Tuesday, July 25, 2017

Sesame Challenge Passed!

My daughter had a sesame challenge on May 11th and she passed! I posted about it on a Facebook group, but just realized that I did not blog about it, here. :O It also felt surreal for her to pass the challenge, so I kept waiting to make sure it was "real" and so far, so good! 

Sesame has been on my list to challenge, for quite a while, and we finally got around to it. It can be so hard to find a time to plan one when you don't have other things going on, but I realized that I really need to get going on these, or it will take forever to get through them all.

Sesame fell into the category of "high IgE but no reaction history". Her IgE to sesame had been as high as 15, then was almost 3 before treatment and then dropped down and hovered in the high 1s, low 2s.

Back in 2015, we did skin prick tests (SPTs) for a few foods, including sesame and flax, and they came out positive, so we were told it wasn't time for a challenge, yet. As time passed, I felt that the SPTs were lagging indicators and I also felt that the IgE levels just weren't going to get to be negative. Treatment with Dr. Li's protocol seeks to regulate the immune system and after a while under treatment, standard IgE testing becomes less and less easy to read as an "up bad/down good" indicator. Though there is an expectation that IgE will fall over time, it may never get back to a pre-allergic level. There's a long story there, but for now, let's focus on the sesame challenge.

For the challenge, I made "tahini cookies" which are pretty much peanut butter cookies using the tahini (ground sesame seeds) in the place of peanut butter. I used the Kevala brand, as their tahini is made in a facility that only processes sesame seeds. I chose tahini, over sesame seeds, because I had read that people sometimes have delayed reactions, when the stomach breaks down the outer seed and gets to the protein. Even with as nervous a person as I can be, I wanted the highest-protein version, so I could be sure that any other forms would only be a lesser risk.

Throughout the challenge, my daughter didn't really have any major issues, thankfully. She sprouted this light pink spot she gets, sometimes. I can't even call it a hive, because it's so small and not raised and it vanished before I could even load my camera option on my phone. Somewhere into the second dose, though, I did see her shrug her right shoulder toward her ear and she was headed toward her ear with her "pinky" finger. I asked her not to touch her ear, but I got the sense it was a bit itchy. I took pictures of both ears and noticed that the right one was a bit pink (more so than really shows in the picture, but not bright red, either.) The funny thing is, when I had some of the same cookie batch the night before, I had an itchy right ear for a bit. :P Anyway, I told the doctor, and she decided to make the next "dose" a little bit smaller. The subsequent "doses" were all fine and her ear went back to normal, without intervention.
This ear turned a bit pink...
This ear was fine.

They had us wait 1 hour after the last dose, but said we could go after that, since it went so well. During the 1-hour waiting period, her cheeks were a little pink, but she was lying down, so tired from having gotten up early. The pinkness didn't last and I've seen the same pinkness on many days when we haven't done anything out of the ordinary.

One thing that did calm my nerves a bit, even though it's not definitive, was that she is negative to Ara h 1, which has 80% homology with Ses 1, one of the main sesame proteins. I told myself that it boded well for her challenge, but I also don't want anyone to fret if their child is Ara h 1 positive, when it comes to sesame. She eats plenty of legumes that are supposedly "botanically cross-reactive" with her other allergens, so it's all relative.

I'm happy to cross another food off the list and hope to narrow things down to just the "big ones". She also passed a home "challenge" of fish (Ian's fish sticks). Cod tested negative, always, but I was nervous about fish. The Ian's fish sticks are actually pollock, but it was still OK. She's also still happily eating pinto beans, which were positive on that SPT a couple of years back, so I still look at SPTs sideways. :Þ

Thursday, February 9, 2017

Auvi-Q Direct Delivery Service

for arranging a conference call with kaléo to go over details of their Auvi-Q AffordAbility plan. 
(By the way, FABlogCon Early Bird Tickets are $50 off full-price until 3/15/2017!)

The time to submit your forms for your Auvi-Qs is NOW! As I mentioned in an update to my earlier post, forms are already being processed ahead of the 2/14 release date, so if you are interested in getting your hands on some Auvi-Q sets, follow the steps shown, below.

Auvi-Q Direct Delivery Service

Reasons to go with the Direct Delivery Service:
  • It comes right to your door! I like to think of it as "Auvi-Q Prime" as it arrives in 2 days. :)
    • You have the option of having it delivered to your allergist, as well, if that is more convenient, due to your schedule, or local weather patterns.
  • You'll get "fresh" devices. Pharmacy stock can vary and we've all heard the stories of picking up EAIs with only a few months left before they expire. The devices going out on 2/14 have an expiration date of April 2018. Delivered devices are expected to have a minimum shelf-life of 12 months. 
  • Using Direct Delivery will ensure that you get the Auvi-Q device that your healthcare provider prescribed and won't have it substituted for another device preferred by the pharmacy.
  • Pharmacy stock will take time to proliferate so most pharmacies will not have devices in stock on 2/14. Also, not all pharmacies will be trained on the access program. If you do go to a pharmacy, and you/they need assistance, call 1-877-30-AUVIQ (1-877-302-8847.)
After you've submitted your form for Direct Delivery, make sure to take their confirmation call! The call will come from (844) 357-3968. If you're like me and tend to ignore most "Unknown" calls, you might want to save that number to your contacts, so you'll recognize it when they call. They will confirm your coverage and your delivery address details. You'll also want to save that contact number for refill requests.

If the Auvi-Q is your preferred device, submit your form ASAP!

Friday, January 20, 2017

Auvi-Q List Price - My Personal Perspective

I wanted to discuss this topic as a separate post. 
This is written from a personal, purely speculative perspective.



Some of you may have read about the new pricing plan for Auvi-Q, which includes a "list price" of $4,500. That has prompted many to wonder, "What in the world is up with the $4,500 list price?!"

Yes, that sounds like a lot of money. That is a lot of money, but bear with me for a minute. I'm not surprised that many would find this list price shocking, but we need to understand how flawed the current pharmaceutical system is, at present. For those who watched the Mylan CEO senate hearings, we had a glimpse into the convoluted, opaque system. There is a complex interplay of parties like Pharmacy Benefit Managers (PBMs), insurers, pharmaceutical companies, etc. Here is a primer on the drug-pricing system, as it stands.

I will admit that my eyes look upon the Auvi-Q very favorably. From the moment I saw the device, I was impressed with its size and features. I also feel favorably about Eric and Evan Edwards' direct ties to the anaphylaxis community and their personal story. They are connected and invested, both financially and emotionally. I assure you that this fondness was not paid for with the Sanofi Summit I attended years back. That summit was the seed that sprouted so many wonderful things in my life, so again, there's a fondness there, but it is not something that would prompt me to favor something I didn't believe in. So, when I say that "in my eyes," I feel like kaléo is doing their best to provide the choice and access we asked for, to the best of their ability, given the complicated environment in which they have to operate, I hope it is not dismissed as detrimentally biased.  

Some have expressed concern that with such a high list price, insurance companies will choose not to cover the Auvi-Q. This is not a foregone conclusion. I was previously on a medication for my rare disease that cost my insurance company over $8,000 per month, which would have been over $96,000 for the year had I continued on it. (I had to stop due to side effects.) I paid $0 out of pocket, as my $45 insurance co-pay was covered by the specialty pharmacy handling the medication. I remember being quite shocked at such a price. I remember shaking my fist at the first report we saw stating that the list price was set to be around the $100,000/year mark. I felt guilty for "costing" my insurance company so much money. However, I soon learned that my medication and its cost were not at record-setting levels. I found out that there are quite a few medications that cost even more outrageous amounts of money. I called the specialty pharmacy and I called my insurance company to make sure that my rates were not going to go up and was assured that my rates would not change. I also considered the fact that many of the people with my rare disease either did not have insurance or had poor coverage. My insurance coverage was basically subsidizing their access to the medication. Perhaps others feel differently about such things, but I was happy with that arrangement. Anyone who needed that medication would have access. I knew the money had to come from somewhere. I did feel a little less gracious about their efforts, though, given that I knew this was an existing drug that was "re-purposed" to treat our rare disease, so I did feel a little grumpy about them making so much money off something that already existed. I was grateful, though, that the medication was being made available, because there are few alternatives for my condition. 

With the Auvi-Q, though, I feel things are different. This is not a 20-30 year old drug, like mine was - this is a new(ish), brand-name device. It's an innovation in its market. They haven't had decades to recover R&D costs. It's reasonable for them to expect some form of profit. Yes, it does seem startling to think that some people's insurance will fork over thousands per set, but this is the system we have and it's holding hostage the device we want. Until the system gets a complete overhaul, this is the space they're working in to provide us access. If we don't like it, we need to continue to take it up with those who can make changes. I'm pointing my dissatisfaction at the system and not at kaléo. Maybe that's because they have something I want, but as I said, this is my personal opinion. 

As for how this pricing plan will work, I do not know the following for a fact, but this is my estimation of how this pricing plan will be solvent:
  • Let's say you have someone like me. I have commercial insurance. I don't know if the Auvi-Q will be covered, yet, but let's say it will be covered. My insurance company will "pay" $4,500 for a set of Auvi-Q. Let's assume there are some PBM rebates and they really "only" end up paying $3,000. Let's pick a rough number of $300 needed to cover the cost of the Auvi-Q to the manufacturer. Given these made up, rough numbers, my one prescription can cover 10 other people's prescriptions. I think we can reasonably assume that more than 1/10th of insurers will cover the Auvi-Q. 
I agree that the system is broken, but until the system is fixed, I believe that kaléo is doing its best to work within this flawed system to do what we asked of them - to provide epinephrine access to those who need it. The laws around medications are intricate, perplexing, and in many cases counter-intuitive. Perhaps some day the system will be fixed and this kind of pricing format will not be necessary, but until then, we need protection. We need a device that we feel comfortable with and that we believe our children will willingly carry and use if the need arises.

Edited to Add: 

I was discussing the list price controversy with someone and another point occurred to me. They said, "Weren't people up in arms about the EpiPen having a high list price? Isn't this even worse?"

Is the list price higher? Absolutely, but I see one big difference. With the EpiPen, the list price was rising over time and an increasing number of people ended up on high-deductible plans. This resulted in the customer paying the high list price, which is when the voices of dissatisfaction rightly grew louder. Mylan didn't do anything with their rising revenue to significantly ease the burden that the patient was facing. Kaléo, on the other hand, is using the high list price to keep the cost from falling onto customers. I agree that the fact that Kaléo has to resort to such measures shows that major reform is needed.

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