Dear Colleague,
 
ASHM is running the Treatment of hepatitis C with Direct Acting Antivirals course at the Rydges Melbourne, Victoria on Saturday, 20 February 2016. This course is being delivered as part of the Control and Elimination within AuStralia of HEpatitis C from people living with HIV (CEASE) project in partnership with the Kirby Institute.
 
This full day, face-to-face course is designed to up-skill the primary care-based workforce in the current assessment and treatment of HCV infection, to enable rapid scale-up of interferon-free therapy with direct acting antivirals (DAA) for HCV. The course is designed for HIV prescribers, but may also appeal to General Practitioners, Sexual Health Physicians, OST prescribers, clinicians working in AOD settings, custodial settings and Aboriginal Medical Services.
 
This is a FREE course, which has been approved for 40 Category 1 RACGP points. A small number of travel scholarships for rural and regional medical practitioners to attend may be available upon request.
 
I have attached a flyer with further details – Feel free to forward to your colleagues and extended networks. To register for this course please go to the courses page on the ASHM website http://www.ashm.org.au/courses.
 
Please do not hesitate to contact me via return e-mail if you have any queries.
 
Kind regards,

Annabelle Kennett
Project Officer
National Policy and Education
ashm | Supporting the HIV, Viral Hepatitis and Sexual Health Workforce
Tel: +61 2 8204 0742 | Fax: +61 2 8204 0782 | E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
LMB 5057 DARLINGHURST NSW 1300 | www.ashm.org.au -

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.

Awesome animated video of HCV life cycle.

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:

Hi James

I think we should publicise the following key features of the PBS arrangement:

1. All patients (>=18 years) with chronic hepatitis C will be able to access treatment through PBS. No restrictions based on liver disease stage or otherwise.
2. The PBS is an uncapped program. There are no caps on number of patients who can access these treatments.
3.  GPs will be able to prescribe following consultation with a specialist and community dispensing allowed.

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.

Kind regards

<Not John Denver>

Which is 100% awesome news.

---

And here is the Minister's Official Statement:

http://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2015-ley154.htm

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

http://www.health.gov.au/internet/ministers/publishing.nsf/Content/FAE2B65331456243CA257F20006D4C48/$File/SL-154.pdf

---

And here is what the AMA say:

https://ama.com.au/ausmed/ley-tries-stymie-opposition-hep-c-link

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:

http://www.smh.com.au/federal-politics/political-news/turnbull-government-to-spend-1-billion-on-hepatitis-c-miracle-cures-for-all-20151219-glrib0.html

http://www.9news.com.au/health/2015/12/20/08/14/federal-government-to-spend-1b-to-subsidise-breakthrough-hepatitis-c-cures 

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:

• DAA prices ranging from $15,000-25,000 per patient,
• 24 weeks treatment for the same price as 12,
• Free medication for retreatment, and
• A payment cap in that if enough patients present for treatment all the patients over the cap have their medications provided free (not all that hard given a production cost of $150 per patient).

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.....

Ms Ley said the PBS funding had been accounted for as part of Tuesday’s MYEFO, but was not announced until today due to confidential pricing negotiations with medicine suppliers. 

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:

http://www.budget.gov.au/2015-16/content/myefo/html/11_appendix_a_expense.htm

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:

Year	Spending	Patients
2015/16	112,100,000	7,473
2016/17	150,700,000	10,046
2017/18	165,600,000	11,040
2018/19	181,800,000	12,120
2019/20	200,000,000*	13,333
2020/21	220,000,000*	14,666

* 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.

1. First we find the lowest market price offered by the manufacturer in the world (eg $10 in Egypt for Sofosbuvir).
2. Now we calculate a multiplier factor of four based on Australia’s per capita income ($40,000), divided by Egypt’s per capita income ($10,000).
3. This multiplier is used to set the maximum price that the PBS will pay, so in this case that would be 4 x $10 = $40 – this directly represents our capacity to pay in a world market situation.
4. Should the manufacturer not wish to accept this offer price Australia applies a Super Pharma Profits Tax of 100% to every dollar over the calculated fair market price leaving the manufacturer free to charge whatever they like, but clawing extortionate pricing back into consolidated revenue using an alternate mechanism.
5. In addition we adopt New Zealand’s methodology of not seeking to list every medication on the PBS, instead only listing one or two solutions to the particular problem This simple strategy forces Big Pharma to compete on price to receive (and maintain) PBS listing.

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

Founder

GP2U Telehealth

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.

http://www.fiercebiotech.com/story/gilead-picks-blockbuster-fda-blood-cancer-approvals-idelalisib/2014-07-23 

 

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:

http://hepatitiscnewdrugs.blogspot.com.au/2015/12/sovaldi-investigation-finds-revenue.html

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