NICE

NICE to green-light costly kidney meds

Tracy Staton — Mon, 01 Dec 2008 11:20:07 -0500

A much-lamented ban on new kidney cancer drugs in the U.K. will soon be lifted, the Guardian reports. Of four meds that the National Institute for Health and Clinical Excellence called too expensive for National Health Service use, at least half will be approved--and perhaps all four, the paper writes.

As you know, NICE recently ruled that Pfizer's Sutent, Bayer's Nexavar, Wyeth's Torisel, and Roche's Avastin didn't ace the cost-benefit analysis all NHS drugs are expected to pass. According to NICE's calculations, the drugs were too costly for the additional survival time kidney cancer patients tended to experience when using them. Patient advocates immediately pounced, and a public outcry ensued.

Now, however, sources are telling the Guardian that NICE will OK Sutent next month, when a committee meets to discuss the drugs again. Either Avastin or Nexavar is likely to get the nod, too, the sources said.

This turnabout by NICE follows some pricing negotiations between the agency and drugmakers. The companies have offered some new pricing schemes for the meds, including discounts and risk-sharing.

- read the Guardian story
- see the post at Pharmalot

Industry Voices: NICE tries to expand healthcare coverage

Mon, 17 Nov 2008 21:15:59 -0500

This week Senator Max Baucus released a blueprint to create a national health plan. A central feature of his proposal is something called the The Health Care Comparative Effectiveness Research. The Institute is modeled on Britain's National Institute for Health and Clinical Excellence (NICE) which was established to compare the relative value of medical technology. The Institute has enthusiastic support from advocates of government-run healthcare and the health insurance industry's lobby, America's Health Insurance Plans (AHIP). Both groups argue that the institute should compare treatments for the same disease, find which works best, chuck the one's that are less effective and use the savings to pay for expanded insurance coverage.

Baucus claims the Institute's decisions would not be binding. The problem is that voluntary decisions don't stay voluntary for long. NICE decisions were immediately adopted by Britain's National Health Service to determine what it would pay for and to further tighten the government's control over healthcare.

Comparative effectiveness advocates like the fact that NICE focuses on the value of care. Recently the group ruled that four drugs used to extend the life of people with stomach cancer "aren't effective enough to warrant their high cost and shouldn't be prescribed to new patients." NICE decided that the $39,000 the drugs would cost to keep people alive wasn't worth the money.

NICE determines what's valuable by assuming that anything that costs too much isn't worth the money, even if it helps people live longer or better for a year. That so-called 'quality-adjusted life year' is the upper limit NHS uses to determine what it will pay for. To NICE, breast enhancements and Viagra are a bargain, but new drugs for stomach cancer are a waste of money.

Many comparative effectiveness advocates claim that in America, which spends more per person on health than Britain, the appraisals would only eliminate "wasteful" care. Tell that to Barbara Wagner. She's enrolled in Oregon's Health Plan which used comparative effective analysis from Oregon's Drug Effectiveness Review Project to tell her it wouldn't pay for Tarceva, a drug proven to extend life in people with her particular type of lung cancer.

DERP receives funding from the federal government's Agency for Health Care Quality and Research, which already produces comparative effectiveness research. AHRQ also funds the comparative effectiveness institutes of HMOs who, along with DERP, crank out reports used by Medicaid and insurance plans to ration drugs for cancer, mental illness, arthritis and other serious disease in over 25 states.

AHRQ and these organizations would essentially run the new Institute with a budget of about $300 million a year. The legislation says they should do large studies that compare one drug or device to another. Such research take years to complete. All the better if you want to dodge paying for some new cancer drug or medical device. And such studies ignore racial, gender or genetic differences that allow doctors to match the right treatment to the right patient. That makes it easier to conclude that there is no difference between any treatments, and to recommend using the cheapest available.

Comparative effectiveness fans point to the ALLHAT trial (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) as another "gold standard" for what they want. That five-year, 42,000 patients trial compared older blood pressure drugs (diuretics) against newer medicines in reducing heart attacks.

The study concluded cheaper diuretics were just as effective at reducing death from all forms of heart failure. Michael Weber, professor of medicine at Downstate Medical Center and a study adviser, points out diuretics only seemed better overall because the study produced a 40 percent excess stroke rate in African American patients who were given a type of blood pressure drug called ACE inhibitors. It's known that blood pressure in African Americans responds poorly to ACE inhibitors. The one-size-fits-all approach to treating hypertension taken in ALLHAT exposed black patients to certain danger and even death.

Comparative effectiveness is marketed as a tool for promoting better health and universal coverage. In fact, it's used mainly to deny people care when they need it most by the folks holding the purse strings. Both NICE and the new Institute will ration care by deciding some lives are worth saving and others are not. The difference is, in America, the insurance companies have found a way to have us pay them to do it. - Bob Goldberg

NHS widens access, relaxes drug fees

Christe Bruderlin-Nelson — Wed, 05 Nov 2008 09:40:09 -0500

The UK's National Health Service will now allow patients to receive NHS care even if they privately pay for drugs, and will implement measures to increase access to NHS-covered treatments.

Alan Johnson, the UK's health secretary, overturned a rule that had previously banned patients from receiving services if they paid for their own medications. At the same time, Michael Richards, the National Cancer Director, published a report that showed government plans to work on new pricing arrangements for new drugs as well as speed up the appraisal and approval process for new medications.

As a result, the public will have greater access to drugs for cancer and other terminal conditions. The move ends what some have called a "cruel practice" that prevented individuals from purchasing certain medications by removing other NHS benefits.

- see the full story at the Financial Times

Tories propose NICE approval reforms

Tracy Staton — Mon, 03 Nov 2008 10:51:14 -0500

U.K. politicians are promising big reforms for the National Institute for Clinical Health and Excellence. The drugs watchdog--which decides which meds are used by the National Health Service--has been under fire in recent months for refusing some costly cancer meds and for an approval process that can take 18 months. Well, the Tories are pledging to cut that time frame to three to six months---an improvement of up to 15 months.

How so? The conservative party wants to remove the final step off NICE approval: a ministerial sign-off. And the Tories say they'll shift the burden of proof onto the pharma companies, so that drugmakers have to prove a drug works rather than NICE proving it doesn't.

In potentially the biggest shift, however, the party is proposing that NICE consider not only the bare cost-effectiveness of a drug, but the softer "social cost" of denying its approval as well. That means the agency could be more responsive to societal outcry when certain meds are rejected. That sort of calculus could have paid off for the makers of costly kidney cancer meds that NICE recently nixed, for instance.

Who'll foot the bill for this kinder, gentler approach? The Tories haven't answered that question.

- read the story in The Telegraph

UK patients lobby Celgene for discounts

Tracy Staton — Tue, 28 Oct 2008 11:24:43 -0400

When Johnson & Johnson made a pay-for-performance deal covering Velcade sales to the U.K.'s National Health Service, industry observers figured it was just a matter of time before other companies did the same. And sure enough, Novartis recently forged a cost-sharing deal to get its macular degeneration drug Lucentis onto the NHS formulary. Now, patient groups are lobbying Celgene to negotiate its own price-cutting scheme on the myeloma drug Revlimid.

The background: The National Institute of Health and Clinical Excellence deemed Revlimid unacceptable for NHS reimbursement, saying the drug isn't cost-effective. At $56,400 per year and an estimated three extra years of life, the cost blows past NICE's cost-effectiveness threshold. But patient advocates say Revlimid is a breakthrough that could help make myeloma into a manageable disease.

That's the same conclusion NICE reached on Velcade, before J&J pitched its pay-for-performance deal, under which the drugmaker refunds the cost on patients who don't respond. Whether Celgene plans to negotiate isn't yet clear, but you can count on more calls for discount deals as NICE continues its hard-line stand.

- read the BBC story
- check out Pharmalot's post

NICE snubs Glaxo's pay-for-performance plan

Tracy Staton — Tue, 14 Oct 2008 10:25:10 -0400

Britain's National Institute for Clinical Excellence isn't backing off its tough stance on cancer meds. The cost-effectiveness watchdog yesterday straight-armed GlaxoSmithKline's breast cancer treatment Tyverb--for the second time--despite an innovative pricing proposal from GSK. According to NICE, the drug shouldn't be used by the UK's National Health Service except in clinical trials.

Glaxo has been working to persuade NICE of Tyverb's cost-effectiveness since the agency first indicated it would recommend against the treatment, which is aimed at women with advanced HER-2 cancer. Glaxo even offered to treat eligible patients for free for 12 weeks, collecting payment only for those helped by the drug after that.

But as Glaxo announced today, NICE remained unmoved. "Given our involvement, it is difficult to comment without the appearance of self interest," Glaxo's UK general manager said in a statement. "[H]owever, we strongly believe that the wrong decision has been made for patients, doctors and the NHS." But hope is not lost: This is a draft recommendation; the final decision is expected sometime next month.

- read the GSK release

Roche cuts Tarceva price for U.K.

Tracy Staton — Mon, 06 Oct 2008 10:19:16 -0400

Need more evidence that the U.K. is playing hardball on drug prices? Here it is: The National Institute for Health and Clinical Excellence agreed to pay for Roche's lung cancer med Tarceva--if and only if the drugmaker matched the price of an older, less costly remedy.

NICE had calculated that Tarceva was $3,700 more expensive than the Sanofi-Aventis treatment Taxotere. Roche proposed the discount, and NICE accepted; now, the drug-price watchdog will recommend Tarceva as an alternative to Taxotere in patients whose chemo has failed. Patients and their doctors will decide which drug to use.

Expensive cancer meds have become an explosive issue in the U.K. As NICE has taken a hard line on cost-benefit analysis, patients and advocacy groups have been demanding greater access to new, potentially life-saving or life-extending treatments. For example, NICE recently nixed four kidney cancer drugs--Roche's Avastin, Bayer's Nexavar, Pfizer's Sutent, and Wyeth's Torisel--saying they're not effective enough to warrant the big price tag. Patient groups were outraged. Then, last week, the government suggested that drugmakers should discount their prices if they want these costly meds to be adopted.

Apparently Roche took that advice. Will other drugmakers follow suit?

- read the story in the Wall Street Journal
- check out the WSJ Health Blog post

NICE urges docs to curtail ADHD meds

Tracy Staton — Thu, 25 Sep 2008 10:59:00 -0400

Can parents treat ADHD? The U.K.'s National Institute for Health and Clinical Excellence says the first line of treatment for attention deficit hyperactivity disorder should be parental management. Moms and Dads--and other caregivers--should receive training in caring for and managing ADHD kids. Next comes counselling, for older kids. Drugs, NICE says, should be reserved for kids with severe ADHD or used as a last resort for other children. And they should never be given to kids under 5 years.

NICE's new treatment guidelines come at a time of intense debate over the prevalence of ADHD drug use among youngsters. Prescriptions in the UK, for instance, doubled between 1998 and 2004. But many parents and teachers hail the drugs for their ability to help difficult children learn and behave in the classroom and at home.

NICE also says that, when drugs are prescribed, they should be part of a treatment plan that includes "psychological and behavioral interventions."

Experts figure that actual drug use won't change much initially. But it seems that growth in ADHD drugs could be curtailed over time. And because NICE's decisions are closely watched in Europe and elsewhere, the policy could spread.

- read the BBC story
- check out The Guardian's coverage
- see the article at CTV

UK politicians: Pay for drug performance

Tracy Staton — Thu, 11 Sep 2008 11:11:44 -0400

The flap over cancer-drug funding is heating up even more in the UK Politicians accused the National Institute of Health and Clinical Excellence (NICE) of spending more money on marketing "spin" than on evaluating drugs. (Sound familiar?) But really, the "communications" line item lawmakers cited as 13 percent of the budget largely covers clinical guidance for doctors. And the 10 percent cited as drug assessment doesn't include money spent by other R&D folk.

Typical political-speak, but given the ongoing battle over whether the National Health Service should pay for expensive drugs, politics could end up determining whether drugmakers get access to the UK market. And politicians might determine just how much money pharma gets for those costly meds: Tories are suggesting that the NHS pay for the cancer drugs--but only if they work.

It's true that Johnson & Johnson agreed to a deal where the government only pays for the cancer treatment Velcade if patients respond to it. But that sort of evaluation wouldn't necessarily work for all drugs. But given the penchant for pay-for-performance in business, we can expect this proposal to cause some serious debate.

- see the article in the Guardian
- read the Telegraph story

Costly Lucentis gets NICE nod

Tracy Staton — Thu, 28 Aug 2008 10:37:49 -0400

As researchers in the U.S. compare Genentech's macular degeneration drug, Lucentis, with Avastin, another Genentech drug used off-label to treat the eye disease, notoriously tight-fisted regulators in the UK are clearing the much more expensive Lucentis for funding by the National Health Service.

As you know, Genentech has run into controversy over Lucentis, which costs $2,000 per treatment, versus $60 per dose for Avastin when used for the eye malady. The company had moved to restrict distribution of Avastin to compounding pharmacies that repackage the drug for ophthalmic use, but the outcry from doctors and patients led Genentech to soften its stance.

Genentech has come in for criticism from the National Eye Institute, which wanted the company to be part of the head-to-head study. Unsurprisingly, the company wasn't eager to sink money into a trial that pitted two of its drugs against each other--but some have read that refusal as evidence of the company's lack of faith that Lucentis will prevail.

Most importantly, though the study results won't be available for a couple of years, folks are already talking about the prospect that, if the drugs prove comparable at treating macular degeneration, Medicare would refuse to pay any more for Lucentis than it does for Avastin.

In the U.K., however, the National Institute for Clinical Excellence has decided to make Lucentis available to NHS patients. The series of 14 injections will run about $18,000 per eye; under its deal with NICE, Novartis, which markets the drug in Europe, will cover any additional injections needed. Even at the $18,000 cost, NICE figures it will save money compared with the cost of patients' vision impairment.

Why didn't NICE recommend Avastin instead? There's no trial data showing the drug's effectiveness against macular degeneration. And there won't be--until the National Eye Institute trial wraps. We'll see how NICE reacts then.

- see the Boston Globe story
- read the news from the Wall Street Journal

Does NICE want pricing power?

Tracy Staton — Tue, 26 Aug 2008 11:37:45 -0400

Last week, the chief of the U.K.'s National Institute for Health and Clinical Excellence accused drug companies of overpricing their products. Now, sources are telling PharmaTimes that the attack signals that NICE wants a "central role in price negotiation" as the government is overhauling its Pharmaceutical Price Regulation Scheme.

There's an interim pricing deal now, details of which were released two weeks ago. But experts are saying that the new deal, scheduled to start in January, will be a more radical departure from the past arrangement with industry, which guaranteed drugmakers profits on their products. And NICE may be partly responsible for that. "There will be regulation on prices; NICE will be involved in it and prices will go down," pledged Joe Collier, a medicines policy expert.

- read the PharmaTimes article
- see the post at Pharmalot

Calls for price cuts on cancer meds

Tracy Staton — Fri, 08 Aug 2008 10:32:01 -0400

If the government says cancer drugs aren't worth the cost, then what? Ask drugmakers to cut their prices. After the U.K.'s National Institute for Health and Clinical Excellence rejected four kidney-cancer treatments yesterday, advocates immediately ramped up pressure on pharmaceutical companies to lower their price tags. Report

NICE rejects four cancer meds

Tracy Staton — Thu, 07 Aug 2008 10:16:02 -0400

The debate over costly oncology meds rages on in the U.K. as the National Institute for Health and Clinical Excellence rejected four high-tech drugs for advanced kidney cancer treatment: Sutent (Pfizer), Avastin (Roche), Nexavar (Bayer) and Torisel (Wyeth). NICE acknowledged that the drugs do extend life--by up to six months--but concluded that the money would be better spent on other patients.

The decision drew immediate fire, not only from patient advocates, but from cancer researchers and doctors, too. One doctor said there was no point in accepting referrals for advanced kidney cancer patients without those drugs, because most don't respond to the only other alternative, interferon.

The outcry might actually have some effect: NICE initially rejected Herceptin outright for breast cancer treatment, then relented after receiving an outpouring of complaint. The agency's final kidney cancer treatment guidance will come through in January.

- read the story in the Times
- check out the Telegraph's coverage

NICE wants to limit anti-TNF use

Tracy Staton — Mon, 21 Jul 2008 10:42:48 -0400

Hear those cries of protest? They're coming from the U.K., whose National Institute for Health and Clinical Excellence (NICE) issued guidelines today that would limit patients' access to high-tech arthritis meds. Under the guidelines, each patient could use only one of the anti-TNF drugs--Centocor's Remicade (infliximab), Abbott Laboratories' Humira (adalimumab), and Amgen's Enbrel (etanercept)--and couldn't try another if the first stopped working or didn't help in the first place.

NICE said that giving patients more than one of these meds is not cost-effective, and that if one of them doesn't work, then docs should use Roche's Rituxan--known as Mab Thera in the U.K. and Rituxan in the U.S. Rheumatoid arthritis activists rose to the anti-TNF drugs' defense, saying that a limit of one would amount to "one roll of the dice" and "rationing without rationality."

The guidelines aren't in force yet; a final version is due in September. Activists are hoping that the outcry convinces NICE to change its mind. It worked before; NICE proposed anti-TNF limits in 2006, but recanted after protest.

- see the BBC story
- check out the coverage in the Telegraph

U.K. aims for quicker adoption of new meds

Tracy Staton — Mon, 30 Jun 2008 09:46:04 -0400

Last week, the news from the U.K. was all about restrictions, as the National Institute for Clinical Health and Excellence refused to pay for Roche's cancer treatment Avastin. This week, the British government is pledging the opposite. Under an NHS overhaul set to be unveiled this week, locally run primary care trusts will be pushed to pay for drugs--even if NICE hasn't yet given its blessing--as long as there's a clear benefit for patients.

It's an attempt to replace the patchwork of drug availability--what locals call the "post code lottery"--with a more uniform set of reimbursement standards. Not only will the local trusts be pressured to adopt meds, but NICE will have to speed up its review, ruling on most meds within six months. The watchdog will even be checking out drugs that haven't been approved yet.

The catch: The plan includes $100 million in new funding because the loosening restrictions are expected, of course, to lead to greater demand. Critics no doubt will argue that's not enough. Stay tuned.

- read the Guardian article

More NICE debate over cancer meds

Tracy Staton — Fri, 27 Jun 2008 09:16:33 -0400

It's not just Roche that refused to fork over cost-effectiveness info on its cancer med to the U.K.'s National Institution for Clinical Health and Excellence. So, too, has Merck Serono. Yesterday, you'll recall, NICE said it was rejecting Roche's Avastin for National Health Service use because it lacked that data. Merck Serono's Erbitux is in the same boat. And given the fact that NICE is increasingly skeptical of high-priced cancer meds, there's likely to be more wrangling among the regulators and pharma.

Merck Serono's U.K. oncology chief Denise Richard maintains that NICE needs to change its criteria and procedures--and needs to speed up its reviews, too. For instance, NICE doesn't allow drugmakers to update their applications even during long appeals, she told the Financial Times, even though efficacy data often changes quickly.

Richard also thinks NICE should change its requirements for cost-effectiveness for patients with late-stage cancer. One of the regulators' gripes is that some of these expensive meds only extend life by months rather than years; Richard says late-stage patients rarely live more than a few months. So that extra time can be precious.

Interestingly, the FT posits that the best value might lie in using these high-tech meds earlier in the cancer-fighting game--but at lower prices, so that drugmakers would make up the price difference by selling a higher volume.

- see the FT article

Roche, NICE in Avastin data standoff

Tracy Staton — Thu, 26 Jun 2008 09:25:16 -0400

It's another blow for Roche's Avastin the U.K. The National Institute for Clinical Health and Excellence shot down the high-tech cancer med as a first-line treatment for lung and breast cancer, meaning the National Health Service won't pay for it. That's the second rejection at NICE for Avastin, which was also denied for colon cancer use.

The negative verdict came after NICE asked Roche for more data on the drug's clinical and cost-effectiveness--and Roche refused, figuring the data would just show that Avastin was too expensive to meet the agency's requirements. With the announcement came the expected rhetorical clash. "Other healthcare systems seem to think it's fairly priced," a Roche spokesman sniffed. NICE's chairman sniped, "Roche would rather not supply the drug in the U.K. than risk a negative opinion."

Avastin's thumbs-down comes at a time when expensive cancer meds are under increasing scrutiny in the U.K. And because NICE tends to be influential in the drug-reimbursement world, that scrutiny could follow cancer treatments to other countries, too.

- check out NICE's statement
- get the news from Interactive Investor
- see the Financial Times story

UK's NICE to Sanofi’s obesity drug

Christe Bruderlin-Nelson — Wed, 25 Jun 2008 11:37:53 -0400

The National Institute for Health and Clinical Excellence (NICE) gave a favorable nod to Sanofi's obesity drug, Acomplia, giving a boost to the company despite earlier challenges the drug faced. NICE recommended the drug for overweight adults who cannot take--or who have no success with--other weight-loss medications. However, NICE did place cautions on its recommendations, saying that patients should have an assessment every two years as well as discontinue the drug if they have not lost at least 5 percent of their body weight in the first six months of use.

Debates continue in the E.U. over whether Acomplia is a reimbursable drug or whether it is simply a lifestyle enhancer, but the NICE recommendation represents a small boost for Sanofi, who has suffered much negative publicity after stories that the drug might cause suicidal thoughts in patients. It has also taken a financial hit--with barely over $120 million in sales last year.

The company continues to test the drug as a diabetes medication adjunct, as well.

- see ead story from Forbes
- get the U.K.'s take at BBC

U.K. aims to put 1.5M on preventive statins

Tracy Staton — Wed, 28 May 2008 10:03:15 -0400

New U.K. guidelines for heart-attack prevention could be a major windfall for statin-makers. The National Institute for Health and Clinical Excellence wants docs to search their patient rolls for people over 40 at risk of heart attack and stroke--and put them all on the cholesterol-fighting meds. According to agency estimates, 1.5 million more people would thus be added to the millions who already take statins, preventing 15,000 heart attacks, strokes, and angina cases per year.

The caveat: All the patients turned up during this hunt for heart risk will be put on simvastatin, which of course is a generic form of Zocor. So the intitiative is not likely to aid brand-name drugmakers. But if the idea spreads, the likes of Lipitor and Crestor may end up sharing the wealth.

- see the story in the Telegraph
- read the BBC coverage