[Liz]

Financially has been the biggest challenge. When my husband’s ALS advanced to where he could no longer work, we lost his income and we lost my income. As full time caregiver at home, I slept in 2 hour shifts so that I could give him breathing treatments and whatever else he needed. We are so grateful for every moment we had with him at home even though it is not the life we envisioned. I wish an organization existed to help families like us with financial burdens. We need $12,000.00 to save our house and there was a time where finances were fine but then entered ALS, the greatest thief of all time.  ALS took our loved one and left me without a husband, left our kids without a daddy, left our finances in ruins and left the greatest sadness in our hearts.  We are grateful for every day we had and we fought with the insurance companies for approval of Radicava. I remember thinking how awful it is that we have to spend all this time getting the insurance company to approve this medication when we could be using this valuable time to take care of our loved one.  The ALS dr told me to approach Radicava approval as a full time job. She said to sit at the kitchen table at 9 am every morning and stay in the phone to the insurance company everyday until 5 pm for 2 weeks straight. She said to become their biggest nightmare and let them know that I am not going away. Well, she was right bc after 2 weeks of calling the insurance company and staying on the phone from 9 am to 5 pm talking to every person I could in the insurance company plus the nurses at Mitsubishi Pharmaceutical, the manufacturers of Radicava, I gained all the answers to reply to the insurance company’s reasons for denying the medication. Finally, I got approval but then ended up spending another week, now   Week3, getting approval to do the Radicava IV infusions at home rather than trying to transport a completely paralyzed person to an infusion center 10 days a month. If the insurance company could spend just one day in our shoes they would see how difficult this is and how unreasonable to force the very difficult transportation process to an infusion center when a patient is trached and vented. Finally the battle paid off and infusions took place at home. The muse came to access the chest portal once a month. We then gave the IV transfusions ourselves at home. We learned how to do a lot of medical procedures such as changing the trach, replacing the feeding tube when upon rare occasion it would come out, using an AMBU bag, reviving a patient 8 times over the course of several years, etc.  No matter what, we would do it all over again for the opportunity to have our loved one at home♥️

 

[Liz]

My husband had bulbar onset.
He had slowed speech at first.  In the early years of the diagnosis process, they originally thought he had Lyme tick disease.   He did but that only delayed the ultimate diagnosis of ALS.
He had difficulty swallowing.
After dropping in excess of 60 lbs, he  got the feeding tube placed in his stomach. Afterwards, he said his one regret was not getting the feeding tube sooner bc it made his life so much easier. Before the tube, it took 45 minutes to take all the medicine. After the tube, he could take the medicine immediately. The tube was inserted above his stomach area and was hidden beneath his shirt.  We bought a “blend tech” blender with a sound proof chamber and put food through the blender. We would make chicken or grass fed beef and put the blended amount in a red solo cup. Then we used the feeding tube syringe and put the food in the tube…very fast and easy.  We put blueberries in a separate batch and he would have several syringefuls of that also. We would add fresh turmeric root and fresh ginger to one of the food batches also bc for the anti inflammatory qualities. For the third batch, we put fresh spinach, kale, one green skinned apple  and other vegetables.  We would also use Diabetisource formula to provide enough calories to keep the weight on.
He beat all the odds and lived 8 years. We kept a positive atmosphere and put a hospital bed in the living room so he was always in the center of the hubbub and the kids would talk to him every time they breezed through the room.
I am very sorry this happened to you. My husband never had the head drop.
It seems to affect each person so differently as far as what happens when etc. Keep as much weight on as you can. I am pulling for you. My husband took 10 days a month of IV Radicava infusions to slow down the progression. He also took Rilizole pills daily to slow down progression. We tried to get into the clinical trials for Nurown but weren’t accepted.  I hope and pray for medical advancements to help live with ALS.  Godspeed to you.

[Liz]

I would be very interested to hear if anyone has tried this

[Liz]

My husband has been taking Riluzole for 7 years. He has had no bad side effects at all and I believe it has prolonged his life.

He takes it twice a day.

The neurologist for my husband recommends it for all her ALS patients.

I am glad our prescription insurance covers it.

[Liz]

Today my husband finished Day 3 of this round of IV Radicava. He felt better after the treatment. On the 10 days a month he receives Radicava, he always feels better than the days without Radicava. We joke around and call it Liquid Gold….the good stuff!

 

[Liz]

Did you inquire further regarding his reasons for not recommending the treatment?  Efficacy? Safety? I have seen firsthand the benefits of the treatment so I would be curious as to why he does not recommend it.

[Liz]

Radicava days make him feel better

My husband has been receiving Radicava IV infusions at home since May of 2018.  It always makes him feel better and he usually experiences a little “bounce back” on the days receives the infusions. We still do the infusions regularly.

<b>Staying employed with ALS </b>

He has had ALS for around 6 or 7 years.  He has bulbar onset where his voice was initially affected.   He worked full time with the ALS until 2018.  He continued to work full time for many years with ALS and when his voice didn’t cooperate, he used a text to speech program on his computer called “natural reader.”

<b>First Radicava infusion at hospital </b>

The first Radicava infusion occurred at the hospital as part of their protocol to make sure there was no adverse reaction. They infused through a regular IV line. I do not recall whether that protocol was set by the company or the ALS doctor.

<b>Initial treatment</b>

The initial treatment required 14 days of infusions in a row.   We were traveling out of town to a family reunion so during the car trip, we had the infusion running. I brought the IV pole and adjusted the height to the ceiling level of the car.   It was very problem free.

<b>Initial 14 consecutive days of treatment</b>

For the initial 14 consecutive days of treatment, it was done through a normal IV access. The nurse came by to the house and put in the IV.  Before we left for the trip, they replaced the IV with one on top of the hand. While at the family reunion, the IV blew and we could not get the medicine through. A quick trip to a nearby ER with medicine bag in hand, and problem solved. They simply put a new IV line in the arm and it was problem free for the remainder of the trip.  Now we always use the chest port and that makes it so easy.

<b>Radicava Dosing Pattern</b>
<p class=”p1″><span class=”s1″>The initial treatment requires 14 consecutive days treatment phase. <span class=”Apple-converted-space”>  Then, </span>14 days off.</span></p>
<p class=”p1″><span class=”s1″>Thereafter, IV Radicava infusions for any 10 out of 14 days, followed by 14 days off, then any 10 out of the next 14 days IV infusions and continuing in that pattern indefinitely. </span></p>
For us, since the Radicava makes him feel better, we wanted him to have it the first available day so we chose to do 5 days on, then de-access the chest port and stay off for 4 days, then re-access the chest port and do 5 consecutive days of treatment.  This way, he feels better as soon as the first available day of treatment in the beginning of the dosing schedule plus, he gets in the last 5 days of the 14 day window so that will carry him through.  Plus, to reduce risk of infection, it is good to have the chest port only accessed for 5 days.  If you leave the needle in too long, you run the risk of infection.

<b>Summary of our Radicava dosing pattern:</b>

 

We continue in this fashion:

5 days on

4 days off

5 days on

14 days off

repeat indefinitely.

<b>What to expect when you open the box of medicine</b>

The box of Radicava is sealed with a silver sticker. When you open the box, there are two clear bags of medication each in a clear sealed plastic bag. Only pull out one bag. You will see a pink pill sealed inside the bag. As long as the pill is pink, it means that the outer plastic bag has remained sealed and  that  the medication has not oxidized.   You throw the pill  away with the outer plastic wrap.

Once the medication has been taken out of the plastic seal, you have either 24 or 48 hours (I can’t remember which) to use it although I always use it immediately. It only takes 30 minutes to dispense the first bag of medicine and the home nurse will show you how to do that. Ask them to write the instructions down because for the first few times, you will want to have the instructions as a reminder. If I can find the instructions that the nurse originally wrote for me, I will post them.

I set the timer on my phone for 25 minutes so that I am nearby when the first bag is almost empty. At that point, I pull out the second bag so that I am prepared to quickly switch the bags so that I do not have to prime the IV line again.   It takes 30 minutes to empty each bag for a grand total of 60 minutes.   After you have opened the clear plastic bag that the IV medicine is in, you can see after the bag has been opened and before you discard it, you can see how the pink pill starts to turn purple and or blue from oxidation. Nothing to worry about but I only tell you that so that you know what it looks like in the event it has been exposed to air before you open the bag.  I have never once had a bad bag where the pill was anything other than pink when I first opened it.

<b>Chest port</b>

My husband had the chest port surgery  done at Temple Hospital in Philadelphia as an outpatient. He was originally scheduled to go under anesthesia but the surgeon came in and asked  him if he could “soldier through with topical anesthesia, the surgery would be done in 15 minutes, he would put surgical glue on him, tell him put a shirt on and go home following completion of surgery. He said it would hurt a bit and that he would mostly feel more like pressure but that it would be over very quickly. My husband said that on a scale of 1 to 10, the pain level was a 5. There were two small incisions. I asked my husband :  knowing what he knows now,  after having the surgery done, would he choose to do the same thing or would he rather be put under anesthesia. He said he would do it exactly the same way because it was around 20 minutes of pressure on the area, a little pain and then it was completely done and over and he got to go home immediately with no recovery time whatsoever. They literally told him “put your shirt on, you can go home now.” He was able to use the chest port the next day and it has been problem free ever since.

<b> Itchiness from the plastic covering over the chest port :</b>

In the beginning, after the nurse would come and put the needle in the chest port (they call that “accessing the chest port”), she would put a plastic clear sticky covering on top of the area to prevent infection. My husband experienced an allergic reaction and ended up with elevated blisters beneath the sticker area.  The pharmacy who mails the medication then changed the sticker covering to some thing called “IV 3000“ for people with sensitive skin.

On each side of the clear sticker, there is an orange strip. The nurse takes off the orange strip after she puts the covering on so that he does not have any type of irritation. If memory serves me correctly, on the edges where the orange strip is, it contains a certain amount of the cleaning agent chlorhexidine  to which apparently my husband has an allergic reaction .  The home nurse also puts a clear sticker covering on top of the chest port needle called Tegaderm. Ask them to leave you extra coverings in case it starts to come loose before the next port change.

<b>New covering I saw at the hospital that seals around the tube coming out of the chest port.</b>

The hospital put a plastic cover over the chest port and then a second separate piece on the lower part of the area to help seal the tube and keep it germ free. It worked very well and my husband had no allergic reaction to it. The hospital nurse sent me home with one so that I can show the home nurse.

<b>Say no to hospice services</b>

Not that you are anywhere near close to this but the ALS doctor told me to always say no to any request for hospice services because the first thing they will do is take away the Radicava infusions and the Riluzole pills.

<b>Radicava results </b>

Throughout the course of the Radicava treatment, it seems that it takes the patient from wherever they are and reverses the symptoms to some degree during the dosing stage.  If you cannot move your arm, then after each treatment you might be able to move your arm up to your chest level. If you can’t move your leg, after treatment you may be able to  move your leg.    In our particular situation, the results were more noticeable in the beginning. On the days that my husband has the Radicava infusions, his voice would be improved. The results are a little bit  different for everyone from my experience of talking to other people but most people seem to report feeling a little bounce back, slightly more energy and overall feeling better.

<b>Slows down disease progression</b>

As the ALS doctor says to us, who’s to really know whether it has slowed  down the progression or not but in our particular situation, he has had ALS for six or seven years now so it seems as if it has clearly slowed down the progression. ??

<b>Nightmare of Insurance company approval </b>

I’m providing this information although it may not help in your particular situation because it sounds as if it’s a non-issue but in our situation, I was very glad to have the information. We could not get the insurance company to approve the Radicava treatment when it was first approved by the FDA. No matter how much I argued with them that it’s the first medication that the FDA has approved for ALS in 22 years, it fell on deaf ears. The ALS doctor told me she has over 200 patients and less than 25 of them are on the Radicava because they can’t get approval from their insurance company. She told me that I needed to sit down at the kitchen table and treat this as a job for two solid weeks from 9 AM to 5 PM. That is exactly what I did. I made phone calls all day to the insurance company and asked to speak to their supervisor, then their supervisor etc. and I just continued to make calls. She told me to make myself become the world’s biggest pest until they finally approved. She said in her experience two weeks of nonstop pestering generally results in approval of the Radicava treatment. After two solid weeks of pestering, it was approved.

 

<b>Say NO to infusion center unless it’s close, convenient and what YOU want</b>

Then, they told us we would have to go to an infusion center. We live in the middle of nowhere and that would be a very difficult process. Again, I went back to the phone and pestered for four solid days straight and ended up getting home infusions approved. Initially I was overwhelmed when they told me that I would do the infusions but now it is a big nothing and I could do it with my eyes closed and one hand tied behind my back.

 

<b>Does it help? Yes, it has for us.</b>??

<b><i>I truly believe this medicine has and continues to make a big difference.  It buys time until the next type of treatment for ALS is available. </i></b>

 

<b>Next treatment? I am watching Nurown</b>

We continue taking the Radicava to slow down this disease holding out hope for new treatments on the horizon. In particular, I keep my eye on Nurown, made by Brainstorm which is now in its third clinical trial stage and has been granted orphan drug status to make it go through the system quicker than the normal slow process. Even with the fast track, it still takes 7 to 10 years for treatments to be approved. On the bright side,  Nurown has been in the works for years and is now in its third clinical trial stage. It seems as if it reverses the disease by 25% with the initial treatment. My limited understanding of this is that they extract bone marrow from the patient. They put it in petri dishes, clean it up and expand it with their “secret formula.“ They get enough of the patient’s stem cells to make approximately  three treatments. The first treatment is given to the patients and they see approximately a 25% reversal of the disease. The treatment starts to wear off after a few months and another treatment is necessary. The results are even more dramatic for the second and subsequent treatments. Last week the FDA met with the makers of Neuron and agreed to do everything in their power to fast track this new ALS treatment and it may even be available as early as the end of this year. ?

The bottom line is that Radicava slows down the disease and buys time until the new Neuron treatment becomes available or any other treatments for that matter.  <b> <i>You have nothing to lose and everything to gain. </i></b>

 

<b>Mitsubishi Pharmaceutical, the maker of </b><b> Radicava </b>

One of the nurses from  Mitsubishi  Pharmaceutical reached out to me when they realized we were interested in the Radicava infusions. Of course I know since they are employed by Mitsubishi Pharmaceutical, the maker of Radicava, it is in their interest to get as many people as possible to purchase the Radicava infusions. With that being said, however, I found the information they provided to me to be absolutely invaluable. They told me what to expect the insurance company to say and they gave me the perfect answers to give back to the insurance company. Everything they told me that would happen, did indeed happen and I was thoroughly prepared with all the answers they gave me in advance. For instance, the insurance company said that the Radicava medication is only to be given to people who have been diagnosed with ALS for less than two years. Mitsubishi told me that nowhere in the instructions for the medication does it have any requirement that someone needs to be diagnosed with ALS for less than two years. In fact, that information from the insurance company only relates to one small clinical trial where the qualifying criteria to get into the clinical trial required trial patients to have ALS for less than two years. It was simply one of the limiting factors in a clinical trial and has nothing to do with the final instructions for the medication. Mitsubishi Pharmaceutical has at least one nurse on staff to help navigate the troubled insurance waters and I found that to be most helpful in our particular situation.

<b>Organization</b>

For the 10 days a month that the Radicava infusions are given, the specialty pharmacy company sends a large box with all the necessary supplies.   To make life easier, we bought a good size dresser or I guess technically a chest of drawers to put all the supplies in. The nurse organized it the first time and now each month when the supplies come, we put them in their place. It just makes life easier.