Boycott Makena: March of Dimes responds to KV Pharmaceuticals
The recent hulabaloo with KV Pharmaceuticals and Makena continues, with multiple news and blog articles popping up every day. Senator Brown is trying to get the FTC to do an anti-trust investigation. The FDA is interested, but sadly they have no purview in pricing of drugs. Many newscasts have done pieces on the issue, the vast majority leaning towards condemning KV for their pricing of Makena. One aspect of the issue has been March of Dimes’ initial support of KV getting the FDA approval for the product.
The March of Dimes has been a positive organization for decades, and generally does a lot of good work. This one really blew up in their face. MOD was a major player in pushing the FDA to give orphan drug status to 17-OHP, paving the way for KV to bring Makena to market. Jennifer Howse, PhD, president of MOD, has stated that the MOD had no idea of the planned pricing structure, and I believe her. Nonetheless, the MOD has suffered a great deal of bad press and in some cases decreased donations because of their association with KV and Makena.
Today the March of Dimes delivered a letter to KV Pharmaceuticals, saying a lot of the things that we have been saying. It must have been a tough letter to write, given the amount of financial support KV has given to MOD, and the potential for that to end. While I don’t think the letter was perfect, I think it was pretty good for a major organization that has a lot of difference issues to keep in balance. Here it is:
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 to 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
While some folks on the internet have been critical of this letter as not strong enough, I feel like it is a pretty strong statement. MOD has had a financial relationship with KV for some time, and they are threatening to end that if KV does not address these issues. Their threat of “pursuing alternative strategies” certainly reads as endorsement of continued use of a compounded product. For an organization as large as the MOD, I think this is as close to a smackdown as they could get. For that I say bravo.
The only concern I have is the idea of KV being asked to “justify their pricing rationale” based on “savings to the health care system”, as any comparison to the cost of preterm birth is completely spurious. Health care needs to become less expensive. Fixing something that costs 100 with something that costs 90 is not a savings when the previous fix only cost 1. Claiming that it does is a ridiculous assertion – yet there is no doubt that KV will continue to make such claims.
I also think that some have been a little hard on MOD. I am concerned about their previous financial relationship with KV, but they have such a strong track record of positive contributions to pregnant women that I am willing to give them the benefit of the doubt, particularly after this letter. KV, on the other hand, has a track record of unethical behavior for which they are still paying fines.
While I appreciate MOD’s letter, in the end it doesn’t change my feeling towards the situation at all. No matter what the outcome, KV is deserving of a total boycott of Makena. They have behaved in a completely unethical manner, and deserve to go bankrupt for it. They have attempted to mug the women of this country, aiming to force the healthcare system to pay them billions of dollars a year for nothing that they didn’t already have. No matter how they respond to this issue, it will not change the fact that they are corporate muggers.
If somebody tries to mug you in an alley and you catch them in the act, they don’t get off the hook just because they gave you your money back.
Please join me in a total boycott of Makena. Companies like KV do not deserve to stay in business.
Academic OB/GYN 
“For these reasons and for the health of the pregnant women of this country, AAP, the College and SMFM hope that Ther-Rx reevaluates its pricing structure and ensures that patients who could potentially benefit from Makena™™ have timely and efficient access to this medication regardless of their ability to pay. Ther-Rx should also consider establishing a registry to identify patients who are “eligible” for assistance and did not receive it and for those patients who may have benefitted from Makena™ but could not afford it.”
This is a quote from the 3/11/11 letter written to KV Pharmaceutical (KVP) by ACOG,sMFM, and the AAP. I think it is much kinder to KVP than MOD’s letter from yesterday. It is tempting to throw darts at MOD because, let’s face it, they messed up by poor due diligence on KVP; by being blinded by their own mission; and by being a visible and well-padded organization financially. MOD realized they must listen to “the field”, including or especially physicians. I (as well as many others) spoke to their local and national leadership and they apparently listened. Grassroots efforts work! Let’s hope it does a number on KVP. We have sent a letter to all OB/GYNs in Oklahoma to boycott KVP/Ther-Rx.
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Price of Premature-Birth Prevention Drug Draws Waxman’s Ire
By Rebecca Adams, CQ HealthBeat Associate Editor
The House Energy and Commerce Committee’s top Democrat sent a sharply worded letter Thursday to a company charging $1,500 a dose for a drug to prevent premature births, up from $10 to $85 for a similar product made in stores by pharmacists.
Henry A. Waxman of California demanded to know how much money Ther-Rx Corp. of Missouri believes it will earn from sales and how much it spent to bring the drug, known as Makena, to market. The company did not conduct its own studies to develop the drug, Waxman said, but relied on investigations by the National Institutes of Health to show that it is effective and safe.
Ther-Rx Corp. also has been criticized by Senate Democrats, including Sherrod Brown of Ohio and Amy Klobuchar of Minnesota. (See related story, CQ HealthBeat, March 18, 2011).
Company officials said earlier this month that they hoped to meet with critics to discuss their concerns.
In his letter, Waxman asked the company seven questions about the drug’s development costs and potential profits. He requested a response by April 1.
“Ther-Rx did not invent this drug, or the use of the drug to prevent premature births,” Waxman wrote in the letter to Ther-Rx Corp. CEO Gregory J. Divis. “But this has not stopped your company from charging extremely high prices.
“It appears that the price of this drug is not being set on the basis of the cost to produce or research the drug, but at the maximum level that providers are willing to pay,” Waxman wrote.
The company is the only one that has received approval from the Food and Drug Administration to manufacture the drug. For years, pharmacists made a similar treatment by hand. The insurance trade association America’s Health Insurance Plans has asked the FDA to clarify whether those treatments can still be sold.
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I don’t have a problem (anymore) with MOD or with FDA. I have a huge problem with KV. I really hope that MOD sends a letter every day saying “we’re still waiting”. It was almost like last Sunday KV made it sound like they were waiting on these groups to meet with them. MOD has done good work for years. Keep focus on KV. THe price point needs to change quickly to avoid the tragic loss of life
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The stand point of so many professionals on condemning KV is impressive, and the one to be applauded for.
I read the posts on this issue with great interest, and of course, support for disapproval of KV. I am not as clear on MOD. It is my understanding that MOD has supported the drug approval by FDA. But isn’t it different then promoting KV in getting paid 100x for the same drug? As a non-medical professional, to me the working “approved by FDA” means the federal agency approves the drug for a particular use. Or does it really mean it approves particular brand name and endorses higher pricing?
Sorry, if the question is not a wise one.
And thank you.
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They approve the drug for use for a particular indication. In this case, they provided “orphan drug status”, which gives an extended license to exclusively distribute the drug. orphan drug status is meant for drugs that are used so rarely that the typical exclusive period would be inadequate to justify the development of the drug. It is quite arguable whether 17-OHP should have been considered in this category.
The FDA does not have any involvement in the pricing of a drug.
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Thank you for explaining that!
It seems one can try and give MOD a benefit of a doubt, and think that MOD was not aware of the implications of the KV’s drug becoming FDA approved. Though MOD is professional enough to anticipate the end results.
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I love that so many health care professionals are coming together on this issue. I firmly believe that the only people with the money and power is solve this issue is either the government or the political pressure exerted by a group like MOD. MOD needs to reminded everyday that we were doing fine with this medication before they spent lots of moneypushing for FDA approval. I know this was an unintended consequence but their actions indirectly lead to this outcome. KV is evil but MOD needs to help fix this.
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Jeff, I agree with you here. I’m not sure if KV is evil, but they certainly aren’t been good. They are a company that like any other wants to make money. They have worked the system to be able to do that, at the expense of the women of this country. I don’t like it one bit. At the core, the FDA should never have approved the drug as an orphan drug, nor allowed restriction of continuing compounding of the drug.
In the end, the market should decide KV’s fate. Let’s make sure that fate is utter failure of Makena.
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OK, people- are we blowing off steam or are we doing anything about our angst? We physicians are quite articulate when it comes to expressing our views on line and in the surgery lounge, but when it comes to action… Please share with me what is being done about KVP/Ther-Rx in other states.
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FDA STATEMENT
For Immediate Release: March 30, 2011
Media Inquiries: Beth Martino, 301.796.7603, beth.martino@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Statement on Makena
On February 3, 2011, the U.S. Food and Drug Administration approved the drug Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. KV Pharmaceuticals, the drug’s owner, received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness. It also obtained seven years of exclusivity under the Orphan Drug Act, obtained approval under FDA’s accelerated approval program, and received expedited review.
For many years, a version of the active ingredient of Makena, which is a synthetic progestin, has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug. Generally, FDA has exercised enforcement discretion with respect to most products made through traditional pharmacy compounding. This has included products made from the active ingredient in Makena, hydroxyprogesterone caproate.
Because Makena is a sterile injectable, where there is a risk of contamination, greater assurance of safety is provided by an approved product. However, under certain conditions, a licensed pharmacist may compound a drug product using ingredients that are components of FDA approved drugs if the compounding is for an identified individual patient based on a valid prescription for a compounded product that is necessary for that patient. FDA prioritizes enforcement actions related to compounded drugs using a risk-based approach, giving the highest enforcement priority to pharmacies that compound products that are causing harm or that amount to health fraud.
FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct.
In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products. As always, FDA may at any time revisit a decision to exercise enforcement discretion.
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SERIOUSLY?
Ther-Rx Corporation Takes Action to Further Ensure High-Risk Women
Are Able to Access FDA-Approved Makena™
Announces Reduction in Price and Expansion of Patient Assistance Program for Makena™
St. Louis, April 1, 2011 – As part of its ongoing efforts to ensure that high-risk women have access to FDA-approved Makena instead of unapproved, unregulated compounded drugs, Ther-Rx Corporation, a subsidiary of K-V Pharmaceutical Company (NYSE: KVa/KVb) (the “Company”), announced today important initiatives to reduce the cost of Makena™ (hydroxyprogesterone caproate injection) and encourage stakeholders to provide timely access to this important FDA-approved medication. Effective immediately, Ther-Rx has:
Reduced the list price of Makena by nearly 55 percent, to $690 per injection;
Will offer supplemental rebates that, in conjunction with the list price reduction and the standard Medicaid rebate of 23.1 percent, will result in a substantially reduced cost per injection for state Medicaid agencies compared to list price. This will help ensure that every woman who is prescribed Makena – regardless of her ability to pay – has the comfort of knowing a medication that has been rigorously reviewed by FDA for safety and efficacy is available to her;
Capped the costs for a full course of therapy to a maximum of three vials (15 injections) for contracted health insurance plans and state Medicaid agencies; and
Expanded the Company’s patient assistance program for patients who are prescribed this important medication by removing income caps to qualify for financial assistance. 85 percent of patients will pay $20 or less per injection for FDA-approved Makena, and patients whose financial need is greatest would receive FDA-approved Makena at no out-of-pocket cost.
Under the new pricing structure, the Company believes that the use of Makena by eligible patients will deliver net cost savings to Medicaid programs and private insurance plans in year one, based on third-party economic modeling of costs associated with the condition.
“Ensuring access to an FDA-approved sterile, injectable medication, manufactured under mandatory strict quality controls, is in the best interests of all high-risk women,” said Greg Divis, Chief Executive Officer, K-V Pharmaceutical Company and President, Ther-Rx Corporation. “We understand the concerns that key stakeholders raised under our original pricing structure. We also recognize the current budget challenges facing state Medicaid programs and other payers. In conjunction with our substantial reduction in price, it is our sincere hope that all committed stakeholders will take appropriate action to provide timely access to this important FDA-approved medication.”
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Yeah its not much of a reduction. It hasn’t helped KV in the market, they are still falling like a rock. ACOG has rejected their price reduction as inadequate. It seems that it is not just us that is willing to accept nothing but complete capitulation. They have lost the right to a place in the market.
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I wish Makena was around when I needed it. I used compound and I am now childless and have lost 30 use of my left sude because of compound. I took the pharmacy to court and got only 50 000$ and now my life is ruined. What about cancer drugd that cost 90 000$ . Go after them instead
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I’m not only boycotting Makena, but I’m not writing for Clindesse, Gynazole, Evamist, and any other product I find associated with KV Pharmaceuticals. Having a pharmacopia full of choices with equal efficacy, I see no reason to recommend that my patients patronize such an unethical company.
I’m as much of a capitalist as anyone, but when your company didn’t do the research necessary to reach this endpoint, I find this type of behavior repugnant. First you take advantage of the fact that taxes funded the NIH grants and research on this drug, then you stick it to the taxpayer again by charging Medicaid exorbitant amounts for manufacturing and distribution.
They know very well that most of the highest risk patients are low-income, low socioeconomic status women whose preterm babies are costing America billions of dollars every year. They can’t afford this drug, and we can’t afford their high risk babies. How dare they justify the price hike with, “At least it costs less than a NICU baby.”
Disgusting…
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We are talking about our future Mothers here, this should not be a debate on pricing or a company capitalizing on this drug. It should be about safety, control and purity as ops sided to god knows whats in these unregulated coumpounded formulas which we are spoon feeding these expected mothers.
I’ve never seen such a fiasco and circus when we should be focusing and concentrating on the flip side to this coin.
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So where are we at now? What does KV charge for this drug now – for inscos and medicaid and for cash-paying patients?
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Hi,I started taking Makena this morning.
I was not sure if I should do it but doctors assure me it was safe and had nothing to worry about. They also told me there were no side affects. Once I got my first shot I asked for the information paper that comes with the box,I went home and read a lot of it and it only brought me to distress and unsure!!!
Please help!!! What happens if I stop taking it??? I had a miscarriage before my daughter,another one after her, then had my boy at 33 weeks and then 3 other miscarriages after him. I’m now 16 weeks pregnant and I’m worried about this makena! Doctor’s never mentioned anything this paper has to say.
Please help!
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I can’t give you specific medical advice, but all of my concerns about Makena are about the way it way brought the market and it’s pricing. The drug had been used safely for decades. Trust your doctor over the internet anyway.
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