Tarceva

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

SPOTLIGHT: NICE rejects Roche drug as too costly

Fri, 25 Apr 2008 06:59:52 -0400

Roche's lung cancer med Tarceva got the goodbye gong from the U.K.'s National Institute for Clinical Excellence, which ruled that the drug wasn't a cost-effective option for treating non-small cell lung cancer. Roche said it would appeal as patient advocacy groups assailed NICE's decision. Report

Roche, Cipla trade jabs on Tarceva

Mon, 21 Apr 2008 06:59:55 -0400

We turn to India for updates on another cancer-drug battle, this one between Roche's brand-name Tarceva and Cipla's copycat version, Erlocip. A Roche distributor tattled to India's Drug Controller General, accusing Cipla of promoting its version for an unapproved use. Taksal Pharma alleged that Cipla is touting Erlocip for head and neck cancer and colorectal cancer, as well as for the approved uses in non small-cell lung cancer and pancreatic cancer. One source close to the situation said, "They are selling it for uses that even the innovator hasn't discovered."

This is just the latest skirmish between Roche and Cipla. The two companies have been wrangling over Tarceva's patent for some time now: Cipla launched a generic even though Roche had a patent on the med, so Roche sued to keep Cipla's drug off the market. Then Cipla countersued, alleging that Tarceva didn't deserve a patent anyway because it's a tweaked version of an older med. Delhi high court denied Roche's injunction, saying that it's in patients' best interest to have Cipla's cheaper version available. Roche appealed. And the beat goes on: hearings are continuing in the patent revocation case. Stay tuned.

- see the item at Pharmalot
- check out LiveMint's coverage

Related Articles:
European committee gives negative ruling on Tarceva. Tarceva report
FDA panel endorses Tarceva for pancreatic cancer. FDA report
The specter of generic competition grows. Report

Court sends Mircera case to ITC

Thu, 20 Mar 2008 07:59:55 -0400

Another chapter in what's becoming a long Mircera saga: A federal appeals court ruled that Roche could import the anemia drug so long as it wasn't for sale--but sent the case back to the International Trade Commission for its opinion. Previously, the ITC had said that it couldn't rule on whether importing the med in itself would infringe on Amgen's patents. The appeals court says it can.

Meanwhile, a federal judge is still weighing his opinion in the case. Last month, he told Roche he might let Mircera onto the market in spite of the patent infringement if Roche would meet five conditions. Roche said yes. Amgen said, Not fair. How the judge will respond now is anyone's guess.

- read the update in the Wall Street Journal

ALSO: The shoe's on the other foot for Roche in India. The Delhi High Court ruled that domestic drug maker Cipla could market its copycat version of Roche's lung cancer med Tarceva, pending another hearing in August. The court also accepted a patent challenge to Tarceva from Cipla; Roche has four weeks to respond. Report

Related Articles:
Amgen: Mircera deal would set precedent. Report
Roche accepts judge's deal on Mircera. Report
Mircera gets FDA nod, but blocked by patent case. Report
Amgen wins patent fight with Roche. Report
Roche: Patent ruling won't stop Mircera. Report
Roche to Launch Mircera in U.K. and Germany. Report

Thai official backs off licensing fight

Tue, 11 Mar 2008 07:59:57 -0400

The brief ray of patent-respecting sunlight from Thailand has gone behind the old compulsory licensing cloud. A month ago, new Public Health Minister Chaiya Sasomsab said he'd review the previous minister's practice of overriding patents on some expensive cancer drugs so that Thai patients could get cheap generic versions. One possible reason: The country was getting pressure from Western trade officials. But now, Chaiya says he'll press ahead with those compulsory licenses.

Why the about-face? Thai doctors, health activists, academics, and patients pitched a fit, that's why. As soon as Chaiya announced his willingness to reconsider sidestepping the patents on those drugs--Novartis' Gleevec and Femara, Sanofi-Aventis' Taxotere, and Roche's Tarceva--various groups put on the full-court press to change his mind. The Rural Doctors Society even started circulating a petition to get Chaiya impeached, a campaign the group says it will continue.

- see the Bangkok Post story
- check out the article in the Wall Street Journal

Related Articles:
Thailand reconsiders compulsory licenses. Report
Thailand skirts Plavix patent. Report
Thailand may bust cancer patents. Report

ALSO NOTED: Wyeth wins FDA blessing for hemophilia med; India considers compulsory licensing;

Fri, 22 Feb 2008 06:59:50 -0500

> Wyeth got the FDA's nod for its hemophilia drug Xyntha, which also got the green light to prevent surgical bleeding in patients with the disease; the company was named in a related patent infringement lawsuit filed by rival Novartis. Report

> India is considering issuing compulsory licenses for generic versions of two cancer drugs--Roche's Tarceva and Pfizer's Sutent--to be made in India and exported to Nepal, which cannot afford the drugs nor manufacture them. Report

> New research suggests that Crohn's disease patients should start with biologic drugs such as Johnson & Johnson's Remicade rather than reserving them for use after steroids and other remedies fail. Report

> PDL BioPharma has agreed to sell a Minnesota plant to Genmab for $240 million cash; the new owner plans to keep the facility's 170 workers. Report

> Endo Pharmaceuticals posted fourth-quarter profits of $50.6 million, more than triple its previous-period results; accounting charges weighed down the company's 4Q 2006 numbers. Report

> Ipsen got backing from Europe's Committee for Medicinal Products for Human Use for its gout drug Adenuric. Report

> Antisoma is sending out signals that it's looking for new acquisitions to add to its pipeline. Report

> Researchers at Novocell report a key breakthrough in their program to find a cure for diabetes. The company reports that the researchers were able to turn embryonic stem cells into insulin-producing cells in mice. Report

> The blog Eye on FDA sees lessons in the high number FDA approvable letters. Report

And Finally... Computers spot Alzheimer's more quickly and accurately than docs do. Report

ALSO NOTED: Japan to get Roche's Tarceva next week; Barr sues two generics makers over Seasonale;

Fri, 14 Dec 2007 06:59:50 -0500

> Roche's Japanese unit Chugai Pharmaceutical is preparing to launch the lung-cancer drug Tarceva, approved in Japan in October for treatment of the non-small cell form of the disease. Report

> Barr Pharmaceuticals sued Watson Pharmaceuticals and Sandoz for infringing the patent on Seasonale, a birth control product made by Barr's Duramed unit. Report

> The FDA gave its blessing to Kuvan, a BioMarin Pharmaceutical drug designed to treat the genetic disorder phenylketonuria. Report

> Isis Pharmaceuticals promoted B. Lynne Parshall to chief operating officer; she'll also retain her position as CFO and director. Release

> Forest Laboratories announced that several companies are seeking approval to sell copycat forms of its Alzheimer's drug Namenda. Report

> GlaxoSmithKline is sinking $100 million into a neuroscience research center in China that will play a pivotal role in its ongoing drug discovery work. Report

And Finally... For protection, HIV and aggressive cancer cells cloak themselves in carbo-clothing worn by human sperm. Report

ALSO NOTED: Tarceva gets Japan's nod; FDA blesses Novartis arthritis remedy;

Mon, 22 Oct 2007 06:59:50 -0400

> Japanese drug regulators approved Roche's lung cancer drug Tarceva, made by OSI Pharmaceuticals. Release

> The FDA has given its blessing to Novartis' Voltaren, a topical non-steroidal anti-inflammatory gel for relief of osteoarthritis pain; systemic absorption is 94 percent less than with oral NSAID formulations, the company said. Release

> Solvay has inked a deal with Abbott Laboratories to jointly promote Abbott's combination cholesterol drug Simcor, which puts simvastatin and Niaspan in one pill. Release

> In a major setback for Dor BioPharma, the FDA has issued a not approvable letter for the company's lead drug orBec, a treatment for gastrointestinal Graft-versus-Host disease (GI GVHD). Report

> Ranbaxy, one of India's largest drug makers and a dominant force in the generic drugs business, is spinning off its R&D unit that will develop new medicines. Report

And Finally... Cancer death rates, part II: They're down overall, but certain cancers, such as myeloma, are on the uptick. Report

Roche cuts UK price on cancer drug

Wed, 03 Oct 2007 06:59:57 -0400

Here's a strategy for penetrating the market when state healthcare won't yet pay for your drug: Cut the price. Roche is doing just that with Tarceva, its lung cancer treatment, until the UK's National Health Service committee determines whether to add Tarceva to its formulary.

Last month, the National Institute for Clinical Excellence rejected Tarceva, but an appeals panel questioned that decision. NICE has just agreed to reconsider--and this second appraisal could take up to a year.

- read the PharmaFocus article

Related Articles:
European committee gives negative ruling on Tarceva. Report
FDA panel endorses Tarceva for pancreatic cancer. Report