Seattle Genetics: The Next Litmus Test for High Priced Cancer Drugs

8/22/11Follow @xconomy

[Update: 9:20 am ET] Dendreon ran into a buzz saw of opposition last year when it priced its new prostate cancer drug at $93,000 per patient. Genentech has loads of critics who say it has overreached on price with its antibody drugs for cancer, especially in cases where the data supporting the drug is controversial, as with bevacizumab (Avastin) for breast cancer. But despite all the pressure from insurers, elected officials, patients, and doctors, drugmakers are showing no signs of backing off.

Many times, I’d say the critics are right to complain about excessively high drug prices. But in a few cases, the drugmakers are right to stand firm, and today we’re going to see an interesting test case.

Today, we’ll see a new player emerge in the great cancer drug price debate: Seattle Genetics (NASDAQ: SGEN). The company won FDA clearance on Friday to start selling its new antibody drug for Hodgkin’s disease and another rare lymphoma. [Updated 9:20 am ET, with pricing info] Seattle Genetics revealed the price of this new drug, called brentuximab vedotin (Adcetris), on a conference call with analysts this morning. The company set the price at $13,500 per dose, given intravenously every three weeks. If patients get eight infusions on average, consistent with clinical trial experience, then it will cost $108,000 per patient. Wall Street was expecting it to cost about $109,800 per patient for a course of treatment, based on the average estimate of five Wall Street analysts I surveyed last week.

Most Americans will never make that much money in a single year of their life, so this could be an easy target for critics of high drug prices. But this is one case in which a drug is worth a six-figure price tag.

Here’s why: For starters, the Seattle Genetics drug is being aimed at a small group of patients. About two-thirds of the 8,500 patients diagnosed in the U.S. with Hodgkin’s disease are successfully treated with chemotherapy, leaving about one-third who eventually get relapsed, treatment-resistant forms that make them candidates for the Seattle Genetics drug. The other group of anaplastic large cell lymphoma patients who are eligible is even smaller. Insurance companies do most of their watchdogging on price with much more common medicine. They usually, or at least should, have better things to do than mess with a tiny handful of customers in their risk pool.

Those who are afflicted with this disease aren’t just dealing with some minor annoyance, or theoretical risk. Many patients with relapsed Hodgkin’s disease are in their primes (their 30s and 40s), and are being threatened with an illness that offers a life expectancy of just two to three years. These patients have no other options left. The Seattle Genetics drug is bringing innovation to a moribund field of cancer drug development. It is the first product approved for Hodgkin’s disease since 1977, and the first ever for anaplastic large cell lymphoma.

And most importantly, the data to support this drug’s approval was simply superb. About 75 percent of patients with Hodgkin’s disease had significant tumor shrinkage, and 86 percent did that well with anaplastic large cell lymphoma (ALCL). About a third of the Hodgkin’s patients and more than half of the ALCL patients went into complete remissions. These are the kinds of tumor shrinkage rates that you rarely see in the cancer drug business.

There’s no major rub here in terms of side effects, which are pretty typical for other compounds in this drug’s class. Patients get depletion of infection-fighting white blood cells, nerve damage in the fingers and toes, fatigue, nausea.

One big question here is still about survival. Nobody knows how much longer patients can expect to live if they are among the lucky ones to go into complete remission, or if their tumors shrink by half. We do know there are so many patients from clinical trials who are still alive it will take years to really answer that question. There are much worse kinds of uncertainty to have.

It’s hard to have an open and honest conversation about the factors that go into pricing a cancer drug today, because this stuff is so politicized, but I tried last week in an interview with Seattle Genetics co-founder and CEO Clay Siegall and the company’s commercial chief, Bruce Seeley. They clearly need to thread the needle very carefully on this pricing question.

Think about it. There’s risk in pricing a drug too high, and risk in pricing it too low. Price it too high, and you invite “pushback,” as Siegall puts it, from insurers and patient advocates, which could mire the drug in red tape, protests, and various pencil-pushing challenges, discouraging doctors from prescribing the drug to eligible patients. Price it too low, and you might fail to generate enough sales to satisfy the investors who supported the company through 14 long years of development, and more than $545 million of R&D spending just to get this far.

“We want to make sure we price this drug so that we can maximize the impact on patients, and maximize the effect for the company as well,” Siegall says. “What we are excited about doing is making sure we can treat as many patients as possible, and also do well for our shareholders.”

Seattle Genetics’ officials say they have spent months of work talking with doctors and insurers about the “value proposition” of the drug, essentially trying to suss out how valuable customers think the drug is, and how much they’d be willing to pay.

Feedback from these talks has been positive. One of the big reasons is that this drug is scientifically designed to hit a target known as CD30 that is overabundantly expressed on tumors of patients with these cancers. A simple lab test can tell doctors when a patient’s tumor has a lot of these CD30 targets. And when they do, there’s basically a 75 to 85 percent chance that the patient will see a significant improvement.

Seattle Genetics CEO Clay Siegall

That’s different from a lot of cancer drugs on the market today, in which doctors play a guessing game that goes something like this: Prescribe a $100,000 cancer drug, and give the patient a 100 percent chance of suffering from side effects, and a one-fourth to one-third chance of seeing any benefit. That’s not what most people consider a good deal. When you start talking about a three-in-four chance a patient with a death sentence will really benefit, with minimal side effects, now you’re talking about something that’s worth a six-figure check.

The key here is this: If you’re a drugmaker who can show doctors and patients that the odds are obviously in their favor, that they will see a really big benefit from one of these new drugs, then you’ll probably get less pushback. Roche/Genentech and Daiichi Sankyo/Plexxikon’s vemurafenib (Zelboraf), a drug for patients with metastatic melanoma, has followed a similar pattern with striking effectiveness in a specific group of people. The price is $56,400 for a six-month course of treatment. I haven’t seen a peep of complaint.

It may be hard for those in the biotech business to swallow, but nobody outside the industry cares that drugmakers spent a lot of money and took a lot of risk and need to be rewarded when they get an FDA approval. It’s all about getting paid for the value you bring to patients. And your drug better deliver the goods. Because if it doesn’t, maybe it’s time to listen to the patients and back off a bit on price.

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