TOPIC: Consumer Medication Information

Anyone planning on taking generic versions of the brand name Hep C medications should read the Consumer Medication Information provided by the manufacturers.

You will find that here or by using the links below

Harvoni (Sofosbuvir+Ledipasvir) CMI

Solvadi (Sofosbuvir) CMI

Daklinza (Daclatasvir) CMI

Rabetol (Ribavirin) CMI

Hi Doc,
I have another Mum question.
Your mum is sick, diagnosed 18 months ago with HCV. She was shocked when she heard the doc's words. So shocked, in fact, her first words were "Is this a death sentence?" After being reassured she wasn't knocking on death's door, the lovable old gal gets a referral to see the clinic GI. Well, he doesn't know much about HCV, he's mostly a "tube pusher", sticking them in from both ends. Well, he tells old mum she is very lucky, some brand spanking new drugs have just come out, both are FDA approved, but not as a combined treatment. He tells mum how well they work and how lucky she is because, she's not that sick and the old treatments were expensive, long, hard to impossible to endure, and, for the most part, ineffective. So he prescribes Sovaldi & Olysio "off label" and tells mum, by the way, these are pretty expensive and your insurance may not cover them. Well, mum being mum, she has saved her pennies, has a fairly comfortable pension from working hard all her life and has "good" insurance. So she's not too worried, UNTIL the doctor says "I'm talking $1800 a pill expensive". When mum wakes up, she is in shock, but decides to get the script. She is not surprised by the insurance company's denial, appeals it and gives up after the subsequent "final" appeal's finding: Not an FDA approved treatment. Fast forward, Harvoni is approved, mum gets her script, mum is denied, denied again on appeal, but this time, she appeals directly to the "Board", explaining all her EHMs and how she has felt sick all her adult life, but just found out the reason. Appeal denied, not F-3 or F-4. So mum, not satisfied with her "plumber" GI, gets a referral to a liver specialist at the state's flagship university medical center. They are busy, so she has to wait 7 months just to see an APN. In the meantime, she educates herself, about HCV, about the insurance system, about all relevant things concerning her plight. She also demands one more script from the plumber. The plumber has an APN now that specializes in HCV-seems HCV business is picking up. Well, the APN says mum's vl has gone from 5 million down to 1.6 million in the past year and mum can be treated with 8 weeks of Harvoni instead of 12. (Mum's been known to enjoy a glass of wine or three, but has been a teetotaller since being diagnosed. VL? Hmmmmmm) Well, script written: denied, appealed, denied, appealed to the "Board": denied. So mum writes a letter to the Board asking to see the criteria for treatment. They won't furnish it (said talk to the plumber, but he was tired of wasting his time with old mum by now and simply ignored her requests. So mum FOIs the insurance (state) for the criteria, gets it and finds a person can get treatment based on EHMs, regardless of Metavir score. She also discovers Greg Jeffreys, Dr, Freeman, fixhepc and Mesochem generics. So, the now extremely well-informed old biddy develops a plan to get well: Go to India, Go to Australia or Get the meds straight from Mesochem. She also pursues the "ultimate" and final independent external review for her Harvoni denial as is allowed under new federal law, with little hope if a reversal after all the denials. So mum decides to import the sof & led, and begins treatment. After 3 weeks, she is feeling lots better now, she gets a letter saying the independent review overturned her denial. She can get her factory Harvoni for $5 a bottle. Of course, she is going to get it, but is in a bit if a quandry: Start the real Harvoni now, wait and start after being tested at 4 weeks. Finish up the 12 week course of generic and get the next $5 bottle of real Harvoni in 4 weeks. OR just take all 20 weeks worth, finishing up the generics and then, taking the factory meds. But then, testing issues come in.
Well, mum trusts her PCP to help guide her and also her new GI, who said "I don't care where you get the medicine, I just want you to get it and let me monitor your treatment".
So, 8 weeks, 12 weeks, 20 weeks?
What would you tell your MUM?
Thanks,
Mike

ps: this is s long post snd you are a busy man. I really want to know your feelins on this, but would like to hear others as well. Been one hell of a fight. The specialty pharmacy people were amazed. They said, of the hundreds of people seeking approval from my insurance company for the new DAAs, only those on the transplant list have been approved. She also said I was the first to go all the way to the external review stage. I am F-1.

Wow, quite a story. I could almost be the mum. Did a lot of research, got my own fibroscan done, pushed my GP for VL 15 million, genotype testing GT1a and LFTs 139 and 235, no prior treatment and got an appt. with a GI specialist , After finding out the fibroscan was F4, 20.9 kpa, I was afraid waiting the two months and who knows how long before maybe be approved for Harvoni. It seemed time to take my destiny more in my own hands. This forum, emailing with Greg, Emilio, an online appt with Dr. Freeman have helped me decide. I have ordered APIs from Mesochem and they should be here within 10 days. Now my appt with the Liver doc is the 23rd of this month. So, I might have the generics and perhaps a script for factory Harvoni. Since I have been advised I need 24 weeks of treatment, and I think the docs here are only going for 12 weeks I might just do both. Next decision is if the generics come quickly, do I start right then or wait a bit so the GI thinks I'm taking his drugs and will be monitored. I feel blessed at least I should have some options on treatment. Thank you all who have spoke with me and helped sort this out, I feel confident I have a fighting chance to live a much healthier life.

What stories guys I don't think I would cope well having to wait until my claim for life saving treatment was approved or denied. As for the question posed I know what I would do but wouldn't advise anyone else to do same.

Hi Jan,
Take whatever pill you can get your hands first is my advice, but doing that has put me in the same pickle as you described. I'm just going to tell my doctors the truth and go from there.
Follow your heart.
Mile

Guys - there is a little technical hitch that you need to think about.

When you start tx, your doctor will almost certainly take your baseline viral load and bloods. If you have already started on the generics (unbeknown to him) then you are going to have a bit of explaining to do when you come up UND before you even start his factory drugs. Worse case scenario, that anomaly could result is his withdrawing his treatment. I mean why would a doc treat somebody for Hepc who doesn't have hepC, let alone spend a fortune doing it? This would be especially unfortunate for you if you need his 12 weeks of drugs to supplement the 12 weeks of generics you have already gone out and bought. Plus, you want the medical supervision from him, at least at first.

So it's tricky. Good luck, however you decide to deal with it.
dt

Hey DT,
I told my GI I was going to start the generics in October. She said my lastest labs, done in July, were all she needed. Thats in MY case. When I dumped the plumber and saw her the first time, I knew I had found the right care giver. Sure enough, when I told her my plan to import, she simply asked if I was certain they were the real deal and if I wanted her to monitor my treatment.
Like I said, I found the right doc.
I plan to self pay for my four week labs. If the insurance company gets nosy, I will just tell them I was anxious about only treating for 8 weeks (they are SO tight) and wanted to see what my levels were after 2 weeks of treatment. If the results were questionable, I was going to self pay for the extra month. I'm pretty sure my "2" week results will be stellar!
Mike

There is another possible hitch and that is the Insurance company thinking that 8 weeks and 12 weeks treatment respectively is enough treatment. Whilst it won't affect you guys it may compromise their statistics and others later unless you tell em later that you added to the supplied treatment. Just a thought.

Hey Mike, sounds like you got your scenario figured out re. what you can get away with and what lies are going to be necessary, if any.
I personally hate to lie, I really do. I feel that there is not much in this world worth lying for. Unfortunately, getting rid of HCV has turned out to be one. I have failed to find any strategy that gets me through my tx without lying my head off about what I am doing. I am not advocating that, just saying. With attitudes towards generics the way that they are, I haven't had the good fortune to find a doctor like yours.

I am finding this situation with the drugs a bit mind-boggling actually. It's either feast or famine. One minute we can't get our hands on the drugs for love nor money, next minute we have an oversupply from every corner, including our 'legitimate' sources who have been nothing but a source of uncertainty up until the point where we give up and order the generics. Does that action somehow open the floodgates on some mystical plane to make our docs and insurance cos. suddenly bend over backwards to cough up the drugs that have hitherto been harder to extract from them than blood from a stone? What's a sane person supposed to do with all this stop-go madness? And the time going by. And not getting any better. And then these clowns turning up just in time to put a spoke in the works, just when you are all set to go with the generics.

Well, that turned into a bit of a rant. But honestly, frustrating isn't in it.
dt

Yeah, frustrating is about the mildest way I can phrase it. Since my insurance only covers people on the transplant list, I don't think I'm going to skew any data for them. They just pay if they are looking at having shell out half a million for a transplant-until persistant me comes along.
They will probably change the language in their treatment criteria and take the EHM language out because of me. That is my only concern.
CM

Yep Mike, I'm hoping he will just go by the tests done by my GP 9/22/15. When I go for my appt on the 23rd hopefully I will know then if he will want more tests done. His nurse already gave me a heads up the insurance will also want a HIV test, drug and alcohol screen and Hep A and B vaccine, done, done and done. If it looks like he wants more tests done and insurance is going to not approve ASAP, then I'll just go for the generics. We have a lab that will do viral loads and etc and I'll wing it on my own. From all the reports on this site I feel it will be ok to "fly without a parachute".

Surely they will consider those labs as meeting the pretreatment requirements. Less than two months.
M

dointime wrote:
I won't suggest what each of you should do as that is a decision you must make for yourselves. However as food for thought on the above quote:

Imagine you are on the board of a large insurance or medical corporation. Your job as a board member is not just to make a profit for the shareholders, it is to grow that profit each and every year. There are a few ways to do this including cutting/minimising costs as you have successfully been doing (especially with all those publicity shy hepers) but the real growth is in an expanded customer base which you have been instrumental in achieving and for which you have been well rewarded.
But today you are staring out the boardroom window at the dark clouds gathering........you can see the storm of bad publicity that is coming when cured and no longer shy ex-hepers start telling the press that they cured themselves after your business(XYZ Corp), who they had been with for 30-40 years, repeatedly denied them treatment until it would have been too late. Now, you didn't get where you are by being stupid......so you are pondering how many "not too late" customers you need to treat to convince potential new customers that you will look after them better than your competitors......thus growing your business faster so the shareholders will continue to reward you.

GT1 F1 only needs 12 weeks so you have 8 weeks spare. Taking them may offer a slight benefit, but it would only be slight. Treatment success is probably already in excess of 95% so there are not a lot of spare % points to be had.

A hypothetical alternative would be to sell them to someone wanting to avoid a $10-15k copay, fly Business Class to Bangladesh, Nepal, India, Australia etc and source 12 weeks generics, stay in a luxury hotel while you're there, and return home.

Now you have an extra 12 weeks medication (unlikely to be required), just had a luxury holiday, one extra person got cured, and you have spare money for Christmas.

Now that would certainly breach one or more US laws but as somebody pointed out, it would be cheaper for US insurers to fly patients to Egypt, put them up in the Presidential suite at the Hilton, get the same medication there, then fly them home.

Thanks Doc,
The nicest place I can think of visiting right now would be Hobart.
There is a doctor there.
I owe him a beer.
And a life.
Mike