17P

Mamas on Bedrest: The War against Mamas and Babies wages on.

March 22nd, 2011

On February 4, 2011, the US Food and Drug Administration approved the use of 17 alpha OHP (Alpha Hydroxyprogesterone Caproate) injections for the prevention of preterm labor. We in the high risk pregnancy world were jumping for joy! 17P (the name by which the injections are often referred) have been long shown to prevent preterm labor in studies carried out by the National Institute of Child and Health Development and have been used for decades “off label”. Everyone from the March of Dimes to The American Congress of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP) and The Society of Maternal Fetal Medicine (SMFM) has recommended that the shots receive this particular indication. So yes, it was a great day when K-V Pharmaceutical Company and its subsidiary Ther-RX received the go-ahead from the FDA to market 17P injections as Makena for the treatment of preterm labor.

But our joy was very short lived. Immediately following approval from the FDA, K-V Pharmaceuticals jacked up the price of 17P injections from about $10 per shot to $1500 per shot. There has been no change to the formulation, no change to the method of administration and no change to how the medication acts once administered. The only change is that The FDA has given exclusive rights to K-V Pharmaceuticals and its subsidiary Ther-RX to market and distribute the 17P injections as Makena. Ther-RX has taken what was once a $150-$200 ($10 per injection for approximately 20 injections) treatment and turned it into a $30,000 treatment. Likewise, to date the drug is not covered my many insurance companies, so women who require the medication are required to pay for the drug out of pocket. KV Pharmaceuticals and Ther-RX have taken what is a lifesaving medication for thousands of unborn children and made it inaccessible to their mothers unless they can pay this “extortion” fee. Additionally, K-V Pharmaceuticals has launched a campaign against compounding pharmacies insisting that they “cease and desist” from compounding 17P.

The outrage surrounding this fleecing of the medical community in general and pregnant women in particular has been swift and fiery. Angela Davids who created and runs KeepEmCookin.com has been following the 17P debate and posting responses and resources in the news section of KeepEmcookin.com. These news items are truly worth reading because many of the leaders in the field of Maternal, child and Fetal Health have spoken out vehemently against the excessive rate hike and have demanded that Ther-RX change their pricing structure.  The Presidents of ACOG, AAP and SMFM got together and wrote a letter to the Sr. Vice President of Marketing for K-V Pharmaceuticals expressing their outrage. They are encouraging K-V Pharmaceuticals to re-evaluate their pricing structure and to consider making the cost of Makena affordable to the thousands of high risk pregnant women who need it. Dr. Jennifer Gunter has also been writing regularly about Makena on her blog on the Preemie Primer website.

While K-V Pharmaceuticals/Ther-RX  has not budged on its price, they have instituted an assistance program for those unable to afford Makena as part of their Makena Care Connection, a one stop resource for patients. Here is a summary of the program provided by KeepEmCookin.com.

The financial support program for Makena offers assistance to both uninsured and insured patients, and is based on income. According to K-V Pharmaceutical:

Insured patients with annual household incomes of up to $100,000 who apply for and are eligible for co-pay assistance will have a co-pay of $20 or less per injection for Makena.

Uninsured patients with annual household incomes of up to $60,000 who apply for and are eligible for patient assistance will receive Makena at no cost. Uninsured patients with annual household incomes between $60,000 and $100,000 will be able to acquire Makena at a cost that is comparable to the average co-pay assigned by commercial insurance plans.

Makena will not be carried by retail pharmacies. The prescription process for Makena will be managed by the Makena Care Connection, which is available by calling 1-800-847-3418 from 8 a.m. to 9 p.m. EST, Monday through Friday.

While the Makena Care Connection is a step in the right direction, it in no way atones for the unspeakable markup of 17P by K-V Pharmaceuticals and Ther-Rx. It is truly a shame that a proven therapeutic treatment is now being hoarded and meted out by a single, selfish source. Because of this price gouging, thousands of women who need 17P to maintain their pregnancies and have a chance at having a healthy full term baby will not receive the treatment that they need. For those of you that qualify for the Makena Care Connection, do apply for any and all assistance that is available to you. For those of you that don’t qualify and need Makena, know that there are many still fighting on your behalf. The battle wages on.

Mamas on Bedrest & Beyond is standing with Dr. Jennifer Gunter, ACOG, Oklahoma Physicians and compounding pharmacies in speaking out against KV-Pharmaceuticals. This company needs to know that their business practices are unacceptable and that citizens of the United States, and mamas in particular, won’t stand for it. If you need Makena and must get the prescription, we support you in your decision to do all that you can to have a healthy happy baby. But if this whole situation even remotely turns your stomach, please write a letter, a blog, sign a petition or even write a congressman, senator or the FDA to voice your opposition to K-V Pharmaceuticals.