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`Will Kadcyla suffer the same fate as Zaltrap? Medical Marketing and Media
`
`Kevin McCaffrey
`Follow @kevinemccaffrey
`
`February 27, 2013
`
`Will Kadcyla suffer the same fate as Zaltrap?
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`The FDA approval of Roche/Genentech's breast cancer treatment
`Kadcyla last week comes amid new research showing disturbing
`prevalence rates of the disease among women. But the drug's price
`leaves some analysts pondering its fate.
`
`Kadcyla, which was known during company clinical trials as T
`DM1, extended the median survival of women with HER2positive
`metastatic breast cancer by several months.
`
`The treatment combines blockbuster Herceptin with a taxane
`chemotherapy, as well as a third chemical developed by San
`Francisco based ImmunoGen and licensed by Genentech that binds
`the medicines together. The goal is for Herceptin to bind to a tumor
`site, where the chemo is locally released.
`
`Sandra Horning, head of global oncology for Roche, described the
`cocktail as “a superHerceptin,” in an interview with Bloomberg,
`and said the company sees potential for the drug, approved in the
`metastatic setting, to move into early breast cancer as well. An
`earlier forecast by Bernstein analyst Tim Anderson, MD, projected
`annual sales of CHF 623 ($660 million) by 2016.
`
`On the heels of the approval comes new research suggesting the
`unmet need in breast cancer may have grown considerably: a study
`appearing in Journal of the American Medical Association showed
`that cases of advanced breast cancer in women under 40 has tripled
`in the US over the past 30 years. Particularly worrying is that those
`diagnosed at a younger age (2034 years old) have a fiveyear
`survival rate of only 31%.
`
`Kadcyla pulled in $173 million in sales
`since its introduction in the US market in
`February
`
`Roche/Genentech have priced Kadcyla at $9,800 per month, or $94,000 for a standard course of treatment. That's
`double the cost of topselling cancer drug Herceptin, which comes in at $4,500 per month. It follows the approval of
`Perjeta, which FDA sanctioned last year as a complement to Herceptin/chemo in treating firstline HER2positive
`metastatic breast cancer and costs $6,000 a month.
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`With both drugs designed to be added on top of an already pricey therapy, they bring the rhetoric over cancerdrug
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`price increases to a new level. “At some point, the ability to set such aggressive prices for oncology drugs in the US—
`even those like Kadcyla that extend survival—will be challenged,” said Marc Engelsgjerd, MD, senior analyst,
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`A sign of resistance to the notion of unfettered price increases for these drugs came in October, when Memorial Sloan
`Kettering Cancer Center refused to use colorectal cancer treatment Zaltrap due to its high price tag. The fallout was
`cataloged in a New York Times oped by three physicians from the hospital, who lashed out at the FDA for pushing
`expensive drugs with minimal advantages over existing treatments: “In most industries something that offers no
`advantage over its competitors and yet sells for twice the price would never even get on the market. But that is not how
`things work for drugs. The Food and Drug administration approves drugs if they are shown to be ‘safe and effective,'”
`the group wrote. “It does not consider what the relative costs might be once the new medicine is marketed.”
`
`Zaltrap was rebuffed because it was no more effective than Genentech's Avastin yet, according to the doctors, was
`twice as expensive. In contrast, Kadcyla appeared to extend patients' overall survival by nearly six months vs. standard
`of care in this setting, lapatinib and Xeloda (30.9 months vs. 25.1 months).
`
`Still, relative costs could bring domestic prices in line with overseas models: “Costeffectiveness considerations similar
`to those in Europe seems inevitable as, unfortunately, even the newest oncology drugs extend life by a few months, on
`average, and sometimes only when combined with other similarly expensive agents,” added Engelsgjerd.
`
`Other analysts, like Gordon Gochenauer, Director, Kantar Health, said they believe Kadcyla offers a sound value
`proposition for its price, one which falls in line with other combination oncology agents. “It's only slightly higher than
`the cost of Tykerb + Xeloda and at a similar price to Herceptin + Xeloda," he said. "Both are reasonable alternatives to
`Kadcyla…However, one of the real advantages of Kadcyla is that it spares the patients from much of the toxicity of
`Xeloda or other chemotherapies…thereby reducing supportive care costs."
`
`That reduction in toxicity could make a real difference in treating cancer. “This antibody goes seeking out the tumor
`cells, gets internalized and then explodes them from within. So it's very kind to patients—there's no hair loss, no
`nausea, no vomiting,” said Dr. Melody Cobleigh of Rush University Medical Center, who helped conduct studies of the
`drug, the AP reported.
`
`Nevertheless, Gochenauer said he expects payers to fiercely enforce the drug's secondline indication. Kadcyla was
`approved for patients who fail to respond to Herceptin and a taxane. He said that “in the short term, payers will hassle
`MDs enough to ensure that patients are previously treated with Herception to minimize any offlabel use of Kadcyla."
`
`But Gochenauer said the real issue for payers may come from the pending MARIANNE trial. Currently in Phase III,
`this study is testing a combination of Kadcyla and the Roche/Genentech drug Perjeta as a potential firstline
`combination chemotherapy treatment for HER2positive breast cancer that could “push the cost of therapy in firstline
`to over $15,000/month.”
`
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`For now, the pricing trend along with Kadcyla appears here to stay. “We'll continue to see prices
`increase," Gochenauer said, "particularly when the drugs bring a good value proposition by showing high efficacy, a
`better toxicity profile and [if it] meets an unmet need, while payers will manage utilization to a higher extent.”
`
`ExPfizer chief takes over at troubled Optimer
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`12/29/2014
`Will Kadcyla suffer the same fate as Zaltrap? Medical Marketing and Media
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