[Ip-health] Article on pricing of breast cancer treatment Kadcyla (T-DM1) -- $9, 800 per month, wholesale

Jamie Love james.love at keionline.org
Thu Mar 28 15:53:31 PDT 2013


This article looks at the insane prices on new breast cancer drugs.  I
believe there are close to zero members of Congress expressing much concern
about the trends in cancer drug prices, now that PhRMA members more evenly
split their money between Republicans and Democrats.

Jamie


http://www.mmm-online.com/will-kadcyla-suffer-the-same-fate-as-zaltrap/article/282173/

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* 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 top-selling 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 first-line HER2-positive metastatic breast
cancer and costs $6,000 a month.


Will Kadcyla suffer the same fate as Zaltrap?

Kevin McCaffreyFebruary 27, 2013

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 HER2-positive 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 super-Herceptin,” 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 (20-34 years
old) have a five-year survival rate of only 31%.

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 top-selling 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 first-line HER2-positive metastatic breast
cancer and costs $6,000 a month.

With both drugs designed to be added on top of an already pricey therapy,
they bring the rhetoric over cancer-drug 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, inThought.
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 op-ed 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: “Cost-effectiveness 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 second-line 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 off-label 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 first-line
combination chemotherapy treatment for HER2-positive breast cancer that
could “push the cost of therapy in first-line to over $15,000/month.”

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.”


-- 
James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.
twitter.com/jamie_love



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