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The U.K.'s NICE: A Model for the U.S.?

By Jim Edwards | Dec 3, 2008

317265004_e6abb49905.jpgThe New York Times has aired another episode of its “Evidence Gap” series, and it’s infuriating. This one is about the National Institute for Health and Clinical Excellence, the U.K.’s price-approval body for National Health Service drugs.

The purpose of NICE is to evaluate drug efficacy and prices, and to approve those drugs that are cost-effective for the benefits they provide. Conversely, NICE declines to give government funding for drugs that are expensive and provide little benefit. Drug companies hate this because they believe the NHS should be the Santa Claus of drugs, dispensing everything to everyone regardless of price.

The Times story starts by creating the impression that NICE’s job is to nickel-and-dime cancer patients. It uses the example of Bruce Hardy, a British man suffering from kidney cancer. He cannot get Pfizer’s Sutent for free on the NHS because of a NICE decision:

If the Hardys lived in the United States or just about any European country other than Britain, Mr. Hardy would most likely get the drug, although he might have to pay part of the cost…at that price, Mr. Hardy’s life is not worth prolonging, according to a British government agency, the National Institute for Health and Clinical Excellence.

Is this really true? Hardy is, arguably, in exactly the same position in the U.K. as he would be in the U.S. He could pay for the drug himself, like Americans do. Or maybe he would be one of the 40 million without health insurance, and he wouldn’t get the drug, the position he’s in now. Sutent isn’t banned by NICE, it just isn’t provided free of charge because it is so expensive and shows so little benefit. (Notice Hardy isn’t complaining about all the free cancer therapy he received on the NHS up until the NICE decision.)

The drug is, in fact, available to Hardy and other U.K. patients (as this story shows), he just doesn’t want — or can’t — pay for it.

The Times doesn’t give any indication of Hardy’s prospects for survival. We don’t know his age, although the story says he has been married 45 years. We don’t know his condition, although the Times says Mrs. Hardy speaks for him. I’ll ask the unpleasant question: Is it worth bankrupting a free national healthcare system in order to throw $54,000 — the cost of Hardy’s Sutent — at patients who are going to die anyway?

Despite the scary stories, U.S. healthcare could probably improve if we had a NICE-like body. As the Times notes:

At the present rate of growth, medical costs will increase to 25 percent of the nation’s gross domestic product in 2025 from 16 percent, with half of the increase coming from new drugs and devices, according to the Congressional Budget Office … paying for costly treatments [for terminal cancer patients] means less money for, say, sick children.

I felt the lead in the Times story was buried. Why are these drugs so expensive? Here’s one clue:

Take the case of Celgene, the maker of Revlimid, a drug for multiple myeloma, a bone-marrow cancer, that in a preliminary ruling on Oct. 28 the institute [NICE] said was too costly. Celgene’s first big seller was thalidomide, a decades-old medicine now used as a cancer treatment, which is so cheap to manufacture that a company in Brazil sells it for pennies a pill.

Celgene initially spent very little on research and priced each pill in 1998 at $6. … the company raised the price 30-fold to about $180 per pill, or $66,000 per year. The price increases reflected the medicine’s value, company executives said.

In 2005, the company introduced Revlimid, a derivative of thalidomide that is supposed to be less toxic, but may be no more effective. Celgene priced it at about $260 per pill, or $94,000 per year.

Moreover, NICE has actually been successful in bringing down the cost of drugs and thus extending their benefits to more patients. Pfizer already agreed to cut the price of Sutent. And Roche agreed to cut the rice of Tarceva. Even better, NICE has gotten drug companies to actually put their money where their mouths are:

It has also been revealed that manufacturers of kidney cancer drugs have held talks with the Department of Health about introducing a pricing arrangement that might persuade Nice to approve their products. One scheme being discussed is to ‘cost-share’, a scheme that would see the NHS paying for a drug if it extended a patient’s life by an agreed time, while the pharmaceutical company would refund the cost if the patient experienced no benefit and died.

Bottom line: NICE isn’t perfect but it’s better than runaway costs triggered by ineffective drugs. Which is what we have in the U.S., where Medicare is banned by law from negotiating drug prices.

  • Note to readers: For more on the Times’ “Evidence Gap” series, see here and here.

Image by Flickr user ZanaStardust, CC.

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

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  •  
    1

    lizamamauag

    12/04/08 | Report as spam

    RE: The U.K.'s NICE: A Model for the U.S.?

    I'm fully convinced that U.K.'s NICE plays a role model for the U.S.healthcare and even for other continents.Everyone has the right to live,but if few benefits will gain and more will suffer then i couldn't find the logic of spending too much money by the government for those expensive drugs that are not proven to be life prolonging.If one has to maintain the economic stability and go for growth,any governing bodies should be meticulous in approving government funding to avoid bankruptcy.

  •  
    2

    Ruddie01

    12/04/08 | Report as spam

    RE: The U.K.'s NICE: A Model for the U.S.?

    Be very careful when thinking the use of NICE is a way forward for the US, here in the UK objections to the NICE appraisals are gathering pace, one of the main reasons being the use of Quality Adjusted Life Year (QALY)and Incremental Cost Equation Ratio (ICERs) as part of the methodology used by NICE. By it's very definition QALY discriminates against the elderly and those in poorer health. The taxpaying public pay into the NHS all their working lives, it is a form of health insurance, so for a tax funded, independent, unelected body to tell you when you become ill that you are really not worth saving we have to ask why we are wasting millions of pounds a year on this exercise in genocide that is supported by this government who thinks nothing of sending billions of taxpayers money to tin pot dictatorships who use this money for their own devices, where is the QALY there. Clinicians at NICE who make decisions using QALY also break the Declaration of Geneva by discriminating on age and disability. Having recently attended a conference on cancer the general feeling is there must be a reform of NICE sooner rather than later. Many of the decisions made by NICE have been challenged and the challenger has won the right to treatment deemed by NICE to be too expensive, costing the taxpayer even more money to defend lawsuits. Jim you are wrong to assume the subject involved in the article can't or will not fund his treatment he already has!The other problem is many terminally ill patients have paid into the state pension system and won't live long enough to claim it where does that money go, I think it goes to line the pockets of unelected bodies who remove the life preserver from a dying man!

  •  
    3

    Ruddie01

    12/04/08 | Report as spam

    RE: The U.K.'s NICE: A Model for the U.S.?

    In response to Lizamamauag: The National Health Service in the UK is a non profit making organisation funded by the taxpayer for a service that is "Free at the Point of Need" those are the words in the NHS constitution. NICE often say if a particular treatment is refused based on it being "not cost effective" and to fund it another treatment would be forfeited the question to ask is what other treatment and why is one person more deserving than another. The problem with QALY is a 34 year old with an ingrowing toenail and 18 years paying into the NHS (if he worked from the age of 16) whilst suffering some pain, will get treatment for his problem, a 60 year old with melacular degenerative disorder and still working with 54 years of NHS contributions will be refused until both eyes are affected and the permanent loss of sight is imminent, we are supposed to live in a civilised society but there is nothing civilised about NICE. This unelected body spent ??4.3 million of taxpayers money on communications that was ??1.1 million more than they spent on appraising treatments. Another question is if age and disability discrimination is acceptable then why not other forms of discrimination say for instance ethnic minorities who suffer from illnesses that are linked to their ethnicity, for example sickle cell anaemia, one could ask why they have paid into a service all their lives only to be refused treatment but the growing immigrant population takes precedence. It is outrageous to think of discrimination in the terms of health care but that is exactly what NICE does. Cancer patients live in the hope that just maybe someone will discover a cure and for that hope to be removed is morally, ethically and legally wrong. Here's a poser for you: The local town thug aged 24 never worked, receives security benefit steals a car and crashes critically injuring himself, no-one else, the emergency services are called out, police, paramedics and fire service, an operating theatre is prepared and emergency room staff are ready for his arrival, hours of operating to save his life it becomes apparent he will be a quadraplegic should he survive, he is placed in the ICU his mother crying over his bed, in the next bed is a lady crying over her husbands bed, this man is dying because NICE refused to fund vital treatment,he is 63 years old and worked all his life up until 6 months ago when he was diagnosed, the town thug will be kept by the state for the rest of his life and any medical treatment will be his for the asking. Is that a fair and equitable way to run a health service?

  •  
    4

    BNET's Jim Edwards

    12/05/08 | Report as spam

    RE: The U.K.'s NICE: A Model for the U.S.?

    I think this is the most intelligent, well-reasoned thread of comments I've ever seen on BNET Pharma. Keep it up, readers.

  •  
    5

    Ruddie01

    12/08/08 | Report as spam

    RE: The U.K.'s NICE: A Model for the U.S.?

    Further to the two comments I have already posted I would like to add my distaste for the drug companies who it seems are guided purely by profit. The company who make Bortezomib (Velcade), after previously being turned down for funding by NICE on the grounds of cost, had this much needed life line for Multiple Myeloma patients granted funding by selling out the very people it was supposed to help, NICE decided to fund the treatment at first relapse, after four cycles a bone marrow biopsy was to be carried out to ascertain whether the drug was working, if so then another four cycles would be funded to complete the eight cycle treatment, if the results were negative then the drug company would refund the cost of the treatment, sounds good doesn't it? Unfortunately by stipulating "at first relapse" NICE, with a stroke of a pen, condemned thousands of Myeloma patients to death, my point being that drug companies will go to any lengths to get their product into the public domain, even if it means people being sacrificed to achieve this aim. The company who is at present having the drug Lenalidomide (Revlimid) appraised by NICE is exactly the same, Lenalidomide is a Thalidomide based drug, all tests had been carried out years ago, yet it is priced at ??3480.00 per month so why the exhorbitant cost? Because it is a life prolonging drug.
    Why has Thalidomide rocketed in price since being used to treat relapsed myeloma patients? These are the problems we need to be addressing, not allowing a bunch of faceless people to play God. I have had one very well orchestrated meeting with Celgene representatives, not wanting to be disrespectful but they weren't the people who had the answers to my questions nor the authority to come to an agreement regarding pricing and marketing. Until these companies realise they too must take responsibility for people dying because of the extortionate cost of their drugs, the very patients they are purportedly hoping to help are fast becoming their victims.

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    6

    debrahantonette

    12/09/08 | Report as spam

    RE: The U.K.'s NICE: A Model for the U.S.?

    It is amazing how much money we continue to spend on death, yet we withhold all necessary hopes for life. Shame on the agencies, industries, and policymakers who continue to support the decadence that has become breath we take in a world that has far been removed from humanity.

  •  
    7

    Ruddie01

    12/09/08 | Report as spam

    RE: The U.K.'s NICE: A Model for the U.S.?

    Hooray for Debrahantonett, Mars Jones a judge here in the UK said in a famous judgement, "However gravely ill a man may be...he is entitled in our law to every hour...that God has granted him. That hour or hours maybe the most precious and most important hours of a mans life. There maybe business to transact, gifts to be given, forgiveness to be made, 101 bits of unfinished business, which have to be concluded.
    If a patient is facing end of life and the only treatment that could possibly help is deemed too expensive by NICE what to level has humanity sunk? Not all treatments are proven clinically effective for all patients, but they should be granted the human right to try with hope, the outcome could be only one of two ways, death, in which case it wont cost the taxpayer any more money, or prolonged life for up to several months. What we are forgetting is these treatments are not easy, one myeloma patient, having been told by his clinician he had between 8-12 weeks to live unless Bortezomib (Velcade) was funded, he fought for and got the drug, during the course of his treatment he had an horrendous time but his answer to any one asking about him was "I don't like the alternative!" he had enjoyed 20 months free of myeloma, sadly it has returned and he has been granted another 4 cycles of Velcade, but because he survived for so long the rule for "exceptional circumstances" was used to acquire the drug on this occasion, however another patient had suffered complications and unfortunately passed away, if we were to listen to NICE the gentleman with the successful outcome would have passed away in September 2006. This particular man is in what is termed "double jeopardy" which means the myeloma cancer has caused another illness, renal failure, he wasn't dialysing at the time of his first application for funding but almost certainly would have needed it if funding hadn't been granted and he was left to die, the kidneys would have failed completely, I did a cost analysis for the health department and this is how it read. To keep this mans kidneys working for the remaining maximum term of his life expectancy of 12 weeks it would cost the NHS ??14,790, if you granted funding of Velcade for a probationary period of 4 cycles before biopsy it will cost ??11,000 if it works then all well and good, if it doesn't then you would have done the ethically and morally right thing by giving him the chance to try.

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