cancer drugs

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

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

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

Have cancer drugs hit a cost ceiling?

Tracy Staton — Mon, 13 Oct 2008 10:45:32 -0400

Ask any Big Pharma CEO these days which drugs offer the most promise for future earnings, and the likely answer will be oncology meds. Indeed, as the patents on other blockbusters expire, there's been a headlong rush toward cancer treatments to fill in the revenue gaps. It's not just that these meds bear big price tags, but also because there's less need for advertising and marketing support. As one analyst told Business Week, to sell oncology drugs, "You don't need thousands of sales reps, you just need good data."

But drugmakers may find themselves rushing headlong into a wall. Witness the reluctance of British regulators to pay for expensive treatments that often add only months to a patient's life. As you know, Roche recently slashed the price of its lung cancer treatment Tarceva, just to get the Brits to pay for it. Experts say this pushback against prices is just the beginning. "At some point--and that point will come sooner rather than later--payers are not going to approve spending $100,000 for someone to live an extra six months," Erik Gordon, director of biomedicine at Stevens Institute of Technology, told BW. Another expert said that as insurers increasingly scrutinize cancer drugs, "many will never reach their markets."

- read the BW article

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

Costs put cancer docs in financial bind

Tracy Staton — Tue, 08 Jul 2008 09:14:54 -0400

Pricey cancer meds aren't just putting the squeeze on patients and insurers. They're putting oncologists in a financial quandary as well. We got an inkling of this recently when the American Society of Clinical Oncology convened a task force to help guide doctors in discussing treatment costs with patients. At the time we saw that rising drug costs were starting to affect treatment decisions; a 2007 survey found that 23 percent always or most always figured cost into those choice, and 86 percent felt it their duty to consider the impact of treatment on a patient's finances.

Perhaps the next survey should measure how many oncologists-in-arrears have had to beg wholesalers to continue sending cancer meds. Or how many are sending patients to nearby hospitals for drug infusions because they can't bear the costs themselves. Or how many are millions of dollars in debt to their drug suppliers.

The problem is obvious: With expensive cancer meds such as Genentech's Avastin and Tarceva, Abraxis's Abraxane, and ImClone's Erbitux, patients have to foot the bill for thousands of dollars in copays over the course of their treatments, and digging up that money isn't easy for some people--so they're slow to pay. Private insurers turn around their reimbursements slowly, say 90 days or so. And after decades of allowing 50 percent markups on some chemo meds, Medicare cut IV drug margins to 6 percent. (FYI, the most expensive drugs were only ever marked up by 10 or 15 percent.)

Now, it's tough to weep for an oncologist whose pay isn't growing when that pay already amounts to an average of $360,000 per year. But with more and more oncology practices deep in debt and many of them forced to dun very sick patients for their payments, treatment can suffer. And the monetary woes of cancer docs just emphasize the fact that the debate over funding healthcare in general and pricey drugs in particular is far from over.

- read the Wall Street Journal article

Is Avastin really worth the cost?

Tracy Staton — Mon, 07 Jul 2008 09:34:40 -0400

Is Avastin an object lesson in weighing the costs of an expensive drug against its benefits? Some experts think so, and the New York Times over the weekend took an extensive look at the controversy. The facts are these, the NYT says: Avastin is expensive, up to $100,000 per year. It's proven only to prolong life by a few months, if that. And it has side effects, some of which are rare but lethal.

According to the newspaper, some pharma insiders worry that the half-dozen or so drugs like Avastin--which are expensive and offer "arguable benefits"--will cause a backlash such as drug-price controls or usage restrictions. Even patient advocates question its use. But because cancer-treatment issues are emotionally touchy, and because Americans are accustomed to treatment whatever the monetary cost, the debate hasn't been very public. And that's what needs to change, some say. "I think of Avastin as a model that is showing us where the problem is," one told the Times.

The issue raises questions about how drugs are priced, too. Genentech and Roche say they spent $2.25 billion developing Avastin and will spend an additional $1 billion on clinical trials. But is this why Avastin is so costly? Yes and no, the experts say. One analyst told the Times, "It's high because Genentech can price it high."

- see the article

Breast-cancer uptake boosts Avastin sales

Tracy Staton — Tue, 01 Jul 2008 09:12:15 -0400

Avastin may have lost its chance to go on the U.K.'s National Health Service formulary, but it's still blowing past sales expectations. Wall Street analysts are saying that faster-than-expected uptake of Avastin in breast cancer--for which it was FDA-approved in February--likely has boosted the Genentech cancer med past second-quarter forecasts. According to investor notes, Avastin sales grew 4.6 percent in May to surpass one analyst's $648 million monthly estimate; another analyst pegs second-quarter sales at $677 million.

Genetech's other two revenue drivers--the rheumatoid arthritis treatment Rituxan and breast-cancer med Herceptin--also appear to be beating their targets.

If Avastin does make a forecast-beating showing when Genentech posts its results July 14, it would be a vindication for the company: When the drug got FDA's blessing for breast-cancer use, some skeptics predicted it wouldn't be adopted quickly. Indeed, an FDA advisory panel voted against approval. In its breast cancer trials, Avastin did slow tumor growth, but didn't help patients live longer. The agency's blessing came despite the committee's doubts, and industry observers said the decision appeared to lower the bar for cancer approvals.

- read the article in Forbes

ALSO: Avastin "significantly" boosted survival in patients with metastatic colorectal cancer whether or not the patients carried a gene mutation that commonly influences the efficacy of cancer drugs, a new study showed. Release

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

Costly cancer meds put NHS in quandary

Tracy Staton — Tue, 24 Jun 2008 09:53:34 -0400

The hand-wringing over costly cancer medicines in the U.K. is something of an object lesson, raising questions about medical care for the haves versus the have-nots, and about just how much money a few more months of life might be worth.

You see, the National Health Service has long had a policy that patients who fork over their own money for expensive meds that aren't reimbursed by the government automatically become private-pay customers who have to pay the whole bill. But after years of complaint from patients--and intense lobbying by advocacy groups--the health minister is reviewing that policy. It's an ethical snarl for the NHS, whose stated mission is equal access to care for all. If the NHS gives the go-ahead for "top-up" payments, that could be a windfall for drugmakers.

Meanwhile, as we all know, the cost of healthcare is rising, and it's not only the NHS that's scrutinizing every expenditure for cost-effectiveness. There's been talk in the U.S., for instance, of some sort of comparative effectiveness research that could in turn limit use of certain meds that may work wonders in some but have little effect on the rest (unless they can be targeted with genetic screening, but that's another story).

With so many drugmakers pinning their financial hopes on a new generation of costly cancer therapies, the debate is destined to drag on.

- read the story in the Financial Times

New drug-spending leader: Diabetes

Thu, 15 May 2008 06:59:58 -0400

New data on pharma sales details some big shifts in spending. Diabetes meds have displaced cholesterol drugs as the leading drivers of spending growth, for one thing; generic competition is reining in cholesterol costs even as usage of the meds is increasing. Meanwhile, there's been growth in overall diabetes-drug use, and a shift toward pricier treatments, boosting 2007 spending by 12 percent. Overall drug spending grew by only 2 percent last year as patients used more generics.

Plus, safety concerns affected spending on antidepressants, hormone replacement therapy, and anemia drugs, Medco Health Solutions reports. Safety warnings on Procrit, Epogen, and Aranesp depressed sales by 15 percent, while hormone replacement therapy usage dropped by 9.2 percent. Suicide-risk warnings (and generic competition) hampered growth in the antidepressant market.

A separate report from IMS Health showed that the global market for cancer meds is advancing by leaps and bounds, twice as fast as the growth in all other pharmaceuticals. As emerging countries spend more on healthcare, they're investing more in cancer treatments; they're expected to power up spending on these meds by 12 to 15 percent a year through 2012. The overall global drug market, by contrast, is expected to grow by 6.4 percent.

- find the news at the Wall Street Journal Health Blog
- see the Pharmalot item
- check out the story from the Associated Press
- read the article at CNN Money