17p and compounding pharmacies

CBS ran a story this afternoon about Makena. I didn't actually see it (my aunt told me about it) but read the article online. You can see the online article here. Apparently the FDA released a statement announcing that it will continue to allow the compounding pharmacies to manufacture 17p "at this time". You can read the FDA's statement here. I'll take it!

To all of you who voiced your concern, way to go! Still want MOD to be held responsible and be forced to publicly acknowledge their link to this whole mess, but whatever. Win for preemie moms!

*edited to add: KV's stock price drops after FDA announcement.

amazed!

Our little guy is constantly amazing us with what he comes up with. A few weeks ago his OT brought a scooter to the house, the type from elementary gym where you either sit or lay on it and use your hands to maneuver yourself, hoping Rhys would lay on his belly and push/pull himself around on it. Well, he was more interested in using it as an obstacle to climb over, than figuring out how to move. Yesterday he was laying on it and suddenly starting pushing himself around on a circle. Cody and I walked into the kitchen to eat dinner and here he comes! While on his stomach he followed us by pulling himself. It was really remarkable.

We've also been working for literally months trying to get Rhys to scribble with colors, but he's always more interested in tearing paper than drawing. He got a magnadoodle for Christmas so I hoped that would help, but he didn't really care for that either. So imagine my surprise when he recently started writing on the magnadoodle, knowing which way to hold the pen. Not only that, but he started erasing it! This may not seem like such a big deal, but for Rhys it is. Cognitively Rhys is much more advanced than what his communication/motor skills demonstrate, so it's very exciting for us to see him figure out how to do these seemingly simple things.

On a different note, I think we're seeing some of the negative side effects from Rhys's baclofen. We were very positive the first few weeks because we didn't see any of the decreased appetite, moodiness or sleepiness we were warned about. So we really thought we were in the clear. We increase the dose by one-half a pill per week, and though we aren't positive yet we're pretty sure that the most recent increase in his medicine has made him a total fuss bucket. I am talking extreme irritability for no reason whatsoever. I called his doctor to discuss it with her and we are now going to decrease his dose back to where it was prior to the bad behavior. If he goes back to "normal" we know it is the baclofen. If it doesn't change anything we know we are in trouble! No seriously, it will not be good if he stays this cranky so we are really hoping it is the baclofen because dealing with his behavior on a regular basis would be miserable for the whole household. Once the dose is decreased (and hopefully the screaming stops) we will then determine if the response from the medicine is adequate enough to help Rhys, or if we need to switch him to a different medicine.

Regardless of what happens with the baclofen we are requesting a behavior consult for Rhys via ECI. Why? Because Rhys has always had a certain level of whining and acting out (though nothing compared to what we've seen the last week or two) due to his frustration associated with the delayed motor/communication, and we've always struggled with a way to appropriately deal with it. It is very minor all things considered, but since Rhys doesn't learn skills at the same pace as his typical counterpart he still hangs on to this whining/throwing/screaming as a way of expressing himself. He is very opinionated despite not speaking clearly, and he'll definitely let you know what he likes and doesn't like. We've worried about the transition when he starts school next fall, simply because we don't want him whining the whole day when he has to do things he doesn't care to do. Hopefully this behavior consult will give me and Cody some instruction on how to respond correctly and not reinforce Rhys's bad behavior.

first dose of 17p

Today I had my first 17p shot. The meds I received from the home health group are a compounded version, not Makena. I intended to ask my OB about it at my checkup today, but he was running behind so I saw another doctor in the practice. But I will ask about it when I see him next time. It was my understanding that Makena was available as of March 14. I'm really curious about all this, for it seems there is truth to the compounded version still being available despite the C&D letters. At least for now.

For what it's worth, my nurse visit is billed at $90 per the paperwork, so again, if you're having trouble with getting insurance approval/paying for Makena, this may be another option. I do not know if the 17p is available from my particular provider without the nursing service, but even if it isn't the $90 for the nurse + $40 for the 17p is still significantly cheaper than the list price of Makena. Anyway, just trying to pass along information for ways around the crazy price for those who may be having issues getting the drug.

In continued attempts to keep this in the news, I emailed two local news stations last week. One reporter responded immediately, stating she was already working on a story about KV Pharmaceuticals and asked if I'd be interested in doing an interview. Um, absolutely not! I so hate being center of attention like that, but I took one for the team. She came out the next morning and took some footage of us and the kids. Thankfully she didn't use much of me - I'm terrible on camera - but there were good shots of Rhys. The story turned out well, but it was only a story on KV with no mention of March of Dimes. So, I'm going to contact the other station a second time, as well as another one I didn't email before. I really think the MOD connection needs more attention and I'm honestly disappointed people aren't addressing it.

17p/insurance info

I have been waiting to hear back from my OB's office regarding the 17p for my pregnancy. I know what my OB told me at my last visit, but his PA was waiting on official word from him before she put in the order for anything. He was out of town at the end of last week, so she called me first thing Monday morning to tell me we are doing exactly what we did last time, with the exception of the terb pump.

With Zoe, it was a one stop shop with a home health group. They provided my contraction monitor and monitoring service, the terb pump/med, the 17p and a weekly visit from an RN to give me the shot and look me over. My 17p never went through my prescription plan, it was included in the services from the home group group, who I am assuming has their own compounding pharmacy. It seems that will be the same this time around. Soon after I spoke to my OB office I received a call from the home health group verifying all my personal information. They were then going to forward all requests to my insurance to verify benefits.

Today (you still with me?) my insurance company called. All patients prescribed 17p are considered high risk and are assigned an RN who works the case. They check in periodically and are available to the patient for whatever assistance they may need. When I spoke to my insurance RN today (she incidentally is the same one who I had with Zoe) I asked her about the coverage given all the new developments with the drug. According to her, she was told last week that my insurance and the home health group are still in agreement in terms of coverage and all things will remain the same as it was previously. She did not tell me specifically that I was going to be receiving a compounded version, but that is what it sounded like to me. And if that is the case, I suppose there may be some truth to the claim regarding compounding pharmacies still being able to provide the drug if ordered by the doctor.

Anyway, just thought I'd share this information in case it could be beneficial to someone else. The home health route is more expensive because you pay for a weekly nurse visit and the drug, but I am pretty darn sure it would still be cheaper than $1,500 a pop to pay for a nurse visit and compounded 17p if this is in fact allowed. Had I only needed 17p I am unsure whether my OB was have ordered it from the home health group, because I know several of my friends got the drug via their prescription plan and then gave the shot to themselves. I'll post again once I get some clarification on things.

new statement from KV Pharmaceuticals

Well, guys, maybe everyone's complaints and concerns are actually being heard. KV released a new statement today regarding the price of Makena. For those of you contributing to the noise, keep it up!!


*Edited to add:

activity from Ohio Senator Sherrod Brown

Has anyone seen/heard that compounding pharmacies can still make an FDA approved drug if it is deemed appropriate by the medical provider? Wonder if there is any truth to the claim. Sorry some of the references are taken out of context, didn't want to copy/paste the entire article, which is posted here.

The compounding pharmacies for now are striking a defiant pose. On March 14, the International Academy of Compounding Pharmacists issued a statement to patients and providers saying that, although many pharmacies had received a warning letter dated Feb. 17 from Ther-Rx that they could no longer compound an FDA-approved medication to which Ther-Rx had exclusive marketing rights, "In our estimation, the letter is nothing more than a ‘scare tactic.’ ... Pharmacists can legally compound FDA approved products when a prescriber determines that the compounded preparation is more clinically appropriate for an individual patient."

David G. Miller, R.Ph., the group’s chief executive, said in an e-mail that the answer to the question of whether 17P can legally be compounded, in light of an FDA-approved product with market exclusivity, was "clear and simple."

"If a prescriber determines that a compounded preparation of a medication is in the best clinical interest of his or her patient and discusses the available options with a pharmacist, there are no statutory or regulatory prohibitions on that professional decision," Mr. Miller said.

One criticism raised by Mr. Miller and others was that Makena had received FDA approval in part as a way to offer 17P with guaranteed consistency across the market. However, Ther-Rx’s parent company, KV Pharmaceutical Company, has recently faced legal trouble over active-ingredient inconsistencies and false labeling of its FDA-approved products.

Just last week, KV Pharmaceutical Company’s former chief executive pleaded guilty to breaching federal food and drug statutes by selling oversized morphine tablets.

Dr. Harman said he had no relevant financial disclosures.

more on March of Dimes

It keeps getting better! A friend pointed out this article on MOD's website today. Pay special attention to the "Who pays for the treatment?" question and their response. It can be expensive. Really?! Three days ago you wrote a mildly worded letter to KV expressing concern over the price increase and now you are publishing a write-up encouraging women to ask their doctors about it even though "it's expensive"??

And though it is nothing new, the eligibility requirements for who could benefit from the drug make me angry. I had a premature delivery while carrying multiples, but my insurance company approved the drug for my second pregnancy even though according to these guidelines I wouldn't benefit. The drug is supposedly not effective when pregnant with more than one child, as I guess it is assumed that women carrying multiples go into premature labor more frequently and with less provocation than with a singleton. If my OB had gone by those guidelines he would have assumed my first delivery was a fluke and done nothing preventative with Zoe. I had contractions with Zoe from about 20 weeks on, while on 17P and a terb pump. I can not say how much either of the drugs contributed to helping me make it to 36 weeks, but I would not have been willing to chance it. My concern is that insurance companies who are willing to pay for the drug will now use these guidelines more strictly to determine whose treatment they'll cover, and many women will miss out.

I have been angry with MOD over this whole thing, but I am done with them now. Other than posting on their facebook page and website they've made no public announcement taking a stand against this issue, and now the publishing of this article (which to me condones KV's behavior) has pushed me over the edge.

birthday girl!

Happy 1st birthday, Zoe! We love you baby girl!

March of Dimes and KV Pharmaceuticals

A couple posts ago I linked to an article about the recent FDA regulation of the progesterone/17P drug. This regulation has taken away compounding rights from pharmacies and bestowed them to one, single company (KV Pharmaceuticals), who subsequently increased the price from $10-$20 to upwards of $1,500 per dose even though this drug is well past the R&D stage and has been used for years. Instead of costing $200-$400, patients/insurance companies are now faced with a cost of $30,000 to treat a full-term pregnancy. March of Dimes was mentioned in the article as a supporter of the FDA ruling. How convenient that March of Dimes receives hundreds of thousands of dollars from Ther-Rx, a KV subsidiary. I'm not saying I believe March of Dimes condones this behavior (see here for a letter written by MOD to KV), or even supported the FDA ruling with ill intent. But clearly they've aligned themselves with a company and a purpose without giving full consideration to all possible eventualities of that support.

Please take the time to read this blog post. This woman sums it up quite nicely and it's worth the read. In her post she provides several ways to contact and voice opposition to this shady deal. Please consider that even if you've never directly benefited from this drug, the price increase does concern you because your insurance companies and/or government will ultimately pick up the tab. Even worse is the possibility that thousands of premature births, that previously were preventable, will now not be because it is cost prohibitive.

I'm still unbelievably disgusted. Especially with March of Dimes's connection. I've not gotten word yet on whether my insurance company has approved the shots this time around. But either way the problem is much larger than just me.

*Edited to add* that KV has created a patient assistance program that provides the drug at discounted or no cost for those who qualify. You can see their announcement here. While this is a step in the right direction, it still excludes many women. Who is crazy enough to think that any household making a penny more than $100k a year can afford to drop $30k on a single drug for pregnancy? I've also looked a bit more into the orphan drug status. This is a great article if you're interested in reading. I know there have been a lot of them in this post.

Thursday recap

Baby boy looked good on the ultrasound. I still get excited saying baby boy!

Cervix is still closed. I'm getting to the point I'm starting to freak out about everything so we went ahead and checked it.

OB wasn't yet aware the FDA-approved regulation of progesterone has caused a potential price spike of 75x - 100x per shot.

OB told me the FDA also recently banned the use of the terbutaline pump for preterm labor due to potential maternal heart problems and/or death. Nice!

No immediate alternative for the terbutaline, but progesterone is still planned to begin in two weeks (assuming no insurance issues).

We found a nanny! We met and had dinner with her and her husband tonight. She starts week after next.

anyone else seen this...?

I was browsing the news today and came across this article.

http://www.msnbc.msn.com/id/41994697/ns/health-pregnancy/

All I can say is wow! How ridiculous. In general I am always disturbed at the prices of medical procedures, drugs, etc. Luckily we have good insurance, but I still check EOBs to see the breakdown of how things are billed and paid. This drug is the progesterone/17P you hear pregnant women speak of. I had it weekly with Zoe from 20 weeks on. My insurance covered it then, so I'm curious to see how they'll respond now that the price has increased 75x. I'd like to think if they covered it before, and it is the only option, they can't very well refuse it only because of the price. But we'll find out soon because I am due to start it the week after next. I'm really disgusted and disturbed by this company and that there isn't a law against what they're doing.

it's a....

Zoe is movin' and groovin'! She is so stinking funny, always keeping us entertained. She is now walking with assistance, pushing anything she can get to move. There is now no hesitation when transitioning from standing to the floor, and she is also getting very brave when letting go from the surface she's holding onto to grab for something else. She's especially funny when she sticks her rear in the air, straightens her legs like she is going to stand, but can't figure out exactly what it is she wants to do.

And, finally! My mom instinct was right in regards to gender. With my first pregnancy we were so concerned about multiples that the gender thing didn't really figure much into the equation early on. I had lots of boy dreams, but it never occurred to me to imagine they'd both be boys. With Zoe I just knew she was a boy, but we were blessed with a little princess. From the day I found out I was pregnant this time I was completely certain of what this baby was. Even when my OB told us it looked like a girl at 15 weeks, I never doubted that we were expecting a little boy. And today there was no doubt. Our newest addition will be the youngest brother in our family. And we are so excited!

Not only did we find out we're expecting a new little guy, he looked great and I wont need to go back to the peri for 8 weeks. I went once a month with Zoe, most likely because of her kidney issue (sugar intake on my part), but I'll take once every two months. Though it was nice to get a full anatomy scan once a month I welcome the less frequent doctor's appointments.

it's been a while

Wow, I didn't realize it had been so long since I last posted. We've been busy around here doing things to the house and yard. Things that were planned prior to our little surprise and need to be completed before the baby gets here. Cody has been working really hard to get as much done as possible, and of course I am unable to contribute as much as I normally would so he's really picked up my slack.

Zoe is pulling up on everything and cruising along the furniture. She is an extremely busy little body. She's also starting to walk behind things which we're excited about, because for so long she kept her feet firmly planted to the floor and refused to lift them. Baby proof has an entirely different meaning in this house now, when every single day she discovers something I never would have thought she could get to. I can already tell we're going to have to establish a timeout corner with her name on it. She is a complete mess! My favorite thing she does these days is grab my finger to push the buttons on the her toys.

Our little man is doing well. He is very into crawling under and between things. Most times he tries to squeeze himself through an opening that is about half as wide as he is. He loves obstacles so we've been looking for something that would give him things to crawl through and over. I found this tunnel for cheap the other day at Target and he loves it. Just prior to snapping this picture he had crawled through to the end, turned onto his back, and was just lying there watching tv. We're continuing with the baclofen and we're really seeing a nice response. So far I can't say I've noticed any of the undesirable side effects, for which I'm thankful. I just hope they don't spring up on us at a later date. His hair is just like this. I promise. I couldn't make it do that on purpose if I tried. He desperately needs a haircut, but I'm dreading it because of the reaction we had last time so I've been putting it off.

In new baby news, everything with the polyp seems to be fine so far. I've been for several visits the last two weeks and the polyp and baby both look fine. No bleeding, save for very minor spotting, since it was treated. We'll continue to keep an eye on things and address anything as it may come. I go for my major anatomy scan next week with the peri and I'm very excited to find out what we're having. My OB tried the last two weeks to determine gender with no luck.

Cody called me yesterday morning after he got work, telling me they were asking him to go to Africa. And he'd be leaving in two days. At first I thought he was joking, but turns out he wasn't. We couldn't figure out a help situation on such short notice, I'm getting really close to lock down, and wasn't sure I'd feel comfortable toting and lifting two active kids by myself for a week and a half so he decided not to go. I really hate restricted activity. I am a very independent person for the most part and not being able to do what I want is driving me mad! We've already begun the search for a temporary nanny, so hopefully we'll be able to find someone good without too much trouble.