Premature labor drug spikes from $10 to $1,500

[marjar]

ATLANTA — The price of preventing preterm labor is about to go through the roof.

A drug for high-risk pregnant women has cost about $10 to $20 per injection. Next week, the price shoots up to $1,500 a dose, meaning the total cost during a pregnancy could be as much as $30,000.

That's because the drug, a form of progesterone given as a weekly shot, has been made cheaply for years, mixed in special pharmacies that custom-compound treatments that are not federally approved.

But recently, KV Pharmaceutical of suburban St.Louis won government approval to exclusively sell the drug, known as Makena (Mah-KEE'-Nah). The March of Dimes and many obstetricians supported that because it means quality will be more consistent and it will be easier to get.

None of them anticipated the dramatic price hike, though — especially since most of the cost for development and research was shouldered by others in the past.

"That's a huge increase for something that can't be costing them that much to make. For crying out loud, this is about making money," said Dr. Roger Snow, deputy medical director for Massachusetts' Medicaid program.

"I've never seen anything as outrageous as this," said Dr. Arnold Cohen, an obstetrician at Albert Einstein Medical Center in Philadelphia.

"I'm breathless," said Dr. Joanne Armstrong, the head of women's health for Aetna, the Hartford-based national health insurer.

Doctors say the price hike may deter low-income women from getting the drug, leading to more premature births. And it will certainly be a huge financial burden for health insurance companies and government programs that have been paying for it.

The cost is justified to avoid the mental and physical disabilities that can come with very premature births, said KV Pharmaceutical chief executive Gregory J. Divis Jr. The cost of care for a preemie is estimated at $51,000 in the first year alone.

"Makena can help offset some of those costs," Divis told The Associated Press. "These moms deserve the opportunity to have the benefits of an FDA-approved Makena."

The U.S. Food and Drug Administration is not involved in setting the price for the drugs it approves.

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

[ed1066]

But recently, KV Pharmaceutical of suburban St.Louis won government approval to exclusively sell the drug, known as Makena (Mah-KEE'-Nah). The March of Dimes and many obstetricians supported that because it means quality will be more consistent and it will be easier to get.

None of them anticipated the dramatic price hike, though — especially since most of the cost for development and research was shouldered by others in the past.

This is a perfect example of the Law of Unintended Consequences at work when the government gets involved in what should be a free market determination...if the government didn't stick it's nose in and grant "exclusivity" to a single supplier, the price would have continued to be set by a competitive market. Turn it into a monopoly, as the government just did, and this is the result...

[marjar]

Unreal.

[Angel!]

Well, the company spent hundreds of millions of dollars in research & the article also says The Ther-Rx patient assistance program promises free injections or much reduced prices based on income. Uninsured households making less than $100,000 are eligible for a copay of $20 or less.

Personally I would prefer a drug that has gone through rigorous testing & is made by a pharmaceutical company. A fairly untested drug mixed in a compounding pharmacy could easily be screwed up.

[mmhmm]

None of them anticipated the dramatic price hike, though — especially since most of the cost for development and research was shouldered by others in the past.

This is pure greed.

[The Walk of the Penguin Mich]

Quality control is expensive and that's what they're paying for. I'd be curious as to how effective the compounded drug was, since there were no standards in place.

[marjar]

This is not a case in which a company spent millions and millions of dollars developing a new drug. They took a variation of an old drug, that was being used for this purpose, and did efficacy and safety trials on it. In essence, they borrowed the work of others and ran with it. I don't see how that justifies the cost of this drug and I see the potential for ramifications with insurance issues and women at risk for pre-term labor.

[jkapp]

Mar 9, 2011 21:13:01 GMT -5 @marjar said:

This is not a case in which a company spent millions and millions of dollars developing a new drug. They took a variation of an old drug, that was being used for this purpose, and did efficacy and safety trials on it. In essence, they borrowed the work of others and ran with it. I don't see how that justifies the cost of this drug and I see the potential for ramifications with insurance issues and women at risk for pre-term labor.

The justification is that the government just gave them exclusive rights to sell it...undercutting the open market tends to do that.

[mmhmm]

KV is a relatively small pharmaceutical company with two subsidiaries. One specializes in the production of generics. I know they make Micro-K, an extended release potassium supplement. Not sure what else they make. Don't remember the name of the other subsidiary. However, they already have quality control departments in place, as they have to have it to produce Micro-K. The second subsidiary would have its own quality control department. It's not like they're starting from the ground up. Adding a product wouldn't have a massive effect on quality control.

[mmhmm]

www.stltoday.com/business/local/article_5c9f1174-3076-11e0-8d79-0017a4a78c22.html

Interesting article on this matter. There is no indication that the generic version, 17P, will be discontinued. It will be up to the prescribers whether they use the generic they've been using, or turn to the brand name produced by KV. Apparently, KV has been struggling.

[Mad Dawg Wiccan]

The exclusive patent rights on ANY FDA approved drug is only good for five years, and then generics can apply for permission to manufacture it. Generics only have to prove that their product is equal in quality, safety, and efficacy to the branded drug. The real way to decrease the costs of "branded" drugs is to increase the patent time limit on them.

[mmhmm]

This drug, however, has been being marketed as 17P, Wiccan. It's been available in that generic form, but wasn't branded by any particular pharmaceutical company. Now that KV has the open door to produce a branded version, we'll have to see what the medical community does with it considering the eye-blasting rise in price. I didn't read anything that suggested the previously produced 17P would no longer be available. I will keep looking, though.

[Mad Dawg Wiccan]

Mar 9, 2011 21:43:20 GMT -5 mmhmm said:

This drug, however, has been being marketed as 17P, Wiccan. It's been available in that generic form, but wasn't branded by any particular pharmaceutical company. Now that KV has the open door to produce a branded version, we'll have to see what the medical community does with it considering the eye-blasting rise in price. I didn't read anything that suggested the previously produced 17P would no longer be available. I will keep looking, though.

Being compounded by a pharmacy isn't the same thing as a generic produced by a pharmaceutical manufacturer in the eyes of the FDA.

[marjar]

I think it is 7years for patent rights, Dawg.

[mmhmm]

Mar 9, 2011 21:47:54 GMT -5 Mad Dawg Wiccan said:

Mar 9, 2011 21:43:20 GMT -5 mmhmm said:

This drug, however, has been being marketed as 17P, Wiccan. It's been available in that generic form, but wasn't branded by any particular pharmaceutical company. Now that KV has the open door to produce a branded version, we'll have to see what the medical community does with it considering the eye-blasting rise in price. I didn't read anything that suggested the previously produced 17P would no longer be available. I will keep looking, though.

I'm aware, Wiccan; however, 17P has been being used to date. Some may choose to continue with it rather than absorb that phenomenal price jump.


Being compounded by a pharmacy isn't the same thing as a generic produced by a pharmaceutical manufacturer in the eyes of the FDA.

I'm aware, Wiccan; however, 17P has been being used to date. Some may choose to continue with it rather than absorb that phenomenal price jump.

[marjar]

It's going to be the FDA approval that is the stickler.

[mmhmm]

It's been sold without FDA approval to date, Marjar. It will be interesting to see if it's continued, or if only the brand name will be available ... which is certainly a possibility. Mommas and babies, and all related, ain't my field, thankfully! ;D

[Mad Dawg Wiccan]

Mar 9, 2011 21:56:04 GMT -5 @marjar said:

I think it is 7years for patent rights, Dawg.

Nope, just five. The branded manufacturer can apply for an extension, but they are rarely granted.

[marjar]

Mar 9, 2011 22:39:32 GMT -5 Mad Dawg Wiccan said:

Mar 9, 2011 21:56:04 GMT -5 @marjar said:

I think it is 7years for patent rights, Dawg.

Nope, just five. The branded manufacturer can apply for an extension, but they are rarely granted.

Okay.