Makena Debuts, but at What Cost?

News of KV Pharmaceutical’s plan to sell Makena (hydroxyprogesterone caproate injection) at up to $1500 per injection is receiving some serious backlash. The drug-perhaps best known to physicians as 17P-has been used for years to prevent preterm deliveries. Before Makena’s FDA approval last month, 17P had an “orphan drug” designation; forms of the medication were custom-compounded in pharmacies, which were then provided to patients at a cost of around $10. 

Although KV Pharmaceutical hasn’t commented on Makena’s price tag, according to other blogs, the company previously cited the high costs of premature birth and the expense of winning FDA approval. In addition to other steps KV Pharmaceutical is taking in an effort to ensure patient access, Makena’s Web site currently outlines the company’s “Commitment to Patient Access to Therapy”:

“Ther-Rx Corporation is fully committed to helping ensure that every woman who needs Makena (hydroxyprogesterone caproate injection) will have access to it. We know how important Makena is to the thousands of mothers who are eligible for this therapy. We understand and share the public's interest in ensuring that every mother – whether insured or uninsured – who needs the medication will be able to access it in an affordable manner. That is why we recently announced a patient financial assistance program (PAP) that reduces the total out-of-pocket costs for qualified patients, and that eliminates out-of-pocket costs entirely for patients whose need is greatest. We appreciate the concerns expressed by multiple audiences, and are committed to working collaboratively with all interested parties to make this vital medication even more available and affordable to women across the country.”

(Ther-Rx is a branded marketing subsidiary of KV Pharmaceuticals.)

But this effort isn’t enough to appease physician groups and lawmakers. On Friday, the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists (the College), and the Society for Maternal-Fetal Medicine (SMFM) sent a letter to Scott E. Goedeke, SVP of Marketing for Ther-Rx, urging the company to reconsider Makena’s drug pricing as well as its plans for providing patient access and ensuring patient eligibility.

In the letter, the organizations highlight the impact of increasing treatment costs when considering that ideal treatment should begin at 16-18 weeks gestation and continue until 36 weeks:

“A woman will receive as many as 20 doses during her pregnancy at a cost of approximately $30,000. Frankly, in our current climate of controlling health care costs in the United States an added cost of $30,000 for as many as 140,000 pregnancies per year, or 4.2 billion dollars, is a staggering figure.”

In addition, the letter calls to attention some potential “gaps” in RV Pharmaceutical’s plan for providing adequate access to patients, which will offer financial assistance to insured patients with household incomes of up to $100,000 and assistance to uninsured patients with household incomes of up to $60,000:

“There are significant gaps in the number of pregnant women who could potentially benefit from this therapy yet may not receive it. Uninsured patients with an annual household income greater than $100,000 will not be eligible for the financial assistance package. Thus, at a cost of $30,000 per pregnancy these women will most likely not be able to afford Makena™. Women with high insurance deductibles may find it difficult to afford Makena™. Questions also exist about an insured patient’s out-of-pocket costs for the therapy.

[. . .]

Medicaid programs are crumbling financially. It is unclear whether state Medicaid programs, which cover the majority of these high-risk pregnancies, will be willing or able to pay for the cost of treatment. Further, it remains unclear how women who are undocumented immigrants will be treated under this program and whether these women will have adequate access to treatment.”

The letter also criticizes Makena Care Connection-an online resource created by the drug manufacturer that is designed to provide administrative support, patient financial support, and treatment support:

“AAP, the College and SMFM are concerned about the effectiveness and efficiency of the Makena™ Care Connection. AAP, the College and SMFM are worried that this will create a bureaucratic barrier for pregnant women receiving therapy in a timely and efficient manner. Low income woman who potentially can benefit from the financial assistance program are also among the most vulnerable of populations in the US and suffer from other barriers, including health literacy which would prevent them from accessing this program.”

On March 10, Senator Sherrod Brown (D-Ohio) addressed a letter to Greg Divis, CEO, KV Pharmaceutical, asking the company to “immediately reconsider” its pricing:

“I am gravely concerned that the exorbitant price increase your company plans to implement next week will increase rates of preterm birth nationwide. Fewer women will be able to afford the drug, health insurance companies could either stop coverage of the treatment or impose higher premiums on consumers, and state Medicaid programs-which are already struggling to make ends meet-will be forced to deal with the financial repercussions of your company’s decision.”

Do you think KV Pharmaceutical is justified in its pricing of Makena? What changes should the company make to improve patient access to the drug, if any? If you currently administer 17P treatments to patients, what’s your next move?