OK, I'll Talk About It

I've been avoiding this post because I've been sincerely hoping that the March of Dimes and/or Ther-RX would put on their big kid pants and do something about this whole situation. But alas, I don't think that's the case.

What situation? you ask. Lucky you! For many preemie parents, the past few weeks have been a huge roller coaster ride.

Last month a drug was approved by the FDA which significantly lessens the chance of premature birth for women who have previously had pre-term labor. This drug, known as 17P has been on the market for a few years, but it is made by compounding pharmacies, meaning any pharmacy can mix it up and there isn't really a great regulation system in place for the drug. A pharmaceutical company presented 17P to the FDA and with the support and backing from the March of Dimes, the FDA approved 17P to be marketed as brand name Makena. This means drug production will be universal, ensuring quality and making it easily available to all women. This is a HUGE deal.

But then came the whiplash. The drug is going to jump from $10 a shot to $1500 a shot. Women would need this injection once a week, making a full term pregnancy come close to $30,000 just for this one medication.

To make matters worse, Ther-RX has made large (we're talking $1.5 million) donations to the March of Dimes in the past year, making it look as though the pharmaceutical company bought the endorsement of the MOD. The MOD denies this, but their statements aren't changing the minds of many preemie parents. Ther-RX has promised that all women, regardless of ability to pay, will be able to receive this medication. They've promised that there will be financial aid available to those who need it. They've promised.

The reality is, the preemie community is still working day in and day out to get insurance companies to cover a immunity boosting shot for all preemies during RSV season. This shot (Synagis) delivers antibodies to protect preemies from RSV, a common cold in adults but the source of massive lung damage for children. Charlotte, born at just over a pound and 16 weeks early was DENIED for this shot the first time we applied. RSV would ravage her already fragile lungs, and easily place her in the PICU, most likely back on the ventilator. Thankfully, she has received all of her shots this season, and has not contracted RSV. For reference, Synagis costs about $1,200 a month.

My question is, if we can't even get insurance companies to cover Syangis for children who are already here, who are already at risk for serious medical complications, how in the world are you going to get insurances to cover a medicine that gives a theoretical protection (not all babies are born term, even when the mother gets this shot) when it costs $5,000 a month?

And... if we are to get insurances to cover the crazy cost of this drug, who do you think will really pay for it? Yeah, we all will.

Those who are truly financially incapable of paying for it will get it and will receive financial assistance. For that I am grateful. But there are those who might appear to be financially capable (have insurance, make over $60,000 a year) who will not qualify for this assistance. What about those women? Those children? Those families? One person recently stated that her insurance company, a nationwide insurance carrier, informed her that her cost per shot would be $3,000 out of pocket.

So what to do? Many parents are demanding the MOD return the funds donated to them by Ther-RX in an effort to show how outraged they are by the price-hike. The MOD says that those funds are already earmarked for programs and they would have to cancel programs that support women and children in the community.

Many more parents are refusing to raise money for the MOD. If they really didn't see this price-hike coming, as they claim, how aware are they of everything else they are supporting? Why should we as parents give them our hard earned money if they cannot be responsible for what they are supporting?

I don't really know the answer to this. I'm devastated over this. I fully support drug companies re-cooping the cost of the research and development of their drugs, but Ther-RX didn't even develop this drug! It was already in existence! Ugh.

All I know is that this situation is ridiculous. The MOD has worked hard to make lives better and has spent a lot of money on research to increase the prognosis for preemies. For preemie parents and the MOD to be at odds is not a good thing and I hope both sides focus on what matters most: protecting women and babies.

Here are other reviews of this situation you might want to check out:

Anne's:  http://eliza-grace-micro-preemie.blogspot.com/2011/03/march-of-dimes-and-kv-pharmacueticals.html
Bridie's: http://supersellers.blogspot.com/2011/03/my-baby-is-more-expensive-than-your.html 

Melissa's: http://catchupdaphne.wordpress.com/2011/03/15/a-big-mess-for-the-march-of-dimes/

In an effort to be completely fair, here are the responses from the MOD:

RESPONSE FROM MOD PATIENT AMBASSADOR 2010:

Hello Everyone.
Just wanted to chime in and give info other than the articles from media that have been posted. This is information directly from the March of Dimes, and I hope this will help dispel any concerns and frustrations you might be feeling about Makena/17P and the involvement of the March of Dimes.

The March of Dimes agrees that the price of Makena is too high. They have shared their concerns about the price with Ther-Rx in the past and have done so again today. The needs of moms and babies are their only priority and they are making sure Ther-Rx hears their voice – and your voice, too. Ther-Rx has promised that every eligible woman will get care regardless of her ability to pay and the March of Dimes will hold them to that promise. The March of Dimes will also work with insurance companies and Medicaid to be sure that there is coverage for every woman. Women are able to apply for financial assistance through the Makena Cares Connection, an assistance program. Here’s that information.

Makena Care Connection™ at 1-800-847-3418, Monday−Friday, 8 AM−9 PM (ET)

If you have issues with getting treatment, please don’t hesitate to contact the March of Dimes directly via their website at www.marchofdimes.com. The March of Dimes staff reads each posting and they will respond to you. The March of Dimes says they are hopeful that between insurance and financial assistance, the system will work for people. But if it doesn’t, the March of Dimes will be fighting on the side of pregnant women, not the drug company.

I really hope this helps.

Love,
Melanie 

OPEN LETTER FROM MOD TO THER-RX: 

Dear Mr. Divis:

I write to share the serious concern of the March of Dimes about access of clinically eligible women to the newly approved drug for prevention of preterm birth recurrence, MakenaTM. As you are aware, the March of Dimes co-sponsored a scientific symposium in 2004 to review the details of the National Institutes of Health (NIH) prevention trials with the drug, and was among the health care leaders who reviewed the compelling scientific evidence of the effectiveness of 17 α- hydroxyprogesterone caproate (17P) to prevent preterm birth. We supported the clinical guidelines of the American College of Obstetricians and Gynecologists that recommended the use of 17P for selected patients at risk for recurrence of preterm birth. We were supportive of expedited review of 17P by the FDA because of our understanding of the efficacy of the drug and the known benefits to access, quality, and consistency of having the good manufacturing practices of a regulated pharmaceutical company responsible for drug production and distribution.

As FDA approval seemed imminent, March of Dimes leaders met with your staff and were assured that every effort was being made to standardize distribution methods, work with physicians and patients to streamline insurance and managed care issues, and most importantly, to ensure that every eligible patient who is offered the drug by her physician has access to the drug regardless of ability to pay. Your staff described the “care connection” program that has been created to assure all of these aspects of drug supply and availability, including a substantial financial assistance program for uninsured and under-insured women both in the private and public sectors. They also described efforts to work with public payers to assure access to 17P at reasonable costs for Medicaid, and other public health insurance plans.

However, since its approval on February 4, 2011, there have been numerous reports that the price of a course of treatment with MakenaTM could reach $30,000, thus raising questions about whether health plans and public insurance programs like Medicaid and CHIP will cover it. So we remain deeply concerned that the cost of this lifesaving treatment could be put out of reach to thousands of women at risk for preterm delivery.

Therefore, we respectfully request that you reconsider the market price of MakenaTM and commit your company to the promise that every eligible woman who is offered the drug will receive it without regard to ability to pay. The March of Dimes is prepared to work with Ther-Rx to help prevent preterm birth and we hope that you will be responsive to our concerns.

Sincerely,

Jennifer L. Howse, PhD Alan R. Fleischman, M.D.
President Senior Vice President and Medical Director

IN RESPONSE TO RETURNING THER-RX's DONATIONS: 

We’ve certainly talked about whether we should give Ther-Rx back their money. It might be helpful as a public relations tactic. But we’re more concerned that a give-back would reduce funds available for our mission. We need both public and sponsor funding to sustain programs like research, health education, and advocacy. We’ve already committed the Ther-Rx sponsorship money for this year. Without it, we’d have to cut some of our programs for mothers and babies. We don’t think that you or the families of preemies would want us to do that. Especially not now when the federal government, states, and other private sources are cutting back their spending on programs for babies and children. So you can see the dilemma. In addition, by holding on to the money, we still have the option to make a public give-back in the future if Ther-Rx does not honor its promise that every woman who needs 17P will get it, regardless of her ability to pay.