[Ip-health] Can Patients Get Around the Exorbitant New Cost of a Pregnancy Drug?

Krista Cox krista.cox at keionline.org
Mon Mar 21 13:51:08 PDT 2011

Can Patients Get Around the Exorbitant New Cost of a Pregnancy Drug?


The cost of a drug used to prevent premature birth in high-risk
mothers will rise from around $10 per dose to $1,500, now that the FDA
has approved a branded version of the medication.  The new medication
is a form of progesterone, which has already been prescribed for
decades and is currently made for this purpose by specialty drug
stores known as compounding pharmacies.

Now, KV Pharmaceutical Company, the maker of the new drug called
Makena, has warned compounding pharmacies that they face FDA action if
they continue to sell nonbranded versions of the drug, technically
known as 17-hydroxyprogesterone caproate. KV's new price means the
drug could cost mothers up to $30,000 per pregnancy — but some doctors
and pharmacists say there may be ways to avoid the massive price

But first, why has a drug that has been used for decades suddenly
become so expensive? Premature birth affects 1 in 8 pregnancies — some
543,000 annual births — resulting in intensive care and often lifelong
disabilities in the child. It's responsible for $26 billion a year in
medical expenses — a figure KV cites to justify the new price of

To help offset the cost of the weekly injection, KV just announced a
patient-assistance program for families in financial need. "We
established this comprehensive patient-assistance program as part of
our commitment to ensure that all eligible women have access to
FDA-approved Makena," KV's CEO Greg Divis said in a statement.

The March of Dimes — which has received hundreds of thousands of
dollars in donations from KV's subsidiary Ther-RX, which will market
Makena — supports the introduction of the new drug. "An FDA-approved
product is a good thing," says Dr. Alan Fleischman, medical director
of the March of Dimes. "The drug is expensive but it's a very
important drug for a very important purpose. The company has promised
that every eligible woman whose doctor prescribes it will [be able to
receive it] and ability to pay will not preclude that." (More on
Time.com: Expecting? Text 'BABY' for Advice About Healthy Pregnancy)

But many other doctors expressed outrage over the price hike. "This is
ridiculous. This medicine has been used for 40 or 50 years," says Dr.
Sam Kim, division director for reproductive endocrinology and
infertility at the University of Kansas Hospital.

"It's going to be prohibitively expensive for a lot of patients," says
Dr. Robin Kalish, director of clinical maternal-fetal medicine at New
York-Presbyterian/Weill Cornell Hospital in Manhattan.  She adds that
much of the research on the drug— including a major 2003 study showing
that the drug cuts premature birth by one third in women carrying
single pregnancies who'd previously had premature babies—was funded by
the government.

Since low-income women are at high risk for premature birth, the
burden of cost for Makena is likely to fall to Medicaid, which is
already facing massive budget cuts in many states. Matt Salo,
executive director of the National Association of Medicaid Directors
told the AP: "There's no question they can't afford this."

The March of Dimes' Fleischman responds: "The Medicaid programs and
the insurance companies have only begun their discussions with the

Already, many patients and doctors may be wondering whether they can
use other types of progesterone to lower the risk of premature birth,
without paying for Makena. Indeed several types are already on the
market. Almost all women who have been through in-vitro fertilization
(IVF) have taken some form of the hormone, either as a vaginal
suppository or intramuscular injections, which are one of the most
uncomfortable parts of the procedure. Those drugs will still be
available at their current prices, but they must be used daily, rather
than once a week like Makena.

"It is possible to use daily gels, creams, suppositories [or
injections]," says John Preckshot, director of marketing of the
Professional Compounding Centers of America, the leading trade
organization representing specialty pharmacies.  Many of these drug
stores currently make versions of weekly hydroxyprogesterone to
prevent premature birth.

A small Brazilian study found that daily vaginal progesterone does
work to reduce the risk of premature birth, notes Kalish, but that was
just one small study.

Preckshot adds that compounding pharmacies may still be able to make a
different version of hydroxyprogesterone that would not violate the
patent on Makena. "There's the possibility of using different
vehicles, other oils, than the one used in Makena," says Preckshot,
who is also a compounding pharmacist himself.

"Compounding pharmacies have already been making this for the
patient," says Dr. Kim. "The problem is that depending on the pharmacy
and depending on who is making it, it varies — there is not always the
same level [of the hormone in the product]. That's the reason the
company took over, but I don't have any problem if compounding
pharmacies can continue to do it."

Still, liability issues may deter doctors from using other options,
now that a branded product has been federally approved. Moreover, the
alternatives have not been tested. "Theoretically, you could use any
progesterone. The problem is, there are no studies [of most of these
alternatives]. And it's impractical to give daily intramuscular shots
for so many months," says Dr. Zev Rosenwaks, director of the
Cohen/Perelman Center for Reproductive Medicine at New
York-Presbyterian/Weill Cornell.

Now, it seems the business interests of KV, insurance companies,
compounding pharmacies, government policies and doctors will determine
how Makena will affect prematurity rates and high-risk women's access
to a substance which could mean the difference between a normal life
and one of severe disability for thousands of babies.

Krista Cox
Staff Attorney
Knowledge Ecology International

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