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Author Topic: Anthem 2016 Tx Criteria  (Read 11529 times)

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Offline Coach Mike

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Anthem 2016 Tx Criteria
« on: January 12, 2016, 06:23:22 pm »
Anthem's Criteria for Harvoni approval.
I am not sure what this means in English.

https://www.anthem.com/provider/noapplication/f0/s0/t0/pw_e225443.pdf

Coach Mike
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline FutureThinker

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Re: Anthem 2016 Tx Criteria
« Reply #1 on: January 12, 2016, 08:33:07 pm »
Great find, CM!!  But is appears to still use fibrosis stage, just in different language?? FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline Coach Mike

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Re: Anthem 2016 Tx Criteria
« Reply #2 on: January 12, 2016, 08:40:45 pm »
Yeah, Thats what it looks like. Can you have a "compensated" liver disease and not have cirrhosis?
CM
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline FutureThinker

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Re: Anthem 2016 Tx Criteria
« Reply #3 on: January 12, 2016, 08:44:41 pm »
We need some input from our moderators on the wording of this document.  I was just reading another topic re: insurance and all I can say is, as of today, as I await the state's IMR decision over the next 30+ days is that I am just sooooo grateful that there are options now: several trials going on not too far from me, generics now available, even if I am still a bit afraid of that route, new drugs in the pipeline....... at least there is HOPE!!  FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline Coach Mike

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    • Affordable Hepatitis C Treatment
Re: Anthem 2016 Tx Criteria
« Reply #4 on: January 12, 2016, 08:57:29 pm »
I think the IMR will favor you. Anyway you cut it, you still have a potentially life-threatening disease for which there is a cure.
I wouldn't be concerned about Dr. Freeman's REDEMPTION trials. The medicines are tested and guaranteed to arrive. Kingswood and West Lindfield Compounding Pharmacies in Australia will also ship if you send them your prescription.
CM
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline Lynn K

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Re: Anthem 2016 Tx Criteria
« Reply #5 on: January 13, 2016, 12:17:09 am »
To me it appears as far as cirrhosis status they are defining different treatments for those with compensated cirrhosis, those with or without compensated cirrhosis and treatment for those with decompensated cirrhosis.

So the "without compensated cirrhosis" means for those who don't have cirrhosis. Then "with or without compensated cirrhosis" wold be the recommended treatment for those who do not have cirrhosis or those with compensated cirrhosis.

They recommend  "treatment-na├»ve or -experienced, post liver allograft transplant with decompensated cirrhosis" 12 weeks of Harvoni with Ribavirin.

With liver damage we can have compensated liver disease whether or not we have cirrhosis. For example someone with F2 fibrosis their liver is able to compensate for the level of damage all the way up to F4 compensated cirrhosis. I guess that is what they are going for but I can see how it would be confusing.


Ah found it see page 3:

Compensated Liver Disease:
According to the American Association for the Study of Liver Diseases (AASLD, 2009, 2015),
the specific criteria for compensated liver disease include all of the following: a total bilirubin;
serum albumin; prothrombin time/INR; presence of ascites; and presence of hepatic
encephalopathy. However, these criteria do not establish a comprehensive definition of
compensated liver disease. The AASLD guidance refers to compensated liver disease as
Class A based on the Child Pugh-Turcotte (CPT) classification scoring system.

So anyone with liver disease that has not progressed would be a child A and thus considered compensated Liver Disease
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline Coach Mike

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Re: Anthem 2016 Tx Criteria
« Reply #6 on: January 13, 2016, 05:25:48 am »
Thanks Lynn,
So, they took away the old F-score restrictions?
CM
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline Coach Mike

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    • Affordable Hepatitis C Treatment
Re: Anthem 2016 Tx Criteria
« Reply #7 on: January 13, 2016, 05:57:46 am »
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline Coach Mike

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    • Affordable Hepatitis C Treatment
Re: Anthem 2016 Tx Criteria
« Reply #8 on: January 13, 2016, 07:20:06 am »
Lynn,
Isn't Child-Pugh an indication of the severity of cirrhosis?  I mean, can you have be a "Child A" and not be cirrhotic?

If that's the case, are they are effectively restricting treatment to F-4 patients?
CM
« Last Edit: January 13, 2016, 07:21:38 am by Coach Mike »
Genotype 1a, Biopsy:11/2014: F-1, Tx Naive
Fibrosure, 7/20/15: F-1-2
Pre tx v/l: 1,600,000, ALT: 75, AST: 48
Started generic sofosbuvir & ledipasvir: 10/23/15
4 wk labs: 11/19/15, ALT: 21, AST: 16, V/L:  UND
Started 8 week Harvoni tx: 11/20/15
8 wk labs, 12/15/15, ALT: 15, AST: 13, V/L: UND
4/11/16 12 week EOT-Undetected
7/5/16 SVR 24

Offline Philadelphia

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Re: Anthem 2016 Tx Criteria
« Reply #9 on: January 13, 2016, 10:59:53 am »
I thought F4 indicated cirrhosis and Child-Pugh was the cirrhosis continuum, from A to C. But I could be wrong and I sure someone likeLucinda will have the right answer.
CURED SVR24  Class of 2015
Wk 12 post EOT 30.11.15: ALT 14 AST 22 GGT 22 VL UND
Week 19 07.08.15: ALT 17 AST 23 GGT 25
Week 12 18.06.15: ALT 21 AST 23 GGT 28
Week 8 25.05.15: ALT 23 AST 27 GGT 30 VL UND
Week 4 20.04.14: ALT 30 AST 36 VL 40
Treatment start 23.03.15: ALT 137 AST 185 VL 342,600
Cirrhosis Child-Pugh A, Genotype 1a - Viekira Pak + riba 24 weeks
Total failure interferon/ribavirin/boceprovir Mar 2013
https://www.hepmag.com/blogger/grace-campbell

Offline lporterrn

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Re: Anthem 2016 Tx Criteria
« Reply #10 on: January 13, 2016, 11:10:13 am »
First, the 2 insurance documents in this thread open the door to treating F0-F4. The only restrictions they continue to have that aren't consistent with the HCV guidelines http://www.hcvguidelines.org/ are those pertaining to drug and alcohol use. However, there are ways to work around that.

RE Child-Pugh - technically it could be applied to everyone, but its only clinically significant when someone is cirrhotic. In the case of the Anthem criteria, they are using to determine which treatment is appropriate, and not using it to exclude earlier fibrosis stages.
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 lporterrn

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    • LucindaPorterRN
Re: Anthem 2016 Tx Criteria
« Reply #11 on: January 13, 2016, 11:17:33 am »
About the Child-Pugh, here's another way of looking at it:
You could apply it to anyone, but why? Just like you could apply the Glasgow Coma Scale to assess my consciousness level, but given that I am sitting at my computer rather than in a neuro ward, you wouldn't.
So, if a patient presents with obvious cirrhosis, than a C-P score is warranted.
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 Philadelphia

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Re: Anthem 2016 Tx Criteria
« Reply #12 on: January 13, 2016, 11:39:29 am »
I think there are times when you could apply that coma scale to me when I'm sitting at my computer ...
CURED SVR24  Class of 2015
Wk 12 post EOT 30.11.15: ALT 14 AST 22 GGT 22 VL UND
Week 19 07.08.15: ALT 17 AST 23 GGT 25
Week 12 18.06.15: ALT 21 AST 23 GGT 28
Week 8 25.05.15: ALT 23 AST 27 GGT 30 VL UND
Week 4 20.04.14: ALT 30 AST 36 VL 40
Treatment start 23.03.15: ALT 137 AST 185 VL 342,600
Cirrhosis Child-Pugh A, Genotype 1a - Viekira Pak + riba 24 weeks
Total failure interferon/ribavirin/boceprovir Mar 2013
https://www.hepmag.com/blogger/grace-campbell

Offline FutureThinker

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  • Onward and upward!
Re: Anthem 2016 Tx Criteria
« Reply #13 on: January 13, 2016, 11:54:50 am »
Philly, thanks for the laugh, God knows I need one!! So it appears that while Anthem is overall opening up their criteria for coverage, they are using language that doesn't make it readily clear as to their intention.

I unfortunately don't have Anthem, so still hoping/praying the IMR works!! So much valuable info on this forum, thanks to all of you, really appreciate it.  FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

Offline lporterrn

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Re: Anthem 2016 Tx Criteria
« Reply #14 on: January 13, 2016, 12:27:39 pm »
Here is Aetna's plan - bless them they don't say a word about substance use. They have always been ahead of the curve with the newest hep C meds. However, I have no idea why they include Victrelis - someone needs to update that,. http://www.aetna.com/products/rxnonmedicare/data/2016/GI/hepatitis_c.html
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 Lynn K

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Re: Anthem 2016 Tx Criteria
« Reply #15 on: January 13, 2016, 03:28:00 pm »
Yes Child Pugh is used to stage cirrhosis as well as the MELD score. But as Lucinda said anyone could be evaluated in the scale and obviously if you don't have cirrhosis you would score as child A.

They did say without compensated cirrhosis as well on certain regimens so they are not cutting out those who are not F4 as I read this.

But yeah could they have made this harder to understand what they mean lol :)

Cirrhosis without hepatic coma is my official diagnosis good to officially know I am not in a coma

Maybe the Matrix?
« Last Edit: January 13, 2016, 03:32:38 pm by Lynn K »
Genotype 1a
1978 contracted, 1990 Dx
1995 Intron A failed
2001 Interferon Riba null response
2003 Pegintron Riba trial med null response
2008 F4 Cirrhosis Bx
2014 12 week Sov/Oly relapse
10/14 fibroscan 27 PLT 96
2014 24 weeks Harvoni 15 weeks Riba
5/4/15 EOT not detected, ALT 21, AST 20
4 week post not detected, ALT 26, AST 28
12 week post NOT DETECTED (07/27/15)
ALT 29, AST 27 PLT 92
24 week post NOT DETECTED! (10/19/15)
44 weeks (3/11/16)  fibroscan 33, PLT 111, HCV NOT DETECTED!
I AM FREE!

Offline FutureThinker

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  • Onward and upward!
Re: Anthem 2016 Tx Criteria
« Reply #16 on: January 13, 2016, 04:38:49 pm »
Lynn, thanks for the laugh and we are so glad you are NOT in a coma!!  FT
Treatment naive
Likely contracted mid-70s
Diagnosed 1a, 2011
F1-2
Harvoni X 12 weeks, completed 5/17/16
Pre-treatment: VL 3 mil, AST 64, ALT 84
4 week labs: VL 30, AST 21, ALT 14
8 week labs: VL UD!!!, AST 22, ALT 16
12 week labs: VL UD, AST 23, ALT 14
2 wk EOT: VL UD
12 wk EOT: VL UD, AST 22, ALT 13 =  SVR 12! Yay! 
Last hep appointment: VL UD, AST 19, ALT 12 = SVR 39! I AM DONE!

 


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