As a mother of a baby born early, and a believer that all babies should have the right to be born full term and healthy, this makes me so mad!
As some of you may know, "KV Pharmaceuticals has received FDA approval
to be the exclusive distributor for P17. They are planning to charge $1500 per
injection for a total cost, per pregnancy, of $30,000!!!!
The current cost is $10 per injection, or $200 per pregnancy.
There are several points that I would like to emphasize.
The rationale for a commercial manufacturer is to ensure a standard
concentration. In theory, this can be a problem with compounding pharmacies
although the vast majority of the compounding pharmacies producing this product
that present have extremely exacting standard. The March of Dimes has,
unfortunately, bought into this rationale with absolutely no proof that a
variation in strength is of any clinical significance. By law, once a drug is
commercially available, compounding pharmacies must stop production of that
We have been using P17 for the past ten years from these compounding pharmacies
with obvious beneficial effect. So where is the rationale for this change?
March of Dimes receives several million dollars a year in support from KV
Pharmaceuticals - I wonder why! This suggests to me that March of Dimes can be
bought. I, personally, have informed the March of Dimes that I am ceasing all
support of their organization, financial and otherwise, until they divorce
themselves from KV Pharmaceuticals and support for Makena. They do not realize
that they are going to cause an increase in the preterm birth rate, not a
decrease. At best, there will be no change other that a massive over-expenditure
of health-care dollars.
You have seen the propaganda stating that no-one will be denied the medication
because of ability to pay. However, what they don't tell you is that they are
going to use very strict criteria. In essence, the only women who will qualify
is those who have had a prior preterm birth before 32 weeks secondary to preterm
labor. To illustrate this more fully, Aetna/US Health care (one of the largest
insurers in the country) covers this therapy when patients meet their strict
criteria. Currently, they are paying for P17 for only 1,000 women nationwide per
year! There are 4.2 million births in the US annually. 10 - 15%, or 420,000 to
610,000 are premature. And Aetna is only going to cover 1,000 of these women.
30% of all prenatal care is covered by Medicaid. An additional 10% is covered by
charity care. KV is going to insist that since this care is not coming out of
the patient's pocket, the cost should be borne by Medicaid and charity care.
Currently, we can provide good prenatal care for about $2,000 per pregnancy. So
for every patient placed on P17, we have to somehow find away to cover an
additional 15 pregnant patients. And who pays the medicaid and charity care bill?
We all do through higher taxes and higher healthcare premiums!
Studies show that approximately 30 women need to be treated with P17 to prevent
one preterm birth. At $200 per patient, this is very cost effective. That is an
expenditure of $6,000 to save the average of $51,000 per preterm delivery. With
current pricing, we will have to spend $9 million dollars in P17 therapy to save
$51,000. Does this make sense? And people want to know why health care costs so
Most of you (greater than 90%) who will be on P17 now will be faced with doing
without or paying $1500 per injection out-of-pocket. If you are currently on
this medication, make sure that your doctors order enough for you right away to
cover the entire pregnancy. You could have as little as one week. If you are
early in pregnancy or planning a pregnancy soon, talk to your doctors about
getting this now to have on hand. Most suppliers warrant the drug to be
effective for one year.
So, what can you do?
Firstly, contact KV Pharmaceutical and voice your displeasure:
Second, notify your local media outlets about this issue.
Third, write or email your congressman and senator.
Fourth, contact the FDA and find out why they elected to give KV exclusivity for
this product. Competition will bring down the price dramatically.
Fifth, write to the president.
Sixth, contact your state Medicaid offices and your insurance carriers. Get them
Seventh, get as many of your friends, family members, co-workers, etc. as
possible to do the above.
Eighth, feel free to cut/paste/email the above to as many contacts as you can.
Let's make this issue go viral!
If we can get enough of a protest mounted, we stand a chance of averting this
"rape" of the healthcare system that is motivated almost entirely by a profit
motive. Even if KV decides to not manufacture the drug for fear of losing money,
we will be better off than with what they are currently planning. "
(Copy and pasted from Four walls, a roof, a door, some windows)