Amgen's Xgeva Hits Resistance Over Cost-Benefit Debate
April 05 2011 - 12:12PM
Dow Jones News
Amgen Inc.'s (AMGN) bone-strengthening drug Xgeva, used in
cancer patients, is a potential multibillion-dollar product, but
questions remain whether the treatment's benefit compared to
well-established competition justifies the significantly higher
price.
Studies have shown Xgeva to be more effective than commonly used
Zometa, from Novartis AG (NVS, NOVN.VX), but it costs almost twice
as much. That price difference has prompted resistance to its use
and sparked a discussion about whether the benefit to patients is
proportional to the increased expense.
The Xgeva debate also comes amid a much larger examination of
the rising cost of healthcare in relation to the actual benefits
provided to patients.
Xgeva's success is important for Amgen, which has faced numerous
pressures to its business in recent years from rising competition
and regulatory issues related to its aging suite of drugs. Xgeva,
approved in December, is a high-dose version of Amgen's
osteoporosis treatment Prolia, which launched in June 2010 to
disappointing sales.
Josh Ofman, Amgen vice president of reimbursement and payment
policy, stressed the clinical data supporting Xgeva and said that
skeletal complications cause "significantly higher medical costs."
In a statement, he described the insurance coverage for Xgeva as
"outstanding" and noted the drug's convenience of simple injection,
compared to intravenous infusion with Zometa.
Oppenheimer projects 2014 Xgeva sales in this usage at $1.5
billion, which is equal to Zometa's sales last year.
Many analysts are optimistic for Xgeva because of Amgen's
experience in selling cancer and specialty drugs, but the market is
competitive, and Zometa is well established with a cheaper generic
version arriving in early 2013.
In advanced cancer patients, the disease often invades bones,
weakening and destroying them, which both drugs help prevent. In
late-stage head-to-head trials in advanced breast and prostate
cancer, Xgeva was superior to Zometa. But a monthly dose of Xgeva
costs about $1,650, compared to about $844 per dose of Zometa given
every three to four weeks.
Some aren't willing to pay that much. Regence BlueCross
BlueShield, an insurer in the Northwest that covers 2 million
people, recently conducted an analysis and decided to pay for Xgeva
only if patients are unable to use Zometa or the generic
pamidronate, a drug in the same class as Zometa.
In a statement, Regence said the evidence of Xgeva's superiority
"is uncertain" and that other drugs have a more established track
records of safety and effectiveness. Furthermore, Regence said one
clinical study of Xgeva, a breast cancer trial, was "flawed"
because more than half of the enrolled patients didn't complete the
study. The insurer also questioned the metric used in the study to
determine Xgeva's superiority.
Amgen's Ofman defended the testing of the drug, saying the
design of the trials used the "most scientifically appropriate
methods" with measurements based on the precedent of Zometa. The
majority of patients that dropped out of the trials did so because
of death or disease progression, he said, as is common.
"The results of the trials are clear based on the differences
observed in the accepted and appropriate endpoint," he said.
In a recent editorial in the Journal of Clinical Oncology,
Howard West from the Swedish Cancer Institute in Seattle questioned
whether a "modest" improvement over Zometa could justify "a
disproportionate increase in cost", estimated at hundreds of
millions of dollars per year in the U.S.
While there is criticism, many insurers are covering the usage
of Xgeva. Cigna Corp. (CI) covers both Xgeva and Zometa with no
restrictions for approved uses. An Aetna Inc. (AET) spokeswoman
said the insurer considers Xgeva "medically necessary" when cancer
from solid tumors spreads to the bone. Notably, the insurer
requires precertification before using the drug, something it
doesn't require for Zometa.
Recent updates to treatment guidelines from the American Society
of Clinical Oncology and the National Comprehensive Cancer Network
include both Zometa and Xgeva, but don't give a preference to
either. The ASCO guideline, for breast cancer, notes that there is
"insufficient evidence" to show that either drug is more
effective.
Meanwhile, some cancer centers said they are reviewing Xgeva and
how it fits into treating patients.
Oncologists at Vanderbilt-Ingram Cancer Center have "informally"
agreed to not use Xgeva in patients currently on Zometa until their
disease progresses. The physicians "are certainly aware of the
difference in price and are cognizant of how this affects treatment
costs for our patients," a spokeswoman said.
Julie Gralow, a breast-cancer specialist at the University of
Washington, highlighted Xgeva's convenience and said her
institution is conducting a detailed analysis of all aspects of
Xgeva.
"I think that just looking at the price of the drug in an
isolated manner is not the way to evaluate these drugs," Gralow
said.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com
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