Some doctors balk at inhaled insulin
March 21, 2007 04:03:37 PM PST
Pfizer’s stab at giving diabetics insulin without needles is getting
more praise than prescriptions so far. Exubera, a powdered form inhaled
through a special device, was introduced last year in a targeted launch
to specialists, a debut analysts deemed disappointing. While doctors
applaud Pfizer Inc.’s effort to find a new way to deliver insulin, some
are concerned about the drug’s long-term effects on the lungs, cost and
insurance coverage.
Observers fear Exubera won’t fare much better as Pfizer expands the
sales effort to primary care doctors.
"I think Pfizer will wish they had never gotten into this. I doubt
they’ll regain their investment," said Dr. John Buse, president-elect of
the American Diabetes Association, who participated in Exubera’s trials.
"There is no advantage to Exubera and there may be a safety risk. I see
it as my job to talk people out of (using) it."
Pfizer won’t disclose Exubera’s development costs but said it is a major
advancement in diabetes care because needle-phobia keeps many patients
from using the insulin when they would really benefit from it. Susan
Silberman, Pfizer’s senior vice president of worldwide commercial
development, said Exubera’s performance is meeting expectations.
"I think we have to manage this product differently," she said. "Insulin
is intuitive. What has changed is the approach to delivery — so
(marketing) is about the education."
Pfizer already has hired approximately 900 part-time diabetes educators
to explain the product to doctors and patients, and more will be added,
although the company won’t say how many. A small, non-branded ad
campaign for the drug that doesn’t mention Exubera by name started
recently, and a bigger direct-to-consumer marketing effort will debut
during the second quarter.
Company executives touted Exubera as one of the new drugs that would
revitalize Pfizer’s stagnating sales. Others, such as smoking cessation
treatment Chantix, are performing well.
But some analysts said Exubera’s lackluster debut is worrisome because
Pfizer needs more blockbusters. Its best-selling drug, cholesterol agent
Lipitor, loses patent protection as early as 2010 and development of its
successor drug was scrapped last year because of safety problems.
Exubera, which Pfizer is codeveloping with Nektar Therapeutics, was
introduced last September but sales for 2006 weren’t report.
Les Funtleyder, an analyst at Miller Tabek & Co., doubted it would meet
his sales target of $200 million for this year. Assessing Exubera’s
market share and the number of patients on the drug is difficult because
of the way it is sold. Patients need to buy a kit which includes the
device but then also need to regularly purchase blister packs and
release units, which help create the mist.
"Exubera isn’t going be a big driver," he said. "Pfizer needs every
dollar in sales. It (Exubera) is a negative."
Others aren’t as quick to judge. Deutsche Bank analyst Barbara Ryan said
that while the launch has been slow, Exubera still could reach $1
billion in sales in the next few years.
Silberman insists Exubera represents a good value because its
needle-free status means more people who should be taking the medicine
will start, allowing them to better manage their diabetes and saving
money in the long run.
Insurers don’t necessarily believe Pfizer has demonstrated Exubera’s
value. WellPoint Inc., the country’s largest insurer, is either not
covering Exubera or placing it in the most restrictive tier, with higher
copays, depending on the plan.
WellPoint estimates that Exubera costs 11 percent more than one popular
brand of injected insulin and 22 percent more than another.
Pfizer hasn’t offered enough evidence that patients will use Exubera
before they begin injecting insulin or that it would really improve
quality of life, said Brian Sweet, WellPoint’s chief clinical pharmacy
officer.
"We want to see more documentation of the value of the product," he said.
Doctors also worry about potential long-term side effects from
constantly inhaling the powder into patients’ lungs. Pfizer has two
years of data showing the drug is safe, but doctors want to see results
from longer-term studies.
"If I can treat patients now with something I know is OK, why give them
something that might (eventually) hurt their lungs?" asked Dr. Michael
O’Dell, director of the Family Residency Program at the North
Mississippi Medical Center in Tupelo, Miss.
He added that few insurers in his region cover Exubera and that "the
delivery system is still a little clumsy."
The inhaler is the size of an eyeglass case when closed. Once expanded
to expose the inhalation chamber that holds the insulin mist, it is the
size of a pepper mill. Patients insert blister packs of the dry powder
insulin into the device, press a button and then press a lever which
creates the mist. The patient inhales the cloud, sending the insulin
into the lungs where it is absorbed into the bloodstream.
Some doctors said the blister packs come in limited strengths that can
make it difficult to prescribe the correct amount of insulin. Also,
Exubera is fast-acting insulin that is taken at mealtime; some patients
still need the long-acting insulin that is delivered through needles.
Dr. Robert Fafalak said he has prescribed Exubera for patients who were
hesitant to use insulin even though the pills they were taking weren’t
sufficiently controlling their diabetes.
"I have patients that are doing much better now. They have their sugar
under control, and I think that gain outweighs concerns about long-term
effects," said Fafalak, who practices in New York.
Jamie Villastrigo, 51, a secretary who lives in Boerne, Texas, began
taking Exubera three years ago as part of a clinical trial and has
become a fan. She doesn’t pay for the drug because she is still in a
clinical trial.
"There is a concern about the cost and whether my insurance will pay for
it," Villastrigo said. "But I’ve still got another year and a half in
the program. "
Villastrigo said Exubera hasn’t affected her lungs and has allowed her
to cut her daily insulin shots to one from four. She maintains that the
device is easy to use, and she has no qualms about using it in
restaurants or public places where she’d never pull out a syringe.