You may remember I said that IL28b testing could backfire when we intiallially discussed it?
Well now my docs are telling me the good genes that allow me to respond well to Interferon means that this denial of new protease inhibitors will apply to me!!!
This is horrible news and will I fight this...of course.
My rational for having the genetic testing was valid:
A. to discover what may have cause me to fail tx so as not to fail again
B. to help me decide whether to include interferon in any future tx as opposed to say trying amantadine or some other new therapy shown to work well on those who either cannot tolerate INF or whose genes don't work with the INF. Had I tested as having the wrong genes I definitely would have pushed for one of these alternatives so in my mind there were two excellent reasons for having the testing.
This was a calculated risk of course, doing the testing, given that the chatter after the stats came out at ASSLD was that insurances might deny the PI based on the expense and the genetics. I spoke of this as a cautionary in my original thread, but concluded there were more reason to have the test as a relaspser than not to.
This is also an issue I think I can overcome due both to the stats on the the Prove trials as well as the ERISA laws which forbid insurance denials to the self insured. The Hopefully, if I get a denial based on my genes the tacitcs of my rational coupled with the self insurance laws being in my favor will be the hail mary pass needed here.
However, if my docs won't even recommend the PI then I'll have an uphill battle even with good insurance, and even were I to get a new doctor.
For these reasons, and the fact that many patients may soon face what I now face, who are not protected by ERISA as well, (workers whose companies do not self-insure are not as well protected by the law and ergo subject to more denials, so that's most of us).
Ergo I think now would be a great time to all put our heads together as to how to solve these issues.
Not normally depressed I have found the last 3 conversations with my doc very discouraging.
It's got me very concerned as they have brought this warning up to me in my last 3 visits, so I get the feeling that they are trying to hammer the idea home, prepping me me to live without the PI on board.
Even though the PI doesn't make a huge percentile jump amongst those with good genes, it's still a bump none the less and I believe based on research one could make a good case for 3 or 4 drugs to halt mutations best even though each individual drug may not up the stats that much, the combo tends to make the virus less recouperative and less able to rebound and find an alternative way to replicate.
Ergo cutting off multiple avenues of replication simultaneously seems to afford much more protection than say higher doses of just 2 drugs. This I beleive is why the PROVE trials were invaluable as stats there showed a correlation between the third drug and a much lower rate of mutation across all groups, naives, relapsers, rebounds etc.
The real kernal being missed here is that it's not all about the Lambna genes....sure it helps if you don't cancel out INF and your body works well with it...but it's only part of the equation.
I also don't get why it wouldn't be cheaper to add the PI up front, given that tx time can be cut in half or close to it, and given that the last half of tx is when many must be put on Epo. In my case this will undoubtedly be the case once again, so at least with the PI I think it might be a break even. Especially if I opted for just 6, or maybe a 9 month course vs. a full year.
What I would appreciate very much is any brainstorming on rationals that may help me make my case.
I've seen the IL28 stats and the PROVE trials, but if anyone has run across some little known factoids or studies I may have missed they would be appreciate very much.
Several heads are better than one so please add your imput even if you think it's been mantioned before.
I have not been around much due to my depression and surgeries so if this topic was already discussed I'm unaware of it.
This coming TUESDAY so I will be spending the weekend preparing my defense.
Also picking a doctor friends brain I learned that all the insurances have not yet defines their criteria, but that if one orders the drugs, and they are denied, that the best approach is NOT to go for a pre-authorization but to have the doctor write a letter of PRE_DETERMINATION instead. These have higher priority in the insurance hieachry and are given more close consideration.
Hopefully that last little factoid will help any number of us.
Thanks in advance for any and all responses.
Does anybody know or have you seen any studies where adding the PI for just the first couple of months was tried?
I'd love to see some stats on those outcomes.
Who would tell the Ins company you had the test? Since this is an out of pocket test the Ins company shouldn't have a clu. Worse case is you may need to pay for the new PI. At least this is how I will approach it.
Get your doctor to appeal decision, also appeal the decision yourself with the insurance company, get a local journalist involved in the story (they love suff like this), you may have lost a battle but you may still win the war... Good luck...
Upbeat- they know because the test was approved, as I said with self insurance the law favors the patient...they cannot by law deny anything the doctor orders. Ergo they know, after the second Lambna test became available I had the testing done as with 2 tests accuracy is higher than the original 85%.
Yes, one approach is to self pay...which is why I'm wondering if the 2 or 3 month initial tx might be enough...this way I could avoid the worst sides somewhat, and get the mutation protection without so much expense.
Desrt- you make an excellent point, which I will add to my questions. The fact that I was compliant means that the INF was not suffiecient, or the riba wasn't. I suspect the riba more (see my thread on purines) however I also suspect the INF due to my blood sugars.
When Cowriter came in and explained that it made sense, as my sugars were 10-20 pts above normal, meaning in spite of the right genes my insulin was suppressing the INF. Unfortunately none of us were told...I was 90% through with tx when I found out...better luck next time. What gets me, is they told us that diebetics do worse with tx..BUT not WHY...only cowriter brought that to our attention not our doctors.
Magnum My doctor has to make the right decision to begin with. Right now HE is the bigger part of the problem...he has seen the stats for the IL28b and the differentiation is not that great....ergo he thinks it might not be wisdom.
However I am willing to take that right. Right now I am leaning towards the boce, since I will need the Epo anyway, and since the rash is less and I have autoimmune stuff.
I think that at least until getting UND the PI is wisdom with all my factors...i.e. Type 2, stage 3/4, autoimmune, etc.
Willing--most clearly demonstrable, my thought precisely. overthinking, my specialty...
I'm inclined to say once I press on my points and the Erisa he will acquiese but the bigger issue is what will happen to others...those not blessed self insurance. Rest assured the chatter is definitive that they are expecting insurance to balk or at least set criteria disallowing if they can such a costly adjunct. I would equate this with refusing to treat folks with penicillin for syphylis and deferring to arsenic instead....when a drug with such a pronouced effect can be dismissed in favor of one with only 20-30% cure rate amounst relaspers...and at higher more toxic doses than before even to get that 30%...something is rotten in Denmark.
I'm already planning to schedule a second hepatologist this week...just in case...but I am hoping my doc will do as you said...just order the drugs...if they come back rejected, we write a predetermination letter...by law Erisa protects against denying the self insured anything the doctor orders, so the real issue is whether he will buy into my stategy.
Since it took him 6 months to even consider my Alinia info I'm not certain which way he will go on this, but will give it the college try.
Cindy --don't get entiely discouraged, it is going to vary from insurance company to insurance company and doctor to doctor how they handle the info.
In my mind it suks because INF is only one part of the equation...so much else factors in that to conclude definitively that ones response to INF should preclude one from other treatments is to be shortsighted. It's also important to note that every stat is an average.
An average is just the number taking into account everyone and doesn't factor anything else in. Like for instance is the proteease inhibitor more apt to stop the early mutations.
Also, id the average bump for the good genes was only 5% that would still mean some of the good gene people had a 1% increase while others would have had a 9 or 10% advantage. So even at that low number the PI COULD still be adding a 10% advantage to some folks, or more, we don't know for sure, but that's certainly worth looking at.
What really gets my goat is that it is REALLY woth looking at and knowing your genetics...and this is going to put a lot of people off that if it will be used against them.
The truth is knowing could save a person from treating with a drug not likely to work, and it could cause some to use drugs much more likely to work...so the idea that somehow they would turn this on its ear is very egregious to say the least.
I think it's going to be up to we the patients to really contend here, and even educate our doctors a bit more as to the far reaching implications of taking a hard line on genetic testing.
After all Cidy, they regularly treat folks with cancers where the tx has only a 5% chance of working...and think nothing of it...to deny these drugs especially after the PROVE trials seems highly irrational.
Much Ado About Nothing...
Hold on folks the world isn't ending yet. If you prefer catastrophe, cynicism, drama, paranoia, etc. Don't read is as it will probably make you feel incredibly cheerful and ruin your mood. For those interested in the known data read on.
A few basic facts...
IL28B genotype (a PRE-TREATMENT predictor of the effectiveness of an artificial interferon treatment for Hepatitis C) in the case of people who have treated and failed to achieve SVR is not a major factor in treatment decisions, because a person's viral kinetics when on previous treatment is the actual response you had while on SOC treatment. Your predicted response is trumped by how you actually did respond when on treatment. So in Merry's case she was a "relapser". In the case of relapsers it is the remaining virus that causes relapse. IL28B genotype does do not predict the risk of relapse. See 2nd article from EASL below. Merry, your doctor (a hepatologist?) doesn't realize that the reason you relapsed was because the interferon alone did not eliminate the virus completely? "Well now my docs are telling me the good genes that allow me to respond well to Interferon..." Well I would say he/she isn't qualified to be treating patients with the new DAAs as he doesn't have a basic understanding of hepatitis C, IL28B genotype and its treatment. As willing said, find another doctor who understands the latest treatment protocols. Your current doc obviously doesn't.
As far as insurance, it is per conjecturer. No insurance company is paying for or not paying for these meds now. If you want to create a doomsday scenario that is all fantasy to begin with? Don't we who are still chronically infected have better more pressing things to think about with the new DAAs coming to market?
The rest of this post will focus on telaprevir and relapsers but by reading these or other materials you can figure out the new DAAs data relating to your own viral kinetic response to treatment previously.
Can someone explain this to me? How can it be justified (by doctor, Insurance, etc.) that you should retreat relapsers with SOC and have about a 24% chance of SVR when treating with the addition of telaprevir gives you about an 85% chance of SVR? So that 3 out of 4 SOC patients would fail treatment again. Even from a purely financial perspective it makes no sense. It could never be justified.
IL28B Genomic-Based Treatment Paradigms for
Patients With Chronic Hepatitis C Infection:
The Future of Personalized HCV Therapies
"Host IL28B genotype is the strongest pretreatment predictor of response through its effect on viral kinetics. On-treatment viral kinetics (currently RVR or early viral response, but potentially even earlier measures) provides direct measurement of treatment response
and remains the most powerful on-treatment response predictor and the key criteria for on-treatment therapy decisions."
PREDICTION OF RELAPSE AFTER PEGINTERFERON ALFA-2B/RIBAVIRIN THERAPY IN CHRONIC HCV GENOTYPE 1 PATIENTS IS DEPENDENT ON MINIMAL RESIDUAL VIREMA BUT NOT ON IL28B GENOTYPE
Conclusion: Viral kinetics during therapy, but not IL28B genotype at baseline, predict the relapse risk after therapy with peginterferon alfa-2b plus ribavirin."
To further spoil the depressed and embattled mood...
..."RESULTS: There was no statistically significant benefit to taking a 4-week peg/rbv lead-in for relapsers as 83% of prior relapsers who did not use lead-in achieved SVR, 88% who did use a 4-week lead-in achieved SVR but the difference does not appear to be statistically significant, vs 24% receiving only peg/rbv achieved SVR;.."
..."There were no differences for prior relapsers as whether one had minimal fibrosis, bridging fibrosis or cirrhosis SVR rates were 84-86%."
..."Regarding 1a vs 1b genotype there was little difference in SVR rate between 1a & 1b for prior relapsers (84% vs 88%, respectively)."
SVR rates in the mid 80s! If that doesn't sound hopeful then I don't know what does.
You haven't been denied for anything. Your doctors haven't come right out and even said so, your Insurance company hasn't said so. Wish you would take more care. The title of your thread is alarmist and downright misleading - how many people waiting for PI's are going to see that and get unnecessarily concerned? You could ask for supporting information without the unnecessary and potentially damaging scaremongering. Good info from Hector, good approach from willing and hopefully that settles yourself AND others down. Can't see any reason a knowledgeable doc would not consider a PI for a relapser regardless of IL28B status.
Sorry about the depression. Not fun. Might be contributing to your outlook? Hope you are getting adequate help for that.
Blue cross- blue shield never paid for mine. You would think that if you were a non responder or null responder or someone with cirrhosis it would be a no brainer. I wonder how Medicare will be dealing with this? This is a work in progress and I believe the Ins companys will come around.
There are many people on the forum who already have a plan with their hepa's to treat with a pi added, especially the relapsers. Denial is often part of the insurance process and sometimes requires some more detailed info from the doc.
I agree with Trish though, how could you be denied before the drugs have even been approved. It's difficult to imagine the insurance company will want to spend more money on having you treat several more times or risk your disease getting worse and more expensive.
There is and will be some serious lobbying of insurance companies going after vertex and merck have spent billions getting their drugs approved. I doubt that this stuff is going to stay on the shelves very long.
Good luck, relapsers will be kicking viral *** with these new drugs.
Upbeat, can you please explain how your insurance company didn't pay for you taking one of the DAAs? When did you treat and how? Clinical trial?
How can an insurance company pay for a medicine that is not FDA approved?
"Before a physician can legally prescribe a drug for a patient, the drug must be approved by the Food and Drug Administration (FDA). Until a drug is approved by the FDA, it cannot legally be given to anyone except through an approved clinical trial or through a drug manufacturer’s compassionate-use program approved by the FDA."
How can a 3rd party pay for a drug that has no NDC (National Drug Code) number?
"THE INCLUSION OF A FIRM OR ITS PRODUCTS IN THE NDC DIRECTORY DOES NOT DENOTE APPROVAL BY THE FDA OF THE FIRM OR ANY OF ITS MARKETED PRODUCTS, NOR IS IT A DETERMINATION THAT A PRODUCT IS A DRUG AS DEFINED BY THE ACT, NOR DOES IT DENOTE THAT A PRODUCT IS COVERED BY OR ELIGIBLE FOR REIMBURSEMENT BY MEDICARE, MEDICAID, OR OTHER PAYERS." - FDA
Please don't mis-inform people that there is a general denial of PI's, this is not accurate or true ! The result of this is folks like Cindy having to deal stressing out over something that is not true.
Unless you can a statement by the FDA about the use of a drug that hasn't even been approved you are broadcasting B.S.
though it seems hard to imagine il28b status as a basis for denying relapsers, here's a more plausible scenario. In deciding whether to pay for triple tx for a naive, the insco/public-health-single-payer first requires an il28b and if cc, a 4w lead in. If pt RVRs they might refuse to pay - anyone see this as an abuse of genetic information?
also re Hector's quote above it's important to remember the advantage of a soc lead-in in triple tx is not the few % points of improvement but critical information before you start the PI about whether your triple tx SVR odds are in the 80s or 30s.
In your scenario, you have a CC gene, a 4w lead-in that produces an RVR and a treatment naive. In the case of a Genotype 1, rather than not funding a PI, I would see that perhaps the insurance company might go for the shorter 24 week therapy in your scenario, with the thinking that this would be a candidate for a more potent, shorter and therefore less expensive course of therapy when all the elements that would point to optimal conditions for that exist, providing there are no other factors that might be a contraindication for success.
Beyond that, not sure how productive it is to get overly concerned what they might do until there is some indication which way this is going to go. Considering that doctors are chomping at the bit to get their hands on these drugs and the high level of success achievable with them compared to SOC drugs, I can't see how the insurance companies are going to be able to get away too easily with being stingy on funding them. Perhaps I'm being overly optimistic but if it does happen, I'd like to see what reasoning an insurance company could possibly come up with for not funding drugs that produce a significantly improved result and drugs that are being so eagerly anticipated by the medical and patient community alike.
If these drugs are so close to approval, perhaps it might warrant some phone calls to insurance companies to ask how quickly they are prepared to put plans in place to fund these drugs once they're FDA approved.
Imagine how complicated the process will be If insurance company approval to ad a PI becomes response guided, the possibilities are endless. Hopefully the discretion will be left to the doctors. The again I suppose it's rather naive to believe the insurance companies would allow the doctors to spend their money without close supervision.
At least it won't be long before we won't have to speculate any longer.
24w for RVRs already seems the norm in parts of the EU and in any event will become so with tela RGT - so no cost savings there (also a full course of tela is 12w),
From Craxi's comments it sounds like the EU is already balking at the cost of coverage and so will be looking for ways to reduce this. There's a group of RVR/CC naives whose prospects with soc are so good (lucky ones!) that the extra 35-45K spent on a PI makes no further improvement. They would seem to be the first candidates for cost cutting - but I wonder how they'll be identified.
Agreed we'll know soon enough - and wish I had that problem...
Initially, the cost saving is that neither Canada nor the U.S. are at the 24 week course of treatment for an RVR. So a 24 week RGT for a CC/RVR with a PI from 48 weeks would be a cost saving or at least a better ROI with the higher cure rates, compared to what treatment currently is for either.
I would agree that there are times when the addition of a PI makes minimal difference in some cases and then it's back to your SOC lead-in scenario where actual treatment experience trumps IL28B results.
RGT certainly does add extra layers to all of this. Differing health care systems does as well. In the U.S., you'll be able to change it up per doc and per insurance company and I suppose that has it's pros and cons. In Canada with universal health care, the decisions are made for a whole province and docs are bound to some degree with a government decision on what drugs under what scenarios will be funded and there is much less flexibility for individual treatment approaches. In a universal health care system where "the greater good" is the consideration, including a PI when there is nominal benefit in exchange for the extra cost may be cause for exclusion and that is not necessarily a bad thing and hopefully it doesn't become one.
All a waiting game at this point and I'm hoping for you that you'll have no cause to wish you had PI earlier on.
I would not expect a Doctor to be an expert on changing insurance decisions any more than I would expect an insurance company to be expert on rocket science. The drugs are not even approved yet. How could a doctor render an opinion of something for which the insurance company has not opined. Sorry to say that the sky is still suspened in the firmament.
"if my docs won't even recommend the PI then I'll have an uphill battle even with good insurance" Be truthful here, did your doctor really say that??? He won't recomment a PI for your condition ???
I really appreciate everyones comments. Thanks guys.
thanks for the links and you are right, he may not really have processed the info, which is baffling since he was supposed to be tops around here, and Stanford trained.
I am NOT trying to panic anyone however....if anything I think my docs have tried to panic me!
They sing their mantra about the insurances not going to pay ever since they came back from the ASSLD last year. In fact the one doc (I see two liver people) brought it up with me immediately after the conference and said that this was the chatter. That because the companies were expecting shorter treatment times they were going to jack up the prices to offset their losses to maybe 75K for the PI, and that this was going to complicate any insurances companies being on board. Since then I've heard various numbers from 60K to 100K from various sources but any way you slice it it isn't going to be cheap.
I have no idea what they are basing their expections on, I have no idea if it is even factual.
Last thing I want is to discourage anyone.
I'm just stating what has been said to me, which is disconcerting to be sure.
Meaning I really don't get why they keep bringing up insurance denials...it's like they are either expecting the denials and don't want the patients to get their hopes up, or else they are trying to discourage me before they even know because they know I want to retreat aggresively as soon as possible.
In any case, it's not me trying to do any of this....I bring up my optimism about the soon approval of the PI's and they shoot it down by saying insurances won't pay and besides with my genes it may not help that much....this since they study came out showing CC's didn't get the bump other relaspser's did. The conjecture is that the folks with bad genes are getting 90-95% SVR adding the PI while the folks with good genes are only getting a 5-10% bump.
Before the testing was even available I had mentioned that I thought if those numbers proved out it might be harder to get the PI's approved, simply because the way it is now in this country, and even more so in Europe is that the lower the odds and greater the expense the less likely policy will allow for the treatment. This has happened with various meds, and Berlins recent EASl also made mention of the policy issues based on genetic testing.
In any event as I said, there were good rationals for me getting the tests after my relaspse, how else can someone know how best to proceed....but it's a crying shame if it backfires on anyone.
I'll be looking for a doc who is not so cynical if I can't convince them tomorrow.
The problem is they aren't looking at just the studies giving the stats for relaspsers across the board...they are looking now at the stats based on genetics showing the improvement adding the PI to those with good genes doesn't help as much as it helps those with bad genes. It seems to me that a patient should still be offered a drug even if that drug only adds 10% to their chances, but the question remains what will insurances do.
If someone is denied, based on their genes I think our best option will be to fight it.
Example, say someone has a condition that means they have half the odds of succeeding at treatment than someone else....is treatment therefore denied to them? No.
In the case of geno type 1 we knew our odds were 30% less on average than for some other genos, and yet treatment was not denied, so if a CC gets less of a bump that same rational should still apply, right?
So in my mind there's no reason why every patient should not push for the more successful drugs whether they get a 10% bump or a 40% bump isn't the issue, the issue is that if it is a drug that is helping to cure it needs to be tried, regardless.
FI guy...yes he brought up the fact that the CC group had the lowest percentile advantage 2 weeks ago...when I went in for a different procedure...a colon exam, so even when I'm not in there for liver issues, and was drowsy and about to be put under anesthetic he was still going on about that one study. My concern is that since Europe is kind of a measure of what is coming, that as our "socialized" medicine kicks in more and more we are going to becomes more subject to the same policies as they are employing, and this will not be good for liver patients at all.
yes, I am getting help, thanks. I'm don't usually have things get to me. But I have been waiting TWO long years for this PI to get here. So hearing only discouraging news on every check up was really taking a toll. After talking to my therapist I realized someone has to convince these folks to fight FOR their patients and not just assume there will be denials and shrug them off...so once again I'll be doing the proactive thing and making the case for those who might otherwise fall through the cracks and not just for myself.
It's just that after enough years of having to convince people who don't want to hear it, one gets tired.
I'm not sure why anyone would accuse me of misinformation, all I have offered up is what's been happening to me, and it's not misinformation if it is really happening.
To clarify, I am being TOLD that the insurance will deny the treatment in all likelihood, but I have not been refused the recommendation....yet.
Unfortunately the mention of the genetic predictors and policy changes was only mentioned to me as I was about to become unconscious and I have not seen the doctor since that event. I will get clarification tomorrow hopefully.
Part of my concern stems from the fact that in 3 office visits as well as one totally unrelated visit they keep bringing up that insurance will probably deny the treatment.
I don't know if this means they agree with the socialized approach and won't go to bat for me, or if they are just assuming based on past experience or insider information and trying to brace patients for what they know is coming.
In either case I think THIS CAN BE A POSITIVE thread if we as patients take the bull by the horns and go in prepared to defend why we should have the drugs.
This may then help the doctors make more salient arguments with those insurance companies that do balk at these treatments.
"To clarify, I am being TOLD that the insurance will deny the treatment in all likelihood, but I have not been refused the recommendation....yet.
Unfortunately the mention of the genetic predictors and policy changes was only mentioned to me as I was about to become unconscious and I have not seen the doctor since that event. I will get clarification tomorrow hopefully.
Part of my concern stems from the fact that in 3 office visits as well as one totally unrelated visit they keep bringing up that insurance will probably deny the treatment. "
So, I take it that the person/entity that actually approves or denies has not even weighed in yet. Why not wait until the question is asked and answered before alarming people who are counting on the prospects of these new drugs. Geesh.
Hector those links are very helpful, thanks. I think you hit it regarding understanding polymorphism, the original tests told a different tale than now...you may recall the original findings were that there were 3 fols increases in SVR with the right alleles, at 95% likely to SVR some were concluding that the need for PI would be minimal.
please note Pawlotskys remarks at the bottom of this page, and also the next page goes into the Insulin resistance being under addresses
http://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/Vienna%202010/Tracks/HCV/HCV/Pages/Page%201.aspxJean-Michel Pawlotsky, MD, PhD:
Although I think the discovery of the strong association between IL28B polymorphism and response is one of the most important breakthroughs in HCV research during the past few years, we do not yet understand the mechanism. Therefore, before making recommendations, it is important to first assess the individual predictive value of the marker as was done with receiver operating characteristic curves in the study by Dill and colleagues. This analysis showed that at the individual level, the predictive power of IL28B was not very strong. Therefore, clinicians need to be careful before using this marker when making treatment decisions; nonetheless, it is a very interesting topic for research studies.
A second point regarding this study is that the experiments have opened a field of research aimed at trying to understand why there is an association and asking if it is related to an induction or down-regulation mechanism. In addition to this genetic marker, there are many other polymorphisms that may impact the response mechanism, making the situation more complicated than it currently appears. Uncovering the reason for the relationship may reveal a biomarker, something that is up regulated or down regulated, that is measureable in blood or elsewhere in the body. Such a marker may have an even better predictive value, because although it is related to the polymorphism, it may also be impacted by other factors that are not accounted for by the polymorphism genotype.
It is useful to challenge the IL28B story and try to gain a better understanding of the mechanism behind the association. Although it is not yet clear if the findings from this study are correct, it is good that there is some controversy and discussion to propel the research in different directions. Ultimately, the conflicting findings will be reconciled and the full picture will emerge; that is the basis of scientific discovery.
WOW, how much a year can change things...so in other words, and this piece concludes by reemphasising the insulin factor....which I am type 2 and they DID NOT tell me how important this was to regulate, so many factors not just alleles at work.
The consensus is out if I read this and similar remarks, so I'm stumped at to why he thinks the most recent Easl makes his case. I haven't found anything yet from EASL that would make his case.
Plus, I've been exploring diet, and my system. Autoimmune people react differently to substances. For instance I still have a rash were I touched a plant 5 years ago...my body is STILL reacting as the cells there will not turn off the histamine reaction. The cells are grossly over-reactive and even though they have been replaced by now they are being replaced with faulty cells with the histamine still turn on.
ERGO a person with autoimmune could react very differently to PEGASUS.
The general idea is the PEg absorbs more slowly, over 7 days...but if one has an overreactive system, as I do, it's possible my body might have been absorbing in more quickly, as any time the system reacts to a foreign substance it sends more cells to absorb and carry away the foreign material. ERGO a highly allergic person might want to reconsider whether Pegasus is the best choice for them as time release is only going to work better if it releases evenly over the entire 7 days.
For this reason I will choose CIFN daily, and eliminate that as a possible cause.
I will also control blood sugar from the get go, as I would have, had they TOLD me to.
I will also limit purines in my riba meals in order to better absorb my riba.
All told, I think these folks should not be prepping patients for denials, and I'm pretty steamed about it...it's not right.
Now that I've stopped feeling depressed about it, that seems like the right response.
your point was well taken, I think that's the best approach, point blank, are you in my corner or not!! That will be my question.
My concern with switching doctors is that what happens then if I need a transplant?
I mean, do these folks talk, and decide based on whether a patient is cooperative....because if I switch docs that means I could be marked as some sort of "problem patient". Right now, they are just amused that they have a patient who even reads the studies or keeps abreast...and I'm more likely to get favorable treatment down the road as long as that remains the case, but if we get too contentious with them, well it could backfire if you follow.
I think how we present our concerns is perhaps just as important as what the concern are because we are still dealing with people, and people can get irked when we disagree with them if we don't grease the gears just right.
I think these docs can be fragile at times. Like my GP who got very mad that I diagnosed several things correctly when she had been incorrect....she wrote in my chart in big caps, this patient "has been reading on the internet" as if I was some kind of problem for having done so...NO, the problem was she could not diagnose me, and so I HAD to...and when I successfully narrowed it down it did not sit well.
Well time for some good news and an insight into my docs. I was not able to see the hepatologist but his nurse practioner clinician who handles all the hcv patients when the docs are not available. She spent an hour with me, and it was she as well as my doc who had been concerned about the insurance.
Made the trip and made all my points yesterday, as well as several of your points.
Bottom line is, they are in my camp and will prescibe as per my requests.
A little hesitant about the Boce vs. the Teleprevir but I anticipated that.
They were relieved to learn of the self insurance, but were not aware of the differenences in ERISA laws in this regard.
As I had been so effected by all the former remarks I thought it imperitive to explain that and suggest that maybe there needed to be some reflection on how much is said to patients as repetition of gloomy prospects can really effect a patients hope.
I got an apology and also the explaination that this is what all the worry was about at the ASSLD conferences which she also attends each year. They are planning on taking up the gaunlet for patients beginning in the fall because they want to see how other clinics will fair in the new climate and because all the docs are gone in the summer and August and they want to be there when folks start these new regimes.
They are also planning on not adding their relapsers all at once, because they fear that the flood of new treaters may also put the insurances off the idea, and also could overwhelm their system and how they go to bat for each patient. I got the feeling that they may be feeling a little overwhelmed with what's coming.
Very relieved that they will at least try to get me approved, and she mentioned they are of the mind that the only predictive really proven at this point is the VEVR and EVR. All the other predictives are still in question including the IL28b to some extent.
I brought up my overactive immune response and she agreed CIFN would be a good solve for this potential issue. She also showed interest in my purine findings, which was encouraging since she is the one that teaches the clinics 2 hour class for all new patients.
She took my literature on this topic.
She also requested my studies on Insulin resistance, whereas before they hadn't asked to see it...this is hopeful as well.
Come to think of it, I think I may know why these folks are so afraid of insurance.
When I first became a patient I remember her saying something to me about the reason she left the diebetes practice was she was tired of fighting insurances. She said she had less trouble getting approval for an amputation than she did for putting the patients on the needed meds in the first place. This is a good insight into why mind sets can be negative.
I can't imagine months of fighting to get someone meds, but no trouble cutting off a limb. That indeed would be the cart before the horse.
I think 20 years of arguing to get folks on insulin as a preventative, but no trouble getting them amputations must had been a bitter pill, and one that must effect a healers psyche.
It doesn't really excuse scarring patients into thinking they won't get treatment,
but at least it makes it a little more understandable. She's really a caring doc who listens well and has been in my court...she spent an hour with me yesterday.
anyway the good news is they are going to try to get all there relapsers treated...they just don't want to start any of them this summer...but that's fine with me, I want to enjoy the summer anyway.
The last thing she said again was, "you know we just are concerned because of the cost that they may not approve....it may be 75K...I just smiled and said, still lots cheaper than a transplant, or a year long dying process...
I realize now they can't help themselves...when someone is worried they tend to pass the fear on, whether it's a rational fear or not....and the fact that after the whole hour she ended on that note just means that we all tend to return to our own thoughts even when we've been given good reasons to think otherwise. It's forgivable.
Personally I don't have that dim a view of insurances. It may be naivity, but at the same time that this treatment is costly, it's still going to be 80-90% of patients who will become SVR, and as a result not go on to having the dozen other costly conditions that occur in those who carry the virus. From blood pressure to internal bleeds, esophageal issues, spleen issues, the list gos on and on. Endocrine sdysfunction and diebetes, all things related to the continual rampage and toll the virus takes; there is no earthly or monetary reason NOT to eradicate this disease if it can be done.
Assuming that criteria is determined by those not still wet behind the ears I really cannot envision any rational medically trained person thinking that the cogent and humane thing to do would be to add the PI's to SOC. The fact that monetarily it's also better long term shouldn't hurt either.
To conclude, I deeply aplogize if I scared anybody with my thread's title, as someone mentioned. The intent was only to get folks attention the better to come up with some questions and rationals to bolster my case. Had I used a less noticable heading, the thread might not have gotten the attention it needed.
Hopefully going forward we won't need any of this info as docs and insurances will all line up on our side, but if anyone does have issues at least they'll have some ammunitions provided by our helpful members.
Again however, if I scared anybody, that wasn't my intention. My intention was to get help fighting this very real concern.
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