32 replies to this topic

[CallMeLucky]

This is really messed up.

http://online.wsj.co...3155198288.html

U.K. Panel Balks at Drug Payments

Agency says government shouldn't pay for higher-priced Novartis, Bristol-Myers medications

In another sign of growing opposition to high drug prices, an arm of the U.K.'s health-care system said Britain shouldn't pay for a group of expensive leukemia drugs for certain patients, saying their cost outweighs their benefits.

The decision is preliminary and applies only to a limited group of patients with chronic myeloid leukemia, or CML. But it is a blow to the drugs' makers—Novartis AG and Bristol-Myers SquibbCo.—and a sign of the increasingly frugal environment they face for drugs that cost tens of thousands of dollars a year. The U.K. is considered a leader in the scrutiny of health-care costs, and its decisions are closely watched by other health systems and insurers around the world.

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The ruling applies to three drugs: Tasigna, Sprycel and high doses of an older drug called Glivec, which is known as Gleevec in the U.S. These treatments are typically prescribed to patients who haven't responded well to a standard dose of Glivec.

Patients who don't respond to standard doses of Glivec shouldn't be given the other treatments, because the evidence for their effectiveness is "very weak," the National Institute for Health and Clinical Excellence, or NICE, said in a statement.

"When we recommend the use of very expensive treatments, we need to be confident that they bring sufficient additional benefit to justify their cost," the NICE statement said. The agency's rulings apply to England and Wales only.

Sprycel, made by Bristol-Myers, and Tasigna, made by Novartis, both cost over £30,000 ($49,500) per patient a year, NICE said. Novartis also makes Glivec and recently raised the price, so that a high dose now costs more than £40,000 a year, NICE said.

U.K. patients currently using the drugs in this way will be able to continue, but no new patients will be offered the treatments. The decision doesn't apply to patients taking standard-dose Glivec as an initial, or "first-line," treatment. NICE, which regularly reviews all classes of drugs, said it is currently reviewing the clinical and cost effectiveness of standard-dose Glivec as a first-line treatment.

NICE has rejected a number of pricey drugs for cancer and other diseases in the past, including Nexavar from Bayer AG and Onyx Pharmaceuticals Inc.; Tyverb from GlaxoSmithKline PLC; and the kidney-cancer treatments Sutent and Torisel, both from Pfizer Inc. Sometimes NICE rejects drugs for all patients with the disease, and sometimes just for patients with a specific form of the disease, where the efficacy doesn't appear to justify the price.

NICE's decisions often anger patients, their families and drug companies. After issuing preliminary guidance, the agency gives patients and companies time to submit responses before making a final decision. NICE doesn't have the authority to ask companies to lower their prices, but companies sometimes cut deals with the agency in order to get their drugs approved, such as offering a certain number of doses for free. Companies are often reluctant to lower their prices, saying that other countries and insurers would then also demand price reductions.

In a statement, Bristol-Myers said the ruling "may significantly set back the treatment of CML." In the same statement, a patient group called CML Support called the ruling "very disappointing" and urged NICE to reconsider.

In a statement, Novartis said it was "concerned" that the decision could leave patients "with a potentially poor prognosis due to a lack of effective treatment options." It added that it hopes to persuade NICE to overturn the ruling.

Bristol-Myers and Novartis launched Sprycel and Tasigna several years ago as successor products to Glivec, which was first launched in the U.S. in 2001. Glivec is considered one of the great successes of cancer treatment, and has extended many patients' lives by many years. Glivec last year had global sales of $4.3 billion.

But some patients don't respond well to Glivec; Sprycel and Tasigna were approved to treat these patients. In a 58-page decision, NICE said it is "clear" that the drugs "provide clinical benefit for people" with Glivec-resistant CML, but that "the paucity of the evidence base means that the magnitude of the benefit is uncertain."

Sprycel and Tasigna have so far rung up healthy sales. Sprycel had global sales of $576 million last year, while Tasigna had $399 million in global sales.

[CallMeLucky]

I'll tell you, this seriously makes me reconsider my thoughts about National Health coverage in the US.

[lala]

woooooooooow...i only read the first part....scary.......can you imagine if our insurance stopped paying?????  i have always joked about the price of our meds and if our families really wanted us and all that cost!!!!!!  not funny!!!!  i've gotta read this more carefully....and look forward to the responses....and why are these drugs sooooooooo expensive?

~lala

[lala]

hi, Lucky, i almost said that in my post a minute ago.....my aunt, THE NURSE!, always worried about that---she said in other countries you can HOPE to get some services......these meds keep us alive and productive---they are not just keeping us alive ----- oh, boy, let's not worry too much yet!!!  ~lala

[Ludwigh]

Scary, espcially since many depend on Spycel (like myself) for suvival. In the UK, what do they do with those that fail Gleevec (up to 30% of CML patients). Transplant or death?

The American People were sold on the national run health care by using the UK NHS as a an example. What do they do for even rarer cancers in the UK?

The next train of thought is that the drug companies are charging too much. Well, if there is no financial incentive to develop these designer cancer drugs, who will then develope them.

I think if the Government wants to make sure everyone is covered then it should subsidize insurance companies to take on the burden. I worked in the federal government for a while and effecency was the exception. I can't imagine a Federal run health care system,

Terry

[Happycat]

The scary thought is if they don't think the TKIs are enough of a success story and provide enough benefit to justify the cost, then what WOULD they approve in cancer?  I don't see how they can even support their hypothesis that they haven't seen enough of a benefit with 2nd gen TKIs.  I personally think they're drawing a line in the sand for price negotiations and trying to bend the pharma companies to their will.

How ironic the panel is called NICE!

I've been meaning to look up the synthesis of Gleevec and see if I agree with the "it's so darn hard to make" argument.

Traci

[Taylor]

Wow...definitely not good, especially since these drugs can be models of so many other targeted therapies which in the long run would reduce the financial aspects of cancer treatment, from initial treatment all the way to pallative care costs (if things were more easily treatable and curable).  Moves like this would stifle the research.  Hope it doesn't take hold.

[CallMeLucky]

I agree that this a shot across the bow to the drug companies to cut a deal and lower the prices.  They clearly have room.  If I recall correctly, Gleevec was initially considerably cheaper until they realized exactly what they had and then it became a lot more expensive.  Druker has said there is no justification for the cost where it is today.  On the other hand if the drug companies cave to NICE, then they are basically telling NICE they can set the price for their products.  Meanwhile real people are caught in the middle.

[SunNsand]

  I saw this article somewhere else and I hoped it was being discussed here. I have the same thoughts as HappyCat, what kind of evidence do they need to show it saves lives? This article is really disturbing.

SunNsand

[chriskuo]

UK already gets a substantial discount from the US price.

The UK price for Sprycel/Tasigna is about $50K/year.

[CallMeLucky]

I think their behavior contradicts their findings and they are being extremely hypocritical.  They state

"U.K. patients currently using the drugs in this way will be able to  continue, but no new patients will be offered the treatments."

Well that doesn't make much sense now does it?  If they are convinced that individuals who fail Gleevec do not do well on second generation drugs, then why keep paying for people on a treatment that doesn't work?  Shouldn't they cease all treatment of the drug in all patients if it isn't working?  Of course then they would have people who were in a stable remission progress and die from lack of medication and they would be held accountable.  So instead they grandfather in existing patients and deprive new patients so they can use the defense that it is not their fault people died due to lack of treatment because there is no way to prove the drug would have worked for them unless they got the chance to start taking it.  It would be interesting what their response would be to someone who pays for treatment themselves initially and then goes back to NICE and says "look, the treatment is working, but I can't afford it any longer".  Now what?

It is absolutely disgusting and all parties involved (Gov't and drug companies) should be prosecuted for murder for anyone who dies because the drug was not made available to them.  If the UK wants to negotiate prices with drug companies, they should not sacrifice patients in the middle.  They can penalize them via taxes to recuperate some of the money if they want to, but using sick people as pawns is unbelievably cruel.

While I would never wish CML on anyone, you have to wonder if one of the people making these decisions was suddenly diagnosed with CML if they would realize exactly how horrible they really are?

[Happycat]

Lucky,

Maybe you are on to something there.  ALL of these panel members should have their own lives on the line with a life threatening disease so they will perhaps learn some compassion.  Can you make that part of a job description in the UK??

Traci

[rct]

The real thing to worry about is that once they get away with it there the insurance companies here will be working double overtime to get away with it here.  For some reason, in America it is all cool and all to hate the government, people never stop to consider just how deep The Market is screwing them to the floor.  Somehow, the insurance companies will figure out how not to pay for it too, and they'll blame Uncle, and things will roll on as they were.

You'll prolly end up with a "voucher" to pay for your Gleevec.  Good luck to all of us with that.

rct

[Happycat]

Just saw this today, don't have access to WSJonline, so all I could do was google it a bit.  Seems Novartis fired some managers for a breach of ethics.  What exactly the breach was I could not determine.  Doubt they'll talk about it.  Kinda makes you wonder, doesn't it?  Were they lying about the drug costs??  Probably was something else, but really makes you wonder.

Traci

[CallMeLucky]

http://www.borehamwo...aemia_patients/

Borehamwood man's anger at denial of new therapies for leukaemia  patients

12:29pm Thursday 12th May 2011

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• By Josh Darlington  »

A PROPOSAL by the medicines watchdog to oppose innovative therapy options for  people with a form of leukaemia will "shorten the lives of patients".

Steven Davies, 54, of Boreham Holt, Borehamwood, was diagnosed with chronic  myeloid leukaemia (CML) in 2004, the result of an abnormality in the bone  marrow, which causes a massive increase in the number of white blood cells.

The National Institute for Health and Clinical Excellence (NICE) announced on  May 5 a provisional decision not to recommend a new generation of drugs for the  treatment of CML that is resistant to the standard prescribed medicine.

Mr Davies says it means patients like himself, who suffer side effects such  as eye-bleeds, weight gain, joint pain and exhaustion from imatanib, will not be  able to try different medications.

He said: "It's been proven that people who move onto the second generation of  drugs survive longer. Why are we being denied drugs that could prolong our  lives?

"We're not talking about hundreds of thousands of people here, but why should  a couple of hundred people's lives be shortened because of a wrong decision by  NICE?"

Mr Davies said the medical body would be leaving patients with "nasty"  alternatives such as bone marrow transplants and older, less effective drugs.

He added: "What they are saying to people is take it or leave it."

Mr Davies said his whole life had changed since he contracted the illness,  forcing him to change his career from working in the fashion industry to become  a driving instructor.

He said he tries not to let CML be an overriding factor in his life, despite  three-hour fasts morning and night and immense tiredness due to his medication.

He was placed on a new drug called nilotinib around a year ago, but has  unfortunately proved intolerant. He is eager to try an alternative called  dastanib, but under the proposals this would not be possible.

The decision by the medical body would effectively freeze all patients on the  medication they are currrently taking, and close off more powerful therapies to  the 540 people who are diagnosed with CML each year.

Mr Davies said he felt NICE were playing God and taking a short-term  financial view of the situation.

Mr Davies said: "If you're dying and a drug will improve your quality of life  for three months they may prescribe it. But if it lasts too long, it costs too  much. It means it's not down to whether the drugs work, but the money.

"We're always behind in this country. I've had the most wonderful treatment  from the NHS. I've got the biggest praise for it, but something needs to be done  about NICE.

"Look at the rate of take-up in other countrie. Why do we lag behind in so  many appraisals of drugs that could help people with lots of different  illnesses?"

The reason given by Andrew Dillon, chief executive of NICE, for the  opposition of new therapies was: "The evidence for the effectiveness of  dastanib, high-dose imatanib and nilotinib is very weak.

"When we recommend the use of very expensive treatments, we need to be  confident that they bring sufficient additional benefit to justify their cost."

The medicine watchdog says the more powerful dasatinib and nilotinib cost  more than £30,000 per patient per year.

The proposal by NICE is open to public consultation, before a final decision  is made in June.

Members of The CML Support Group, which provides advice and information for  patients, are campaigning to try to overturn the plans. They are asking  residents to sign an online petition and write to their MPs.

Sandy Craine, director of the group, said the news had been a crushing blow  for patients who faced a "bleak therapeutic future" should the recommendation be  confirmed.

She asked: "Will we see CML patients in England, Wales and Northern Ireland  unable to join the citizens of Scotland and Western Europe in their right to  access the best standards of healthcare possible?

"To remove the right to choose new therapies that show real clinical benefit  will inevitably shorten lives and cause unnecessary distress to many.

"The CML Support Group urges the NICE appraisal committee to reconsider its  preliminary decision and recommend that patients have the right to choose  therapies that offer optimal clinical benefit, a reduction of side effects,  improved quality of life and the best chance to live a full and normal life."

A petition has gone live, along with letter templates for people to write to  their MPs, at www.cmlsupport.org.uk

[helenet]

The link to the existing petition is posted in an earlier email on this site.  

[threedprof]

Woo! Signer #2503!!!

[gunner]

Interesting situation.

Drug company grudgingly agrees to produce drug that was basically handed to them by the researchers.

Drug company prices it out-of-sight, earning it the reputation of the world's most expensive daily maintenance drug (temporarily, until other companies note the positive press)

UK panel decides it is time to kill the geese that lay the golden eggs (by refusing to pay the bill).

You can buy the India equivalent for pennies on the dollar. The challenge comes with buying product from one of the most corrupt countries in the world. I can deal with the curry and the rat hair so long as they put the proper dose of the drug in as well.

One of the reasons that I prefer to stay with Gleevec is that within a few years the cost may come done (when it goes off-patent). 

[Trey]

Just to clarify, Gleevec was invented by Novartis researchers (actually by a company called Ciba-Geigy that merged with Sandoz to become Novartis -- same thing).  They developed initial versions that led to a final version of the drug as it went through testing on mice.  Novartis also paid the costs to get the drug through early testing, clinical trials, and the FDA approval process.  This is why Novartis owns the patent; otherwise, someone else would own the patent.  Other scientists and researches were important and instrumental in cheerleading for the drug, suggesting tweaks to the design, and running the clinical trials that Novartis paid for to enable Gleevec to become approved by the FDA and produced, but Novartis invented the compound we know as imatinib/Gleevec/Glivec.  Not taking away any credit from anyone else, but Gleevec is a Novartis product in every sense.

[Happycat]

Gunner,

I'll second Trey on this one.  Novartis definitely developed this drug.  The lead compound was in their screening library, and then they modified that hit to get to Gleevec.  Nor was it a one stroke of luck change.  They had to make hundreds (thousands?) of analogs to figure out what increased the activity.

It is actually pretty expensive to bring a drug to market, roughly around $500M to $1B in today's dollars.  Novartis paid for all those trials, which ultimately benefited us.  I'm sure they've made back their money by now, but part of the profits gets used to develop other drugs which will hopefully save other lives.  

I can certainly understand the anger people feel at having to pay so much for this drug.  It feels like you're being gouged, just for the privilege of staying alive.  You are right,the price will likely stay high until the generics can provide competition.  It will be very interesting to see where the price finally settles.

Personally, I'm not sure I want to get a generic from overseas, China or India.  I've heard too many horror stories about drug production in developing countries (that contaminated heparin a few years ago, remember that?).  But we do what we gotta do.  I bought a drug called Motilium from Janssen Pharmaceuticals in Australia (I think), because you can't get it in the US at all.  I just kinda ordered it and hoped the feds never looked at the package too closely.

Traci