Nowhere Special

I was hoping that it wouldn’t come to this, but when it happened I was very pleased to see it unfold the way that it did.

Earlier this week, KV Pharmaceutical/Ther-Rx met with the March of Dimes, American College of Obstetrics and Gynecology, American Academy of Pediatrics, and Society for Maternal and Fetal Medicine. As a result of that meeting, Ther-Rx agreed to significantly modify the pricing of Makena, and said that they would announce the new pricing today. Because the drug was so outrageously priced, a “significant” decrease could result in anything from a reasonable price to still being extortionist. Many of us awaited the announcement, hoping that it would be the former.

If you’ve been following this story, you’re already aware that the initial list price of Makena was $1,500 per dose, a 7,400%-14,900% increase over the previous price of $10-$20/dose from compounding pharmacies. This is especially heinous because a standard course of treatment for an expectant mother who has gone into labor prematurely on a prior pregnancy is 18-20 doses. That means that a full course of treatment went up from $200-$400 to a whopping $30,000! While a significant price increase was not unexpected, and Ther-Rx will have substantial expenses related to the drug, there’s a difference between making a profit after recouping your investment and financially raping pregnant women, insurers and other payers.

Ther-Rx announced their new price today: $690 per dose, a 54% price cut. That makes the net increase over the compounded version $670-$680 per dose, or 3,350%-6,800%. As I wrote in yesterday’s post, there’s no reason that Ther-Rx shouldn’t make a profit. They’re entitled. There are limits to everything, though. A price of $200 per dose, as anticipated by some drug outlook services during Makena’s application process, would have been just fine, and would have given Ther-Rx an estimated $533 million in net revenue, as opposed to the $4 billion that they were extorting. $690 per dose? $13,800 per course? Not acceptable.

And the March of Dimes agreed. The March of Dimes first issued a press release stating that the price drop was a step in the right direction, but that “the March of Dimes has decided to exercise our right to terminate our current contract and sever all professional relationships with Ther-Rx.” They also condemned Ther-Rx’s approach, noting that their “handling of the launch of Makena, and the initial list price, were highly unsatisfactory and unacceptable to the March of Dimes and the families we represent.”

March of Dimes then sent a letter to Ther-Rx President Greg Divis making it official. The letter, from March of Dimes President Jennifer Howse, thanked Ther-Rx for their support of fundraising efforts and the NICU Family Support Project over the past several years, and then informed them that the March of Dimes was “exercising our option to terminate our agreement with Ther-Rx Corporation, and hereby provide you with thirty days written notice of such termination. We ask that you immediately cease and desist the use, distribution or publication of or reference to the March of Dimes name and/or logo on any and all materials or communications in connection with KV Pharmaceuticals, Ther-Rx and Makena.”

The letter went on to note that “Access to 17-P is and always has been our paramount concern. We hope to continue to work with you to address the issues discussed by stakeholders over the last several weeks, and to ensure the intention you strongly expressed: that this therapy is accessible and affordable to all clinically eligible women.”

The contract being terminated was a more-or-less standard sponsorship contract, in which Ther-Rx provided funding for the NICU Family Support project in exchange for getting their logo on materials and announcements related to the program. The contract also stated that March of Dimes would participate in the announcement of Makena’s approval, though they would not endorse the product.

It’s likely that—when Makena’s price was first revealed—March of Dimes wanted to try to preserve the partnership, and work within the bounds of their relationship to quietly convince Ther-Rx to make the price more reasonable. They said that they also relied quite a bit on assurances that Ther-Rx’s patient assistance program would cover the costs of the treatment. But as word of $385/week and $1,900/month copayments emerged, confidence in that program eroded and March of Dimes started being more vocal. First, they released a letter “respectfully requesting” that Ther-Rx revisit the pricing structure. After there was no movement, a stronger statement was released, warning that continued lack of response would result in termination of the contract.

Now, with the contract at an end (or, at least, after the 30 days notice has concluded), the March of Dimes is free to take a more adversarial approach with Ther-Rx and rightfully separate themselves from the situation that they found themselves embroiled in after Ther-Rx surprised many with their price point.

It should be noted that Ther-Rx’s latest press release contained the promise of a series of other cost-containment measures, such as capping the cost of treatment for health insurance plans and state Medicaid agencies to 15 doses (instead of the full course of 20), promising supplemental rebates in addition to the standard Medicaid rebate of 23.1%, and expanding the patient assistance program. But really, why are they creating all of these artificial adjustments to the price if they really are planning to reduce the actual cost of the medicine? Why don’t they just cut the price further in the first place? Could it be that these reductions aren’t really going to do what they say they will? I don’t know. I don’t have enough familiarity with the industry to know. But I do know that “rebates,” especially to consumers, are frequently not submitted and/or paid, due to laxness in consumers submitting rebate forms and restrictions on filling out forms in a specific fashion.

Instead of putting forth the array of rebates, price caps, and patient assistance programs, why not be more straightforward and just cut the price of the drug? I don’t buy Ther-Rx’s plan, and neither does the March of Dimes. And that’s why I’m a March of Dimes supporter. They tried to work collaboratively with Ther-Rx, and when that didn’t work they realized that the only way to accomplish anything was to switch to a confrontational approach and terminated their relationship.

I’m back on board. I applaud the efforts and stance of the March of Dimes against the outrageous pricing of Makena, and I will restart my March for Babies fundraising appeal, with the added emphasis that more money is needed to help fill the funding gap left by the termination of the Ther-Rx contract. Let’s raise more money so that the March of Dimes doesn’t feel the loss of money from Ther-Rx. Let’s raise more extra money than Ther-Rx was giving. If you’re already walking, use this as a rallying cry to increase donations. If you’re not already walking, please consider signing up. If you won’t walk, please donate. You can click on the donation badge above and to the right to donate to my walk (or to join my fundraising team), or you can go to the March of Dimes website to make a direct donation.

You can also donate directly to the NICU Family Support Program, the program that will be directly losing the money from Ther-Rx. Now, more than ever, the March of Dimes needs your support. Let’s fill the gap created by the March of Dimes taking a stand against Ther-Rx and more!

If you’re willing to lend your voice, sign up for one of the organization’s advocacy programs. Talk with your local chapter to find out when the next advocacy day is with your state or local governments. Ask whether there will be any public activities to bring light to the Makena situation and get involved with it. Blog, tweet, post on Facebook or use any other email or social media channel to spread the word about the outrageous pricing of Makena and demand that something be done. We’ve got Ther-Rx on the run now, and maybe we can get Makena to a price point that we can actually support. If not, then support the use of compounding pharmacies to distribute 17P for the next seven years until an official generic version of Makena is available.

What do you think? Is the action of the March of Dimes in alignment with your expectations? What do you think is the next step? Did I miss anything, or is my logic flawed anywhere? Please comment below!

Since my last regular post, there’s been a bit of a pressure on KV Pharmaceutical and their Ther-Rx subsidiary, and their pricing of Makena. Forces from the U.S. Congress and the FDA have weighed in, with supportive statements from the March of Dimes and the American College of Obstetricians and Gynecologists (ACOG).

On Friday, Rep. Henry Waxman (ranking member of the House Committee on Energy and Commerce), sent a letter on behalf of the committee to Ther-Rx president Greg Divis, cosigned by Rep. Frank Pallone, Jr. (ranking member of the Subcommittee on Health) and Rep. Diana DeGette (ranking member of the Subcommittee on Oversight and Investigations) demanding that Ther-Rx provide:

1. Any fiscal or other contributions made by Ther-Rx to the two National Institutes of Health studies that were used to gain approval for the drug.
2. Any additional research costs to date incurred by, or studies conducted by TherRx in obtaining FDA approval for Makena, and the expected costs of ongoing research, including all information about clinical trial officially listed with the government, and for any published study information.
3. Any research or data on similarities between Makena and the compounded versions of 17P or any previously FDA-approved versions of the drug (such as Delalutin).
4. How much Ther-Rx has spent on promoting Makena, and details on how that money was spent, for past, current and anticipated future expenses.
5. Ther-Rx’s total cost, and estimated unit costs, to manufacture Makena, and a breakdown of those costs.
6. Ther-Rx’s expected revenues and profits from sales of Makena.
7. Ther-Rx’s anticipated revenues and profits from sales of Makena to government programs such as Medicare, Medicaid, and other federal or state health care programs.

This was whipping out the big stick and threatening KV big time. Basically, Waxman is telling KV/Ther-Rx that “you used government studies as the primary means to get approval for your product, and now you’re soaking the American public on the price of the drug, including soaking the same government that funded the studies that you’re using in the first place. How much are you planning to overcharge us as a show of gratitude?”

KV Pharmaceutical released a preliminary response to Waxman and the advocate groups:

KV Pharmaceutical Company Response to Letter from Democratic Leaders.

Ther-Rx Corporation takes very seriously the concerns raised about the list price of Makena™ (hydroxyprogesterone caproate injection) by Members of Congress and other stakeholders. Ther-Rx has received a letter from Members of the Committee on Energy and Commerce and will respond to the letter. Ther-Rx is committed to ensuring that this significant, FDA-approved medication is covered at an affordable cost and available to all women who are prescribed Makena, and looks forward to cooperating with the Members of Congress on these issues.

Ther-Rx Corporation to Address Cost of and Access to Makena^TM with Key Stakeholders

Ther-Rx Corporation has been carefully listening to all stakeholders following the announcement of the list price for Makena™ (hydroxyprogesterone caproate injection). We recognize the concerns that have been raised regarding the list price, patient access, and potential cost to payors of this important orphan drug. The company already has established a Patient Assistance Program with the goal of ensuring that every woman who is prescribed Makena will be able to access and afford it. However, we have heard clearly from various stakeholders that we need to do more because the cost of therapy remains a significant concern.

Ther-Rx is fundamentally committed to the community of women, children and families whom we serve. We are scheduling meetings with key audiences – including payors and national organizations that are committed to the advancement of obstetric care and infant health. We hope to meet with them at the earliest possible dates to discuss and address all of their concerns. We are committed to working closely with all parties to develop and implement plans that will ensure that this important, FDA-approved product will be covered by the payor community and available to all women who are prescribed Makena at an affordable cost. Visit www.makena.com to learn more.

Tuesday, KV met, as scheduled, with the March of Dimes, ACOG, the American Academy of Pediatrics (AAP) and the Society for Maternal & Fetal Medicine (SMFM) to discuss the pricing of Makena and the extent of the patient assistance program. No news came immediately from that meeting.

Wednesday, the U.S. Federal Drug Administration (FDA) released a press announcement that basically cut the feet out from under Ther-Rx:

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.

In other words, the FDA recognizes that Ther-Rx is overcharging for Makena, has recognized that KV is trying to use the FDA to threaten compounders into stopping production of the generic version of the drug that has been made by them exclusively for years, and is not going to stand for it. The FDA basically told KV that “we’re not your lap dog and stop using us to threaten the compounders.”

The FDA’s announcement was met with immediate support from ACOG and March of Dimes. The statement from March of Dimes went a bit further with their statement, noting that “To date, Ther-Rx Corporation’s handling of the launch of Makena has been unsatisfactory to the March of Dimes and to the families we represent. We’ve asked Ther-Rx in writing and in discussion to substantially lower the price of Makena and to expand coverage for patient financial assistance. We’re waiting for their public statement on this matter, which we expect will occur within the next week.” It’s nice to see them stay on the attack.

Following these actions, Ther-Rx released their own press announcement yesterday, entitled “Ther-Rx Corporation Commits to Take Action Regarding Makena Pricing.” In the press release, Ther-Rx states that they have “invested or committed over a quarter of a billion dollars to-date to bring Makena to market, including more than $50 million in research and clinical trial costs, including those associated with conducting major, multi-year follow-on health studies of Makena involving 1,700 mothers and more than 500 infants.” One point that it doesn’t note is that $199.5 million of that is the amount that Ther-Rx has paid or committed to pay to Hologic for the rights to Makena.

Now, don’t get me wrong. I don’t think that anyone denies KV/Ther-Rx the right to make money on their investment. It’s just that it’s one thing to earn a profit and another to try to extort money from a captive population. A reasonable price of $200, as anticipated by some drug outlook services during Makena’s application process, would probably not be challenged. While still 10 times what it had cost previously, it would have been reasonable for recouping the cost of getting the drug approved and purchased from Hologic. And the ability to have an FDA-approved use of 17P to prevent premature labor would be a tremendous boost to the ability of women throughout the country to receive the drug, since many still have to deal with doctors that will not prescribe 17P for off-label use. It’s just that it’s one thing to make a fair profit, and an entirely different thing to charge an outrageous price for the sole purpose of digging yourself out of a financial hole that you put yourself in through misconduct and trying to use the government to strongarm legitimate small manufacturers out of competition with you, especially when you only had a limited role in getting approval for the drug in the first place.

KV probably started their involvement in Makena (then called Gestiva) with reasonable expectations for profits from the drug. Several months later, when they got into trouble with the FDA, resulting in a two-year shutdown and having to agree to a consent decree, then watched their stock plummet along with their finances, that they decided that they needed to milk Makena for everything that they could.

Now, it’s time for KV/Ther-Rx to get hit with the reality stick.

Let’s do some math. If I understand what I’ve been reading correctly, the average cost of initial health care for a premature baby is estimated at $51,000. (While many cost a tremendous amount more, many babies considered to be premature do cost less.) Spending $30,000 to save $50,000 would seem to be an easy choice for insurers, except for the fact that 17P is reportedly effective in approximately 1 out of 5 cases. That makes it an expense of $150,000 to save $50,000. A price of $200 would give Ther-Rx gross revenues of an estimated $533 million per year (instead of $4 billion), and would cost insurers $15,000 to save $50,000. Those numbers work much better.

In another development, which I’m deciding to believe is not any type of official action on the company’s part, a KV employee posted a comment on the first of my Makena-related posts, trying to discredit me. I originally thought that this was a person in a position of some responsibility in the company, but I’ve since gotten some information from a person knowledgeable in the industry that this person’s position is really just to ensure that documents prepared by others are properly formatted, and then submitting those documents to the federal authorities using an automated tool. While his position would put him in a position of responsibility for ensuring that KV’s submissions were done properly, there is no product, testing, or other technical responsibility for the products at all. And since he’s apparently an IT guy, I’m surprised that he didn’t do a better job of covering his tracks. I find it hard to believe that KV Pharmaceutical does not have an official policy about their staff posting on social media about the company from the company’s computers. I think the guy may have been upset at everybody beating up on the company and felt that he had to lash out against me, and may have been unsure about company policy.

Moving forward, I’m looking forward to seeing Ther-Rx’s response to Rep. Waxman’s letter, and to the March of Dimes/ACOG/AAP/SMFM meeting. It’s starting to look like this is becoming a one-sided battle, but it’s not over yet.

What do you think? Has enough been done by others and it’s time to wait for KV/Ther-Rx to respond? Should more pressure be put on in the interim? Is there a sound justification other than “we need to dig ourselves out of debt” for KV/Ther-Rx to be charging $1,500 per dose? I’m looking to gain knowledge and understanding. Please share your thoughts in the comments.

No, I haven’t suddenly fallen off the face of the earth. I am far behind in posting due to family and work stuff. I know that I’ve missed posting stuff like Rep. Henry Waxman spanking Ther-Rx over Makena pricing, as well as sharing info updates that I’ve gotten from March of Dimes like the fact that they’re trying to verify with the FDA whether or not the prohibition on compounding 17P only applies to interstate commerce (no further info yet).

I also have some info to post on March of Dimes’ contract with Ther-Rx (not as much to it as you’d think), as well as some more history of KV/Ther-Rx, Gestiva/Makena, and the March of Dimes. Not only that, but today (OK, yesterday. I wanted to get this written earlier, but it’s already tomorrow) was the day that KV/Ther-Rx sat down with March of Dimes, the American College Obstetricians and Gynecologists, the American Academy of Pediatrics, and the Society for Maternal and Fetal Medicine to discuss the pricing of Makena. Look for press releases on that later tomorrow (OK, today).

The insanity around here seems to be slowing down. I hope to be able to have enough time to write a full post or two after I get home from work. Look for more information coming in the evening or overnight.

Thanks for your patience.

Well, my still-nascent blog about life, preemies, and everything is continuing to be hijacked by the Makena controversy and analyzing everyone’s actions since the story broke, so I thought that perhaps it’s time to try again to figure out how we got here in the first place. A lot of information has come out since this started—from other bloggers, from comments made by knowledgeable people on those blogs, and by people passing other information to me through other channels.

By the way, since it’ll probably be a while before this goes away, I’ve made a new Makena category to make it easy to follow this in case I manage to find time to make any posts on my usual topics in between the Makena posts.

Now bear in mind that this is all speculation on my part, though I’ve got a pretty solid feeling about all of this.

First, we have to start with a bit of a history lesson.

In 1956, the FDA approved a drug called Delalutin for treatment of habitual and recurrent miscarriage, threatened miscarriage, postpartum after-pains, and advanced uterine cancer. Delalutin was 17-HPC, or 17 alpha-hydroxyprogesterone caproate. Delalutin was withdrawn from the U.S. Market in 1999 for reasons not related to safety or effectiveness. 17-HPC is the active ingredient of 17P, which is the compounded drug that has been used for the same purpose since Delalutin went off the market.

In 2006, Adeza Biomedical submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) to get approval to market Gestiva—a particular formulation of 17P—in the U.S. for the prevention of recurrent preterm birth. The application was largely based upon a 2003 study conducted by the National Institute for Child of Child Health and Human Development (NICHD), part of the National Institutes of Health. That October, the Gestiva NDA was granted orphan drug status by the FDA.

Adeza was acquired by Cytic Corporation in April 2007, and Cytic merged with Hologic, Inc. in October 2007. Hologic then sold the rights to Gestiva to KV Pharmaceutical in January 2008, pending approval by the FDA. The complete package, which included multiple payments at specific intervals following the approval of Gestiva (now known as Makena) totaled nearly $200 million, which doubtlessly increased the pressure on KV to generate a profit. In an SEC filing, KV stated that by 2013 Makena could reach net sales of about $420 million, or about 90 percent of KV’s net revenues.

We know the rest of that part of the story. Makena was approved, KV and Hologic completed the rights sale, and KV/Ther-Rx set the price of Makena at $1,500 per dose. So how did the March of Dimes end up supporting the approval and keep quiet for the first couple of weeks after the price was announced?

First of all, while 17P was available through compounding pharmacies, it was still considered an off-label usage of the drug. There were women with at-risk pregnancies whose doctors would not prescribe 17P because it was an off-label use, and the women did not have other doctors available to them. Some did go into premature labor and lose their babies. An on-formulary drug was needed to ensure that all women had access to this therapy. This is why March of Dimes supported the application. It wasn’t possible to go straight to a generic-enabled approval because that’s not how the system works.

The application changed owners several times during the process, so while March of Dimes was initially working with Adeza Biomedical to get the drug’s approval, they then had to work with Cytic, and then Hologic to before finishing the process. It wasn’t until after Makena’s approval that KV took ownership of the drug. And of course, KV’s financial woes probably played a big part in their setting the outrageous price point. March of Dimes would have been supportive of the approval process in order to take the huge step forward of getting the drug approved and on formulary.

How could the March of Dimes have been surprised by the $1,500 price tag if everyone else knew?

Dr. Jennifer Gunter wrote a blog post noting, among other things, that every industry analyst that she spoke to predicted the $1,500 price point. However, a commenter on that post notes that during the approval process, some drug outlook services were indicating that the drug could be marketed in the ~$200 price range. The commenter also indicates that the FDA also expected the price to be in that range, and was as surprised as the March of Dimes likely was. So while many industry analysts were predicting that the price would be in the $1,500 per dose range, March of Dimes was probably thinking that $200 per dose would be the price point.

Once the astronomical price was announced, the March of Dimes may have been restricted from what they said by a sponsorship agreement with KV. It’s not beyond the realm of possibility that they were concerned about losing a major sponsor, and thought that they could have a better chance to resolve the situation collaboratively rather than confrontationally. While initially the March of Dimes put a great deal of faith in Ther-Rx’s patient assistance program, the reality of the implementation proved questionable. The lack of progress led to the wimpy letter of March 14, and it was only after a further lack of progress that they issued a second letter on March 23 that finally got tough.

While many are deriding the March 23 letter as insufficient, the commenter notes that, within the confines of the pharmaceutical industry, that letter is actually “a very, very aggressive slap across the face to Ther-Rx/KV,” and “virtually calling out the bullshit.”

Now that the pressure’s on KV and Ther-Rx, let’s see how the meeting in Washington goes next week.

Some other points have been raised, which I was curious about as well, so I did a little research:

Much has been made of the fact that March of Dimes President Dr. Jennifer Howse’s salary is $641,760. While I will not attempt to justify that figure, I will note that a Forbes Magazine study of the top 200 charities in the U.S. found that the average top salary for the charities was $624,225, which puts Howse’s salary toward the middle of the pack.

That same study shows that March of Dimes’ donor dependency, a measure of “how badly a nonprofit needs your contribution to break even,” is 100%, meaning that it relies heavily on donors to stay afloat. Its fundraising efficiency, a measure of “the percentage of gifts left after subtracting the cost of getting them,” was 84%, putting it in the bottom quarter of the 200, a bit below the average of 90%. March of Dimes’ charitable commitment, or “much of a charity’s total expense went directly to the charitable purpose,” was 75%, which put it in the bottom 10% of charities, well below the average of 86%. So there’s certainly room for improvement in the operations. Still, its organizational efficiency (taking into account program expenses, administrative expenses, fundraising expenses, and fundraising efficiency), as rated by Charity Navigator, earns it three out of four stars. Where it loses out, and brings its overall rating down to one out of four stars, is its organizational capacity (looking at primary revenue growth, program expenses growth, and working capital ratio). So the March of Dimes depends very heavily on private donations, and it needs to work at its overall financial stability and growth, and at trimming administrative and fundraising expenses.

Based on the wording of the March 23 letter, it’s apparent that March of Dimes has had a “longstanding and productive corporate relationship” with Ther-Rx, so it’s not a recent marriage of the two over Makena, as some were wondering.

I learned a lot from this research. How about you?

I’m still holding off on jump-starting my March for Babies campaign for this year pending results from next week’s meeting, but I’m feeling a lot better about March of Dimes than I did last week at this time.

What do you think? Do you still have unanswered questions about March of Dimes? Post them in the comments below!

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 17^th. 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.