Eliza Grace was born on March 15, 2006, at 26 weeks, 4 days, weighing 1 pound 4 ounces and measuring just 11.5 inches long. She is the light of my soul and this is the story of our life in the big city.

Friday, March 11, 2011

The March of Dimes and KV Pharmacueticals

Unless you spend time in preemie-land this article may not have caught your attention: Premature labor drug spikes from $10 to $1,500

Up until this week there was a drug known simply as 17P which was used to prevent premature labor in certain pregnant women. It was a compounded drug, widely available, at a cost of about $10 to $20 per injection. In the world of pharmaceuticals this was a bit of a bargain drug. This past week a drug company, KV Pharmaceuticals won FDA approval to be the exclusive manufacturer of this drug which KV Pharma has named Makena. KV Pharma, by all accounts, has a pretty shaky past, only recently having avoided bankruptcy and whose CEO was recently sentenced to prison. You can read about KV Pharma here and here, but I am sure you can find many more tidbits on your own.

KV Pharma seemingly performed no research and development into this drug but got lucky when it purchased the rights to Gestiva (now known as Makena) in 2008. You can read the press release here.

So what does all this have to do with the March of Dimes you ask?

The following is a post from Dr. Davis (a specialist who places Transabdominal Cerclages (TACs) which was posted on "Abbyloopers" (a yahoo support group for incompetent cervix).

As many of you have become aware, 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 tat 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 drug.

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 patient. 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 much.

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:

KV Pharmaceuticals Contact Information: investorrelations@ kvpharmaceutical.com

Second, notify your local media outlets about this issue.

Third, write or email your congressman and senator:

http://www.senate.gov/general/contact_information/senatorscfm.cfm

https://writerep.house.gov/writerep/welcome.shtml

Fourth, contact the FDA and find out why they elected to give KV exclusivity for this product. Competition will bring down the price dramatically.

http://www.fda.gov/AboutFDA/ContactFDA/default.htm

Fifth, write to the president:

http://www.whitehouse.gov/contact

Sixth, contact your state Medicaid offices and your insurance carriers. Get them involved

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.

Thank you.

Dr. D

When the public, or at least the public in preemie-land got wind that the MOD endorsed the proposal to give KV Pharma the exclusive manufacturing rights, there was, well, outrage. All was not well in preemie-land. Many parents of preemies, like myself, had raised tens of thousands of dollars for the MOD and we were disappointed to see that the MOD had made such a bone-headed and irresponsible (and possibly deliberate) decision to endorse KV Pharma's exclusive rights to manufacture this drug.

There are only a few reasons that the MOD blindly endorsed KV Pharma's application to be the exclusive manufacturer of Makena. Either (a) the MOD was so tickled pink with the continued contributions from KV Pharma and its subsidiaries that it ignored the fact that having an exclusive manufacturer of the drug would lead to a price increase (particularly a manufacturer that seems to have had its recent share of financial troubles); (b) the MOD, despite being a huge corporate entity, felt no obligation to perform any due diligence into whether or not the granting of exclusive rights to KV Pharma would be beneficial to the very population the MOD purports to serve or (c) someone at the MOD was so naive as to think that switching to an exclusive manufacturer and thereby creating a monopoly would not have an ill effect on the price of the drug (under this scenario one must accept that no one in the employ of the MOD majored in history or has a law degree).

The MOD's response to the outcry today was posted on the MOD's Facebook page:

Thank you to everyone who has shared their concerns about the cost of Makena. The March of Dimes agrees that the price of Makena is too high. We have shared our concerns about the price with Ther-Rx in the past and will do so again today. Ther-Rx has promised that every eligible woman will get care regardless of their ability to pay and we will hold them to that promise.

The MOD also stated on its Facebook page that:

We will also work with insurance companies and Medicaid to be sure that there is coverage. The needs of moms and babies are our only priority and your voices will be heard.

The MOD's responses are nonresponsive to the question of why the MOD chose to endorse this decision. Now the MOD shares its concerns about pricing? The MOD is relying on the promise of a subsidiary of KV Pharma (Ther-Rx) to provide the drug to "eligible" women who can't pay for it? The MOD is going to "work with" insurance companies to be sure there is coverage? Exactly how does the MOD plan to do this? The MOD can't even get insurers to offer Synagis to babies who need it so why should anyone have faith in the MOD's newly found powers of persuasion?

My decision to no longer fund raise for the MOD was made last year, before this latest debacle. There are many charities that perform admirable work toward preventing birth defects and prematurity and which support families of premature babies in ways far more effective than the MOD. Those charities and non-profits are no doubt not immune from problems, but at least so far none of them to my knowledge have contributed, directly or indirectly, to the financial burdens already faced by families raising premature children or who are having an already difficult (and therefore more costly) pregnancy.

4 comments:

Mama Miya said...

I love Dr. Davis. He did my TAC surgery. He is quite an advocate for us!

Anne, Eliza Grace's mom said...

In case anyone was wondering how much money the MOD received from Ther-RX, KV Pharmaceuticals' subsidiary and the company involved in this debacle, here is what was posted on another sight by an MOD National Ambassador

"Ther-Rx committed $1 million to the March of Dimes NICU Family Support program from 2009 through 2011. Also, they donated more than $500,000 to sponsor March for Babies and other programs, such as professional education."

That's just 2009 to 2011.

You can read the entire thread at:

http://www.inspire.com/groups/preemie/discussion/march-of-dimes-response-to-makena-17p/

Anonymous said...

You write at the end that there are many charities that also work to prevent prematurity. Would it be possible for you to post some of these? I have tried very hard to find them, and the only ones I can find are in the UK and Australia. As the mom of a 27 weeker, I desperately want to raise funds and awareness, but I do not want to do so for my local NICU. I've raised several thousand for MOD, but I stopped this past fall b/c I've been displeased with so many of their practices. Please post info on other charities RE: prematurity. THanks!!!

Anne, Eliza Grace's mom said...

Anonymous,

I think selecting a charity is very personal choice. For example. one of the many causes of prematurity is pre-eclampsia and there is the pre-eclampsia foundation www.preeclampsia.org/

Another way to help ease the effects of preterm birth on those living in less fortunate countries, is through an organization called Embrace, that makes portable warmers for premature infants in third world countries where they do not have isolettes www.embraceglobal.org.

You can call your local medical school to see what type of research they are doing. You can also contact your own NICU to find out what projects they are funding for their NICU.

If your child had a specific birth defect, there are charities geared toward virtually every birth defect, whether it be a heart defect or a genetic issue.

I think finding a charity that sparks something in your heart because of the nature of your child's early birth, your stay in the NICU (and maybe how to improve it) or how to improve the life of a premature child born without the benefits many of us have can be just as rewarding as donating to the MOD.