A snapshot of all that is wrong with healthcare in America

If you've ever been to a neonatal intensive care unit (NICU), you know the pain, terror, hope, fear, grief and love that can be found there. This is where premature babies are nurtured and cared for, a place where you can find diapers the size of big bandaids, a place where medicine can work incredible miracles. Sometimes, it's a place where tiny babies take their first and last breath.

It's a place you hope you never have to be.

There is a drug that can help prevent premature birth. It's a progesterone shot administered weekly, and it's been used for years to help families stay out of the NICU.

In 2003, a study sponsored by the National Institute of Child Health and Human Development showed these weekly injections "resulted in a substantial reduction in the rate of recurrent preterm delivery among women who were at particularly high risk for preterm delivery and reduced the likelihood of several complications in their infants" (as reported in the New England Journal of Medicine.)

This week, the shot costs about $10 to $20 a dose. Next week, thanks to KV Pharmaceuticals and the FDA, a single dose will now cost $1500.

What happened?
Apparently, progesterone has been used successfully for years as an "off-label" drug, made on site at specialty pharmacies. Thus, this product - readily available to women who need it - had never been "branded." Until now.

KV Pharmaceuticals saw a great opportunity to enhance its bottom line by packaging up research done by others and submitting it to the FDA as a "new drug application," which the FDA approved. They're also conducting new research about the effectiveness of the product, but the FDA approved KV's NDA prior to the completion of the new research. Which means they're comfortable with the research to date showing the safety and efficacy of this drug.

With a "branded" product on the market - known as Makena - specialty pharmacies now must purchase progesterone shots - which they've been making for years - exclusively from KV Pharmaceuticals.

KV considers themselves the good guys. Here's their spin, from their press release:

“Prior to FDA approval of Makena, women who could benefit from therapy may have faced barriers to access due to the absence of a commercially-available, FDA-approved product,” said Greg Divis, Chief Executive Officer, K-V Pharmaceutical Company and President, Ther-Rx Corporation. “We established this comprehensive patient assistance program as part of our commitment to ensure that all eligible women have access to FDA-approved Makena.”

Their patient assistance program lets insured patients with incomes up to $100,000 pay only a $20 copay for the product. Uninsured patients with incomes up to $60,000 get it for free, and uninsured patients with incomes between $60,000 and $100,000 get it for the cost of the copay.

So the patient pays only $20 or so a dose (unless they make more than $100k!) But SOMEONE has to pay for the rest of the cost of this product. That would be the health insurance companies. And how do they pass on rising costs? By having their customers (patients) pay more in premiums.

The whole thing is a disaster. Slapping a brand name onto a commonly used product to justify an astronomical price increase is a terrible way to address a significant health care challenge.

It's been a busy news week for KV Pharmaceuticals, who also saw their former CEO plead guilty to two federal charges of misbranding drugs...

Some links...

KV Pharmaceutical press release on the "patient assistance program" it has in place for people who need financial help obtaining KV's very expensive progesterone shots to prevent premature pregancy.

NEJM article on the 2003 study

Mayo Clinic article on preterm pregnancy, including mention of progesterone shots to prevent premature delivery

The FDA's press release

WSJ story on Makena