March of Dimes strengthens stance against Makena pricing; is it enough?

Last night I posted that I was contacted by, and had a productive discussion with, Doug Staples, SVP of Marketing for the March of Dimes. Today, I let him know that a comment under that post showed that although he had indicated that expectant mothers who were already on compounded 17P would be allowed to continue to do so, one mother had already posted that she had been informed that she would have to switch to Makena, and that she had been told that her monthly copayment would be near $2,000. I suggested that she might make a good test case for the patient assistance program.

Doug thanked me, said that he’d have someone look into the case, and told me to look out for a new letter to be posted to the website later today. Doug later forwarded the letter to me. I haven’t seen it on the March of Dimes site yet, so I’ll post it here for you to read:


March 23, 2011

Greg Divis, President
Ther-Rx Corporation
One Corporate Woods
Bridgeton, MO 63044

Dear Mr. Divis:

Thank you for your letter of March 17th. I am pleased to learn that you are ‘listening carefully to stakeholder concerns about list price, patient access, and cost to payers’. Thank you for considering additional steps tp ensure that Makena is available to all eligible women, and for convening stakeholders from the March of Dimes, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and the Society for Maternal Fetal Medicine next week.

In advance of that meeting, I want to go on record that March of Dimes expects Ther-Rx to come to the table with substantive commitments including:

1)      A significant reduction in the list price of Makena.
2)      Adjustments to the patient assistance program to ensure adequate coverage of all patients, insured, uninsured and underinsured.
3)      A method for reporting on a regular basis to stakeholders on the patient assistance program to ensure that it is meeting needs in a timely and adequate way.
4)      A justification or rationale for your pricing based on your investment in the product, savings to the health care system, or other appropriate methodology, which you are prepared to make public.

Without these elements, I do not believe that Makena can succeed in the current marketplace environment, and as a result, at-risk women will be denied access to a safe and effective treatment to reduce preterm delivery. Therefore if you are unable to make a clear commitment to significantly address the above issues at the meeting, the March of Dimes will need to pursue alternative strategies for ensuring that this proven intervention to prevent preterm birth is made available to all medically eligible pregnant women, and we will step away from our longstanding and productive corporate relationship with Ther-Rx. Thank you for your consideration of this critical matter.

Sincerely,

Jennifer L. Howse, PhD
President


I think that this letter that should have been sent two weeks ago, when the pricing for Makena was first announced, but it’s still a move in the right direction. It’s much stronger than the limp first letter to Ther-Rx, it lists specific changes and information that it is looking for, and it includes the threat of stronger action.

Is it enough? Not in itself, no. But it’s a good move in the right direction.

Words are good, but they’re just words. Everything starts with words, so I’m glad to see the letter, but the next step is following with concrete action. There has to be significant movement.

While some may be looking for the home run on the first swing, I view this as more of an iterative process. Unfortunately, we’re starting far from an optimal situation, with a lot of ground to make up. Will we eventually get to a point where Makena Is not only affordable for all expectant mothers, but for the insurers and other payers? Maybe. Will that be accomplished this month? No way. Will it be this year? Possibly.

This will be a long slog through the mud, I have a feeling. But by continuing to make strides in the right direction and never letting up, we keep moving toward our goal. If it takes until the drug loses its orphan status and becomes available as a generic, that will be a failure. It will cost far too much and put far too much money in the pockets of the deceitful and greedy well before then (it will hit that point in mere weeks, to be honest). We were sold out in this process, but the game is not over. As long as we persist, there is hope.

What can you do? Contact your local March of Dimes office. Let them know that you are upset about the price of Makena. Tell them that your continued support of the organization hinges on their ability to fix the pricing debacle. Tell them that you’ll be watching. And follow up. If progress slows down, let them know that you’re not happy about it. But also let them know that you’re willing to help if there’s something that you can do. March of Dimes is an advocacy organization, and it does rely on us to provide support. If they set up a day for action on Makena, be sure to participate. While I expect a lot of the heavy lifting will have to be done by the organization itself, we also can’t turn our back on them if they’re making an effort and need grassroots support. And if the grassroots support is putting enough pressure on them, they’ll listen.

Also, if there’s anyone out there that has any pull with the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, or the Society for Maternal Fetal Medicine, talk to them, as well. The more organizations that we have putting pressure on K-V and Ther-Rx, the better.

Now, does all of this mean that I’m starting up my March for Babies campaign and that I’m back in the fold? Not just yet. Words are important, but that’s all we have so far. I will wait to see what kind of response comes from K-V/Ther-Rx, and what comes from the meeting next week. If Ther-Rx offers a “significant reduction” of Makena’s price from $1,500 to $750 per dose, that’s still a $3,750%-7,500% price increase. That’s relatively closer to realistic, but still absolutely far away. If the definition of “adequate coverage” for the patient assistance program doesn’t cover enough, there’s still work to be done. As long as the March of Dimes shows continued diligence in righting this wrong, I will work to help them achieve the goal. But the money won’t follow if there aren’t solid results. My decision on participation will be made by April 3, as that is 6 weeks before my walk. I’ll decide at that time whether I’ve regained sufficient trust to continue financial support or if I’ll take my dollars elsewhere while I continue to spend time working to get March of Dimes in a position to be successful in addressing the Makena situation.

I’ve got more thoughts on the issues behind this whole situation, and how things may have gone wrong, but I’ll save that for another post. In the meantime, what do you think about this letter to Ther-Rx? Is it a good start? Are you looking for a home run right from the start? Do you have any other concrete suggestions on how March of Dimes can address the Makena situation? Comments are open below. Please share your thoughts.

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4 Responses to March of Dimes strengthens stance against Makena pricing; is it enough?

  1. Pingback: The March of Dimes finally responds about Makena price and Ther-Rx, well, sort of… | The Preemie Primer Guide from Dr. Jen Gunter

  2. Pingback: More Makena/March of Dimes | Catching Up With Daphne

  3. Max Kennerly says:

    A good start, but still more to go. I am still deeply disappointed that an organization with a >$21 million administrative budget, supposedly staffed by people with knowledge and insight about prematurity, claims to have been blindsided by this.

    How could they not know? Is it, perhaps, because their President is paid over $600k annually but has no medical qualifications (her PhD is in “psycholinguistics”). Does no one there understand the pharmaceutical industry, or FDA approval? If that’s the case — and it would be shocking if it was — then they couldn’t have spent a small part of that $21 million administrative budget on a couple FDA lawyers to help them see the bigger picture?

    Even if their heart’s in the right place going forward — and I’m not entirely convinced of that yet — I’ve still lost trust in their competence and ability. 17P is the biggest medical advance related to prematurity in a generation and they not only missed the ball, but made the situation worse by lobbying on KV’s behalf until it was too late!

    I doubt I’ll have confidence in MOD until the leadership steps down and is replaced by more qualified individuals with more credibility in this field. I was already suspicious of them given their relentless fundraising, inability to point to concrete results over the past twenty years, and their extraordinarily high administrative fees (which are part of how they have a “1 star” rating from Charity Navigator). Watching them botch the 17P / Makena debacle sealed the deal for me. MOD needs serious internal changes.

  4. Martha says:

    It’s too little, too late. It’s hard to believe that MOD would mess up something as important as 17P, but they did and they have offered no explanations or apologies. This second letter simply isn’t enough. As a parent of preemies, I don’t expect KV to have my best interest in mind–they are a for-profit company out there to make as much as they can from a desperate group of parents. But I expected more from the MOD. It makes me wonder if their mission is to prevent prematurity (which 17P could do in some cases) or just make as much money as they can (which they did with contributions from KV at the expense of their stated mission). They definitely should have used some of their enormous administrative budget to hire lawyers who understand pharmaceuticals and the Orphan Drug Act. Whatever Dr. Howse’s educational background is (and I was surprised to learn it’s in psycholinguistics; I had always thought she was a medical doctor given the type of organization it is), she should have been saavy enough to surround herself with the right people who have the right experience when it came to handling something as important as 17P is in the preemie world. Someone at the top messed up here, and I agree with the previous poster that MOD needs serious internal changes.

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