New Hepatitis C Drug Has Steep Price Tag

[Boobert]

Because it will more than double the current cost of treatment, the Fair Pricing Coalition is furious about the price affixed to Incivek™, the newest approved Hepatitis C medication.

Fair Pricing Coalition Says Vertex's Incivek Price 'Outrageous'

May 25, 2011

The Fair Pricing Coalition is again sounding the alarm regarding the price of newly approved treatments for hepatitis C, this time questioning the cost of Vertex's protease inhibitor Incivek (telaprevir). The advocacy group is concerned that Incivek's price tag of $49,200 per 12-week course will adversely affect the ability of people with HCV to access the drug, while also setting an excessively unreasonable future price point for the many hepatitis C virus (HCV) drugs in the pipeline.

"Merck's Victrelis costs $48,400 for 48 weeks of treatment," said FPC member Lynda Dee in a statement from the organization. "Now Vertex has set a price approximately four times greater than Victrelis for 12 weeks of Incivek treatment. While we welcome a shorter course of Incivek treatment, both price points are outrageous. What is worse, you can bet that no future HCV drugs will be priced less than Victrelis and Incivek. What a terrible way to begin!"

Continue reading this entire article:
http://www.aidsmeds.com/articles/incivek_price_advocacy_1667_20508.sh

[desrt]

"test tubes" and "coffee"?

And here I thought it was the royalties everyone has to pay to the HCV patent holder that made any type of research so expensive.

http://hepcproject.typepad.com/hep_c_project/2004/06/chirons_hepatit.html

Silly me.

[Interfurgen]

remenmber it is still are money the gov, spends!!!

[Trish77]

Since this discussion started out being about drug costs, this is one of the reasons that drug costs in Canada are held to a cap of sorts - we have a government body called the Patented Medicine Prices Review Board.  I don't know if you have the equivalent in the U.S.  It makes for interesting reading.

http://www.pmprb-cepmb.gc.ca/english/home.asp?x=1

[willbb]

Lots of pluses and minus to both systems

[Trish77]

" then it's going to be more easier. "  That's some mighty fine grammar there. :)

[Trish77]

I wouldn't go so far as to say Canada's system is more efficient.  If you only have one body/insurer to deal with to submit your invoices, i.e. the government, then it's going to be more easier.  That just stands to reason.

Behind the lower cost in admin, however, there are other things to take into account such as what Andy mentioned.  

Also from the perspective of a Hep C patient, I was turned down for drug support from the government for my choice to treat at Stage 1 - funding reserved for those Stage 2 and beyond. I can't get a PCR past six months post EOT - likely because I am SVR.  While I understand those restrictions in a "fund the ones who need it most" system, people who hold up Canada should be aware of what it means to have those admin costs.

I had to wait 10 months for my first GI appointment.   I would not have had much control over how many PCR's I had, whether they were quant or qual and to what sensitivity.  I would have gotten what the government was willing to give.  When I got my first PCR in 2007, the sensitivity at that time was <600 and only measurable up to 1.3mil viral load.  Anybody starting treatment with that test would not have had a clear picture of the viral load they were starting treatment with if their viral load was higher than 1.3 as mine was - I was fully planning to go to the U.S. for my baseline viral load and got into the trial instead.  By the time I started treatment in Feb 2008, they had brought in a better test with a higher threshold and a better sensitivity, I think <15.  If I want something better than that, I wouldn't be able to get it.

On the other hand....as a Hep C patient.....my biopsy and blood tests were completely free, my appointments with the GI and then the Hepatologists when I did get in to see them were completely free.  My appointments with the Endocrinologist when I got thyroid issues were free.  The ultrasounds on my thyroid were free.  The treatment with the psychiatrist on my treatment team was free.  The operation on the perforated appendix just over one month EOT was completely totally free in every way.   My treatment was on a clinical trial, however if it was not, every doctor's visit and every CBC I required would have been free.  A fellow I know had to have a liver transplant.  There were no concerns whatsoever with costs all the way through to his new liver, subsequent successful treatment and ongoing medical care.  His subsequent medications are an issue and that's a whole other and separate discussion.

I'll take that trade-off.  I get frustrated by the roadblocks we run into here and some of the decisions are not necessarily good medical sense only, they are good financial sense.  And some of the things you want here, even if you are willing to pay for them, you cannot get them.  Some you can, some you can't.

I just want people to realize it's not all rainbows and stars up here, some people post as if medical care here is like candybowls of it just sitting out there for the taking and it's not.  It also comes at a tax cost that people don't see and they take it for granted too much to my liking without realizing that every time they use or abuse the system, we all pay for that.  

Having said all that, I am very grateful for what we have here, despite how my comments may sound.  My son is moving to the U.S. in a little while and one of my first and main concerns was his healthcare situation as he loses his Canadian healthcare after a time.  Thankfully, where he'll be working and his qualifications mean that his healthcare plan will be stellar.....but certainly I would not have had to worry about that here.  Benefits matter but healthcare in general doesn't come into the equation here.  It is simply available to a very large extent to all.  

I think that's very telling for me that I have to worry about his healthcare because he's crossing the border for employment.  Despite his benefit situation, if anything happens to him there it's going to cause me real concern.  I really hope they fix some things in the U.S. - like your past or current health situation disqualifying you for or affecting your eligibility for insurance.  I hope you can take what works and doesn't work in systems like the Canadian one and come up with something better.

I hope I haven't offended any of my American counterparts with this (or my Canadian ones for that matter).  A very difficult topic as it's truly a matter of life and death for some people.  That part distresses me the most.

Trish

[andy_k]

i know nothing about US health system, or how good or bad it is...
i live in canada, and the numbers are for US and Canada. it looks like Canada is much more efficient

but, from my point of view as a hep c patient:

1. i was waiting for my first GI appt for 8 months ( it looks like in US it happens much faster). the GI receptionist told me in march 2011 that she books appt for march 2012 for new patients...

2. IL28B still not available here, have to travel to US if decide to get it done

3. new meds are still 6 month to 1 year away. nobody really knows how they will be covered...

ps
i'm not trying to compare US and canada system, just a couple of thing from a point of view of a hep c patient

[neptune235]

Very nicely done, Hector, thank you for posting that good info!

[Willy50]

I couldn't quite believe the article but after doing some digging it appears that yes..... Victrelis could be dosed up to 44 weeks?!!?  
That is the thing that amazes me as much as the price difference between the 2 products.

http://www.merck.com/newsroom/news-release-archive/prescription-medicine-news/2011_0513.html

"Treatment-failure patients: Patients (previous partial responders or relapsers) who are undetectable at treatment weeks 8 and 24 complete all therapy at treatment week 36. Patients who are detectable at treatment week 8, but undetectable at treatment week 24, complete VICTRELIS at treatment week 36 and continue on peginterferon alfa and ribavirin alone until treatment week 48. Response-guided therapy was not studied in treatment-failure patients who had less than a 2 log decrease in virus (HCV-RNA) at treatment week 12 of prior treatment (null responders). If treated, these patients should receive 4 weeks of peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS in combination with peginterferon alfa and ribavirin.
==============================
"44 weeks of Victrelis"?!!

I don't believe that under any circumstances Telaprevir (incivek) is to be used for any more than 12 weeks, in ANY response.

http://pi.vrtx.com/files/uspi_telaprevir.pdf
(see page 2)

Telaprevir when used in monotherapy saw resistant virii pop up in the first and second week.  It blows my mind that a very similar PI (victrelis) could be dosed for up to 44 weeks.
http://www.natap.org/2006/EASL/EASL_12.htm

"VX-950 alone group
- about 3-log initial reduction in median HCV RNA
- 4.0-log reduction in median HCV RNA by Day 14
- Rebound or plateau in 4/8 patients----------------------<<<<<(what I'm talking about-W)
- Results consistent with prior VX04-950-101 study"
==================================
Anyway....amazed that they would treat w/ a PI for that long.  I wonder if it is worthwhile or advisable.

The 2 compounds offer a similar enough response profile that it appears that compared to Telaprevir (incivek) the boceprevir (Victrelis) is being *priced to move*.....  lol; relatively speaking....

People have been waiting and waiting for the approval of the drugs; dying for them to be approved.  Unfortunately, some may be waiting and dying for the prices to come down.  : (

All that I can say is that don't be deterred; look into the costs and look into the assistance programs.  It is also predicted that the prices could come down as the other drugs are approved and as even better treatments come into development.

willy

[HectorSF]

For anyone who uses the U.S. health care system regularly I think intuitively knows about the high cost of overhead...

Insurance Overhead

Medicare, the publicly managed plan for the elderly in the United States, spends 5 percent of each health care dollar on administrative expenses, compared with the 17 percent by private insurers on average. This is because private companies spend more on marketing, often pay exorbitant salaries to executives, and take a cut of each health care dollar for profits and company reserves.

Countries with a public insurance plan for the population immediately save over 10 percent on every health care dollar by cutting out private insurance overhead.

Health Insurance Overhead Insurance per person

U.S. $412
Canada $77
Australia $106
Netherlands $119
Germany $167
Switzerland $181

Hospital and Physician Overhead

Hospitals and physicians by virtue of having to deal with dozens of private insurance companies, as well as many individuals who have to be billed directly for care uncovered by insurance, incur enormous overhead expenses. The result is a large billing department at every hospital and, far more importantly, an enormous percentage of every physician, nurse, and technician’s time lost to paperwork.

The waste incurred by a commercial insurance system even at the level of health providers is vividly portrayed by a comparison of overhead expenses for hospitals and physicians in the United States versus Canada. Remember, Canada does not have “socialized medicine” - hospitals and physicians are privately owned and run - these costs are incurred solely by the insurance system.

Hospital billing and administration per person
U.S.        $487
Canada     $85

Physician billing and administration per person
U.S.        $561
Canada    $144

The Bureaucracy is Growing Faster Than Direct Care

The net result of commercial health insurance in the United States has been an explosion of bureaucracy at all levels of the health care system. This is clear from a comparison of the growth in health care administrators over time relative to the growth in physicians.

The number of Health care administrator has grown 2,500% since 1970

Cheers!
Hector

[HectorSF]

Here are some of the benefits gained through passage of "The Affordable Care Act" that may affect person with hepatitis C.
------------------------------------------------------------------------------------------------------------------------
For persons who are disabled by hepatitis C or advanced liver disease and receiving healthcare through Medicare....

"The Affordable Care Act includes benefits to make your Medicare prescription drug coverage (Part D) more affordable. It does this by gradually closing the coverage gap (also called the “Donut Hole”).

It requires the Secretary to negotiate drug prices directly with pharmaceutical manufacturers for Medicare Part D plans. (Effective upon enactment; applies to drug prices beginning on January 1, 2011)

What This Means for You

Starting January 1, 2011, if you reach the coverage gap in your Medicare Part D coverage, you will automatically get a 50% discount on covered brand-name drugs. You receive the discount when you buy them at a pharmacy or order them through the mail, until you reach the catastrophic coverage phase.
You will also get a 7% discount on generic drugs while in the Donut Hole.
You can expect additional savings on your covered brand-name and generic drugs while in the coverage gap until the gap is closed in 2020.
---------------------------------------------------------------------------------------------------------------------
For everyone including those with private or company health insurance.

The Affordable Care Act...
"Enhances competition in the pharmaceutical market by stopping agreements between brand name and generic drug manufacturers that limit, delay, or otherwise prevent competition from generic drugs. (Effective upon enactment)"

Requires disclosure of financial relationships between health entities, including physicians, hospitals, pharmacists, and other providers, and manufacturers and distributors of covered drugs, devices, biologicals, and medical supplies. (Effective March 2011)

Reviewing Insurers’ Premium Increases. HHS recently offered States $51 million in grant funding to strengthen review of insurance premiums. Annual premium hikes can put insurance out of reach of many working families and small employers. These grants are a down-payment that enable States to act now on reviewing, disclosing, and preventing unreasonable rate hikes. Already, a number of States, including California, New York, Maine, Pennsylvania and others are moving forward to improve their oversight and require more transparency of insurance companies’ requests to raise rates.

Starting in 2014, many low-income, uninsured people will be able to get health care and treatment through an expanded Medicaid program and those with higher incomes now have access to private insurance because the ACA eliminated the ‘pre-existing conditions’ clauses enabling everyone to access health insurance regardless of their health status. The benefits of the ACA are only just beginning but will increase over the next few years, helping more people with hepatitis B and C to get the care and treatments they need.
--------------------------------------------------------------------------------------------------------------------
Also, U.S. patients pay the highest prices in the world for meds. Most first world countries have price controls on the cost of meds as well as affordable healthcare for all their citizens.

Cheers!
Hector

[FlGuy]

You're right.  The scientists work for small companies like Vertex.  Over the past several years Vertex has ben bleeding money with the development of several drugs. Making money - not even close.  things became so dire that they had to sell distribution rights to Teleprivir just to continue development and raise money for the costs associaed with testing.

"This does not have to be from some humongous corporation which is sucking us all dry."  Re-think that sentence unless you mean USA Inc.

[orphanedhawk]

Thee truth is the profits are obscene.
Scientists will continue to do research on whatever as long as there is financial support.
This does not have to be from some humongous corporation which is sucking us all dry.
Personally I think the whole system is broke.

[GoofyDad]

VTX has limited time to recoup investment costs before market forces drive the price down. Better drugs will emerge. Or even a slightly inferior drug that sells for less. If the InsCos start on that, VX will poop bricks.  The prize of profit is the only thing that keeps the drug developers in the game. And we want them in the game.

[willing]

where costs are excessive, getting rid of  blood-sucking for-profit leeches seems an excellent place to start reducing them.  How many more  crash test dummies ( and chemists, biologists, crystallographers, nurses, biostatisticians and physicians ) can you get if you trade in one investment banker?

Time will tell, but I'd bet public-health organizations in EU/Canada and elsewhere end up waiting longer but negotiating far better prices than the above.   Which underscores that pharma is in no danger of going belly up,  even under significantly reduced profit margins.

[neptune235]

Imagine a world without health insurance companies, and multi-billion dollar advertising campaigns by drug-makers...

There is plenty of material on the internets about the superiority of removing the profit motive from the health-care-industrial complex -- absolutely no desire to rehash the issue  here.

One little notion for curious minds to consider -- do you know what the administrative overhead is for Medicare?  How about Wellpoint?

[flcyclist]

Seems to me the lower your income and lack of any insurance dramatically raises the probability of assistance given through gov't subsidies.  Sounds like some are paying little or nothing, while those with some insurance coverage and a decent income are bearing the burden and get no assistance at all.  Typical.

I understand the cost of developing new meds is extremely expensive to go through approval, but level the playing field a little.

[FlGuy]

And just who the heck is FPC?    A bunch of whiners who complain and want something for the mere cost of whining about it.

[FlGuy]

Who, exactly, is that Single Payer? And, where does that Single Payer get his money to pay?  Oh yeah, SP is the same one that so efficiently runs those other wonderful programs like Social Security, Medicare, National Debt, Congress, Post Office, Amtrack, Fannie Mae, Freddie Mac, FEMA, the IRS and covers the costs for stuff like food stamps, unemployment.  Quite a resume' of success!

[ellen1960]

I don't think any healthcare reform will affect the cost of developing a new drug and getting FDA approval.  The only incentive for investors is the potential to make a profit some day.  Healthcare reform won't change that.  Without investors who puts up the $billions for new product development?

[Trish77]

Full article for context.

May 25, 2011

Fair Pricing Coalition Says Vertex’s Incivek Price 'Outrageous'



The Fair Pricing Coalition is again sounding the alarm regarding the price of newly approved treatments for hepatitis C, this time questioning the cost of Vertex’s protease inhibitor Incivek (telaprevir). The advocacy group is concerned that Incivek’s price tag of $49,200 per 12-week course will adversely affect the ability of people with HCV to access the drug, while also setting an excessively unreasonable future price point for the many hepatitis C virus (HCV) drugs in the pipeline.

“Merck’s Victrelis costs $48,400 for 48 weeks of treatment,” said FPC member Lynda Dee in a statement from the organization. “Now Vertex has set a price approximately four times greater than Victrelis for 12 weeks of Incivek treatment. While we welcome a shorter course of Incivek treatment, both price points are outrageous. What is worse, you can bet that no future HCV drugs will be priced less than Victrelis and Incivek. What a terrible way to begin!”

According to FDA labeling for Incivek, approved May 23, the drug should be taken for 12 weeks with either 24 or 48 weeks of pegylated interferon and ribavirin, depending on a patient’s response to the regimen. The wholesale price for 48 weeks of HCV treatment with pegylated interferon and ribavirin is about $30,000. The $49,200 WAC price for 12 weeks of Incivek, the FPC wrote, “will more than double the already exorbitant 48 week price” of hepatitis C treatment.

“Although the addition of Incivek to pegylated interferon and ribavirin should significantly increase the HCV cure rate, it will be impossible to sustain these prices in light of the current U.S. health care crisis,” Dee said.

“The HCV community is anxiously awaiting interferon-sparing regimens because of the terrible side effects caused by interferon as well as ribavirin,” said FPC member Murray Penner. “An encouraging number of these drugs are currently in development. It will take three and maybe even four of these new drugs in a combination regimen to effectively cure HCV in the future. Future HCV drugs will invariably be more expensive than Victrelis and Incivek.

“If each of the new drugs costs $50,000, we are looking at regimens that will ultimately cost between $150,000 and $200,000 in the very near future. This is unsustainable and will unacceptably limit access to the regimens.”

Other costs need to be considered as well, the FPC states. According to a paper presented at the annual conference of the American Association for the Study of Liver Diseases (AASLD), the costs of treating the side effects of HCV protease inhibitors such as Victrelis are expected to be 30 percent higher than for existing treatments. And many of those with hepatitis C suffer from other illnesses. Some have diabetes or bleeding disorders; others are coinfected with HIV. All of these add completely new sets of medical expenses.

“We were very disappointed by the cost set by Merck for Victrelis earlier this month. Our fears about Vertex’s price for Incivek have now unfortunately come to pass,” Dee said. “How will this all end? We fear it will end in a lack of patient access to promising new HCV treatments that will result in morbidity and mortality for hundreds of thousands of Americans.

“Both Merck and Vertex have pledged to make their new drugs available to patients who cannot afford these exorbitant prices through their co-pay and patient assistance programs (PAP). Vertex’s PAP is particularly generous,” Dee pointed out. “The FPC will continue to advocate for people with HCV to ensure that both companies keep their word. We have kept a tight watch on HIV drug manufacturers in this regard. We intend to do the same thing in the viral hepatitis arena.”

[neptune235]

It does no good to ignore the elephant in the room.  If we had *real* health care reform, as in universal coverage single payer, the profit motive would be removed, and prices would fall.

But then, I hear politics are banned from this place.

[Proactive]

Don't forget, they're is another player involved as well, JnJ..Vertex gave up rights to market the drug vx 950 in Europe (I believe they only retain North America now)..Cost to develop exceed $1,000.000.000, then there is marketing costs, rep costs--Free assistance costs..Now figure in the actual volume of the drug sold, as Flguy put it, compared to aspirin..
Have you seen cancer drug prices?

[nygirl7]

There is a certain amount of years before they can sell generic versions here I forget how long but I would guess they know they gotta squeeze out every nickel before then.