So I've been on Peg IFN for close to 5 years and my body can't seem to tolerate it anymore. My white counts just keep going lower. Current counts at just 65mcg are: [WBC "1.51", ABS-Neut ".66", ABS Lymph ".60"]. I was taking over 135mcg for several years. I'm starting to get sick and having mouth infections requiring surgery, which I'm pretty sure is all related, among other issues.
I've had PV for over 10 years total and currently only 52, so still young and wanting to stay with a drug that might have a positive affect on disease progression (i.e. improved allele counts, bone marrow improvement, etc.). My insurance company denied Jakafai and said I had to try HU first. Jakafai patient assistance would have helped, but said due to the denial that I have to work through my doc who does not want to bother with an appeal to begin with.
From doctor:
"When this type of denial comes through, there is little recourse for appeal. Insurance companies language stated: " Documentation of therapeutic failure, intolerance, or contraindication to hydroxyurea must be provided for the requested medication to be considered for approval." We would have to have a reason other than patient preference.
Here my question. My understanding is HU does not help with progression where as I believe Jakafai does. So my rationale is simply that this has a better chance of extending my life. Regarding switch to HU, can I get some opinions on this? Should I do it, change doctors, try and appeal it by myself if that's even possible? Any advice on rationale for an appeal? I'm hoping someone here has been through this and has some advice.
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jon1972
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I assume your IFN dose was driven by HCT, is that right? Has your Dr discussed a lower dose with HU combo? But if your "other issues" involve anything autoimmune, it's time to quit right away.
So you now have documented intolerance to IFN, which doesn't help the current issue.
I got onto Rux with commercial insurance. But it was from Besremi prior. I did start with HU. I think at the time (early 2022) the same HU failure requirement may have applied to Bes. I had known reactions to HU, split nails fatigue etc. It's possible my Dr described it as intolerant. But I got CHR fine on all three meds.
It could also be different ins cos have different criteria. Are you on an HMO? I had a good quality PPO.
If you want quantifiable results for disease modification it would be VAF mutation reductions. What is your current VAF%? It's likely whatever it is, there won't be large further reductions with IFN after 5 years, and in fact on avg VAF increases slightly after 6 years. So maybe Rux can help it continue down. But this is mushy stuff for an insurance co..
Anyway these criteria are not officially recognized as measurable responses, although we saw a post re UK recently that it is getting there. Marrow improvement is not recognized as a response criteria anywhere I know of, and is less predictable than VAF anyway.
You have asked a complex question that has to do with both the label for Jakafi and how your insurance plan works. The label indicates that failure of HU is on the path to approval for Jakafi. This, unfortunately, was driven by the difference in cost when Jakafi was originally approved. PharmaEssentia wisely dodged this issue in obtaining their FDA approval with Besremi being recognized as a first-line treatment option. No need to fail on HU first.
Bear in mind that private insurance companies exist to make a profit for shareholders. Not-for profit insurance companies are also driven by the bottom line of cost. Providing effective treatment for patients is a cost of doing business and an expense that needs to be closely managed. Denial of more helpful but expensive therapies is in the best interests of shareholders. To keep it in perspective, compare the monthly costs.
Hydroxyurea = 60tabs = $25
Jakafi = 60tabs $14,308
Pegasys = 4 doses $4,177
Besremi = 2 doses $15, 000+
When I first sought approval for Besremi, right after it was FDA approved, my insurance company said that not only would they not pay for it, they would never pay for it. Wrong answer! My doc tried to appeal it, but did not get approval. I filed my own appeal. After a lot of time and effort, I won. Something to know is that a patient originated appeal has more legal weight than a doctor originated appeal. It is a matter of contract law. Insurance companies do not want patients to understand this.
You have several options.
1. Switch to Besremi and see if it works better for you.
2. Try hydroxyurea then discontinue the moment you encounter an adverse effect of any sort (e.g. fatigue, GI upset) . Thus, you are hydroxyurea intolerant and qualify for Jakafi. This is what my daughter's doctor recommended she try if she needed to. (My daughter also has a MPN). Her doctor knows how to play the game, focusing on the patient's best interests rather than the insurance company's.
3. File your own appeal since your doctor will not try and likely would not succeed anyway. This requires considerable effort and research on your part. You will need to find the plan rules that determine treatment decisions for your insurance plan. These may be on-line but you may need to get the insurance company to send them to you. When a medication is a "step" medication on the formulary, there may be ways around this; however, you need to know the rules. The reference to "contraindication" applies here. (see below). Understand that when talking to the "Patient Navigators" at the insurance company, they work for the insurance company, not for you. Still, they can be helpful but you must be persistent and ask the right questions. You may also need to speak to a more senior person than the person who answers the phone. Most people find this process overwhelming. You can hire an independent Patient Advocate who works directly for you to provide technical assistance. Here are some lists.
Wishing you success in accessing the care you wish to receive.
These may form the basis of an appeal if relevant
Contraindications / Cautions .
hypersensitivity to drug or ingredient
pregnancy 1st trimester
myelosuppression
anemia, severe
leg ulcer
avoid: breastfeeding during tx and for at least 24h after D/C
caution: pregnancy 2nd trimester
caution: pregnancy 3rd trimester
caution: female pts of reproductive potential
caution: male pts of reproductive potential
caution: interferon use, concurrent
caution: interferon use hx
caution: chemotherapy use hx
caution: XRT hx
caution: long-term use
caution: CrCl <60
caution: myeloproliferative disorder
Additional Relative Contraindications and Precautions
Renal Impairment: Hydroxyurea is excreted by the kidneys, so dose adjustment may be necessary in patients with renal impairment.
Liver Dysfunction: Caution is advised in patients with hepatic dysfunction.
Previous or Concurrent Radiotherapy or Chemotherapy: The combined use can exacerbate bone marrow suppression and increase the risk of toxicity.
Active Infections: Because of its potential to cause bone marrow suppression, patients with active infections may be at increased risk for complications.
History of Leg Ulcers: Patients with a history of leg ulcers may experience worsening of these ulcers while on hydroxyurea.
Concurrent Use of Other Myelosuppressive Agents: Use with caution in patients taking other drugs that suppress bone marrow function.
I have never heard of hiring independent patient advocates. Very interesting. I suppose the patient advocates provided by my insurance are not going to advocate for me over the insurance company huh? 😄
One thing you and the doctor may wish to consider is the alternatives to ruxolitinib. I had to stop this because of lowering platelets and I believe fedratinib , mometalib and others do similar things to rux but are kinder on lowered red cells etc
I wonder if a lower dose of Peg might work, possibly after a Peg holiday, your Neuts are too low, is there some reason you are not taking a lower dose, some people are on 45 a month or less
I actually had taken a whole month off of Peg and then when I got the Jakafai denial I tried to resume at only 65mcg. When I had my labs a week later I had the WBC numbers above. So I had a total of only 65 mics over 5 weeks. We dont really know what my numbers were prior to me taking the 65 as my last lab was a month before. So was this an extreme reaction to the 65mcg, infection, was i already compromised previously, nobody knows.
My Dr had me on hydroxyurea for only 3 weeks because I felt bad on it. That was long enough to switch me to Jakafi. Insurance wanted to charge me a huge deductible so the Dr hooked me up with a grant from PAN foundation. Jakafi is now free! I am in the U S. Hoping you can do the same?
You have to be aggressive. Go ahead and try HU. Then 2 weeks later tell your doc you can't tolerate the side effects - exaggerate if you have to. I told my doc: "the morning fatigue is so bad I can't get out of bed until noon." Then if your doc still won't write the appeal letter go see another doctor that will.
Your doctor sounds marginally competent in other ways. Like keeping you on a very high dose of Pegasys (135 mcg) when your WBC count is extremely low. A competent doc would greatly lower the Peg dose and if some other counts like RBC/HGB stayed too high he/she might suggest taking a low dose of both Peg & Jakafi together.
I'd like to thank everyone for the responses. Regarding some of the questions asked, my high IFN dose was due to runaway HCT. It controlled it for a while but then gradually just couldn't keep up anymore and I couldn't exceed 135mcg due to sides. Then my body seemed to start outright rejecting it. Another question was whether I tried Besremi, and the answer is yes. I seem to be very allergic to it and had problems with my gums, mouth, and throat. I tried taking a break from it and when I tried again and the reaction was extreme the 2nd time. When I returned to Peg for the last time it was as if that exposure to Besremi caused me to start reacting similarly to Peg and it was all downhill from there.
My insurance is provided directly by my employer as I work in healthcare. It has been very good insurance for me in the past but it sounds like this is a typical response on the Jakafai. I was hoping that a simple explanation as to the benefits of VAF reduction, and the fact that I've already been on Interferon would be sufficient, but it sounds like I have to go the HU route first. I saw a few responses about just try HU long enough to have any kind of side effects and request to switch. I spoke with my doc about this today and he's good with it, but felt we couldn't overturn the ruling about using HU first due to that being on the label for Jakafai as Hunter pointed out. Thank you for providing such a detailed response btw, Hunter. Much appreciated. I find the part about filing my own appeal interesting but not sure how much confidence I have in myself lol.
Sorry you are going through this. As someone else stated has a lower dose of Pegays been considered? The side effects can certainly be dose related. I have been on Pegasys for 5 years, at 45mcg, no side effects. My white counts get a bit low, but remain stable, and platelets consistently stay around 160-170.
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