* Amgen, J&J likely may face pressure over kidney use
* Medicare agency's panel to meet March 24
* Some analysts see sales of anemia drugs slipping
(Adds Amgen comment)
By Susan Heavey
WASHINGTON, March 19 Closer government scrutiny
of controversial anemia drugs made by Amgen Inc (AMGN.O) and
Johnson & Johnson (JNJ.N) is likely to reopen debate on how
much the drugs should be used and could further depress sales.
Next week, the Centers for Medicare & Medicaid Services
(CMS) plans to seek advice from a panel of outside experts over
use of the blockbuster drugs in patients with chronic kidney
disease, given concerns over possible heart dangers.
The drugs, known as erythropoiesis-stimulating agents
(ESAs), have already weathered recent warnings and restrictions
over their use in cancer patients that have caused doctors to
lower doses and sales to slump.
On Wednesday, the agency will ask its panelists how
confident they are that current data supports use of the drugs
-- Johnson & Johnson's Procrit and Amgen's Aranesp and Epogen
-- in a smaller group of patients with all stages of kidney
CMS, which insures more than 45 million elderly, disabled
and poor Americans, currently has no formal reimbursement
policy for such use, leaving it to vary region by region.
Analyst Joshua Schimmer, managing director of biotechnology
research at Leerink Swann, said CMS is ultimately likely to
push for less use of the drugs nationwide.
"It's probably going to clip sales to some extent," said
Schimmer, who estimates sales could dip 15 percent to 20
percent. "At the end of the day, we're all expecting it."
ESAs have come under scrutiny in recent years after studies
emerged showing high doses could lead to heart complications or
even death. While dosing has been affected, the costly drugs
are still widely used.
The drugs -- synthetic versions of the hormone
erythropoietin -- aim to boost red blood cells hampered by
anemia in patients who have kidney disease or are undergoing
chemotherapy, giving them more energy and reducing weakness.
CMS officials declined to talk ahead of the meeting. But in
an agency notice announcing Wednesday's meeting, CMS noted that
ESA use has greatly expanded since the drugs were introduced in
1989 for patients at risk for blood transfusions.
Today, more than 95 percent of kidney patients undergoing
dialysis are prescribed the injectable drugs. "It is unclear
how many" receive them before dialysis, it wrote.
Duke University medical professor Lynda Szczech said before
ESAs were introduced, anemia patients given blood transfusions
suffered iron overload that could trigger heart disease.
"It went from the dark ages to the renaissance when (they)
came on board," said Szczech, president-elect of the
corporate-funded patient group the National Kidney Foundation,
who has also served as a consultant for Amgen, among others.
But now there are concerns that the pendulum might have
swung too far and that too much use could pose other risks.
CMS has already taken action to change the way it pays for
ESAs in kidney patients already undergoing dialysis, calling
for doctors to receive one "bundled" payment for each patient's
care rather than paying for each drug separately.
While aimed at saving money, the move is also directed at
giving doctors an incentive to use safer amounts of the drugs.
Officials at the Food and Drug Administration, which
oversees the medicines themselves, also plan to hold a separate
meeting on ESA use in kidney disease later this year.
Trials -- either voluntary by the companies or mandated by
U.S. regulators -- are needed to find "the sweet spot" for
dosing and treating different types of patients, Szczech said.
Wall Street has already factored in much of the regulatory
pressure on ESAs, and their use in kidney patients is dwarfed
by that in cancer patients.
Still, potential remains for shares to fall further --
particularly for Amgen -- as Medicare and the FDA take a
closer look, according to some analysts.
ESAs are a core franchise for Amgen, bringing in $2.7
billion in worldwide Aranesp sales and $2.6 billion in U.S.
sales of Epogen in 2009.
Any change in use weighs less on Johnson & Johnson, a
diversified healthcare company that sells a wide variety of
other health products. It had $2.25 billion in global anemia
drug sales in 2009.
Most of the data expected to be presented at the government
meetings has already been made public, and both companies plan
to make public comments at the CMS meeting backing continued
use of their ESAs.
"We can demonstrate that the drug is effective in raising
hemoglobin levels and is safe," said Marsha Wolfson, senior
medical director at Johnson & Johnson's Centocor Ortho Biotech
Amgen said it appreciated CMS' review of the evidence and
it expected the upcoming FDA meeting to "provide important
insight that will inform decisions about coverage and
CMS has not officially said whether the agency is weighing
a formal nationwide coverage decision, and FDA has yet to
announce details for its public meeting. But both agencies will
have to weigh the drugs' risks with testimony that the drugs
help patients feel better and more energetic.
"CMS is going to be in a really difficult position to
impose rules that can be applied across the board when it's not
everybody that feels the benefits," Szczech said.
(Reporting by Susan Heavey; additional reporting by Deena
Beasley; Editing by Gerald E. McCormick and Steve Orlofsky)