Hepatitis Forums
Hepatitis C Main Forums => Considering Hepatitis C Treatment => Topic started by: elias on September 30, 2016, 02:25:19 pm
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Hi again:
Here's what I found so far with regard to prescriptions for medication not on a plan's Formulary.
This does pertain to Medicare/Medicaid specifically. But possibly similar in non-gov't insurance as well:
https://www.cms.gov/Medicare/Appeals-and-Grievances/MedPrescriptDrugApplGriev/Exceptions.html (https://www.cms.gov/Medicare/Appeals-and-Grievances/MedPrescriptDrugApplGriev/Exceptions.html)
Exceptions
An exception request is a type of coverage determination.
An enrollee, an enrollee's prescriber, or an enrollee's representative may request a tiering exception or a formulary exception.
A tiering exception should be requested to obtain a non-preferred drug at the lower cost-sharing terms applicable to drugs in a preferred tier.
A formulary exception should be requested to obtain a Part D drug that is not included on a plan sponsor's formulary, or to obtain a formulary drug that is subject to a utilization management restriction (e.g., step therapy, prior authorization, quantity limit) which the enrollee or the enrollee’s prescriber believes should not apply..
For formulary exceptions, the prescriber's supporting statement must indicate that the non-formulary drug is necessary for treating an enrollee's condition because all covered Part D drugs on any tier would not be as effective or would have adverse effects, the number of doses under a dose restriction has been or is likely to be less effective, or the alternative(s) listed on the formulary or required to be used in accordance with step therapy has(have) been or is(are) likely to be less effective or have adverse effects.
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More details at that site.
So it does appear that even if a drug is not listed on the plan's Formulary, it might in fact still be covered if proper forms are submitted.
I called my physician's office . Secretary told me that Dr's request for Epclusa is still pending. she couldnt (or wouldnt) tell me if they were aware of Exception to Formulary provisions etc. All she could say is that the necessary forms were sent
My impression was the secretary answering the phone wanted little input from me. So either they dont care for pro-active patients, or they feel I'd just confuse matters by interjecting. For now, I guess I'll just wait for the insurance to respond and hopefully, give reason for rejection -if rejected.
If (as I expect) the initial request is turned down, I sure wish I'd get opportunity to meet with the person in Drs office who works on insurance. So they could apprise me of how they intend to proceed, if at all. That way, I'd have better sense of what to do on my own, without going cross-purposes to their own plan of action.
No idea how to best finesse all that
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From my understanding of what others have said the process would be to appeal 3 times and if still turned down to appeal to your states insurance commissioner sounds daunting I know but it can and has been done so hang in there it will all workout eventually.
Is there any treatment you could be prescribed that is formulary like Harvoni? Is that formulary and a possible option for you sorry I don't know your genotype maybe you could add a signature with some of your data
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Im GT2
(Dont yet have much more data)
So Harvoni wont work.
My GI had said if he can't get the Epclusa, he'd have to go with Sof/Ribavirin which I'm dreading for I think good reasons.
I had posted here last week about Sof/Daklinza combo for GT2.
It is not an FDA approved combination for GT2, though it is for GT3. Which does not at all mean it wont work as well.
The EASL (European Association for the Study of the Liver) specifically does list that combination as the alternative to Epclusa for GT2. . I think its the standard alternative in Canada as well (not absolutely certain) AASLD is a tad more ambiguous about Daklinza for GT2. At one place saying it is the alternative to Epclusa. Elsewhere, that it's a reasonable alternative to it if Ribavirin is poorly tolerated.
Regardless of above:
Since my GI actually put in for Epclusa, that's the path I'd of course prefer. And its unanimously the optimal tx for GT2 . EASL even says Sof/Ribavirin is sub-optimal for GT2. Major obstacle as I see it is its not yet listed on any part D Formulary. But that's just my own conjecture here as to possible reason for non-approval. I mention the Daklinza issue only as potential way to counteract if insurer offers Ribavirin as an approved alternative.
I think Medicare Prescription Drug Plans cannot by law refuse all treatments. (Not yet sure of this) But they can put forth alternative regimens. So I'm thinking of ways to refute a Rivavirin-based alternative, if that's what's offered.
As Lucinda has noted, Epclusa is also the least costly of the options, if one goes by WAC: "wholesale acquisition cost"
So my focus now ought to be on how to best do the appeal this if Dr's prescription is turned down, and a medically less advisable treatment is proposed instead.
I had not even heard of Hepatitis C prior to a few weeks ago. Nor have i ever appealed anything in my life. Nor do I have real legal skills. So I dont wish to "get in the way" But, it does seem I'm processing much of the original scientific information , more or less accurately. So perhaps I ought to have more input.
I possibly could put together some strong arguments as to why Ribavirin would not be good for me in my current state.
But I'm also trying not to interfere with the process already underway on the part of the doctor/insurance worker at my physician's end.
I do wish they'd welcome a more pro-active input from me. And that's the quandary I now face. Let their own procedure/process ride out, as they have more experience in dealing with insurers... And if that fails, then jump in n fight. Or be more pro-active from the get-go. I don't wanna get on their bad side if I think they're already doing their best meanwhile. But i'm not sure if they are.
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Genotype 2
OK per the AASLD (American Association for the Studyof Liver Diseases) treatment guidelines
Genotype 2 Treatment-Naïve Patients Without Cirrhosis - Recommended
Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg) for 12 weeks is a Recommended regimen for treatment-naïve patients with HCV genotype 2 infection who do not have cirrhosis.
Rating: Class I, Level A
Genotype 2 Treatment-Naïve Patients Without Cirrhosis - Alternative
Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 12 weeks is an Alternative regimen for treatment-naïve patients with HCV genotype 2 infection who do not have cirrhosis.
Rating: Class IIa, Level B
Even though a med may be of label or non formulary does not mean you can't be approved. I took Sovaldi Olysio off label and was approved for that by Express Scripts after appeal which was handled by my doctors office. I have BCBS of Illinois through my employer. I am in Washington but my employer's HQ is in Illinois.
None of us here are lawyers and you don't need to be. But first just see how it goes as far as approval then take it from there those that had to appeal I am sure will add to your question if it comes to that.
So yeah just let the folks do their jobs and check in with them periodically. Although remember people are human and sonetimes forget to send in information or faxes can get misplaced by the recipient as well. It will probably take some time but the process will work itself through.
Good luck
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Thanks Lynn:
Feeling bit more reassured. Trying to organize game plan now, because i might be too depressed and less clear-headed after I'm turned down.
I had heart-breaking experience a few days ago.
I accesssed my online Patient Portal to print out more of my test results. And lo n behold!!! I see Epclusa listed as the medication I'm currently on!!! It even gave dosage, and start date of tx !!! Thought of course it meant that it was approved. So I ecstatically called dr's office to arrange for delivery. But, they said it's really still pending approval. Of course I was devastated. I had rejoiced too soon. So one goes through this rollercoaster of mood swings with all this. How sad. We should be focussed on getting our health back, and not on the vagaries of insurance co's. But alas, its not so.
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Epclusa declined by Medicare Prescription Drug Plan
Reason: Not on Formulary
They said Sovaldi is on formulary and is used for my condition.
They neglected to say its used in conjunction with Ribavirin
The point of Epclusa is to avoid the Ribavirin and works for all genotypes
How long does it generally take for newly approved drug to make it on to the formulary?
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Well no idea but just consider this is the US government not generally known for being speedy. My wild guess is they may have an annual review of drugs in some unknown by me date where they would consider such changes then if approved the revisions would be implemented a few months later.
Is there a number you can call to discuss this with them? And just to add ribavirin is not the end of the world if you have to you can do this.
Good luck
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hi lynn:
It is Medicare, which is federal. But part D , that part of medicare which covers --or doesnt cover-prescription medication is handled by private prescription drug plans (PDPs), such as United Health Care, Humana, eg make their own decisions on coverage for Part D and have their own formularies. Epclusa is not on any of them that ive looked at.
Whether there r federal laws, or precedents requiring these plans to offer "non-formulary" coverage if a drug regimen is FDA approved and a physician prescribes it . I cant find answer to this either.
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hi lynn:
It is Medicare, which is federal. But part D , that part of medicare which covers --or doesnt cover-prescription medication is handled by private prescription drug plans (PDPs), such as United Health Care, Humana, eg make their own decisions on coverage for Part D and have their own formularies. Epclusa is not on any of them that ive looked at.
Whether there r federal laws, or precedents requiring these plans to offer "non-formulary" coverage if a drug regimen is FDA approved and a physician prescribes it . I cant find answer to this either.
Elias, Im on a medicare advantage plan here in Ct. I just got my new formulary for 2017 and its not there either. My hunch is that this formulary has been in the works for some time, and since I just got it, Im sure it was prepped some time ago, and Epclusa was just approved in June, wasnt it? So my hunch is its not being denied because they dont want to cover it; its being denied because it was approved too late for its inclusion. We went through the same thing with Harvoni which was FDA approved in Oct. 2014. I started taking it in December 2014. As has been suggested, either call them and inquire about the status of this drug relative to its FDA approval and its exclusion from the formulary.. Also, appeal.. Thats another way to bring it to their attention. In time, they will surely add it.
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I had called the plan many times. They simply never heard of Epclusa.
I'm wondering if they may never include it?
GT2 is very uncommon in the West. So that just leaves one small group with HCV needing Ribavirin
The lower cost of Epclusa often referred to here is WAC=wholesale acquisition cost. Those other drugs they do cover maybe have been negotiated downward from that.
So maybe its more than just being slow? Would really be good to know if its worth holding out for..
I'm just wondering if insurers are really seeing the "pan-genotypic" drugs such as Epclusa as a way to streamline this whole process and make it less costly in the long run. Thats how I see it
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I saw GI today, and he will put in an appeal of that Epclusa denial.
Sounded like he was determined to try and prevail
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Excellent!
[Bearing in mind that SOF and RIBA has a 95% cure rate with GT 2], RIBA's well-known adverse side-effects may deem an alternative treatment 'necessary' for the purposes of an exception to the formulary?
Now, if Epclusa turns out to be cheaper than SOF and DAC (which if I remember correctly IS on the formulary) - you should be home and hosed!
Again - it's great that your GI is getting his teeth into this.
That's what you want!
On an a more personal note:
Trust yourself, and the efforts you are making.
It's good that you are involving yourself, trying to get the best treatment / outcome possible.
That's how it should be.
Here in New Zealand, anyway, the reln. between patients and doctors / health-care providers is supposed to be 'collaborative'.
Good on you!
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Thanks Andrew:
Now, if Epclusa turns out to be cheaper than SOF and DAC (which if I remember correctly IS on the formulary) - you should be home and hosed!
I asked GI why he thought none of the Medicare plans had it listed on formularies . His guess was because of its price. Which he guessed was ~$90,000. He was a bit surprised when I told him Gilead had actually priced it lower than all the others (in terms of "wholesale acquisition cost"-whatever that really means) at~ $75,000 According to this reckoning, the older Sovaldi+Ribavirin tx which the insurance wants me to undergo and is on their formulary, is actually more costly in terms of "wholesale acquisition"
He seemed more "collaborative" this visit than on last visit. And not resentful that I put forth my own knowledge and interest of options.
He did dictate a memo to his insurance secretary of letter he'd like sent to insurance as to medical reasons for preferring Epclusa
I sensed he wants me to win this
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Good, Elias.
(Daklinza is, or isn't on the formulary?).
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Daklinza
Harvoni
Sovaldi
Are all on my plan's "specialty tier" (Tier 5) formulary, as well as on quite a few other plans I'm looking at.
So it is odd that Epclusa is not. Hopefully, it's absence only because its been so recently approved.
Daklinza--in itself-- is priced a bit lower than the others in terms of "WAC". But I think Daklinza is always taken along with another specialty tier med. Making the combo actually very costly. The combo Dak+Sol is FDA approved here for GT 3 , but not GT2. Though some medical bodies (such as EASL) do recommend the combo for GT2. I guess too few GT2 in the trial research?
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Dragonslayer wrote:
My hunch is that this formulary has been in the works for some time, and since I just got it, Im sure it was prepped some time ago, and Epclusa was just approved in June, wasnt it? So my hunch is its not being denied because they dont want to cover it; its being denied because it was approved too late for its inclusion
Thanks. I sure hope you're right. I guess for those who used Harvoni, this must be kinda dejavu
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Yes. That'll be why it isn't included.
It appears that SOF and DAC is a generally accepted treatment for GT2.
Again - an Exception to the Formulary is possible, because
a) there are significant side-effects associated with RIBA;
b) Eplclusa is generally more effective than SOF and DAC, or SOF and RIBA; and
c) Epclusa may well be (hopefully is!) cost-effective compared to either SOF and DAC or SOF and RIBA.