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Author Topic: Genotype 2-Follow-up question  (Read 15821 times)

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Offline elias

  • Member
  • Posts: 285
Genotype 2-Follow-up question
« on: September 24, 2016, 07:41:46 am »
Hi

I'm confused as to the current recommended treatments for Genotype 2.
So I'm hoping someone can help clarify.

From the AALSD site:

http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection

Quote
II. Genotype 2

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


 

* The dose of daclatasvir may need to increase or decrease when used concomitantly with cytochrome P450 3A/4 inducers and inhibitors, respectively. Please refer to the prescribing information and the section on HIV/HCV coinfection for patients on antiretoviral therapy.

Genotype 2 Treatment-Naïve Patients with Compensated 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 have compensated cirrhosis.
    Rating: Class I, Level A

 

‡ For decompensated cirrhosis, please refer to the appropriate section.

I do not even see any Ribavirin combo listed in those guidelines for GT2 !!


However, theres this paragraph following the above, which I do not understand. I also see the FDA had approved Daklinza for Genotype 3. But I see nothing about FDA approval for GT 2. Any ideas why?

Heres the paragraph directly following the protocol quoted above:

Quote
Daclatasvir with sofosbuvir for 12 weeks was approved by the FDA for the treatment of HCV genotype 3 infection in patients without and with cirrhosis. Although daclatasvir with sofosbuvir was not approved for the treatment of HCV genotype 2 infection, daclatasvir maintains adequate activity against HCV genotype 2 despite a 50% effective concentration (EC50) that increases by several logs in the presence of the prevalent M31 polymorphism. (Wang, 2014) In fact, daclatasvir with sofosbuvir was associated with high rates of SVR in treatment-naïve patients with HCV genotype 2 infection with both 12 weeks and 24 weeks of therapy. (Wyles, 2015); (Sulkowski, 2014a) It is unclear if there is a subgroup of HCV genotype 2-infected patients who would benefit from extending treatment. For patients who require treatment but cannot tolerate ribavirin, a regimen of daclatasvir with sofosbuvir for 12 weeks is reasonable.

The reason I'm asking is that my GI said that if Epclusa for my GT2 is not approved, he will have to treat me with some Ribavirin combo. And I didnt quite understand why. I was too stunned to ask. From the above AASLD citation, it seems Daklinza +Sofosbovir is the Alternative. And Ribavirin combo isnt even mentioned.  But that little prargraph after might be a clue to something. I dont really understand what that paragraph is saying. I also see that Squibb's own website on Daklinza mentions GT3 but not GT2 :

http://www.daklinza.bmscustomerconnect.com/about-daklinza

The reason I'm trying to pin this down is in case Epclusa is turned down for me, I'm so much hoping that a Daklinza combo without Rivavirin is an option. And surprised the GI hadnt mentioned that.

Hope someone here can help clarify


« Last Edit: September 24, 2016, 07:49:34 am by elias »
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline lporterrn

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  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Genotype 2-Follow-up question
« Reply #1 on: September 24, 2016, 03:24:52 pm »
Your doctor may not have current info. You read the treatments correctly, and sofosbuvir with ribavirin is NOT the alternative.

Let's just hope Epclusa is approved - it would be cheaper than either alternative, even the one no longer approved.
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

Offline elias

  • Member
  • Posts: 285
Re: Genotype 2-Follow-up question
« Reply #2 on: September 24, 2016, 03:47:05 pm »
Thank you kindly, Lucinda:

1) Might it be he went with the sofo/ribavirin as alternative  because the Daklinza combo isnt (as far as i can tell so far) FDA approved for GT 2? Only for GT 3

2) What might be a discrete way of conveying this to the GI in case the Epclusa is rejected?

3) Im Medicare Part D. But I can change Prescription Drug Plans if one of them does cover Epclusa. Epclusa not yet listed on any of the Formularies. Is there a way I can be updated if any of the Part D Prescription Drug plans add Epclusa to their formularies.?

Since its the least expensive of the options, Im desperately hoping at least a  few of them might add Epclusa.But would be good to know beforehand , so I can switch during the October-December Medicare part D "changeover" period

Thanks again, Lucinda. Sorry for bombarding you with so many follow-up questions.

I'm very panicked

-elias
« Last Edit: September 24, 2016, 03:48:39 pm by elias »
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Genotype 2-Follow-up question
« Reply #3 on: September 25, 2016, 11:46:26 am »
Hi Elias,
1) In my opinion, the HCV guidelines trump the actual FDA-designation. Medicine is evidence-driven, and most MDs follow this. I can't guess as to why your doctor made that suggestion.
2) After your treatment with Epclusa is approved, you could mention that you saw that DAC/SOF is listed as the alternative by the HCV guidelines and you were curious as to why your doc preferred SOF/rib.
3) Good news that you have Medicare - you should get an approval. If there is a large co-pay, if you run into trouble, or if you want to change insurance plans, my favorite patient assistance program is Patient Advocate Foundation's Hepatitis C CareLine - 800-532-5274 or www.hepatitisc.pafcareline.org

Happy to field questions - that's why we are here - we were all in your shoes at one time
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

Offline elias

  • Member
  • Posts: 285
Re: Genotype 2-Follow-up question
« Reply #4 on: September 26, 2016, 06:22:27 pm »
I called Gilead about Medicare Prescription Drug Plan coverage for Eclupsa.

The Support Path re said she could find none that have it listed on their formulary as of now. Whether to list it or not, is something initiated by the PDP plan , not by Epclusa. She didi entertain possibility that its because its still so new. she suggested I call my plan and ask if there rf anyh plans to includee Epclusa in formulary

I called my Part D and the rep said the 2017 formulary is already out and it comes out only once a year. Epclusa is not listed and she didnt think it would be changed over course of 2017. She said once 2017 formulary comes out, no meds are added to it

She did mention that sometimes exceptions are made by special application on part of healthcare provider, but often theyll go with the alternative

I'm very distraught over this. I'm GT 2 so Harvoni (which is on their formulary  wont work. (As far as i can tell Daklinza is simply not used for this GT in spite of AASLD. t would be off-label)

I dread taking Rivavirin which seems its coming down to


« Last Edit: September 26, 2016, 06:25:20 pm by elias »
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Genotype 2-Follow-up question
« Reply #5 on: September 26, 2016, 07:43:51 pm »
Hi,
I've see this a lot, and it is way too early to be distraught. The first few months after a new drug is out, it can take awhile for the insurance to catch up. The formulary changes can happen midstream. Remember that Epclusa is cheaper than Sovaldi+rib or Dakilinza + Sovaldi, so it is in their interest to include it.

I suggest that rather than make lots of calls, either wait to see what happens when your doc submits the prescription, or call the Patient Advocate Foundation's Hepatitis C CareLine - 800-532-5274 or www.hepatitisc.pafcareline.org They know their stuff. Let them manage the headache for you.

I know how frustrating this all is, but most everyone prevailed and got the best treatment they needed. It just takes time...
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

Offline elias

  • Member
  • Posts: 285
Re: Genotype 2-Follow-up question
« Reply #6 on: September 26, 2016, 08:25:03 pm »
Thanks, Lucinda:

The representative at the Prescription Drug plan said they only make changes once a year. So that's the part that got me all panicked .Its not in the 2017 formulary, which I just gota week ago

Gilead Sciences rep. was very polite about it. They said if I had no insurance at all, they could help me. If I have insurance (which I do) they can help me with the copay or direct me to places that can. But if my insurance doesnt even cover it  , and puts forth an alternative, its the end of the line.

Medicare-the national  office- itself did say that if a drug is or is not on the formulary,  shouldnt have much effect on whether I can get it. Since a physician must put in a request for it anyhow. However, Medicare doesnt make decisions on the actual drug. It's the Part D Plan youre on that decides. Its all quite dizzying and im feeling very ill from it

I did call that patient advocate foundation number , and they said theyd refer my case to a caseworker and get back to me in a few days.

Is there a specific caseworker i might ask for that would have special expertise with this aspect of it? Not sure I'll be given much choice in caseworker, but if theres someone really savvy with this kinda thing, might be worth asking

Thanks again
« Last Edit: September 26, 2016, 08:26:34 pm by elias »
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline andrew j

  • Member
  • Posts: 477
Re: Genotype 2-Follow-up question
« Reply #7 on: September 27, 2016, 05:38:20 pm »
I think just wait and see what the caseworker who is assigned to you says, at this stage.


Offline elias

  • Member
  • Posts: 285
Re: Genotype 2-Follow-up question
« Reply #8 on: September 27, 2016, 06:46:31 pm »
The caseworker from: Patient Advocate Foundation's Hepatitis C CareLine told me she checked and none of the  2016 Medicare Prescription Drug plans cover Epclusa.

Doesnt know bout the 2017. I know my current plan does not  list Epclusa even for  2017.

She suggested i call EPCLUSA Support Path which I had already done previously.And reported about that earlier in this thread.

I  have no idea where to take this next.

I have come across brief references to one or two here who have in fact been prescribed Epclusa via Medicare. But Medicare drug coverage is via Drug Plans they have arrangement with. Someone mentioned "Humana" Plan, but its not on their formulary either.
============
One thing I cant seem to get an answer for is:

"Does the fact that a drug isnt on the Formulary mean its not covered?"

Implication from patient advocacy was that it means its not covered (yet).

Other places i called said they didnt know.


So I'm beginnnig to feel like I'm going around in circles with this.


Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline andrew j

  • Member
  • Posts: 477
Re: Genotype 2-Follow-up question
« Reply #9 on: September 27, 2016, 06:50:39 pm »
I just posted something on your other thread, Elias.

Offline elias

  • Member
  • Posts: 285
Re: Genotype 2-Follow-up question
« Reply #10 on: September 27, 2016, 07:15:33 pm »
Thanks Andrew. Sorry bout the two-thread thing..

In terms of my GI planning Sof/Ribavirin in case Eclupsa is decidedly turned down, im wondering if a strong case might be made for an "exception to the formulary". I think there might really be such a thing if I'm understanding it correctly?

i dont know this GI very well. Doesnt spend more than a minute or two. But he did mention he might appeal if Epclusa is rejected. Which is why its important how viable such "exclusion to formulary" I mentioned above is:

https://q1medicare.com/PartD-CoverageDeterminationRxException.php

Offhand i can think of several grounds for such an exclusion. But would be difficult for me to convey it to him, since he takes very little time interacting with patient
« Last Edit: September 27, 2016, 07:23:40 pm by elias »
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline andrew j

  • Member
  • Posts: 477
Re: Genotype 2-Follow-up question
« Reply #11 on: September 27, 2016, 07:29:20 pm »
Often (to my surprise I would have to say) they are looking for the best treatment or treatment options possible for their patients.
That's what they are trained to do, and what they like to do.

See what he comes back with.

If things are not working out, it might be up to you to 'create more space' in your reln. with him.


Offline lporterrn

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  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Genotype 2-Follow-up question
« Reply #12 on: September 27, 2016, 07:45:59 pm »
I am getting you the name of someone at PAF. I still think you need to give your insurer and doctor a chance - I've seen quite a few of these work out, making all the upfront calls unnecessary work.
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

Offline elias

  • Member
  • Posts: 285
Re: Genotype 2-Follow-up question
« Reply #13 on: September 27, 2016, 08:07:32 pm »
Thank u ever so kindly, Lucinda.

Unfortunately, I had already been assigned a PAF caseworker. We communicated  very briefly via email. She couldn't tell me anything I didnt already know. Namely,  no current Medicare Prescription Drug Plan lists Epclusa on their 2016 formulary. And that since the medication I'm hoping to get isnt being covered, PAF cant help me with co-pay, as theres no coverage to begin with. She didnt know if the 2017 formularies would be different (I know mine wont)

In my conversations with Gilead, the representative there didnt even see that Epclusa was "reviewed" for formulary inclusion by my PDP

If you feel you know of a caseworker at PAF who might be more savvy about how to deal with "non-formulary"  or "pre-formulary" medications, how do I go about changing to that caseworker/ If you think that might help me some?

If not, I guess i could wait and see how the request is responded to. i just dont want to be railroaded into Ribavirin for bureaucratic reasons, since a less toxic medication is available. So I'm trying to plan ahead in case of (expected) rejection here.

Would be really helpful to have caseworker for the process. The one I communicated with today essentially told me to call Gilead's: EPCLUSA Support Path. Which i had already done. So felt like was going in circles

Thanks again
-elias




« Last Edit: September 27, 2016, 08:38:14 pm by elias »
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline lporterrn

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  • LucindaPorterRN
    • LucindaPorterRN
Re: Genotype 2-Follow-up question
« Reply #14 on: September 27, 2016, 09:54:52 pm »
I suggest waiting for a reply from your insurance and then if no luck, see if your doc is going to appeal. If you need to work with someone at PAF, request Brendan Bietry.
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

Offline elias

  • Member
  • Posts: 285
Re: Genotype 2-Follow-up question
« Reply #15 on: September 27, 2016, 10:14:04 pm »
Thanks, Lucinda. Will wait it out  bit longer. I'll urge for an appeal when and if rejected  if GI doesnt push for it himself.

Much of the labyrinth of insurance way over my head and overwhelming. So I'd very much like to have input and guidance from PAF. I will ask for Brendan Bietry as a case worker, as you suggest. Very much hoping  they're amenable to my changing workers. The interaction with the one they had assigned me to  today was a very cursory back n forth via email.

-elias
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline rk

  • Member
  • Posts: 99
Re: Genotype 2-Follow-up question
« Reply #16 on: October 08, 2016, 12:31:11 pm »
Elias don't give up. My doctors initial request for epclusa was denied as well. It was not on United health cares formulary either. They basically used that and as an excuse and said that Sovaldi & Daklinza was reccomended. I am GT2 as well, after an appeal it was approved. It was like an oversight on their part, they said thanks for bringing this to our attention. We decided after further review to approve Epclusa. I think its all in who does it and that an appeal is requested. It took a week to approve my first appeal. Your mileage may vary but have them submit an appeal. Medically necessary may be the key, I don't know I did not file it personally. good luck Rod
9/14/2016 pre-treatment
GT 2
Viral load 2940
Platelets 142
AST        16
ALT        6
Fibrosis stage  F3
LSM        10.1 kPa
Started Epclusa 10/7/16
EOT + 12 weeks HCV undetected

Offline elias

  • Member
  • Posts: 285
Re: Genotype 2-Follow-up question
« Reply #17 on: October 08, 2016, 04:21:34 pm »
Elias don't give up. My doctors initial request for epclusa was denied as well. It was not on United health cares formulary either. They basically used that and as an excuse and said that Sovaldi & Daklinza was reccomended. I am GT2 as well, after an appeal it was approved. It was like an oversight on their part, they said thanks for bringing this to our attention. We decided after further review to approve Epclusa. I think its all in who does it and that an appeal is requested. It took a week to approve my first appeal. Your mileage may vary but have them submit an appeal. Medically necessary may be the key, I don't know I did not file it personally. good luck Rod

Thanks RK. What they did say in their denial was that the drug theyre offering was Sovaldi, which is officially used for GT 2. They neglected to add that this is combined with Ribavirin (They probably omitted that because Ribavirin is not a specialty drug) The GI dictated memo for a letter to the insurer's essentially saying that the regimen theyre putting forth would be intolerable for me based on my medical conditions. He dictated really fast, so I couldnt hear the details.Some reference to cardiac condition. My heart rate does go up to bizarre levels (140 bpm) when i panic. He may have added that I'd have difficulty completing the regimen theyre putting forth. He  probably added a few other medical/psychiatric things. But it went down really fast, and i was way too panicky to absorb it all

Anynow, it does sound from what youre saying that theyre not always that entrenched, even after an official denial.

I'm hoping theres further recourse if denied again. Like independent review board type things.  My way of coping with the panic around this is to actually look into concrete ways of preparing such a further appeal if it becomes needed. Hopefully, it wont. Thanks much for the reassuring comment. Been a total wreck since the dreaded denial
« Last Edit: October 08, 2016, 04:30:36 pm by elias »
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Genotype 2-Follow-up question
« Reply #18 on: October 09, 2016, 11:50:59 pm »
Elias - You may want to check out NVHRs site - lots of info related to access, including letters docs/patients can use http://nvhr.org/hepatitis-c-treatment-access
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

Offline elias

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  • Posts: 285
Re: Genotype 2-Follow-up question
« Reply #19 on: October 10, 2016, 03:48:41 am »
Thanks Lucinda:

I've looked thru that site carefully. I still cant get sense of exact steps in appeals process in cases such as mine. Would be nice if it were outlined somewhere.

 The insurer is agreeing to cover HCV treatment, but their alternative to GI's recommendation is the "sub-optimal one" with Ribavirin. Based, not on the current medical recommendation, but on absence of Epclusa from their formulary.

 AASLD first choice is Sofosbuvir/Velpatasvir=Epclusa

The first appeal was already sent in --or at least drafted-- by the GI. it sounded strongly worded, as I've said. But wasnt following a "template". I figured it might confuse the process if I wrote my own letter to insurer to complement his.

I'm trying to map out strategy of exact steps if first appeal fails. Some are listed here in very sketchy form:

https://www.medicare.gov/claims-and-appeals/file-an-appeal/prescription-plan/prescription-drug-coverage-appeals.html

It is not specific to the situation of HCV , nor to situation where a drug has been recently FDA approved. But it is at least an outline of sorts

If GI has no interest in pursuing appeals process further, can I argue for myself before independent review entity? Can I make medical argument on my own behalf based on medical literature and guidelines?

So far organizations/foundations ive contacted seem go around in circles. Have not reached Brendan Bietry yet though, as you had suggested

« Last Edit: October 10, 2016, 03:51:02 am by elias »
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

Offline lporterrn

  • Member
  • Posts: 1,969
  • LucindaPorterRN
    • LucindaPorterRN
Re: Genotype 2-Follow-up question
« Reply #20 on: October 10, 2016, 02:05:34 pm »
Hi Elias,
You can argue on your own behalf, but probably best to work with an advocate first. They know the lingo and the tricks, and they have experience. You can tell them what you would point out.
Lucinda Porter, RN
1988 Contracted HCV
1997 Interferon nonresponder
2003 PEG + ribavirin responder-relapser
2013 Cured (Harvoni + ribavirin clinical trial)
https://www.hepmag.com/blogger/lucindakporter

Offline elias

  • Member
  • Posts: 285
Re: Genotype 2-Follow-up question
« Reply #21 on: October 10, 2016, 04:59:35 pm »
I left message for  Brendan Bietry at Patient Advocate Foundation.

Hope its ok that I said he comes highly recommended by you.

I actually had already been assigned a caseworker there. Without going into much detail, I was not under the impression she knew much about such issues. Not sure how easy it is to shift caseworkers there
Contracted HCV ~age 12
Diagnosed: September 2016 GT2b
F3 by Fibrosure: 0.66
Necroinflammat activity: A3 0.76
================
VL Sep. 12, 2016: 1.44 million/ Log: 6.157
AST:71/ ALT:114   Sept. 1, 2016 Before treatment
==================
4 week after beginning  Epclusa:
Viral Load: UNDETECTED
AST 17/ALT 11
===============
Began Epclusa:  October 22, 2016
End of Treatment [EOT]: January 13. 2017
====================
EOT+4 Weeks: UNDETECTED
====================
SVR 12 April14-HCV Not Detected

 


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