my duties. I used vacation, sick and personal days to cover the hours I didn’t work or make up. I used FMLA intermittently for two years.
I was unreliable and my work product suffered tremendously. My ability to multi-task, manage employees, and maintain one of the largest client portfolio’s in the company quickly became overwhelming.
In March 2013, my doctor insisted that I stop working. With hope that my health would turn for the better during 90 days of short-term disability, I didn’t even clean out my office. On my way out the door on my last day of work, I ran into an executive who was very concerned about my health. I told him this was temporary and I’d be back in a few months. Yet, I remember the feeling in the pit of my stomach that told my condition was worse than I was willing to admit. That was the last time I set foot in my office.
My condition actually worsened during what was supposed to be a three-month break. I was forced to apply for Social Security disability benefits, which I was awarded as of September 2013. However, during a recent re-assessment of my condition and ability to work, I was denied benefits. I am currently appealing this decision as my condition has not substantially changed. I wish it had.
Impact of Migraine on Daily Life
On average, I spend 70% of my time in my apartment. The other 30% has to be carefully planned. Will there be any noise, lighting, food or other triggers that will make the migraine attacks worse? I have to take medication before I leave and have all medications with me for any possible scenario when I leave the house. I need an exit strategy. Will I be able to lie down if the pain is suddenly unbearable? Do I have a way home if I feel I can’t drive? Will my impaired cognitive function cause me to become disoriented, forgetful, or lost?
I’ve been forced to make drastic changes in my daily life. I have a small radius (about 5 miles) around my house where I am comfortable going by myself. Anywhere outside of my comfort zone, I prefer to have someone with me no matter what my pain level is that day. I always carry a notebook with me because I can easily forget my tasks or what people tell me. I build in extra time because any task now takes me twice as long to complete. Restaurants or places with crowds cause sensory overload and I have to walk away to find a quiet respite.
I use sleep as a coping mechanism. Even while sleeping, my body is tensed up to battle the pain. I curl into a ball to protect myself and often find fingernail marks in my palms because I’ve been clenching my fists while I was asleep. I also grind my teeth and need to wear a mouth guard.
During long stretches of time with high levels of pain, my sleep cycle is interrupted, my food intake is altered, showering is a chore and my body feels like it has been beaten up. Simple house chores drain me of energy. My long-term partner picks up the slack, but he didn’t sign up for this when we met. My parents didn’t imagine that I would still need their help at this point in my life. My chronic migraine disease has altered their lives as well.
Why “Headache” and “Migraine” Should Never Be in the Same Sentence
For the past seven years I have not had a reprieve from the pain associated with chronic migraine.
I belong to an exclusive club I call the 24/7/365 club in which our “lucky” members are not only chronic (experiencing 15 or more migraine days per month), but they are in a constant state of intractable migraine, never experiencing any relief from migraine attacks and related symptoms. The symptoms can be just as bad or worse than the head pain. These are the associated symptoms I experience on a daily basis:
- Impaired Cognitive Dysfunction
- Olfactory & Gustatory Hallucinations-I smell cigarette smoke and burning trash when neither are present. Food can sometimes taste like metal
- Paresthesia-Tingling in hands and feet
- Phonophobia-Sensitivity to sound
- Photophobia-Sensitivity to light
- Scintillating Scotoma-Visual disturbance or aura
- Akathisia-Need to be in constant motion
- Alloydynia-Sensitivity to touch
- Aphasia-Trouble finding words
Does this list seem like something a simple Tylenol would alleviate? The words “migraine” and “headache” are NOT synonymous. “Headache” fails to capture the effect migraine has on my entire body.
The Search for Better Treatment
I’ve lived with varying degrees of migraine disease now for 32 years. I take 15 pills a day just to enjoy a few hours of lower pain. I know that I haven’t tried everything, but the lists below show that I am pretty close to having explored all of the options that are currently available to someone with my level of chronic migraine. The lack of prolonged efficacy and side effects seems cruel as my quality of life hasn’t significantly improved.
|Previously Tried Medications|
|Imitrex- pill & injection||Morphine||Melatonin|
|Inderal||Magnesium||Compazine – Allergic|
|Percoset||Reglan – Allergic||Benadryl|
Current Daily Medication/ Treatment Regimen
|Daily Medications for Migraine PREVENTION||Daily Medications for Co-Morbidities||Other Prevention Treatments|
|Amitriptyline HCL||Famotodine – Acid Reflux||Botox Injections every 3 months|
|Venlafaxine HCL ER||Pramipexole ER -Myoclonus||Nerve Blocks once a month|
|Vyvanse||Clonazepam – Myoclonus||Complementary & Alternative Methods|
|Spironolactone||Amantadine – Myoclonus||Yoga|
|Magnesium Supplement||Dulcolax – Constipation||Deep Breathing|
|Iron Supplement||Light Exercise (as tolerated)|
|Rescue Medications/ Treatments|
|Rescue Medication||Type||Average Usage|
|Toradol IM||Anti-Inflammatory||Average 2 shots per week|
|DHE IM||Ergotamine used as main line of defense for bad migraine attacks||Average 2 shots per week|
|Ondansetron||Anti- nausea||Average 4 per week|
|Ketamine Nasal Spray||Pain Management||40 nasal sprays per week|
|In-patient, 5-day ketamine infusions||Pain Management & Migraine prevention||Twice per year|
|Negative Side Effects Experienced|
|Lost my hair in clumps||Severe dry mouth has caused tooth decay|
|Weight Loss and Loss of Appetite||Weight Gain|
|Severe Impaired Cognitive Function||Irritability|
|Feeling of skin crawling – allergic reaction to Reglan and Compazine||Numbness and Tingling|
|Acid reflux||Skin on fingers and toes shedding|
I do NOT want to be on all of these medications in order to survive my day. The negative side effects of many medications have been difficult to manage at times. At one point, I have stopped all medications only to find that they were absolutely necessary in managing my illness.
What matters more?
I recently had a headache specialist ask me if I would rather have one day a month that was symptom free or to be more functional overall. More productive everyday or one day without pain? It’s a trick question. When I was episodic, I would have said more functional. Now that I’ve been chronic for seven years, my answer was the opposite. Holding back tears, I told him I would give anything to have one day a month without pain. I don’t remember what that’s like.
I’m almost 37. Will I live for decades without ever experiencing a day without pain? I’ve learned to manage the days where I struggle to put a sentence together. That’s the devil I know. Looking forward to one pain-free day a month would give me hope, something to look forward to, a reason to be optimistic.
On the flip side, of course I would be ecstatic if there was a medicine or treatment that could reduce the severity and/or frequency of my daily migraine. Even a 30% reduction would be life-changing for me. I realize CGRP inhibitor drugs might not work for me. However, I deserve the chance to try it if my doctor thinks I’m a good candidate and so do a large population of those with migraine. I advocate for me, but also for my community.
To date, the two treatments that have helped me most significantly have been Botox injections every three months and in-patient ketamine infusions with a ketamine nasal spray to use at home. However, access to both of these treatments were denied by insurance at every turn. Providing documentation, filing appeals, requesting letters from my doctors – this became a full-time job at a point in my life when I was the most sick I had ever been. I fought for years to get these treatments approved.
I was relentless and determined to gain access to these two treatments. I eventually won my appeals for both treatment plans. Again, Botox and ketamine have turned out to be the most effective treatments in managing my migraine disease. I still am in some level of pain every single day, however the severity of the attacks lessen for a period of time after receiving these two treatments.
What if CGRP inhibitor drugs make an even bigger impact on the severity and frequency of my chronic migraine disease? Will I have to jump through these same hoops? Will I have to spend the limited good hours I have daily on fighting for access? Will the practice of step-therapy, fail-first, or outrageous co-pays deny me months or years of potential improvement in my health?
Cost of Migraine
In 2017, my medical expenses totaled approximately $100,000. Of that, I paid $16,000 out of pocket for insurance premiums, medication co-pays, doctor visits, hospitalization and emergency room visits. That’s over $1,300 a month. My Social Security disability income is all but eaten up in paying for these expenses.
Does it make sense for insurance to pay $100,000 per year for the next 30-40 years to manage my chronic migraine? Of course not. It makes more sense for insurance companies to responsibly cover and provide access to new preventative medications that could reduce my need to take 15 pills a day and maybe keep me out of the emergency room or hospital. I shouldn’t have to physically suffer when a CGRP drug could improve my functionality enough to return to work.
Measuring My Life
Migraine doesn’t discriminate. It takes and it takes. It’s not a headache. It’s an attack. It’s not a female issue, it’s a disease. I measure my life in quality, not quantity.
I ask that ICER uses their role responsibly by supporting both episodic and chronic migraine patients in getting access to these desperately needed medications.
Katie M. Golden
Golden Graine is not just for those living with chronic migraine, it’s for anyone dealing with chronic pain. We are all in the same boat. Feeling misunderstood, wanting others to take the time to listen. For this Medical Monday, I want to talk about a condition called Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic…