Radicava (oral) approval time

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Active member
Jun 24, 2022
Hi Everyone,

We’ve been waiting for almost a month trying to get the Radicava approved for my husband. He has been able to contact someone through “journey mate” and I guess it’s in an authorization process with his insurance. He had to do a lung function test last week at the dr office for the insurance to approve the medicine. They said that his values are good and the medicine should be approved. Have others encountered this? Just feel like time is ticking and wanting to get him on the medicine ASAP.
My neurologist told me every single radicava ors prescription in their very large clinic has needed appeal. I was just talking to a friend who has been waiting over a month for approval. It is very frustrating
I'll add my 2 cents here, I have been arguing with Caremark CVS Speciality Pharmacy, Insurance and my ALS clinic for 4 months over this drug. I've been getting it through infusion for 2 1/2 years and decided I would switch to the oral form. My first problem was the original doctor that prescribed the infusions was my 2nd opinion from Cleveland Clinic in Weston. I no longer see her because they didn't offer a multidisciplinary ALS clinic, so I started going to UA Miami since they did. The prescribing doctor understood and had no problem continuing to write the prescription. When I wanted to switch to the oral she sent in the order. Insurance required prior authorization and clinical data which she couldn't supply being she no longer sees me so I was denied.

I let UA Miami know and they said they would write a new prescription since they have all my data. Here's where it gets complicated. My original neurologist left clinic to go to the research side. My new neurologist and I just don't seem to click and he was scoring me lower on the ALS/FRS scoring system. I would argue with him that it wasn't fair because I'm still independent just slower, so when they rewrote the prescription it was denied because Insurance said my ALS/FRS score of 29 didn't meet the criteria. At this point I was livid. I knew of someone with an ALS/FRS score of 14 that was approved for the drug! So I contacted UA Miami and requested to be evaluated by another neurologist. Sure enough being examined and answering their questions honestly my score changed from a 29 to a 36, so an appeal was done and that's where I am now, waiting. I'm still taking the drug by infusion.

You would think we deal with enough with this disease, we shouldn't have to fight for one of the only 2 drugs available to us. Marie I hope your process goes alot smoother than what I'm dealing with. Good luck.
UGH thank you both. It kind of makes me feel a bit better that we’re not the only ones, but this is just such a frustrating process where you want to get your PALS on medicine asap and then it’s almost impossible AND it’s also going to be very expensive after insurance too. :/
I'm trying to understand why the appeals are necessary if it's supposedly the same drug, cheaper and easier to take. Makes me wonder if they are going to stop paying for the drug period. My husband has been on the iv for over three years and hasn't gotten approval . Maybe I'm just paranoid because his insurance had paid for amylyx for a year and then denied it. I think the later was an error on their part. Just curious- we will ask at his next dr's appt. Thanks Nikki for your info and insight....
If you have an infusion in a center or office that should go under part b. Oral meds are part d so different payers. There is a rule about iv meds for oncology that have an oral equivalent become available still being covered under part b. It doesn’t cover us So it is a new cost for part d insurance.

when you say amylyx Sassy you mean sodium phenylbutyrate? If amx0035 is approved it will be a new battle because sodium phenylbutyrate was on formula for its primary indication. Some people were able to get the off label use because their neurologist cited the amx0035 trial. Amx0035 would have to be added to formularies. my neurologist and I agreed radicava wasn’t worth trying for for me but I do want to try amx0035
Nikki said it all. The problem we're finding with getting Radicava by infusion is 80% covered by Medicare part B the additional 20% would be picked up by your secondary insurance. When you change to the oral version it becomes a non-formulated drug that won't be covered by Medicare part B. In my case my secondary insurance would be responsible for the major part of the cost and I would have a co-pay. When I checked with my insurance the initial starter kit for Radicava ORS is over $19,000 with my co-pay of $150.00 a month. Each cycle after that is $13,000 still with my co-pay of $150.00. So I can see where insurance doesn't want to pay out the cost when before they only had to pick up what Medicare didn't cover. Don't give up keep appealing the denial.
And your insurance is different than standard medicare Lisa. Standard medicare the supplement is separate from part d so part d didn’t pay 20% they paid zero for iv. medicare advantage plans generally include drugs but not regular medicare with a supplement. Part d is the weak part of medicare if you are sick
I have an update on our situation - the specialty pharmacy just called and his insurance approved it. It’s getting processed now and they’ll call back to schedule delivery.

My husband is still working and is on private insurance through his work (Cigna). I’m not sure if that impacted the approval. The other day the nurse at his dr office warned us that the insurance might reject and they asked if we gave permission to appeal (we said yes).

So I have a sense of relief knowing he’ll be getting the medicine, soon …
That's great news. I'm still in limbo with the appeal. My secondary insurance is Cigna they're the ones holding up the process.
Nikki- Commercial (my employer) insurance not Medicare is my husband's primary carrier. They paid for the sodium phenylbutyrate for one year then denied the rx and we are still waiting for oral radicava approval.
Lisa g - He said there appears to be no refills and he was wondering what the process will be like next month with Cigna. Are they going to make him do another lung function test and/or really look at everything again? Not sure, but we’ll ask the journey mate ambassador and his dr office at the appointment next week.

I would like him to try AMX0035 if/when it’s available and we were thinking it’s going to be a nightmare getting it. Even with the Radicava we’ll be paying a couple thousand a month (he’s not on Medicare and his prescription insurance coverage is only 80%). There is some type of Radicava assistance program but it’s only like 7500 per year …
I'm happy to report after 4 months of going back and forth with insurance and CVS CAREMARK I just received a call telling me that I've been approved for the drug. I will receive my first order on Tuesday and have a co-pay of $150.00 a month. Hallelujah
Yay Lisa!!! I’m so glad. My husband’s medicine arrives on Tuesday too.

Question - does anyone know if once you hit the “out of pocket maximum” you don’t have to pay for prescriptions?! I am crossing my fingers that that could be true because we’re almost at the OOPM and that there wouldn’t be weird restrictions on the specialty prescriptions. Will call Cigna on Monday to ask.
If rx meds are included in the policy's OOP limit, which is not always the case, and specialty meds (like Radicava ORS in most plans) are included within that benefit, you wouldn't have to pay more for the rest of the year, but prior authorization, if required, will still be required for reimbursement, regardless of what you pay out of pocket.
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