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Procrit vs Riba Reduction
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Procrit vs Riba Reduction

I started Procrit at week 10 after my hgb was in the 9s for a couple of weeks.  It took almost a month to get the hgb back into the 10s.  I did 8 shots of procrit once a week.  When we tried to refill in December they told me it would only be covered by my medical plan, subject to a $2,500 deductible rather than the pharmacy plan with a $60 co-pay.  So I chose not to refill until 2012 so if I did have to pay the deductible at least I would have a year with that paid.  Meanwhile BCBS forced me to change to their specialty pharmacy.

Now a month later my hgb is back in the 9s.  Last night at Tai-Chi class, I got dizzy and had to sit down a few minutes.   BCBS is denying the claim due to (1) not dropping the riba to 1000 for 2 weeks and (2) having no history of cirrhosis.  The doctor's office has provided information that I do have cirrhosis.  Still no procrit.  So now, end of week 21, the doctor said I must reduce the riba.  It infuriates me that the insurance companies are calling the shots and not allowing the doctors to do their jobs.

I know what all the labeling says. I have read the CCO summaries on triple therapy and riba reductions. The Riba labeling is clear -- option is to reduce riba by 200.  It seems that a lot of doctors carry that too far and reduce it and stop the riba.  The Victrelis labeling is not much better.  It still refers to the riba dose reductions.  However it also clearly states that it was up to the trial doctors to determine whether the patient should use epogen and 43% of trial patients did.

I told the doctor's office I will reduce dose today.  I have 600mg pills and will have to cut 1/3 off of one.  They won't be able to rx any 400mg pills for 3 weeks and I am hoping my hgb does not go up and they won't have to. I PROTEST DOSE REDUCTION!

Facts are, I have been UND since wk 6 - after 2 weeks of VIC.  BUT (1)  I do have compensated cirrhosis, (2) I have relapsed before, never reducing dose and taking procrit, (3) I am 64 and don't plan on treating again no matter what.
To me and my doctor, my best shot is full dose and procrit.

This is not a pity me thread.  I want to know what you are doing.  What your doctors say.  Are you still UND with dose reductions. Especially I want to know if anyone has seen any trials or articles that indicate with cirrhosis one shoule not reduce doses if at all possible.

This is a money thing for the insurance companies and has nothing to do with medical necessity.

HELP
frijole
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19 Comments Post a Comment
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96938_tn?1189803458
For the exercise of it and to try an additional angle...Get a referral to an Oncologyst/Hematologist for a CBC.  Maybe they can administer Procrit (or similar - like longer lasting Aranesp) in a clincial setting which may have a different impact on insurance coverage and deductible
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1148619_tn?1332014584
I am so sorry you are going through this. I would be so pissed, yelling at people, etc.  I can't relate other than the few battles I have had with insurance. My hgb is staying at 9,2 since beginning of November except for a slight increase over Thanksgiving thank God and I would love to get it back up to 10. When its at 9.2 even my Pilates class wipes me out, LOL.

Good luck and keep us posted. You have been such great help to all of us here on the forum.  Mo
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Avatar_m_tn
Hi Frijole..I couldn't find anything in particular for dose red. as it pertains only to chirrotics ,however I linked this article to have a look at if interested. You may not have seen this one ,,and I apologize if you have.
Personally my opinion is (that and a couple of bucks will get you a coffee) is that it seems by all the data ,because you have been already UND. for about 15 weeks a slight reduction will not adversely affect success whatsoever.
From everything I have read ,the  slight reductions that are done well into therapy once UND. are far less adversely consequential to success than they were when doing SOC.  

Good luck with this......
Will


http://onlinelibrary.wiley.com/doi/10.1111/j.1478-3231.2011.02707.x/abstract


The management of anaemia in TVR and BOC clinical trials is summarized in Table 1. In BOC trials, 43% of patients received erythropoietin alpha (EPO) for the management of anaemia, de facto using a quadruple combination therapy [10, 11, 12]. This may be problematic in clinical practice, as BOC will have to be administered for 24 or 44 weeks. In phase II/III TVR trials, the use of EPO was generally prohibited, but EPO was used in 1% of patients only [9]. Blood transfusion was required in less than 5% of the patients for both drugs. A similar proportion of patients underwent RBV dose reductions to manage anaemia, approximately 22–26% (Table 1) [7, 8, 9, 10, 11, 12]. The retrospective analysis of phase III clinical trials with BOC and TVR showed that RBV dose reduction did not seem to have a negative impact on SVR (Figs 1 and 2) [13, 14]. In addition, the use of EPO did not seem to have a positive impact on SVR rate in BOC studies. These initial analyses must be discussed in relation to the results of large retrospective studies of patients treated with PEG-IFN/RBV. These studies have shown that a dose reduction of RBV only has a negative effect on the efficacy of outcomes when the cumulative dose is less than 60% of the initially planned dose. If the dose reduction of RBV occurs when HCV RNA is undetectable, the impact on SVR seems to be reduced [15]. When EPO is used, the full dose of RBV can often be maintained and the quality of life is improved [16]. In a post hoc analysis of a controlled study involving more than 3000 patients, it has been shown that patients who developed anaemia during a course of PEG-IFN/RBV had higher SVR rates than those who did not develop anaemia [17]. In this study, EPO increased the chance of eradicating HCV when it was administered in the first 8 weeks, probably when HCV RNA was still detectable. After the eighth week of treatment, EPO had no beneficial effect on the SVR rate. If these results are extrapolated to triple therapy, it may be necessary to maintain the full dose of RBV until HCV RNA becomes undetectable. Thus, EPO could be used according to the local regulations of each country. If anaemia occurs when HCV RNA is undetectable, the RBV dose could be reduced by stages of 200 mg daily. The value of administering EPO or reducing the dose of RBV in patients with haemoglobin levels below 10 g/dl is under investigation in a prospective clinical trial with BOC. The results of this important study will be available in 2012. The initial dose of protease inhibitors must be maintained in all cases. Finally, a few patients with
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446474_tn?1404424777
My friend I believe you are getting very worked up over very little. I understand your fear of treatment failure, but using riba dose reduction instead of erythropoietin treatment makes no difference in SVR rates when treating with Victrelis.

Let me comment on your "Facts are.." paragraph.
1) I understand cirrhosis is the largest factor that could reduce your odds of SVR,BUT you where UND at week 6 indicating that you responded as most relapsers should to the peg/riba plus antiviral. Response to treatment with Victrelis has been shown to increase response even in cirrhotics. This is what counts. It over rides the poor response in most cirrhotics where many of us were non-reponders to peg/riba not relapsers.

2) "I have relapsed before, never reducing dose and taking procrit".
Having relapsed before on peg/riba is the best indicator of success with the the addition of Victrelis. In the past with peg/riba treatment, dose reduction was a serious issue. It reduced SVR rates. But with the addition on Victrelis that is NO LONGER THE CASE. DOSE REDUCTION HAS NO IMPACT ON SVR RATES FOR PATIENTS TAKING VICTRELIS!

3) I am 64 and don't plan on treating again no matter what.
I appreciate your concern about not treating again especially being cirrhotic. But as I have said riba dose reduction has no affect on SVR rates when treating with Victrelis. Your worrying is based on treatment with 1peg/riba. Treatment with an antiviral is very different.

'To me and my doctor, my best shot is full dose and procrit.'
I am not sure why you say this because the data shows this NOT to be true. There is NO DIFFERENCE between the SVR rates of those patients that dose reduced riba vs those that managed their anemia with Procrit.

Let's look at a summary of the data...
----------------------------------------------------------------------------------------------------------
AASLD PRACTICE GUIDELINE
An Update on Treatment of Genotype 1 Chronic Hepatitis C Virus Infection: 2011 Practice Guideline by the American Association for the Study of Liver Diseases

HEPATOLOGY, October 2011

...'However, neither anemia nor RBV dose reduction adversely affected the SVR rate. Of note is that in the BOC trial, SVR rates in patients managed by RBV dose reduction alone were comparable to those in patients managed with erythropoietin therapy.'
...'Because the duration of BOC therapy (24 to 44 weeks) is longer than the duration of TVR therapy (12 weeks), the frequency of anemia is likely to be greater in BOC-containing regimens, leading to more RBV dose reductions and consideration of erythropoietin use. However, the potential benefits of erythropoietin must be weighed against its potential side effects, the fact that its use in HCV therapy is not approved by the FDA, and its considerable cost.'

'Recommendations:
15. Patients who develop anemia on protease inhibitor-based therapy for chronic hepatitis C should be managed by reducing the ribavirin dose (Class 2a, Level A).'
-----------------------------------------------------------------------------------------------
Good luck with your treatment!
Hector
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223152_tn?1346981971
I appreciate your responses (and the reality check)

fl guy-having a hemotologist monitor my bloodwork is an option and I have spoken with the office of the doctor I used in 2005/2006. The insurance company is not only giving me the run-around, but I am still unclear whether (if approved) it can be covered either under the  pharm - $60 co pay or the medical -- $2500 deductible + out of pocket. If it can only be covered under the medical plan, I will talk to the hemo.  I still think she used a chemotherapy code (not hcv) and that is why there was no problem last time.

brianmo -- pilates and hgb of 9.2?  Holy moly!  I have cut out most excercise and when I do it , it wipes me out for the day.  My favorite thing is walking and I just haven't been able to motivate.

will -- yes, I have seen those articles and my googling has not turned up a link between cirrhosis and dose reduction.  Most of the googled info is pre triple.  I think we are the test subjects for a lot of future literature.  I mean 1000s of trial patients are just not that much.  Still, you point out I have been UND for 15 weeks and a slight reduction should not hurt chances for SVR.  

Hector  -- well call me Spock -- but that is just illogical.  How can reducing treatment drugs not matter? I know, I know, and I thank you for the reality check.  Still I am not convinced that dose reduction has no impact on treatment.  But the reality is I cannot substantiate my opinion.  I will bend to it and see if the hgb comes up with a 200 reduction.  But if it doesn't, and the next step is to reduce another 200 and then another 200 I will take another tack.  

frijole
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1835200_tn?1327071367
For what it's worth my hgb went to 9.6 and they reduced riba from 1000mg to 600mg. In one week hgb was up to 10.0, 2 weeks still 10.0 so they increased 200mg to 800mg and my last hgb was 10.5.
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96938_tn?1189803458
Your reference to the code used is a good point.  Now that I think about it, I think that was the case with me too.  The GI was hcv-watching and by agreement, the Hema doc was blood-watching and treating for the blood effects of the meds. Therefore, the coding used by the Hema doc was not a HCV dignosis code.
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Avatar_m_tn
I always demanded full doses with Peg/Riba SOC but the PIs have changed the landscape. I agree with Hector regarding Riba dose reduction with Victrelis - it won't compromise your odds of SVR.

Hey, Good luck to you......and peace of mind too.

Mike
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223152_tn?1346981971
nowhine - The way I look at -- from the trial data Victrelis wll reduce the hgb 1 point more than with SOC - and this apears to be the case for me except we started procrit at 10 my last treament so I don't know if it would have dropped any lower.  you reduced by 400 to get a 1-point increase.  I am just not sure how ..... anyway we shall see

FL
Just out of curiosity, do you think if I go to the hemo and she uses a chemo code will they not cross reference all the HCV or will it be treated as a new claim.  I actually liked having the blood expert on board.

mike
a man of my heart.  Hell no, we won't go! I think maybe if I understood the biology/chemistry of the PIs more and what they did, I might be able to see why riba reduction doesn't matter -- but I don't and it does.

bean
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Avatar_f_tn
My husband is on Inc., not Vic., but when his hgb dropped to 11.1 (granted not very low, but he started at 14 something), his NP reduced his riba from 1200 to 800 for two weeks.  Last year, when he was on daily infergen injections and 1400 mg of Riba, when his hgb dropped to 11.4, she reduced had him skip only 1 dose of Riba and then ordered Procrit that same day.  Same NP. Same doctor.  Similar numbers.  So, I'm pretty sure it's the recommended procedure for managing anemia with the PIs.  I agree with you, it's terrible having insurance companies determining what steps should be taken, but on the other hand, the statistics from the PI trials, and the recommendations for managing anemia with the PIs all seem to indicate that the dose reduction in Riba is the right thing to do.  My husband postponed a few days following through on the dose reduction because he was worried that it would affect his chances at SVR, but finally reduced the dose after about 4 more days, and within a few days he felt better.  We haven't done the 16 week VL yet, because of our snow/ice storm here, but based on the trials, we are expecting that he will still be UND!  :)
Advocate1955
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223152_tn?1346981971
advocate
Yeah, I heard about that storm.  Wasn't it the worse in modern times?  How are you handling it?  When it snows down here in West Texas it shuts us down.   We just don't have the equipment.

Well, the jury is still out, folks, but I got a call from my insurance company that they had approved the Procrit. It appears that the combo of my doctor reducing the riba by 200 and my hemoglobin being under 10 for 2 weeks was enough for approval.  I am still in wait and see mode but the pharma company shows it approved too and gave me the co-pay amounts and it is currently with their department that is checking my coupons for the Victrelis and PegIntron.  I won't hold my breath, but it could possibly be shipped by Tuesday.  Go figure!

beam me up scottie
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Avatar_m_tn
I have to wonder why they just don't reduce everyone once they become UND? Why subject them to procrit and blood transfusions? Less riba would make one feel a lot better and make treatment a lot easier.

So now cirrhotics should be treated the same as people with very little liver damage?
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163305_tn?1333672171
I'm in a completely different situation but I gladly reduced my riba two weeks ago and am happy to have my breath back.

Beano, you're going to feel better and we are both going to be hep C free !!
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1669790_tn?1333666195
Good news frijole.  Looks like your persitance has paid off.  I understand your reluctance to dose reduce, so hope the minor Riba reduction and the Procrit does the trick and helps to avoid further reductions.  Time to relax now.  Enjoy the weekend. ;o)
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Avatar_f_tn
Hi frijole, the snow/ice storm has been pretty bad. I've lived in Seattle all my life, and I've only seen one or two other significant snow/ice storms like this before:  first lots of snowfall (which is bad enough since Seattle is all hills and we do not have the snowplows to handle it) and then immediately afterwards a sudden drop in temp and ice rain absolutely encasing everything in ice (I put some photos on my page)...warm air then following a snow/ice storm really causes quite a bit of rain, rapid melting, and flooding, and that's where we are right now.  Lots of power outages, maybe up to 5 days to get all the outages restored, but we got our power back in the early morning hours today, thank goodness.  Thanks for asking.  I'm going to check in with the two others on the forum that I know are from western Washington too to see how they're doing.  In the meantime, I'm glad you'll be getting your Procrit.  Must be very tough to have the hgb below 10 for so long.  Maybe your doctor will let you up your riba in a week or two when your numbers come back up and then you won't have to worry about the dose reduction impacting SVR.  You've been UND for a long time, so I know you're headed to being virus free!
Advocate1955
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223152_tn?1346981971
can-do - good point

"So now cirrhotics should be treated the same as people with very little liver damage? ."

You know I would have fought for the procrit even if I didn't have beginning cirrhosis but do they get treated the same?  This treatment is a lot harder on my overall and I don't know if it is the increase in age or the cirrhosis or the Peg Intron or the addition of the VIC.  I am still confused by my hepatologist who said at first - 48 weeks and then said 36 since I have been clear since week 6.    Everything I read says Victrelis recommended dosing for cirrhotics is 48 weeks.  So the question is am I cirrhotic or "pre-cirrhotic?"

OH - when you dose reduced your riba were you under dosed for your weight?    I would still rather not underdose riba because I felt like the interferon did it's job first treatment and the riba failed me.  I just can't see that the VIC makes that different except to compound the anemia.  You are still taking the Neupogen, aren't you?  The doctor (I thought) put that rx on hold because  one shot has kept my ANC over 1 for over a month.  However the insurance company is sending it next week along with the other treatment drugs.  I still have 3 in the fridge but I am going to let them send it because they have been hard to deal with, and then I will have it when I need it and not have to deal with them.

advocate - I just don't understand these weather patterns.  I'm glad your power was turned on quickly.  The best of luck to your hubby.  It looks good.

bean

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Avatar_m_tn
I can empathize-my hgb is 8.6 (dropped again) and wbc is 2.0. We began riba reduction last week. I was given the new riba by my hep doc as samples, since I was told it is not a good idea to cut the riba tablet; I was on 400 2x, not on 200 2x. Are you gasping for air also; I have dizzy spells too. I asked hep if he used rescue meds and he said he prefferred to see results before transfusion (transfusion in 1979 is what got me here in the first place!!) He also said he would consider Epo (?); I see hep doc Tuesday morn. I hope you feel better soon frijole!
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Avatar_f_tn
I have no idea but thank you for posting this question as I haven't started to yet, but I am very grateful for your question and all the answers

Also thank you for all the work you do with the spreadsheet charts
Xoxoxoxo C
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163305_tn?1333672171
Okay, I hope this explains things. . .

I weigh 105.
When I saw the nurse practitioner on my first month check up , my doctor had written in my chart that I could reduce from 800mg riba to 600 if I had problems with sx..
It wasn't until 2 weeks ago that my breath started getting short. I could barely walk up an incline never mind stairs and hills.
The NP and my doc approved the reduction.

Also, when I saw the hepatologist at my 2 month visit, in reply to my neupogen questions offered to let me reduce my interferon to 135mg. Upon further questioning, he admitted  he preferred I stay with the full dose but essentially, he'll do whatever it takes to keep his patients on treatment.
At that time with my 8 week PCR, MIA, I decided to keep with the full dosage.
A little over a week ago,( week 15) we went ahead and cut my interferon to 135. The reason for this long explanation is to explain why I didn't take nuepogen this week. MY anc were 900 and my wbc climbed up to 2.0, haven't been there in weeks.
If they get back down to 500, I take nuepogen.

Neupogen is strange stuff. I'm not convinced at all that your one shot has kept your anc higher.Supposedly it doesn't last in the system more than a few days.
My first week, anc dropped to 500. I took the 300mg shot. Next week, anc was back to 500. In tears I asked to reduce the neupogen shot because it hit me so strongly. So I took 150mg. Next week, my anc was 1000.
Does that make sense??
Using myself only as a guinea pig, I can't figure out this stuff at all.

Let me say one last thing, nobody should use me as an example of what to do.
I know my body. I'm petite but more than that, I'm med sensitive.
My body doesn't need the amount of meds other people do, and I know that.
I believe I could have gone with the smaller dosages from the beginning, but this is me, and one size fits all, doesn't fit me!

My nurse said they will take any unused meds back from me at the end.

Hugs,
OH
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