Importing Tx

[Coach Mike]

The recent widespread availability of quality, affordable HCV treatments in south Asia has raised many questions about access to those medications by people in the U.S.

This appears to be the situation in the U.S. at the moment:

1. Customs is not interested in detaining medications, especially doctor prescribed, life-saving medication that is unaffordable in the U.S.
2. FedEx basically preclears everything shipped using their service before it leaves the origin country. If it doesn't clear,it goes back to the shipper. The shipper can then refund the buyer. Other shippers probably do the same.
3. The FDA doesn't appear to be willing to intercede either at this point concerning these particular medications. Both Customs and the FDA are part of the executive branch. Right now, it looks like their next boss will probably be Hillary Clinton, who has gone on record as saying she intends to deal with pharmaceutical price gouging.
4. The Republicans are against more government regulation and interference in peoples' lives.
5. The Democrats believe in accessible, affordable health care for all.

I think if medicine were being detained at the border, we would be hearing about it. If a person has their meds detained, I think a letter from their doctor and a prescription would quickly get them undetained. Gilead is not very popular anywhere right now. Their money spends, but it is viewed as "blood money" by many in power.

The pipeline is open. We need to start using it. If someone tries to shut it down, we all need to scream bloody murder.
the buyers' club at fixhepc has more information about reputable pharmaceutical companies and their shipping policies and pricing.

Coach Mike

[Coach Mike]

We also need to understand one thing that seldom gets mentioned regarding insurance coverage for incredibly expensive treatments: Who actually pays for that? The insurance companies will raise their premiums to cover their expeditures. They are businesses and that's what must happen for them to remain solvent. So, Gilead makes their money, insurance premiums go up and, because it is long, drawn out process, people will contract HCV faster than people can be cured.
Something has to change.
CM

[lporterrn]

Here's another way of looking at this. One of the reasons that Gilead cut back their patient assistance program (which was initially quite generous and easy to get approved for), was because they said they wanted to force insurance companies to step up and cover patients. Well, that isn't working, so if Gilead sees they are losing sales to generic purchases, perhaps they will lower their prices.

[Gaj]

Hi Lucinda & Coach Mike,

Obviously I don't expect either of you to respond to the below on behalf of either the insurance companies or Gilead. I believe you are both after the best outcome for those with Hep C but I think these are questions we should all be pondering.

I have to ask how the insurance companies were able to offload their clients on to what was presumably an attempt by Gilead to provide compassionate access to those who could not afford access any other way?
Surely a better approach would have been for Gilead to call the insurance companies bluff by refusing access to the patient assistant program for those who had insurance cover and to publicly state why that approach was being taken rather than reduce access for those who needed it?
The only outcome of the approach taken would appear to be business as usual for both sides with less access for those who really needed it?

Now, there does seem to be a slight increase in people managing to get access by using the approach advocated often here of appeal, appeal & appeal again usually finally requiring an independent appeal to force the insurance company to pay. But this seems to require articulate, strong willed people who are aware of their rights and push continually for what they are entitled to. It usually also involves a professional advocate? The costs of this advocate, the appeals process and preparation for it by medicos and their staff are presumably covered by the insurer if they lose the appeal process? So further costs that need to be covered by everyone's premiums?

I really suspect that the insurers and drug companies approach is largely driven by the stigma and EHMs associated with this disease with both insurers and drug companies relying on the fact that the sufferers are not prepared to stand up in the media or in court and say "no fair!"
I myself, while now having the confidence (and less brain fog) to start telling a wider circle of family and friends of my status, would still be reluctant to go fully public just yet because of the implications career wise but also for those loved ones who may face ostracism just due to being associated with someone who still has Hep.

So I think one of the big gains from cheaper access to medications via generics will be many, many more people's ability to cure themselves privately and hopefully then to feel confident and physically and mentally capable enough to "come out" and advocate for those who are unable to do so for themselves.

Best wishes
Gaj

[Coach Mike]

Hello Gaj,
Well put. However the Patient Advocate Foundation is a free service. My advocate was Brendan Bietry and he knows which buttons to push, levers to pull and words to write. His contact info is under the topic "External Review Success".
I can see by your signature that you have been through the mill with this disease. A person who should have been granted treatment coverage without any issues whatsoever, yet you have been forced to find another path to wellness: generics.  Good for you and great for your liver!
Both you and Lucinda had it far, far worse than me. Although I was infected in the late 1980s, I was diagnosed as suffering from Chronic Fatigue Syndrome. Seemed to be an epidemic of that going around then. I look back and wonder if some of those other people diagnosed with CFS were actually starting their long relationship with HCV. I was a 38 year old distance runner. One day, I went for a run, and BOOM! I felt like I a balloon that had popped. Never been the same since. But, I didn't have to live with the knowledge that I had this crap for nearly as long as you and Lucinda. I was "lucky" enough to be diagnosed about the same time Sovaldi and Olysio were first being prescribed "off-label" for the price of $150,000. Now, you can be diagnosed on Monday and have your generic medicaton by Friday for 1/100 of that price!
I respect you both for what you are doing, what you went through and how you found a way to get well.
I owe my undetected status to this site and Lucinda. They pointed me toward a man with a vision: Dr. James Freeman.
He also has a plan.
Coach Mike

[Philadelphia]

As someone who for many years kept my HCV diagnosis a fairly poorly kept secret  (people knew, but generally only close friends and family) the decision to go public was in the end an easy one.

I was tired of keeping a secret that I should not have had to keep.

So when I decided to share my diagnosis and treatment I did so very publicly, with a nearly hour long  interview on ABC radio. I did a follow up interview to let people know of my cure which again had a fair bit of coverage

I have never regretted it. It was not something I did lightly - as a school principal I knew what I was doing could have had negative repercussions. But I did so with the full supporte of my family,my boss, my work colleagues and my friends.

The feeling of freedom, and of being able to share the joy of my cure with many others has been priceless. I took control of my own story and I don't fear peoplediscovering my secret any more.

Of course, I fully understand why people don't want to share their own story, having taken along time (28 years) to publicly share mine. But for me it was the best thing. I can speak freely.

In keeping such a secret I  underestimated people's capacity for understanding and for compassion. I didn't allow them to support me. I expected so much less from them. I got so much more.

[Coach Mike]

My “Summary”
I am a public school teacher.  My PCP diagnosed my disease two years ago and referred me to the clinic’s GI.  I was so naïve.  I had heard about hepatitis, but never gave it much thought.  I had no clue about the A, B or C’s.  At any rate, the first words out of my mouth were: “Is this a death sentence?”  Anyway, that is where my journey started.  The GI said I wasn’t that sick, but he would prescribe a treatment that was “off-label” that was very effective, had few side effects but was very expensive.  So, denial, appeal, denial, appeal and denial-not FDA approved, not on the formulary.  The learning curve had begun.  A year later, Harvoni was approved.  So the appeal, denial process again.  This time the reason was: Metavir score too low. (F-1).  The GI didn’t fight for me.  He had the specialty pharmacy people write the appeal letters and he signed them.  My PCP said he was more of a “technician” than a caring doctor and spent most of his day running tubes in various body openings.  I knew something had to change when his nurse called and said they had done all they could do for me. I found a new GI at the state university flagship medical center and waited seven months to get in to see a liver specialist.  Meanwhile, the same liver specialist had convinced my insurance company to add EHMs to their criteria for treatment.  I saw a glimmer of light at the end of the tunnel and started documenting every single affliction I suffered with a visit to my PCP and a prescription to treat my symptoms. So, a new doctor, a new Harvoni prescription, a new appeals process and a patient advocate, Brendan Bietry form the Patient Advocate Foundation.  We took this one all the way the external review and prevailed.  In the end, it was the letter from my PCP documenting my EHMs that carried the day and Brendan’s fine cover letter.  The review said treatment was a medical necessity based on my EHMs.
I have never been ashamed of my disease.  I told everyone at work who was in the “at risk” age group to get tested.  I told my principals I was sick and doing the best I could.  I went public in the statewide newspaper trying to draw attention to the unaffordable drug prices and the unattainable insurance coverage.
In the end, I had the satisfaction of getting two treatments: one from Mesochem in China, which destroyed the virus and brought my enzymes level down to normal, and one from my insurance company.
I will treat for 12 weeks.  If the powers that be see fit to grant me SVR 12, I will donate my remaining meds to someone in need.
The insurance process can work, but it also can take a very long time.
Market pressure from generics is what will force prices down.
8 week labs tomorrow!
Coach Mike

[Coach Mike]

The FDA’s policy on personal prescription drugs into the U.S.

In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States. For example, if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.
FDA, however, has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:
•   The drug is for use for a serious condition for which effective treatment is not available*  in the United States;
•   There is no commercialization or promotion of the drug to U.S. residents;
•   The drug is considered not to represent an unreasonable risk;
•   The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and
•   Generally, not more than a 3-month supply of the drug is imported.

The operating word appears to be available. Is something available if you can’t afford it?  If a person can’t afford to pay $90,000 for Harvoni, but can afford to pay $1450 for a generic version, then the generic version is available to them, the regular Harvoni is not.  I am no lawyer, but I would argue that point for as long as it took.
Coach Mike

[lporterrn]

Gaj - I agree with you wholeheartedly that this is about stigma. I wrote a piece for the HuffPost that addresses this: http://www.huffingtonpost.com/lucinda-porter/what-we-talk-about-when-we-talk-about-hepatitis-c_b_7984878.html
However, Gilead started the ball rolling when it set the price. Before that, we had access to cheaper treatments, and the stigma was there then. If Gilead dropped the price, insurance would pay. 

[beto]

Great thread everyone a good read.

Coach I applaud your resourcefulness, Gaj great perspective and love the blog Lucinda.  I find it interesting that HIV has become less a stigma than hep-C.  We learned through the years to be compassionate and achieved political correctness, with respect to AIDS...however, Hep-C for the most part has remained in the closet.  It's the 'gentlemen's' dirty disease.  I myself was once forthcoming until I had a few of those experiences...being refused dental treatment in Tiajuana of all places and being reprimanded by to IV nurses in a holistic infusion clinic for not 1st loudly disclosing my viral status.  When I mentioned that it was clearly in my chart and had they even looked at it. ...and besides, they must always take precations.  By now I had no fight in me or a leg to stand on, because I was now a leper.

Always seemed that the first question from those who had learned of my condition was, "how'd you get it."  I must say that dealing with my insurance company, I never felt a morsel of compassion though I got plenty of it from the Walgreens special Hep-C wing. 

This disease has always lacked public (and professional) education.  I even encountered a seemingly very intelligent health professional that mixed up his (hep) A's, B's and C's...

We all knew this was gonna be a crazy ride.

[MaryC]

I agree...very thought provoking thread.

Lucinda...excellent Huff Post article. 

I was only recently diagnosed with chronic HCV so am fortunate in many ways that I did not need to live so many years with this dx weighing heavily on my mind.  I have notified all my medical providers.  I had an interesting experience at my dentist's office when I informed them of my status for the first time.  The hygienist actually asked me to write it down in my chart then abruptly left the office (with my chart in hand) to talk directly with the dentist for what seemed like an eternity.  I could hear them whispering in the adjacent office, but couldn't make out what they were saying. When she came back, she said nothing directly to me, but I felt vaguely uneasy.  I felt a bit like 'Typhoid Mary'. 

I have 'come out' to my family, co-workers, and friends. This has been a positive experience for me.  It has help bring me closer to those I care about and who care about me.  It has also given me the opportunity to 'educate' others around me...hopefully take a step towards reducing the stigma associated with this disease.  Having been a RN working in mental health the majority of my career, I am well aware how damaging living with negative stigma can be. 

I love reading the stories and experiences of others on this blog.  It has helped me feel more connected and less isolated before and during my treatment journey.  I now I have a chance to celebrate my EOT with others who know how important a milestone that is!

Mary

[Gaj]

MaryC, congratulations on reaching EOT! Look forward to celebrating an even bigger milestone when you acheive SVR. 

Lucinda, thank you for the HP article, a coherent, succinct summary of the situation.

beto, thank you for the HIV/HCV comparison, I suspect that the difference is due to the level of advocacy for tolerance around relationship choices. It tends to be more difficult to advocate for the "junkie" lifestyle as many see the HCV scenario.

Coach Mike, I am about 12 hours drive southwards of Philadelphia (the poster not the city ) so I wasn't aware that Patient Advocates provided a free service in the U.S.

Philadelphia, thank you for you comments, I just now realised that I have recently seen/heard your second interview which was very moving for me and had given me pause for thought about being more open with my journey. I have now found your earlier interview and bookmarked to listen.

[dbirch1229]

Hello, My name is Dottie and my son has Hep C and has had it for twenty years or more.  His virals are in the millions and he needs Harvoni but don't have a clue how to get it from another country. Is there any advise, number, website, or information that you could give me to get the Generic brand overseas.  I would like to get it for my son before its to late.  Is there a certain stage in the Hep C cycle that someone should not take it, like at stage one cancer or stage two or three.  In the state he lives in they won't even consider fighting to get it for their patients until they are stage four and almost dead.  So sad.  If you could give me some advise that I could use for results and for him I would be so grateful.  Thank you and God Bless you for telling and helping others your own story and the information you give.   Dottie

[lporterrn]

Dottie,
I am a moderator here at Hep and I removed your email from your message. There are many wonderful people here on the forum but this is a public place, so it's best not to reveal personal info. Also, there is a lot of counterfeit hep C meds out there, and giving your email puts you at risk.

As for your questions, let's start with some basic info. You wrote, "Is there a certain stage in the Hep C cycle that someone should not take it, like at stage one cancer or stage two or three.  In the state he lives in they won't even consider fighting to get it for their patients until they are stage four and almost dead." I think by this you may be confusing cancer stages with liver fibrosis stages. If he has stage 1 liver fibrosis, that means he hardly has any damage at all and may have decades ahead before facing potentially serious consequences. However, if he has cancer, he has different issues entirely.

Now, having said that, I believe people have a right to treatment even at stage 0. Many states are changing their policies, especially after Jan 1. I would start by trying to get the meds in the U.S. - Make his insurance pay for it rather than pay the cost of getting meds from oversees. The best way to do this is to contact the Hep C Careline - www.hepatitisc.pafcareline.org

If that doesn't work out, I suggest contacting Hep blogger Greg Jefferys http://blogs.hepmag.com/gregjefferys/ or the folks at the fix hep C website (I trust no one else. You can read Coach Mike's blog on his travel experiences: http://forums.hepmag.com/index.php?topic=3276.msg34200#msg34200

[Coach Mike]

Hi Dbirch,
You have come to the right place to get the info you need to help your son. Lucinda's advice is right on the money.  Since you said your son needs Harvoni, I assume a doctor has prescribed that for him.  If not, that is the first step after diagnosis, seeing a specialist to determine exactly what type of HCV he has and how much damage it has done.  The GI will then prescribe the treatment needed based on your son's condition.  If the doctor has prescribed Harvoni, then there are three real options: Go through the health insurance approval and coverage process, have the meds shipped to the U.S. or go abroad and get them. I recommend trying the insurance approach first.  That's how the system should work, but the treatments are so expensive, many insurance companies are restricting access to all but the sickest.  It never hurts to try though.  Your son might be approved right away.  Many, if not most, insurers are not very easy to deal with, especially when it comes to guiding a person through the process of approval for drugs that cost them over $50,000.
There are options now.  Be very wary of someone offering you anything other than advice.  I saw your email address here earlier.  If someone contacts you offering to sell you the drugs, delete it.  That is not how the process works.
There is never a good time to be diagnosed with HCV, but now there are treatment choices that have never existed before and more are becoming available on a regular basis.
Best wishes,
Coach M

[Philadelphia]

Thanks GAJ, the first interview is pretty overwhelming - at least it was for me. And long. It weighs in at about 45 minutes, broke into two parts. I cry a bit in it.  There's also an interview with my specialist, Prof Greg Dore.

It's funny - I had you pinned for an Australian! I've been through Philadelphia on a train from NYC to DC but that's as close as I've come. The name comes from one of my horses.

[Gaj]

Thanks Philadelphia, I had seen you comment on here before about being Australian yourself so when you said about the interviews I thought "I wonder?" Checked a few Tx dates and matched timings. 

And now I have a confession.....I have been misleading people on this site as I stated I was genotype 2 which I was sure was what I was told when Dx'd nearly four years ago. Well, today I visited my Hepatologist for week 4 and other results and during discussion I said "I realise I'm G2 but which subtype?" His response was that I was G3a and always had been??? Checked his files including originals of test reports and confirmed. Well, my excuse is that I was taking in a lot of new information about the virus and its impact on me when I was first informed and it doesn't come up often in idle chit-chat!
The good news is that the generic treatment is working as you will see from my signature though I won't get VL results until a day or two before Xmas. And my latest CT is all clear. Yay! And I haven't felt this well in at least 15 years.

[Gaj]

Hi dbirch1229,

Excellent advice from both Coach Mike and Lucinda about the various steps needed to proceed with treatment.

And just to expand a bit on Lucinda's comments should your insurance avenues fall through. Neither of the trusted options she mentions sells you the generics themselves. In both cases they assist and/or guide you in the process of purchasing from trusted, reliable sources so that you know you are getting what you pay for.

Gaj

[Westy]

Hi all  This is the trial Dr Freeman from Tasmania some other doctors are now running. It's the 3rd phase and is concentrating on generic Harvoni.  If you wish to know more google is your friend so is Dr Freeman


The REDEMPTION-3 eTrial is now open to patients with Genotypes 1 4 5 and 6.

REDEMPTION-3


REDEMPTION-3 is using tablets containing generic Harvoni ® (Sofosbuvir 400 mg / Ledipasvir 90 mg) sourced from a variety of reputable manufacturers such as Cipla, Incepta, Hetero, Natco, Beacon and Julphar.

There is no placebo, and the trial is open label (meaning you will know who made your medication), however you will not have a choice of manufacturer as part of the trial goal is to establish clinical equivalence between different manufacturers products and provision confidence in them.

Fixhepc

Regards Westy

[Coach Mike]

Great info above,
There is also a wealth of information on fixhepc about treatments for ALL genotypes. The REDEMPTION meds will be delivered to your door. All have been tested. The cost for entering the 12 week trial is $1600.
This is your opportunity to get well and help increase peoples' awareness of the effectveness of the affordable generics now available.
Start the new year off right!
Coach Mike