Let's put ourselves in the shoes of Joe, a Hepatitis C patient, in late 2013. When Joe was diagnosed with genotype 1, he was told that he had Hepatitis C for more than 10 years but now things are starting to go bad for his liver. He needs a cure as soon as possible.
At that time the only cure available was treatment with interferon injections and supplemented by ribavirin pills. If Joe went with this treatment, there were 50% chances he'll get well in half a year. However, there is also 50% of chances that his liver will not respond to treatment.
Luckily, in December 2013 he got another option for treatment. Gilead Sciences, a pharmaceutical company, had just developed and started to market a Hepatitis C wonder drug called Sovaldi (sofosbuvir 400mg). According to clinical trials, the cure rate is more than 90% in only 12-week treatment. The newly developed Harvoni is even better. With his life in danger, Joe was very happy to see the miracle of modern science and was more than willing to go on treatment.
However, what Joe did not plan is the price of the treatment. The price tag of Harvoni was $94,5000 per treatment. The meds do save lives but $94,500 is still a very large sum. This is where Twinvir enters the story.
New age Hepatitis C medicines are more than just a medical wonder. They gave humanity an ability to save lives.
How good are we at saving those lives?
Hepatitis C is a serious disease that ultimately results in death of patients. Approximately 500,000 people die from Hepatitis C and related illnesses in 2013 alone, more than 20,000 of them were US citizens. To put it in perspective: HIV/AIDS has longed been talked about as a very serious disease with a disastrous death toll. However, according to Dr. Laura J. Martin of WebMD nowadays more people die from Hepatitis C than from HIV/AIDS.
Today, there are more than 3.2 million of Hepatitis C patients in the US alone.
In late 2013, however, humanity had a break-through that should by all accounts drastically change lives of people living with Hepatitis C. A new drug, Sovaldi (400mg sofosobuvir), was approved in December 2013 on the US market.
With it, more than 90% of people with Hepatitis C can be cured. But are they really being cured?
For any disease to be deemed a very problematic one, there are two conditions:
Polio, for example, was a very serious disease with a disastrous outcome. However, after discovering an efficient polio vaccine, the number of patient and number of death relating to polio was reduced dramatically.
Hepatitis C prior to 2013 was a very problematic disease because it caused death via liver cirrhosis and liver cancer, and the only treatment we had was 50% efficient.
Hepatitis C patients were put on 6-months long interferon-based treatment which consisted of injecting oneself with interferon and taking additional oral medicines such as ribavirin (antiviral molecule). Nonetheless, for 1 out of every 2 patients treated the treatment has been proven to be unsuccessful.
There was a need for an efficient cure. Newly-discovered sofosbuvir molecule was the answer.
With the launch of Sovaldi and Harvoni medicines by a company Gilead Sciences, humanity finally attained a very effective cure for Hepatitis C. Being an all-oral regimen, sofosbuvir pills are taken on a daily basis for 12-weeks (standard treatment), have mild side effects and, above all, more than 95% cure rate. This is what in pharmaceutical industry refer to as a game-changer. Now almost everyone can be cured and Hepatitis C suddenly became an easily curable disease.
Simple answer is 'YES'. While the number of deaths has decreased from 500,000 per year, there are still hundreds of thousands of people dying every year. The reason: Hepatitis C.
But if we know Hepatitis C is so easily treatable nowadays, why are people still dying?
When we spoke about Harvoni and Sovaldi being a game-changer in industrial industry, it was meant more in profits than in saving lives. Here are two simple reasons why people even in the developed world are still dying of Hepatitis C.
With this in mind, let us calculate the US Hepatitis C market. If we know there are 3,2 million Hepatitis C patients, each in need of an $80,000 cure, the total comes to staggering number: Gilead Sciences is looking to sell more than $250 billion worth of Hepatitis C medicine to patients who can die without it.
Here is a horrifying realization. We have people who will die without the cure. We have the cure. But people who are dying cannot afford the cure because it is priced extremely high. 'What have we come to as a society?' is the right question here.
Gilead Sciences, company that markets Sovaldi and Harvoni, offered licences to Indian manufacturers to produce generic version of sofosbuvir-based medicines. In short, India refused to recognise a level of innovation for sofosbuvir molecule that would grant Gilead Sciences a patent and monopoly over Hepatitis C market in India.
This created a loophole. This loophole is now saving lives.
All around the world there are Hepatitis C patients that will die without getting the cure - and they are not getting it because the prices of the drugs are so extremely high. This is where FixHepC Buyers Club comes in.
It is our mission to deliver life-saving Hepatitis C medicines to your doorstep for a negligible cost. We have set up a supply chain consisting of sofosbuvir production, packaging and distribution across the world. It is our hope this will bring down the Hepatitis C death toll under 100,000 and that in near future Hepatitis C death cases will be as few in number as possible with sofosbuvir-based medication.
We strive to deliver generic Harvoni anywhere on the planet for less than $2,000 per treatment in about 2-3 weeks. With this prices, we could cure all Hepatitis C patients in the US for less than $7 billion.
Hardly. Pharmaceutical industry holds on to patents for drugs that last for 20- to 25-years. During this time, the prices of original Sovaldi and Harvoni will be extremely high, and Hepatitis C patients don't have 20 or more year to wait for patents to expire.
A short excerpt from a recently discovered audio recording of the Rev. Dr. Martin Luther King Jr. speaking at Syracuse University in July of 1965.
There are some things so dear, some things so precious, some things so eternally true that they're worth dying for. And if a man has not discovered something that he will die for, he isn't fit to live.
At FixHepC our goal is to see everyone, everywhere with Hepatitis C treated with affordable DAA medications so that no man, woman or child is left behind. The target is nothing less that sending this disease to the annals of history, as was done for smallpox.
Sounds impossible? Nothing is impossible (with the possible exception of breaking the Law's of Thermodynamics, but that's a different story, and the Big Bang Theory suggest maybe even that is possible).
First consider this:
And now consider what Lexus have just achieved:
The Lexus Hoverboard uses magnetic levitation to achieve amazing frictionless movement. Liquid nitrogen cooled superconductors and permanent magnets combine to allow Lexus to create the impossible.
Nothing is impossible - it may take a lot of work, by a lot of dedicated people - but hey, we've invented a Hoverboard and curing HCV is a simple willpower and logistics problem.
E = mc2
Everyone, everywhere = manufacturing * political clout * cooperative effort
They (who are they anyway) say, if it sounds too good to be true it probably is.
If you are GT1 or GT3 then the PBS looks like it is going to come through for you (and that is 90% of all patients), however if you're GT2 then your only option is Sofosbuvir +Ribavirin and if you're GT4 GT5 or GT6 then you're still looking at Interferon and Ribavirin + Sofosbuvir.
Here is the draft of the Australian HCV-DAA-Protocols that are in circulation and happened to appear in my email.
You can see what they mean for you using our beta Decision Support Tool - just put in your details to see what options are going to be offered (assuming there are no changes between now and then). At the moment the AASLD and EASL guidelines have not been added, but the PEG/Rib free option implements a subset of them.
I don't have permission to attribute this but the source is impeccable:
I think we should publicise the following key features of the PBS arrangement:
The last point is something I am sure you will be pleased with. There apparently will not be an accreditation required, just an arrangement with a specialist clinician.
<Not John Denver>
Which is 100% awesome news.
And here is the Minister's Official Statement:
OMG they are serious, although there is a get out of payment free card:
Ms Ley said like access to all PBS medicines, funding was demand driven and the Government would account for any potential variations in spending accordingly.
And here is the Official Fact Sheet
And here is what the AMA say:
Yes it will be paid for by the pathology cuts.....
And here is what Australian Doctor had to say about it:
Hepatitis C cures to be listed on the PBS
Alice Klein | 21 December, 2015
The PBS listing of four new hepatitis C drugs will enable patients to clear the infection in as little as eight weeks, the Federal Government says.
The antivirals sofosbuvir (Sovaldi), sofosbuvir and ledipasvir (Harvoni), daclatasvir (Daklinza), and ribavirin (Ibavyr), which cost as much as $100,000 for a full course of treatment on the private market, will be made available through the PBS on 1 March 2016.
Combinations of the new-generation antivirals will be used to target the six different genotypes of hepatitis C, with the cure rate expected to be more than 90%.
"With this announcement, there is great hope we can not only halt the spread of this deadly infectious virus, but eradicate it altogether in time," Health Minister Sussan Ley said on Sunday.
GPs will be able to prescribe the four hepatitis C drugs in, or following, consultation with a specialist, according to a factsheet published by the minister's office.
All hepatitis C patients will be eligible for the drugs on the clinical advice of their treating doctors.
A spokesperson told Australian Doctor that GPs will be able to consult with a specialist by phone, mail, email or videoconference.
The new treatments are better tolerated and require shorter durations than existing therapies, he said.
Treatment times range from 8 to 24 weeks depending on the hepatitis C genotype, the drug used and the patient's treatment history.
Because the prevalence of hepatitis C is markedly higher in prisons, the new antivirals will also be made available to prisoners through the PBS, even though their healthcare costs are usually the responsibility of state and territory governments.
Hepatitis Australia has welcomed the news, with CEO Helen Tyrrell calling it a "watershed" for the 230,000 Australians living with the disease.
"So many people have been anxiously waiting for this announcement. This is wonderful news and it is such a relief to have an end to the uncertainty," she said.
However, some doctors are unhappy that the $1 billion funding for the new hepatitis C drugs has come at the expense of funds being redirected from other health services.
Ms Ley has confirmed that budget cuts to pathology and radiology announced last week as part of the mid-year economic and fiscal outlook were made so the government could fund the hepatitis C treatments.
The AMA said it was wrong to cut funding for pathology and diagnostic imaging in order to fund one specific treatment.
"They shouldn't be using patients to justify these funding cuts," AMA President Professor Brian Owler told News Corp.
"I don't think there is a place for moral debate in health policy. As doctors we treat everyone, it's not about having a debate about more deserving citizens than others."
I'm writing this to help people understand what the recent announcement that DAA medications for HCV will be listed on the PBS. Here are a couple of links to it, both with interviews with the minister:
First let me say I think it's fantastic that the government has committed to listing these medications because it will make them more available.
You go girl!
The questions on everyone's mind, including mine, are "How much more available?" and "When?"
If you like executive summaries the answer is "We just don't know". We don't know because the key listing documents are not public and they are what will define access. The waiting is not yet over.
What follows might best be regarded as an informed guesstimate.
I have heard rumours on the grapevine like:
So you could get all excited and think, hey, wow, if all that is true and the government spends a billion next year and that gets 66,666 treated and the overflow patients are free!
How good would that be? Too good to be true I expect.
Before you get too excited remember that the minister said $1 billion, and within a generation along with the "everyone will be able to have treatment".
She did not say "everyone will get treatment next March" and that would be practically impossible due to all the access bottlenecks.
A friend of mine told me, "If you really want to know what's going on then follow the money" and as luck would have it.....
Hmm, never heard of a MYEFO but let's find it, trawl through it, and see what we can find. Ah ha, here it is:
Scroll down to the Health portfolio and you can read:
|Pharmaceutical Benefits Scheme||2015/16 $m||2016/17 $m||2017/18 $m||2018/19 $m|
|— new and amended listings||‑||112.1||150.7||165.6||181.8|
So given the minister said the expenditure had already been accounted for in the MYEFO, the $1 billion appears to represent spending over the next 6 years.
Assuming that the $15,000 cost per patient is correct (and this would be 3-4 times better than anyone else in the Western World has negotiated) we could estimate the treatment targets as:
* Estimated based on the 10% rise we see between 2016/17 2017/18 2018/19
For your interest I've included an Excel spreadsheet that allows you to play with various scenarios around cost, spending and infection rates.
For everyone to have access our government needs to have pulled a rabbit out of the had and negotiated a payment cap. I really hope they have, and that when the medications are listed they are routine Authority items (so any GP could prescribe them), not S100 (meaning only a limited number of specialists could prescribe them).
For anyone who has paid for medications that have not yet been delivered, and would now like to wait and see, we will be happy to refund your money.
HYDERABAD, DEC 8: Generic pharmaceutical company Hetero today announced that it has received the approval for the fixed-dose combination Ledipasvir-Sofosbuvir (90mg/400mg) from the Drug Controller General of India (DCGI).
The drug, Ledisof, is a generic version of Gilead Sciences’ brand Harvoni which is approved by the US FDA.
The Hyderabad based Hetero had signed a non-exclusive licensing agreement with Gilead in September last year to manufacture and market the drug indicated for the treatment of chronic hepatitis C and is the first company to receive DCGI approval for this category of drug.
"We are happy to extend the fixed dose combination therapy Ledipasvir sofosbuvir (Ledisof) to Indian patients which is much more effective than Sofosbuvir," B P S Reddy, Chairman and Managing Director of Hetero said in a release issued here on Monday.
We expect approval for other Indian generics manufacturers to follow soon.
An open letter to all members of Australian Cabinet
If current medication pricing trends are allowed to continue then, when we finally invent a cure for cancer, you can almost guarantee it will be too expensive for all but the super rich to afford.
Take the new Hepatitis C medication Sofosbuvir as an example. The sponsor – Gilead Sciences – is, according to Bloomberg, demanding $1000 a tablet for it, making the monthly price $30,000 and the total price $84,000 for a full 12 week course. With 233,000 Australians having Hepatitis C, a 95% cure rate, and an annual death rate three times that of cervical cancer, there is little doubt securing affordable access is an important issue.
The Australian Pharmaceutical Benefits Scheme (PBS) is the system we have to make expensive medications affordable. It does this by paying a subsidy to the manufacturers so that the maximum patient monthly price is $37 even if that medication costs $30,000 a month. In a case like this the PBS would chip in $29,963 to assist a patient to pay the manufacturer’s eye watering price.
Gilead sell Sofosbuvir for $10 a tablet in Egypt, so we are being asked to pay 100 times more and pricing negotiations have been stalled since 2014. Gilead has already made over $10,000,0000,0000 in profits from a drug that is documented to have cost less than $375 million to develop and $1 a tablet to make.
The scale of the problem is staggering. Worldwide, although over 150 million people suffer from Hepatitis C, a mere ½ a million people have been treated. During this same time 1,500,000 people have died from lack of affordable access. In a tragedy of breathtaking proportions, by the time Gilead’s patent expires, 12 million people who could have been saved will be dead.
The PBS provides equitable access to medication for all Australians but the increasing prices being demanded by Big Pharma for new medications mean the PBS is rapidly becoming too expensive for us to afford. The TPP, if signed into law, may well entrench this problem permanently. For example to provide all Australians needing Sofosbuvir with access would cost our country more than the entire current PBS budget.
I propose the PBS adopt a new model for setting the price at which it is willing to subsidise medications.
We have plenty of scope to improve our negotiating. New Zealand pays 1/8 the price of Australia for our most common medications. Overall they pay less than half what we do while still enjoying similar health outcomes. It's already bad enough that the Kiwis beat us a rugby.....
It is time for Australia to take a firm and unequivocal stance on Pharmaceutical pricing and not allow sick Australians to be held to ransom by amoral corporations.
Currently we pay the 3rd highest prices for medications in the world.
We can, should, and need to do better.
Dr James Freeman
Footnote: You may be interested to know that the forecast when a cure for cancer has been invented it will be too expensive to afford has already come true. Gilead's new leukaemia/lymphoma drug (which like Sofosbuvir they simply purchased rather than developed) comes in with their trademark $84,000 price tag.
A report released Tuesday by US Senators Ron Wyden and Charles Grassley claims that Gilead Sciences priced the hepatitis C treatments Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) with the sole goal of maximising revenue. The report was based on an investigation of 20 000 pages of internal company documents, dozens of interviews with health care experts and data from Medicaid programmes in all 50 states and the District of Columbia.
You can read an overview here:
The report in full is available here
An executive summary is available here.
A timeline of events pertaining to Gilead, Sovaldi and Harvoni is available here
A glossary of terms pertaining to the investigation is available here
Letters from state Medicaid programs are available here
In 1961, Polio Vaccine Inventor Jonas Salk explained his decision to make his invention freely available with the words "You can't patent the sun".
185,000,000 people are infected with Hepatitis C and since a cure was invented only 613,000 people have been treated - during the same time 1,500,000 have died.
To mark World AIDS day on 1st December we have made this short video. If you care please share.....
This is a screenshot of an article in the Australian today.
Here is a link to the full text of the study published in the British Medical Journal
And topping the list is..... No prizes for guessing.
So Big Pharma's argument about pricing goes like this:
We spend a lot on R&D so we need to make a lot back when we find a winner.
Now with Pharmasset we can look at the balance sheet immediately prior to Gilead's purchase. At the time the sunk capital cost (accumulated deficit) was $324 million. That's a lot of money, but nothing like the $7 billion valuation in the market (20x) or the sale price of $11 billion (33x).
That $324 million represents almost the ENTIRE development cost of this medication. There would have been another $50 million for the Phase 3 trials. Call it $400 million all in.
With some 613,000 people treated to date at around $50,000 per person the return is already north of $30 billion. That is 60 x the sunk cost in 3 years.
To treat the entire US population would be north of $200 billion. That is 500 x the sunk cost.
I believe Big Pharma takes big risks and has a right to big profits. The investors in Pharmasset got a 20 x + return and took almost all the risk. That does not seem entirely unfair. Gilead on the other hand took very little risk and is already sitting on 3 x at the price of 185,000,000 of our fellow citizens of the world being unable to access treatment and 500,000 a year perishing of a treatable disease.
If we are happy to live in a world where the cure for cancer is invented but only the super rich can afford it then that's fine.
If however we want to live in a world where patient lives balance patent rights we probably need to start thinking about how we provision decent, but not indecent profits and pricing practices.
You've almost certainly seen a version of this picture. It's called earthrise and really hammers home the idea that we live co-operatively on a tiny speck in a dark black void.
This particular version was taken out of the window of Apollo 13 on its ill fated journey to the moon.
So, why is it here?
According to Reuters John Martin, CEO of Gilead Sciences, has taken home $400.6 million dollars between 2009-2013 and is on track to take home $600 million making him the best remunerated executive in the USA.
Since HCV DAA medications became available 500,000 people have been treated, 1,500,000 people have died and 150,000,000 remain infected.
At that rate, this week one man will take home over $2 million based on profits from HCV medications while 10,000 fellow citizens of the world will die due to lack of access to those medications.
I don't know about you, but to me, there is something not quite right about these numbers.
I wonder what sort of world we would be living in if the companies behind penicillin and polio vaccine had behaved in the same way...
Rumour has it that PBS listing of HCV DAAs is not going to happen this year. It's not official yet, but...
We've started treatment for 5 patients on the transplant list in the last week, all referred from various centers.
If you're F4 waiting might not be your best option.
I just sent an email called "There are no words" because... there simply are not.
Please accept my condolences about M's passing and know that the opportunity to meet such a beautiful human being, who became so suddenly unwell, and still, staring death in the eye was weighing up the financial needs of his family with the costs of personal survival touched me.
It helped turned abstract statistics into the thought: "f**k, this is real, people die from this, and I need to help."
I am sorry we were unable to get medications to M in time or at all.
I have copied in Nevil, who was my personal patient zero, challenged me to become involved, and made the connection.
Without both M and Nevil I might have chosen the coward's route and satisfied my conscience with an "It's all too hard" cop out.
I wish more could have been done but it would be fair to say I helped setup FixHepC as a direct result of meeting both Nevil and M.
2 million people from 100 countries have found it.
Last week I started over 50 patients on treatment, including 5 on the transplant list.
None are M but all have family and friends.
There are no words, but I share this with my patients when faced with similar circumstances:
For some it provides, if not solace, at least understanding of what you must be feeling and comfort that it is normal.
My thoughts are with you.
M's loss will not be in vain.
We have previously tested Incepta's Twinvir and today have received samples of Beacon Pharma's Sofosbuvir, Daclatasvir and Ribavirin products for testing.
We will share the testing results as soon as they are available.
The quality of production of the packaging is extremely impressive, and I must say somewhat better than Sofosbuvir and Ribavirin I have seen from India.
Great packaging won't cure anybody, but it is very encouraging to see such meticulous attention to detail.
Beacon's product even have holographic seals.
Here is some interesting data from the Google Analytics about the FixHepC visitor demographics.
It's kind of spooky that Google knows your age and sex, but here's their analysis.
One of the interesting things is that with 1% of the population infected if you consider the impact of spouses and voting age children an organised Hep C "faction" could easily swing 4% of the votes. With an election required by 14th Jan 2017, and therefore likely late next year...
Here is where we all come from - over 100 different countries and counting